cyrilzakka/clinical-trials huggingface dataset:
Design of a Prototype Garment Adapted to Demented Elderly Subjects With Disturbing Behavioral Problems in the Management of Sphincter Disorders

Alzheimer's disease and related disorders (ADRD) are diseases whose frequency is increasing in elderly subjects. Their evolution is marked by the occurrence, in addition to cognitive disorders, of increasingly disruptive behavioral disorders that interfere with their management, as well as impairment of basic functions, including the occurrence of sphincter disorders responsible for daytime and nighttime urinary and fecal incontinence. These disorders are present in more than 80% of LAM patients and are of multifactorial origin.

It is difficult to get patients to accept wearing the necessary protection. They tend to remove or tear them off. This can frequently lead to stressful situations of agitation and inappropriate behavior for patients and uncomfortable continence management for caregivers.

In order not to be forced to use heavy physical restraints or therapeutics that promote drowsiness so that the patient cannot remove his or her protections, the only effective response today is to wear a garment. Unfortunately, the ones that exist today are strictly functional and are worn at night.

The use of such garments, during the day, in this indication, is therefore a common and usual practice today.

This results in an ethical problem for the caregivers. Indeed, worn during the day, rompers give the impression to the latter that they show a devaluing, infantilizing or even degrading image of the elderly person. This practice, although common and accepted because it is the only recourse to physical and chemical restraints to preserve the cleanliness and presentation of elderly patients, could lead to an impaired dignity which could be badly experienced by their close circle of friends and family as well as by the carers and could also have an impact on the overall effectiveness of the care .

This is the first time that a multi-professional team integrating doctors, caregivers, occupational therapists and engineers have reflected on the design of a garment that meets the expectations of caregivers, patients and their families. The romper thus designed must be able to retain the aesthetic characteristics of a garment that meets the tastes of the elderly while respecting their dignity.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized in a cognitive-behavioral unit or long-term care or residents of the EHPAD at the St-Victor center - CHU Amiens-Picardie,
* patients with behavioral and sphincter disorders justifying the prescription of a romper.
* signature of a consent exclusion criteria

Exclusion Criteria:

* No next of kin
* Patients in terminal palliative care
* Patients whose morphology does not allow the use of prototypes (no adapted size)
Utilizing CT Based Imaging Parameters of Body Composition to Understand Heterogeneity of Response to Biologic Therapies in Severe Asthma Cohorts

This study will utilize University of Michigan EMR data to form a retrospective cohort of severe asthma patients on biologic therapies for asthma with computed tomography (CT) imaging and known outcomes on therapy. These images will then be analyzed using morphomics, a combination of high-throughput image analysis and deep learning techniques, to derive imaging biomarkers that will be able to predict therapeutic response to biologics. These biomarkers will then be tested in a second cohort from the National Jewish Health to assess for validity.

The two arms for this study represent the two cohorts: the University of Michigan cohort, and the National Jewish Health cohort. The cohorts were split into arms, as the National Jewish Health cohort was intended to act as a validator group for results derived from participants in the University of Michigan cohort.

Eligibility Criteria:
Inclusion Criteria:

* Asthma diagnosis defined as a positive methacholine test, supportive PFTs, or clinician diagnosis with appropriate supporting clinical context
* Prescribed and taking an FDA-approved biologic medication for severe asthma (mepolizumab, benralizumab, reslizumab, omalizumab, or dupilumab)
* Chest computerized tomography (CT) images taken for any clinical purpose

Exclusion Criteria:

* 10-year history of smoking
* Evidence of emphysema on CT imaging
* Severe bronchiectasis secondary to other causes (subjects with scattered bronchiectasis secondary to severe asthma will not excluded)
* Lack of accessible adequate follow-up information (4 or more months from drug initiation with clear documentation of response) will be excluded from final analysis due to inability to assess response but will be included in the initial cluster identification
Prediction of MMSE Scores for Cognitive Impairment

This study aims to explore the potential of using machine learning (ML) algorithms to predict cognitive status, specifically MMSE scores, based on oral health and demographic data. The objective is to evaluate the effectiveness of various ML models and identify the most relevant oral health indicators for predicting MMSE scores of 30 (normal cognition) or ≤26 (cognitive impairment) in individuals aged 60 and above.

This cross-sectional study utilizes oral health and demographic data from two existing cohort studies: the European collaborative study Support Monitoring and Reminder Technology for Mild Dementia (SMART4MD) and the Swedish National Study on Aging and Care (SNAC-B). Participants aged 60 years or older will be included in the analysis. The data will be used to develop and evaluate machine learning models for predicting cognitive status.

Objectives:

1. Primary Objective: To assess the potential of oral health parameters for binary classification of MMSE scores (30 vs. ≤26).
2. Secondary Objective: To identify the most influential oral health parameters contributing to cognitive impairment predictions.
3. Tertiary Objective: To compare the performance of Random Forest (RF), Support Vector Machine (SVM), and CatBoost (CB) classifiers in predicting MMSE scores using oral health data.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 60 years or older.
* Participants with recorded oral health parameters and MMSE scores of either 30 or ≤26.

Exclusion Criteria:

* Individuals with MMSE scores of 27, 28, or 29, as these scores represent a transition phase between normal cognition and cognitive impairment, which could introduce variability.
* Individuals younger than 60 years.
Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's Disease

The purpose of this study is to evaluate the effectiveness of neuroprotection from granulocyte colony-stimulating factor on Parkinson disease

Parkinson's disease (PD) is the second most common neurodegenerative disease and the severity of PD still progress during the ensuing years. Currently, there is no promising medical or surgical treatment to abrogate the disease deterioration. Granulocyte colony-stimulating factor (G-CSF), one of hematopoietic growth factors, has been routinely used for hematologic disorders and stem cell harvest from normal subject. G-CSF also demonstrated neuroprotection for rodents PD model. We hypothesize G-CSF will exert the effectiveness of neuroprotection for PD patients.

Eligibility Criteria:
Inclusion Criteria:

* Hoehn \& Yahr stage I\~III
* Patients with idiopathic Parkinson's disease(PD), who meet the United Kingdom Parkinson's Disease Society Brain Bank diagnostic criteria, with a good response to levodopa
* The onset of PD symptoms must be occurred \> = 40 years of age (to exclude YOPD), and the patient must have been diagnosed with idiopathic PD \> =40 years of age
* Patients may have symptoms of wearing OFF and/or levodopa induced dyskinesia
* Patients must rate between Hoehn \& Yahr stage I to III, when in an OFF medication state
* Patients must in their optimal medication treatment state, and will not changing their medications within 3 months before and after enrollment

Exclusion Criteria:

* Patients who are proved to be Young Onset Parkinson's Disease (YOPD) and/or genetically related (e.g. Parkin).
* Women of child-bearing potential, pregnant or lactating.
* Patients who are proved to have tumor growth and/or malignancy.
* Patients with a past (within one year) or present history of psychotic symptoms requiring anti- psychotic treatment.
* Patients with active symptoms of major depression with suicidal ideation or suicide attempt.
* Patients with previous brain surgery (including pallidotomy and deep brain stimulation).
* Patients with significant cognitive impairment ( Mini-Mental State Examination, MMSE \< 24).
* Patients who do not sign the inform consent,
Human Dopamine Transported Imaging in Cocaine Abuse: 2 - 2

The purpose of this study is to determine the density of DA transporters during prolonged cocaine abuse and during withdrawal from cocaine use. This aim will test the hypothesis that DA transporters are altered by cocaine abuse and reestablished during withdrawal.


Eligibility Criteria:
Please contact site for information.
Assessment of Patient Experience and Needs for Patients Undergoing Invasive Inguinal Lymph Node Procedures for Penile Cancer

To learn more about the patient experience undergoing inguinal (in the groin) lymph node procedures for penile cancer during and after surgery.

Objectives

Primary Objective:

To understand the lived experience of patients undergoing invasive inguinal lymph node procedures.

Secondary Objective:

To determine factors that influence decisions and improve experience for patients who need invasive inguinal lymph node procedures.

Eligibility Criteria:
Inclusion Criteria:

--Patients diagnosed with penile cancer who have undergone invasive inguinal node procedures (ILND and/or DSNB) and are at least 6 months post-procedure

Exclusion Criteria:

* Patient's ≤18 years of age
* Patients who have not undergone invasive surgical procedures involving the inguinal lymph nodes
* Non-English-speaking patients For interviews: people who are physically and/or cognitively incapable of participating in a 60minute telephone interview as determined by a clinical provider or the patient.
Treatment of Alopecic Scars by Follicular Unit Extraction Hair Transplantation

This study aim: is to completely hide the alopecic scars in a way that it will not be visible.

Practicing scar revision, there is an increasing demand for almost complete reconstruction and camouflaging scars in hairy areas rather than scars in non-hairy skin. Scar revision rendered insufficient reconstructive tool in such cases. Whatever a Plastic surgeon pay efforts in alopecic scars rejuvenation and reconstruction, it is still apparent and noticeable. One of the best surgical techniques to camouflage an alopecic scar is hair transplantation. FUE is the state-of-the-art technique for hair transplantation.

In the field of hair restoration, there has been a significant increase in demand with patients for facial hair transplantation procedures. Modern techniques in hair transplantation is based on follicular unit extraction and implantation, in which follicular units are the exclusive structures used as hair grafts allow for facial hair transplantation and for the attainment of natural-appearing results. Facial hair transplantation is a subspecialty within hair restoration with many gratifying benefits for the patients as well as for the hair restoration surgeon. Adapting these advanced techniques into a hair restoration practice allows a surgeon to offer their patients these procedures and provides an expanded artistic element to a hair restoration surgeon's practice. The art and science of hair transplantation have come a long way since its introduction in 1959. Both the technique and instruments have been greatly improved, thus offering the patient an excellent cosmetic result that will last a lifetime.

Eligibility Criteria:
Inclusion Criteria:

* small scalp alopecic scars.
* post traumatic alopecic beard scars
* post traumatic alopecic moustache scars.
* post traumatic alopecic scalp scars.
* post traumatic alopecic eyebrow scars.
* post burn small alopecic scars.
* mature scars.
* controlled infective scars.

Exclusion Criteria:

* large alopecic scars
* post burn alaopecic scar
* uncontrolled active scar
* male pattern baldness
* female pattern baldness
Post Operative Pain Management Through Adductor Canal Block With Bupivacaine for ACL Reconstruction

Liposomal bupivacaine injectable suspension (Exparel), manufactured by Pacira Pharmaceuticals, is an FDA-approved, long-lasting nonopioid analgesic that is indicated for single-dose infiltration in adults to produce postsurgical local analgesia. Exparel's extended bioavailability allows for 48 hours of pain control. Periarticular infiltration of liposomal bupivacaine has been safely and effectively used for total knee arthroplasty as an alternative to FNBs, avoiding transient quadriceps weakness and potential in-hospital falls. Recently Exparel has been FDA approved for interscalene brachial plexus nerve block to produce postsurgical regional analgesia for upper extremity/shoulder procedures. It is not yet approved for peripheral nerve blocks of the lower extremity.

No study to date, to our knowledge, has evaluated the efficacy of single-dose adductor canal blockade with Exparel compared to femoral nerve catheter with bupivacaine. We pose that Exparel used for an adductor canal block can offer the benefit of a single-dose injection with extended pain control without the burden of an indwelling catheter and to avoid adverse events of femoral nerve blockade related to quadriceps weakness and dysesthesias.

The purpose of this study is to determine whether adductor canal blockade with liposomal bupivacaine (Exparel) is a safe and effective alternative to femoral nerve catheters for post-operative pain control for patients undergoing ACL reconstruction.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing primary anterior cruciate ligament reconstruction with autograft
2. Has not used narcotic pain medication in 3 months
3. Ages of 18+
4. Proficient in the English language
5. Willing and able to follow study protocol

Exclusion Criteria:

1. ACL repair, revision surgery, or allograft
2. Multi-ligamentous knee injuries
3. Cartilage procedures that prevented adherence to the immediate weightbearing and range of motion rehabilitation protocol
4. Patients taking baseline opioid for other injury
5. Dementia or other psychiatric illness that would preclude accurate evaluation
6. Pregnant or lactating patients
7. Non-English speakers as questionnaires are only available in English
Phase 1 Study of ACR-2316 in Specific Advanced Solid Tumors

This is a first in-human, Open-label Phase 1 study to assess the safety of ACR-2316 for the treatment of subjects with specific, histologically confirmed, locally advanced, recurrent or metastatic solid tumors.

The Phase 1 monotherapy clinical trial for ACR-2316 is designed to assess the safety and tolerability of ACR-2316. Additional objectives include the determination of the maximal tolerated dose and recommended Phase 2 monotherapy dose, characterization of the pharmacokinetic profile, and preliminary evaluation of anti-tumor activity.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent.
2. Histologically or cytologically proven metastatic, recurrent or locally advanced selected solid tumors.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months.
4. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST v1.1.
5. Adequate organ functions.
6. Must have progressed after prior line of treatment.

Exclusion Criteria (all participants):

1. Participants with known symptomatic brain metastases.
2. Participant had systemic therapy or radiation therapy within 2 weeks prior to the first dose of study drug.
3. Women who are pregnant or lactating.
Predictors and Outcomes of Meropenem Treatment Failure Among Patients With Septic Shock in Intensive Care Unit

Lately, the inappropriate used of Meropenem in critically ill patient were increased. Therefore, increased development of drug resistance bacteria towards Meropenem.

As known that Carbapenem-Resistance Enterobacteriaceae (CRE) is part of complication when Meropenem is widely used in the intensive care unit. CRE are very difficult to treat within Gram negative bacteria as it encodes Carbapenemase enzyme which breaks down Carbapenem anti-microbial such as Meropenem. The widespread carbapenemase production in the Enterobacteriaceae was unknown until the early 2000 until first reported in 2001. Despite that, most doctors and physician favourite, and still prescribe Meropenem as the antibiotic of choice for the critically ill patients empirically. This is because of its broad spectrum of coverage for bacteria. Thus, a number of Meropenem treatment failure were increased as resistance increase.This study will evaluate the appropriate use of Meropenem and determine the predictors of Meropenem treatment failure as well as the patient outcomes.As a result, it can be a guidance prior prescribing the Meropenem base on patient clinical condition and parameters while balancing the risk and benefits of its used.


Eligibility Criteria:
Inclusion Criteria:

1. Septic shock patient admitted to ICU
2. Age equal or more than 18 years old (No upper limit of age)
3. Receive Meropenem for at least 3 days

Exclusion Criteria:

1. Meropenem as prophylaxis
2. Patient who had culture Carbapenem Resistant Enterobacteriaceae organism (CRE)
3. Patient who admitted with proven diagnosis of Cardiogenic shock
4-weekly Versus 12-weekly Administration of Bone-targeted Agents in Patients With Bone Metastases

The current Rethinking Clinical Trials (REaCT) trial will compare two schedules(12- vs. 4-weekly) of bone-targeting agents (BTAs) to evaluate quality of life, pain and skeletal events within the Canadian Health Care System. This study will use an "integrated consent model" that involves "oral consent" rather than a written informed consent writing process as the study is comparing standard schedules and not a new administration schedule.

Bone metastases are common in patients with advanced breast and prostate cancers. Skeletal metastases can be associated with reduced Quality of Life (QoL), pain and skeletal-related events (SREs) (defined as pathological fractures, surgery/radiotherapy to bone, spinal cord compression and hypercalcaemia). Maintaining QoL while avoiding or delaying SREs are the main goals of therapy. Patients therefore receive bone-targeted agents (e.g. pamidronate, zoledronate and denosumab) which are typically given every 4 weeks. However, this 4 week dosing is based on convenience so the treatment could be given concurrently with chemotherapy. The half-life of these drugs in the bone is many months or even years. Hence studies have been performed evaluating 12-weekly therapy. These have confirmed similar palliative outcomes in the 4 vs 12-weekly groups for both breast and prostate cancer patients. However, there remains clinical equipoise about which dosing interval physicians prescribe. The current trial will compare these two schedules of bone-targeting agents (12- vs. 4-weekly) to evaluate quality of life, pain and skeletal events within the Canadian Health Care System. This study will use an "integrated consent model" that involves "oral consent" rather than a written informed consent writing process as the study is comparing standard schedules and not a new administration schedule.

Eligibility Criteria:
Inclusion Criteria:

* Patients with either radiologically and/or histologically confirmed bone metastases from castrate resistant prostate cancer (36) or breast cancer.
* About to start or currently receiving BTA therapy.
* Serum creatinine \>30 ml/min and corrected serum calcium ≥ 2 mmol/l
* Age ≥ 18 years.
* Able to provide verbal consent

Exclusion Criteria:

* For CRPC patients - Definite contraindication for denosumab at baseline (e.g. hypocalcaemia \[Albumin-corrected serum calcium \< 2.0 mmol/l\]).
* History of or current evidence of osteonecrosis of the jaw.
* Radiotherapy or surgery to the bone planned within 4 weeks after randomization.
* Known hypersensitivity to trial drug or hypersensitivity to any other component of the trial drug (e.g. fructose).
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol.
Open-label Extension Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Neovascular ("Wet") Age-related Macular Degeneration (AMD)

The primary objective is to assess long-term safety and tolerability of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in patients with neovascular AMD.

The dose evaluated in this study, Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg, will be the higher of the 2 dose strengths evaluated in parent study VGFT-OD-0605 (NCT00509795) and is the dose level administered in study VGFT-OD-0702 (NCT00527423), a long-term open-label extension study. For these reasons, this dose has been selected for this extension study.

Participants will be seen in the clinic for quarterly visits starting with day 1 to assess safety. Study drug will be administered on an as-needed basis at the discretion of the investigator with a minimum allowed interval of every 4 weeks and a maximum allowed interval of every 12 weeks. This study will assess the frequency that re-treatment is needed and the effect of continued Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) treatment on BCVA.

Eligibility Criteria:
Inclusion Criteria:

* Participation in Study VGFT-OD-0605 through week 96.
* In the opinion of the investigator, the study eye has neovascular AMD and may continue to require treatment.

Exclusion Criteria:

* Presence of any condition that would jeopardize the patient's participation in this study.
* Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study.