louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05877976: Impact of Visual Arts Immersion
Official title: Impact of Visual Arts Immersion on Cultural Competency and Self-reflection Among Nurses Working in an Academic Health System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cultural Competency
Personal Reflection
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Library of Medicine (NLM)
First posted: 2023-05-26
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to enhance engagement, coping and self-reflection by attuning nurses to creative and observational skills drawn from a visual arts pedagogical framework. To fulfill this goal, the investigators will cultivate an existing relationship between NYU Langone Health (NYULH) Nursing, the NYU Health Sciences Library, and museum educators at The Met to design and deliver an intervention of museum educator-led workshops that introduce nurses to arts appreciation skills to improve their practice and overall wellbeing. Participants will be asked to complete two surveys, pre- and post-intervention, Cultural Awareness Scale (CAS), which measures cultural awareness, sensitivity, knowledge and skills, and the Interpersonal Reactivity Index (IRI), which measures four separate aspects of empathy and its relationships with measures of social functioning, self-esteem, emotionality, and sensitivity to others. We will also solicit qualitative feedback via REDCap survey at the end of the intervention to gain insight into nurse's experiences of the art immersion program.


Eligibility criteria: Inclusion Criteria:

1. A Registered Nurse at NYULH
2. Willing to provide an email address or cell phone number of choice
3. Willing to attend one workshop in person at The MET and one virtually via WebEx
4. Willing and able to provide consent
5. Age 18 years of age or older

Exclusion Criteria:

1. Not a Registered Nurse at NYULH
2. Not willing to provide an email address or cell phone number of choice
3. Not willing to attend one workshop in person at The MET and one virtually via WebEx

Primary outcomes:
measure: Change in Cultural Awareness Scale (CAS) Score From Baseline to Month 6
timeFrame: Baseline, Month 6
measure: Change in Clinical Interpersonal Reactivity Index (CIRI) Score From Baseline to Month 6
timeFrame: Baseline, Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Lita Anglin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00550576: Antibodies to Digoxin for Bipolar Disorder
Official title: Antibodies to Digoxin for Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bipolar Disorder
Keywords: Digoxin Antibodies
Bipolar Disorder
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2007-10-30
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Subjects suffering from bipolar disorders treated with specific medications will give their informed concent and will receive intravenously only one dose of Digoxin antibodies (Fab). Their response to this therapy will be measured accordingly.Previous medications will be not changed A base line serum Endogenous Digitalis-like Compounds (DLC)levels will be measured using a specific laboratory technique and these compounds will be measured at 6 and 24 hours after Fab therapy.

Patients also will be followed using clinical and psychological tests

Detailed description: Twenty subjects suffering from bipolar disorders treated with specific medications will give their informed concent and will included in the study. All will receive in an open study only one intravenously dose of Digoxin antibodies (Fab). Their response to this therapy will be measured accordingly.Previous medications will be not changed A base line serum Endogenous Digitalis-like Compounds (DLC)levels will be measured using a specific laboratory technique and these compounds will be measured at 6 and 24 hours after Fab therapy.

Patients also will be followed using clinical and psychological tests

Eligibility criteria: Inclusion Criteria:

* Admitted patients suffering from Bipolar Disorder
* abillity to give informed concent

Exclusion Criteria:

* Allergy to Digoxin Antibodies
* Renal and Liver function impairment
* Liver Cirrhosis
* Asthma
* Patients on Digoxin or Digitoxin
* Patients receiving Aldactone therapy
* Heart A-V Block
* Hypo or Hyperkalemia on admission
* Potential Suicidal Behaviour

Primary outcomes:
measure: improvement
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Ehaud Klein, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04658576: Pre-operative Ultrasonographic Evaluation of Caval Aorta Diameter Index as a Predictor for Post-induction Hypotension
Official title: Pre-operative Ultrasonographic Evaluation of Caval Aorta Diameter Index as a New Predictor for Hypotension After Induction of General Anaesthesia: A Prospective Observational Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypotension on Induction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: • Patients scheduled for elective orthopedic surgeries under general anaesthesia

Brief summary: Comparison between ultrasound measurement of IVCD-AOd index in prediction of post induction hypo tension

Detailed description: This study aims to evaluate the ability of preoperative ultrasound measurements IVC to aorta diameter index to predict post-induction hypotension in comparison with ultrasound measurements of the IVC collapsibility index.

Eligibility criteria: Inclusion Criteria:

* • Adult patients (\>18years)

  * ASA I-II

Exclusion Criteria:

* • ASA physical status \> II

  * Dyspnea
  * Systolic blood pressure ≥ 180 mmHg
  * Systolic blood pressure \< 90 mmHg
  * Agitation (RASS \> 1)
  * IVC non visualized
  * Epidural catheter in use
  * Patients with increased intraabdominal pressure (intrabdominal mass compressing IVC).
  * Pregnancy

Primary outcomes:
measure: • Comparison of the accuracy Area under receiver operating characteristic curves (AUROC) of IVCD:AoD index and IVCCI in prediction of post-induction hypotension
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine- Cairo University
Study officials:
affiliation: Cairo University
name: Shymaa Fathy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02093676: Applying the "New Authority" Model in the Treatment of Poorly Controlled Diabetic Adolescents and Their Families
Official title: Development and Assessment of a Treatment Protocol for Poorly Controlled Diabetic (Type 1) Adolescents, Based on "The New Authority" Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: diabetes
type 1
adolescents
parents counselling
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2014-03-21
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is presumed that families of poorly controlled diabetic adolescents (type 1) would benefit from parents' counselling, guided by "the New Authority" model.

Detailed description: "The New Authority" model has been shown to be helpful in risk behaviors such as children's violence and school refusal. It is assumed the model would prove helpful in the risk behavior of lack of adherence to diabetes treatment regimen. The treatment is give to parents only, without the adolescent's participation. It is predicted to improve self care, parents' monitoring, family conflict and parents' helplessness.

Eligibility criteria: Inclusion Criteria:

* diagnosis of diabetes type 1
* condition duration a year or more

Exclusion Criteria:

* family does not speak Hebrew
* adolescent doesn't live at home
* serious psychiatric condition in the family

Primary outcomes:
measure: change in self monitoring of blood glucose
timeFrame: assessment at 4 points: enrty, after 3 months, after 6 months and after 9 months
Secondary outcomes:
measure: change in reported adherence
timeFrame: assessment at four points: entry, after 3 months, after 6 months and after 9 months
measure: change in parents' helplessness
timeFrame: assessment at four points: entry, after 3 months, after 6 months and after 9 months
measure: change in family conflict
timeFrame: assessment at four points: entry, after 3 months, after 6 months and after 9 months
measure: change in parental monitoring
timeFrame: assessment at four points: entry, after 3 months, after 6 months and after 9 months
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Orit Hamiel, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06652360: Chemical Debridement and Leg Ulcers
Official title: A Pilot Study to Investigate the Relative Effectiveness and Safety of Chemical Wound Debridement and Curettage in the Treatment of Venous and Mixed Aetiology Leg Ulcers.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Venous Leg Ulcers
Mixed Ulcer
Keywords: chemical debridement
mechanical debridement
topical dessicating agent
venous leg ulcer
chronic wound
Lead sponsor: DEBx Medical B.V.
Sponsor class: INDUSTRY
First posted: 2024-10-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A pilot study to investigate the relative effectiveness and safety of chemical wound debridement and curettage in the treatment of venous and mixed aetiology leg ulcers.

Detailed description: A pilot study to investigate the relative effectiveness and safety of chemical wound debridement versus the curettage wound debridement in the treatment of venous and mixed aetiology leg ulcers in the United Kingdom

Eligibility criteria: Inclusion Criteria:

* Participants with a venous leg ulcer or mixed aetiology ulcer.
* Duration of wound ≥ 6 weeks ≤ 5 years
* Wound is ≥ 5 cm2 ≤ 200cm2
* Presence of at least 25% visible slough within the wound bed
* The Participant must be able to understand the study and provide written informed consent
* No clinical signs of infection

Exclusion Criteria:

* Known hypersensitivity or contraindications to any of the wound treatments, dressings or compression bandaging to be used in the trial
* Current local or systemic antibiotics in the week prior to inclusion
* Clinically infected wound as determined by the presence of 3 or more of the following clinical signs: perilesional erythema, pain between two dressing changes, malodorous wound, abundant exudate and oedema
* Prolonged treatment with immunosuppressive agents or high dose corticosteroids
* Participants who have a current illness or condition which may interfere with wound healing in the last 30 days (carcinoma, connective tissue disease, autoimmune disease or alcohol or drug abuse)
* Participants who have participated in a clinical trial on wound healing within the past month
* Participants with a known history of non- adherence with medical treatment

Primary outcomes:
measure: Wound surface
timeFrame: 12 weeks
measure: Wound Debris
timeFrame: 12 weeks
Secondary outcomes:
measure: Wound healing
timeFrame: 12 weeks
measure: wound condition
timeFrame: 12 weeks
measure: Quality of Life
timeFrame: 12 weeks
measure: Patient Comfort in treatment process
timeFrame: 12 weeks
measure: Device Safety
timeFrame: 12 weeks
measure: Treatment Comfort in performance and acceptance
timeFrame: 12 weeks
measure: wound condition
timeFrame: 12 weeks
measure: wound condition
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Eastbourne
country: United Kingdom
facility: Pioneer wound healing and lymphedema centres
Study officials:
References:
Clinical trial NCT05029960: Tolerability and Activity of Brivaracetam (BRV) in Patients With Diffuse Gliomas
Official title: Tolerability and Activity of Brivaracetam (BRV) in Patients With Diffuse Gliomas
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Brain Tumor
Keywords: Brain Tumor
Brivaracetam
Epilepsy
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the study medication, brivaracetam, is tolerable and safe for patients with brain tumors.

Detailed description: In this study, subjects will receive usual treatment for their brain tumor. In addition, they will be given brivaracetam at a dose of 50 mg twice daily.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years with pathologic diagnosis of a supratentorial diffuse astrocytic or oligodendroglial tumor
* Patients must be able to provide informed consent

Exclusion Criteria:

* A pre-existing seizure disorder or epilepsy syndrome prior to tumor diagnosis
* Active maintenance therapy with an antiepileptic seizure drug (AED) prior to diagnosis of tumor
* Patients who have experienced an epileptic seizure as the presenting symptom of their brain tumor
* Predicted life expectancy of less than 6 months from the time of screening
* Pregnancy
* Patients with clinically significant hepatic disease (elevated aminotransferases \[bilirubin, alkaline phosphatase\] \> 3 times upper limit normal)
* Patients with stage 4 or greater renal disease (GFR \<30 mL/min/1.73 m2)
* Patients who are unable to swallow a tablet
* Patients with active suicidal ideation or a history of suicide attempt or other serious psychiatric disorder having required hospitalization within the previous 2 years.

Primary outcomes:
measure: Safety of Brivaracetam
timeFrame: 6 Months
Secondary outcomes:
measure: Voluntariness for study participation
timeFrame: 6 Months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT00208260: Intensified Chemotherapy in CRC After Resection of Liver Metastases
Official title: Randomized Phase II Trial Followed by Phase III Trial With Molecular Biology Study, Comparing a Standard Bi-therapy vs 3 Arms of Intensified Chemotherapy in Patients With Unresectable or Not Optimally Resectable Colorectal Cancer Liver Metastases.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Colorectal Cancer
Liver Metastases
Chemotherapy
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
Collaborators: name: Pfizer
name: Sanofi
name: Chugai Pharmaceutical
First posted: 2005-09-21
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, open label, multicentre phase II trial followed by phase III comparing overall survival after having selected the best experimental arm.


Eligibility criteria: Inclusion Criteria:

* Histologically proven adenocarcinoma of the colon or rectum without previous resection, or clinically asymptomatic (with or without stent)
* Hepatic unresectable metastases R0: due to close vascular contact, or due to liver remaining mass less than 25 to 30 % of functional liver.
* Not optimally resectable metastases
* Extra-hepatic disease will be accepted in case of: asymptomatic primary tumour or tumor requiring no urgent surgery (in less than 3 months); three of less than three lung metastases (thoracic scan diameter less than 2 cm) and potentially respectable.
* Synchronous and metachronous hepatic metastases
* WHO performance status 0-1
* Adjuvant chemotherapy allowed, except oxaliplatin and irinotecan based combination.
* No prior treatment of the liver metastases, whatever.
* Life expectancy equal or more than 3 months

Exclusion Criteria:

-

Primary outcomes:
measure: Response
timeFrame: end of chemotherapy
Secondary outcomes:
measure: Safety
timeFrame: during study treatment
measure: Survival
timeFrame: 2 years
measure: Secondary resection
timeFrame: surgery after chemotherapy
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CRLC Val d'Aurelle
Study officials:
affiliation: CRLC Val d'Aurelle
name: Marc YCHOU, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CRLC Leon Berard - Lyon
name: Michel RIVOIRE, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01991860: US Phase III Study of APD421 in PONV
Official title: Randomized, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Prophylaxis Against Post-operative Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: PONV
Lead sponsor: Acacia Pharma Ltd
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.


Eligibility criteria: Inclusion Criteria:

* Male or female patients ≥ 18 years of age
* Patients undergoing elective surgery (open or laparoscopic technique) under general anaesthesia, expected to last at least one hour from induction of anaesthesia to wound closure and expected to require at least one overnight stay in hospital

Exclusion Criteria:

* Patients scheduled for outpatient/day case surgery
* Patients scheduled to undergo intra-thoracic, transplant or central nervous system surgery
* Patients scheduled to receive only a local anaesthetic/regional neuraxial (intrathecal or epidural) block
* Patients who are expected to remain ventilated for a period after surgery
* Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed

Primary outcomes:
measure: Number of Participants With Complete Response
timeFrame: 24 hours after the end of surgery
Secondary outcomes:
measure: Number of Participants With no Nausea.
timeFrame: 24 hours after end of surgery
measure: Number of Participants With no Emesis
timeFrame: 24 hours after end of surgery
measure: Number of Participants With no Use of Rescue Medication
timeFrame: 24 hours after end of surgery
measure: The Number of Participants With no Emesis, no Significant Nausea and no Use of Rescue Medication
timeFrame: 24 hours after the end of surgery
measure: The Number of Participants With no Significant Nausea
timeFrame: 24 hours after the end of surgery
measure: Number of Participants With "Total Response"
timeFrame: 24 hours after the end of surgery
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke
state: North Carolina
Study officials:
affiliation: Duke University Medical College
name: Tong J Gan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03527160: Assessment of Urinary NGAL to Predict AKI in Children Receiving Multiple Nephrotoxic Medications
Official title: Assessment of Urinary Neutrophil Gelatinase-Associated Lipocalin to Predict Acute Kidney Injury in Children Research Multiple Nephrotoxic Medications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Nephrotoxicity
Keywords: AKI
NGAL
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: BioPorto Diagnostics
First posted: 2018-05-17
Enrollment: 134
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All inpatients in non-ICU settings at participating pediatric institutions

Brief summary: Nephrotoxic medication (NTMx) exposure is one of the most commonly cited causes of acute kidney injury (AKI) in hospitalized children, and is the primary cause of AKI in 16% of cases. Through initial work at Cincinnati Children's Medical Center, NTMx exposure was found to be potentially modifiable and the associated AKI is an avoidable adverse safety event. Currently, only serum Creatinine monitoring is available to monitor for NTMx-associated AKI. The hypotheses of this NINJA NGAL study are that (1) urine NGAL is highly sensitive to detect NTMx-associated AKI, and (2) Bedside test of urine from high risk NTMx-exposed patients are adequate and reliable compared to urine NGAL measured from the clinical platform.


Eligibility criteria: Inclusion Criteria:

* Receiving 3 or more nephrotoxic medications on the same day OR
* Receiving 3 or more days of an intravenous aminoglycoside or vancomycin

Exclusion Criteria:

* Currently being treated for a urinary tract infection
* Presence of an acute kidney injury prior to enrollment

Primary outcomes:
measure: Number of Patients With Nephrotoxic Medication Associated AKI Detected by Urinary NGAL
timeFrame: 9 Days
Secondary outcomes:
measure: Point of Care NGAL Reliability Compared to Clinical Urinary NGAL
timeFrame: 7 Days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's of Alabama
state: Alabama
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References: