cyrilzakka/clinical-trials huggingface dataset:
THRIVE Feasibility Trial

To evaluate the feasibility of a pragmatic, large scale, comparative effectiveness, randomized evaluation of patient experience of intravenous propofol versus inhaled volatile anesthesia.

Two-center single-blinded randomized feasibility study, with randomization 1:1 to either propofol TIVA or inhaled volatile general anesthesia for patients who are receiving elective non-cardiac surgery. Patients will be stratified by clinical site with 150 participants per site.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Undergoing elective non-cardiac surgery expected to last ≥ 60 min requiring general anesthesia, including a tracheal tube or laryngeal mask airway (or similar supra-glottic device)

Exclusion Criteria:

* Inability to provide informed consent in English
* Pregnancy (based on patient report or positive test on the day of surgery)
* Surgical procedure requiring general, regional, neuraxial anesthesia administered by an anesthesia clinician (anesthesiologist, CRNA, anesthesiology assistant) occurring within 30 days prior to or planned to occur within 30 days after surgery date
* Contraindication to propofol TIVA or inhaled volatile (for example, documented allergy to propofol, history of severe postoperative nausea or vomiting, concern for or history of malignant hyperthermia)
* Surgical procedures requiring specific general anesthesia option (for example, TIVA required for neuromonitoring).
* Hospital approved, written protocol mandating a particular technique
* History of intraoperative awareness during general anesthesia based on patient self-report on the day of consent
* Planned postoperative intubation
Effects Of Unilateral Vibration On Contralateral Forearm Muscle Activity

This study hypothesize that radius subjecting to mechanical loading may affect excitability of alpha motor neuron innervating muscle, based on its bone mineral density or bone mineral content.

A total of 80 voluntaries are planned to include in this study. Vibration will be applied the right forearm. Muscle electrical activity will be measured on ipsilateral and contralateral flexor carpi radialis (FCR) muscle at rest as EMGrms by surface electromyography (EMG). The rest-EMGrms will be measured at before and during vibration. An increase in muscle electrical activity at rest indicates an increase in motor neuron pool activation. The right distal radius bone mineral content (BMC) and density will be measured by dual energy X-ray absorptiometry (DXA).

The right radius bone mineral density (BMD) and BMC will be evaluated by bone densitometer (GE-LUNAR DPX PRO).

Motor unit potentials will be measured by electromyography at left flexor carpi radialis. Neurotrac ETS device will be used.

A functional cooperation exists between bones and skeletal muscles. Bones work together with muscles as a simple mechanical lever system to produce body movement. One of the important functions of bones is to exert resistance against gravity in order to carry the body. In order to carry out their mechanical functions, bones need to have considerable resistance to deformation under load. It is well-known that muscle activity (i.e., exercises) improves the resistance of bone to mechanical loading, and that it is also important for treating and preventing osteoporosis. Resistance and impact training have been shown to induce bone formation and/or prevent bone resorption. Skeletal muscles have positive effects on bone structure and function. Can bones have an effect on muscle activity? There is only one study about the effect of bones on muscles. In this study, it was shown that bones may affect muscle strength gain in healthy young adult males.

Vibration has a strong osteogenic effect. Vibration-induced bone formation is neuronally regulated. Vibration can also effectively enhance muscle strength and power. Previous studies have shown that vibration increases muscle electromyographic (EMG) activity. But, it has not been reported whether bone has an effect on the increase in muscle EMG activity caused by vibration or not. The aim of this study was to determine whether radius bone exposed to cyclic mechanical loading affects muscle electrical activity of contralateral untrained m. flexor carpi radialis in healthy adult volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Right handed
* Young adult women and men

Exclusion Criteria:

* secondary osteoporosis
* neuropathy (central or peripheral)
* myopathy
* systemic diseases (arthritis, endocrine-metabolic diseases, bone diseases)
* professional sportswoman/sportsman
* subjects doing regular sports activities
* tendinopathy
* amputee, endoprosthesis, metal implants
tDCS and Upper Extremity Function in Stroke

Research on the effects of Anodal transcranial Direct Current Stimulation (tDCS) on hand dexterity and quality of life in stroke patients is limited. While the highlighted article focuses on Parkinson's disease, it underscores anodal tDCS potential to modulate brain activity and promote neural plasticity, suggesting potential relevance to stroke rehabilitation

tDCS seems like a hopeful way to help stroke patients improve their upper limb function, but there are still some problems and questions that need to be answered. Previous studies have investigated the impact of (tDCS) on upper limb recovery among stroke patients. However, evidence is scarce on the effect of tDCS on hand dexterity and quality of life in stroke patients. Furthermore, these studies have not adequately explored how the severity of stroke influences the efficacy of tDCS on upper limb motor recovery. Additionally, there is a lack of research examining the cumulative effects of tDCS on both upper limb motor recovery and hand dexterity, as well as QoL, particularly concerning stroke severity.

Eligibility Criteria:
Inclusion Criteria:

* Stroke for more than 6 months.
* Age 40-80 years
* Both gender
* National Institutes of Health Stroke Scale (NIHSS) for severity level (Mild (1-4), Moderate (5-15), Moderate to Severe (16-20), Severe (21-42)

Exclusion Criteria:

* Any patient with Upper limb amputation on the effected side, contracture, burn injury that leads to joint limitation and functional limitation.
* Known cases of Multiple Sclerosis and Parkinson and any Musculoskeletal disorder and Cardiopulmonary disorder.
* Any patient with Metallic implants
* Individuals with a history of seizures or epilepsy
* Individuals with Skin allergies on the scalp
Community-based Partnership's Efficacy in Decreasing Injury Rates At Night in Dallas, TX

According to the Centers for Disease Control and Prevention (CDC), "88,000 people die every year due to alcohol-related issues including homicide, sexual assault, intimate partner violence, and suicide". In the city of Dallas, violent crimes have decreased by roughly 4% in 2022 compared to 2021. Dallas Police Department (DPD) implemented changes in May 2021 to combat violent crimes.

To address these issues, 24Hour Dallas, a community-based non-profit organization, has utilized public health approaches at the business and city level. Their overarching goals are to reduce drunk driving, violence against women, human trafficking, and general violence or injuries related to alcohol use, all within the nighttime hours of 6pm and 6am through the application of their Good Neighbor initiative and Copper Star certification for businesses. Both the Good Neighbor initiative and the Copper Star certification follow a model from Safe Night LLC, an organization that was built on the premise of The Arlington Restaurant Initiative in Arlington, Virginia.

Eligibility Criteria:
Inclusion Criteria:

* • Chief complaint or diagnosis associated with a trauma mechanism of injury: assault (i.e., gunshot wounds, knife wounds, general assault, or sexual assault), MVC, motorcycle/all-terrain vehicle collision (MCC), or auto-ped/bicycle collision

  * Injury occurred between 6pm-6am
  * Injury occurred in City of Dallas, TX

Exclusion Criteria:

* • Injuries from mechanism other than assault, MVC, MCC, or auto-ped/bicycle

  * Assault occurs outside of 6pm-6am window
  * Assault occurred outside of Dallas city limits
Study of Natural Killer Cells in Patients With Metastatic Prostate Cancer: Relationship With Survival and Response Time to Castration

Prospective research of Natural Killer cells as predictive biomarkers to stratify patients likely to have longer response time to castration.

The main objective is to validate prospectively the results of a retrospective study showing a correlation between the level of NKp30 and NKp46 receptor-activators expression on the surface of NK cells and 1) the survival time, 2) the response time to castration in patients with metastatic prostate cancer.

Prospective monocenter, open-label study.

During a visit in the frame of management of the disease, a single blood sample will be collected. Patients will then have a standard care follow-up for a period of 5 years. Follow up data (death, progression) will be collected every 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with metastatic prostate cancer.
2. Aged of 18 years or more.
3. Patient in period of sensitivity to castration (patient non castrated or castration performed less than 1 year ago) and lack of progression.
4. Patient having signed an informed consent.
5. Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen.

Exclusion Criteria:

1. Patient under chemotherapy treatment at the time of sampling
2. Patient under corticotherapy treatment at the time of sampling
3. Patient in emergency situation, adult subject to a measure of legal protection (placed under judicial protection, tutorship, or curatorship), or unable to give consent.
4. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study medical follow-up
5. Contraindications to study procedure
ConfirmMDx Assay in Multiparametric MRI (mpMRI) PIRADS Scored Lesions After a Negative MR/US Fusion Biopsy

The purpose of this study is to see if the ConfirmMDx assay is useful in finding prostate cancer in patients who are at increased risk for prostate cancer based on elevated PSA and prostate lesion identified on mpMRI.


Eligibility Criteria:
Inclusion Criteria:

* Prior documented elevated PSA (\> 4.0 ng/ml)
* MRI lesion based on PIRADS scoring within the past 3 years
* Completed MR/US fusion prostate biopsy with concurrent systematic biopsy for PIRADS score 2-5 with negative pathological findings completed subsequent ConfirmMDx assay (regardless of result). The most recent biopsy can be within 4 years if ConfirmMDx already completed.
* May have had prior negative biopsy sessions prior to the most recent MR/US fusion biopsy
* Must be able to stop anticoagulation/antiplatelet therapy 5-7 days prior to obtaining biopsy
* Ability to give informed consent

Exclusion Criteria:

* Any metastatic cancer
* Any prostate cancer
* Active infection: urinary tract infection or prostate infection precluding prostate biopsy
* Anal stenosis or severe anal disease preventing prostate biopsy
COVID-19 Serologic Strategies for Skilled Nursing Facilities

The COVID-19 pandemic ravaged United States skilled-nursing facilities (SNFs). Novel strategies that maximize the safety and quality of life for SNF residents with ADRD and staff who care for them are urgently needed. Thus, the study's objectives are:

1. To rapidly plan and pilot test an intervention that leverages COVID-19 antibody and PCR status to pair SNF staff with residents in the safest way possible
2. To reduce reduced COVID-19 incidence rate compared to SNFs not using this novel staff-resident assignment strategy.


Eligibility Criteria:
Inclusion Criteria for Staff Stakeholders:

* Must be employees of ArchCare
* Must be members of included unit staff or those that float on those designated units
* Willing to participate in focus groups or semi-structured interviews with study team

Inclusion Criteria for Family Participants:

* Family members of residents who reside at either TCC or MMW (ArchCare facilities)
* Family member of resident who is on designated study unit or eligible to be transferred to such unit
* Willing to participate in focus groups or semi-structured interviews with study team

Inclusion Criteria for Resident Participants:

* Resident has ability to communicate and follow simple commands
* Resident has ability to communicate and follow simple commands
* English- or Spanish-speaking
* Resident has capacity to consent assessed with standard questions used to assess capacity or having a surrogate who can provide consent.
* Must agree to have serologic testing for COVID-19
* Agrees to remain on one of the facility units of study or to be transferred to such unit

Exclusion Criteria for Staff Stakeholders:

* Not employees of ArchCare
* Not members of included unit staff or those that float on those designated units
* Not willing to participate in focus groups or semi-structured interviews with study team

Exclusion Criteria for Family Participants:

* Not family members of residents who reside at either TCC or MMW (ArchCare facilities)
* Not family member of resident who is on designated study unit or eligible to be transferred to such unit
* Not willing to participate in focus groups or semi-structured interviews with study team

Exclusion Criteria for Resident Participants:

* Resident is not living in the unit of intervention
* Resident does not have ability to communicate and follow simple commands
* Not English- or Spanish-speaking
* Resident lacks capacity to consent assessed with standard questions used to assess capacity and does not have a surrogate who can provide consent.
* If resident lacks capacity, that resident does not assent with surrogate who provides assent
* Does not agree to have serologic testing for COVID-19
* Refuses to agree to remain on one of the facility units of study or to be transferred to such unit
Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery

The primary objects of this study is to explore the potential effect of the autologous patch to optimize wound healing after skin cancer surgery with Mohs micrographic surgery (MMS) in the face in a randomized controlled trial comparing autologous patch healing versus secondary intention healing.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects undergoing MMS for biopsy verified primary nodular basal cell carcinoma in the face, head and neck area on a location suitable for secondary intention healing and thus may also be suitable for autologous patch healing
2. Presenting relevant medical record report at study initiation
3. Written informed consent obtained from subject
4. Understanding of investigation procedures and willingness to abide to all procedures during the course of the investigation.

Exclusion Criteria:

1. A subjects with major systemic disease not yet stabilized
2. Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
3. Pregnant or breast feeding
4. Unable to follow the outlined study protocol
5. Participation in other studies at the same time that may affect the wound healing.
Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)

Open-label study of an investigational product (IP), QLS-101, with 28-day every morning (QAM) dosing to both eyes (OU) in adolescents with SWS who have clinical evidence of glaucoma and/or ocular hypertension (OHT) related to SWS elevated EVP in at least one eye.


Eligibility Criteria:
Inclusion Criteria:

* Between 12 and 19 years of age at Screening.
* Diagnosed with SWS
* Elevated IOP
* Willing to continue current dosing regimen of IOP-lowering medications
* Able to provide informed consent and follow study instructions

Exclusion Criteria:

* Expected to undergo IOP-lowering surgery
* Incisional or laser surgery of any type 4 months prior to study
* Ocular infection, inflammation, clinically significant blepharitis or conjunctivitis, history of herpes simplex keratitis in either eye
* History of or active clinically significant ocular disease
* Use of topical ocular corticosteroids in the 6 weeks prior to study
* Patient cannot be applanated or tolerate IOP measurements
* Patient is pregnant or lactating
* Uncontrolled systemic disease that can interfere with study participation
* Inability to self-dose or identify a caregiver for all study eye drop administration
Isthmocele - Prediction, Prevention, Diagnosis, and Management

An Isthmocele is a scar defect or uterine niche that develops in the myometrium due to an inadequate healing process at the site of the caesarean section incision. The management of isthmocele is not standardized and a correction typically involves invasive procedures (hysteroscopy/resectoscopy, laparoscopy, vaginal surgery). This study is to investigate the effectiveness of the procedures used to treat isthmocele.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing isthmocele correction surgery within the period from 01.01.2017 to 31.12.2020 at the University Hospital Basel, Women's Hospital

Exclusion Criteria:

* Missing information on the preoperative initial situation (preoperative myometrium thickness, lack of imaging via TVUS)
* Missing information on key characteristics that are important in the collection of retrospective data analysis (e.g. data on the previous caesarean section)
* Inability to give an informed consent
* Lack of German language skills
Effect of Spironolactone and Vitamin E in Patients With Nonalcoholic Fatty Liver Disease

The primary aim of the study is the effect of spironolactone and vitamin E versus vitamin E on serum levels of adipokines 52 weeks post-treatment.

Unlike other chronic liver diseases (e.g., hepatitis C), there are no effective treatment strategy for NAFLD. Currently, the management of NAFLD includes modification of underlying risk factors, detection of patients that have progressed to cirrhosis, management of cirrhosis-related morbidity and transplantation in patients with end-stage liver disease. Diet, exercise, bariatric surgery and pharmacologic treatment, including weight loss agents, insulin sensitizers, lipid-lowering agents, ursodeoxycholic acid and vitamin E have been investigated with some promising results.

The renin-angiotensin-aldosterone system (RAAS) has been implicated in the pathogenesis of insulin resistance (IR) and nonalcoholic fatty liver disease (NAFLD). Recently, low-dose (25-50 mg/day) aldosterone antagonists in patients with heart failure diminish mortality, possibly by reducing cardiac and vascular fibrosis. Moreover, the beneficial effect of spironolactone in a mouse model with diet-induced diabetes and NAFLD has been reported. However, to our knowledge, the role of spironolactone in NAFLD patients has not been investigated yet.

The primary aim of the study is the effect of spironolactone and vitamin E versus vitamin E on serum levels of adipokines 52 weeks post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Bright liver on ultrasound imaging and increased liver function tests for at least 6 months before liver biopsy
* Biopsy-proven NAFLD (either NAFL or NASH) according to NAFLD Activity Score (NAS)

Exclusion Criteria:

* Ethanol consumption more than 20 g/day
* Known intolerance to spironolactone or vitamin E
* History of liver disease (chronic viral hepatitis, autoimmune hepatitis, drug-induced liver disease, primary biliary cirrhosis, hemochromatosis, Wilson's disease and α1-antitrypsin deficiency)
* Previous exposure to hepatotoxic drugs
* Spironolactone or vitamin E administration within one year before screening
* Type I Diabetes Mellitus
* Pancreatitis
* Uncontrolled hypothyroidism or hyperthyroidism
* Adrenal Insufficiency
* Renal Failure
* Cancer
* Pregnancy

Exclusion criteria were generally the same as those proposed for PIVENS trial design with two modifications: a) known intolerance to spironolactone as an exclusion criterion and b) the inclusion of patients with T2DM not receiving thiazolidinediones or insulin.
Correlation Between Radiographic Bone Density in CBCT and Implant Stability Quotient Value: Clinical Observational Study

Correlate the implant stability quotient values measured by ostell device with radiographic bone density measured on CBCT by bluesky software pre-operatively

Dental implants have been widely used in the field of dental rehabilitation. Nowadays implant sucess rate is very high but to keep faliure rate as low as possible patient selection is very important especially regarding bone density to achieve high primary stability. Primary stability plays an important role in successful osteointegration of dental implants. This study was done to correlate between the bone density pre operatively measured on CBCT represented by HF unit and implant stability measured post operatively by ostell device represented by ISQ unit

Eligibility Criteria:
Inclusion Criteria:

* patients receiving dental implants in both arches
* patients should be free from any systemic diseases that may affect normal healing of bone, and predicated outcome
* no intra-oral soft tissue defect that would render primary closure of the intra-oral wound

Exclusion Criteria:

* patients with systemic diseases

  _ patients with ridge augmentation such as ridge expansion, ridge splitting and bone grafting
* patients with sinus lifting done to place implants
* immediate extraction sockets
Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis

Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe Plaque Psoriasis.

A Phase 1b Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe Plaque Psoriasis.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female of any race, at least 18 years old of age (inclusive)
* Freely provides both written and oral informed consent.
* Has a clinical diagnosis of psoriasis at the Baseline visit with an Investigator's Global Assessment Score of 3 or 4. The face, scalp ,axillae, and intertriginous areas are to be excluded in this calculation.
* Has an area of plaque psoriasis for topical treatment that involves a BSA of at least 20%.
* The willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.

Key Exclusion Criteria:

* Has spontaneously improving or rapidly deteriorating plaque psoriasis or postural psoriasis, as determined by the investigator.
* Presents with psoriasis that was treated with prescription medication and failed to respond to presents).
* Has a history of adrenal disease.
* Presents with any other concurrent skin conditions that could interfere with the evaluation of the treatment areas, as determined by the investigator.
* Is pregnant, nursing, or planning pregnancy during the study period.