cyrilzakka/clinical-trials huggingface dataset:
Post Operative Cognitive Dysfunction After Breast Surgery

Aim of this trial is to define if Post-Operative Cognitive Dysfunction, detected analyzing changes between pre-operative and post-operative Neurocognitive Test, and Postoperative Delirium, relate to concentration of effector's site concentration of propofol and remifentanil TCI and to the common intraoperative neuromonitoring values as well as to Pupillometry values (in particular Pupil Diameter, Pupil Latency, and Maximum Contraction Velcoity).

Post-Operative Cognitive Dysfunction has not been yet investigated after general anaesthesia with Targeted-Controlled-Infusion (TCI) and Laryngeal-Mask-Airway (LMA), daily used in the investigator's Hospital to anesthetize women undergoing breast surgery. Aim of this trial is to define if neurocognitive tests (Montreal Cognitive Assessment, Trail Making Test A and B, Digit Span Test) before and after surgery, and CAM for Postoperative Delirium relate to concentrations at effector's site (Ce) of propofol and remifentanil TCI and the values of Bispectral Index and Entropy monitoring and Surgical Plethysmographic Index (SPI), as well as to Pupillometry values.

Eligibility Criteria:
Inclusion Criteria:

* General Anaesthesia delivered with Propofol and Remifentanil with Targeted Controlled Infusion
* Use of Laryngeal Mask airway

Exclusion Criteria:

* Neurological pathologies
* Haemodynamical instability during surgery
Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization

The purpose of this trial was to determine the safety and efficacy of eculizumab in the prevention of antibody-mediated rejection (AMR) in sensitized recipients of a living donor kidney transplant requiring desensitization therapy.

The main objective of this study was to evaluate the safety and efficacy of eculizumab to prevent AMR in sensitized recipients of living donor kidney transplants requiring desensitization therapy prior to transplantation. The primary endpoint focused on acute AMR during the first 9 weeks post-transplantation.

Patients were to be vaccinated against N. meningitidis at least 14 days prior to study drug initiation and revaccinated 30 days later. If not vaccinated 14 days prior, prophylactic antibiotics were to be administered. Pre-transplant infectious disease assessment was to be performed as part of the screening assessment.

Patients were to undergo desensitization therapy according to the practice of the local transplant center prior to transplantation, and this desensitization practice was to be uniformly applied for all patients at that center throughout the study. The actual length of desensitization for an individual patient was based on the clinical judgment of the Transplant Center team. Rituximab was prohibited in all patients as part of the pre-transplantation desensitization therapy due to potential pharmacodynamic interactions.

The control group was designed to test eculizumab against the best available care (referred to as standard of care, or SOC) consisting of plasmapheresis (PP) and/or intravenous immunoglobulin (IVIg). The best available care consisting of PP and IVIg was chosen because these modalities combined represented the most prevalent therapy reported in the literature and were the best available therapies at the time of this protocol's inception as per the transplant community.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients ≥18 years old
2. Patients with Stage IV or Stage V chronic kidney disease who will receive a kidney transplant from a living donor to whom they are sensitized and require desensitization prior to transplantation

Exclusion Criteria:

1. ABO incompatible with living donor
2. Any medical condition that, in the opinion of the Investigator, might interfere with the patient's participation in the study, poses an added risk for the patient, or confounds the assessment of the patient
Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma

Collect real world safety data on the use of sonidegib in adult patients with laBCC. Document major safety parameters such as on treatment deaths, adverse events (AEs)/ serious adverse events (SAEs) and discontinuation secondary to AEs.

This is a non-interventional, multinational, multi-center post-authorization safety study (PASS), to assess the safety of sonidegib administered in routine clinical practice in patients with laBCC who are not amendable to curative surgery or radiation therapy. This study is observational in nature and does not impose a therapy protocol, diagnostic/therapeutic interventions or a specific visit schedule. For this study, each enrolled patient will be followed up for 3 years after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent or equivalent document (e.g., written information) as per country regulation
* Patients aged 18 years or older with a diagnosis of laBCC who are not amenable to curative surgery or radiation therapy
* Patients must be treated with sonidegib 200 mg orally taken once daily (dose modifications according to the approved local country prescribing information are permitted)
* Sonidegib treatment must be started either at the first visit for this study or prior to study entry.

Exclusion Criteria:

* Patients treated with any hedgehog pathway inhibitor besides sonidegib within 3 months prior to study entry
* Patients currently enrolled in an interventional clinical trial
* Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the Summary of Product Characteristics (SmPC)
* Pregnancy and breast-feeding
* Women of childbearing potential who do not comply with the Odomzo Pregnancy Prevention Programme (as defined in sections 4.4 and 4.6 of the approved SmPC).
* Male patients who are unable to follow or comply with the required contraception measures (as defined in sections 4.4 and 4.6 of the approved SmPC).
Platelet Rich Therapy for Facial Rejuvenation

This study will be a prospective study of patients who undergo platelet-rich therapy (PRT) for facial rejuvenation at NYU Langone Medical Center. PRT has been increasingly used for wound healing, fat grafting, hemostasis as well as facial enhancement. PRT involves injection of patient's own platelets and fibrin, and has evolved as a less invasive technique for facial rejuvenation compared to more traditional techniques. Through the use of pre and post treatment photos, in addition to the FACE-Q Questionnaire and a clinician assessment, it is our hope that we will confirm the rejuvenating capabilities of PRT.

To assess patient-reported satisfaction of using platelet rich therapy for facial rejuvenation using a validated questionnaire (the FACE-Q scale). This is a prospective study of patients who will undergo platelet-rich therapy for facial rejuvenation at NYU Langone Medical Center. Platelet rich therapy (PRT) has been increasingly used for wound healing, fat grafting, hemostasis as well as facial enhancement. PRT involves injection of patient's own platelets and fibrin, and has evolved as a less invasive technique for facial rejuvenation compared to more traditional techniques. However, while platelet rich therapy for facial enrichment continues to gain popularity; little evidence exists to support its use in the current literature. Therefore, this study sets out to determine patient satisfaction as well as quality of life following PRT for facial rejuvenation. PRT has been previously used successfully in facial plastic surgery and is being offered as an option as part of standard of care for facial rejuvenation (Sclafani).

Subjects will be identified by the principal investigator as they present to the office for facial rejuvenation and are interested in an alternative to soft tissue fillers. All such patients will be given PRT as an alternative option for facial rejuvenation and any patient who agrees to this therapy will be enrolled in the study. Subject enrollment will continue until a total of 30 subjects are recruited.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Ages 21 - 80
* Patients of all racial and ethnic origins
* Patients of Dr. Hazen undergoing facial rejuvenation

Exclusion Criteria:

* Patients undergoing facial rejuvenation using other methods including botox injections, chemical peels, face lifts and others.
* Patients using blood thinners that cannot be stopped
* Patients who have used aspirin within a week of the procedure date
The Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Female Participants With Interstitial Cystitis /Bladder Pain Syndrome (MK-7264-005)

The purpose of this study is to assess the efficacy of gefapixant (AF-219/MK-7264) in female participants with moderate to severe pain associated with interstitial cystitis/bladder pain syndrome (IC/BPS) after 4 weeks of treatment.

This study is a double-blind, placebo-controlled, randomized trial designed to assess the efficacy and safety of gefapixant in female participants with moderate to severe pain associated with IC/BPS. The study will consist of 4 phases: Screening, Baseline, Treatment, and Follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Women of child bearing potential must not be pregnant during the study and must use two forms of birth control
* Clinical evidence of Interstitial Cystitis /Bladder Pain Syndrome (IC/BPS)
* Have provided written informed consent

Exclusion Criteria:

* History of diseases that can be confused for IC/BPS
* Unable to void spontaneously
* Immunosuppressant, intravesicular, nerve stimulator or opioid treatment for certain periods prior to start of the study
* Changes to doses of Elmiron®, antidepressant, alpha-adrenergic antagonist, H1 antagonist, or anti-muscarinic treatment within a certain period prior to the start of the study
Neurophysiological Attention Test (NAT) for Objective Assessment of Adult ADHD

The purpose of this study is to refine a new assessment tool for Attention Deficit/Hyperactivity Disorder (ADHD) and then to test its validity (i.e. ability to discriminate between individuals with ADHD and healthy controls.

The purpose of this study is to build upon the success the novel approach and software for analyzing electroencephalography (EEG) data to identify biomarkers of ADHD in adults by further refining the method. Then to test the ability of this new assessment tool to differentiate between adults with ADHD and healthy controls by comparing the classification accuracy of the metrics from the new tool to the classification accuracy of existing behavioral tests for ADHD.

Eligibility Criteria:
Inclusion Criteria:

Specific inclusion criteria for ADHD are:

1. meet established Diagnositic and Statistical Manual-5 criteria for ADHD predominately inattentive or combined subtype with clinically significant levels of impairment, diagnosed by structured clinical interview, the Mini International Neuropsychiatric Interview, and corroborating information
2. Clinical Global Impression-Severity (CGI-S) score ≥ 4 for ADHD
3. no lifetime history of DSM-5 bipolar disorder, psychotic disorder, pervasive developmental disorder, obsessive-compulsive disorder, substance abuse, or substance dependence (except nicotine) as assessed with the Mini International Neuropsychiatric Interview (MINI).
4. able in the opinion of the investigator to complete all required study procedures.

Exclusion Criteria:

Exclusion criteria for both groups are:

1. History of diagnosis of childhood disorder other than ADHD (e.g. autism, dyslexia)
2. history of any general medical condition likely to require chronic use of medication with identified central nervous system (CNS) effects suspected to alter cognitive performance
3. history of seizure disorder, brain tumor, other major neurological disorder or head injury resulting in loss of consciousness
4. serious oxygen deprivation
5. current psychopathology requiring ongoing treatment with antipsychotic medications, mood stabilizers, benzodiazepines, or anticonvulsants
6. current untreated psychopathology which is rated to be primary in terms of severity (greater than ADHD severity)
7. current treatment with guanfacine.
Outcome Measures of Modified Constraint Induced Movement Therapy Versus Dual Task Training on Upper Extremity and Cognitive Functions in Patients With Hemiparesis

All stroke patients were assessed via isokinetic dynamometer, Montreal cognitive assessment scale (MOCA) and Fugl Myer Upper extremity (FMUE) before and after the treatment program.

The patients were classified randomly into three equal groups, Study group A (GA) receiving modified constraint induced movement therapy in addition to conventional physical therapy program, Study group B (GB) receiving dual task training in addition to conventional physical therapy program and control group C (GC) receiving only conventional physiotherapy program.

Eligibility Criteria:
Inclusion Criteria:

* Patients with age range between 55 and 65 years old.
* The patients were from both genders (males \&females).
* Patients were of duration of illness between 6 and 12 months.
* The patients were scoring 1 \&1+ on modified Ashworth scale (mild spasticity).
* The patients were of good ability to see and hear.
* Consent form was obtained from all participants to approve the study and follow the commands.
* All patients were scoring more than 26 on MMSE. All patients were medically stable.

Exclusion Criteria:

* patients with moderate and sever spasticity.
* patients with cognitive disorder due to other cause rather than spasticity.
* patients with unstable medical conditions.
* patients with previous or recurrent stroke.
* patients with respiratory problems.
* patients with shoulder dislocation or subluxation or frozen shoulder.
* patients with uncontrolled hypertension, diabetes mellitus, unstable angina or heart failure.
A Phase I/II, Randomized, Double-blind, Placebo, and Active Controlled Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, and Preliminary Efficacy of JHM03 in Subjects With Moderate to Severe Glabellar Lines

This is a phase 1/2, multicenter, randomized, double-blind, active-controlled and placebo-controlled study to evaluate safety, immunogenicity and efficacy of JHM03 for the treatment of moderate to severe glabellar lines in male and female subjects of Chinese origin. The purpose of this study was to observe efficacy and safety of JHM03 compared with placebo and BOTOX® in moderate to severe glabellar lines.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects between 18 and 65 years of age.
2. Moderate to severe glabellar lines at maximum frown at baseline.

Exclusion Criteria:

1. Previous use of any botulinum toxin within 6 months prior to screening, or plan to use any botulinum toxin during the study.
2. Use of medications that affect neuromuscular transmission within 4 weeks prior to screening, such as muscle relaxant,aminoglycoside antibiotics,anticholinergic drugs,benzodiazepines,etc.
3. Suffering from any neurological disorders that increase the risk of exposure to botulinum toxin type A, including peripheral motor nerve diseases (such as amyotrophic lateral sclerosis and motor neuropathy), as well as neuromuscular junction diseases (such as Lambert-Eaton syndrome and myasthenia gravis).
4. Known allergy or hypersensitivity to any component of the study products.
5. Use of any non-steroid anti-inflammatory drug or anticoagulant within 1 week prior to study treatment.
6. History of alcohol or drug abuse.
Evaluation of Radiesse® Dermal Filler for Hand Treatment

The purpose of this study is to assess the safety and effectiveness of Radiesse® Injectable Dermal Filler for hand treatment.

This is a prospective, randomized, masked, controlled study to investigate the effectiveness of Radiesse® Dermal Filler for hand treatment, comprised of a 3-month main study followed by an open-label extension (OLEX) study through 12 months. At 3 months, untreated controls received Radiesse Dermal Filler for hand treatment and were followed for the remainder of the study. All study subjects were eligible for retreatment 6 months after initial treatment, and all subjects were followed through 12 months from study enrollment in the OLEX.

Eligibility Criteria:
Inclusion Criteria:

* Has right and left hands with rating of 2 or 3 on the Merz Hand Grading Scale (MHGS) as determined by a live, masked evaluator
* Is at least 18 years of age

Exclusion Criteria:

* Has history of hypertropic scarring
* Has a known bleeding disorder or receiving medication that will increase the risk of bleeding as the result of injection
* Has a known hypersensitivity to any of the components of Radiesse or local anesthesia
* Has received in past 6 months or plans to receive during the study dermal resurfacing procedure (chemical peel, dermabrasion, ablative laser resurfacing) or non-invasive skin tightening (Thermage®) in the dorsum of the hands
* Has received in past 2 weeks or plans to receive during the study prescription wrinkle therapies, topical steroids, skin irritating topical preparations, or pigmenting agents (self-tanning agents) in the dorsum of the hands
* Has had any dermal fillers or surgery in the dorsum of the hand
Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children

This was a pilot study to determine the safety and effectiveness of a twice daily, seven-day dosing regimen in acute, pediatric, otitis media in children with tympanostomy tubes. The currently approved regimen is twice daily for 10 days.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 6 months of age to \<12 years of age
* weight = or \>4.5 kg
* Patent tympanostomy tube(s) in the affected ear(s)
* Purulent or mucopurulent otorrhea of recent onset of presumed bacterial origin

Exclusion Criteria:

* Non-bacterial otic infection
* Known or suspected hypersensitivity to ofloxacin
* Cystic fibrosis
* HIV infection
* Neutropenia
* Receiving immunosuppressive therapy
Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer

The purpose of this study is to study patients presenting with stage IV breast cancer. Stage IV means that the breast cancer has spread to another part of the body outside the breast. This study is important because in different parts of the country some patients are being offered surgical treatment for the breast tumor and some are not. The doctors do not know if surgery for the breast tumor is helpful in patients with stage IV breast cancer. The doctors will collect information about the patient and their treatment to learn more about how patients and doctors make treatment decisions. The doctor will also collect blood samples and tissue samples for laboratory studies to learn more about tumors that have spread to other parts of the body.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Known or suspected Stage IV breast cancer with intact primary tumor
* Known or suspected Stage IV breast cancer with intact primary tumor, having begun systemic therapy within the past 12 months
* Known or suspected Stage IV breast cancer within 3 months of local breast surgery
* Known or suspected Stage IV breast cancer within 3 months of local breast surgery, having begun systemic therapy within the past 12 months

Exclusion Criteria:

* Primary breast cancer diagnosis made by FNA only and no pre-treatment core biopsy planned for diagnostic or research purposes.
* Failure of MSKCC or participating site to confirm Stage IV breast cancer diagnosis by biopsy within 30 days of study enrollment
The C-MERIT Screening Cohort: Contrast-enhanced Mammography for Breast Cancer Screening and Risk Assessment in Women With Dense Breasts

To learn whether a new imaging technology, Contrast-Enhanced Mammography (CEM), compared to standard mammography, can better detect breast cancers in women with dense breasts

Primary Objectives:

* To establish a cohort of 1,000 female MDACC patients with dense breasts who undergo screening contrast-enhanced mammography.
* To establish a comprehensive integrated database of imaging, clinical data, health measurements, and questionnaire data including data from the companion protocol PA17-0584.

Secondary Objectives:

* To perform within-subject comparison of the cancer detection rate between CEM and FFDM.
* To perform within-subject comparison of the sensitivity, specificity, and recall rates of CEM compared to low-energy (LE) images (FFDM equivalent) and compared to a combination of LE and DBT images among women with dense breasts.
* To evaluate the effect of the availability of prior imaging for comparison on the recall rates of CEM, FFDM and DBT.
* In patients who undergo screening breast ultrasound as a standard of care, to evaluate the performance of screening ultrasound for breast cancer detection and compare it with other imaging modalities of CEM, LE images, and DBT.

Exploratory Objectives:

* To combine imaging, blood biomarkers, health measurements and questionnaire data for assessment of breast cancer risk.
* To evaluate if the intensity of background parenchymal enhancement on CEM predicts breast cancer risk in women with dense breasts.
* To evaluate if patients consider CEM as a potentially acceptable imaging modality for routine breast cancer screening.

Eligibility Criteria:
Inclusion Criteria:

1. Female patients 30-75 years of age with dense breasts (ACR BI-RADS categories C and D) who undergo routine yearly mammography at participating MDACC sites
2. Willingness to co-enroll or currently enrolled in PA17-0584
3. Willingness to participate in the study and ability to provide informed consent

Exclusion Criteria:

1. Self-reported new breast symptoms since last mammogram including nipple discharge, palpable mass, skin dimpling, or focal pain.
2. Current or recent (within the prior 6 months) history of pregnancy or breast feeding
3. Personal history of breast cancer (DCIS or invasive breast cancer)
4. Treatment of any other type of cancer within the past 5 years excluding in-situ cervical and non-melanoma skin cancer
5. Breast biopsy within 6 months
6. Breast surgery within 12 months
7. Breast MRI, MBI, or CEM performed within 24 months
8. Known allergy to iodine-containing contrast agents
9. History of anaphylactic reaction to any substance that required hospitalization or IV placement in a patient with no known prior uneventful exposure to iodine-based IV contrast
10. Renal insufficiency (as defined by UTMDACC policy 3.30- attachment 1 (appendix D)