louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07003750: Surgical Wound Infection Prevention Bundle in Patients Undergoing Coronary Bypass Graft Surgery
Official title: Surgical Wound Infection Prevention Bundle in Patients Undergoing Coronary Bypass Graft Surgery Sohag Experience
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Infection Due to Coronary Artery Bypass Graft (Diagnosis)
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: estimate the utilization of locally customized surgical wound infection bundle to prevent and or control of infection in patients undergoing CABG surgery in Sohag


Eligibility criteria: Inclusion Criteria:

* coronary artery disease ,diebetes mellitus,hypertension,

Exclusion Criteria:

* patients who have cancer , immunocompromised patients, cardiac surgeries other than CABG

Primary outcomes:
measure: surgical site wound infection
timeFrame: From enrollment to 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04798950: Bronchi Dilation in Polynesian Patients: Monocentric Retrospective Study
Official title: Bronchi Dilation in Polynesian Patients: Monocentric Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polynesian Bronchiectasis
Keywords: bronchi dilatation
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 500 patients with bronchial dilatation over the study period: Jan 1, 2010 to Dec 31, 2020

Brief summary: The study hypothesis is that dilations of idiopathic bronchi are particularly common in French Polynesia, and that there are arguments in favour of an underlying genetic factor.

The study will retrieve retrospective data in the history of bronchial dilation, patients' personal and family history, microbiological and scannographic data, and the latest cardio respiratory checkup.


Eligibility criteria: Inclusion Criteria:

* Polynesian patient
* Patient with bronchial dilation followed by Centre hospitalier de Polynesie Francaise or patient with bonchial dilation no longer consulting in the hospital over the study period Jan 1, 2010 to Dec 31, 2020

Exclusion Criteria:

* Expressed refusal to participate in the study for patients undergoing follow-up

Primary outcomes:
measure: Describe the detailed phenotype of bronchi dilation in the Polynesian population
timeFrame: Day 1
Secondary outcomes:
measure: Highlighting indirect arguments for a genetic cause
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01080950: Vitamin D Zinc Fever
Official title: Vitamin d and Zinc Levels in Patients With Fever
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Fever
Vitamin D
Keywords: zinc
sepsis
fever
vitamin d
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-03-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients hospitalized with fever and or sepsis.

Brief summary: Zinc and vitamin d deficiency are associated with a state of inflammation/atherosclerosis.

There are studies demonstrating an association between vitamin d deficiency and respiratory illnesses.

Both zinc and vitamin d are associated with oxidative stress and inflammation.

Detailed description: Both vit. d and zinc share anti inflammatory and anti oxidative actions. vit. d deficiency is associated with an increase in serum levels of proinflammatory cytokines and decreased levels of anti inflammatory cytokines.

there are reports concerning the association of vit. d deficiency with infections.

Eligibility criteria: Inclusion Criteria:

* age\>18 years

Exclusion Criteria:

* CCT\<90
* taking calcium
* hyper/hypoparathyroidism
* active malignancy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Mc
Study officials:
References:
Clinical trial NCT06425250: Campylobacter Spp. Bone and Joint Infection: a Retrospective Cohort Study
Official title: Campylobacter Spp. Bone and Joint Infection: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Campylobacter Infections
Keywords: Management
Risk factors
Campylobacter spp.
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients treated for prosthetic joint infection caused by Campylobacter spp. between 01/01/2013 and 12/31/2022

Brief summary: Campylobacter bacteria, a Gram-negative bacillus commensal in the digestive tract of many animals and mainly responsible for human infections with digestive origins, has been little studied in the field of osteoarticular infections (OAI). Campylobacter spp. are, however, well described, mainly for C. fetus, and pose a dual therapeutic problem: i) a capacity for persistence due to the capacity of most strains to form biofilm; and ii) potential resistance to many antibiotics. The management of IOA caused by Campylobacter spp. is not codified, and is based on small series of cases reported in the literature.


Eligibility criteria: Inclusion Criteria:

* \> 18 years
* Osteoarticular infection (whatever its type), mono or polymicrobial with Campylobacter spp., diagnosed between 01/01/2013 and 12/31/2022:
* Septic arthritis: compatible clinical signs + joint fluid sample positive in culture and/or PCR positive for Campylobacter
* Spondylodiscitis: clinical signs and MRI compatible + blood cultures and/or disco-vertebral biopsy puncture positive in culture and/or PCR positive for Campylobacter
* Osteitis/osteomyelitis: compatible clinico-radiological picture + bone sample (biopsy or intraoperative sample) positive in culture and/or positive PCR for Campylobacter
* Infection on joint prosthesis or osteosynthesis equipment: documented Campylobacter infection and meeting the definition of probable or confirmed JIBS infections
* Patient who was informed and did not object to participating in the study

Exclusion Criteria:

-

Primary outcomes:
measure: Outcome of Campylobacter spp. BJI, measured as the proportion of treatment failure.
timeFrame: Outcome will be measure at 1 year. For patients lost of follow-up or followed-up less than a year, the date of last visit will be used for survival curve analysis .
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service des maladies infectieuses et tropicales - Hôpital de la Croix-Rousse
Study officials:
References:
Clinical trial NCT04289350: Day to Day Variation in Fetal Heart Rate Variability
Official title: Day to Day Variation in Fetal Heart Rate Variability Based on Fetal Electrocardiography (FECG), in a Standardized Setting: A Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Growth Retardation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
name: Hartmann Fonden
name: Augustinus Fonden
name: The Dagmar Marshall Foundation
name: AP Moeller Foundation
First posted: 2020-02-28
Enrollment: 44
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy singleton pregnant women. Danish.

Brief summary: This study evaluates the day-to-day variation in fetal heart rate variability based on non-invasive fetal-ECG (NI-FECG). Furthermore, the effect of fetal movements on fetal heart rate variability will be assessed.


Eligibility criteria: Inclusion Criteria:

* Healthy singleton pregnant women with an expected healthy fetus

Exclusion Criteria:

* fetal malformations, multiple pregnancy, obstetric complications, maternal chronic disease and labor. Low birth weight or malformation diagnosed at birth.

Primary outcomes:
measure: Root mean square of successive inter beat interval differences (RMSSD)
timeFrame: 1/8-2020
measure: Standard deviation of normal to normal inter beat interval (SDNN)
timeFrame: 1/8-2020
measure: High frequency power (HF-power)
timeFrame: 1/8-2020
measure: Low frequency power (LF-power)
timeFrame: 1/8-2020
measure: Low frequency power/High frequency power (LF/HF)
timeFrame: 1/8-2020
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Obstetrics and Gynecology. Aarhus Unive
state: Aarhus N
Study officials:
References:
Clinical trial NCT04520750: VALO-2: Study Evaluating the Safety and Efficacy of PTX022 in the Treatment of Adults With Pachyonychia Congenita
Official title: VALO-2: A Multicenter, Phase 3b, Open-Label Treatment Extension Study Evaluating the Safety and Efficacy of PTX022 in the Treatment of Adults With Pachyonychia Congenita
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pachyonychia Congenita
Lead sponsor: Palvella Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label
Primary purpose: TREATMENT

Brief summary: VALO-2 is a multicenter, open-label extension (OLE) study enrolling patients with genotyped keratin mutations KRT6A, KRT6B and KRT16 who were previously treated with investigational PTX-022 during the VALO study. The purpose of the OLE study is to investigate long term exposure to investigational PTX-022 and evaluate safety and efficacy data. A sub-study is included to evaluate safety and efficacy of patients with genotyped keratin mutations of KRT6C and KRT17 not previously treated with investigational PTX-022.


Eligibility criteria: Key Inclusion Criteria:

* Adult patients 18 years or older,
* Previously completed the VALO protocol, or VALO-2 K6C/17 sub-study, and received meaningful benefit from investigational PTX-022 as determined by the clinician.

Key Exclusion Criteria:

* Any history of allergy or hypersensitivity to sirolimus, or sirolimus-like medications or to PTX-022

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 18 Months
measure: Changes in vital sign measurements from baseline
timeFrame: 18 months
measure: Changes in weight measurements from baseline
timeFrame: 18 months
measure: Changes in clinical laboratory measurements from baseline
timeFrame: 18 months
Secondary outcomes:
measure: Patient Global Assessment of Activities Scale
timeFrame: 18 Months
measure: Pain at its worst as assessed by NRS
timeFrame: 18 months
measure: PROMIS Pain Interference Short 6A as assessed by likert scale
timeFrame: 18 months
measure: PROMIS Physical Function as assessed by likert scale
timeFrame: 18 months
measure: Patient Global Impression of Severity as assessed by likert scale
timeFrame: 18 months
measure: Clinician Global Impression of Severity as assessed by likert scale
timeFrame: 18 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Murray
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT00853450: Bleeding Time Study With AZD6482, Clopidogrel and ASA
Official title: A Randomised, Open-label, Single-Centre, Phase I, Crossover Study to Evaluate the Effect of AZD6482, Compared With Clopidogrel, on Bleeding Time in Healthy Volunteers Receiving Low-Dose ASA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Antiplatelet Effect
Keywords: Antiplatelet
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-03-02
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the effect of AZD6482 and clopidogrel on bleeding time when taken together with low-dose ASA.


Eligibility criteria: Inclusion Criteria:

* BMI between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg, inclusive
* Provision of written informed consent

Exclusion Criteria:

* Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms.
* Acute illness, surgical procedure or trauma from 2 weeks before pre-entry visit until the first baseline visit or clinically significant abnormalities in clinical chemistry, haematology, urinalysis or supine BP or pulse
* Known impaired glucose tolerance, known galactose intolerance, total lactase deficiency or glucose-galactose malabsorption or known or suspected Gilbert's syndrome

Primary outcomes:
measure: Capillary Bleeding Time (CBT)
timeFrame: Prior to first dose in each treatment period, on study day 6 and 7 in treatment period A and on study day 7 in treatment period B
Secondary outcomes:
measure: Effect on bleeding
timeFrame: Prior to first dose in each treatment period, twice on study day 6 and three times on study day 7 in treatment period A and twice on study day 7 in treatment period B
measure: Pharmacokinetics
timeFrame: Prior to AZD6482 infusion and repeatedly during 6 hours after end of infusion
measure: Safety variables (adverse events, blood pressure, pulse, ECG, safety lab)
timeFrame: Repeatedly during the study
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca Mölndal
name: Peter Held
role: STUDY_DIRECTOR
affiliation: AstraZeneca Clinical Pharmacology Unit, Lund
name: Bo Fransson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05066750: What Makes People Better at Retrieving Difficult Words?
Official title: What Makes People Better at Retrieving Difficult Words?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Aging
Keywords: mindful breathing
anxiety
word retrieval
Lead sponsor: University of Colorado, Colorado Springs
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-10-04
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to one of two behavioral intervention conditions before performing a word retrieval task
Primary purpose: BASIC_SCIENCE

Brief summary: This study is being conducted to learn more about how various personal and situational characteristics are related to the ability to produce words in response to definitions. Participants will watch a video, then see definitions and try to come up with a word that fits each one. Participants will also complete some surveys and other measures. Collected data will give researchers a better understanding of how individuals' personality and cognitive traits and setting in which word retrieval occurs relate to the ability to produce individual words.

Detailed description: This study is being conducted to learn more about how various personal and situational characteristics are related to the ability to produce words in response to definitions. Adult participants ages 18-30 and 65-80 will participate in videoconference calls during which a video is shown and definitions are presented. Participants will try to come up with a word that fits each definition, and then complete some surveys, including some about anxiety, mindfulness, attention, vocabulary, and demographics. Participation will take approximately 1.25 hours. Collected data will be de-identified, and the aggregate data will give researchers a better understanding of how individuals' personality and cognitive traits and setting in which word retrieval occurs relate to peoples' ability to produce individual words.

Eligibility criteria: Inclusion Criteria:

* fluent speakers of English ages 18-30 or ages 65-80

Primary outcomes:
measure: Word Retrieval Performance
timeFrame: During the 1.25 hour experimental session
Secondary outcomes:
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: UCCS
state: Colorado
Study officials:
affiliation: University of Colorado, Colorado Springs
name: Lori James, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00001050: Study of Women Who Have AIDS
Official title: Women's AIDS Cohort Study (WACS)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: HIV Infections
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 1250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY

Brief summary: To study the effect of pregnancy, age, drug use, and coinfections on HIV progression rate. To document the prevalence, incidence, characteristics, and course of HIV infection and anogenital intraepithelial neoplasia among HIV-positive and HIV-negative women. To study the effect of HIV disease on gynecologic health including infections and reproductive function.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: SUNY - Brooklyn
state: New York
Study officials:
References:
citation: Bassuk SS, Albert CM, Cook NR, Zaharris E, MacFadyen JG, Danielson E, Van Denburgh M, Buring JE, Manson JE. The Women's Antioxidant Cardiovascular Study: design and baseline characteristics of participants. J Womens Health (Larchmt). 2004 Jan-Feb;13(1):99-117. doi: 10.1089/154099904322836519.
citation: Mason PJ, Manson JE, Sesso HD, Albert CM, Chown MJ, Cook NR, Greenland P, Ridker PM, Glynn RJ. Blood pressure and risk of secondary cardiovascular events in women: the Women's Antioxidant Cardiovascular Study (WACS). Circulation. 2004 Apr 6;109(13):1623-9. doi: 10.1161/01.CIR.0000124488.06377.77. Epub 2004 Mar 15.
Clinical trial NCT02552550: Swallowing, Speech and Quality of Life of Patients With Carcinoma of the Oropharynx
Official title: Analysis of Swallowing, Speech and Quality of Life of Patients With Stage T3-T4 Squamous Cell Carcinoma of the Oropharynx Before and After Multimodal Treatment With Curative Intent
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Squamous Cell Carcinoma of the Oropharynx
Keywords: squamous cell carcinoma of the oropharynx
swallowing, speech
quality of life
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-09-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patietn with T3 or T4 stage squamous cell cancer of the oropharynx

Brief summary: The curative treatment and organ preservation in advanced squamous cell carcinoma of the oropharynx is multimodal. It involves induction chemotherapy and depending on the response radio-chemotherapy or surgery. The combination of these methods has important functional consequences.

The aim of this prospective pilot study is to describe swallowing, speech, but also patients' quality of life before and after therapeutic management (existing studies measuring these functions after treatment but not before).

Detailed description: This study will not change the patient's treatment. This will just be an evaluation, before any treatment, his ability to swallow, speak then, as in normal practice, after 3, 6 and 12 months after treatment.

Eligibility criteria: Inclusion Criteria:

* Patient with stage T3 or T4 squamous cell carcinoma of the oropharynx previously untreated.
* Performance status 0 or 1
* Tumor histology proving squamous cell carcinoma

Exclusion Criteria:

* Visceral metastases at initial assessment
* Contraindication to surgery and / or chemotherapy such as:
* A history of other cancer (except basal cell carcinoma skin or cervical cancer in situ)
* 2nd associated cancer

Primary outcomes:
measure: change from swallowing disorder
timeFrame: between day 0 and 1 year
Secondary outcomes:
measure: Change from phonation disorder
timeFrame: between day 0 and 1 year
measure: Change from quality of life
timeFrame: between day 0 and 1 year
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHu de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Jean-Michel PRADES, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: