louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04026464: Addition of Acetaminophen in Standard PDA Management
Official title: Monotherapy (Ibuprofen) vs. Combination Therapy (Ibuprofen and Acetaminophen) in the Management of Patent Ductus Arteriosus in Premature Infants: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Patent Ductus Arteriosus
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 0
Sex: ALL
Minimum age (years): 23
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patent ductus arteriosus is a common morbidity in preterm infants and management of PDA varies among neonatologist. The investigators are conducting a randomized controlled trial to determine the rates of initial patent ductus arteriosus (PDA) closure after completion of a first treatment course.


Eligibility criteria: Inclusion Criteria:

* Infants 23 0/7 to 27 6/7 weeks' gestational age and birth weight \< 1000 grams
* Hemodynamically significant PDA as defined by any of the following:

  1. Increased ventilator or oxygen support attributed by the clinician to be due to increased left-right shunting through the PDA
  2. Hypotension and/or widening pulse pressure requiring continuous dopamine infusion (hypotension is defined as mean arterial pressure (MAP) at least 2-3 mmHg below the infants' post menstrual age)
  3. Signs of congestive heart failure (e.g increased pulmonary congestion on chest radiograph or hepatomegaly on physical examination)
* Echocardiographic criteria:

  1. Ratio of the smallest ductal diameter to the ostium of the left pulmonary artery \> 0.5

Exclusion Criteria:

* No enteral feedings
* PDA-dependent congenital heart disease
* Prior treatment with prophylactic indomethacin
* Prior PDA treatment with any medications
* Suspected or diagnosed acute necrotizing enterocolitis (NEC) or spontaneous intestinal perforation
* Abnormal liver enzymes (ALT \> 60 IU/L and AST \> 60 IU/L)
* Platelets count \< 50,000 /μl; and / or active intracranial, gastrointestinal, or other bleeding
* Major congenital anomalies such as neural tube defect, known or suspected chromosomal abnormality, and gastrointestinal defect
* Prior enrollment to other interventional clinical study where PDA is an outcome variable

Primary outcomes:
measure: Percentage of infants with PDA closure.
timeFrame: During hospitalization, up to 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Sanket D Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06917664: Treatment of Moderate Ischemic Mitral Regurgitation in Patients With Coronary Artery Disease
Official title: Treatment of Moderate Ischemic Mitral Regurgitation in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Coronary Artery Disease
Ischemic Mitral Regurgitation
Angiotensin Receptor/Neprilysin Inhibitor
Keywords: coronary artery disease
ischemic mitral regurgitation
angiotensin receptor/neprilysin inhibitor
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Chinese Academy of Medical Sciences
First posted: 2025-04-08
Enrollment: 220
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: This study aims to evaluate the effect of angiotensin receptor/neprilysin inhibitors (ARNI) on improving ischemic mitral regurgitation (IMR) in patients with coronary artery disease undergoing isolated coronary artery bypass grafting (CABG) through a randomized controlled clincial trial.


Eligibility criteria: Inclusion Criteria:

1. Fully informed and voluntarily signed informed consent;
2. Received CABG and moderate IMR was diagnosed on two consecutive preoperative transthoracic echocardiography (according to 2021 ESC/EACTS Guidance Standards )

Exclusion Criteria:

1.Symptomatic hypotension and/or a SBP \< 100 mmHg at screening; 2.Estimated GFR \< 30 mL/min/1.73m2; 3.Serum potassium \> 5 mmol/L at screening; 4.History of angioedema or unacceptable side effects while receiving ACE inhibitors or ARBs; 5.Patients receiving mitral valve intervention at the same time, or have participated in other clinical trials, or are unwilling to participate in this study.

Primary outcomes:
measure: effective regurgitant orifice area (EROA)
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: proportion of patients with moderate or higher IMR ,LVEF,LVESV,LVESVI,LVEDV,LVEDVI
timeFrame: 6 months postoperatively
measure: major adverse cardiovascular and cerebrovascular events (MACCE)
timeFrame: 6 months postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: China National Center for Cardiovascular Diseases
state: Beijing
Study officials:
affiliation: China National Center for Cardiovascular Diseases
name: Wei Zhao
role: STUDY_CHAIR
References:
Clinical trial NCT06346964: Self-Care Management in Chronic Disease
Official title: The Effect of Health Education on Chronic Disease Management in the Elderly
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Disease Self Management
Keywords: elderly
self management
chronic disease
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Self-management of chronic diseases includes treatment and adoption of healthy behaviors. The research was planned to determine the effect of health education on disease management in the elderly with chronic diseases. The research will be conducted in a parallel group, randomized controlled manner. Older adults will receive 6 weeks of health education. After the training, the scales will be re-administered face to face or online.


Eligibility criteria: Inclusion Criteria:

* Being in the 65-75 age group,
* Having a chronic disease

Exclusion Criteria:

* Having vision and hearing problems
* Being 76 or older
* Having a neuro-psychiatric disease

Primary outcomes:
measure: Chronic Disease Self-Management Scale
timeFrame: baseline
measure: Chronic Disease Self-Management Scale
timeFrame: within first week
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University
state: Çubuk/Turkey
Study officials:
References:
Clinical trial NCT00002264: The Effectiveness of Cow's Milk Immune Globulin in the Treatment of AIDS-Related Diarrhea
Official title: Efficacy of Cow's Milk Immune Globulin in the Treatment of Chronic Intestinal Cryptosporidiosis in Patients With AIDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cryptosporidiosis
HIV Infections
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To examine the efficacy of cow's milk immune globulin in the treatment of diarrhea due to chronic intestinal cryptosporidiosis in patients with AIDS. The secondary end points of the study involve functional improvement which will be determined from nutritional and absorption studies.


Eligibility criteria: Inclusion Criteria

Patients must have:

* Diagnosis of diarrhea associated with intestinal cryptosporidiosis.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Survival time projected to be \< 9 weeks.
* Inability to tolerate any oral intake.
* Known allergy or intolerance to milk products.
* Organic mental syndrome precluding informed consent or following directions.

Patients with the following are excluded:

* Survival time projected to be \< 9 weeks.
* Inability to tolerate any oral intake.
* Known allergy or intolerance to milk products.
* Organic mental syndrome precluding informed consent or following directions.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Saint Luke's - Roosevelt Hosp Ctr
state: New York
Study officials:
References:
Clinical trial NCT05838664: A Study to Learn About the Effects of Medicines That Help in Thinning the Blood in People With Atrial Fibrillation (AF) Between 2016 and 2020 in France
Official title: SIFNOS STUDY: RETROSPECTIVE STUDY IN PATIENTS WITH ATRIAL FIBRILLATION (AF) EXPOSED AND UNEXPOSED TO AN ORAL ANTICOAGULANT THERAPY BETWEEN 2014-2020 IN FRANCE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-05-01
Enrollment: 3691397
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 years old AF Patients and older will be included from January 1st, 2016 to December 31st, 2020:

Brief summary: The purpose of this study is to look at how many patients with AF had strokes, major bleeding and death in both people who had and had not taken any oral anticoagulant. Atrial fibrillation (AF) is an irregular and often very rapid heart rhythm (arrhythmia) that can lead to blood clots in the heart.

This increases the risk of stroke. Anticoagulants are medicines, also called blood thinners, which help prevent blood clots from forming or getting bigger.

This study includes patient's data from the database who:

* Had at least one hospital stay with AF
* Are new users of OACs for AF treatment
* Are 18 years and older when they were confirmed to have AF All the patient's data included in this study would have either received the OAC therapy or not.

This study aims to look at any events of strokes, major bleeding and death. The data of patients will be collected from the French national health insurance claims database (SNDS). The planned study period is thought to be from 1st January 2016 till 31st December 2020


Eligibility criteria: Inclusion Criteria:

* Identified patients with AF aged 18 years and older at diagnosis of AF

Exclusion Criteria:

* AF Patients with at least one hospital stays for associated valve disease or valve surgery
* Patients treated with an OAC for another indication than AF

Primary outcomes:
measure: clinical outcome in participants
timeFrame: up to 5 years
Secondary outcomes:
measure: clinical outcome in participants
timeFrame: up to 5 years
measure: clinical outcome in participants
timeFrame: up to 5 years
measure: clinical outcome in participants
timeFrame: up to 5 years
measure: clinical outcome in participants
timeFrame: up to 5 years
measure: clinical outcome in participants
timeFrame: up to 5 years
measure: clinical outcome in participants
timeFrame: up to 5 years
Other outcomes:
measure: clinical outcome in participants
timeFrame: up to 5 years
Locations:
city: Paris
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01799564: Micropulse Laser for Geographic Atrophy
Official title: A Phase I Study to Establish the Safety and Efficacy of Retinal Pigment Epithelium Micropulse Laser in Subjects With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Geographic Atrophy
Age-related Macular Degeneration
Keywords: Geographic atrophy
Age-related macular degeneration
Fundus autofluorescence
Lead sponsor: Institut de la Macula y la Retina
Sponsor class: OTHER
First posted: 2013-02-27
Enrollment: 11
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Geographic atrophy (GA) causes the loss of the retinal pigment epithelium (RPE) cells in broad areas of the retina. The application of subthreshold micropulse laser spots in healthy RPE in the vicinity of the area of GA may restore the imbalance in survival factors caused by the disease (ie, the laser may decrease vascular endothelial growth factor and RPE-derived transforming growth factor beta, upregulation of pigment epithelium-derived factor). This may slow or even stop the enlargement of atrophy secondary to GA, and therefore, avoid further vision loss.


Eligibility criteria: Inclusion Criteria:

* GA \> 0.5 disk areas secondary to AMD in both eyes
* 50 years or older
* The periphery of the atrophic lesions must demonstrate increased autofluorescence
* Best corrected visual acuity between 20/20 and 20/400 inclusive
* Clear ocular media
* Ability to provide informed consent and attend all study visits

Exclusion Criteria:

* GA secondary to other causes aside from AMD
* Evidence of choroidal neovascularization in either eye
* Any prior treatment for AMD, aside from antioxidants
* Any other ocular condition that would progress in the study period and confound visual acuity assessment
* Any ocular or systemic medication known to be toxic to the lens, retina or optic nerve
* Presence of idiopathic or autoimmune-associated uveitis
* Any intraocular surgery 3 months of entry
* Any prior thermal laser in the macula
* History of vitrectomy, filtering surgery, corneal transplant or retinal detachment surgery
* Previous therapeutic radiation in the ocular region in either eye
* Any treatment with an investigational agent in the previous 60 days before study entry

Primary outcomes:
measure: Change in area of atrophy as measured with fundus autofluorescence (FAF)
timeFrame: Change in area from baseline to week 48
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institut de la màcula i de la retina
Study officials:
affiliation: Institut de la màcula i de la retina
name: Jordi Monés, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03852264: Oxytocin Pathways and the Health Effects of Human-Animal Interaction
Official title: Oxytocin Pathways and the Health Effects of Human-Animal Interaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human-Animal Bond
Human-Animal Interaction
Keywords: Oxytocin
Cortisol
Human-animal interaction
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: University of Virginia
First posted: 2019-02-25
Enrollment: 55
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Within-subjects, 3 conditions, 2 condition orders balanced across participants
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the roles of oxytocin pathways in human-animal interaction.

Detailed description: This study investigates the roles of oxytocin pathways in human-animal interaction. Children will participate in three conditions involving friendly interactions with dogs, or play with toys at a university laboratory. Child and dog saliva and urine will be assayed for oxytocin concentrations. We will assess variation in oxytocin concentrations in relation to different experimental conditions, and in relation to specific behaviors and psychological constructs.

Eligibility criteria: Inclusion Criteria:

* Participants in this study will include typically-developing children between 8-10 years who have lived with a companion dog in the household for at least 6 months.

Exclusion Criteria:

* known medical diseases or injuries involving the central nervous or endocrine systems, major physical abnormalities, seizures, and significant sensory, cognitive, or motor impairments, current use of psychoactive medications

Primary outcomes:
measure: Salivary Oxytocin, Area Under the Curve
timeFrame: baseline, 15 minutes
measure: Urinary Oxytocin, Area Under the Curve
timeFrame: baseline, 50 minutes
Secondary outcomes:
measure: Salivary Cortisol, Area Under the Curve
timeFrame: baseline, 50 minutes
measure: Urinary Vasopressin, Area Under the Curve
timeFrame: baseline, 50 minutes
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
References:
Clinical trial NCT04547764: Evaluation of Triple Antibiotic Paste Pulp Therapy Compared to Vitapex in Primary Molars.
Official title: Clinical and Radiographic Evaluation of Triple Antibiotic Paste Pulp Therapy Compared to Vitapex Pulpectomy in Non-vital Primary Molars.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Pulp Cavity
Keywords: Deciduous teeth, endodontic treatment, primary molars, pulpectomy.
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 54
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study was to compare the clinical and radiographic success of triple antibiotic paste (TAP) which includes (metronidazole, ciprofloxacin, and minocycline) and Vitapex (calcium hydroxide/iodoform paste) for root canal treatment of pulpally involved teeth.

Detailed description: This study evaluated and compared the clinical and radiographic efficacy of non-instrumentation triple antibiotic paste pulp therapy (TAP) versus Vitapex pulpectomy in non-vital primary molars. Healthy 5 to 9 years old children with at least one non-vital primary molar were included in the study. molars were divided based on the subject's cooperation level and parental preference into two groups. In the first group, molars received TAP and in the second group, they received Vitapex pulpectomy followed by a stainless-steel crown. The TAP was freshly prepared and proportioned in equal parts by volume (metronidazole, minocycline, and ciprofloxacin=1:1:1) before the scheduled treatment appointment. The clinical and radiographic examination was performed by two calibrated and trained pediatric dentists at the pre-operative baseline and at the six- and 12-months follow-up visits.

Eligibility criteria: Inclusion Criteria:

Primary molars with at least one of the following signs and symptoms were eligible and were included in the study:

* badly decayed with signs of irreversible pulpitis,
* necrosis and chronic infection such as: pain or tenderness to percussion and palpation, abscess, fistula-opening, gingival swelling, grade II and greater pathological tooth mobility, evidence of periapical/bifurcation radiolucency,

All the teeth included, had physiological root resorption of less than one third of the root.

Exclusion Criteria

* Teeth showing radiographic evidence of excessive internal or external root resorption,
* perforated pulpal floor,
* excessive bone loss in furcation area involving the underlying tooth germ,
* non- restorable teeth were excluded from the study.

Primary outcomes:
measure: fissure-exact test
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University
state: Makkah
Study officials:
affiliation: Assistant Professor, Department of Pediatric Dentistry King Abdulaziz University
name: heba sabbagh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01013064: A Study of HM10760A (Long-acting Erythropoietin (EPO)) in Healthy Korean Subjects
Official title: A Randomized, Double-blind, Placebo-controlled, Sequential Dose Escalation Study of the Safety, Pharmacodynamics and Pharmacokinetics of Single Intravenous Doses of HM10760A in Healthy Adult Korean Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Erythropoietin
Long acting
EPO
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2009-11-13
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study design:

* Randomized, double-blind, placebo-controlled, sequential dose escalation
* Six ascending dose cohorts are planned

Primary Objective:

* To evaluate the safety profile of single escalating intravenous dose levels of HM10760A

Detailed description: Secondary objectives:

* To evaluate the dose response relationship of a single IV dose of HM10760A on pharmacodynamic parameters including hemoglobin, reticulocyte count, and reticulocyte hemoglobin content
* To evaluate the pharmacokinetic profiles of single IV dose levels of HM10760A
* To determine the pharmacologically active dose(PAD) of HM10760A
* To assess the immunogenicity of a single IV dose of HM10760A

Eligibility criteria: Inclusion Criteria:

* Age 20 to 55 years
* Able and willing to provided written informed consent
* Hemoglobin \< 16 g/dL

Exclusion Criteria:

* Prior exposure to EPO, darbepoetin, other EPO support proteins
* hypersensitivity to EPO, darbepoetin, E.coli derived proteins
* Hemoglobinopathy
* SBP \> 140 mmHg or \< 90 mmHg or DBP \> 95 mmHg
* Chronic, uncontrolled, or symptomatic inflammatory disease
* Malignancy(except non-melanoma skin cancer)

Primary outcomes:
measure: Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and immunogenicity
timeFrame: 84 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanmi Clinical
Study officials:
References: