cyrilzakka/clinical-trials huggingface dataset:
Naproxen Sodium ER Pharmacokinetic Study

To determine the pharmacokinetic profile of the investigational product following dosing under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy ambulatory, male and female volunteers between 18-55 years of age with a Body Mass Index (BMI) of approximately 18 to 30kg/m2, and a total body weight \>50 kg (110 lbs)
* Results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the principal Investigator and the Sponsor
* Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g oral or patch contraceptives, intrauterine device, NuvaRing, Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and Day 0 of each Dosing Period. Female subjects of non childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy
* Be willing and able to participate in all scheduled visits, treatment plan, laboratory tests and other trial procedures according to the protocol
* Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial

Exclusion Criteria:

* History of hypersensitivity to aspirin (ASA), naproxen sodium, or acetaminophen, and similar pharmacological agents or components of the products
* History of gastrointestinal bleeding or perforation, related to previous nonsteroidal anti-inflammatory drug (NSAID) therapy. Active, or history of recurrent peptic ulcer/ hemorrhage (two or more distinct episodes of proven ulceration or bleeding)
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases or malignancies
* Have taken ASA, ASA-containing products, acetaminophen (acetyl-para-amino-phenol or APAP) or any other NSAID (Over the counter (OTC) or prescription) 7 days prior to dosing or during the treatment period, other than trial treatment
* Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (e.g., nicotine patch, nicotine gum)
* Have taken any vitamin or herbal supplement within 7 days prior to dosing or refuse to refrain from use during the trial
* Alcoholism or drug abuse within 2 years prior to the Screening Visit
* Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit
Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain

The study will provide information to assess the benefits versus risks of extended exposure to oxycodone HCl and naltrexone HCl extended-release capsules in a chronic noncancer pain population.


Eligibility Criteria:
Inclusion Criteria:

* Subject has moderate to severe chronic noncancer pain (duration of at least 3 months) requiring a continuous around-the-clock opioid analgesic for an extended period of time. Conditions may include, but are not limited to, osteoarthritis, chronic low back pain, or other opioid -responsive pain conditions.
* Subject agrees to refrain from taking opioid medications other than study drug during the study. (The exception is during the Pre-Treatment Period when the subject may continue current opioid therapy to guide first 4 weeks of the Treatment Period when the subject may administer immediate-release oxycodone to support conversion to study drug.)

Exclusion Criteria:

* Subject has moderate or severe chronic pain due to cancer, migraine, recent trauma, infection, or other pain expected to be short-term (duration less than 3 months).
* Subject has a documented history of alcohol or drug abuse within 1 year prior to study entry that in the Investigator's judgment would impact subject participation.
* Subject has ongoing or active alcohol or drug abuse that in the Investigator's judgment would impact subject participation.
* Subject has a positive urine drug test for illicit drug use or medications at screening without legitimate medical explanation.
* Subject has a clinically significant medical condition (e.g., cardiovascular, neurological, renal, hepatic, pulmonary, gastrointestinal, endocrine, hematological, immunological, rheumatological, metabolic, or psychiatric) or physical examination, vital signs (VS), 12-lead electrocardiogram (ECG), clinical laboratory abnormalities that in the opinion of the Investigator would impact the safety of the subject during study participation.
* If female, the subject is pregnant or breast-feeding.
* Subject has a known history or known hypersensitivity to oxycodone, oxycodone salts, naltrexone or acetaminophen,or pharmacological similar compounds.
* Subject is historically non-responsive to oxycodone treatment or requires greater than 160 mg oxycodone in a 24-hour time interval.
Effect of Extracorporeal Shock Wave Therapy (ESWT) and Phonophoresis Treatment in Patients With Lateral Epicondylitis

This study aimed to investigate the effects of Extracorporeal Shock Wave Therapy and phonophoresis treatment on pain, function, hand grip strength and tendon thickness in ultrasonography in patients with lateral epicondylitis.

Lateral epicondylitis (LE) is tendinopathy of the forearm extensor muscles, often caused by overuse or repetitive use, forced wrist extension, or direct trauma to the epicondyle. It is the most common cause of lateral elbow pain. Although also known as tennis elbow, lateral epicondylitis often develops as a work-related condition and is therefore a significant public health problem.

ESWT; It involves transmitting high-intensity acoustic pressure waves produced by electrohydraulic, electromagnetic or piezoelectric devices to the target area of the body in a short time through the gel. It has been reported that ESWT increases collagen synthesis in tendons, bones and other soft tissues, accelerates vascularization and reduces pain.

ultrasound; It has been used for many years in the treatment of musculoskeletal disorders such as tendinitis, epicondylitis, tenosynovitis, bursitis and osteoarthritis. It produces acoustic waves through the conversion of electrical energy. These waves turn into heat as they pass through tissues at different resistance levels. Ultrasound is also used to enhance percutaneous absorption of drugs in phonophoresis applications.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18-65
* Those who signed the informed consent form
* Painful palpation of the lateral epicondyle
* Positive Mill\&#39;s, Maudsley\&#39;s and Cozen\&#39;s tests
* Patients who have had complaints for at least 3 months

Exclusion Criteria:

* Those who have had corticosteroid, PRP, prolotherapy, hyaluronic acid etc. injections into the elbow area within 3 months or those who have received physical therapy
* Those with cervical radiculopathy
* Those who have had surgery on the elbow
* Those with an open wound on the elbow
* Those with a history of malignancy
* Those with rheumatological diseases
* Those with neurological diseases
* Pregnancy
* Infection
Long Term Safety and Tolerability Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

The objective of this study is to evaluate the long-term effects and tolerability of ABT-089 in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).


Eligibility Criteria:
Inclusion Criteria:

* The subject was randomized into Study M10-346 and completed the study.
* Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements.
* Male subjects must agree to comply with applicable contraceptive requirements.
* The subject is judged to be in generally good health.

Exclusion Criteria:

* The subject has taken any ADHD medication between the last dose of study drug in Study M10-346 and the first dose of study drug in the current study.
* The subject anticipates a move outside the geographic area.
Comparative Study of Gene-activated Bone Substitute and Xenogenic Bone Matrix in Alveolar Ridge Augmentation

The study aim is to compare the effectiveness of two bone substitutes, the gene-activated bone substitute based on octacalcium phosphate and plasmid DNA encoding VEGFA gene and xemogenic deproteinized bone matrix, mixed with shredded autobone in vertical and horizontal augmentation of alveolar ridge before dental implantation

An open-label randomized controlled clinical trial, two cohort. Patients who met the inclusion criteria is planned to be enrolled into the trial. On enrollment, all patients will have screening, a set of clinical examination, instrumental investigations and laboratory tests, including dental CT of the affected jaw with the assessment of alveolar ridge width and height.

All patients enrolled in the study will be subjected to guided bone regeneration surgery of the upper or lower jaw with the use of investigational bone substitutes mixed with shredded autobone harvested during the surgery. If the height of alveolar ridge needs to be augmented, the non-resorbed systems for granular material fixation will be used.

The clinical study results will be evaluated at the time points of 1, 2, 10, 30, 90, and 180 days with clinical examination, instrumental investigations and laboratory tests. A control dental CT will be carried out before dental implantation for the primary outcome measure, at 180 days after surgery. The clinical trial completion date is the day of the second surgery, a dental implant placement. During the procedure, trephine biopsy samples will be harvested from the bone grafting area addressing the secondary outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* partial or full edentulism;
* alveolar ridge atrophy and defects preventing from dental implant placement;
* obtained voluntary informed consent for participation in the clinical study

Exclusion Criteria:

* disability or unwillingness to give a voluntary informed consent or follow requirements of the clinical trial;
* plaque index (PI) score \> 15%;
* gingival sulcus bleeding index (SBI) \> 10%
* decompensated chronic diseases;
* alcohol addiction;
* a history of drug addiction;
* a history of medication with drugs affecting bone tissue metabolism;
* participation in other clinical trials (or the administration of investigational products) within 3 months prior to the study;
* conditions limiting study compliance (e.g., dementia, psycho-neurological diseases, drug addiction, and alcoholism);
* pregnancy or lactation
Innovative Stratification of Arrhythmic Risk (ISAR-Trial): Diabetes Mellitus

The purpose of this study was to evaluate the performance of established and new risk predictors in predicting mortality in post-infarction patients suffering from diabetes mellitus


Eligibility Criteria:
Inclusion Criteria:

acute myocardial infarction, presence of sinusrhythm

Exclusion Criteria:

-
The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea

This study is an exploratory, multicenter study of up to 300 subjects diagnosed with obstructive sleep apnea who are being evaluated for airway surgery. Subjects will undergo standard evaluation for airway surgery as part of standard of care. In addition to the standard airway assessment, a simple, non-invasive measurement of the width of the inside of each subjects mouth will be performed. This measurement takes 2-3 minutes to perform.

The objective of the study is to determine whether pharyngeal width (inside of the mouth) is an appropriate measurement to predict absence of complete concentric collapse (CCC) at the soft palate

Eligibility Criteria:
Inclusion Criteria:

* Patient meets the indications for the Inspire Upper Airway Stimulation
* Patient is being evaluated by drug-induced sleep endoscopy as standard-of-care diagnostic for OSA surgery.

Exclusion Criteria:

* Patient is unable to lie supine for 2-3 minutes in order to undergo airway measurement
* Any other reason the investigator deems that the patient is unfit for participation in the study.
The Influence of PRN Dry Eye Omega-3 Nutritional Regimen on Tear Osmolarity In Cases Of Dry Eye Disease

The investigators hypothesize that oral omega-3-acid triglyceride form will decrease dry-eye related symptoms as well as clinical markers associated with dry eye disease (TearOsmolarity, Schirmer-1 test values, corneal staining, and fluorescein tear break-up time) when compared to administration of placebo.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and ≤ 90 at the time of informed consent
* Subjects experiencing dry eye based on a global clinical assessment by the attending clinician, subject complaint of dry eye symptoms
* Presence or History of Tear Osmolarity (Appendix 2) equal to or greater than 312 mOsm/L in at least one eye
* Presence or History of Meibomian Gland Dysfunction (Grade 1 or 2) in at least one eye

Exclusion Criteria:

* Allergy to fish oil or safflower oil
* Clinically significant eyelid deformity or eyelid movement disorder that is caused by conditions such as notch deformity, incomplete lid closure, entropion, ectropion, hordeola or chalazia
* Previous ocular disease leaving sequelae or requiring current topical eye therapy other than for DED, including, but not limited to: active corneal or conjunctival infection of the eye and ocular surface scarring Active ocular or nasal allergy
* LASIK or PRK surgery that was performed within one year of the Screening Visit or at any time during the study
* Ophthalmologic drop use within 2 hours of any study visits. Any OTC habitual artificial tear should be continued at the same frequency and no change in drop brand
* Contact lens wear within 12 hours of any study visits
* Pregnancy or lactation during the study
* Abnormal nasolacrimal drainage (by history)
* Punctal cauterization or punctal plug placement within 60 days of screening
* Prohibited Medications - Cyclosporine (Restasis®); any topical prescription medications (i.e., steroids, NSAIDs, etc); glaucoma medications; oral tetracyclines or topical macrolides; oral nutraceuticals (flax, black currant seed oils, etc...) within 3 weeks (21 days) of Screening and at any time during the study
Personalized Nutrition Therapy Using Continuous Glucose Monitoring to Improve Outcomes in Type 2 Diabetes Mellitus

Nutrition guidelines state that multiple eating patterns are effective for type 2 diabetes and that therapy should be individualized. Yet many nutrition plans fail to account for interpersonal variability in blood glucose response to meals. This diminishes the ability of dietary interventions to optimize glycemic control and may lessen patient satisfaction, self--efficacy, and adherence. Continuous glucose monitoring (CGM) can facilitate behavior change in type 2 diabetes and has been associated with improved outcomes in nutrition intervention studies; this literature is limited by small study sample sizes and heterogeneity of study design and outcomes, and more data are needed. CGM could be a powerful tool for adapting a nutrition plan based on blood glucose response at an individual level. This study will test the use of CGM to personalize nutrition therapy compared to nutrition therapy alone (without CGM) for participants with type 2 diabetes who are not meeting glycemic treatment goals.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Have a previous diagnosis of type 2 diabetes
* HbA1c of 7.0 - 9.5%
* Stable medications for diabetes for at least 3 months prior to enrollment, with no plans to change medications or doses during the intervention period.

Exclusion Criteria:

* Type 1 diabetes
* Treatment with insulin, sulfonylurea, or meglitinide
* Use of a nondiabetic medication affecting blood glucose (e.g. corticosteroid)
* BMI \<25 kg/m2
* Weight change \&gt;5 pounds in the 3 months prior to enrollment
* Estimated glomerular filtration rate \&lt;60 ml/minute/1.73 m2
* Pregnant or breastfeeding
* Anemia (which affects HbA1c)
* Presence of any disease that would make adherence to the protocol difficult
Pulp Capping in Primary Molars Using TheraCal (LC)

A randomized clinical trial that aims to evaluate clinical and radiographic success rates of indirect pulp capping and direct pulp capping in primary molars with reversible pulpitis using a light-cured tri-calcium silicate base material (TheraCal (LC)).

