louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05449756: A Follow-up Study With Children Who Participated in the TEMPO Study in Their First Year of Life
Official title: A Virtual, Decentralised Observational Follow-up Study Investigating Feeding Patterns in Infancy and the Associated Parent-reported Allergic Manifestations, Allergies and Infections in Childhood.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Allergy
Infections
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2022-07-08
Enrollment: 705
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: TEMPO study subjects who completed the final (12 months) visit in the TEMPO study and consented to be approached for follow-up

Brief summary: This is a follow-up study of a randomised clinical trial, called TEMPO (a double-blind randomized clinical trial investigating infant formula and human breast milk consumption), in which infants participated in their first year of life. The investigators like to know if these children develop allergies or infections in childhood and whether their feeding pattern in infancy plays a role.


Eligibility criteria: Inclusion Criteria:

* Subjects are eligible to participate in the TEMPO Follow-Up study in case:
* they completed the final (12 months) visit in the TEMPO study.
* parents agree that their contact details will be shared with a third party for study purposes.
* parents agree that data collected in the TEMPO study will be used in the TEMPO Follow-Up study.
* parents provide written informed consent for participation in the TEMPO Follow-Up in accordance with local law.

Exclusion Criteria:

* Parents who do not have a smartphone, tablet or personal computer with internet access.

Primary outcomes:
measure: Parent-reported symptoms of allergies and infections
timeFrame: 7.5 years
measure: Parent-reported use of medications and/or a medical device
timeFrame: 7.5 years
measure: Parent-reported - hospitalisations and visits to the emergency room
timeFrame: 7.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beek
country: Netherlands
facility: PreCare Trial & Recruitment
Study officials:
References:
Clinical trial NCT04567056: Specific Methylation Profiles in HNSCC
Official title: Validation of Specific Methylation Profiles Ind Head and Neck Cancer - a Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: Head and neck cancer
Squamous Cell carcinoma
Methylation
DNA
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cancer group:

Patients referred from the region of Northern Denmark to the Department of Otorhinolaryngology - Head and Neck Surgery with suspicion of, or with already verified Head and neck squamous cell carcinoma. Only patients with verified squamous cell carcinoma after diagnostic work-up will be eligible.

Control group:

Patients referred from the region of Northern Denmark to the Department of Otorhinolaryngology - Head and Neck Surgery for evaluation or treatment, but without suspected or verified malignancy of the head and neck.

Brief summary: In the study, N-20190047, the investigators aim to define specific methylation patterns in a group of patients with head and neck squamous cell carcinomas.

With this study the investigators aim to validate these findings in a larger cohort.


Eligibility criteria: Cancer group:

Inclusion Criteria:

* Written informed consent
* Verified head and neck squamous cell carcinoma

Exclusion Criteria:

* Other active cancer
* Uncontrolled comorbidity
* Unable to give informed consent

Control group:

Inclusion Criteria:

* Written informed consent
* Normal ENT-examination

Exclusion Criteria:

* Other active cancer
* Uncontrolled comorbidity
* Unable to give informed consent

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: At diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Otolaryngology - Head and Neck Surgery
Study officials:
affiliation: Department of Otolaryngology - Head and Neck Surgery, Aalborg University Hospital
name: Michael Gaihede, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05482256: A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis
Official title: The Role of Detergents in the Pathogenesis of Eosinophilic Esophagitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Eosinophilic Esophagitis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this research is to determine if detergents in everyday products such as toothpaste make the lining of the esophagus leaky and cause allergic inflammation.


Eligibility criteria: Inclusion Criteria:

* Normal, healthy volunteers.
* Able to swallow pills.

Exclusion Criteria:

* Personal history of esophageal disease including but not limited to eosinophilic esophagitis, esophageal dysmotility, or GERD/reflux.
* History of dysphagia (i.e., difficulty swallowing), chronic vomiting, chronic abdominal pain, unintentional weight loss.
* Celiac disease, inflammatory bowel disease, irritable bowel syndrome, esophageal varices, chronic aspiration, connective tissue disorder, or known parasitic infection.
* Gelatin allergy.
* Use of a toothpaste containing SLS within 2 weeks of the study.
* Pregnancy.

Primary outcomes:
measure: Change in Mucosal impedance 15 minutes after exposure
timeFrame: Baseline, 15 minutes after teeth brushing
Secondary outcomes:
measure: Change in Mucosal impedance 30 minutes after exposure
timeFrame: Baseline, 30 minutes after teeth brushing
measure: Change in Mucosal impedance 45 minutes after exposure
timeFrame: Baseline, 45 minutes after teeth brushing
measure: Change in Mucosal impedance 60 minutes after exposure
timeFrame: Baseline, 60 minutes after teeth brushing
measure: Change in IL-33 levels
timeFrame: Baseline, approximately 60 minutes after teeth brushing
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Benjamin Wright, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02730156: Effect of High Altitude Exposure, Acclimatization and Re-exposure on Right Ventricular Function in Lowlanders
Official title: Effect of High Altitude Exposure, Acclimatization and Re-exposure on Right Ventricular Function in Lowlanders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of High Altitude
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University of Calgary
First posted: 2016-04-06
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Prospective interventional trial in lowlanders evaluating effect of acute exposure, acclimatization and re-exposure to high altitude

Detailed description: Low altitude baseline measurements will be performed in Santiago de Chile, 520 m, over the course of 3 days. Participants will then travel by commercial airline (5 h flight) and by bus (3 h ride) to the ALMA base camp located at 2900 m near San Pedro de Atacama, northern Chile. Participants will stay there for the next 7 nights and they will be spend the days (6-8 h daily) at the telescope station at 5050 m while undergoing physiological testing. Daily transports from 2900 to 5050 m will be by car (1 h ride, one way). After the first 7 day altitude sojourn participants will return to the Santiago area (520 m) for a 7 day recovery period.

A second altitude sojourn cycle with an identical schedule as the one described above and a final low altitude stay of 3 days will follow.

Measurements on study subjects will be performed at baseline (lowland, Santiago de Chile), then at 2nd day of altitude exposure and 7th day at altitude before returning to lowland; those are repeated in the second altitude sojourn cycle. Measurements will be conducted by qualified specialists using a portable ultrasound device.

Eligibility criteria: Inclusion Criteria:

* Born, raised and currently living \<800m
* No overnight stay at altitudes \>1500 m 4 weeks before the study

Exclusion Criteria:

* Previous altitude intolerance to altitude \<3000 m
* Pregnancy
* Health impairment, which requires regular treatment

Primary outcomes:
measure: Systolic pulmonary artery pressure measured by echocardiography
timeFrame: [Time Frame: lowland baseline at 520m, day 2; first sojourn at 5050 m, day 2, 7; second sojourn at 5050 m, day 2, 7]
Secondary outcomes:
measure: Indices of right ventricular dysfunction
timeFrame: [Time Frame: lowland baseline at 520m, day 2; first sojourn at 5050 m, day 2, 7; sec
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich
Study officials:
affiliation: University of Zurich
name: Konrad E Bloch, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02828956: Motivation to Change, Coping, and Self-Esteem in Adolescent Anorexia Nervosa
Official title: Motivation to Change, Coping, and Self-Esteem in Adolescent Anorexia Nervosa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Personality Features in Anorexia Nervosa
Keywords: eating disorders
ANSOCQ
anorexia nervosa
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 92
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: N=92 adolescents referred to our eating disorders clinic meeting criteria for anorexia nervosa (AN).

Brief summary: By use of several questionaires, this study aimed at an investigation of the changes in motivation, symptoms, self-esteem and coping style in adolescent patients with anorexia nervosa.. The psychometric properties of the Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ) and its relation to coping style and self-esteem were assessed. After a treatment period of nine months, clinical AN diagnosis and the body mass index (BMI) were re-assessed. Besides construct validity of the ANSOCQ, its predictive validity in terms of predicting the outcome of AN was assessed.

Detailed description: N=92 adolescents referred to an eating disorders clinic meeting criteria for anorexia nervosa (AN) gave written informed consent to participate in this study and completed the ANSOCQ, the Eating Disorder Inventory (EDI-2), the Eating Attitudes Test (EAT), the Body Image Questionnaire (BIQ), two questionnaires measuring Self-Related Cognitions (SRC) and the Coping Across Situations Questionnaire (CASQ). After a treatment period of nine months, clinical AN diagnosis and the body mass index (BMI) were re-assessed. Exploratory factor analysis and logistic regressions were performed.

Eligibility criteria: Inclusion Criteria:

* Consecutive cohort of patients aged 12-19 years with a certified diagnosis of anorexia nervosa

Exclusion Criteria:

* none

Primary outcomes:
measure: Stages of Change
timeFrame: 9 months
measure: Eating-Disorder inventory
timeFrame: 9 months
measure: Rosenberg Self-esteem Scale
timeFrame: 9 months
measure: German Coping Across Situations Questionnaire
timeFrame: 9 months
measure: Body Mass Index
timeFrame: 9 months
measure: Body-Image-Questionnaire
timeFrame: 9 months
measure: Eating Attitudes Test
timeFrame: 9 months
measure: Questionnaire for the assessment of dispositional self-awareness
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Child and Adolescent Psychiatry and Psychotherapy
name: Hans-Christoph Steinhausen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pauli D, Aebi M, Winkler Metzke C, Steinhausen HC. Motivation to change, coping, and self-esteem in adolescent anorexia nervosa: a validation study of the Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ). J Eat Disord. 2017 Apr 17;5:11. doi: 10.1186/s40337-016-0125-z. eCollection 2017.
Clinical trial NCT06852456: QL1706 in Combination With Neoadjuvant Chemotherapy Versus Neoadjuvant Chemotherapy for Locally Advanced, Resectable Esophageal Squamous Cell Carcinoma
Official title: A PhaseⅡ/Ⅲ, Randomized, Double-blind, Placebo-controlled Trial to Evaluate QL1706 Perioperative Treatment in Combination With Neoadjuvant Chemotherapy for Locally Advanced, Resectable Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Resectable Locally Advanced Esophageal Squamous Cell Carcinoma
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled Phase II/III clinical trial to evaluate the perioperative treatment with QL1706 in combination with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma. The primary objective of the Phase II is to evaluate the pathological complete response rate of QL1706 perioperative treatment in combination with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma; the primary objective of the Phase III is to compare event-free survival of QL1706 perioperative treatment in combination with neoadjuvant chemotherapy versus placebo in combination with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma.


Eligibility criteria: Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.
* Patients with thoracic esophageal squamous cell carcinoma diagnosed by pathologic histology or cytology and cT1-2N1-3M0 or cT3-4aN0-3M0 according to AJCC/UICC 8th edition.
* Expected to undergo surgery after completion of neoadjuvant therapy and expected to achieve R0 resection.
* Have not receiv any anti-tumor therapy for esophageal cancer.
* Have adequate organ function.

Exclusion Criteria:

* Significant tumor invasion into organs adjacent to the esophageal lesion;
* a history of gastrointestinal bleeding or those with a high bleeding tendency;
* The presence of supraclavicular lymph node metastases;
* the presence of uncontrollable third interstitial fluid;
* poor nutritional status.

Primary outcomes:
measure: Pathologic complete response rate (pCR) as assessed by the investigator; (Phase II stage)
timeFrame: 30 days after operation
measure: Event-Free Survival (EFS) as assessed by BIRC; (Phase III stage)
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04524156: COVID-19 : Transcutaneous pO2 and pCO2 as Predictive Factors for Acute Respiratory Destress Syndrome in Patients Affected With SARS-Cov-2
Official title: COVID-19 : Transcutaneous pO2 and pCO2 as Predictive Factors for Acute Respiratory Destress Syndrome in Patients Affected With SARS-Cov-2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID
Acute Respiratory Distress Syndrome
Endothelial Dysfunction
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The first case of a person infected with SARS-Cov-2 virus can be tracked back on November the 17th, 2019, in China. On March 11, 2020, the World Health Organization (WHO) declared COVID-19 outbreak a pandemic. On April 13, COVID-19 is affecting 210 countries and territories worldwide, about 2 million positive cases have been officially declared along with 115.000 deaths. The real number of infected and deaths is scarily higher, considering that up to 65% people are asymptomatic and thus, not tested.

The percentage of patients with COVID-19 needed for intensive care unit (ICU) varied from 5 to 32% in Wuhan, China. It was up to 9% in Lombardy, Italy. According to available data from Lombardy, 99% of patients admitted to the ICU needed respiratory support (88% invasive ventilation, 11% non invasive ventilation).

The aim of the present investigation is to test the hypothesis whether transcutaneous partial O2 and CO2 pressures may be reliable predictive factors for acute respiratory distress syndrome (ARDS) development in hospitalized clinically stable COVID-19 positive patients and to clarify the role of the Angiotensin Converting Enzyme 2 (ACE2) and its final product, angiotensin 2 (Ang II) in the pathogenesis of this systemic disease.

We also aim to test the hypothesis that plasma concentration of Clara Cell protein (CC16) and surfactant protein D (SPD), which are a biomarkers of acute lung injury, are severely decreased in COVID-19 positive patients and the plasma concentration is related to the severity of lung injury.


Eligibility criteria: Inclusion Criteria:

* SARS-CoV2 infection (PCR positive and/or TDM Imaging)

Exclusion Criteria:

* None

Primary outcomes:
measure: Transcutaneous pO2 and pCO2 as predictive factors for respiratory deterioration
timeFrame: 6 months
measure: Pneumoproteins CC16 and SDP as predictive factors for respiratory deterioration
timeFrame: 6 months
measure: Diagnostic and prognostic utility of plasma concentration of ACE2, Ang II, Ang 1-7, Ang 1-9 in COVID-19
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Erasme Hospital
Study officials:
affiliation: Erasme hospital
name: Sofia Morra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00245609: Trial of Pregabalin, Alprazolam, and Placebo in Subjects With Anxiety Prior to Dental Procedure
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial Of The Anxiolytic Efficacy Of Pregabalin And Alprazolam IR In Subjects With Anxiety Prior To Dental Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Anxiety
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-28
Enrollment: 90
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 primary purpose of the trial is to assess how effective pregabalin, alprazolam, and placebo are at reducing anxiety levels of subjects who take a dose of these treatments 4 hours before a scheduled dental procedure.


Eligibility criteria: Inclusion Criteria:

* Male or female outpatients 18 years of age or older who score 12 points or more on the Dental Anxiety Scale at screening and baseline evaluations and have a scheduled appointment for an elective dental procedure.

Exclusion Criteria:

* Current diagnosis of any of the DSM-IV anxiety disorders.
* Current diagnosis of major depressive disorder, dysthymia, schizophrenia or any other psychotic disorder, bipolar disorder, and eating disorders as assessed by the M.I.N.I. at screening, or current diagnosis of delirium, dementia, or body dysmorphic disorder.

Primary outcomes:
measure: Change from baseline to endpoint on the Visual Analogue Scale for Anxiety.
Secondary outcomes:
measure: The changes from baseline to endpoint, and changes from baseline to each rating timepoint differ among the three treatment groups for the VAS-Anxiety, VAS-Sedation, Time to Onset of Activity Scales scores, and, Dental Anxiety scales.
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Goettingen
country: Germany
facility: Pfizer Investigational Site
city: Heidelberg
country: Germany
facility: Pfizer Investigational Site
city: Koeln
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Tuebingen
country: Germany
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
state: Greater Manchester
city: Leeds
country: United Kingdom
facility: Pfizer Investigational Site
state: West Yorkshire
city: Sheffield
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03235609: Sedation During Pediatric Diagnostic Gastrointestinal Endoscopy Gastrointestinal Endoscopy
Official title: Propofol-Ketamine vs. Propofol-Fentanyl for Sedation During Pediatric Diagnostic Gastrointestinal Endoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sedation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: comparison between propofol-fentanyl and propofol-ketamine for sedation in pediatric diagnostic gastrointestinal endoscopy.

Detailed description: It is a prospective double blinded controlled study that will be carried out on 60 pediatric patients undergoing GIT endoscopy; they will be divided into two groups of 30 patients each:- Group I (PF): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV. Group II (KF): will receive Ketofol (1 ketamine: 4 propofol) 0.5 mg/kg ketamine + 2 mg/kg propofol IV.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients undergoing diagnostic GIT endoscopy
* ASA I-II

Exclusion Criteria:

* Emergency endoscopy
* Respiratory infection and hyperactive airways
* History of serious adverse effects related to anesthetics (e.g. allergic reactions), a family history of reactions to the study drugs
* Morbid obesity, and neuropsychiatric disorders

Primary outcomes:
measure: incidence of desaturation
timeFrame: up to 2 days after operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Michaud L; Francophone Pediatric Hepatology, Gastroenterology, and Nutrition Group. Sedation for diagnostic upper gastrointestinal endoscopy: a survey of the Francophone Pediatric Hepatology, Gastroenterology, and Nutrition Group. Endoscopy. 2005 Feb;37(2):167-70. doi: 10.1055/s-2004-826144.