louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04604119: Anxiety and Burnout in Anesthetists and Intensive Care Unit Nurses During Covid-19 Pandemic
Official title: Anxiety and Burnout in Anesthetists and Intensive Care Unit Nurses During Covid-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sars-CoV2
Anxiety
Burnout
Keywords: anxiety
burnout
covid 19
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Attending physicians, resident doctors, nurses working tertiary intensive care units of our institution

Brief summary: The aim is to measure anxiety level and burnout frequency of healthcare workers including attending physicians, residents and nurses working at intensive care unit during COVID-19 pandemic.

The study protocol had consisted of three parts. The first part was related to demographic details including age, sex, marital status, working position, past medical history.

The second part of the survey was validated Turkish form of Beck anxiety inventory (BAI) It has 21 questions. Every question is a somatic symptom of anxiety. Participants scored them regarding how this symptom bothered them past week. Items have four possible answers: not at all (0 point), mildly (1 point), moderate (2 point), severe (3 point). Total anxiety score can be between 0 and 63. Participants were categorized as no or mild anxiety if the total beck anxiety score was between 0-16, and moderate to severe anxiety if it was more than 16 The last part of the survey was validated Turkish form of Maslach Burnout Inventory (MBI) to evaluate components of BOS

Detailed description: Our institution's ICU has served 31 beds for COVID-19 and 21 beds for other patients during pandemic with 27 attending physicians and 35 residents. Number of night shifts for attending physicians and residents were 3 and 8 per month, respectively. The aim of the study was to evaluate the by measuring anxiety level and burnout frequency of HCWs including attending physicians, residents and nurses in our institution's ICU.

Eligibility criteria: Inclusion Criteria:

Healthcare workers in our institute's intensive care units

Exclusion Criteria:

None

Primary outcomes:
measure: Anxiety
timeFrame: 10-25 may
Secondary outcomes:
measure: Burnout
timeFrame: 10-25 may
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli Hamidiye Etfal Education and Training Hospital
Study officials:
References:
Clinical trial NCT00371319: Comparing the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis
Official title: To Compare the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lupus Nephritis
Keywords: lupus
nephritis
tacrolimus
mycophenolate mofetil
Lead sponsor: Tuen Mun Hospital
Sponsor class: OTHER_GOV
First posted: 2006-09-04
Enrollment: 150
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: The purpose of this study is comparing the efficacy of tacrolimus and mycophenolate mofetil for the initial therapy of active lupus glomerulonephritis.

Detailed description: Patients with biopsy proven active lupus nephritis will be randomized to receive tacrolimus or mycophenolate mofetil, on top of corticosteroids, for initial treatment. Efficacy and adverse effects will be compared.

Eligibility criteria: Inclusion Criteria:

1. Patients who fulfill at least 4 of the ACR criteria for SLE
2. Age \>= 18 years
3. Biopsy proven active lupus glomerulonephritis (ISN/RPS class III/IV/V)
4. Serum creatinine \< 200 umol/L at the time of randomization

Exclusion Criteria:

1. Patients who refuse to be randomized for treatment
2. Patients who prefer treatment with conventional agents such as oral or intravenous CYC for various reasons
3. Serum creatinine \>= 200 umol/L at the time of randomization
4. Patients without renal biopsy or those who have lupus nephritis ISN/RPS class I,II,VI
5. Patients who are pregnant or plan for pregnancy within 12 months after randomization

Primary outcomes:
measure: remission rate
timeFrame: month 6
Secondary outcomes:
measure: renal function deterioration, relapse and mortality
timeFrame: month 60
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Tuen Mun Hospital
Study officials:
affiliation: Tuen Mun Hospital Hong Kong
name: CC MOK, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mok CC, Ho LY, Ying SKY, Leung MC, To CH, Ng WL. Long-term outcome of a randomised controlled trial comparing tacrolimus with mycophenolate mofetil as induction therapy for active lupus nephritis. Ann Rheum Dis. 2020 Aug;79(8):1070-1076. doi: 10.1136/annrheumdis-2020-217178. Epub 2020 May 24.
citation: Mok CC, Ying KY, Yim CW, Siu YP, Tong KH, To CH, Ng WL. Tacrolimus versus mycophenolate mofetil for induction therapy of lupus nephritis: a randomised controlled trial and long-term follow-up. Ann Rheum Dis. 2016 Jan;75(1):30-6. doi: 10.1136/annrheumdis-2014-206456. Epub 2014 Dec 30.
Clinical trial NCT00167219: Stem Cell Transplant for Juvenile Myelomonocytic Leukemia (JMML)
Official title: Hematopoietic Cell Transplantation in Children With Juvenile Myelomonocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Juvenile Myelomonocytic Leukemia
Keywords: Stem cell transplant
long term survival
retinoic acid
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 15
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that long-term disease-free survival (DFS) in patients with JMML can be achieved with a treatment of busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by hematopoietic cell transplantation (HCT).

Detailed description: Prior to transplantation, subjects will receive BUSULFAN via the central venous line, six times a day for four days, CYCLOPHOSPHAMIDE via the central venous line once a day for two days, and MELPHALAN via the central venous line for one day. Busulfan, cyclophosphamide, and melphalan are given to destroy the subject's leukemia. As well, these drugs will destroy the subject's own immune system to help ensure the new bone marrow takes and grows after transplantation.

On the day of transplantation, bone marrow or umbilical cord blood from the donor will arrive to the bone marrow transplant unit and be transfused via venous line. These new cells will replace the subject's bone marrow.

Eligibility criteria: Inclusion Criteria:

* Patients must have a diagnosis of JMML and fulfill these minimal criteria (International diagnostic criteria for JMML):

  * Leukocytosis (\> 13,000) with absolute monocytosis (\> 1,000)
  * The presence of immature myeloid cells in the peripheral blood
  * Less than 30% marrow blasts
  * Absence of t(9:22) or BCR-ABL transcript
  * Adequate major organ function including:

    * Cardiac: ejection fraction \> 45%
    * Hepatic: no clinical evidence of hepatic failure (e.g. coagulopathy, ascites)
    * Karnofsky performance status \> 70% or Lansky score \> 50%
    * Creatinine must be \< 2 x normal for age
* Written informed consent.

Exclusion Criteria:

* Active uncontrolled infection within one week of HCT.

Primary outcomes:
measure: Determine Probability of Long-term Disease Free Survival in JMML
timeFrame: at 1 year after transplant
Secondary outcomes:
measure: Combined Incidence of Neutrophil Engraftment, Graft-versus-host Disease (GVHD), Regimen-related Toxicity, and Relapse.
timeFrame: at 1 year after transplant
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Margaret MacMillan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01806519: Motor_Control_Neck_SSED
Official title: A Motor Control Intervention of Patients With Forward Head Posture and Persistent Neck Pain - A Single System Experimental Design With 12 Month Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Forward Head Posture
Keywords: neck pain
motor control
intervention
forward head posture
Lead sponsor: Luleå Tekniska Universitet
Sponsor class: OTHER
First posted: 2013-03-07
Enrollment: 3
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Neck pain is a common problem in the western world. There is a group of people suffering from neck pain with a reduced ability to maintain an upright posture showing a forward head position and an altered muscle function.

The aim of the study was to evaluate a motor control intervention for patients with persistent neck pain and a forward head posture.

This pilot study used a Single System Experimental Design (SSED) with an A-B-A-design and multiple baselines.

The tailored motor control intervention addressed the faulty postural alignment and the deep muscles of the cervical spine.


Eligibility criteria: Inclusion Criteria:

* 20 - 50 years of age with pain originating from the neck for at least three months.
* A visual forward head posture.
* Less than105 points on the Örebro musculoskeletal pain screening questionnaire

Exclusion Criteria:

* neurological dysfunction.
* former cervical surgery or compression fracture of the spine
* no mental retardation
* no physiotherapy treatment during the last 6 months.

