louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05207800: Predictive Value of Maternal Serum Pentraxin 3 (PTX 3) and Heparin-binding Protein (HBP) for Chorioamnionitis in Preterm Premature Rupture of Membranes
Official title: Predictive Value of Maternal Serum Pentraxin 3 (PTX 3) and Heparin-binding Protein (HBP) for Chorioamnionitis in Preterm Premature Rupture of Membranes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Premature Rupture of Membrane
Keywords: pentraxin 3
heparin-binding protein
chorioamnionitis
preterm premature rupture of membranes
term premature rupture of membranes
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women

Brief summary: Objective: The aim of this study was to investigate the predictive value of maternal serum pentraxin 3 (PTX3) and heparin-binding protein (HBP) for chorioamnionitis in preterm premature rupture of membranes (PPROM).

Method: This observational prospective cohort study included a total of 180 pregnant women at 24-40 gestational weeks. There were 60 cases of term premature rupture of membranes (TPROM), 60 cases of preterm premature rupture of membranes（PPROM）and 60 cases of healthy women. The concentrations of PTX3 and HBP were measured in maternal blood and amniotic fluid using an enzyme-linked immunosorbent assay (ELISA). Western immunoblotting was used to analyze the expression of PTX3 and HBP in placental tissue. The localization and immunoreaction of PTX3 and HBP in placenta were determined via immunohistochemistry (IHC).


Eligibility criteria: Inclusion Criteria:

1. The pregnant woman is born at a gestational age of 24-40 weeks;
2. The pregnant woman has a single child;
3. Regular obstetric examination during pregnancy with complete obstetric examination data was diagnosed as premature rupture of membranes (PROM).

Exclusion Criteria:

1. Pregnancy complicated with medical and surgical diseases, such as thyroid dysfunction and chronic hypertension;
2. Insufficiency of vital organ function or complicated tumor;
3. Pregnant women with other pregnancy complications besides PROM, such as preeclampsia, etc.;
4. Neonates had major congenital malformations (congenital anal atresia, congenital biliary atresia, congenital heart disease and so on, whether prenatal suspicion or diagnosis postpartum)
5. Neonatal septicemia, hemolytic disease or other diseases affecting bilirubin metabolism.

Primary outcomes:
measure: PTX3 and HBP concentrations in maternal blood
timeFrame: 24 weeks to 40 weeks gestation
Secondary outcomes:
measure: PTX3 and HBP concentrations in placental tissue
timeFrame: 24 weeks to 40 weeks gestation
Other outcomes:
measure: PTX3 and HBP concentrations in amniotic fluid
timeFrame: 24 weeks to 40 weeks gestation
Locations:
Study officials:
References:
Clinical trial NCT00499200: Study Evaluating Safety, Tolerability, Pharmacokinetics and 5 HT1A Receptor Occupancy
Official title: A Positron Emission Tomography Study to Assess the Level and Duration of Occupancy of Serotonin-1A Receptors Produced by Single Oral Doses of SRA-444 in Healthy Elderly Subjects and in Subjects With Alzheimer Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-07-11
Enrollment: 42
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will include a preliminary pharmacokinetics (PK) / safety / tolerability evaluation in healthy elderly subjects followed by the Receptor Occupancy (RO) evaluations in healthy elderly subjects and in Alzheimer's Disease (AD) subjects.


Eligibility criteria: Inclusion criteria:

* Men or women from 60 years of age at screening.
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

Exclusion criteria:

* History of drug abuse within 1 year before study day 1.

Primary outcomes:
measure: To assess the safety and tolerability of ascending single oral doses of SRA-444 in healthy elderly subjects and subjects with Alzheimer's disease
timeFrame: after each dose group completion
measure: To obtain PK profiles and determine the level and duration of 5-HT1A RO of SRA-444 by PET
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Sweden: MedInfoNord@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03763500: Evaluation of the Added Value of an Internet-based Educational Program for Patients With Atrial Fibrillation.
Official title: AMADEUS Atrial Fibrillation Monitoring in the Ablacure Database Including Patient-reported Outcomes and an Educational Program Used for Structured Care.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Quality of Life
Signs and Symptoms
Health Economy
Keywords: Atrial fibrillation
Symptom burden
Health-related quality of life
Health economy
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Dept of Internal Medicin, County Hospital Ryhov, Jönköping, Sweden.
name: Dept of Cardiology, Örebro University Hospital, Sweden
First posted: 2018-12-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized and open study
Primary purpose: TREATMENT

Brief summary: This study is prospective, open and randomized concerning the value of an Internet-based educational program for patients with atrial fibrillation compared to "care as usual".

