louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06336876: Perceived Coping, Meaning, and Joy at Work
Official title: Perceived Coping, Meaning, and Joy at Work
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Undefined
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to assess and describe employee characteristics associated with perceived horizontal inter-collegial workplace uncivil behavior within nursing services, and identify any relationships with meaning and joy in work (MJW), and assess job satisfaction.

Detailed description: The study design is cross-sectional. This study will be conducted at a single Magnet-designated facility, Methodist Richardson Medical Center (MRMC), within the Methodist Health System. The sample will be a convenience sample of hospital-registered nurses and para-professional nursing services staff (e.g., patient care technicians and specialty area technicians) who agree to participate in an online survey launched via the Survey Monkey® portal. Survey Monkey® is an online, cloud-based survey delivery portal, and the subscription for the use of the portal is paid for by the Department of Education (DOE) at MRMC. Hence, the data will be owned by MHS. The study is a one-time inquiry. The PI and designated sub-investigators will send institutional emails to staff members who meet the inclusion criteria. The timeline for the study will be a total of four weeks. The study will be introduced for one week, be available for three weeks, and will conclude by the end of week four.

Eligibility criteria: Inclusion Criteria:

* The sample of participants will include all willing individuals who are registered nurses (full time, part time, and per-diem) Nursing para-professionals employed by Methodist Health System working at the MRMC campus and provide direct patient care for more than 50% of work hours
* All participants must be able to read and understand English.

Exclusion Criteria:

* employees who do not provide direct patient care for at least 50% of the time
* educators
* managers
* leaders
* advanced practice nurses
* non-nursing service personnel.

Primary outcomes:
measure: Workplace Incivil Behavior
timeFrame: "through study completion, average of one year"
measure: Meaning, Joy in Work
timeFrame: "through study completion, average of one year"
measure: Occupational Coping Self-Efficacy
timeFrame: "through study completion, average of one year"
measure: Demographic
timeFrame: "through study completion, average of one year"
Secondary outcomes:
Other outcomes:
Locations:
city: Richardson
country: United States
facility: Methodist Richardson Medical Center
state: Texas
Study officials:
affiliation: Methodist Health System
name: Maxine Adegbola, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01502176: A Retrospective Register Study to Map the Frequency of Short Duration Atrial Fibrillation (AF) Among All Patients Admitted to Roskilde Sygehus in Denmark in 2010
Official title: A Retrospective Register Study to Map the Frequency of Short Duration Atrial Fibrillation (AF) Among All Patients Admitted to Roskilde Sygehus in Denmark in 2010
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type of Atrial Fibrillation
Medical History
Current Treatment
Complications
Keywords: atrial fibrillation
registry
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-12-30
Enrollment: 1600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted and discharged with a diagnose of atrial fibrillation in 2010 at Roskilde University Hospital

Brief summary: Retrospective observational study of patients with atrial fibrillation admitted to Roskilde University Hospital in 2010.

Detailed description: The study is a retrospective register study of all patients discharged from Roskilde Hospital with a primary diagnosis of AF in 2010. All data will be collected from the patient's medical records and only data from this specific admission will be recorded. No follow-up of the patients after discharge will be performed in this study. The study does not involve any randomization or any drug testing.

Eligibility criteria: Inclusion Criteria:

* Atrial fibrillation

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Roskilde University Hospital
state: Copenhagen
Study officials:
References:
Clinical trial NCT01548976: Validation of a French Version of the PISQ-R
Official title: Validation of a French Version of the PISQ-R: a Tool for Evaluating the Sexuality of Patients With Urinary Incontinence or Pelvic Organ Prolapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Urinary Incontinence
Fecal Incontinence
Keywords: linguistic validation of the PISQ-R questionnaire
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-03-08
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence.

Brief summary: The main objective of this study is to perform the linguistic validation of the french version of the PISQ-R questionnaire in a population of sexually active (or not) patients who have undergone surgery (or not) for stress urinary incontinence or genital prolapse.

Detailed description: Step 1: Establish a French translation of the original questionnaire (English\> French.

Step 2: Perform a first set of comprehension tests with a panel of 15 patients.

Step 3: Establish a revised questionnaire.

Step 4: Perform a second series of comprehension tests with a panel of 10 other patients.

Step 5: Determine the final questionnaire.

Step 6: Perform a back-translation (French\> English.

Step 7: Send the final version of the questionnaire and the questionnaire back-translated to the specific committee of the IUGA for final approval.

Eligibility criteria: Inclusion Criteria:

* The patient is able to read and understand French
* The patient must be insured or beneficiary of a health insurance plan
* Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence.

Exclusion Criteria:

* Patient is pregnant
* The patient is under judicial protection, under tutorship or curatorship
* The patient does not understand French

Primary outcomes:
measure: Patient comprehension
timeFrame: Baseline (Day 0; transversal study)
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Brigitte Fatton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00702676: Quetiapine Fumarate Immediate Release (IR) Versus Extended Release (XR) Dose Escalation Comparison
Official title: A Double-blind, Double-dummy, Randomized, Crossover Study to Compare the Tolerability of Quetiapine Fumarate Immediate Release (SEROQUEL®) With Quetiapine Fumarate Extended Release (SEROQUEL XR®) During Initial Dose Escalation in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-20
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will compare the tolerability of Quetiapine Fumarate immediate release formulation and Quetiapine Fumarate extended release formulation during initial dose escalation in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Weight of at least 50 kg

Exclusion Criteria:

* A history or presence of neurological, hematological, psychiatric, gastrointestinal, hepatic, pulmonary, or renal disease or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
* Positive test results for alcohol or drugs of abuse
* Positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody

Primary outcomes:
measure: Visual Analog Scale (VAS) 1 hour post dose at Day 1
timeFrame: 1 hour after dose administration at the first dosing day (i.e. Day 1) of each period
measure: Area under the VAS-time curve
timeFrame: Calculated daily from the 13 assessments for 5 days
Secondary outcomes:
measure: Pharmacodynamic relationship between maximum VAS and PK concentration
timeFrame: On last day of period (Day 5)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Research Site
state: Maryland
Study officials:
affiliation: AstraZeneca
name: Catherine Datto, MD
role: STUDY_DIRECTOR
References:
citation: Datto C, Berggren L, Patel JB, Eriksson H. Self-reported sedation profile of immediate-release quetiapine fumarate compared with extended-release quetiapine fumarate during dose initiation: a randomized, double-blind, crossover study in healthy adult subjects. Clin Ther. 2009 Mar;31(3):492-502. doi: 10.1016/j.clinthera.2009.03.002.
Clinical trial NCT05746676: Insulin Versus Hyaluronic Acid in Management of Periodontal Defects
Official title: Clinical and Radiographic Evaluation of Insulin Versus Hyaluronic Acid in Management of Periodontal Defects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Periodontal Diseases
Periodontal Pocket
Keywords: periodontitis
insulin
regeneration
Lead sponsor: October University for Modern Sciences and Arts
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: in this study, insulin and hyaluronic acid will be used after open flap debridement in treatment of periodontal defects. outcome will be evaluated clinically and radiographically

Detailed description: n this study, insulin versus hyaluronic acid will be used after open flap debridement in treatment of periodontal defects. outcome will be evaluated clinically and radiographically after a follow up period

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with periodontitis

Exclusion Criteria:

* patients with systemic illness that contraindicate periodontal surgery

Primary outcomes:
measure: clinical evaluation
timeFrame: 6 months
measure: radiographic evaluation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University, Faculty of Dentistry
Study officials:
References:
Clinical trial NCT02661776: The Change of NK Cell Activity After Head and Neck Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Patients Undergoing Head and Neck Surgery Including Tumor Removal and Reconstruction With Flap
Keywords: natural killer cell
head and neck cancer
opioid
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-01-22
Enrollment: 29
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing head and neck surgery

Brief summary: Cellular immunity can be changed after surgery and anesthesia. Tissue injury by surgical procedures significantly reduces the immune function in proportion to the degree of tissue injury. In addition, the use of opioids as analgesics during the perioperative period depress cellular immunity, in particular the activity of the natural killer (NK) cells. This perioperative immunosuppression may cause deleterious consequences on postoperative outcome in cancer patients. The aim of this study is to confirm the presence or extent of the change of NK cell activity between before and after head and neck surgery. Additionally, investigators will identify the clinical or genetic factors related to the change of NK cell activity.


Eligibility criteria: Inclusion Criteria:

1) The patients undergoing head and neck surgery including tumor removal and reconstruction with flap

Exclusion Criteria:

1. patients refusal
2. patients not able to read, or understand the consent form
3. History of Active viral or bacterial infection
4. History of use of immunosuppressive drugs within the last six months
5. History of chemotherapy
6. History of autoimmune disorders
7. Known HIV, Hepatitis B, or Hepatitis C infection
8. Female who is pregnant, nursing
9. ethnicity, other than asian

Primary outcomes:
measure: The change of NK cell activity
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Study officials:
References:
citation: Lee SB, Cha J, Kim IK, Yoon JC, Lee HJ, Park SW, Cho S, Youn DY, Lee H, Lee CH, Lee JM, Lee KY, Kim J. A high-throughput assay of NK cell activity in whole blood and its clinical application. Biochem Biophys Res Commun. 2014 Mar 14;445(3):584-90. doi: 10.1016/j.bbrc.2014.02.040. Epub 2014 Feb 18.
Clinical trial NCT00298376: Oral Tolerance in Cow's Milk Allergy in the Infant
Official title: Oral Tolerance in Cow's Milk Allergy in the Infant: Role of CD4+CD25+ T Cells and Intestinal Microflora
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cow's Milk Allergy
Keywords: Cow's milk allergy,
food allergy
oral tolerance,
infant,
regulatory T cells,
intestinal microflora
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2006-03-02
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: This study aims to determine if there is a link between cow's milk allergy in infants and regulatory T cells dysfunction that should be transient in infant acquiring oral tolerance after 12 month avoiding food and persistent in others.

Cow's milk allergy is evaluated by basophils activation test, T cells activation test, specific humoral response (IgA, IgE, IgG) in allergic infants before and after 12 month avoiding food, before and after low dose milk exposure, before and after oral challenge.

Number and function of regulatory T cells and microflora composition are measured at the same time.

Allergic infants are compared to age matched control group.


Eligibility criteria: Inclusion Criteria:

male or female, age before 6 month, cow's milk allergy with positive prick or patch test for cow's milk

Control group: male or female, age before 6 month or within 12 and 18 month, eating cow's milk every day

Exclusion Criteria:

immunodeficiency syndrome, lactose intolerance Control group: other food allergy, atopic dermatitis.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Alain Lachaux
Study officials:
affiliation: Hospices Civils de Lyon
name: Alain LACHAUX, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01714076: Co-infections in Children Hospitalised for Bronchiolitis
Official title: Co-infections in Children Hospitalised for Bronchiolitis: Incidence, Clinical Symptoms and Influence of Cohort Isolation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchiolitis
Lead sponsor: Princess Amalia Children's Clinic
Sponsor class: OTHER
First posted: 2012-10-25
Enrollment: 172
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children \< 2 years admitted for bronchiolitis

Brief summary: Observational cohort study in children hospitalized for acute bronchiolitis. Patients are nursed in cohort isolation. Aim is to investigate the incidence and clinical impact of co-infections in this group.

Detailed description: Observational cohort study in children hospitalized for acute bronchiolitis. Patients are nursed in cohort isolation, meaning that all patients admitted for bronchiolitis are cohorted together, irrespective of viral diagnosis. Aim is to investigate the incidence and clinical impact of co-infections in this group.

Eligibility criteria: Inclusion Criteria:

* younger than 2 years admitted for bronchiolitis

Exclusion Criteria:

* chronic lung disease congenital heart defect down syndrome

Primary outcomes:
measure: co-infection
timeFrame: approximately 2 weeks
Secondary outcomes:
measure: clinical severity
timeFrame: approximately 2 weeks
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Isala Klinieken
state: Overijssel
Study officials:
affiliation: Isala
name: Jolita Bekhof, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03357276: Mix Vaccine for Metastatic Colorectal Cancer
Official title: Safety and Efficacy Study of Mix Vaccine in Colorectal Cancer Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metastatic Colorectal Cancer
Reaction - Mixed Vaccine
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Jinan University Guangzhou
First posted: 2017-11-29
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of mix vaccine to small metastases of colorectal cancer.

Detailed description: By enrolling patients with small metastases of colorectal cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of mix vaccine.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 2 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree of tumors
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Fuda cancer institute of Fuda cancer hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT06452576: Use of Vibration During Constraint-induced Movement Therapy
Official title: Use of Vibration During Constraint-induced Movement Therapy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hemiparesis
Keywords: constraint-induced movement therapy
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 8
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine whether the hand function will improve more by using low-level vibration during constraint-induced movement therapy (CIMT), compared to CIMT alone without vibration.

Detailed description: The low-level vibration has been shown to increase therapy outcome when used as an adjunct to therapy in adults with hemiparesis. Children who participates in the CIMT camp at MUSC will be recruited to take part in the study. Participating children will wear a watch device on their weaker arm during CIMT. The watch will vibrate only for the children who were assigned to the treatment group.

Eligibility criteria: Inclusion Criteria:

* Unilateral upper limb motor weakness
* Can use the affected upper limb as a gross assist during play and self-care activities
* Ambulatory for their age with intact balance and protective reactions in the less involved upper limb.

Exclusion Criteria:

* Developmental delays limiting spontaneous use of the affected upper limb
* Other health impairment

Primary outcomes:
measure: Box and Block Test
timeFrame: pre-therapy and post-therapy, up to 5 consecutive days
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Na Jin Seo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01797276: Dichloroacetate Treatment of Congenital Lactic Acidosis Phase B: Expanded Access
Official title: Dichloroacetate Treatment of Congenital Lactic Acidosis Phase B: Expanded Access
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Mitochondrial Enzyme Deficiencies
Keywords: Dichloroacetate (DCA)
Congenital Lactic Acidosis (CLA)
acidosis
orphan disease
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2013-02-22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: Expanded access to DCA as continued treatment for congenital lactic acidosis.

Detailed description: Subjects who participated in a Phase 3 Randomized Controlled Trial of DCA for treatment of Congenital Lactic Acidosis (CLA) are eligible to continue treatment with investigational medication DCA at the same dose of 25mg/kg/day for expanded access. Study participants must travel to the study site for bi-annual evaluation by the study investigator. Bi-annual evaluation will include an interim medical history review, physical exam, blood collection for DCA trough level, and urine pregnancy testing (if indicated).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of congenital lactic acidosis
* Participation in Study: #183-1992: Dichloroacetate Treatment of Congenital Lactic Acidosis Exclusion Criteria:
* Intolerance to DCA

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Box 100226
state: Florida
Study officials:
affiliation: University of Florida
name: Peter W. Stacpoole, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: