louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06045130: PUFAs in Preterm Infants
Official title: Characteristics of PUFAs Composition in Preterm Infants and Its Impact on Disease Prognosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Necrotizing Enterocolitis
Intraventricular Hemorrhage
BPD - Bronchopulmonary Dysplasia
Sepsis
Periventricular Leukomalacia
Patent Ductus Arteriosus
Keywords: PUFAs
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Neonates born within 24 hours who were admitted to the Neonatology Department of the First Hospital of Jilin University, including premature infants born between 24 and 36 weeks of gestational age and full-term infants from September 2023 to August 2026, n

Brief summary: The research endeavors to examine the critical composition of Polyunsaturated Fatty Acids (PUFAs) in premature infants across different gestational stages and under varying disease conditions, and delineate the metabolic attributes of PUFAs in premature infants and their interplay with the onset of diseases. This study anticipates furnishing a theoretical foundation for the rationalization of PUFAs supplementation in premature infants and for informing strategies related to disease prevention and management.


Eligibility criteria: Inclusion Criteria:

Infants born between 24 and 36 weeks of gestational age who are admitted within 24 hours of birth, including both premature and full-term newborns.

-

Exclusion Criteria:

Infants with severe congenital developmental abnormalities, those requiring external supplementation of PUFAs in addition to standard intravenous nutrition and breastfeeding, and those with a severe prognosis indicating non-survival during their hospitalization.

-

Primary outcomes:
measure: Mortality and severe complications of premature infants
timeFrame: before discharge
Secondary outcomes:
measure: Mortality
timeFrame: before discharge
measure: NEC
timeFrame: before discharge
measure: PDA
timeFrame: before discharge
measure: BPD
timeFrame: before discharge
measure: IVH
timeFrame: before discharge
measure: PVL
timeFrame: before discharge
measure: sepsis
timeFrame: before discharge
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00877630: Minimal Invasiveness of Endoscopic Thyroidectomy
Official title: Minimal Invasiveness of Endoscopic Thyroidectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Nodule
Lead sponsor: Second Military Medical University
Sponsor class: OTHER
First posted: 2009-04-08
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitted in the ward who are diagnosed with thyroid nodule and will undergo thyroidectomy

Brief summary: The investigators had performed more than 250 cases of breast approach endoscopic thyroidectomy (BAET). The goal of this study is to evaluate whether BAET could be a minimally invasive procedure under the expert's hands.


Eligibility criteria: Inclusion Criteria:

* thyroidectomy nodule diagnosed by ultrasound

Exclusion Criteria:

* thyroid carcinoma

Primary outcomes:
measure: Serum IL-6 and CRP levels before and after operation
timeFrame: 0, 2, 12, 24, 48 hours after surgery
measure: Visual Analogue Scale (VAS) score
timeFrame: 2, 12, 24, 48 hours after surgery
measure: Cosmetic outcomes after surgery
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Minimally Invasive Surgical Center of Changzhang Hospital
Study officials:
affiliation: SMMU
name: Ming Qiu, MD., Ph D
role: STUDY_DIRECTOR
References:
Clinical trial NCT04290130: Dynamic Neural Mechanisms of Audiovisual Speech Perception
Official title: Dynamic Neural Mechanisms of Audiovisual Speech Perception
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Speech Perception
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Baylor College of Medicine
First posted: 2020-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Understanding speech is one of the most important functions of the human brain. We use information from both the auditory modality (the voice the of person we are talking to) and the visual modality (the facial movements of the person we are talking to) to understand speech. We will use intracranial encephalography to study the organization and operation of the brain during audiovisual speech perception.


Eligibility criteria: Inclusion Criteria:

* must be undergoing neurosurgery for the treatment of a brain disorder

Exclusion Criteria:

* must have corrected-to-normal vision and hearing

Primary outcomes:
measure: Measurement of neural activity
timeFrame: During the procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01774825: IQP-CL-101 in IBS Management
Official title: Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate the Safety and Efficacy of IQP-CL-101 in the Symptomatic Improvement of Irritable Bowel Syndrome (IBS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritable Bowel Syndrome
Keywords: Irritable bowel syndrome
IBS
Lead sponsor: InQpharm Group
Sponsor class: INDUSTRY
First posted: 2013-01-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After 2 weeks of run-in period, subjects are randomized to either IQP-CL-101 or a matching placebo. Over 8 weeks, the subjects are monitored for improvements in IBS symptoms


Eligibility criteria: Inclusion Criteria:

* Fulfils Rome-III criteria for IBS diagnosis
* Females' agreement to use appropriate birth control methods during the active study period for females of childbearing potential
* Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply

Exclusion Criteria:

* Known sensitivity to any of the ingredients of IQP-CL-101
* Clinically relevant abnormalities in colonoscopy within the last 2 years prior to randomization
* Other causes of IBS symptoms such as inflammatory bowel disease (IBD), microscopic colitis, celiac disease, history of abdominal obstruction, cholecystitis, pancreatitis, ileus, or any gastrointestinal bleeding
* Use of medications that could influence GI functions (e.g. antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, or anti-diarrheals) within 1 month prior to randomization
* Clinically relevant excursions of safety parameters
* Any other conditions deemed relevant by the investigator(s)

Primary outcomes:
measure: IBS-SSS (Severity Symptom Score)
timeFrame: 8 weeks
Secondary outcomes:
measure: IBS-GIS (Global Improvement Score)
timeFrame: 8 weeks
measure: IBS-QOL (Quality of Life)
timeFrame: 8 weeks
measure: Pain and discomfort diary
timeFrame: 8 weeks
measure: Efficacy assessment by investigator
timeFrame: 8 weeks
measure: Efficacy assessment by subject
timeFrame: 8 weeks
measure: Full blood count
timeFrame: 8 weeks
measure: Clinical chemistry
timeFrame: 8 weeks
measure: Fecal calprotectin
timeFrame: 8 weeks
measure: Blood pressure
timeFrame: 8 weeks
measure: Safety assessment by subject
timeFrame: 8 weeks
measure: Safety assessment by investigator
timeFrame: 8 weeks
measure: Adverse events
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Barbara Grube
Study officials:
affiliation: Private Practice
name: Barbara Grube, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01098825: Vaccine Hesitancy: A Survey of Pediatric Clinicians
Official title: Vaccine Hesitancy: A Survey of District VI Pediatric Clinicians
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaccine Hesitancy
Vaccine Refusal
Keywords: vaccine hesitancy
vaccine refusal
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2010-04-05
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: District VI American Academy of Pediatrics clinicians

Brief summary: The purpose of this study is to explore the experiences and perceptions of District VI pediatric clinicians on parental vaccine hesitancy and vaccine refusal.

Detailed description: This is a retrospective, convenience sample, descriptive study. Participants will be asked to complete a web-based survey on parental vaccine hesitancy/ vaccine refusal. Survey responses are primarily categorical. Frequencies and averages will be reported using group statistics.

Eligibility criteria: Inclusion Criteria:

* Members of District VI American Academy of Pediatrics

Exclusion Criteria:

* Non-English speaking/reading

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Christopher J Harrison, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02085525: A Randomized Comparative Study of a Weekly Versus Every Other Week Nurse Practitioner-led Symptom Management Clinic for Head and Neck Cancer Patients Undergoing Concurrent Chemotherapy and Radiation
Official title: A Randomized Comparative Study of a Weekly Versus Every Other Week Nurse Practitioner-led Symptom Management Clinic for Head and Neck Cancer Patients Undergoing Concurrent Chemotherapy and Radiation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 0
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: A retrospective chart review of patients receiving concurrent chemoradiotherapy for oropharynx cancer was performed to compare clinical data for patients treated prior to the initiation of the NP clinic with those subsequently seen weekly in the NP clinic. The variables studied included; rate of hospitalization, dose completion and dose reductions. The results revealed an overall improvement in all variables for those patients seen in the weekly NP clinic.