Detailed description: In the present guidelines for treatment of atrial fibrillation education and information are underlined as important parts of the care. The investigators developed an Internet-based educational program in close collaboration with patients, specialists in the field, both physicians and nurses, and a phycologist, specialized in cognitive behavioral therapy.

The aim of the study is to evaluate this program in comparison to "care as usual" with reduction in symptom burden as primary endpoint, secondary endpoints being improvement in health-related quality of life and reduction in health-care costs.

Eligibility criteria: Inclusion Criteria:

Patients evaluated for electrical or pharmaceutical cardioversion or evaluated for treatment with antiarrhythmic drugs for paroxysmal or persistent atrial fibrillation.

Exclusion Criteria:

Age below 18, planned for cardiac surgery or catheter ablation, acute coronary syndrome during three months prior to randomisation. Insufficient knowledge of the Swedish language or other reasons making it impossible for the patient to independently fill out the questionnaires.

Primary outcomes:
measure: Symptom burden
timeFrame: One year after randomisation
Secondary outcomes:
measure: Health-related quality of life
timeFrame: One year after randomisation
measure: Health economy
timeFrame: One year prior to and one year after randomisation
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Dept of Cardiology, University Hospital
state: Närke
city: Linkoping
country: Sweden
facility: Dept of Cardiology, HMC, University Hospital
state: Ostergotland
city: Jönköping
country: Sweden
facility: Dept of Internal Medicine, County Hospital
state: Småland
Study officials:
affiliation: Dept of Cardiology, IMH, Linkoeping University, Sweden
name: Ulla Walfridsson, RN PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00349700: Wound Dressings Adapted to Wound Exudate and Bacterial Load in Therapy Resistant Large Sized Leg Ulcers
Official title: An Open Prospective Controlled Trial: Efficiency of Wound Dressings Adapted to Wound Exudate and Bacterial Load in Therapy Resistant Large Sized Leg Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Ulcer
Keywords: healing
skin
infection
wound therapy
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2006-07-10
Enrollment: 139
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: The purpose of the study was to investigated if modern wound dressings adapting to wound exudation and the amount of bacterial colonization can heal large therapy resistant leg ulcers which had a pre-treatment with compresses, ointments and gauze

Detailed description: Background: Moist wound therapy of venous leg ulcers is well established by both in vitro or animal studies and studies at ulcers smaller than 20 cm². Mostly larger venous leg ulcers have a stronger exudation than smaller leg ulcers. Therefore larger ulcers exhibit apparently moist conditions also beneath simple gauze, ointments and compresses.

The purpose of the study was to investigated if modern wound dressings adapting to wound exudation and the amount of bacterial colonization can heal large therapy resistant leg ulcers which had a pre-treatment with compresses, ointments and gauze.

Patients and Methods: In an open, non-randomized prospective trial 139 consecutive patients (86 female, 53 male) with long standing (159 ± 335 weeks) large sized (\> 20 cm², 53.8 ± 90.6 cm²) venous ulcers were included. The pre-treatment with compresses, ointments and gauze and two layer short stretch bandages during the time before consulting our wound outpatient department was compared to the following therapy protocol: After two weeks with four layer bandages compression stockings were applied. After a surgical debridement wound dressings were applied according to exudation (strong: calcium alginate, mean: polyurethane foam, low: hydrocolloid). Critical bacterial colonization was treated by activated charcoal cloth with sil-ver. Criteria for evaluating efficacy were healing time and reduction of ulcer size at the end of observation time.

Eligibility criteria: Inclusion Criteria:

* therapy resistant wounds for at least 3 months
* venous disease
* uncle pressure \> 80mmHg
* wound area \> 20qcm

Exclusion Criteria:

* uncle pressure \<80mmHg

Primary outcomes:
measure: the area of leg ulcers was calculated by multiplication of maximal length and width during the first visit an d at least 6 months after first visit
Secondary outcomes:
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: St. Josef Hospital, Dep. Dermatology and Allergology, Ruhr University Bochum
Study officials:
affiliation: Ruhr University Bochum, Dep. Dermatology and Allergology
name: Peter Altmeyer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00133900: Circulating Tumor Cells and Survival in Hormone Refractory Prostate Cancer (HRPC) Patients Receiving Chemotherapy
Official title: Circulating Tumor Cells and the Prediction of Overall Survival in Patients With Androgen Independent Prostate Cancer Entering Onto Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hormone Refractory Prostate Cancer
Prostate Cancer
Keywords: hormone refractory prostate cancer
Lead sponsor: Immunicon
Sponsor class: INDUSTRY
First posted: 2005-08-24
Enrollment: 276
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Oncology patients from academic institutions and private practices

Brief summary: This study enrolled men with prostate cancer who had failed hormone therapy (as shown by rising prostate-specific antigen \[PSA\] levels) and who were about to start a new line of chemotherapy. Blood was drawn prior to the patient receiving chemotherapy and then monthly thereafter for up to 18 months or until disease progression, whichever occurred first. The blood was tested to find circulating tumor cells (CTC) and to count them. The circulating tumor cell levels were studied in relation to the patient's overall survival. Serum was also collected for PSA testing, and additional blood samples were drawn to test for circulating endothelial cells and RNA was isolated for future gene expression testing.


Eligibility criteria: Inclusion Criteria:

* Age \> or = 18 years
* Pathological diagnosis of adenocarcinoma of the prostate
* First or later line of chemotherapy
* Serum testosterone \< 50ng/mL
* ECOG 0-2
* Serum PSA \> or = 5ng/mL
* PSA progression (2 rises above a reference value)
* Bone scan within 60 days of enrollment
* Computed tomography (CT) scan
* If measurable disease, bone scans every 6-8 months

Exclusion Criteria:

* Systemic radiation
* Prior history of other carcinoma within the last 5 years, except non-melanoma skin cancer
* Brain metastases

Primary outcomes:
measure: Overall Survival
timeFrame: Up to 36 months from time of baseline draw
Secondary outcomes:
measure: Progression Free Survival
timeFrame: Up to 36 months after baseline draw
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
Study officials:
affiliation: University of Michigan
name: Ken Pienta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Derek Raghavan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coumans FA, Ligthart ST, Uhr JW, Terstappen LW. Challenges in the enumeration and phenotyping of CTC. Clin Cancer Res. 2012 Oct 15;18(20):5711-8. doi: 10.1158/1078-0432.CCR-12-1585. Epub 2012 Sep 25.
Clinical trial NCT01602900: Healthy Volunteer Positron Emission Tomography (PET) Brain Occupancy Study of a Phosphodiesterase 4 (PDE4) Inhibitor in Huntington's Disease
Official title: An Open Label Positron Emission Tomography Study in Healthy Male Subjects to Investigate Brain PDE4 Engagement, Pharmacokinetics and Safety of Single Oral Doses of GSK356278, Using 11C-(R)-Rolipram as a PET Ligand(s)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Huntington Disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-05-21
Enrollment: 8
Sex: MALE
Minimum age (years): 22
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate if a new experimental drug to treat Huntington's Disease gets into the brain. If it does get into the brain the study will explore the relationship between the amount of drug in the brain and the amount of drug in the blood. The study will involve healthy male volunteers.

Detailed description: This is an open label, non-randomized, adaptive design PET occupancy study in healthy adult males. The primary aim of this study is to describe the relationship between plasma concentrations and brain PDE4 occupancy of GSK356278 over time. Up to 24 healthy volunteers may be administered single doses of GSK356278 in order to obtain 12 evaluable complete data sets of occupancy estimates. This study will help to optimize the dose selection for future clinical studies with GSK356278.

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteer, aged 22-55 years.
* Normal blood pressure, laboratory values, and body mass index
* Willing to agree to study procedures \& contraception requirements
* Capable of giving written informed consent

Exclusion Criteria:

* Any evidence of disease that would preclude participation in the clinical study (includes sexually transmitted diseases, exessive alcohol consumption, and substance abuse).
* Previously involved in another clinical trial within 3 months prior to scheduled administration of study drug
* Smoker
* Suffers from claustrophobia
* Any contraindications for MRI scanning (e.g. pacemaker, metal implants or fillings)

Primary outcomes:
measure: Positron Gamma-ray emmision & voxel counts
timeFrame: 60 minutes
measure: systemic plasma concentration
timeFrame: 24 hours
Secondary outcomes:
measure: Blood pressure - mm/Hg
timeFrame: 24 hours
measure: ECG - 12-Lead & Telemetry
timeFrame: 24 & 72 hours
measure: Heart rate - bpm
timeFrame: 72 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06099600: Anterior Cruciate Ligament Reconstruction
Official title: Randomized Study Evaluating the Value of a Pre-habilitation Stay and Digital Follow-up, Compared With Standard Management, in Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ligament Rupture
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2023-10-25
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates the effectiveness of a pre-habilitation stay via digital monitoring on patients' short-term post-operative anxiety, compared with conventional management.

Detailed description: This is a prospective, comparative, randomized (2-arm), controlled, single-center study of two management modalities.

Recruitment will focus on adult patients with anterior cruciate ligament rupture and scheduled anterior cruciate ligament surgical reconstruction. Patients will be randomized into 2 arms, an experimental arm A (pre-habilitation management) and a control arm B (conventional management).

Eligibility criteria: Inclusion Criteria:

* Age \> 18 ;
* Partial or complete primary anterior cruciate ligament rupture;
* Partial or complete primary rupture of the anterior cruciate ligament;
* Scheduled anterior cruciate ligament reconstructive surgery;
* Patient with a tablet, computer or smartphone with an internet connection;
* Patient able to understand and read French;
* Willingness to complete questionnaires at regular intervals;
* Membership of a social security scheme;
* Signed informed consent.

Exclusion Criteria:

* Recurrence / contralateral lesion ;
* Stage III collateral ligament injury;-
* Osteotomy ;
* Neurological (motor and/or sensory), vestibular or rheumatic pathology;
* Pregnant or breast-feeding woman;
* Protected adult patient (under guardianship, curatorship or deprivation of liberty).

Primary outcomes:
measure: State-Trait Anxiety Inventory questionnaire
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Clinique de la Sauvegarde
Study officials:
References:
Clinical trial NCT02817100: First in Human Study to Investigate the Safety and Tolerability, Pharmacokinetics, Itraconazole Drug-drug-interaction and Food Effect of BAY1817080
Official title: Randomized, Placebo-controlled, Double-blind, Parallel Group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses (10 - 1500 mg, Tablets) of BAY1817080 Including the Effect of Food and Itraconazole on the Relative Bioavailability of BAY1817080 in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Clinical Trials, Phase I as Topic
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-06-29
Enrollment: 88
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1817080 using a placebo controlled, randomized, single center design. In addition the influence of itraconazole and food on the pharmacokinetics of BAY1817080 will be investigated.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects
* Age: 18 to 45 years (inclusive)
* Body mass index (BMI) : ≥18 and ≤30 kg/m²
* Race: White

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Relevant diseases within the last 4 weeks prior to the first drug administration
* Existing chronic diseases requiring medication
* Known or suspected malignant tumors or carcinoma in situ (including history of malignant tumors, with a status after treatment), known or suspected benign tumors of the liver and pituitary (including after treatment)
* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Use of any drugs which might influence the results of the trial within 14 days prior to administration or during the trial until follow-up including drugs which might affect the pharmacokinetics

Primary outcomes:
measure: Frequency of treatment-emergent adverse events
timeFrame: Up to 4 months
measure: Severity of treatment-emergent adverse events
timeFrame: Up to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: CRS Clinical Research Services Berlin GmbH
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01237600: Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction
Official title: Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Severe Ocular Surface Damage
Limbal Deficiency
Keywords: Ocular surface damage
Limbal deficiency
Cultivated corneal epithelial stem cell transplantation
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2010-11-09
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to elucidate the appropriate condition of developing cultivated corneal epithelial graft and evaluate the surgical outcome of transplantation of the cultivated corneal epithelial stem cell in the patients.

Detailed description: Ocular surface damage caused by severe ocular surface diseases, particularly thermal and chemical burn or Stevens-Johnson syndrome result in corneal epithelial defect, corneal vascularization, corneal conjunctivalization and loss of transparency. Corneal limbal stem cell transplantation has been demonstrated to improve the outcome of ocular surface reconstruction. However, the conventional management of allograft limbal transplantation generally has unsatisfactory outcome because of high risk of rejection and requires long-life immunosuppressive medications.

Eligibility criteria: Inclusion Criteria:

* Unilateral/Bilateral limbal stem cell deficiency proved by specific clinical features and impression cytology result

Exclusion Criteria:

* Age under 18
* Active ocular infection, Severe dry eye, Uncontrolled glaucoma
* Immunocompromised host
* Pregnancy

Primary outcomes:
measure: Ocular surface status (signs of limbal deficiency and immunopathological markers)
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Pinnita Prabhasawat, MD
Study officials:
affiliation: Mahidol University
name: Pinnita Prabhasawat, MD
role: PRINCIPAL_INVESTIGATOR
References: