cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Convalescent Immune Plasma Therapy

The aim of the study is to evaluate the safety, improvement of clinical symptoms and laboratory parameters of convalescent immune plasma treatment in severe Covid-19 patients with ARDS.

The aim of the study is to evaluate the safety, improvement of clinical symptoms with hypoxemia, metabolic and laboratory parameters of patients with convalescent immune plasma treatment in severe Covid-19 patients followed up in critical care unit.

Eligibility Criteria:
Inclusion Criteria Clinical diagnosis of Covid-19

Exclusion Criteria Age lower than 18 Lower plasma IgA levels PaO2/FiO2 higher than 300 mmHg SpO2 higher than 90
Post-operative Exparel Study Following Rotator Cuff Repair

The primary purpose of this study is to determine if the postoperative oral narcotics consumption in patients receiving liposomal bupivacaine (LB) interscalene brachial plexus nerve block (ISBPB) is different than the narcotics consumption receiving traditional bupivacaine ISBPB for arthroscopic rotator cuff repair analgesia.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18 years or older with a full-thickness rotator cuff tear (confirmed on MRI) undergoing arthroscopic rotator cuff repair surgery.
* Anesthesiologists physical status 1, 2, or 3 and normal preoperative motor (Lovett scale: biceps, wrist, thumb) and sensory function.

Exclusion Criteria:

* Revision shoulder surgery
* History of more than 1 prior surgery performed on the operative shoulder
* Concomitant severe glenohumeral arthritis
* Concomitant adhesive capsulitis
* Worker's compensation claim
* Pregnancy
* History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics
* History of renal or hepatic failure
* Chronic neuromuscular deficit affecting the surgical limb.
* Uncontrolled psychiatric or neurologic disorder
A Dose-finding Study of Silodosin in Patients With Urinary Calculi

The purpose of this study is to evaluate the efficacy and the safety of silodosin in urinary calculi patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have a unilateral ureteral calculus with ≥ 5 mm and ≤ 10 mm at Week 0.
* Patients who are able to visit the site continually as out-patient during the study

Exclusion Criteria:

* Patients who have multiple urethral stones.
* Patients who have or have history of a ureteral stricture or other structural passage obstruction of the ureter on affected side.
* Patients who have been diagnosed with myasthenia gravis, myopathy, spina bifida, spinal cord injury, or fibromyalgia syndrome.
* Patients who have a clinically significant hepatic or renal disorder.
* Patients with postural hypotension or with a history of postural hypotension.
* Patients with a history of sever drug allergy, or patients with a history of hypersensitivity to silodosin.
* Patients who are pregnant, nursing, or desire pregnancy during the study period, or patients who cannot strictly comply with a physician's contraception directions.
Effectiveness of Stability Ball Training, Dead Bug Exercises, and Their Combination on Reducing Specific Low Back Pain

This study is a single-blinded, randomized controlled trial (RCT) focused on individuals aged 30 to 50 with acute specific low back pain (lumbar radiculopathy). Participants will be divided into three groups: one performing stability ball exercises, one doing dead bug exercises, and the third group combining both types of exercises.

The study aims to assess the effectiveness of these regimens in reducing pain and improving quality of life. The trial will be conducted at Sheikh Zayed Hospital and Alara Health Care Clinic, with simple random sampling used to assign participants. The study will run for 6 months, with follow-up assessments at 1, 4, and 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* participants aged 30 to 50 years with a specific diagnosis of acute lumbar radiculopathy lasting less than three months but severe enough to impair daily activities were included in the study.
* They were required to provide informed consent and agree to adhere to the study procedures,
* including attending sessions and completing evaluations. Eligibility was limited to those without other physical conditions, such as joint replacements or fractures,
* that could interfere with the ability to perform stability ball or dead bug exercises. Individuals who had participated in similar therapeutic exercises, such as stability ball training or core strengthening, within the last six months were excluded to ensure the results reflected the intervention's impact rather than prior training effects.

Exclusion criteria:

* included participants with severe musculoskeletal or cardiovascular disorders, such as spinal surgery, herniated discs, scoliosis, fractures, or osteoarthritis, due to the potential risks associated with exercise.
* Pregnant women were excluded as balance-related activities, like stability ball exercises, could pose safety concerns. Individuals using pain medications, particularly opioids or muscle relaxants, were excluded to avoid interference with exercise performance or altered pain perception.
* Participants who had undergone back surgery within the last six months, or those currently undergoing other physical therapy or treatments for back pain, such as physiotherapy or chiropractic care, in the previous month were also excluded
Additional Effect of Pain Neuroscience Education to Spinal Manipulative Therapy in Chronic Low Back Pain

Objectives: The primary objective will be to investigate the additional effect (immediate and after one-month follow up) of pain neuroscience education (PNE) to Spinal Manipulative Therapy (SMT) on primary outcomes of pain intensity and disability in patients with chronic nonspecific low back pain (CLBP).

Design: This study will be a blinded randomized controlled clinical trial. Participants: One hundred and four participants with CLBP (18 and 55 years) both genders. Interventions: Individuals included will be randomized into two possible treatment arms: PNE+SMT or SMT alone. Each treatment will last for 8 sessions. The group submitted to PNE+SMT will received in the first two initial sessions an individual face-to-face PNE program of 40 minutes.Main outcome measures: Pain intensity and low back pain-related disability will be adopted as primary outcomes and as secondary outcomes we will assess fear-avoidance, pain self-efficacy and global perceived effect of improvement. The outcomes will be assessed on three occasions: pre-intervention, immediately after 8 sessions of intervention and after one-month follow-up period. All statistical analysis will be conducted following the principles of intention to treat, and the effects of treatment will be calculated using linear mixed models. Discussion: This study will help to better understand if PNE -a psychosocial cognitive intervention- will add significant effect (immediate and at follow-up) to a movement therapy protocol based on manual therapy.

Eligibility Criteria:
Inclusion Criteria:

1. who present chronic, non-specific, continuous and recurrent low back pain lasting at least three months and
2. contemplate at least three of the following criteria: 1-hip internal rotation with\> 35 °; 2-lumbar spine hypomobility; 3-absence of distal knee symptoms and 4-point FABQ Work score 19.

Exclusion Criteria:

1. pregnant women;
2. red flags (neoplasia, vertebral column fracture, vertebral osteomyelitis, infection or equine tail syndrome, rheumatic diseases, diseases that compromise cognition);
3. disc herniation;
4. women in the luteal phase will be rescheduled;
5. patients with cognitive deficits evaluated according to the Mini Mental State Examination with score less than or equal to 24 points or 22 points (low education level) and
6. previous physical therapy for low back in the past year or submitted to any health/pain education strategy. Patients will be instructed to not use pain relief medications during the intervention period of this trial and if any medication be used, participants will be encouraged to report.
Prevalence Of Deleterious Oral Habits Among a Group of School Children in Cairo, Egypt: Cross-Sectional Study

This study aims to detect the prevalence of practicing oral habits among a group of school children in Cairo, Egypt.

An online questionnaire utilizing the third domain of Nordic Orofacial Test screen will be distributed among school children (aged five to seven years) parents to measure the prevalence of oral habits.

Eligibility Criteria:
Inclusion Criteria:

* school children
* accept to participate
* children within the age group

Exclusion Criteria:

* special health care needs children
A Retrospective Non-interventional Study of Breast Cancer Patients Diagnosed With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib in Denmark

The objective is to retrospectively describe and assess clinical and demographical characteristics, treatment patterns in a real-world (RW) setting of patients with HR+/HER2- (hormone receptor positive/human epidermal growth factor receptor 2 negative) locally advanced or metastatic breast cancer receiving palbociclib in combination treatment


Eligibility Criteria:
Inclusion Criteria:

* Patients with breast cancer (International Statistical Classification of Diseases and Related Health Problems, 10th Revision \[ICD-10\]: ICD-10 code for patients with breast cancer \[DC50\])
* A diagnosis of HR+/HER2- locally advanced or metastatic breast cancer
* Initiated treatment with palbociclib as either 1st or 2nd line treatment between 01 January 2017 and 31 December 2020
* Inclusion date: Date of relapse/stage IV disease/progression leading to initiation of palbociclib+AI/progression leading to initiation of palbociclib+fulvestrant

Exclusion Criteria:

* There are no exclusion criteria for this study
An Open-Label Study of Intra-articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor of the Knee

AMB-051-01 is a multicenter study with an adaptive design that will enroll subjects with Tenosynovial Giant Cell Tumor (TGCT) of the knee for 12 weeks of multiple-dose, open-label treatment with intra-articular AMB-05X.

AMB-05X drug substance is a human monoclonal antibody against the colony-stimulating factor 1 receptor (CSF1R). Study

Eligibility Criteria:
Inclusion Criteria:

1. Subject ≥ 18 years
2. A confirmed diagnosis of tenosynovial giant cell tumor (TGCT) of the knee joint
3. Measurable disease based on RECIST v1.1
4. Stable prescription of analgesic regimen
5. Negative urine drug screen (UDS) at Screening and Baseline
6. Women of childbearing potential must have a negative pregnancy test
7. Agrees to follow contraception guidelines
8. Adequate hematologic, hepatic, and renal function, at Screening
9. Willing and able to complete self-assessment instruments throughout the study

Exclusion Criteria:

1. Prior investigational drug use within 4 weeks or 5 half-lives of Baseline
2. Previous use of therapeutics targeting CSF1 or CSF1R or oral tyrosine kinase inhibitors
3. History of extensive knee surgery
4. Active cancer (either currently or within 1 year before Baseline) that requires therapy (e.g., surgery, chemotherapy, or radiation therapy)
5. Metastatic TGCT
6. Hepatitis C virus (HCV) or hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
7. Known active tuberculosis
8. Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history
9. Women who are breastfeeding
10. A screening Fridericia-corrected QT interval (QTcF) ≥ 450 ms (men) or ≥ 470 ms (women)
11. MRI contraindications (e.g., pacemaker, loose metallic implants)
12. History of hypersensitivity to any ingredient of the study drug
13. History of drug or alcohol abuse within 3 months before the first dose of study drug
14. Any other severe acute or chronic medical or psychiatric condition or clinically significant laboratory abnormality that may increase the risk associated with study participation/treatment or interfere with interpretation of study results and, in the Investigator's opinion, make the subject inappropriate for this study
15. Subjects who, in the Investigator's opinion, should not participate in the study for any reason, including if there is a question about their ability to comply with study requirements
Step'n Out: A Multisite Trial of Collaborative Behavioral Management for Drug-Involved Parolees

The main purpose of this study is to examine whether improved integration between the community supervision system and outpatient addiction treatment system can improve treatment adherence, drug use and public safety outcomes among drug-involved inmates re-entering the community.

The target population consists of male and female parolees with a history of substance abuse treatment who are at moderate-to-high-risk of recidivism. They will recruited from in the criminal justice system and/or transitional residential drug treatment within one or two months of release or at the time they first report for parole supervision.

Participants from six states (KY, OR, RI, CT, VA, DE) will be randomized into the Step'n Out condition (integration of community supervision and addiction treatment with behavioral management) or a comparison condition including traditional community supervision and addiction treatment. Research interviews at baseline, and 3 and 9 months after release from confinement will assess study participants' outcomes.

The Step'n Out intervention will produce significantly better outcomes than the standard referral condition with respect to: recidivism rates (revocation, rearrest on a new charge, reconviction, reincarceration), as assessed 3 and 9 months after the end of the intervention; treatment participation (i.e., proportion of planned sessions attended, proportion of planned days retained in treatment, type of discharge \[successful completion, transfer to another program, elopement, administrative discharge, return to custody\], as assessed after the end of the intervention; self-reported drug use, criminal activity, and psychosocial functioning, as assessed 3 and 12 months after the end of the intervention; cost-effectiveness; collaboration between the supervision officer and treatment counselor ; and therapeutic alliance with the clients.

Eligibility Criteria:
Inclusion Criteria:

1. be at least 18 years old and speak English;
2. have probable drug dependence immediately prior to incarceration as determined by a score of 3 or higher on the TCU Drug Screen II;
3. be at moderate-to-high-risk of drug relapse and/or recidivism as determined by a Lifestyle Criminality Screening Form (LCSF) score of 7 or greater, or a history of 2 or greater prior treatments for drug-related problems or drug-related convictions;
4. must have substance use treatment as a mandated or recommended condition of parole.

Exclusion Criteria:

1. psychotic features;
2. parole or probation conditions that prohibit them from participating in the protocol.
PET MRI Study in Patients With Cardiac Sarcoidosis

Myocarditis or inflammatory cardiomyopathy refers to inflammation of the heart muscle (the myocardium). Sarcoidosis is a multisystem granulomatous disorder that may involve the heart, causing inflammation, and potentially resulting in complications including arrhythmia and sudden death. The objective of this study is to evaluate the diagnostic and prognostic significance of simultaneous combined 18F-FDG PET and cardiac MRI imaging in the evaluation of inflammatory cardiomyopathies including cardiac sarcoidosis. Combined PET/MRI imaging may allow for detection and quantification of active myocardial inflammation as well as chronic fibrosis and scarring. Results of this study may allow for earlier detection of cardiac inflammation when compared with methods in current clinical use, and may lead to better understanding of the disease processes contributing to adverse outcomes. Elucidation of imaging findings associated with future adverse event risk may impact patient management such as providing an indication for pacemaker or defibrillator implantation, or escalation of medical therapy.

Myocarditis or inflammatory cardiomyopathy refers to inflammation of the myocardium. Sarcoidosis is a multisystem granulomatous disorder of unknown etiology, which can result in myocardial inflammation. Approximately 5% of patients with sarcoidosis have clinically apparent cardiac involvement, yet autopsy series indicate that cardiac involvement is present in up to 25% of cases. This discrepancy suggests that cardiac sarcoidosis may be under-diagnosed in clinical practice. Recent studies have demonstrated high diagnostic accuracy of both cardiac MRI and 18F-labelled fluoro-2-deoxyglucose (FDG) PET for detection of cardiac involvement. However, cardiac MRI may fail to identify areas of active inflammation even with fluid sensitive T2-weighted sequences.

Fasting 18F-FDG positron emission tomography (PET) has been shown to identify early cardiac sarcoidosis with relatively high sensitivity. To date, simultaneous PET/MRI evaluation of cardiac inflammation and sarcoidosis has only been described in limited case reports. The objective of the proposed research is to evaluate the utility of simultaneous PET/MRI imaging in patients with cardiac sarcoidosis and other inflammatory cardiomyopathies.

Eligibility Criteria:
Inclusion Criteria:

* The primary criterion for enrolment will be patients ≥18 years of age with known or suspected sarcoidosis or other inflammatory cardiomyopathy who are referred for clinically indicated 18F-FDG PET/CT imaging

Exclusion Criteria:

* Standard cardiac MRI contraindications include arrhythmia, claustrophobia, history of allergic reaction or other contraindication to gadolinium-based contrast agent, impaired renal function with eGFR \< 60 ml/min/1.73m2, pregnancy, breast-feeding, or any other general contraindication to MRI (pacemaker, cerebral aneurysm clips, shrapnel, etc).
Delta Q Value to Discriminate Detrusor Underactivity From Bladder Outlet Obstruction

To determine the significance of delta Q value (Qmax - Qave) in discrimination between BOO and DU, to avoid invasive studies (pressure flow studies (PFSs)) and replace them with noninvasive study (uroflowmetry).

lower urinary tract symptoms (LUTS) in old male patients are usually secondary to prostatic hyperplasia. However, it is becoming clear nowadays that prostatic enlargement is not always the cause of male LUTS, and other factors could cause male LUTS in the presence of benign prostate enlargement (BPE).

Two clinical situations are common in elderly patients like Bladder Outlet Obstruction (BOO) and Detrusor underactivity (DU) they affect the voiding phase in elderly men markedly.

To distinguish one from another may be challenging and could be only done by urodynamic study (UDS), which is the gold standard for diagnosis.

A urodynamic study is an invasive procedure, with side effects of pain and urinary tract infection, and the need for special equipment and expertise has limited its widespread use and made it very stressful for the patients.

On the other hand, Uroflowmetry is a non-invasive procedure that could be used in patients' assessments. A term of Delta Q is being used that focuses on the difference between (Qmax) and (Q-average). The hypothesis is that Delta Q would be lower in Detrusor underactivity because of the undermined detrusor function decreasing both average and maximum urine flow rate, but it is higher in BOO, which has normal detrusor contraction during the voiding phase.

Based on the concept uroflow can be used to replace urodynamic studies to differentiate between these 2 entities and hence to determine the proper management plan and to be a prognostic factor before surgical intervention.

Eligibility Criteria:
Inclusion Criteria:

* male patients aged over 50 years complaining of voiding symptoms
* International Prostatic Symptom Score (IPSS) 8 points or more,
* serum prostate-specific antigen (PSA) below 4 ng/ml
* no hematuria or pyuria.

Exclusion Criteria:

* Patients who were unable to complete the voiding study were deemed not eligible to participate in this review.
* patients with neurological causes of voiding dysfunction
* history of urinary tract abnormalities/lithiasis, lower urinary tract surgeries, urinary tract malignancy.
* acute UTI were excluded.
Effects of Psilocybin in Concussion Headache

The purpose of this study is to investigate the effects of oral psilocybin in post-traumatic headache. Subjects will be randomized to receive placebo, low dose psilocybin, or high dose psilocybin on two separate test days approximately 14 days apart. Subjects will maintain a headache diary prior to, during, and after the treatments in order to document headache frequency and intensity, as well as associated symptoms. Blood samples will be drawn at various timepoints to measure levels of inflammatory peptides.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of post-traumatic headache
* Typical pattern of headache attacks with approximately two attacks or more weekly
* Attacks are managed by means involving no more than twice weekly triptan use

Exclusion Criteria:

* Axis I psychotic disorder (e.g. schizophrenia, bipolar I, depression with psychosis)
* Axis I psychotic disorder in first degree relative
* Unstable medical condition, severe renal, cardiac or hepatic disease, pacemaker, or serious central nervous system pathology
* Pregnant, breastfeeding, lack of adequate birth control
* History of intolerance to psilocybin, LSD, or related compounds
* Drug or alcohol abuse within the past 3 months (excluding tobacco)
* Urine toxicology positive to drugs of abuse
* Use of vasoconstrictive medications (i.e. sumatriptan, pseudoephedrine, midodrine) within 5 half-lives of test days
* Use of serotonergic antiemetics (i.e. ondansetron) in the past 2 weeks
* Use of antidepressant medication (i.e. TCA, MAOI, SSRI) in the past 6 weeks
* Use of steroids or certain other immunomodulatory agents (i.e. azathioprine) in the past 2 weeks
Investigation of the Use of Remote Presence Robots in Delivery of Neuromodulation

In recent years, robotic devices are becoming more and more common in medical practice. Such devices provide an effective way to communicate within a clinical setting, but recent studies have shown far more diverse uses for these robots, ranging from training future surgeons to diagnoses of patients. In the investigators study, the investigators would like to investigate whether it is effective to employ robotic devices in the administration of neurostimulation treatment. It is the investigators hypothesis that the introduction of robotic devices will only yield minimal if any inaccuracies in a standard neuromodulation treatment protocol. In addition, the investigators also predict a high satisfaction rating from all participants involved in conditions involving the robot.

Patients with neuromodulation systems implanted for either movement disorders or chronic pain and who require programming of their systems will be approached to enter the study. Those who consent will be consecutively assigned to either the normal standard of care (i.e. programming of their systems with an experienced clinician) or programming of their systems with an inexperienced programmer (nurse) who will be directed by the experienced programmer via the remote presence robot. Both the nurses and the patients will complete questionnaires rating their satisfaction of the programming experience.

They will each only receive one questionnaire at the end of the programming session. There is no other test point.

Eligibility Criteria:
Inclusion Criteria:

* patients with neuromodulation systems, requiring programming
* nurses who have never programmed a neuromodulation system before

Exclusion Criteria:

* those who are unwilling to give consent