Primary outcomes:
measure: Head posture
timeFrame: Effect from baseline to 8 weeks and being maintained to 12 month
measure: Muscle function of the deep cervical flexors
timeFrame: Effect from baseline to 8 weeks and being maintained to 12 month
Secondary outcomes:
measure: Disability
timeFrame: Effect from baseline to 8 weeks and being maintained to 12 month
measure: Pain intensity
timeFrame: Effect from baseline to 8 weeks and being maintained to 12 month
Other outcomes:
measure: Posture
timeFrame: Effect from baseline to 8 weeks and being maintained to 12 month
Locations:
city: Luleå
country: Sweden
facility: OMT-kliniken
Study officials:
References:
Clinical trial NCT05547919: PSMA in Gastrointestinal Tumors (GIPSMA, Focusing on Neuroendocrine Neoplasms)
Official title: A Molecular Imaging-Derived Biomarker of PSMA Expression - Revealing Theranostic Potential in Gastrointestinal Tumors (Focusing on Neuroendocrine Neoplasms)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Cancer
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The theranostic principle is based on the use of radiolabeled compounds which can be applied for diagnostic molecular imaging and targeted delivery of radiation to the tumor. Gastrointestinal tumors (GIT), including gastroenteropancreatic neuroendocrine neoplasms (GEP-NEN) also express a phenotypic biomarker called prostate-specific membrane antigen (PSMA), thereby rendering it a potential diagnostic (through positron emission tomography (PET) scan imaging) and therapeutic target for radioligand therapy. Aim is to evaluate whether PSMA-directed in-vivo imaging can be also applied to GEP-NEN patients to determine if i) biopsy-derived tissue of newly diagnosed patients exhibit a PSMA expression profile, ii) PSMA-PET shows upregulated PSMA expression in-vivo, iii) such a molecular imaging approach identifies more disease sites relative to conventional imaging, and iv) if the PSMA PET signal predicts further clinical course and outcome under guideline-compatible treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed GEP-NEN prior to initiation of guideline-compatible, anti-tumor therapy
* Available tissue specimen to conduct PSMA expression profiling
* Male/female, above 18 years old
* Patients must provide written informed consent
* Patients must be willing to comply with study procedures and available for follow-up examinations

Exclusion Criteria:

* Curative setting
* Not sufficient tumor tissue available
* Male Patients: No prostate carcinoma
* Other malignant neoplasms in patient's history
* Pregnancy or Breastfeeding
* Contraindications for PET/CT

Primary outcomes:
measure: True positive rate per patient specimen
timeFrame: 24 months
measure: True positive rate per patient
timeFrame: 24 months
measure: Number of patients with identified tumor lesion sites
timeFrame: 24 months
Secondary outcomes:
measure: Ex-vivo PSMA expression
timeFrame: 24 months
measure: PSMA uptake on 18F-PSMA-1007 PET
timeFrame: 24 months
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: University Hospital Wuerzburg
state: Bavaria
Study officials:
References:
Clinical trial NCT05233319: mCVI Confirmatory Clinical Study: Algorithm Verification With Healthy Volunteers
Official title: A Single-Center, Prospective Clinical Study to Demonstrate That mCVI(R) Accurately Captures Pulse Rate and Respiratory Rate in 20 Healthy Volunteers in Comparison to Traditional Measurements of the Nonin Lifesense Capnograph
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Algorithm Verification
Lead sponsor: Intelomed, Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-10
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers

Brief summary: This single center confirmatory clinical study is to verify the algorithm of mCVI® to accurately capture pulse rate and respiratory rate in 20 healthy subjects in comparison to traditional measurements of the Nonin Lifesense Capnograph. This is a non significant risk device.

Detailed description: In this confirmatory clinical study the mCVI® device is a mobile application used to simply verify the algorithm when the mobile video reads a patients pulse rate and respiratory rate while spontaneously breathing. There is no facial recognition technology. There is no immediate feedback given to the research team to act upon or provide for further clinical care decisions. In real time, the mCVI® device will be compared to traditional measurements of the Nonin Lifesense Capnograph.

Eligibility criteria: Inclusion Criteria:

* Healthy adults between the ages of 21 - 70

Exclusion Criteria:

* Medical conditions that could compromise a participant's ability to provide for all breathing samples, pedal the Cubii Pro elliptical, or follow instructions
* Medications that could compromise a participant's ability to participate in the study
* Documented medical history of respiratory or cardiovascular disease
* Excessive facial hair, facial deformities, or obstructions (like glasses or face masks/shields) that could compromise the recording of pulse rate and respiratory rate of the mCVI®
* Any face lotions or make up foundations that could compromise the recording of pulse rate and respiration rate of the mCVI®
* Recent (≤ 1 month) surgical procedure of any kind
* Current participation in another investigational clinical trial
* Inability to provide informed consent

Primary outcomes:
measure: Pulse Rate Verification
timeFrame: 1 month
measure: Respiration Rate Verification
timeFrame: 1 month
Secondary outcomes:
measure: Skin Tone Pulse Rate Verification
timeFrame: 1 month
measure: Skin Tone Respiration Rate Verification
timeFrame: 1 month
Other outcomes:
Locations:
city: Cranberry Township
country: United States
facility: InteloMed, Inc.
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00345319: Purified Rabies Vaccine for Human Use (Chick-embryo Cell)
Official title: Evaluate the Immunogenicity and Safety of Rabies Vaccine Given in a Post-exposure Prophylaxis Regimen to Healthy Children and Adults Aged 10-60 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rabies Post-exposure Prophylaxis
Keywords: rabies
vaccine
post-exposure prophylaxis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-06-28
Enrollment: 630
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate the immunogenicity and safety of rabies vaccine given in a post-exposure prophylaxis regimen to healthy children and adults aged 10-60 years.


Eligibility criteria: Inclusion Criteria:

* male and female healthy subjects aged 10-60 years old

Exclusion Criteria:

* history of rabies immunization
* previous exposure to a suspect rabid animal within the last 12 months
* any significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 7 days
* treatment with corticosteroids, immunosuppressive or anti-malaria drugs during the two month period before enrollment
* known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder
* known hypersensitivity to neomycin, tetracycline, amphotericin-B, or any other vaccine component

Primary outcomes:
measure: serum bactericidal activity
timeFrame: measured at day 14 and day 45 after first vaccination dose
Secondary outcomes:
measure: solicited local and systemic reactions
timeFrame: within 6 days following vaccination and adverse events thought the study
Other outcomes:
Locations:
city: Danyang
country: China
facility: Danyang CDC
state: Jiangsu
Study officials:
affiliation: Novartis Vaccines & Diagnostics
name: Novartis Vaccines - Information Services
role: STUDY_CHAIR
References:
Clinical trial NCT04749719: At Home Brain Stimulation Studies of Memory and Memory Awareness
Official title: At Home Brain Stimulation Studies of Memory and Memory Awareness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: transcranial direct current stimulation
memory
metacognition
brain
Lead sponsor: Brooklyn College of the City University of New York
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2021-02-11
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main goal of this research is to determine the role of several brain regions in memory processes and cognitive functions. Participants will be remotely supervised via video chat while self-administering tDCS, a form of non-invasive brain stimulation. Before participating in the experiment, participants will be properly trained on use of the remote tDCS device and screened for eligibility. While using the tDCS device, participants will be engaging in tasks that assess different aspects of memory and executive functioning. By using remotely supervised tDCS while participants are completing these cognitive tasks, we will be able to make causal claims about the role of the targeted brain regions in different cognitive processes.


Eligibility criteria: Inclusion Criteria:

* between the ages of 18-35
* normal or corrected to normal vision
* fluent in English and speaking English since age 5
* right handed

Exclusion Criteria:

* chronic skin disease or medical skin condition
* unhealed wound or open skin on the scalp, face, neck, or forehead
* metal or electrode implants (e.g., cochlear implants, pacemakers, metal plates, rods, or screws in their head; for complete detail, see the screening form)
* seizures or a family history of seizures, or are taking medications with a lowered seizure threshold
* pregnant or lactating
* any neurologic or psychiatric diseases
* certain hair styles (dreadlocks, cornrows, etc) or hair coverings (e.g., wigs, hajibs, etc that will not be removed; note that a request can be made for an experimenter of a specific gender)

Primary outcomes:
measure: Memory performance
timeFrame: through study completion, an average of 4 weeks
Secondary outcomes:
measure: Memory Confidence
timeFrame: through study completion, an average of 4 weeks
Other outcomes:
measure: Metamemory Accuracy
timeFrame: through study completion, an average of 4 weeks
Locations:
city: Brooklyn
country: United States
facility: Brooklyn College
state: New York
Study officials:
References:
Clinical trial NCT05446519: Anxiety and / or Depressive Disorders in a Population of French Airline Pilot
Official title: Descriptive Study of Anxiety and/or Depressive Disorders in a Population of Airline Pilots Employed in France and Unionized at the SNPL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety Disorders
Depressive Disorder
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 870
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Airline pilot, employed in France and unionized at the Syndicat National des Pilote de Ligne (SNPL)

Brief summary: Throughout their career, the medical abilities of airline pilots are regularly assessed. This population is exposed to occupational constraints and risks, in particular psychosocial, and could constitute a population at risk of developing anxiety and/or depressive disorders. However, mental health remains difficult to apprehend in this population because of a strong stigmatization of mental disorders and the risk of loss of medical certification to fly. In the literature, there are very few studies dealing with mental disorders in airline pilots and the results are heterogeneous, with a prevalence of anxiety and/or depressive disorders ranging from 1.9 to 12.6%. There is no study of this type among airline pilots employed in France. Therefore it seems useful to determine the prevalence of anxiety and/or depressive disorders in this population and to describe the co-factors associated with these disorders.


Eligibility criteria: Inclusion Criteria:

* Airline pilot, employed in France and unionized at the Syndicat National des Pilote de Ligne (SNPL)

Exclusion Criteria:

* None

Primary outcomes:
measure: Depressive and anxiety disorders
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
References: