louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05935397: HanYang University Medical Center (HYUMC) Registry
Official title: HanYang University Medical Center (HYUMC) PCI Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Stenosis
Coronary Artery Disease
Blood Pressure
Lead sponsor: Hanyang University Seoul Hospital
Sponsor class: OTHER
Collaborators: name: Hanyang University
First posted: 2023-07-07
Enrollment: 5000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with CAD

Brief summary: The HYUMC registry is a two-center, real-world registry of percutaneous coronary intervention in patients with coronary artery disease. From January 2012, PCI-treated patients from Hanyang University Seoul Hospitals and Hanyang University Guri Hospitals were enrolled in this registry.

The aim of this registry is to examine the long-term clinical outcomes and identify predictors of adverse outcomes following percutaneous coronary intervention conducted at academic hospitals.

Detailed description: In the HYUMC registry, the researchers have gathered and assessed various demographic, laboratory, echocardiographic, and angiographic measurements (both on-admission and during follow-up), as well as conducted questionnaires among patients who underwent percutaneous coronary intervention. The primary focus of this registry is to examine the effects of these parameters on long-term clinical outcomes.

Eligibility criteria: Inclusion Criteria:

Consecutive patients with CAD who underwent PCI one or more drug eluting stent (DES) with from 2012 at the Division of Cardiology of Hanyang University Seoul Hospital and Hanyang University Guri Hospital, Korea.

Exclusion Criteria:

* second or subsequent hospitalization records of patients with multiple admissions
* patients who died during index hospitalization
* patients who treated with first-generation drug eluting stent
* patients with an outpatient follow-up record of less than 6 months
* patients with insufficient medical records.

Primary outcomes:
measure: MACCE (major adverse cardiac and cerebrovascular event)
timeFrame: 10-year
Secondary outcomes:
measure: All-cause death
timeFrame: 10-year
measure: Myocardial infarction,
timeFrame: 10-year
measure: Stroke
timeFrame: 10-year
measure: Any revascularization
timeFrame: 10-year
Other outcomes:
Locations:
city: Guri
country: Korea, Republic of
facility: Hanyang University Guri Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Young-Hyo Lim
Study officials:
References:
Clinical trial NCT04137705: MultiOrgan Multi-Parametric MRI Study
Official title: MultiOrgan Multi-Parametric MRI Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes
Lead sponsor: Perspectum
Sponsor class: INDUSTRY
First posted: 2019-10-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult volunteers, including healthy volunteers and individuals with Type 2 Diabetes (T2D).

Brief summary: To determine the reproducibility of a single quantitative multiparametric MRI for the assessment of body composition and multiple organ structures.


Eligibility criteria: Inclusion Criteria:

* Any person over 18 years of age.
* Participant is willing and able to give informed consent for participation in the investigation.
* EITHER: Participant has Type 2 Diabetes OR: Person is a healthy volunteer

Exclusion Criteria:

* The participant may not enter the investigation if they have any contraindication to magnetic resonance imaging (incl. pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
* Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the investigation, or may influence the result of the investigation, or the participant's ability to participate in the investigation

Primary outcomes:
measure: Assessment of repeatability (precision under the same conditions in the same subjects: 2 separate MRI acquisitions on the same scanner) of body composition and multiple organ metrics.
timeFrame: 24 months
Secondary outcomes:
measure: Assessment of the reproducibility (precision under different measurement conditions: same participants scanned on separate MRI scanners at both 1.5T and 3T) of multiparametric MRI for the assessment of body composition and multiple organ metrics.
timeFrame: 24 months
Other outcomes:
measure: Assessment of the mean differences in body composition and multiple organ metrics between healthy participants and those with type 2 diabetes acquired with multiparametric MRI.
timeFrame: 24 months
Locations:
city: Oxford
country: United Kingdom
facility: Beaver House
city: Oxford
country: United Kingdom
facility: Oxford Centre for Magnetic Resonance
city: Oxford
country: United Kingdom
facility: Gemini One
Study officials:
References:
Clinical trial NCT04051905: Bone Loss in Posterior Mandible Postextraction Sockets
Official title: Evolution of Bone Volume in the Mandibular Posterior Area After Natural Healing and Flapless Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Guided Bone
Keywords: Regeneration
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population of patients aged between 18 and 80 years with one to two posterior mandibular teeth to extract in absence of bone graft and able to benefit from a flapless technique.

Brief summary: The aim of this study is to evaluate the bone loss after extraction. The surgery protocol is flapless, and the teeth are mandibular premolars or molars leaving sockets with 4 walls intact or at least 3 walls intact and the buccal wall at 80% . This study will include 40 patients

Detailed description: Primary objective :

Estimate the percentage of bone volume loss o and the percentage thickness loss of the buccal and palatal cortical for patients who underwent natural healing in the mandibular molar and premolar areas.

Methods :

Before tooth extraction of a premolar or molar in mandibular area by flapless technique, a CBCT preoperative is performed to verify the integrity of cortical and measure the height and width of the residual cavity. Caliper measurements will also be performed during surgery in order to integrate also the thickness of the bone tables and gingival thickness.

After natural healing , the pre-implant scan performed at six months postoperatively will measure the height and width of the grafted cell, to compare measurements and evaluate the dynamics of alveolar resorption.

Eligibility criteria: Inclusion criteria

* patients requiring tooth extraction
* aged 18 to 80
* Patients showing no indication against-General to surgery

Exclusion criteria

* Patient with against-indication for surgical treatment.
* Patients with an important loss of vestibular cortical
* Patients requiring and accepting a bone graft
* Unstabilized periodontal disease or aesthetic indication.
* Inability to maintain a good level of oral hygiene and good cooperation.
* Higher tobacco consumption has 10cig / day
* Acute dental infection

Primary outcomes:
measure: Cone beam diagnostic examination
timeFrame: Day diagnostic (Day 0)
Secondary outcomes:
measure: Cone beam pre implant examination
timeFrame: 5 or 6 months
measure: Clinical measures
timeFrame: Day of surgery
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UHMontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Philippe BOUSQUET, MCU PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00948805: Evaluation of the Luteolytic Effect of a Gonadotropin Releasing Hormone (GnRH) Agonist After the Administration of Human Chorionic Gonadotropin (hCG) in the Initial Follicular Phase a Its Influence on the Prognosis of in Vitro Fertilization Treatment
Official title: Evaluation of the Luteolytic Effect of a Gonadotropin Releasing Hormone (GnRH) Agonist After the Administration of Human Chorionic Gonadotropin (hCG) in the Initial Follicular Phase a Its Influence on the Prognosis of in Vitro Fertilization Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Infertility
Keywords: corpus luteum rescue
Gonadotropin Releasing Hormone (GnRH agonist)
human Chorionic Gonadotropin (hCG)
infertility
pregnancy rate
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-07-29
Enrollment: 25
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was designed to evaluate the ability of gonadotropin releasing hormone (GnRh) agonist to prevent the rise of progesterone during controlled ovarian stimulation for in vitro fertilization (IVF) after the administration of human Chorionic Gonadotropin (hCG) on the first day of menses.

Detailed description: The aim of this study is to evaluate the efficacy of a GnRH agonist in preventing the functional rescue of corpus luteum in women submitted to controlled ovarian stimulation with administration of hCG on the first day of menses and to evaluate its effect on pregnancy rate and ovarian steroidogenesis.

Eligibility criteria: Inclusion Criteria:

* age \>21 and \< 38 years old
* polycystic ovarian syndrome
* risk for ovarian hyperstimulation syndrome

Exclusion Criteria:

* recurrent abortion
* endometriosis
* more than 3 IVF failures
* use of oral contraceptive pills in the preceding 3 months
* low response to gonadotropins

Primary outcomes:
measure: Frequency of functional rescue of corpus luteum
timeFrame: 6 months
Secondary outcomes:
measure: Pregnancy rate
timeFrame: 6 months
measure: Levels of serum steroids
timeFrame: 6 months
measure: Levels of serum gonadotropins
timeFrame: 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Assisted Reproduction Center "Governor Mário Covas" of the Faculty of Medicine of the University of São Paulo
Study officials:
affiliation: Gynecology of Faculty of Medicine of University of SãoPaulo (Disciplina de Ginecologia da Faculdade de Medicina da Universidade de São Paulo)
name: Paulo Serafini, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03368105: Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain
Official title: Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain in Nephrology and Transplantation Department
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Clostridium Difficile
Keywords: Clostridium difficile Infection
Lactobacillus plantarum 299v
organ transplantation
antibiotic-associated diarrhoea
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study was to analyze whether the use of the LP299v strain reduces the risk of Clostridium difficile infection (CDI) among patients receiving antibiotics and hospitalized in the nephrology and transplantation ward.

Patients from risk group (receiving immunosuppressive drugs and treated with antibiotics) were enrolled into study.

Participants will be divided into two groups. First group will receive one capsule of Lactobacillus plantarum 299v (LP299v) orally per a day. Second group will receive placebo.

Detailed description: Clostridium difficile is currently the most frequently identified pathogen causing antibiotic-associated diarrhoea and the main cause of nosocomial diarrhoea. In regard to observed worldwide increase rate of infection and mortality from CDI the prevention of Clostridium difficile infections seems to be crucial, especially in patients at CDI high risk. So far, it has not been unambiguously proven that probiotics are effective in the prevention of Clostridium difficile infection among patients undergoing antibiotic therapy.

The Lactobacillus plantarum 299v (LP299v) is a Gram-positive lactic acid bacteria that naturally occurs on the surface of human intestinal mucosa. Specific properties to the gut mucosa colonization are due to mannose-dependent adhesion of LP299v to the epithelium of human intestines.This ability of LP299v leads to reduction of bacterial translocation from the intestinal lumen into the blood vessels, can prevent adhesion of many pathogens to intestinal epithelium and modulate the inflammatory response of the epithelium. The strain 299v of Lactobacillus plantarum has been found to decrease the severity of gastrointestinal adverse effects during antibiotic therapy. Limited data are available regarding the efficacy of LP299v for preventing Clostridium difficile infections.

Eligibility criteria: Inclusion Criteria:

* over 18 years old
* organ transplantation or receiving immunosuppressive drugs for any other reasons
* antibiotics therapy

Exclusion Criteria:

* no consent to participate in the study

Primary outcomes:
measure: Clostridium difficile infection
timeFrame: During hospitalization - average of 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01030705: Common Sensing and Right Ventricular Automatic Capture (COGNATE)
Official title: Common Sensing and Right Ventricular Automatic Capture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradycardia
Chronotropic Incompetence
Keywords: Bradycardia
pacemaker
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: University of Pittsburgh
First posted: 2009-12-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic patients

Brief summary: This study will collect data on features for future pacemakers via an external non-implantable system.

Detailed description: COGNATE is an acute, confirmatory prospective, multi-center study designed to gather data on Brady and CRT-P indicated patients, with no restrictions on the type/brand of leads. This study will enroll up to 80 patients in up to 12 centers. Total duration of the study is expected to be 9 months.

Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled to receive either Pacemaker (dual chamber) or CRT-P devices based on physician discretion
* Patients who are willing and capable of participating in all testing associated with this Clinical Investigation
* Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

* Patient enrolled in any concurrent study, without Boston Scientific CRM written approval, that may confound the results of this study
* Patients with a prosthetic mechanical tricuspid heart valve
* Women who are pregnant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cedar Rapids
country: United States
facility: St. Luke's Hospital
state: Iowa
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center, Cardiac Electrophysiology
state: Pennsylvania
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System, Medical College of Virginia, MCV Physicians and Hospitals
state: Virginia
Study officials:
affiliation: Health Care Conusltant
name: Samir Saba, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03894605: Dermatological Abnormalities in Beta-thalassemia Major
Official title: Assessment ofDermatological Abnrmalities in Beta-thalassemia Major in Assiut University Pediatric Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Beta-Thalassemia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 125
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patient examined by single dermatologist to record any dermatological abnormalities

Brief summary: to study the frequency and pattern of dermatological abnormalities in egyptian childern with beta thalassemia.relationof abnormalities to duration of disease and frequency of transfusion

Detailed description: thalassemia refers to agroup of inherited disease characterized by decreased or absent synthesis of normal globin .skinvdisorders are usually neglected and frequently underdiagnosed among these patients.skin disease specially pruritus and xerosis are observed highly frequently in patients with beta-thalassemia.pityriasis alba is arelatively common skin disorder.the trophic skin changes and leg ulcers occurred after the age of 15 years

Eligibility criteria: Inclusio2n Criteria:

* clinical diagnosis of dermatological abnormalities in thalassemic patient. must be on chelator

Exclusion Criteria:

* patient with other hemolytic anemia. childern with any abnormalities prior to the diagnosis of thalassemi

Primary outcomes:
measure: The percentage of patients with dermatological disorders due to iron overload Iron overload cause dermatological abnormalities
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Cao A, Galanello R. Beta-thalassemia. Genet Med. 2010 Feb;12(2):61-76. doi: 10.1097/GIM.0b013e3181cd68ed.
citation: El-Dash H, Adel S. Cutaneous manifestations in Egyptian children with beta-thalassemia major: Relationship with serum ferritin, thyroid profile, and treatment modalities. Pediatr Dermatol. 2018 Sep;35(5):639-643. doi: 10.1111/pde.13570. Epub 2018 Jun 26.
citation: Dogramaci AC, Savas N, Ozer B, Duran N. Skin diseases in patients with beta-thalassemia major. Int J Dermatol. 2009 Oct;48(10):1057-61. doi: 10.1111/j.1365-4632.2009.04176.x.
citation: CHANG PY, KUO CL, KHOO FY. The anatomic distribution of the lesions in pulmonary tuberculosis. Med Abstr. 1945 Oct;63A:237-43. No abstract available.
Clinical trial NCT00645905: Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Official title: Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-03-28
Enrollment: 148
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: Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis


Eligibility criteria: Inclusion Criteria:

* Diagnosis of moderate to severe chronic plaque psoriasis
* Active psoriasis, despite topical therapies

Exclusion Criteria:

* Other active skin diseases or skin infections
* Prior exposure to any anti-TNF therapy
* Subject has other active skin diseases
* Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies)
* Poorly controlled medical conditions
* History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease
* History of cancer or lymphoproliferative disease
* History of active TB or listeriosis, or persistent chronic or active infections
* Known to have immune deficiency or is immunocompromised
* Clinically significant abnormal laboratory test results
* Erythrodermic psoriasis or generalized pustular psoriasis

Primary outcomes:
measure: Psoriasis Area and Severity Index
timeFrame: Week 12-Week 24
measure: Adverse Events
timeFrame: Throughout Study Participation
Secondary outcomes:
measure: Psoriasis Area and Severity Index
timeFrame: Week 12, Week 24 through 360 days after last dose
measure: Physician's Global Assessment
timeFrame: Week 12, Week 24 through 360 days after last dose
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03776305: Imipenem in Critically Ill Patients
Official title: Pharmacokinetics of Imipenem in Critically Ill Patients With Life-threatening Severe Infections During Support With Extracorporeal Membrane Oxygenation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Critically Ill Patients With ECMO
Keywords: pharmacokinetic
imipenem
extracorporeal membrane oxygenation
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2018-12-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Extracorporeal membrane oxygenation (ECMO) has become increasingly used for lifesaving respiratory and/or cardiac failure support in critically ill patients, including those with life-threatening severe infections. This cardiopulmonary bypass device has been shown to enhance the profound pathophysiological changes in this patient population, resulting in an alteration of the pharmacokinetics (PK) of antimicrobial agents. The aim of this study was to determine the effect of ECMO on the PK of imipenem in critically ill patients supported by this cardiopulmonary bypass device.

Methods The study was conducted in critically ill patients with respiratory and/or cardiac failure and suspected severe nosocomial infections who were supported by ECMO. All patients received a 1-h infusion of 0.5 g of imipenem every 6 h and imipenem PK studies were carried out on the fourth dose of drug administration.


Eligibility criteria: Inclusion Criteria:

* Patient age \>18 year
* Patients who diagnosed as severe sepsis
* Admitted into the ICU
* Supported with ECMO

Exclusion Criteria:

* Patients who pregnant
* Patients who have documented hypersensitivity to carbapenem

Primary outcomes:
measure: Concentration of imipenem in plasma
timeFrame: 6 hour after the imipenem dose
Secondary outcomes:
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University
state: Songkla
Study officials:
References:
citation: Jaruratanasirikul S, Vattanavanit V, Wongpoowarak W, Nawakitrangsan M, Samaeng M. Pharmacokinetics and Monte Carlo Dosing Simulations of Imipenem in Critically Ill Patients with Life-Threatening Severe Infections During Support with Extracorporeal Membrane Oxygenation. Eur J Drug Metab Pharmacokinet. 2020 Dec;45(6):735-747. doi: 10.1007/s13318-020-00643-3.