Participating primary molars will be randomly allocated to one of the following groups: Indirect pulp capping group or Direct pulp capping group. A light-cured tri-calcium silicate base material (TheraCal (LC) ) will be used in the two groups as a dressing material. Patients will be recruited from the outpatient clinic of the pediatric dentistry department, Faculty of Dentistry Ain Shams University. The participant will be recalled for follow-up assessments at 3, 6,9, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 4-7 years.
2. Free medical history.
3. Complete physical and mental health.
4. Patient cooperation
5. restorable mandibular primary molars

Exclusion Criteria:

1. Clinical symptoms or irreversible pulpitis as (spontaneous pain, throbbing pain)
2. Soft tissue swelling, draining fistula or sinus tracts.
3. Tenderness to percussion.
4. Pathological Tooth mobility.
5. Widening of periodontal membrane space
Exploring Novel Diagnostic Tools for Periprosthetic Joint Infection

Joint replacement is a valuable surgical intervention that improves quality of life, provides pain relief, and restores function of patients. However, some patients need revision surgery due to failure of the implant, with periprosthetic joint infection (PJI) remaining a rare but serious complication following total hip (THA) and knee (TKA) arthroplasty. Diagnosing PJI is a major challenge as no diagnostic test with absolute accuracy exists. The diagnosis is based on a combination of clinical findings, laboratory results from peripheral blood and synovial fluid, microbiological culture, histological evaluation of periprosthetic tissue, and intraoperative findings. However, the preoperative diagnosis can be inconclusive and operative criteria are required for the definitive diagnosis. Therefore, novel diagnosing tools for identification of PJI are necessary.

A recent study using a gene reporter assay, identified biomarkers in synovial fluid that define joint states in patients with osteoarthritis.However, no previous studies have investigated cellular signaling in synovial fluid of patients with PJI. With this study we want to explore the potential of a reporter gene assay of synovial fluid in patients with PJI and without PJI of their TKA and THA.

Also, flow cytometry analysis of biological fluids has recently received increased attention as a potentially valuable method in diagnosing infections. For example, the method is already used to analyze urine samples for urinary tract infections. Recently, researchers have now also used this method to screen for the presence of bacteria. The most important limitation of flow cytometry analysis of synovial fluids for bacteria to date is that it is unclear as to which bacteria count value - the cutoff value - represent patients with PJI and which represent patients without PJI. With this study we want to explore the potential of flow cytometry analysis of synovial fluid in categorizing patients with PJI and without PJI.

Our primary objective is to explore the value of synovial fluid analysis using a reporter gene assay and flow cytometry in the detection of a periprosthetic joint infection.


Eligibility Criteria:
Inclusion Criteria:

* All patients planned for elective THA or TKA revision surgery with revision of one or more fixed components will be eligible to participate in this study.

Exclusion Criteria:

* are planned for a revision of single mobile parts only;
* have received intravenous and/or oral antibiotics within 2 weeks before the diagnostic workup and/or surgery;
* are unable to provide their consent for use of their human tissues for medical research.
Evaluation of 89Zr-TLX250 PET/CT in Chinese Patients With Indeterminate Renal Masses or Suspected Recurrent Renal Clear Cell Carcinoma

The study is designed to evaluate the safety, tolerability, radiation dosimetry and pharmacokinetics 89Zr-TLX250 (also known as 89Zr-DFO-girentuximab) Positron Emission Tomography/Computed Tomography (PET/CT) in adult Chinese patients with indeterminate renal masses or Suspected Recurrent Renal Clear Cell Carcinoma


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily signed written informed consent
2. Chinese male or female≥18 years old.
3. Have an indeterminate renal mass, suspected renal cell carcinoma, or previously diagnosed ccRCC, suspected recurrence on the pre-screening imaging from Day -90 to Day -1
4. Negative serum pregnancy test for female subjects of childbearing potential at screening. Confirmed negative urine pregnancy test within 24 hours prior to administration of investigational product.
5. Expected survival ≥ 6 months.
6. Agree to follow appropriate and highly effective contraception method for at least 35 days after the administration of 89Zr-TLX250.

Exclusion Criteria:

1. Renal mass is known to be a metastasis of another primary tumor.
2. Have other malignancies that require treatment.
3. Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging).
4. Have received chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the planned administration of 89Zr-TLX250 or such therapy resulted in a persistent adverse event (\> Grade 1) (per National Cancer Institute-Common Toxicity Criteria version 5.0 \[NCICTCAE v5.0\]).
5. Exposure to murine or chimeric antibodies within the last 5 years.
6. Prior use of radionuclides with an interval of less than 10 halflives.
7. Exposure to any investigational diagnostic or therapeutic agent within the first 4 weeks or 5 half-lives (whichever is longer) of the planned administration of 89Zr-TLX250.
8. Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 mL/min/1.73 m².
9. Uncontrolled psychiatric disorders.
10. Women who are pregnant or breastfeeding.
11. Known hypersensitivity to girentuximab or DFO (deferoxamine).
12. Have a serious non-malignant disease (e.g., infectious disease, autoimmune disease, or metabolic disease) that, in the opinion of the investigator, may interfere with the purpose of the study or subject safety or compliance.
13. Vulnerable population (e.g., being in detention).