louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02910947: Comparative Evaluation of Quadratus Lumborum and Transverses Abdominis Plane Block for Postoperative Pain Relief in Lower Abdominal Surgeries
Official title: Comparative Evaluation of Quadratus Lumborum and Transverses Abdominis Plane Block for Postoperative Pain Relief in Lower Abdominal Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain Relief to the Patient Following Abdominal Surgeries
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2016-09-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Two ultrasound guided techniques to give postoperative pain relief to the patients following abdominal surgeries would be compared using scoring systems for pain relief and scientific methods. while one technique is routinely used, other i.e quadratus lumborum has been recently described and relies on posterior deposition of the drug. Both the techniques are safe and ultrasound imaging is to be used for guidance.


Eligibility criteria: Inclusion Criteria:

* patients undergoing lower abdominal surgery 18-60 yrs of age

Exclusion Criteria:

* none

Primary outcomes:
measure: pain relief following abdominal surgery. Visual Analogue Scale (VAS) would be used to record pain at rest. In this patient is asked to describe his/her pain on a scale from 0-10.
timeFrame: 24 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: PGIMER
Study officials:
References:
Clinical trial NCT03835247: Physician-Nurse and Nurse-Nurse Collaboration
Official title: Physician-Nurse and Nurse-Nurse Collaboration in Different Hospitals: An Example From Turkey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nurse
Keywords: physician-nurse collaboration
nurse-nurse collaboration
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 500 nurses working in six hospitals.

Brief summary: This study was carried out to determine the level of collaboration and the factors affecting its between physicians-nurses and nurses-nurses working in different hospitals.

Detailed description: Collaboration is a broad concept with different definitions in the literature. Researches on physician-nurse collaboration and nurse-nurse collaboration has shown that improves the quality of patient care; reduces the medical errors; affects the job satisfaction positively and decreases the intention to quit in the international literature. In the light of this information, the study was planned to determine the level of collaboration and the factors affecting its between physicians-nurses and nurses-nurses working in different hospitals. Research is a cross-sectional study. The study is planned the 500 nurses working in six hospitals in Ordu/Turkey on January 3-12 February 2019. Descriptive questionnaire form, Jefferson Scale of Physician-Nurse Collaboration (JSAPNC) and nurse-nurse collaboration scale will be used in the study.

Eligibility criteria: Inclusion Criteria:

* nurse
* working experiences at least 6 months
* working full time.

Exclusion Criteria

* working experiences less than 6 months
* head-nurses

Primary outcomes:
measure: Descriptive questionnaire form,
timeFrame: 2 minutes
measure: Jefferson Scale of Physician-Nurse Collaboration
timeFrame: 3 minutes
measure: nurse-nurse collaboration scale
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Hospitals
state: Altınordu
Study officials:
affiliation: T.C. ORDU ÜNİVERSİTESİ
name: Ebru Sahin, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01235247: Decision Support AMPATH
Official title: Electronic Medical Records to Improve Patient & Public Health in Rural Kenya
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Behavior
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: Moi Teaching and Referral Hospital
First posted: 2010-11-05
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Computer-generated clinical reminders offered to providers will improve compliance with care guidelines and impact outcomes in resource-limited clinics.

Detailed description: The investigators will assess the effects of computer-generated reminders for the 3 cohorts of patients: (1) pregnant women; (2) HIV-exposed infants; and (3) adults and children co-infected with TB and HIV identified from the AMPATH clinics. Patients will be randomized to either receive the reminders as part of a paper summary, or to not have any of the reminders in their summary. Reminders implemented will vary by type of patient population. Comparisons will be made between the intervention and control groups.

Eligibility criteria: Inclusion Criteria:

* All pregnant women, children born to HIV+ mothers, and TB/HIV co-infected patients visiting these clinics during the this study will be included.

Exclusion Criteria:

-

Primary outcomes:
measure: Compliance rates with care guidelines
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Eldoret
country: Kenya
facility: USAID-AMPATH Clinics
Study officials:
References:
citation: Were MC, Nyandiko WM, Huang KT, Slaven JE, Shen C, Tierney WM, Vreeman RC. Computer-generated reminders and quality of pediatric HIV care in a resource-limited setting. Pediatrics. 2013 Mar;131(3):e789-96. doi: 10.1542/peds.2012-2072. Epub 2013 Feb 25.
Clinical trial NCT04067947: Phase 1 Pharmacokinetics, Safety, and Tolerability Study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Oral Dose Study of the Pharmacokinetics, Safety, and Tolerability of XG005 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Xgene Pharmaceutical Group
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Oral Dose Study of the Pharmacokinetics, Safety, and Tolerability of XG005 in Healthy Volunteers.

Detailed description: This is a randomized, double-blind, placebo-controlled study which will investigate the PK, safety, and tolerability of four ascending single and multiple oral doses of XG005 in healthy subjects. The trial consists of two parts: a single ascending dose (SAD) PK evaluation (Part 1) and a multiple ascending dose (MAD) PK evaluation (Part 2). Approximately 32 Subjects will be enrolled sequentially into a total of 4 ascending dose levels in each part.

Eligibility criteria: Inclusion Criteria:

1. Healthy males or females between 18 and 55 years of age
2. BMI 18.0 to 30.0 kg/m2
3. Non-pregnant, non-breastfeeding female subjects

Exclusion Criteria:

1. Unstable or severe illness
2. History of, or current treatment for, GI disease
3. Clinically significant history of medical condition associated with GI events
4. History of or current glucose intolerance or gestational diabetes
5. Lifetime history of suicidal behavior
6. Creatinine clearance \< 90 mL/min
7. Any elevation of liver function tests
8. Creatine kinase (CK) value of greater than 1.5 times the upper limit
9. Leucocytes or lymphocytes less than 1.5 times the lower limit of normal
10. Positive Hepatitis B surface antigen, HCV, or HIV

Primary outcomes:
measure: Adverse Event related to XG005
timeFrame: Day 1 to 7 days after last dose
Secondary outcomes:
Other outcomes:
Locations:
city: Nedlands
country: Australia
facility: Linear Clinical Research Ltd
state: Western Australia
Study officials:
affiliation: Xgene Pharmaceutical Group
name: Feng Xu, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT02816047: Austrian Wearable Cardioverter Defibrillator Registry
Official title: Indications for and Experience With the Wearable Cardioverter Defibrillator (WCD) - Austrian WCD Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Ventricular Dysfunction
Sudden Death
Sudden Cardiac Arrest
Ventricular Tachycardia
Ventricular Fibrillation
Keywords: wearable cardioverter defibrillator
LifeVest
sudden death
defibrillator
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 450
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: Comprehensive registry including all patients in all Austrian centers who received a WCD in 2010-2016.

Brief summary: Background: The wearable cardioverter defibrillator (WCD) is an established treatment option for patients at high risk for ventricular tachycardia / ventricular fibrillation (VT/VF), either in whom this risk may only be temporarily present, or in patients at high risk for sudden cardiac death (SCD) or after VT/VF in whom an implantable cardioverter defibrillator (ICD is currently not possible for other reasons (infection, recent MI \<40days, recent PCI/CABG \< 3months etc.).

Methods: Comprehensive registry including all patients in Austria who received a WCD in 2010-2016.

Detailed description: Observational study to describe WCD indications, event rates, inappropriate shock rates and follow up (including ICD rate, shock rate, morbidity and mortality) in all Austrian WCD patients

Eligibility criteria: Inclusion Criteria:

* patients, with a prescribed WCD according to guidelines in an austrian center

Primary outcomes:
measure: Number of participants treated with WCD-treated ventricular arrhythmias
timeFrame: during WCD wearing period; average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz/ Division of Cardiology
Study officials:
affiliation: Medical University of Graz/ Division of Cardiology
name: Daniel Scherr, Assoz. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06644547: (Cost)effectiveness of the Intervention 'Gezond En Goed Met Elkaar'
Official title: (Cost)effectiveness of the Intervention 'Gezond En Goed Met Elkaar'
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: The Study is Focused on People with Limited Health Literacy
We Are Not Studying a Disease or Condition
Keywords: health literacy
positive health
intervention
Gezond en goed met elkaar
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Pragmatic stepped-wedge design
Primary purpose: PREVENTION

Brief summary: The goal of this intervention study is to learn if the intervention can increase positive health and health literacy in people with limited health literacy. The main questions it aims to answer are:

* Does participating in the intervention 'Gezond en goed met elkaar' increase participant's positive health?
* Does participating in the intervention 'Gezond en goed met elkaar' improve health literacy?

Researchers will compare people who participate in the intervention with people who haven't participated in the intervention yet.

Participants will:

* participate in the intervention (3 months)
* fill out questionnaires every 3 months


Eligibility criteria: Inclusion Criteria:

* 18 years or older

Exclusion Criteria:

* analfabetism
* insufficient language level of Dutch to be able to participate in the intervention

Primary outcomes:
measure: Positive Health
timeFrame: From baseline measurement to 9 months later
measure: Vitality
timeFrame: From baseline measurement to 9 months later
Secondary outcomes:
measure: Health Literacy
timeFrame: From baseline measurement to 9 months later
measure: Basic Psychological Needs
timeFrame: From baseline measurement to 9 months later
measure: Well-Being
timeFrame: From baseline measurement to 9 months later
measure: Quality of Life (QALYs)
timeFrame: From baseline measurement to 9 months later
measure: Health Care and Productivity Costs
timeFrame: From baseline measurement to 9 months later
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Amsterdam
Study officials:
References:
Clinical trial NCT02595047: Autologous Prefabrication of Body Surface Tissues/ Organs(e.g. Joint)
Official title: Phase 1/2 Study of Autologous Tissues/Body Surface Organs Prefabrication in Tissue Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Soft Tissue Infections
Intentional Self Harm by Other Specified Means
Keywords: Self-regeneration, in vivo tissue prefabrication,
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 1
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to observe the feasibility and its application of autologous prefabrication for body surface tissues/oranges

Detailed description: In the field of tissue regeneration techniques, the in vitro processes and other exogenous factors still have many uncertainties. These uncertainties have hampered road to the clinical application. As the importance of in vivo environment has aroused more awareness, the investigators validated the hypothesis that the feasibility of self-regeneration prefabricated unaided by any in vitro culture process or exogenous elements.

Eligibility criteria: Inclusion Criteria:

* With body surface tissue or organ defects (e.g., ear, nose, bone and joint) requiring reconstruction.

Exclusion Criteria:

* evidence of infection, ischemia, ulcer or other pathological changes within the prefabricated area which defined as not suitable for tissues regeneration
* history of delayed healing, radiational therapy;
* significant renal, cardiovascular, hepatic and psychiatric diseases;
* significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV);
* BMI \>30;
* history of any hematological disease, including leukopenia, thrombocytopenia, or thrombocytosis;
* Evidence of malignant diseases
* unwillingness to participate.

Primary outcomes:
measure: Occurence of major adverse events
timeFrame: through study completion 12 months after prefabrication
Secondary outcomes:
measure: Feasibility of self-prefabrication
timeFrame: 3, 6, and 12 months after prefabrication
Other outcomes:
measure: survival of prefabricated tissue after grafting
timeFrame: 3, 6, 12, and 36 months after grafting
measure: biomechanical function of prefabricated tissue after grafting
timeFrame: 3, 6, 12, and 36 months after grafting
measure: biomechanical function of prefabricated tissue after grafting
timeFrame: 3, 6, 12, and 36 months after grafting
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Department of Plastic and Reconstructive Surgery, Shanghai 9th People'sHospital
name: Qingfeng Li, MD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02180347: Contact Lenses and Myopia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Keywords: Pediatrics
Contact lenses
Lead sponsor: State University of New York College of Optometry
Sponsor class: OTHER
First posted: 2014-07-02
Enrollment: 17
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes children and teens that are recruited from the University Eye Center at SUNY College of Optometry and from the greater New York City area.

Brief summary: The objective of this study is to determine if multifocal contact lenses affect accommodation and/or binocular vision when worn by pediatric patients. This will be accomplished through subjective and objective accommodative and binocular experiments in children wearing single vision and multifocal soft contact lenses.


Eligibility criteria: Inclusion Criteria:

* 7 to 15 years of age
* Refractive error between -1.00 and -8.00 D sphere, with less than or equal to 1.00 D astigmatism
* Corrected visual acuity of 20/25 or better in each eye

Exclusion Criteria:

* Ocular or systemic disease known to affect accommodation or vision
* Convergence or accommodative disorder, or any strabismus
* Use of oral or topical medications known to affect accommodation

Primary outcomes:
measure: Accommodative response
timeFrame: Up to two hours
measure: Binocular posture status
timeFrame: Up to two hours
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: SUNY College of Optometry, Clinical Vision Research Center
state: New York
Study officials:
affiliation: State University of New York College of Optometry
name: Kathryn Richdale, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03001947: IgA Nephropathy Registration Initiative of High Quality (INSIGHT)
Official title: IgA Nephropathy Registration Initiative of High Quality (INSIGHT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: IgA Nephropathy
Keywords: IgA nephropathy
All-cause mortality
Cardiovascular mortality
A composite renal outcome
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 10000
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Biopsy-proven primary IgAN patients

Brief summary: The investigators are registering all biopsy-proven primary IgA nephropathy (IgAN) patients at recruited hospitals and developing a IgAN database in China. Patients will be follow-up every one year, and both baseline and follow-up information will be entered into the registration system. All-cause and cardiovascular mortality and a composite renal outcome of doubling of serum creatinine and end stage renal failure (ESRD, defined as initiation of dialysis or kidney transplantation) of IgAN patients will be compared using the IgAN database.

Detailed description: The investigators are registering all biopsy-proven primary IgA nephropathy (IgAN) patients, and developing a IgAN database in China. Patients' demographic characteristics (including age, gender, height, weight, BMI, smoking, drinking, and education), clinical characteristics (including systolic blood pressure, diastolic blood pressure, primary cause of ESRD, and lab measurements of serum and urine), complications, drug information at the baseline will be collected. Patients will be follow-up every one year, the demographic and clinical characteristics, complications and drug information of patients will be collected at each visit. The investigators also record the clinical events at each visit, such as mortality (including all-cause mortality and cardiovascular disease mortality), ESRD (defined as initiation of dialysis or kidney transplantation) and hospitalization for any cause. All-cause and cardiovascular mortality and a composite renal outcome of doubling of serum creatinine and ESRD for IgAN patients will be compared using the IgAN database.

Eligibility criteria: Inclusion Criteria:

1. Biopsy-proven primary IgAN patients;
2. age ≥14 years old
3. Adequate biopsy sample containing ≥8 glomeruli.

Exclusion Criteria:

Secondary causes of mesangial IgA deposition, such as Henoch-Schonlein purpura nephritis, systemic lupus erythematosus, liver cirrhosis and et al; eGFR≤15ml/min/1.73m2 at biopsy.

Primary outcomes:
measure: All-cause and cardiovascular mortality of IgAN patients
timeFrame: 10 years
measure: A composite renal outcome of IgAN patients
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT01605747: Study of Culturelle in the Prophylaxis of Infection and Diarrhea
Official title: A Blinded Placebo Controlled Clinical Outcomes Study of Culturelle® in the Prophylaxis of Infection and Diarrhea
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pediatric Burns
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
First posted: 2012-05-25
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of this study is to determine if probiotic prophylaxis has immunologic and gastrointestinal advantages in pediatric burn patients.


Eligibility criteria: Inclusion Criteria:

* acute burn injury
* consented within 10 days of injury
* feeding tube present-

Exclusion Criteria:

* GI disorder prior to burn
* milk allergy or insensitivity
* non-burned

Primary outcomes:
measure: Infectious outcome
timeFrame: 3 years
Secondary outcomes:
measure: Clinical outcome
timeFrame: 3 years
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Shriners Hospital for Children
state: Ohio
Study officials:
References: