louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00310778: Effects of Sodium Intake on (PK/PD) Relationship of a Single Dose of a Renin Angiotensin System-Blocker
Official title: Effects of Sodium Intake on Pharmacokinetic/Pharmacodynamic Relationship of a Single Dose of a Renin Angiotensin System-Blocker, or a Beta-Blocker in Normotensive Sodium-Depleted or Replated Volunteers in a Cross-Over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: High sodium diet
Low sodium diet
Renin-angiotensin system blockers
AT1 receptor (AT1R) antagonist
ACE inhibition
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2006-04-04
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The impact of sodium intake on plasma drug concentrations has previously been reported in the literature for verapamil and quinidine but, to the investigators' knowledge, never with renin-angiotensin system blockers such as AT1R antagonists and angiotensin converting enzyme inhibitors.

Detailed description: The impact of sodium intake on plasma drug concentrations concentrations obtained after a single oral dose of RAS blocking drugs (ramipril 10 mg, valsartan 160 mg, candesartan 8 mg) or a blocker as control (ATENOLOL 50 mg) will be compared in healthy normotensive men randomly assigned to a 6-day replated-sodium diet or a sodium depletion.

Eligibility criteria: Inclusion Criteria:

* 64 (16 per treatment goup) non-smoking healthy male volunteers
* Aged between 18 and 35 years after a complete clinical examination
* Safety laboratory measurements
* Having given written informed consent.

Exclusion Criteria:

* hypertension
* known disease
* diabetes mellitus
* known hypersensitivity
* contraindication to ACE inhibitors
* history of cardiac or pulmonary disease or asthma conditions which do not permit medical follow-up and compliance with the study protocol.

Primary outcomes:
measure: Area under the curve (AUC) up to the 48 hour time point of plasma drug concentrations between a replated-sodium diet and sodium depletion
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'Investigation Clinique 9201 Hôpital Européen Georges Pompidou
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Michel Azizi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Azizi M, Menard J, Bissery A, Guyenne TT, Bura-Riviere A, Vaidyanathan S, Camisasca RP. Pharmacologic demonstration of the synergistic effects of a combination of the renin inhibitor aliskiren and the AT1 receptor antagonist valsartan on the angiotensin II-renin feedback interruption. J Am Soc Nephrol. 2004 Dec;15(12):3126-33. doi: 10.1097/01.ASN.0000146686.35541.29.
Clinical trial NCT04917978: Association of Hb F Level With Clinical Severity of Beta Thalassemia
Official title: Association of Hb F Level With Clinical Severity of Beta Thalassemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Beta Thalassemia
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: ZhuHai Hospital
name: Shenzhen Children's Hospital
name: Shenzhen Second People's Hospital
name: Jiangmen Maternity and Child Health Care Hospital
name: Yongzhou Maternity and Child Health Hospital
First posted: 2021-06-08
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: β-thalassemia patients from Southern China

Brief summary: The production of Hb F after birth is an important factor in modifying the clinical severity of beta thalassemia because an increased gamma-globin level will bind the additional a-globin and form Hb F. The objective of this project is to evaluate the association of Hb F level with phenotypic diversity of patients with beta thalassemia.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with beta-thalassemia

Exclusion Criteria:

* Iron Deficiency Anemia

Primary outcomes:
measure: Hb F level and severity of anemia
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Southern Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT02055378: the Effect of Low-Concentration Atropine Combined With Auricular Acupoint Stimulation in Myopia Control
Official title: the Effect of Low-Concentration Atropine Combined With Auricular Acupoint Stimulation in Myopia Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: myopia
atropine
anterior chamber depth
auricular acupoint
axial length
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2014-02-05
Enrollment: 73
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effect of myopia control between patients treated with low-concentration atropine eye drops combined with auricular acupoint stimulation and those treated with atropine alone.

Detailed description: Myopia has been an increasing problem among school children, especially in Asian countries. High myopia is not only a refractive problem, but also a disease that can result in a number of sight-threatening complications such as macular degeneration, retinal detachment, glaucoma, and cataract. Atropine is a long-acting non-selective muscarinic antagonist that blocks accommodation by paralyzing ciliary muscles; it may affect remodeling of the sclera and suppress the elongation of axial length. Acupuncture and acupressure have been widely used in traditional Chinese medicine for thousands of years. Auricular acupoint stimulation by acupuncture or acupressure has been reported to improve visual acuity in myopic patients. Therefore, we want to compare the effect of myopia control between patients treated with low-concentration atropine eye drops combined with auricular acupoint stimulation and those who treated with atropine alone.

Eligibility criteria: Inclusion Criteria:

* Children aged from 6 to 12 years with myopia, defined as spherical equivalent (SE) of -0.5 diopter (D) or less, were recruited from the outpatient clinics from January 2011 to June 2012.

Exclusion Criteria:

* (1) abnormal IOP (\>21 mmHg) at presentation, (2) astigmatism or anisometropia of more than 1.5 D, (3) amblyopia or strabismus, (4) the presence of any related eyelid diseases, ocular diseases, or auricular diseases, (5) the presence of hemostatic disorders or other related major systemic diseases, (6) history of allergy to atropine, (7) previous or current use of contact lenses, bifocals, progressive lenses, or other forms of treatment for myopia.

Primary outcomes:
measure: the change in spherical equivalent (SE)
timeFrame: SE measured at 3, 6, 9, 12 months.
Secondary outcomes:
measure: axial length (AL) elongation, anterior chamber depth (ACD) and intraocular pressure(IOP)
timeFrame: AL, ACD, and IOP measure at 3, 6, 9, 12 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
state: New Taipei City
Study officials:
affiliation: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
name: Liao, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04954378: Radiomics Based on Multimodal Imaging in Predicting Staging and Prognosis of Pancreatic Cancer
Official title: Radiomics Based on Multimodal Imaging in Predicting Staging and Prognosis of Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Ductal Adenocarcinoma
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pancreatic tumor patients

Brief summary: Retrospectively analyzed radiomics features of pancreatic ductal adenocarcinoma to predict staging and prognosis

Detailed description: Pancreatic cancer is the most malignant tumor of the digestive system and the seventh leading cause of cancer-related death worldwide.The rate of lymph node metastasis in pancreatic cancer is as high as 59%.Lymph node metastasis is an important prognostic factor, which is closely associated with poor prognosis of pancreatic cancer patients.Preoperative accurate prediction of lymph node status has important clinical value.At present, the preoperative LN status of pancreatic cancer patients is mainly evaluated by conventional imaging methods such as CT and MRI.The accuracy of evaluating LN state only from the perspective of morphology is poor.Ductal adenocarcinoma of the pancreas is highly malignant, has a median disease-free survival of only about 1 year, and most pancreatic cancer patients eventually relapse.At present, TNM staging system is mainly used for prognosis evaluation.However, even among patients with the same TNM stage, the prognosis is still significantly different, which reflects the lack of prognostic information provided by the TNM stage.Imaging omics extracts a large number of quantitative features from medical images in a high-throughput manner to enable non-invasive analysis of intra-tumor heterogeneity.In this study, we planned to construct a prediction study of preoperative lymph node metastasis and prognosis of pancreatic cancer based on multimodal imaging, so as to provide a basis for clinical treatment decision and prognosis.

Eligibility criteria: Inclusion Criteria:

* radical resection was performed, and histopathologically confirmed pancreatic ductal adenocarcinoma and lymph node status;2) CT and/or MRI enhancement examinations were performed 2 weeks before surgery;3) Patients with complete clinical data

Exclusion Criteria:

* (1)Patients who received radiotherapy or chemotherapy before preoperative imaging examination;2) Poor image quality.

Primary outcomes:
measure: radiomics features
timeFrame: After sketching the ROI
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Huishu Yuan
role: STUDY_CHAIR
References:
Clinical trial NCT00928278: A Study Estimating The Time Course Of PF-04764793 In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers
Official title: An Open Study To Estimate The Plasma Pharmacokinetics Of PF-04764793 Administered Via Oral Inhalation Using Dry Powder Inhalers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-25
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the time course of PF-04764793 concentration in the blood following dosing by oral inhalation from dry powder inhalers.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
* Pregnant or nursing females.

Primary outcomes:
measure: Plasma pharmacokinetic parameters: AUClast and Cmax
timeFrame: 48 hours
Secondary outcomes:
measure: Plasma pharmacokinetic parameters: AUC0-12, AUC0-24, AUCinf, Tmax and terminal half-life.
timeFrame: 48 hours
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04186078: Clinical Characteristics of Patients With Sleep Apnea in Korea
Official title: Clinical Characteristics of Patients With Sleep Apnea in Korea: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Apnea Syndromes
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who are suspected of sleep apnea due to symptoms such as snoring, witnessed apneas, waking up with a choking sensation, excessive sleepiness, non-restorative sleep, difficulty initiating or maintaining sleep, fatigue or tiredness, and morning headache will be prospectively recruited at the outpatient clinic of Seoul National University Hospital.

Brief summary: Sleep-disordered breathing including obstructive sleep apnea (OSA) is an extremely common medical disorder associated with important morbidity. The purpose of this study is to understand the clinical features and course of patients with sleep apnea in Korea. Participants who are suspected of sleep apnea due to symptoms such as snoring, witnessed apneas, waking up with a choking sensation, excessive sleepiness, non-restorative sleep, difficulty initiating or maintaining sleep, fatigue or tiredness, and morning headache will be prospectively recruited at the outpatient clinic of Seoul National University Hospital. After polysomnography (PSG) or respiratory polygraphy, patients with sleep apnea including OSA and central sleep apnea (CSA) will be followed regularly. Participants not having sleep apnea (apnea-hypopnea index \< 5/hour) will only have a baseline visit. For only participants with the informed consent of donating blood, their blood samples will be collected and stored in the Seoul National University Hospital-Human Biobank (SNUH-HUB).


Eligibility criteria: Inclusion Criteria:

* Participants who are suspected of sleep apnea due to symptoms such as snoring, witnessed apneas, waking up with a choking sensation, excessive sleepiness, non-restorative sleep, difficulty initiating or maintaining sleep, fatigue or tiredness, and morning headache

Exclusion Criteria:

* None

Primary outcomes:
measure: The number of participants with adherence to positive airway pressure (PAP) therapy
timeFrame: Median follow up of 2 years
Secondary outcomes:
measure: The number of deaths
timeFrame: Median follow up of 15 years
measure: The cause of death
timeFrame: Median follow up of 15 years
Other outcomes:
measure: Change of FEV1 and FVC in patients with OSA
timeFrame: Median follow up of 5 years
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jaeyoung Cho, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01559571: Registry for Severe ROP and Treatment on Visual Outcomes
Official title: Study Registry for Severe Retinopathy and Treatment on Visual Outcomes of Premature Neonates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinopathy of Prematurity
Keywords: Retinopathy of Prematurity
Lead sponsor: Pediatrix
Sponsor class: OTHER
First posted: 2012-03-21
Enrollment: 324
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates who have a diagnosis of Retinopathy of Prematurity Stage 2 or higher

Brief summary: The purpose of this study is to determine what factors influence the visual outcomes of infants with severe retinopathy of prematurity (ROP) and to monitor the outcomes.


Eligibility criteria: Inclusion Criteria:

* Documentation of informed consent and authorization
* Inborn and those admitted within 7 days of birth
* Infant with a diagnosis of stage 2 ROP or higher
* Site ability to plan close ophthalmological follow-up due to significant and persistent ROP
* Parents must agree to report outcomes following each ophthalmological visit and overall outcomes for up to five (5) years of age
* Ability to obtain follow-up data on outcomes if the child is transferred to another facility
* No known major congenital anomalies

Exclusion Criteria:

* ROP stage 1 or less
* Parents unwilling to participate in follow-up
* Major congenital anomalies

Primary outcomes:
measure: Identification of visual acuity in subjects who were treated for ROP
timeFrame: Five year follow-up
Secondary outcomes:
measure: Recurrence of stage 3+ retinopathy of prematurity in one or both eyes in zone I or posterior zone II Recurrence of stage 3+ retinopathy of prematurity in one or both eyes in zone I or posterior zone II
timeFrame: Five year follow-up
Other outcomes:
Locations:
city: South Bend
country: United States
facility: Memorial Hospital of South Bend
state: Indiana
city: Las Vegas
country: United States
facility: Summerlin Hospital Medical Center
state: Nevada
Study officials:
affiliation: Pediatrix
name: Reese H Clark, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tolia VN, Ahmad KA, Jacob J, Kelleher AS, McLane N, Arnold RW, Clark RH; MEDNAX ROP Registry Investigators. Two-Year Outcomes of Infants with Stage 2 or Higher Retinopathy of Prematurity: Results from a Large Multicenter Registry. Am J Perinatol. 2020 Jan;37(2):196-203. doi: 10.1055/s-0039-1694983. Epub 2019 Sep 3.
Clinical trial NCT06899971: The Association Between Tau & GFAP and Postoperative Neurological Impairment in Patients Undergoing Cardiac Surgery
Official title: The Association Between Tau & GFAP and Postoperative Neurological Impairment in Patients Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiac Surgery Requiring Cardiopulmonary Bypass
Brain Injury
Congenital Heart Defect
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 100
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients less than 18 years old undergoing a cardiac surgical procedure at Boston Children's Hospital with cardiopulmonary bypass.

Brief summary: Patients born with heart defects often undergo surgical procedures on a heart lung machine. With improvements in medical and surgical management, their survival has significantly improved, but their brain insult has not been paid much attention. This study is to determine the relationship between specific proteins in the blood and brain injury in patients less than 18-year-old undergoing heart surgery.


Eligibility criteria: Inclusion Criteria:

* less than 18 years old
* undergoing cardiac surgery with cardiopulmonary bypass at Boston Children's Hospital

Exclusion Criteria:

* undergoing an emergent procedure and do not have more than 1 hour ahead of time to review the consent
* patient in a moribund condition American Society of Anesthesiology (ASA 5)
* patient with a hematological and/or oncological disease
* Jehovah witnesses
* patient on preoperative mechanical ventilation

Primary outcomes:
measure: Characterization of postoperative neurological impairment
timeFrame: 24 hours following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT01448278: Pain Evaluation After Anterior Cruciate Ligament (ACL) Ligamentoplasty
Official title: Pain Evaluation After ACL Ligamentoplasty: "All-inside" Versus Classical Technique. A Prospective Randomised Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthroscopic Anterior Cruciate Ligament Reconstruction
Keywords: Anterior cruciate ligament
Arthroscopy
Incomplete bone tunnels
Anterior cruciate ligament reconstruction
Lead sponsor: Hospital Ambroise Paré Paris
Sponsor class: OTHER
First posted: 2011-10-07
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The "All-inside" method is a new minimally invasive procedure for anterior cruciate ligament reconstruction (ACL). It consists of incomplete bone tunnels drilling and cortical fixation. In the so-called "classical" method, the fixation is achieved with interference screws.

The hypothesis of this study was that the "All-inside" technique causes less pain than the conventional technique. The main objective was to evaluate the immediate postoperative pain for the first ten days and at one month from the intervention.


Eligibility criteria: Inclusion Criteria:

* Total or partial tear of the Anterior Cruciate Ligament

Exclusion Criteria:

* Patient refusal

Primary outcomes:
measure: Pain assessment on a Visual Analogical Scale
timeFrame: One month after surgery
Secondary outcomes:
measure: Pain assessment on a Visual Analogical Scale
timeFrame: First ten days
measure: Analgesics consumption
timeFrame: First ten days
measure: Functional evaluation with IKDC score
timeFrame: Change from base-line in IKDC objective score at 6 months
measure: Discharge of crutches and orthesis
timeFrame: Time frame from surgery
measure: Radiographic analysis of tunnels positioning according to Aglietti's criteria
timeFrame: One month after surgery
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Ambroise Paré Hospital
state: Ile de France
Study officials:
affiliation: Hospital Ambroise Paré Paris
name: Philippe Hardy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ambroise Paré Hospital
name: Horea Benea, MD
role: STUDY_DIRECTOR
affiliation: Ambroise Paré Hospital
name: Henri d'Astorg, MD
role: STUDY_DIRECTOR
References:
citation: Benea H, d'Astorg H, Klouche S, Bauer T, Tomoaia G, Hardy P. Pain evaluation after all-inside anterior cruciate ligament reconstruction and short term functional results of a prospective randomized study. Knee. 2014 Jan;21(1):102-6. doi: 10.1016/j.knee.2013.09.006. Epub 2013 Oct 5.