louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06186453: Effectiveness of Bonding-Based Education Intervention
Official title: Effectiveness of Bonding-Based Education Intervention for Fathers With Preterm Newborn Infants: Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm
Bonding
Keywords: Father
Bonding
Neonatal Intensive Care Unit
Lead sponsor: Akdeniz University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2024-01-02
Enrollment: 66
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aimed to determine the impact of the Father-Preterm Newborn Bonding Programme (B-PreBAP) on fathers' parenting behaviours, stress levels, and support needs. Additionally, the study aimed to investigate the effect of B-PreBAP on the stress levels of preterm newborns.

Detailed description: This study constitutes a part of the doctoral thesis titled "Development of Father-Preterm Newborn Bonding Model".

Eligibility criteria: Inclusion Criteria:

1. Characteristics of the father; Turkish speaking Literate 18+ Open to communication and co-operation Fathers who agree to participate in the study will be included
2. Characteristics of the preterm newborn Hospitalised in the NICU from the first postnatal day Preterm newborns born between 32 and 33 weeks

Exclusion Criteria:

1. Characteristics of the father; Has a diagnosed psychiatric diagnosis Having twin preterm newborns
2. Characteristics of the preterm newborn Intubated

Primary outcomes:
measure: Father Support Scale: Neonatal Intensive Care Unit
timeFrame: Data will be collected two times as pre-intervention and immediately post-intervention.
Secondary outcomes:
measure: Neonatal Intensive Care Unit Parent Stress Scale
timeFrame: Data will be collected two times as pre-intervention and immediately post-intervention.
measure: Postnatal Parental Behaviour Scale
timeFrame: Data will be collected two times as pre-intervention and immediately post-intervention.
measure: Neonatal Stress Scale
timeFrame: Data will be collected two times as pre-intervention and immediately post-intervention.
Other outcomes:
Locations:
city: Kepez
country: Turkey
facility: Akdeniz University
state: Antalya
Study officials:
References:
Clinical trial NCT07013253: Burnout Syndrome Among Anesthesiology Residents in Turkey: A Cross-sectional Study
Official title: Burnout Syndrome Among Anesthesiology Residents in Turkey: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Burnout, Professional
Burnout, Psychological
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anesthesiology and Reanimation residents currently practicing in the Republic of Turkey.

Brief summary: Burnout syndrome is a condition in which an individual experiences loss of self-esteem, chronic fatigue, feelings of helplessness, and hopelessness in their professional work life and human relationships. This study aims to evaluate the prevalence of burnout syndrome among anesthesiology residents working in Turkey, analyze the potential causes and adverse consequences of this syndrome's increase, and provide recommendations for its reduction.


Eligibility criteria: Inclusion Criteria:

* Agreed to participate by completing the online survey form
* Proficient in the Turkish language
* Anesthesiology and Reanimation residents currently practicing in the Republic of Turkey

Exclusion Criteria:

• Participants who do not provide consent to share the requested information in the survey form

Primary outcomes:
measure: Prevalence of Burnout Syndrome as measured by the Maslach Burnout Inventory
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Uludağ Üniversitesi
name: Selcan Akesen, Assc Prof
role: STUDY_CHAIR
References:
Clinical trial NCT02300753: Emergency Administration of EPI-743 to a Single Patient With Leber's Hereditary Optic Neuropathy [LHON]
Official title: Emergency Administration of EPI-743 to a Single Patient With Leber's Hereditary Optic Neuropathy [LHON]
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Leber's Hereditary Optic Neuropathy
Lead sponsor: Edison Pharmaceuticals Inc
Sponsor class: INDUSTRY
First posted: 2014-11-25
Sex: ALL
Minimum age (years): 8
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Expanded access Protocol to treat LHON subjects with EPI743

Detailed description: Emergency use administration of EPI-743 to subjects with LHON. This Protocol was originally developed to treat a single subject but was expanded to treat several at a single institution.

Eligibility criteria: Inclusion Criteria:

* Emergency treatment for subjects with LHON who are actively losing site in one eye

Exclusion Criteria:

* Allergy to EPI-743 or sesame oil
* Clinical history of bleeding or abnormal PT/PTT
* Hepatic insufficiency with LFTs greater than 2-times normal
* Renal insufficiency requiring dialysis
* Fat malabsorption syndromes
* Any other concurrent inborn erros of metabolism
* Severe end-organ hypo-perfusion syndrome secondary to cardiac failure resulting in lactic acidosis
* Anemia with a HCT \<25

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Doheny Eye Institute / UCLA
state: California
Study officials:
References:
Clinical trial NCT05168553: Evaluation of Revascularization of Failed Endodontically Treated Mature Permanent Teeth
Official title: Evaluation of Revascularization of Failed Endodontically Treated Mature Permanent Teeth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Revascularization
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-12-23
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Retraetment of failed previous endodontic treated mature permenant teeth with revascularization versus retreatment by conventional endodontic treatment


Eligibility criteria: Inclusion Criteria:

* Pescence of failed endodontic treated mature permenant tooth
* Healthy patients
* Age of 10 years to 18 years

Exclusion criteria:

* Medically compromised patients
* Mentally compromised patients

Primary outcomes:
measure: Clinical success
timeFrame: 1 year
measure: Radiographic success
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02313753: Evaluation of the Coping Long Term With Active Suicide Program
Official title: Evaluation of the Coping Long Term With Active Suicide Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Lead sponsor: Butler Hospital
Sponsor class: OTHER
First posted: 2014-12-10
Enrollment: 224
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 to evaluate the utility of the Coping Long Term with Active Suicide Program (CLASP) for reducing suicidal behavior.


Eligibility criteria: Inclusion Criteria:

1. Current patient at Butler Hospital
2. Suicide attempt or suicidal ideation with intent to make a suicide attempt within 48 hours of hospitalization as indicated on the hospital chart and confirmed by administration of the C-SSRS
3. Age \> 18 years
4. Have a reliable telephone
5. Ability to speak, read, and understand English well to complete the procedures of the study

Exclusion Criteria:

1. Current psychotic symptoms severe enough to impair study participation
2. Participation in a treatment program with established efficacy in preventing suicidal behavior
3. Cognitive impairment which would interfere with adequate participation in the project (MMSE\< 20).

4. Currently in state custody or pending legal action 5. Already enrolled current or previous CLASP trial

Primary outcomes:
measure: A composite composed of the number of participants with either a suicide attempt or death by suicide
timeFrame: 52 weeks following discharge from hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT02686853: Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis
Official title: Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis Without Acquired Immune Deficiency Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cryptococcal Meningitis
Keywords: Intrathecal administration
Liposomal amphotericin B
Without Acquired Immune Deficiency Syndrome
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to observe the clinical effect of intrathecal administration of liposomal amphotericin B in Cryptococcal Meningitis without Acquired Immune Deficiency Syndrome (AIDS).


Eligibility criteria: Inclusion Criteria:

* Cryptococcus neoformans are found in CSF

Exclusion Criteria:

* Patients with serious heart, lung, liver and renal insufficiency.
* Patients who took broad-spectrum antibiotics and corticosteroids for a long-term.
* Patients with AIDS or obvious immunodeficiency.
* Patients with long term dialysis or intravenous catheter.
* Patients with other brain organic disease such as purulent meningitis, intracranial swelling, etc.

Primary outcomes:
measure: laboratory examination of cerebrospinal fluid
timeFrame: 2 to 4 weeks
Secondary outcomes:
measure: changes of clinical symptoms
timeFrame: 2 to 4 weeks
Other outcomes:
measure: The incidence of adverse reactions
timeFrame: 24 hours
Locations:
Study officials:
affiliation: The Second Hospital of Hebei Medical University
name: Hui Bu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04735653: The Support, Educate, Empower (SEE) Program
Official title: Support, Educate, Empower: The SEE Personalized Glaucoma Coaching Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Glaucoma
Keywords: Ophthalmology
Glaucoma
Medication Adherence
Motivational Interviewing
Tailored Education
Self Management
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2021-02-03
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will test whether the Support, Educate, Empower (SEE) personalized Glaucoma Coaching Program improves eye drop medication adherence among glaucoma patients compared to enhanced standard care in a randomized controlled clinical trial. As a secondary outcome, the study will test whether glaucoma related distress decreases among SEE program participants compared to the control group.

The study hypothesis is that glaucoma patients with poor adherence who receive motivational-interviewing based counseling and personalized education from a trained non-physician glaucoma coach through the SEE Program will improve their medication adherence compared to glaucoma patients standard care enhanced by additional educational handouts.


Eligibility criteria: Inclusion Criteria:

* Taking greater or equal to 1 ocular hypotensive medication with a diagnosis of any kind of glaucoma, suspected glaucoma or ocular hypertension
* Did not opt-out from recruitment letter

Exclusion Criteria:

* Do not speak English
* Have a diagnosed serious mental illness (for example, Schizophrenia)
* Diagnosed cognitive impairment
* Do not instill their own eye drops
* Had laser or incisional glaucoma surgery within three months of enrollment or scheduled during the six-month study period
* Unable to attend all study visits
* Active ocular infection or uveitis

Primary outcomes:
measure: Mean electronically monitored medication adherence at six months
timeFrame: Up to 6 months
measure: Proportion of patients that are ≥80% adherent to their glaucoma medications by electronic monitoring will be compared at 6 months between the intervention and control groups.
timeFrame: Up to 6 months
Secondary outcomes:
measure: Glaucoma-related Distress
timeFrame: 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Paula Newman-Casey, MD MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Suzanne Winter, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT00818753: Randomized, Open Label Study of Dabigatran Etexilate in Elective Percutaneous Coronary Intervention
Official title: The Safety and Pharmacodynamics of Two Doses of Dabigatran Etexilate in Patients Undergoing Cardiac Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Catheterization
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-01-08
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess whether two doses of dabigatran etexilate (110 mg twice daily (b.i.d) and 150 mg twice daily (b.i.d)) as compared to unfractionated heparin (UFH), both in addition to a standard dual antiplatelet regimen, provide sufficient anticoagulation in the setting of elective percutaneous coronary intervention (PCI).


Eligibility criteria: Inclusion criteria:

* patients between 18 and 85 years
* due to undergo elective PCI
* informed consent obtained

Exclusion criteria:

* PCI lesion specific conditions
* class III or IV congestive heart failure
* severe hypertension
* increased bleeding risk
* thrombolytic therapy within 24 hours preceding randomization

Primary outcomes:
measure: Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis
timeFrame: From 22 to 165 minutes
Secondary outcomes:
measure: Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy
timeFrame: From 22 to 165 minutes
measure: Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow
timeFrame: From 22 to 165 minutes
measure: Percentage of Participants Who Experienced Catheter Related Thrombi Not Resulting in Clinical Complications Including Guide-catheter (Wire) Thrombosis
timeFrame: From 22 to 165 minutes
measure: Number of Participants With Bleeding Events
timeFrame: First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: 1160.73.31004 Boehringer Ingelheim Investigational Site
city: Nieuwegein
country: Netherlands
facility: 1160.73.31003 Boehringer Ingelheim Investigational Site
city: Rotterdam
country: Netherlands
facility: 1160.73.1 Boehringer Ingelheim Investigational Site
city: Rotterdam
country: Netherlands
facility: 1160.73.31002 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Vranckx P, Verheugt FW, de Maat MP, Ulmans VA, Regar E, Smits P, ten Berg JM, Lindeboom W, Jones RL, Friedman J, Reilly P, Leebeek FW. A randomised study of dabigatran in elective percutaneous coronary intervention in stable coronary artery disease patients. EuroIntervention. 2013 Jan 22;8(9):1052-60. doi: 10.4244/EIJV8I9A162.
Clinical trial NCT00242853: A Study To Investigate Markers Of Inflammation In Rheumatoid Arthritis
Official title: An Enabling Study to Investigate the Correlation of Biomarkers of the Activity of Inducible Nitric Oxide Synthase (iNOS) With Disease Activity and Treatment Response in Patients With Rheumatoid Arthritis(RA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Osteoarthritis
Keywords: iNOS
Rheumatoid arthritis
Exhaled NO
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-10-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: This study is being conducted to validate various biomarkers in patients with RA with varying levels of disease severity. Subjects with a diagnosis of rheumatoid arthritis (RA) will be included as controls. The sudy will measure the baseline levels and the intra- and inter-subject variability of exhaled nitric oxide (NO) in patients with inactive/mild and moderate/severe RA on stable therapy or during a course glucocorticoids. In addition exhaled NO levels will be correlated with intra-articular inflammation (power Doppler ultrasonography) as well as markers of systemic inflammation (CRP, ESR).


Eligibility criteria: Inclusion criteria:

* Diagnosis of rheumatoid or osteo-arthritis.
* Weight greater than 45kg (females) or 50kg (males) but not overweight.
* Non-smokers.
* Taking stable anti-inflammatory medication for Rheumatoid Arthritis (RA) or Osteoarthritis (OA) for at least 8 weeks.

Exclusion criteria:

* Taking regular doses of glucocorticoid medication (greater than 5mg/day).
* Currently taking biological treatment for RA.
* Recent participation in another clinical trial.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01603953: Bioelectrical Impedance Vector Analysis in Cirrhotic Patients
Official title: Malnutrition Assessed Through Bioelectrical Impedance Vector Analysis is Related to Poor Prognosis in Cirrhosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cirrhosis
Hepatic Encephalopathy
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2012-05-23
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants will be recruited from the Gastroenterology Department of a tertiary care setting.

Brief summary: Protein-energy malnutrition and muscle wasting are a common finding among patients with liver cirrhosis. Its prevalence may range from 50-90% depending on the methods used for nutritional assessment. Even stable cirrhotic patients referred as Child A have muscle depletion and the majority of patients classified as Child C have significant depletion. Malnutrition has been shown to be related to several complications of cirrhosis

Despite the importance of nutritional status in patient's outcome, there is no gold standard for nutritional assessment. Traditional techniques used in healthy subjects to assess nutritional status cannot be used in cirrhotic patients due especially to ascites and peripheral edema, and altered rates of biochemical markers due to liver failure.

Bioelectrical impedance vector analysis has emerged as a useful method to assess body composition and nutritional status especially in patients at the extremes of body weight (fluid overload, excess of adipose tissue, etc.).

The aim of this study is to evaluate whether malnutrition assessed by bioelectrical impedance vector analysis is related to the development of hepatic encephalopathy


Eligibility criteria: Inclusion Criteria:

* Diagnose of cirrhosis.
* Ambulatory patients

Exclusion Criteria:

* Personal history of surgery in the last four weeks
* Thyroid disorders without replacement therapy
* Pregnancy
* Active alcoholism with alcohol ingest in the previous 6 months.
* Acute or chronic renal failure
* Hepatic or renal transplant

Primary outcomes:
measure: Hepatic encephalopathy
timeFrame: 6, 12, 24, 36 and 48 months
Secondary outcomes:
measure: Ascites
timeFrame: 6, 12, 24, 36 and 48 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Study officials:
affiliation: INCMNSZ
name: Aldo Torre Delgadillo, M.D. M.Sc
role: STUDY_CHAIR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Astrid Ruiz-Margáin, B.Sci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06857253: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1301 in Healthy Subjects
Official title: A Phase I, Randomized, Double-blind and Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1301 Following Single and Multiple Dose Administration in Healthy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hyperlipidemia
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-04
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-1301 following single and multiple dose administration in healthy subjects. The study consists of two parts (Part 1 and Part 2) with 82 subjects planned to be enrolled. Possible adjustments to sample size, treatment duration and follow-up time will depend upon emerging data.


Eligibility criteria: Inclusion Criteria:

1. Healthy male and female subjects must be at least 18 years old and no more than 55 years old on the date of signing the ICF.
2. The female subjects must be non-pregnant or non-childbearing potential.
3. Subjects must understand the study procedures and methods, voluntarily participate in this study and sign the ICF in person.

Exclusion Criteria:

1. Have a gastrointestinal, liver or kidney disease or other condition known to affect drug absorption, distribution, metabolism and excretion or to reduce adherence, as determined by the investigator.
2. Those who had severe trauma or had undergone surgery within 3 months prior to screening, or planned to undergo surgery during the trial.
3. Have a history of repeated drug allergies.
4. People who have used any drug in the 2 weeks prior to screening.
5. Those who received live (attenuated) vaccine within 4 weeks prior to screening or planned to receive it during the trial.

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: From the first dose up to Day 21.
Secondary outcomes:
measure: HRS-1301 plasma drug concentration.
timeFrame: Up to 168 hours after the first dosing.
measure: HRS-1301 urine drug concentration.
timeFrame: Up to 168 hours after the first dosing.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
References: