cyrilzakka/clinical-trials huggingface dataset:
Evaluation of 41 Cases of Pediatric Granuloma Annulare

INTRODUCTION: Granuloma annulare is a non-infectious, granulomatous disease that can affect children and adults. Although there are many studies examining adult patients, there are limited studies examining pediatric granuloma annulare cases. It is aimed to examine the demographic, clinical, and pathological features of pediatric granuloma annulare cases in this study.

MATERIALS and METHODS: This study was performed retrospectively in a single-center, tertiary dermatology hospital. Forty-one patients, under the age of 18 who were admitted to the dermatology outpatient clinic between 2008-2021 and diagnosed with granuloma annulare were scanned from the hospital database and patient photograph archive. Demographic characteristics, and clinical and histopathological features were evaluated.

Granuloma annulare; is a non-infectious, granulomatous skin reaction with potential triggers that can affect the adult and pediatric age group. Diabetes mellitus, hyperlipidemia, and malignancy have been described in association with adult granuloma annulare cases. While there are studies on the clinical, pathological features and associated diseases in patients with adult granuloma annulare, a limited number of studies have been conducted on pediatric granuloma annulare patients. Therefore, clinical and histopathological evaluation of pediatric granuloma annulare cases was planned in our study.

This study was performed retrospectively in a single-center tertiary dermatology hospital. Patients under the age of 18 who were admitted to the dermatology outpatient clinic between 2008-2021 and diagnosed with granuloma annulare were scanned from the hospital database and patient photograph archive. Cases with uncertain diagnosis were not included in the study. Cases with dermatological findings recorded in detail and/or diagnosed histopathologically were included in the study. Demographic features, lesion localization, lesion characteristics (size, elementary lesion, color), involvement (localized/generalized), histopathological features, concomitant diseases, differential diagnoses in cases with histopathology, regression time and recommended treatments were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Being under 18 years old
* Having granuloma annulare
* Applying to the Istanbul Training and Research Hospital, Dermatology Outpatient Clinic between 2008-2021
* Consenting to participate in the study

Exclusion Criteria:

-Being over 18 years old
Sodium Nitrite to Treat Arterial Aging

The proposed research will determine the effectiveness of nitrite, a naturally occurring compound in the body, for improving the health and function of arteries in middle-aged and older adults. The study also will provide insight into how sodium nitrite therapy improves artery health by determining the physiological mechanisms (biological reasons) involved. Overall, the proposed research will provide important new scientific evidence on the effectiveness of sodium nitrite for decreasing the risk of developing cardiovascular diseases with aging.

The improvement in blood vessel function and stiffness will be determined over a 10 week period. Subjects will be randomly assigned to either placebo (0 mg/day), low dose (80 mg/day) or high dose (160 mg/day) sodium nitrite. Main outcome measures will be performed at baseline and week 10.

Eligibility Criteria:
Inclusion Criteria:

* 50-79 years of age
* Ability to provide informed consent
* Score greater than 22 on the mini mental state exam
* Blood pressure greater than 100/60 mmHg for past 3 months

Exclusion Criteria:

* Are taking any of the following medications/drugs: hormone replacement therapy, anti-hypertensives, nitrates, nervous system depressants, allopurinol, phosphodiesterase-5 inhibitors, blood thinners
* Are currently sick/have chronic clinical diseases such as kidney disease, diabetes, or unstable cardiovascular disease
* Are hypersensitive to nitrates or nitrites
* Have glucose-6-phosphate dehydrogenase deficiency
* Have blood methemoglobin greater than 2%
* Have a BMI greater than 40 kg/m\^2
* Have a baseline FMD of greater than 6%
* Have not been post-menopausal for at least 1 year
* Perform regular vigorous aerobic/endurance exercise
Glycemic Response of Sorghum

Given the interest in gluten-free foods and discovering dietary means to prevent metabolic disorders, this study was designed to determine the glycemic responses of four (4) grains and flours (corn, rice, wheat, and sorghum). The grain products (gruel) will be eaten by subjects and blood glucose will be collected prior to and after eating over the course of two hours. A dextrose solution, dosed to provide a like amount of available carbohydrate, will serve as the control treatment.

Gruel was formed via a 1:9 ratio of grain (30 g) to water (270 ml) and cooked until thickened by placing water and grain mixture in a beaker and placed in a hot water bath (cooked over a stove/heating unit). The gruel was allowed to cool for 3-5 minutes before eating. The consistency of the gruel was similar to oatmeal. Subjects had a resting blood sample collected for assessment of fasting blood glucose, then ate the gruel (or control sucrose, 22g) that was assigned for that day -- they returned for the other gruel meals or sucrose control determined by Latin Square randomization. Finger stick blood samples where then collected at 30, 60, 90, and 120 minutes after eating the gruel (or sucrose) began.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy with no known diseases

Exclusion Criteria:

* Known metabolic, cancer, cardiovascular disease/condition
Preference and Goal Directed Attention Deficit Hyperactivity Disorder Care- Pilot Study

This pilot intervention study will test the feasibility and acceptability and explore the outcomes of an urban, primary care-based intervention to measure families' preferences and goals for Attention-Deficit/Hyperactivity Disorder (ADHD) treatment and structure clinical care to reach these goals.

The intervention includes provision of enhanced, culturally appropriate education about ADHD and its treatment, completion of a validated preference and goal instrument, use of this instrument in the ADHD treatment decision-making process, and tracking of preferences and goals over time.

Eligibility Criteria:
Inclusion Criteria:

* All interested non-trainee clinicians at study sites
* Parents/legal guardians of children age 6-12, in K-6 grade, diagnosed with ADHD.

Exclusion Criteria:

* child diagnosed with autism or a psychotic disorder
* parents non-English speaking
* parents unable to provide consent
* pediatric residents
A Post-Market Clinical Evaluation of the ReUnion TSA System

This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of one hundred (100) subjects will be enrolled at approximately 4-7 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty subjects, which entails clinical evaluation on a regular ongoing basis, or as needed should the subject become symptomatic in the treated joint.

The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the ReUnion TSA System. Efficacy/performance of the procedure will be measured the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Safety of the ReUnion TSA System will be demonstrated through reporting of device-related intra-operative and post-operative Adverse Events (AEs). Enrolled subjects will be assessed at Pre-Operative, Operative/Discharge, and at 6 Weeks, 6 Months, 12 Months, 24 Months and annually thereafter up to 10 years following the index procedure.

Eligibility Criteria:
Inclusion Criteria:

* Subject is willing to sign the informed consent.
* Subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.
* Subject is male or non-pregnant female and 18 years or older at the time of surgery.
* Subject has one or more of the following:

  * Aseptic necrosis of the humeral head
  * Painful, disabling joint disease of the shoulder resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis
  * Failed previous total shoulder replacement, resurfacing or other procedure

Exclusion Criteria:

* Subject has an active or suspected latent infection in or about the shoulder joint.
* Subject has mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in postoperative care.
* Subject has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
* Subject has anticipated activities which would impose high stresses on the prosthesis and its fixation.
* Subject is obese such that he/she produces a load on the prosthesis which can lead to failure of fixation of the device or to failure of the device itself.
* Subject has absent, irreparable or non-functioning rotator cuff and other essential muscles.
* Subject has concomitant disease(s) which may significantly affect the clinical outcome.
* Subject has traumatic or pathologic fracture of the proximal humerus.
Evaluation of ColdZyme® Mouth Spray on Prevention and Alleviation of Rhinovirus Induced Common Cold

This study evaluates the performance of ColdZyme® mouth spray on prevention and alleviation of induced rhinovirus upper respiratory tract infection in healthy volunteers. Half of participants will receive ColdZyme® mouth spray while the other half will receive placebo.

Common colds can be caused by a number of viruses, e.g. rhinoviruses, coronaviruses, influenza viruses and others. The majority of colds are however caused by rhinovirus infection, which is responsible for up to 80% of all common colds. This study evaluates the effect of creating a physical barrier on the pharyngeal mucosal membrane to prevent or reduce virus cell entry during common cold infection to reduce total virus load and common cold symptoms in vivo in relation to placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female subjects between 18-65 years. The investigator judges the definition of healthy by detailed medical history and physical examination.
2. Females of childbearing potential: should use reliable method of birth control. Reliable methods are hormonal contraceptives (combination pills, injections or implants), intrauterine device, condom or declared absence of sexual contact. Post-menopausal woman is defined as absence of menstrual discharge for at least two years.
3. Signed informed consent form prior to any study-related procedures.
4. Willingness and ability to complete the study.
5. Perceived to have had at least one cold per year.

Exclusion Criteria:

1. Smoker, during the last 12 months.
2. Any cold symptom within the last month such as sore throat, sneezing, rhinorrhoea, malaise, nasal obstruction or cough.
3. Presence of serum neutralising antibodies against human rhinovirus16 at screening.
4. Active allergic rhinitis, asthma or chronic obstructive pulmonary disease in last year.
5. Positive for fur allergy (if subject is likely to come in contact with the specific pet) and/or dust-mite allergy in skin prick test at screening.
6. Nasal disease, e.g. nasal polyposis, significant septal deviation, chronic rhinosinusitis, etc.
7. Females: Pregnant, breast-feeding or intentions to become pregnant during the study.
8. Active autoimmune disease in last year.
9. Evidence or history of drug or alcohol abuse.
10. Use of any prescribed or non-prescribed medication (except for contraceptives, paracetamol and ibuprofen) within 2 weeks prior to the first administration of investigational product until the end of study.
11. Use of any over the counter cold prophylaxis products such as C-vitamins, zinc or Echinacea within 1 month prior to the first administration of investigational product until the end of study.
12. Participation in other clinical study within 60 days
Subtyping of Insomnia Disorders Based on Multidimensional Features

Based on real world and focusing on patients with chronic sleep disorders, this study conducts a data-driven subtyping research on the clinical symptoms, polysomnography, near-infrared scanning, molecular genetics, and other characteristics of chronic insomnia disorders. It constructs a multimodal therapeutic outcome prediction model, providing a basis for personalized interventions for chronic insomnia disorder.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18 and 65 years, regardless of gender;
2. Currently meeting the diagnostic criteria for insomnia disorder according to the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
3. Pittsburgh Sleep Quality Index (PSQI) total score ≥ 10;
4. Sufficient level of education and comprehension to complete the required examinations and assessments for this study;
5. Voluntarily participating in this research and signing the informed consent form.

Exclusion Criteria:

1. Currently diagnosed with other sleep disorders (sleep-related breathing disorders, periodic limb movement disorder, parasomnias, central disorders of hypersomnolence, circadian rhythm sleep-wake disorders, etc.);
2. Currently diagnosed with organic brain diseases (epilepsy, cerebrovascular disease, etc.) or other organic diseases;
3. Patients with a history of or currently diagnosed with bipolar and related disorders, obsessive-compulsive and related disorders, schizophrenia spectrum and other psychotic disorders, trauma and stressor-related disorders, dissociative disorders, or eating disorders;
4. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
5. Insomnia caused by alcohol or substance abuse;
6. High suicide risk, with HAMD-17 suicide factor score \> 2;
7. Inability to cooperate with near-infrared examinations and polysomnography due to physical conditions such as head injury, etc.
ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection

This is a study to evaluate ABT 450/r/ABT-267 and ABT-333 in treatment-naïve and treatment-experienced Asian adults with subgenotype 1b chronic HCV without cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Chinese, South Korean, and Taiwanese descent with full Chinese, South Korean, and Taiwanese parentage
* Chronic hepatitis C virus (HCV) infection prior to study enrollment.
* Screening laboratory result indicating HCV subtype 1b (GT1b) infection.
* Per local standard practice, documented absence of cirrhosis.
* Participant has never received antiviral treatment (including interferon \[IFN\]-based therapy \[alpha, beta or pegylated (peg)IFN\] with or without RBV) for HCV infection (treatment-naïve participant) or participant must have documentation that they met the definition of one of the following categories (treatment experienced participant): Non-responder or Relapser
* Participant has plasma HCV RNA level \> 10,000 IU/mL at Screening.

Exclusion Criteria:

* HCV genotype performed during screening indicating unable to genotype or infection with any HCV genotype other than GT1b.
* Positive test result at Screening for hepatitis B surface antigen (HBsAg), or hepatitis B virus DNA (HBV-DNA) \> Lower Limit of Quantification (LLOQ) if HBsAg negative, or anti-human immunodeficiency virus antibody (HIV Ab) positive.
* Any current or past clinical evidence of cirrhosis.
* Any primary cause of liver disease other than chronic HCV infection.
* Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function.
* Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inhibitors of cytochrome P450 3A (CYP2C8) within 2 weeks or within 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.
Hybrid PET/CT in Cancer Patients

The purpose of the present study is to assess the role of hybrid PET/CT imaging diagnosis of active malignancy in cancer patients with rising tumor markers after treatment and in the diagnosis of primary tumor in patients with metastatic cancer of unknown origin. The clinical impact of PET/CT in the management and treatment of these two groups of cancer patients will be evaluated


Eligibility Criteria:
Inclusion Criteria:

* Cancer patients in complete remission after treatment, with serial elevation of serum tumor markers and negative CT or other conventional imaging test.
* Patients with newly diagnosed metastatic cancer with unknown primary tumor
* Glucose levels below 150-200
* Patient signed informed consent

Exclusion Criteria:

* Pregnant or lactating women
* Patient unable or not willing to tolerate the test until its completion
* One or more of the inclusion criteria is not fulfilled
Cognitive Checking Intervention for Maladaptive Beliefs About Memory

A small (N = 24) pilot study developed a new and brief cognitive-behavioural therapy (CBT) module for checking symptoms (CBT-C) in obsessive-compulsive disorder (OCD). CBT-C targets maladaptive beliefs about memory and results show that it is effective at significantly decreasing checking symptoms as compared to a waitlist control. The objectives of the current investigation are to further investigate CBT-C by (1) replicating the pilot results in a larger sample; (2) using an active control condition (treatment as usual) as the comparison condition (3) including a 6-month follow-up, and (4) determining whether the association between maladaptive beliefs about memory at pre-treatment assessment are related to degree of checking symptom reduction following CBT-C. The findings of the study will have theoretical significance in adding to our understanding of the maladaptive belief domains relevant to the development and maintenance of OCD and supporting the cognitive model of compulsive checking. The relevant clinical significance is the further development of an intervention that could improve outcomes in treatment of persons with OCD. The key practical outcome of the research would be to add a stepped care offering to patients with OCD.


Eligibility Criteria:
Inclusion Criteria:

* Adult over the age of 18 living in the province of Manitoba, Canada.
* Diagnosis of OCD with clinically significant levels of compulsive checking (i.e., able to meet the diagnostic criteria for OCD according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition based solely on checking symptoms. Other OCD symptoms may be present and checking does not need to be the primary symptom.)

Exclusion Criteria:

* Active psychosis
* Active Mania
* Presence of a substance use disorder that would interfere with participation in the treatment
Divalproex Sodium in the Treatment of the Cutaneous Manifestations of Scleroderma

To investigate the ability of divalproex sodium, a histone deacetylase inhibitor, to improve the digital manifestations of scleroderma including digital edema, calcinosis cutis, digital ulcers, and joint contractures.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Diagnosis of scleroderma as defined by the American College of Rheumatology (ACR)
* Presence of at least one digital manifestation occurring within the past 6 months, i.e. digital swelling/edema, digital ulcer, calcinosis cutis, restricted digital range of motion.
* Females of childbearing potential must take an oral contraceptive pill or use an equivalent birth control method during the study.

Exclusion Criteria:

* Age \<18 years old
* Ongoing use of high dose steroids (\>10 mg/day) or unstable steroid dose in past 4 weeks.
* An investigational drug or disease-modifying agent has been started within the past 6 months, including but not limited to systemic corticosteroids, methotrexate, cyclosporine, azathioprine, cyclophosphamide, bosentan, mycophenolate mofetil, thalidomide, colchicine.
* Patient taking a medication with a significant drug-drug interaction with divalproex sodium, e.g. clomipramine and lamotrigine.
* Patient has another connective tissue disease or other condition that could affect rest pain and hand function, e.g. systemic lupus erythematosus, rheumatoid arthritis, or osteoarthritis.
* Patient has uncontrolled diabetes, chronic kidney disease, chronic hepatitis.
* Any of the following laboratory abnormalities at baseline: anemia (Hb \< 8.5 gm/dL), thrombocytopenia with platelets \<100,000, INR \> 1.3 or known bleeding disorder, estimated GFR \< 60 mL/min/1.73m2 or serum creatinine \> 2.0 mg/dL, hyperbilirubinemia or elevation of AST or ALT
* Pregnancy or breast-feeding.
* History of severe depression (i.e. depression requiring medical treatment by a psychiatrist), suicidal ideation, epilepsy, bipolar disorder, or schizophrenia.
Continence Pessary Versus Disposable Intravaginal Device Trial

This is a multi-centered randomized controlled trial of women with stress urinary incontinence or stress predominant mixed urinary incontinence who desire non-surgical therapy.

In this randomized trial, eligible patients who provide written consent for participation will be enrolled. At enrollment we will collect baseline demographic data and ask participants to complete questionnaires and a 3-day bladder diary. Subjects will be randomized in a 1:1 ratio to continence pessary or disposable intravaginal device.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 years or older (based on disposable intravaginal device manufacturing recommendations).
* SUI or SUI-predominant mixed incontinence
* English-speaking

Exclusion Criteria:

* Pregnancy
* Current symptomatic urinary tract infection (UTI).
* Postmenopausal bleeding of unknown etiology
* Neurogenic bladder
* Urinary retention (PVR \>150mL obtained via bladder scan or catheterization)
* Pelvic organ prolapse past the hymen as assessed by POP-Q examination
* Inability to complete questionnaires in English or comply with study protocol
* Contraindication to pessary or disposable intravaginal device use or prior treatment or experience with either intervention.
* Prior surgery for stress urinary incontinence