cyrilzakka/clinical-trials huggingface dataset:
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain

The purpose of the chronic pain master protocol is to compare independent pain interventions and establish an overarching structure for the disease-state addenda (DSA) and intervention-specific appendices (ISAs). The ISAs may start independently of other ISAs as interventions become available for clinical testing.

The chronic pain master protocol (CPMP) establishes entry criteria and includes DSA for osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. The DSA have specific study elements to appropriately define the target population and unique scales for assessment. Also, the master protocol governs ISAs that may start independently of other ISAs as interventions become available for clinical testing.

Note: Results for all outcomes are posted in the intervention records. No need for duplication.

Eligibility Criteria:
Inclusion Criteria:

* have a visual analog scale (VAS) pain value \>40 and \<95 at screening and prerandomization screening.
* have a history of daily pain for at least 12 weeks based on participant report or medical history
* have a value of ≤30 on the pain catastrophizing scale
* have a body mass index \<40 kilogram/square meter (kg/m²) (inclusive)
* are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.
* are willing to discontinue all medications taken for chronic pain conditions, except rescue medication for the duration of the study

Exclusion Criteria:

* have second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia
* have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques)
* have surgery planned during the study for any reason, related or not to the disease state under evaluation.
* have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
* have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
* have fibromyalgia
* have substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association)
* have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, electrocardiogram (ECG), or clinical laboratory test results that could be detrimental to the participant or could compromise the study.
* have a positive human immunodeficiency virus (HIV) test result at screening
* have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.
Study of the Steroid Hormone Milieu in Obese Patients

The aim of this observational study is to evaluate the actual secretion of cortisol and testosterone in obese male subjects, together with the receptor sensitivity to these hormones in order to understand whether the hormonal milieu deriving from these parameters is associated with alterations in bone metabolism, lipoprotein concentration and function, and/or the severity and complications of obesity.

It will be also investigated if this hormonal milieu is a predictive factor for cardiovascular disease in obese patients.

Eligible subjects are male patients (age 18-80 years) with severe obesity and no other known causes of hypercortisolism or hypogonadism.

Questionnaires for the evaluation of mood and symptoms will be collected upon enrollment, patient's anamnestic and clinical data relating to disease complications, BMI, previous blood tests, cortisol suppression with dexamethasone 1 mg will be collected, and blood sample will be sent to and analyzed at a centralized laboratory for the study of Steroid hormones, bone metabolism, lipoprotein function, genetics and receptor analysis.


Eligibility Criteria:
Inclusion Criteria:

* morbid obesity

Exclusion Criteria:

* patients suffering from severe systemic pathologies, fever, chronic inflammatory states known to cause PCR \>10 mg/dL
* use of corticosteroids at the time of enrollment
* the patient's poor understanding of spoken and written Italian
* patients suffering from primary pathologies of the testicle, known at enrollment
* patients suffering from hypothalamic-pituitary or adrenal pathologies already known at the time of enrollment
Combined Neuromodulation and Cognitive Training for Post-mTBI Depression

The primary goal of this clinical trial is to evaluate whether Personalized Augmented Cognitive Training (PACT) plus intermittent theta burst stimulation (iTBS) is effective for treating depression in Service Members, Veterans, and civilians who have sustained a mild TBI. Participants will receive PACT plus 20 sessions of iTBS or sham iTBS over 4 weeks. Assessments will occur at baseline, 2 weeks, 4 weeks, and 8 weeks. Researchers will compare the PACT+iTBS group to the PACT+sham iTBS group to see if PACT+iTBS is associated with more depression improvement.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female
2. All racial and ethnic groups
3. Ages 18 to 65
4. Military service members receiving treatment at NMCSD or civilians receiving treatment at UCSD Health
5. History of mild TBI (as defined by the DoD/VA criteria used in conjunction with the OSU TBI-ID method) over 3 months prior to study entry
6. Meets criteria for current Major Depressive Episode within the context of Major Depressive Disorder, per MINI
7. Score of 18 or higher on the HAMD-17, indicating moderate to severe depressive symptoms
8. Stable on psychiatric medications for 6 weeks, with no changes to psychiatric medications expected during the study period
9. No contraindications to TMS (passes the TMS Adult Safety Screening questionnaire)
10. No contraindications to MRI (passes MRI safety screening questionnaire)
11. Able to commit to the treatment schedule
12. Able to complete assessment procedures in English
13. Intact decision-making capacity and ability to provide voluntary informed consent

Exclusion Criteria:

1. History of moderate, severe, or penetrating TBI
2. History of other neurological condition unrelated to TBI, including but not limited to: conditions associated with increased intracranial pressure; space occupying brain lesions; cerebral aneurysm; stroke; transient ischemic attack within past two years; Parkinson's disease; Huntington's disease; dementia; multiple sclerosis; history of brain surgery; epilepsy; seizure except those therapeutically induced by electroconvulsive therapy (ECT) or a febrile seizure of infancy
3. Implanted medical devices including cardiac pacemaker, medication pump, aneurysm clip, shunt, stimulator, cochlear implant, electrodes, or any other metal object within or near the head (excluding the mouth) that cannot be safely removed
4. Active manic or psychotic illness per MINI
5. Current substance use disorder per MINI
6. Current active suicidal or homicidal ideation
7. Pregnant or intending to become pregnant within the study period; breastfeeding
8. Other sensory conditions or illnesses precluding participation in assessments or treatment
9. Current dose of lorazepam 2 mg or greater daily (or benzodiazepine equivalent) or any anticonvulsant due to the potential to limit iTBS efficacy
10. Taking medication that lowers seizure threshold
11. Previous failed treatment with rTMS, iTBS, or ECT
12. Completed \>4 sessions of cognitive rehabilitation within the last 3 years
uPAR PET/CT in Radium-223-dichloride Treatment of Patients With Metastatic Castration-resistant Prostate Cancer

The purpose of this study is to investigate the applicability of urokinase plasminogen activator receptor (uPAR) Positron Emission Tomography (PET) / CT molecular imaging in patients with metastatic castration-resistant prostate cancer (mCRPC)

68Ga-NOTA-AE105 is a radioligand targeting urokinase plasminogen activator receptor (uPAR), which is a promising imaging biomarker of tumor aggressiveness. 68Ga-NOTA-AE105 PET/CT will be applied in patients with mCRPC during treatment with Radium-223. PET/CT will be performed before initiation of Radium therapy and after two treatment cycles. The initial semiquantitative uptake (standard uptake values, SUVs) of 68Ga-NOTA-AE105 in metastases as well as the change in these parameters after therapy will be correlated with overall survival and progression free survival.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic castration resistant prostate cancer
* Approved to receive Radium-223 therapy
* Written and oral consent

Exclusion Criteria:

* Lack of communication skills
* Other known malignant disease
* Known allergy towards IMP
* Severe claustrophobia
* If a participant exhibits allergic reaction i the IMP, the participant will be excluded from further participation in the study
Histologic Comparison of Healing After Tooth Extraction With Ridge Preservation Using Two Different Xenografts

The purpose of this study is to compare the speed of bone healing of the two most commonly used xenografts on the market, Bio-Oss® and Salvin-Oss® using a tooth extraction ridge preservation model in participants scheduled for tooth extraction and subsequent receipt of a dental implant. Researchers hypothesize that there will be additional vital bone at 16-20 weeks with Salvin-Oss®.

This study focuses on xenografts to preserve alveolar bone after tooth extraction prior to placement of a dental implant. Extraction sites that are not grafted for ridge preservation may lose up to 50 percent of their ridge width the first year after extraction. Xenografts are one of several products on the market used to maintain ridge width after tooth extraction. This study aims to compare the two most commonly used, FDA-approved xenografts on the market, Bio-Oss® and Salvin-Oss, in the preservation of alveolar bone after extraction of non-molar teeth.

The primary objective of this study is to histologically evaluate and compare the percentage of new bone formation in healing extraction sockets of non-molar teeth grafted with Bio-Oss® versus Salvin-Oss®. The secondary aim is to observe clinical changes in ridge height and ridge width after grafting with these two materials.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.
* Consent to be in the study.
* Planned for non-emergent dental treatment.
* American Society of Anesthesiologist Class I or II.
* Require extraction of a single-rooted non-molar tooth.
* Committed to have the dental implant placed at the site of extraction 16-20 weeks after extraction and ridge preservation.
* Adequate restorative space for implant-retained restoration.
* \> 10mm alveolar bone height without impingement on the maxillary sinus or inferior alveolar canal.
* Root location and angulation that would be consistent with the subsequent implant placement.
* Roots with minimum of 10mm of radiographic bone support.
* Root angulation similar to the angulation of the implant to be placed at the site.

Exclusion Criteria:

* \< 18 years old.
* Currently pregnant.
* Require antibiotic prophylaxis prior to dental procedures as outlined by the 2017 American Heart Association guidelines.
* Decisionally challenged individuals.
* Current smokers.
* American Society of Anesthesiologist Class III or IV.
Positron Emission Mammography and Standard Mammography in Women at High Risk of Breast Cancer

RATIONALE: Screening tests may help doctors find cancer cells early and plan better treatment for breast cancer. It is not yet known whether positron emission mammography is more effective than standard mammography in finding breast tumors.

PURPOSE: This phase III trial is studying positron emission mammography to see how well it works compared with standard mammography in women undergoing screening mammogram at Boston Medical Center.

OBJECTIVES:

* To install the breast Positron Emission Mammography system and to test and ensure its compliance with all regulatory agencies including the American College of Radiology and the Food and Drug Administration.
* To measure and compare the number of call-backs for positron emission mammography (PEM) imaging and conventional mammography.
* To measure and compare patient satisfaction for both conventional mammography and positron emission mammography in terms of comfort and pain.

OUTLINE: Patients undergo a conventional two-view mammogram and positron emission mammography (PEM). Immediately following treatment, patients complete a questionnaire on their satisfaction with the standard mammogram and the positron emission mammography.

After completion of study treatment, patients are followed annually.

Eligibility Criteria:
Inclusion criteria:

DISEASE CHARACTERISTICS:

* Scheduled to undergo screening mammogram at one of the Boston Medical Center-affiliated primary care clinics and meets 1 of the following criteria:

  * Dense breast tissue
  * At high-risk for breast cancer

PATIENT CHARACTERISTICS:

* Has 1 of the following racial or ethnic backgrounds based on the patient's country of birth or the mother and father's country of birth:

  * Hispanic
  * Haitian Creole
  * African American
  * Caucasian

PRIOR CONCURRENT THERAPY:

* None specified

Exclusion criteria:

* No history of breast cancer, palpable breast mass, abnormal nipple discharge, or other focal complaints warranting diagnostic mammogram
Prevalence and Pathological Features of C3 Dominant Glomerulonephritis Among Egyptian Population

A classification has introduced C3 glomerulopathy (C3 glomerulopathy consensus report) that should be used to designate a disease process due to abnormal control of complement activation, deposition, or degradation and characterized by predominant glomerular C3 fragment deposits with EM dense deposits. Also, the consensus suggested that the term glomerulonephritis with dominant C3 should be used in practice as a morphological term for those cases with dominant C3 (C3c satining) which is defined as C3 intensity ≥ 2 orders of magnitude more than any other immune reactant on a scale of 0 to 3.

C3 glomerulonephritis with 3 dominant C3 deposits include C3 glomerulopathy, post-infectious glomerulonephritis (PIGN) and others such as para-protein associated glomerulonephritis.

In C3 glomerulopathy; the alternative pathway plays a major role in pathogenesis of this group of diseases. It occurs because of dysregulation of alternative complement pathway. Dysregulation can be due to mutations of complement proteins or to autoantibodies that promote complement activation.

Classical/lectin complement pathway has shown potential in evaluation of C3 glomerulopathy. It's suggested that presence of glomerular C4d which is a product of early classical/lectin pathway, should not exclude a C3 glomerulopathy.

Another disease group with prominent C3 deposits is postinfectious glomerulonephritis (PIGN) and although PIGN has traditionally been thought of as a disease triggered by glomerular immune complex deposition but C3 deposition in absence of immune complex deposits can be seen in patients with PIGN but with the emergence of C3 glomerulonephritis (C3GN), the distinction is difficult as the clinical and pathological presentation may be similar. However, their treatment and clinical course vary significantly.

In addition there is overlap between PIGN and C3 glomerulopathy as they may both show prominent sub-epithelial humps on electron microscopy. This overlap means that it may be very difficult to decide on morphology alone whether a biopsy is a typical PIGN that will resolve, or whether it represents a C3 glomerulopathy due to an underlying complement abnormality that will lead to persistent glomerulonephritis.


Eligibility Criteria:
Inclusion Criteria:

1. Adequate sample with at least 10 glomeruli
2. Enough residual tissues in the paraffin blocks
3. Available clinical data

Exclusion Criteria:

Other glomerular diseases such as lupus nephritis, IgA nephropathy, membranous glomerulonephritis and immune complex-mediated membranoproliferative GN. Cases of minimal change were also excluded.
Utility of High-resolution Ultrasound to Evaluate Dorsal Osteophyte

This study will evaluate the usefulness of ultrasonography in detecting dorsal osteophytes associated with claw nails compared to radiographs. The hypothesis will be that the larger the size of the osteophyte, the greater the nail curvature.

Nail curvature and osteophyte height will be measured in patients with clamp nails. Nail-phalange distance will also be measured with radiography and ultrasonography.

The investigators to find a positive correlation between nail curvature and osteophyte height. Furthermore, a strong agreement is expected between both imaging techniques to measure nail-phalange distance.

Ultrasonography could constitute a safe and effective alternative to radiology for detecting dorsal osteophytes in claw nails, especially in mild cases, follow-ups or young patients.

Main objective:

The investigators aim to explore the possible relationship between the degree of dorsal curvature of the nail plate and the height of the dorsal osteophyte in subungual exostosis patients before and after surgery.

Secondary objectives:

The investigators will compare the distance between the nail surface and the dorsal cortex of the distal phalanx using plain radiographs and high-resolution ultrasonography.

Materials and Methods:

This is an Interventional study patients experiencing nail pain due to clamp nails will be enrolled. Two groups will be formed depending on the presence of exostosis or not. Patients diagnosed with subungual exostosis who consent to surgery will undergo preoperative measurements. After surgery, these patients will be re-evaluated to assess the restoration of normal nail curvature values, as well as the height of the exostosis or its distance from the nail.

Measurements:

Nail curvature will be assessed using the nail curvature index, and nail height and thickness will also be measured. Dorsal osteophyte height will be assessed on radiographs and ultrasound images before and after treatment.

Expected results:

The investigators anticipate a positive correlation between dorsal osteophyte height and nail curvature. In addition, they do not expect significant differences in nail-phalange distance measurements between radiography and ultrasonography.

Conclusions:

High-resolution ultrasonography may emerge as an alternative diagnostic tool to detect subungual exostosis without exposure to ionizing radiation.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiological diagnosis of claw nail in at least one toe.
* Pain associated with claw nail for at least 1 month.

Exclusion Criteria:

* Pregnancy or breastfeeding
* Previous trauma or surgery on the affected toe
* Systemic diseases such as diabetes mellitus, renal insufficiency, rheumatoid arthritis
* Current or previous treatment for ingrown toenail within the last year
* Severe digital deformities (e.g. Hallux Valgus, hammer toe, claw toe)
Two Group Experimental Trial Promoting Sports and Exercise Among Female University Students in Saudi Arabia

The study provides insights into the use of awareness counselling sessions for physical activity promotion, which may have a significant impact on physical activity education, promotion, practice and policy making and will be more effective to ensure adherence to activity among young adults.


Eligibility Criteria:
Inclusion Criteria:

* Participants scoring between 0 to 10 (normal) and 11 to 16 (mild) and 16 to 20 (moderate) in DASS-21 depression subscale
* voluntary participants
* physical activity level lightly active

Exclusion Criteria:

* University students diagnosed with psychiatric disorders and taking therapy or family history of mental illness
* Students with comorbid conditions such as chronic pain, respiratory disorders, musculoskeletal diseases, cardiac diseases, neurological diseases or any disabilities and pregnancy
Treatment of Acute ACL Injuries in Young Patients Using a Rebound ACL Brace

This study evaluates the use of a brace in acute anterior cruciate ligament (ACL) injuries in children and adolescents. Half of the participants will receive a so called rebound ACL brace together with a standardized rehab program supervised by a physiotherapist, while the other half will receive only the standardized rehab program supervised by a physiotherapist

A well known treatment of posterior cruciate ligament injuries in the acute phase is a brace which pushes the tibia anteriorly, and the result of the treatment is often successful with healing of the ligament. Similarly, in anterior cruciate ligament injuries, it is suggested that a rebound ACL brace which pushes the tibia posteriorly can facilitate healing of the ACL. It does not have as successful treatment results as the PCL brace, but the type and location of the ACL injury has in previous studies not been well defined. We will, after having described the localisation and type of ACL injury treat the intervention group with the rebound ACL brace and a standardized rehab program and the control group with standardized rehab program alone.

The randomization is made blockwise of 4, to treatment A= Brace+physiotherapy or B=Physioterapy. The groups are stratified for gender and age (\<=14 years and \>14 years)

Eligibility Criteria:
Inclusion Criteria:

* No previous significant knee injury
* Trauma followed by hemarthrosis and clinical suspicion of an acute ACL injury
* Acute ACL rupture seen on MRI

Exclusion Criteria:

* Previous ipsilateral knee surgery
* Associated injuries which require early surgical intervention
Study to Evaluate the Effect of Different Warm-Up Times of Risankizumab Autoinjector (AI) on the Injection Pain Experiences in Healthy Volunteers

The objective of this study is to assess the impact of different warm-up times of risankizumab autoinjector (AI) on the participant injection site pain experience in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

- Body mass index (BMI) is \>= 18.0 to \<= 30.0 kg/m2.

Exclusion Criteria:

* Any findings in the medical examination that are deviating from normal and judged as clinically relevant by the investigator.
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
* Any evidence of a concomitant disease judged as clinically relevant by the investigator.
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, or psychiatric disease or disorder, or any other uncontrolled medical illness.