louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03768284: Genetic Analysis of Pediatric Psoriasis
Official title: Genetic Analysis of Pediatric Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Psoriasis Foundation
name: Icahn School of Medicine at Mount Sinai
First posted: 2018-12-07
Enrollment: 86
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will ascertain approximately 150 subjects, which will include pediatric psoriasis patients diagnosed before age 12, parents not affected by psoriasis, and if a family history is indicated, up to third-degree family members.

Brief summary: This study will ascertain approximately 150 subjects, which will include pediatric psoriasis patients diagnosed before age 12, parents not affected by psoriasis, and if a family history is indicated, up to third-degree family members. Saliva (or buccal swabs in the case of infants) will be obtained for DNA isolation.


Eligibility criteria: Inclusion Criteria:

* Patients (of any age) who developed psoriasis before 12 years of age and who have no family history of psoriasis in either parent.
* Parents of patients who developed psoriasis before 12 years of age
* Up to third-degree family members (first cousin, grandparent, great-grandparent) with or without psoriasis, if family history is indicated.

Exclusion Criteria:

* Patients, parents, and other family member unable to give a saliva or buccal swab sample.
* Patients, parents, and other family member unable to give written informed consent.

Primary outcomes:
measure: CARD14 mutations
timeFrame: one year
Secondary outcomes:
measure: De novo mutations
timeFrame: one year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Northwestern University
name: Amy Paller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02073084: A Thorough Corrected QT Interval Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemia
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2014-02-27
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of K-877 on ECG parameters with a focus on cardiac repolarization compared with placebo in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Subject provides written informed consent before any study specific evaluation is performed.
* Subject is a healthy adult male or female volunteer, of any race and ethnicity, between the ages of 18 and 45 years, inclusive.
* Subject has a body mass index of 18 to 30 kg/m2, inclusive.

Exclusion Criteria:

* Subject has clinically relevant abnormalities in the screening or check in assessments.
* Subject has a supine blood pressure after resting for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic.
* Subject has a supine Heart Rate (HR) (as measured at Screening or Check-in during collection of vital signs) after resting for at least 5 minutes that is outside the range of 40 to 90 beats per minute.

Primary outcomes:
measure: QTcI (QT interval corrected) duration
timeFrame: 24 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT00986284: Epidermal Growth Factor Receptor (EGFR) Status Based Gefitinib Neoadjuvant Therapy in Non Small Cell Lung Cancer (NSCLC)
Official title: Phase II Study of EGFR Status Based Gefitinib Neoadjuvant Therapy in NSCLC Patients
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: Non Small Cell Lung Cancer
Gefitinib
Neoadjuvant Therapy
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2009-09-29
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the efficacy and safety of gefitinib as neoadjuvant therapy in stage IIIA NSCLC patients.


Eligibility criteria: Inclusion Criteria:

* Patients pathological diagnosed with NSCLC,with EGFR sensitive mutation;
* Stage IIIA patients with technical operable disease evaluated by image and lab results;
* Patients without chemotherapy or targeted-therapy before;
* Inform Consent.

Exclusion Criteria:

* Patients with malignant tumor other than lung cancer;
* Patients with other diseases such as cardiovascular disease that may hamper follow up;
* Patients that may not coordinate well,judged by researcher.

Primary outcomes:
measure: Response Rate
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Cancer Institute & Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Changli Wang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01125384: Comparison Between Two Methods of Throat Swabbing
Official title: Comparison Between Two Methods of Throat Swabbing
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pharyngitis
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-05-18
Enrollment: 500
Sex: ALL
Minimum age (years): 3
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Throat swabbing is an important instrument in the diagnosis of strep pharyngitis and sometimes the main argument for antibiotic treatment. There is no firm knowledge about an appropriate method of the swabbing for receiving maximal sensitivity. We hypothesize that accurate swabbing from the pus will increase the sensitivity of the swabbing as compared to free swabbing. In order to check this hypothesis we will compare two swabs from the same throat. One that will be taken by a physician specifically from the pass and the second will be taken by a nurse as she used to do it. An increase of 10% of positive results will be accepted as a significant advantage.


Eligibility criteria: Inclusion Criteria:

* patients with sore throat, classified 2-3 according to Cantor's criteria

Exclusion Criteria:

* patients on antibiotic treatment
* suspected carriers of streptococcus

Primary outcomes:
measure: sensitivity of "accurate" swabbing versus sensitivity of habitual nurses' swabbing
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06454084: Investigation of Endothelium-dependent Vasodilation in Human Gingiva
Official title: Investigation of Endothelium-dependent Vasodilation in Human Gingiva Depending on Serum Estrogen Level
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Vasodilation
Oral Soft Tissue Conditions
Keywords: spreading vasodilation
gingival microcirculation
LSCI
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The first aim of this study is to create a cumulative dose-response curve for acetylcholine in men (low serum estrogen levels) to determine the lowest concentration with which we can induce a maximal vasodilation effect on the human gingiva. Furthermore, the second aim of this study is the characterization of the age-dependent effect of sex hormones on gingival blood flow, as well as of the gender differences by applying this concentration to premenopausal men and women with low and high estrogen levels, as well as to postmenopausal subjects.

Detailed description: Gender differences were observed in studies according to gingival microcirculation between physiological circumstances and during wound healing as well.

For blood flow measurement, Laser Speckle Contrast Imaging is a reliable tool. It has good reproducibility, does not touch the measured surface, is easy to use, and can simultaneously measure on a bigger surface.

Two wells are fabricated on the surface of the right lateral incisor (test site) and the labial surface of the left central incisor (control site). These wells are opened towards the high-permeability gingival sulcus, so the dropped solutions acetylcholine vs. physiological saline can easily penetrate the gingival tissues. After applying the solutions, the blood flow is monitored for 19 minutes.

In the study's second phase, blood sampling is taken before the gingival blood flow measurement.

Eligibility criteria: Inclusion Criteria:

* healthy systemic and periodontal conditions

Exclusion Criteria:

* systemic disease and medication
* periodontal disease
* smoking

Primary outcomes:
measure: 1. Blood flow change after applying the test solution
timeFrame: 19 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Department for Restorative Dentistry and Endodontics, Semmelweis University
Study officials:
References:
Clinical trial NCT03630484: Ventilator Hyperinflation and Manual Rib Cage Compression
Official title: Comparison Between Ventilator Hyperinflation and Manual Rib Cage Compression: Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Atelectasis
Keywords: Ventilator Hyperinflation
Expiratory Rib Cage Compression
Physical Therapy
Mechanical Ventilation
Lead sponsor: Brazilian Institute of Higher Education of Censa
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized crossover trial to evaluate the effects of thoracic compression applied alone or in association with hyperinflation maneuver with the ventilator. In addition, the mobilized volume and peak expiratory flow resulting from both maneuvers will be evaluated.

Detailed description: Ventilator hyperinflation is widely used in hypersecretive patients. It consists of increasing alveolar ventilation by facilitating the coughing mechanism so that the secretions of the peripheral airways are mobilized into the central airways so that they can be removed by tracheal aspiration or cough. Thoracic compression consists of manually compressing the rib cage during expiration, in order to increase expiratory flow, mobilize and remove pulmonary secretions. A randomized crossover clinical trial was performed with 30 patients submitted to isolated compression or associated with ventilator hyperinflation, with a 6 hour interval. Patients were evaluated through compliance and resistance of the respiratory system.

Eligibility criteria: Inclusion Criteria:

* patients under mechanical ventilation
* diagnosis of pulmonary infection
* hypersecretive

Exclusion Criteria:

* haemodynamic instability (heart rate \> 130 bpm and mean arterial pressure \< 60 mmHg)
* acute bronchospasm
* acute respiratory distress syndrome
* untreated pneumothorax

Primary outcomes:
measure: Static compliance of respiratory system
timeFrame: Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
measure: Total Resistance of respiratory system
timeFrame: Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
measure: Airway Resistance
timeFrame: Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
measure: Peak expiratory flow
timeFrame: Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Brazilian Institute of Higher Education of Censa
name: LUCIANO M CHICAYBAN, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05835284: Clinical Data Collection On Advanced CT System
Official title: Clinical Data Collection On Advanced CT System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: CT Photon Counting
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Karolinska University Hospital
First posted: 2023-04-28
Enrollment: 120
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subject population will consist of adults that are 25-years of age or older, and who have undergone prior clinically indicated CT examinations within the past 90 days of at least one of the following anatomical area(s): head, neck, heart, chest, abdomen, pelvis, and extremities. Images from prior standard of care diagnostic CT examinations of these subjects will also be collected.

Brief summary: The purpose of the study is to evaluate the investigational Edge-on Silicon Photon Counting CT device in a clinical setting.

Detailed description: Images from prior standard of care diagnostic CT exams for these subjects will also be collected. Data collected in this study will be used for technology development, scientific evaluation, marketing and education, and regulatory submissions for future products. This is a pre-market, prospective, open-label, non-randomized, single arm data collection clinical study conducted at one site in Sweden.

Eligibility criteria: Inclusion Criteria:

1. 25 years of age or older;
2. Able to sign and date the informed consent form; AND
3. Have undergone a clinically indicated CT exam of the head, neck, chest, abdomen, pelvis, or extremities where images are available within 90 days of investigational scanning.

Exclusion Criteria:

1. Pregnant or lactating;
2. Previously enrolled in this study;
3. For contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents;
4. For contrast-enhanced CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel;
5. Need urgent or emergent care;
6. Have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject; OR
7. Are unwilling to have GEHC personnel present for the CT exam.

Primary outcomes:
measure: Data Collection
timeFrame: 12 months
Secondary outcomes:
measure: Safety Information
timeFrame: 12 months
measure: Image Quality
timeFrame: 12 months
Other outcomes:
Locations:
city: Solna
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: GE Healthcare
name: Brian W Thomsen
role: STUDY_DIRECTOR
References:
Clinical trial NCT00436384: Cell Mediated Immunity and the Prediction of CMV Infection In Solid Organ Transplant Recipients
Official title: Cell Mediated Immunity and the Prediction of CMV Infection In Solid Organ Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transplant
Keywords: liver transplant
lung transplant
kidney transplant
heart transplant
CMV CMI
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2007-02-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Cytomegalovirus (CMV) is a common cause of illness in patients who have undergone a transplant. Serious infections due to CMV can affect many parts of the body including the lungs, the gut, and the liver. Since transplant recipients are at risk for CMV or have evidence of infection with CMV, they are given an antiviral drug (usually ganciclovir or valganciclovir). Despite this, there are a chance that CMV infection may cause problems in the future. The purpose of this study is to assess how well patients'immune systems responds to the CMV virus, so that in the future it may be possible to predict which patients are at highest risk of CMV.


Eligibility criteria: Inclusion Criteria:

* Male or female patients who fulfill the following criteria are eligible for inclusion.

  * CMV D+/R- liver, kidney and heart recipient
  * CMV R+ liver,kidney and heart recipients who have received thymoglobulin induction therapy.
  * D+/R- and R+ lung transplant recipients.
  * Able to give written informed consent
  * Are willing and able to comply with the protocol
  * Age \>=18 years

Exclusion Criteria:

* Patient unwilling or unable to give informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Atul Humar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Deepali Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01772784: Effects of Phenolic Acids on Endothelial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: subjects
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2013-01-21
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Epidemiological studies suggest dietary (poly) phenols decrease the risk of death from cardiovascular diseases. (Poly)phenol-rich foods include fruits and vegetables as well as tea, coffee, red wine, and chocolate. The aim of the present study is to investigate whether endothelial function is altered by ingestion of phenolic acids. Moreover, the investigators will evaluate the effect of phenolic acids on blood pressure and platelet adhesion.


Eligibility criteria: Inclusion Criteria:

* Healthy
* males
* Smokers

Exclusion Criteria:

Any food allergy

* Abnormal blood pressure defined as follow: systolic \<100 or \>160 mmHg and diastolic \<50 or \>100mmHg
* Regular consumption of medication within 2 months before the study inclusion
* Caffeine intake 1 day before screening measurements (and 1 day before each visit),
* Any intake of multivitamin-tablets and other supplemental compounds 10 days before the study start and throughout the study.
* Excessive alcohol intake defined as \> 280 g per week

Primary outcomes:
measure: endothelial dysfunction
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Swiss Cardiovascular Center Bern, University Hospital
Study officials:
affiliation: University Hospital, Bern, Switzerland
name: Yves Allemann, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mills CE, Flury A, Marmet C, Poquet L, Rimoldi SF, Sartori C, Rexhaj E, Brenner R, Allemann Y, Zimmermann D, Gibson GR, Mottram DS, Oruna-Concha MJ, Actis-Goretta L, Spencer JPE. Mediation of coffee-induced improvements in human vascular function by chlorogenic acids and its metabolites: Two randomized, controlled, crossover intervention trials. Clin Nutr. 2017 Dec;36(6):1520-1529. doi: 10.1016/j.clnu.2016.11.013. Epub 2016 Nov 30.
Clinical trial NCT06499402: The Effect of Pregnant-controlled Sacral Massage on Mothers' Labor Pain, Perception, Process and Midwives' Satisfaction
Official title: The Effect of Pregnant-controlled Sacral Massage on Mothers' Labor Pain, Perception, Process and Midwives' Satisfaction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Labor Pain
Labor
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Our study aims to determine the effect of pregnant-controlled automatic sacral massage on mothers' labor pain, perception, process and midwives' satisfaction. The research was planned as a randomized controlled experimental study. A total of 112 women, 56 pregnant women in the experimental and control groups, will be included in the study. In this project, an automatic massage device will be used during the active phase (when the cervical opening is between 5-6 cm and 10 cm) and a massage device in line with the pregnancy-controlled sacral massage application protocol. Pregnant women are followed throughout the active phase of labor and indicators reflecting labor pain, progress of labor, and the health status of the mother and the baby are used with the "Individual Identification Form", "Visual Comparison Scale", "Labor Monitoring Form", "Mother's Birth Perception Scale (ADAS)". The satisfaction of midwives will be evaluated with the "Evaluation of Satisfaction Status of Midwives Form".


Eligibility criteria: Inclusion Criteria:

* Participating in the study voluntarily
* having a cervical dilatation of 5-6 cm,
* being between 38-40 weeks of pregnancy,- being a single fetus, having a cephalic presentation,
* having a fetal weight between 2.5-4 kg,
* having no vision-hearing problems,
* having communication and cooperation skills

Exclusion Criteria:

* having pregnancy complications
* Those who have acute inflammatory problems in soft tissues, skin or joints, burns, nerve injuries, open wounds, rheumatoid and gouty arthritis,
* those who have used any non-pharmacological methods will not be admitted.

Primary outcomes:
measure: stress
timeFrame: 1 day
Secondary outcomes:
measure: labor pain
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References: