louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06939426: Music Therapy and Humanization in ED Healthcare Professionals
Official title: Impact of a Short Music Therapy Program on Intra- and Interpersonal Factors of Humanized Care in a Group of Emergency Nursing Staff at the University Hospital Fundación Santa Fe de Bogotá: a Mixed-methods Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress
Burnout
Quality of Life (QOL)
Music Therapy
Humanization of Care
Lead sponsor: Fundación Santa Fe de Bogota
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Background: Healthcare professionals in emergency departments frequently experience stressful situations that could jeopardize their mental health, sense of purpose, and ability to empathize with patients, families, and colleagues.

Research question: What is the impact of a short music therapy program on the intra- and interpersonal factors of humanized care among emergency nursing staff at the University Hospital Fundación Santa Fe de Bogotá (FSFB)? Methodology: This research is a mixed-methods pilot and feasibility study. For the quantitative component, we will apply the HUMAS (Healthcare Professional Humanization Scale) and ProQOL (Professional Quality of Life) measure at the start and at the end of the music therapy program. For the qualitative component, focus group interviews will be conducted and analyzed via thematic analysis.

Discussion: This study seeks to support the nursing staff of the FSFB emergency department through an interactive, creative, and participatory music therapy self-care program focused on one of the most important pillars of the institution: the humanization of care.


Eligibility criteria: Inclusion Criteria:

* Be a member of the emergency department nursing staff at the FSFB for a minimum of 6 months.
* Be able to commit to participating in eight music therapy sessions over a four-week period.
* Have the minimum reading skills to understand the questionnaires

Exclusion Criteria:

- Staff with untreated mental health disorders.

Primary outcomes:
measure: HUMAS (Healthcare Professional Humanization Scale)
timeFrame: From enrollment to the end of the music therapy program after one month
Secondary outcomes:
measure: ProQOL (Professional Quality of Life) measure
timeFrame: From enrollment to the end of the music therapy program after one month
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: University Hospital Fundación Santa Fe de Bogotá
Study officials:
References:
Clinical trial NCT06125626: Prevention of Traveler's Diarrhea
Official title: Prevention of Traveler's Diarrhea While Crossing the Amazon Forest by Bike With a Supplement Based on Lacticaseibacillus Rhamnosus LR04 + Streptococcus Thermophilus FP4 + Bifidobacterium Brevis BR03: a Phase Two, Randomized, Placebo-controlled, Double-blind, Cross-over Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diarrhea
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 3
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The prevention of traveller's diarrhea makes use of the selection of foods and drinks, the purification of water, the use of pharmacological substances such as bismuth salicylate and rifaximin (which can only be taken for short periods). The very attractive prospect of preventing travellers' diarrhea without systemic antibiotics has fueled interest in probiotics for this purpose. However, not all probiotics are identical, and the results of studies conducted with a particular agent cannot be generalized to indicate that any probiotic agent would be successful in the same clinical situation. Probiotics such as Lactobacillus GG have been shown to reduce the incidence of diarrhea in travelers in randomized controlled trials. In contrast, another Lactobacillus preparation, non-viable Lactobacillus acidophilus, showed no benefit over placebo in a randomized, double-blind, controlled trial of 174 travelers. The reasons for this are unclear, but could be related to the fact that the bacteria were not viable or a peculiarity of the strain selected for testing.


Eligibility criteria: Inclusion Criteria:

* Healthy bikers
* Able to pass the Amazonia forest by bike

Exclusion Criteria:

* None predifinied

Primary outcomes:
measure: Incidence of diarrhea
timeFrame: 12 weeks
Secondary outcomes:
measure: Mean quality of life
timeFrame: 12 weeks
measure: Incidence of severe diarrhea
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Nicola Veronese
Study officials:
References:
citation: Briand V, Buffet P, Genty S, Lacombe K, Godineau N, Salomon J, Vandemelbrouck E, Ralaimazava P, Goujon C, Matheron S, Fontanet A, Bouchaud O. Absence of efficacy of nonviable Lactobacillus acidophilus for the prevention of traveler's diarrhea: a randomized, double-blind, controlled study. Clin Infect Dis. 2006 Nov 1;43(9):1170-5. doi: 10.1086/508178. Epub 2006 Sep 27.
citation: Hilton E, Kolakowski P, Singer C, Smith M. Efficacy of Lactobacillus GG as a Diarrheal Preventive in Travelers. J Travel Med. 1997 Mar 1;4(1):41-43. doi: 10.1111/j.1708-8305.1997.tb00772.x.
Clinical trial NCT03771326: KP-10 and Insulin Secretion in Men
Official title: Preliminary Evidence Suggesting That Acute Administration of KP-10 Induces Insulin Secretion in Normal Weight But Not in Obese Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kisspeptin Action on Insulin in Healthy Normal Men
Kisspeptin Action on Insulin in Obese Diabetic Men
Lead sponsor: Quaid-e-Azam University
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 14
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Fourteen volunteers (aged 20-45 years), including seven adult normal weight healthy men (mean body weight and BMI 75.5±4.8 kg and 23±0.7 kg/m2, respectively) and seven obese men (mean body weight and BMI 115±15 kg and 34±2 kg/m2, respectively), participated in this clinical study
Primary purpose: BASIC_SCIENCE

Brief summary: Induction of insulin secretion by kisspeptin is observed in mouse, pig, rat, and human islets in vitro and in rats, mice and monkeys in vivo, but its mechanism is not fully clear. The present study was designed to investigate the role of KP-10 on insulin secretion in adult healthy and obese men with insulin resistance. The aim of selection of obese persons for the present study was to investigate the effect of acute KP-10 administration in a metabolically challenged condition where the pancreatic beta cells are already highly activated. The long-term objective of this study was to understand the physiological role of kisspeptin signalling in the regulation of insulin secretion in human health and disease.


Eligibility criteria: Inclusion Criteria:

* Normal BMI
* Normal renal function
* Normal liver function
* Normal blood count

Exclusion Criteria:

* Disease history
* Diabetes
* Other trauma

Primary outcomes:
measure: Changes in the response of insulin secretion to acute exogenous kisspeptin administration
timeFrame: Each participant was studied up to 4 hours. Blood samples from each individual was collected for 30 minutes pre and 120 minutes post KP-10 administration, at 30 minutes interval.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bowe JE, Foot VL, Amiel SA, Huang GC, Lamb MW, Lakey J, Jones PM, Persaud SJ. GPR54 peptide agonists stimulate insulin secretion from murine, porcine and human islets. Islets. 2012 Jan-Feb;4(1):20-3. doi: 10.4161/isl.18261. Epub 2011 Dec 23.
citation: Wahab F, Riaz T, Shahab M. Study on the effect of peripheral kisspeptin administration on basal and glucose-induced insulin secretion under fed and fasting conditions in the adult male rhesus monkey (Macaca mulatta). Horm Metab Res. 2011 Jan;43(1):37-42. doi: 10.1055/s-0030-1268458. Epub 2010 Dec 6.
Clinical trial NCT06804226: Advancing Discussions Using a Video-based Support Tool About End-of-life Care
Official title: Advancing Discussions Using a Video-based Support Tool About End-of-life Care: the ADVISE Project
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Injury
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 270
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate the effectiveness and implementation considerations of a video aid to improve communication and patient-centered outcomes in older injured adults


Eligibility criteria: Inclusion Criteria:

* English or Spanish speaking
* admitted to any level of care following trauma

Exclusion Criteria:

* Prisoners
* Existing do not resuscitate (DNR)/do not intubate (DNI)
* Patients admitted while on hospice
* Patients not expected to survive over 24-48 hours

Primary outcomes:
measure: Number of participants who had a transition in code status from full code
timeFrame: at time of discharge (about 5 days after admission)
Secondary outcomes:
measure: Percentage of participants that recognize survival after Cardiopulmonary resuscitation (CPR) as less than 50 percent as assessed by a survey
timeFrame: at time of discharge (about 5 days after admission)
measure: Number of participants that received information about life-sustaining care outcomes as assessed by a survey
timeFrame: at time of discharge (about 5 days after admission)
measure: Number of participants that desire more information regarding life-sustaining care as assessed by a survey
timeFrame: at time of discharge (about 5 days after admission)
measure: Number of participants that had hospital-free days
timeFrame: in the first 30 days after admission
measure: Number of participants that had ICU-free days
timeFrame: at time of discharge (about 5 days after admission)
measure: Discharge disposition
timeFrame: at time of discharge (about 5 days after admission)
measure: Number of participants that had ventilator-free days
timeFrame: at time of discharge (about 5 days after admission)
measure: Decisional conflict score as assessed by the Decisional Conflict Scale
timeFrame: at time of discharge (about 5 days after admission)
measure: Number of interventional procedures
timeFrame: at time of discharge (about 5 days after admission)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Thaddeus J Puzio, MD, MS, FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01146626: Does Vitamin D Improves Sustained Virologic Response (SVR) in Genotype 2,3 Chronic Hepatitis C Patients?
Official title: Does Vitamin D Supplement Improve SVR in Chronic Hepatitis C (Genotype 2,3) in naïve Patients Treated With Peginterferon Alpha and Ribavirin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis C
Keywords: Vitamin D
Hepatitis C
Genotype2,3
SVR
Naive
RVR rate
EVR rate
SVR rate
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Hillel Yaffe Medical Center
First posted: 2010-06-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2,3. Studies rarely address the issues of improving host factors. The current study examines

1. whether adding vitamin D, a potent immunomodulator, could improve viral response and shorten treatment duration (from 24 weeks to 12 weeks)
2. whether Vitamin D levels predictes negative treatment outcome.

Detailed description: Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2,3. Studies rarely address the issues of improving host factors. The current study examines whether adding vitamin D, a potent immunomodulator, could improve viral respons.The working hypothesis is that Adding vitamin D to conventional Peg/RBV therapy for naïve, genotype 2,3 patients with chronic HCV infection significantly improves RVR, EVR, and SVR

Eligibility criteria: Inclusion Criteria:

* 18 to 65 years of age,
* Chronic genotype 2,3 HCV infection, Traetment Naive
* Negative sero for HBV, HDV and HIV viral infections
* Absolute neutrophil count of \>1500 per cubic millimeter, a platelet count of \>90,000 per cubic millimeter
* Normal hemoglobin level

Exclusion Criteria:

* Decompensated liver disease (cirrhosis with CP score \>9)
* Another cause of clinically significant liver disease
* Hepato cellular carcinoma
* Psychiatric Disorder
* Chronic heart failure
* Pregnant women
* Uncontrolled diabetes with retinopathy
* Arythmia
* Active CAD
* Positive sero for HBV, HDV and HIV viral infections or other autoimmune liver disease

Primary outcomes:
measure: SVR rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hedera
country: Israel
facility: Liver clinic
city: Safed, Israel
country: Israel
facility: Ziv medical center liver unit
Study officials:
References:
Clinical trial NCT06137326: PEMF vs Laser for Stress Urinary Incontinence
Official title: Efficacy of Pulsed Electromagnetic Field Therapy Versus Laser Acupuncture on Female Stress Urinary Incontinence: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a parallel group randomized controlled trial with two arms receiving different interventions.
Primary purpose: TREATMENT

Brief summary: Stress urinary incontinence, or involuntary urine leakage during activities like coughing, laughing, or exercise, is a common condition that impacts quality of life for many women. Pelvic floor muscle training is often used to treat stress incontinence, but additional therapies may enhance outcomes. This randomized controlled trial will compare two physical therapy modalities, pulsed electromagnetic field (PEMF) therapy versus laser acupuncture, along with pelvic floor training for improving stress urinary incontinence in 60 adult women. The study will evaluate their effects on pelvic floor muscle strength, severity of urine leakage, and quality of life. We hypothesize that PEMF and laser acupuncture will both improve stress incontinence, but PEMF will be more effective based on greater pelvic floor stimulation. The study aims to provide evidence on these physical therapy options so that optimized treatment plans can be developed for women with stress urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* Adult females aged 18-65 years with stress urinary incontinence
* Able to comply with study procedures and schedule

Exclusion Criteria:

* Prior pelvic floor surgery
* Pregnancy
* Active urinary tract infection
* Pelvic organ prolapse \>Stage 2
* Neurologic disorder affecting urinary function

Primary outcomes:
measure: Change in pelvic floor muscle strength
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in Severity Index for urinary incontinence
timeFrame: Baseline and 8 weeks
measure: Change in ICIQ-UI SF score
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Mahmoud Hamada, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT02492126: Esophageal Motility in Reflux Induced Cough
Official title: Chronic Cough and Reflux: Is Esophageal Motility the Key?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cough
Keywords: Chronic Cough
Gastroesophageal Reflux
Esophageal Motility
Cough Sensitivity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: University of Manchester
First posted: 2015-07-08
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic cough patients

Brief summary: To determine whether contraction abnormalities in the esophagus plays a role in gastroesophageal reflux induced cough, and thus cough severity in patients with chronic cough.


Eligibility criteria: Inclusion criteria:

1. Adult patients (ages 18-75 years old)
2. Cough for more than 8 weeks
3. Additional clinical evaluation of cough including a complete pulmonary function test with methacholine challenge and a high resolution CT scan of the chest.
4. Ability to understand the purpose and nature of the study
5. Willingness to participate and provide consent form

Exclusion criteria:

1. Actively smoke in the preceding 6 months.
2. Recent respiratory tract infection (\<4 weeks).
3. Drink above the recommended safe alcohol limit (21 units per week).
4. History of respiratory or gastrointestinal malignancies.
5. Previous gastrointestinal surgery (excluding minor surgeries, such as cholecystectomy, appendectomy).
6. Subjects with established and significant cardiac, pulmonary, or neurological disorders as deemed by the clinician or study personnel
7. Use of angiotensin converting enzyme inhibitors
8. Use of H2 blockers or proton pump inhibitors in the seven days prior to reflux testing (impedance/pH), or inability to withhold such medications for the duration of the study
9. Women of childbearing potential, using adequate birth control. Adequate birth control includes: (i) hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants; (ii) barrier methods (such as, a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm); (iii) intrauterine device (IUD); or (iv) abstinence (no sex). Adequate birth control must be maintained for the duration of the study. Women not using adequate birth control will be excluded from the study, as funding for the pregnancy tests was not included in the small grant awarded for this study.
10. Nursing mothers will be excluded.
11. Persons with allergies to citrus will be excluded.
12. Inability to understand the purpose and nature of the study
13. Unwillingness to participate and provide consent form

Primary outcomes:
measure: Percentage of subjects with reflux related cough
timeFrame: 24 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Kenneth DeVault, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04092426: Prevelance of Keratoconus
Official title: Prevelance of Keratoconus in Individuals Attending Refreactive Surgery Centers in Assiut
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Keratoconus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with keratoconus in people attending refractive surgery

Brief summary: Keratoconus is a degenerative disease entity characterized by conical shape ectasia of the cornea. progressive conical deformation of the cornea leads to substantial astigmatism. Patients who are at an advanced stage of ectasia are often led to corneal transplant or other treatments, which essentially aim at correcting the refractive error and not in treating the ectasia. The top of the protruding cone that corneal configuration may be close to the visual axis or below and nasal of that. The disease manifests during adolescence, followed by slow progressive course, although it is possible to stabilize anytime. In 85% of cases both eyes are affected, but the severity of the attack can present significant asymmetry.

Detailed description: Often in keratoconus a positive family history is present. Prevelance of keratoconus varies greatly worldwide.The reported prevalence of keratoconus varies widely depending upon the geographic location, diagnostic criteria used, and the cohort of patients selected. Environmental factors may contribute to the wide variation in prevalence.

the Middle East have higher prevalence than locations with cooler climates and less sunshine

Eligibility criteria: Inclusion Criteria:

1. persons attending refractive surgery centers in Asssiut.
2. patients found to have keratoconus are included , based on history , clinical examination and corneal topography

Exclusion criteria :

1. patients not attending those refractive surgery centers.
2. patients attending these centers but not diagnosed to be keratoconus .
3. Pregnancy or breastfeeding

Primary outcomes:
measure: Prevalence of keratoconus in different areas in assiut
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Jonas JB, Nangia V, Matin A, Kulkarni M, Bhojwani K. Prevalence and associations of keratoconus in rural maharashtra in central India: the central India eye and medical study. Am J Ophthalmol. 2009 Nov;148(5):760-5. doi: 10.1016/j.ajo.2009.06.024. Epub 2009 Aug 11.
Clinical trial NCT01501526: Unusual Clinical Findings of Herpes Esophagitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Herpes Esophagitis
Vocal Fold Palsy
Keywords: herpes esophagitis
dysphagia
vocal fold palsy
immunocompetent
husky voice
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2011-12-29
Enrollment: 1
Sex: MALE
Minimum age (years): 50
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: Herpes esophagitis presents a clinical diagnostic challenge. The investigators report the first case of herpes esophagitis presenting as vocal fold palsy in an immunocompetent host. The investigators case highlights the importance of performing a detailed laryngoscopic examination in any patient with prolonged husky voice.


Eligibility criteria: Inclusion Criteria:

* Patient of Herpes esophagitis with vocal palsy presentation

Exclusion Criteria:

* Patient of Herpes esophagitis without vocal palsy presentation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References: