cyrilzakka/clinical-trials huggingface dataset:
Micro Plug Set - Post Market Clinical Follow-up (PMCF) Plan

This is an observational, post market clinical follow-up (PMCF) intended to evaluate the residual risks of the Micro Plug Set which is intended for use during arterial embolization of the peripheral vasculature. This PMCF will collect data pertaining to any adverse events as well as the identification of any unanticipated risks up to the first 12 months following device implant.


Eligibility Criteria:
Inclusion Criteria:

* Subject is scheduled for arterial embolization in the peripheral vasculature.
* Subject is greater than 18 years of age

Exclusion Criteria:

* Subject is unable to give informed consent
* Subject is pregnant or breastfeeding
* Subject has allergy to nickel
* Patient requires neurologic or cardiac use of an occlusion device, contrary to the Micro Plug Set Instructions For Use.
Study to Evaluate and Compare the Bioequivalence of Two Abaloparatide-sMTS Treatments in Healthy Women.

A study to evaluate the bioequivalence of abaloparatide between 2 abaloparatide-sMTS treatments 300 μg treatments applied to the thigh for 5 minutes.

This is a single site, open-label, randomized, 4-period crossover study to evaluate the bioequivalence of 2 abaloparatide-sMTS 300 μg treatments (Patheon sterile abaloparatide-sMTS and Kindeva ultra-low bioburden abaloparatide-sMTS) applied to the thigh for 5 minutes. The study will also evaluate the effect of small deviations in the wear-time of the Patheon abaloparatide-sMTS worn for 4 minutes or 7 minutes compared to the Patheon abaloparatide-sMTS worn for the prescribed 5 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects aged 40 to 65 years old, inclusive, at Screening
* Good general health as determined by medical history and physical exam (including vital signs, and has a body mass index between 18 and 34 kg/m\^2 inclusive)
* Laboratory tests within the normal range
* Serum 25-hydroxyvitamin D values must be \> 20 ng/mL

Exclusion Criteria:

* Presence or history of any disorder that may prevent the successful completion of the study.
* Diagnosed with osteoporosis, Paget's disease, or other metabolic bone diseases (eg, vitamin D deficiency or osteomalacia), or had a non-traumatic fracture within 1 year prior to the initial screening;
* History of any cancer within the past 5 years other than squamous or basal cell carcinoma;
* History of allergy to abaloparatide or drugs in a similar pharmacological class;
Evaluating the Effectiveness of Using a Home Laser Device to Treat Patients With Knee Osteoarthritis

Osteoarthritis is a degenerative disease affecting joint cartilage and its surrounding tissue. It is the leading cause of disability in the elderly. Photobiomodulation (PBM), has been used widely for alleviation of pain, reduction of inflammation, and acceleration of wound healing, and particularly to treat knee osteoarthritis (KOA). The purpose of the current study is to determine if a near-infrared PBM device (B-Cure Laser), applied at home, by the patient or personal caregiver in a real-life situation, can reduce pain and improve functionality in patients with KOA.

This is a prospective double blind randomized sham-controlled clinical trial. Eligible participants with KOA will be randomly allocated to receive active or sham devices for self-treatment at home in addition to standard care. Patients will be invited to the clinic for 3 visits: baseline, 1 month, and 3 months. Evaluations will include physical examination, range of motion, and patient reported outcomes including subjective pain level by visual analogue scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and quality of life questionnaire (SF-12). Participants will document treatments and analgesic-drug use in a diary.

The study hypothesis is that B-Cure laser treatments, applied at home by the patient, can reduce pain and improve functionality compared to standard care alone.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnoses of knee osteoarthritis by American College of Rheumatology (ACR)
2. Kellgren \& Lawrence classification 1-3
3. Knee pain on movement 40 to 90 mm Visual Analog Scale
4. Knee pain and related functional reduction for at least 1 month

Exclusion Criteria:

1. Pregnant or nursing, or with the ability to become pregnant and not using an accepted form of birth control
2. Other causes of knee-related pain (e.g. hip OA, arterial insufficiency, radiculopathy etc) have been ruled out by physical examinations.
3. Knee surgery for KOA
4. Intra-articular steroid injection and/or oral steroid treatment within the last six months
5. Rheumatoid arthritis
6. Symptomatic OA in other joints (i.e. hip, hand)
7. Use of narcotics on the day of evaluation
8. Active malignancy
9. Uncontrolled diabetes mellitus
10. Neurological conditions: sciatica, neuropathy, multiple sclerosis
11. Other chronic pain conditions that may affect results: Fibromyalgia, back pain, hip pain
12. Has any photobiomodulation (low level laser) device at home or has previously used photobiomodulation for knee pain
13. Has known dermatological sensitivity to light
14. Enrolled in any other clinical trial within the last 6 weeks or enrollment in another clinical trial during participation in this trial.
Intervention for Human Papillomavirus Vaccine Acceptance in Mexican Mothers

Randomized clinical trial with two groups, with a test-retest model, with single-blind approach, using a probabilistic sampling and the population was mothers of girls aged 9 to 12 years from a public elementary school in the state of Puebla. The objective was to determine the effect of the intervention "Vaccine for HPV Prevention" aimed at the acceptance of the HPV vaccine in mothers of girls aged 9 to 12 years old in the urban area of the State of Puebla.

Introduction: Human papillomavirus is a serious health problem worldwide, being immunization the viable prevention strategy to combat the infection, however, there is a low acceptance of the vaccine in mothers to immunize their daughters, derived from social, economic, cultural and educational aspects. Objective: To determine the effect of the intervention "Vaccine for HPV Prevention" aimed at the acceptance of the HPV vaccine in mothers of girls aged 9 to 12 years old in the urban area of the State of Puebla. Methodology: Randomized clinical trial with two groups, with a test-retest model, with a single-blind approach, a probabilistic sampling was used and the population was 10 mothers of girls from 9 to 12 years old from a public elementary school in the state of Puebla.

Eligibility Criteria:
Inclusion Criteria:

* Women from 20 to 59 years old.
* Mothers of girls from 9 to 11 years old.
* Who agree to participate in the study.
* Who know how to read and write.
* Who have an electronic device (cell phone, tablet or computer).
* That they have access to social networks such as WhatsApp and Facebook.
* That they have an internet connection.

Exclusion Criteria:

* Mothers with a history of CACU and/or HPV infection in themselves or a family member.
* Mothers who have received information about CACU, HPV and/or the HPV vaccine at least one month prior to the educational intervention.
Brain Lesions Following Endovascular and Surgical Treatment of Unruptured Intracranial Aneurysms

The purpose of this study is to determine the incidence and impact of brain lesions in MRI after coiling and clipping of unruptured intracranial aneurysms on clinical and neurological outcome of patients.

Silent ischemic lesions after treatment of unruptured intracranial aneurysm (UIA) might alter patients' clinical and neurological outcome. Furthermore silent brain lesions are not well documented after endovascular and surgical treatment of unruptured intracranial aneurysms. Therefore, the investigators investigate the incidence and influence of treatment-related ischemic lesions in magnetic resonance / diffusion-weighted-imaging after endovascular and surgical treatment of UIA.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis and treatment of unruptured intracranial aneurysm
* age ≥ 18 yrs
* written informed consent by patients prior to study participation
* willingness to participate in follow-up

Exclusion Criteria:

* ruptured intracranial aneurysm
* contraindication for MRI
* Participation in an intervention-/AMG-study
Impact of Chemokine Receptor 5 (CCR5) Inhibition on Sarcoidosis Immunophenotypes

The study hypothesizes that inhibition of the receptor CCR5 by maraviroc will diminish inflammation in patients with sarcoidosis. Subjects with active sarcoidosis will first undergo bronchoscopy with bronchoalveolar lavage to recover lung immune cells for baseline analysis. They will then receive the drug maraviroc for 6 weeks duration. They will then undergo a repeat bronchoscopy with bronchoalveolar lavage to recover lung immune cells for analysis following maraviroc treatment.

The investigators hypothesize that inhibition of CCR5 by maraviroc may have a beneficial immunomodulatory effect on the granulomatous inflammation of pulmonary sarcoidosis. The specific aim of this proposal is the investigate the effect of CCR5 inhibition on the trafficking of mononuclear cells to the lung, skin, peripheral blood in subjects with active sarcoidosis exposed to the CCR5 inhibitor, maraviroc. A second aim will be to isolate by cell sorting cluster of differentiation 4 (CD4)+CCR5+ T cells for amplified gene expression profiling before and after CCR5 inhibition, experiments the investigators believe will elucidate genes associated with downstream activation and inhibition of CCR5 receptor function.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven sarcoidosis from any site (noncaseating granulomas without other causes).
2. Diagnosis of active sarcoidosis (Sec. 5.5.4.t) clinical stage II by Chest X-ray (CXR).
3. Forced Vital Capacity (FVC) \>45% and Diffusing Capacity for Carbon Monoxide (DLCO) \>50% of predicted values.
4. Evidence of active sarcoidosis (see criteria above)
5. Able and willing to complete all study procedures (e.g., bronchoscopy, post-drug surveillance)
6. Age: 18+ years old (prevalence greatest in young adults; pediatric maraviroc safety not established).
7. Not on immunosuppression for sarcoidosis at the time of recruitment, (e.g., steroids, tumor necrosis factor alpha (TNF-a) blockade)
8. Liver function (transaminases, bilirubin), coagulation (International Normalized Ratio (INR), partial thromboplastin time (PTT), platelet count), blood urea nitrogen (BUN), creatinine, and white blood count (WBC) within normal limits.
9. If female: negative pregnancy test, agreement to use reliable contraception if of childbearing potential 30 days prior and for 30 days after study completion (drug safety during pregnancy not established).
10. Negative HIV and HBsAg tests

Exclusion Criteria:

1. Diagnosis of infection based upon clinical evaluation and/or microbial testing.
2. The diagnosis of any disease involving the heart, lungs, liver (HVC), kidney, hematologic, endocrine, or Gl systems which, in the judgment of the PI, would pose an undue risk to the subject if they participated in this study. This includes but is not limited to diabetes, uncontrolled hypertension, liver disease (HVC), or history of malignancy.
3. Medications that will either inhibit or induce CYP3A4 (including St John's Wort)
Large-scale Multi-omics Analysis of Cerebrospinal Fluid

The aim of this study is to explore the role of cerebrospinal fluid (CSF) biomarkers in aging and neurodegenerative diseases.

This study aims to investigate the role of cerebrospinal fluid (CSF) biomarkers in aging and neurodegenerative diseases, with a focus on the following objectives:

Analysis of Age-Related Changes in CSF Biomarkers: The study will analyze CSF samples from different age groups to identify biomarkers that undergo significant changes during the aging process. This includes the investigation of amyloid-beta (Aβ42), Tau proteins (including the phosphorylated form p-tau181), and other proteins related to neuroinflammation and blood-brain barrier function.

Development of a Predictive Model for Early Diagnosis: By categorizing and quantifying CSF proteins across various age groups, the study aims to establish a predictive model for the early diagnosis of neurodegenerative diseases, such as Alzheimer's disease. The ability to detect these diseases before clinical symptoms emerge could enable early intervention and treatment, offering a crucial window for therapeutic strategies.

Investigation of Dynamic Changes in CSF Biomarkers Across Disease Stages: The study will examine the dynamic changes in CSF biomarkers at different stages of neurodegenerative diseases, including early, middle, and late stages. Understanding the role of these biomarkers in disease progression will provide insights into the pathological processes and potential therapeutic windows.

Creation of a Comprehensive CSF Biomarker Database: A database will be established, encompassing CSF biomarkers from various age groups, disease states, and treatment responses. This resource will be invaluable for future research, facilitating the scientific community's understanding of neurodegenerative diseases and the development of new therapeutic approaches.

Through the achievement of these objectives, this study aims to advance the application of CSF biomarkers in neuroscience research and clinical practice, ultimately improving the diagnosis, management, and treatment of aging-related and neurodegenerative conditions.

Eligibility Criteria:
1. Inclusion Criteria:

   * Patients aged 0 to 90 years will be selected for the study.
   * Patients admitted for surgery under spinal anesthesia due to non-neurological conditions, such as lower limb fractures or hemorrhoids.
   * Pediatric patients undergoing surgical treatment for tethered spinal cord syndrome.
2. Exclusion Criteria:

   * Patients with neurological conditions, including encephalitis, Parkinson's disease, Alzheimer's disease, hydrocephalus, brain tumors, and psychiatric disorders.
Liposomal Bupivacaine (Exparel ® ) Plus 0.5% Bupivacaine HCL Versus 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB) for Patients Undergoing Total Shoulder Arthroplasty(TSA)

This is a phase IV , randomized, single-blind, single-center study comparing patient related outcomes such as postoperative pain and opioid usage for patients who receive ISB 's containing liposomal bupivacaine (Exparel®) plus 0.5% bupivacaine HCL versus 0.5% bupivacaine HCL undergoing total shoulder arthroplasty. The objective of this study is to compare opioid utilization and pain management of patients who receive Exparel in an ISB vs standard 0.5% bupivacaine HCL during the initial 72 --- hour post --- operative period. Additionally, to understand the duration of block after addition of Exparel® to bupivacaine in an Interscalene block after TSA.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing total shoulder arthroplasty;
* Patients who consent to be randomized.

Exclusion Criteria:

* Patients younger than 18 and older than 75;
* Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer;
* Patients who are allergic to oxycodone;
* Patients who are unable to speak English;
* Patients with diagnosed or self---reported cognitive dysfunction;
* Patients with a history of neurologic disorder that can interfere with pain sensation;
* Patients with a history of drug or recorded alcohol abuse;
* Patients who are unable to understand or follow instructions;
* Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
* Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;
* Patients with BMI over 40;
* Any patient that the investigators feel cannot comply with all study related procedures;
* NYU Langone Health students, residents, faculty or staff members
Oral Glutathione As A Skin Whitening Agent

The objective of the study was to evaluate the efficacy and safety of oral glutathione for 12 weeks, used as a skin-whitening agent. The study was a randomized, double-blind, placebo-controlled, multicenter study, set at Dermatology outpatient clinic at three different hospitals in Indonesia, Gatot Seobroto Army Hospital Jakarta, Dr. dr. Wahiddin Soedirohoesodo Hospital Makassar, and University of Sumatera Utara Teaching Hospital Medan. Ninety healthy females, aged between 33 and 50 years, were randomized to receive either glutathione capsules or placebo for 12 weeks and evaluated every 4 weeks. The main outcome was total reduction (improvement) of spot UV, spot polarization, and skin tone measured at five different sites for each indices, recorded by Janus Facial Analysis System®.

The objective of the study was to evaluate the efficacy and safety of oral glutathione for 12 weeks, used as a skin-whitening agent.

The study was a randomized, double-blind, placebo-controlled, multicenter study, set at Dermatology outpatient clinic at three different hospitals in Indonesia, Gatot Seobroto Army Hospital Jakarta, Dr. dr. Wahiddin Soedirohoesodo Hospital Makassar, and University of Sumatera Utara Teaching Hospital Medan.

Ninety healthy females, aged between 33 and 50 years, were randomized to receive either glutathione capsules (500 mg) or placebo capsules, which were identical in appearance and packaged in identical-looking containers. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks. Compliance was assessed by counting the remaining capsules at each follow-up visit.

At each follow-up visit, subjects were asked to grade the overall response and questioned regarding adverse events. The objective or main outcome was total reduction (improvement) of spot UV, spot polarization, and skin tone measured at five different sites for each indices, recorded by Janus Facial Analysis System®.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects with skin type Fitzpatrick IV and V
* Women aged from 30 to 55 years with an understanding of all the information given by a written consent form
* Working indoor office jobs (for minimum 8 hours)

Exclusion Criteria:

* Personal or family history of skin cancer, especially melanoma
* Consumption of any preparations containing glutathione within 1 month of enrollment
* Use of any topical skin brightening or whitening preparations within 1 month of enrollment
* Pigmentary disorders or any dermatoses, which may affect the measurement within the study areas
* A pregnant or breastfeeding mother
* Personal history of drug allergy or skin disorder due to side effects of oral therapy
Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation

A Prospective, Open, Multi-Center, Controlled Study to Evaluate the Safety, Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation.

The clinical study is intended to establish the efficacy and safety of the CardiacSense1 wearable device intended to monitor and detect heart arrhythmia, specifically atrial fibrillation (A-Fib) based on a comparison to a control device, which is an off-the-shelf cleared Holter ECG device

The clinical study is intended to establish the efficacy and safety of the CardiacSense1 wearable device intended to monitor and detect heart arrhythmia, specifically atrial fibrillation (A-Fib). Study design as as follows:

100 subjects, 50 (at least 30% of each gender) with A-fib and 50 without (at least 30% of each gender).

All subjects will be measured during at least 24 hours. Primary endpoint - A-Fib detection Control: Holter device will be the reference

For PPG analysis, each one hour will be considered as an event:

If A-Fib is present for more than accumulated 5 minutes in that specific hour then it shall be considered an "A-Fib hour" If A-fib was present for less than accumulated 5 minutes then it shall be considered a "Non-A-Fib hour".

For ECG analysis, each measurement of between 1-3 minutes will be considered an event.

If A-Fib is present at that specific measurement, then it shall be considered an "A-Fib event" If A-fib was not present at that specific measurement, then it shall be considered a "Non-A-Fib hour".

Sensitivity (true positive) is defined as the percentage of Holter defined "A-fib hours"/"A-Fib event" found by PPG/ECG.

The asked sensitivity is 90%. Specificity (true negative) is defined as the percentage of Holter defined "Non-A-fib hours"/"A-Fib event" found by PPG/ECG. The required specificity is 90%.

Eligibility Criteria:
Inclusion Criteria:

* Age of eighteen (18) year and above
* Diagnosed with atrial fibrilation (Permanent of persistent), or healthy participants able to and willing to sign the informed consent form For control group-no known cardiac problems

Exclusion Criteria:

* Subjects who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study.
* Subjects with low perfusion as indicated by the watch
* Women who are pregnant or breastfeeding
Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration

The main objective was to test the hypothesis that adding lidocaine to hyperbaric levobupivacaine could change the duration of levobupivacaine spinal block.

A satisfactory spinal anaesthesia requires both a fast onset and proper duration at the same time. Transurethral resection of the prostate (TUR-P) is a surgery of medium duration. The addition of lidocaine to hyperbaric bupivacaine shortens the duration of bupivacaine spinal block and therefore provides more rapid recovery. This property of lidocaine is not verified with other local anesthetics. Levobupivacaine is a S-enantiomer of racemic bupivacaine and is a long acting local anesthetic.The aim of this prospective randomized controlled study was to investigate this effect of lidocaine, with a local anesthetic other than bupivacaine. It was hypothesized that the duration of the intrathecal block could change when performed with hyperbaric levobupivacaine mixed with low dose lidocaine and this technique could be consistent for the duration of TUR-P surgery. Participants will be followed on the day of surgery for primary and secondary outcome measures and 3 days postoperatively for complications (TNS).

Eligibility Criteria:
Inclusion Criteria:

* elective transurethral resection of the prostate (TUR-P)

Exclusion Criteria:

* patients with contraindications for spinal anesthesia,
* known sensitivity to the study drugs,
* emergency cases, and
* patients who refused spinal anaesthesia were excluded