To further analyze this data a randomized, prospective study is proposed to validate the findings of the retrospective study. It is predicted that a weekly NP led clinic will decrease costly hospitalizations, increase patient treatment completion and improve overall patient quality of life and satisfaction.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of stage III or IV HNC
* Are initiating concurrent chemotherapy and radiation
* Are able and willing to sign informed consent
* Ages 18 years or older
* ECOG (Eastern Cooperative Oncology Group) score of 0 or 1 (The ECOG score attempt to quantify cancer patients' general well-being and activities of daily life)
* Able to read and complete the required survey

Exclusion Criteria:

* Cannot provided informed consent
* Any medical or psychiatric illness which in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment.
* Have a history of prior cancer within past 5 years (excluding non-melanoma skin cancer)
* Are unwilling or unable to complete the required QOL (Quality of Life) survey

Primary outcomes:
measure: Percentage of Patients that Experience a "Problem" during Cancer Treatment
timeFrame: 11 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Francis Worden, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05982925: Longitudinal Cortical Demyelination in Multiple Sclerosis and Related Disorders
Official title: Longitudinal Investigation of Cortical Demyelination and Meningeal Inflammation in Multiple Sclerosis and Related Disorders
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Multiple Sclerosis
Neuromyelitis Optica
Demyelinating Autoimmune Diseases, CNS
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with MS or other neuroinflammatory diseases and healthy volunteers

Brief summary: In this protocol, a combination of MRI, blood, and cerebrospinal fluid (CSF) analysis will be used to understand the natural history, underlying immunologic mechanisms, and clinical implications of central nervous system (CNS) lesions, in particular lesions in the cerebral cortex, in multiple sclerosis (MS) and other inflammatory and autoimmune disorders affecting the CNS. Patients with these disorders, as well as healthy controls, will undergo baseline clinical evaluation and testing, bloodwork, and MRI, with follow up clinical evaluation, bloodwork, and MRI at years 1, 3, and 6. Additional MRIs may be performed in patients with possible new lesion formation or to compare MRI techniques. Lumbar puncture will be performed on participants who are not currently being treated with disease modifying therapies and who are willing to undergo the procedure.


Eligibility criteria: Inclusion Criteria:

* 18 years old
* able to provide consent in English
* able to undergo MRI

Exclusion Criteria:

* contraindication to MRI
* pregnancy

Primary outcomes:
measure: Cortical Lesion Number
timeFrame: at 6 years (end of study)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Erin S Beck, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03011125: A Clinical Trial to Evaluate the Safety and Tolerability of Dexlansoprazole Injection in Healthy Chinese Adults (Part 1)
Official title: A Phase 1 Double-blind, Dose-escalation, Placebo-controlled Tolerance Study in Healthy Chinese Adults After Single Intravenous Administration of Dexlansoprazole
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety Issues
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
Collaborators: name: Jiangsu Aosaikang Pharmaceutical Co., Ltd.
First posted: 2017-01-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single center, randomized, double-blind, dose-escalation, placebo-controlled phase 1 clinical trial. This study will determine the safety and side-effect profile of an investigational dexlansoprazole injection after single intravenous administration in healthy Chinese adults.

Detailed description: This is a single center, double-blind, dose-escalation, placebo-controlled clinical trial. Dose escalation will be proceeded according to 3+3 design in five predefined dosing groups. After completion of the 90mg dosing study, dose-escalation will be stopped, even though MTD is not be observed. A total of 28 participants is scheduled to be recruited. The whole follow-up period for each participant will be 3 days.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 Years;
* Male (weight ≥50kg) or female (weight ≥45kg);
* BMI between 19\~28 kg/m2;
* Healthy subjects (at screening);
* Subject who totally understand the aim and progress of this clinical trial, make decision by his/her free will, and signed a consent form to follow the progress.

Exclusion Criteria:

* Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator;
* Subject who has past or present history of any serious diseases, including (but not limited to) digestive, cardiovascular, respiratory, urinary, musculoskeletal, endocrine, psychiatric or neurological, hematologic, immunological or metabolic disorders;
* Medical examination, laboratory tests or ECG judged by the investigator to differ significantly from normal clinical values;
* HIV, HBV, or syphilis positive;
* Drug dependency or abuse;
* Heavy smokers (\>5 cigarettes per day);
* Alcohol use;
* Participation in another study with an investigational drug within the last 3 months preceding this study;
* Blood donation within the last 2 months (\>= 400 ml), or have a plan to donate blood within 1 month after this study;
* Intake of any other drug which might influence the results of the trial during two weeks previous to the start of the study.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: Lihua Wu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01114425: Safety Study of Isentress® + Truvada® in Post-exposure Treatment of HIV Infection
Official title: Etude Observationnelle Multicentrique Relative à la tolérance de ISENTRESS® + TRUVADA® Prescrite en Prophylaxie Post-exposition de Personnes récemment Soumises au Risque de Transmission d'Une Infection Par le VIH
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: tolerability of post exposure to HIV infection prophylaxis
Lead sponsor: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
Sponsor class: NETWORK
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2010-05-03
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective are to assess the nature and incidence of drug intolerance observed with a new antiretroviral triple therapy, Truvada® \[0-0-1\] + Isentress® 400 mg tablets \[1-0-1\], prescribed in a setting of the treatment of individuals with recent exposure to a risk of transmission of HIV infection and to compare the results with those of previous studies conducted according to the same methodology, with other combinations of antiretrovirals.


Eligibility criteria: Inclusion criteria

* age 18 years or over
* consultation immediately following exposure to the risk of transmission of HIV infection (less than 48 hours, except in the case of rape when this period may be increased to a maximum of 120 hours)
* person capable of understanding the principle of the study and giving his/her informed consent

Exclusion criteria

* subjects recently exposed to a risk of transmission of HIV infection in which the source patient is known to be infected with HIV and treated, and whose therapeutic history justifies the introduction of PET other than that proposed in this study
* subjects with a contraindication to the prescription of Truvada® and/or Isentress® (renal impairment, allergy, etc.)
* subjects previously treated with phenytoin, phenobarbital and rifampicin, since combination with raltegravir is contraindicated subjects known to be infected with hepatitis B virus, whether or not treated with lamivudine
* subjects refusing to take part in the study
* pregnant women

Primary outcomes:
measure: To assess the nature and incidence of drug intolerance and to compare the results with those of previous studies conducted according to the same methodology, with other combinations of antiretrovirals.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: GERES
Study officials:
affiliation: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
name: Christian RABAUD, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06553625: Radiofrequency (RF) Ablation Prospective Outcomes Study for Central Nervous System - RAPID for CNS
Official title: Radiofrequency (RF) Ablation Prospective Outcomes Study for Central Nervous System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Dystonia
Essential Tremor
Movement Disorders
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2024-08-14
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients planned to receive treatment with a commercially approved Boston Scientific RF system to create lesions in the central nervous system (CNS) for use in functional neurosurgery.

Brief summary: The objective of this study is to compile real-world outcomes of Boston Scientific commercially approved radiofrequency (RF) ablation systems used in the central nervous system (CNS) for use in functional neurosurgery.

Detailed description: The objective of this study is to compile real-world outcomes of Boston Scientific Corporation commercially approved radiofrequency (RF) ablation systems used in the central nervous system (CNS) for use in functional neurosurgery.

Eligibility criteria: Inclusion Criteria:

* Study candidate is scheduled to be treated with a commercially approved Boston Scientific RF system for pain or for CNS applications per local Directions for Use (DFU)
* Signed a valid, IRB/EC/REB-approved informed consent form

Exclusion Criteria:

* Meets any contraindications per locally applicable Directions for Use (DFU)
* Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments

Primary outcomes:
measure: Change in patient's quality of life (QoL) during the study as compared with baseline
timeFrame: Up to 24-Months
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Uniklinik Köln
city: Dusseldorf
country: Germany
facility: Universitaetsklinikum Dusseldorf
city: London
country: United Kingdom
facility: St. Georges Hospital
Study officials:
affiliation: Boston Scientific Corporation
name: Natalie M Bloom Lyons, M.A.
role: STUDY_DIRECTOR
References: