louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04002700: A Study to Assess Stroke Risk Among Users of Typical Versus Atypical Antipsychotics Stratified by Broad Age Group
Official title: Stroke Risk Among Users of Typical vs. Atypical Antipsychotics Stratified by Broad Age Group, a Post-authorization Safety Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-07-01
Enrollment: 1234412
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is the participants in (any of) the target or comparator cohorts. Each target and comparator cohort will be drawn from the appropriate database: IBM MarketScan Commercial Database (CCAE) if the participants are aged 18-64 years and IBM MarketScan Medicare Supplemental Database (MDCR) if participants are aged greater than or equal to (\>=) 65 years.

Brief summary: The purpose of this study is to extend the recent Food and Drug Administration (FDA) Sentinel tabulations regarding stroke risk among new users of typical and atypical antipsychotics to participants who were aged 18-64 years and did not have dementia to participants aged 65 years and older regardless of dementia status.


Eligibility criteria: Inclusion Criteria:

For entry event of an initial drug exposure:

* First exposure to the particular drug(s) in the past 183 days (index date)
* Had at least 183 days of continuous observation time prior to index
* Exactly 0 condition occurrences of 'Cancer' any time in the 183 days before or on the index date
* Exactly 0 condition occurrences of 'Stroke' any time in the 183 days before or on the index date
* Exactly 0 exposures to any other typical or atypical antipsychotics any time in the 183 days before or on the index date

Primary outcomes:
measure: Number of Participants with Stroke as a Principal Inpatient Diagnosis
timeFrame: Up to 16 years (from 01-January-2002 through 31-December-2017)
Secondary outcomes:
measure: Number of Participants at Stroke Risk when Compared Among New Users of Typical Antipsychotics/Haloperidol versus Atypical Antipsychotics
timeFrame: Up to 16 years (from 01-January-2002 through 31-December-2017)
Other outcomes:
Locations:
city: Titusville
country: United States
facility: Janssen Investigative Site
state: New Jersey
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT03226600: OrACELL™ vs. Connective Tissue in Miller Class 3 Defects
Official title: A COMPARATIVE STUDY OF ROOT COVERAGE USING OrACELL™ VERSUS SUBEPITHELIAL CONNECTIVE TISSUE GRAFT: A RANDOMIZED CONTROLLED TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: Gingival Recession
Connective Tissue Graft
OrACELL
Decellularized Dermis
Periodontics
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: LifeNet Health
First posted: 2017-07-24
Enrollment: 24
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: Randomized Controlled Trial between two treatment modalities for gingival recession with 6 month follow-up
Primary purpose: TREATMENT

Brief summary: The purpose was to compare root coverage outcomes between autogenous connective tissue graft (CTG) and decellularized human dermis (OrACELL™) in areas of facial gingival recession.

Detailed description: Twenty-four non-smoking, healthy patients, with 2mm or greater facial gingival recession at a minimum of one site that classified as a Miller Class I, II, or III recession defect were included. Patients were randomly assigned to either control (CTG) or OrACELL™ (test) groups, which were treated with identical surgical techniques. All root coverage clinical parameters were evaluated at baseline, 3-, and 6-months.

Eligibility criteria: Inclusion Criteria:

1. Patients must be between 18 and 80 years old, with recession present in one quadrant as either single or multiple buccal vertical recession sites
2. The defect must be at least 2mm in length, (measured from the CEJ to the midfacial gingival margin) and classified as either Miller Class I, II or III
3. Study is limited to vital and nonvital incisors, canines, and premolars
4. If teeth adjacent to the site to be treated had recession as well, they were included in the grafting procedure but not included in measurement
5. Plaque control defined as modified O'Leary Index of 85% was established before surgical intervention
6. Only sites with probing depths of 3mm or less and no bleeding on probing were accepted for surgery

Exclusion Criteria:

1. Subjects who smoke more than ten cigarettes per day or use nicotine replacement therapy
2. History of previous history of surgery performed at surgical sites included in study
3. Subjects who have uncontrolled or poorly controlled systemic conditions that could compromise or contraindicate periodontal surgery
4. Non-English speakers
5. Pregnant or lactating females
6. Immunosuppressant medications

Primary outcomes:
measure: Gingival Recession (Root Coverage)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04364100: Experience of Hospital Students in the Odontology Department
Official title: Qualitative Study of the Experience of Hospital Students in the Odontology Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Occupational Stress
Keywords: Stress
well-being
anxiety
confidence
satisfaction
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 12
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: Volunteer students of Brest Dental University Hospital in fourth, fifth and sixth academic year

Brief summary: During their studies, the dental students of Brest (France) learn their future profession by working in the Dental University Hospital, from the fourth academic year. This clinical activity is considered as both a source of satisfaction and stress by most of the students. The main objective of this study is to investigate the experience of Brest dental students through a qualitative methodology, with individual interviews, followed by an analysis by grounded theory (Paillé, 1994).

Detailed description: During their studies, the dental students of Brest (France) learn their future profession by working in the Dental University Hospital, from the fourth academic year. This clinical activity is considered as a source of satisfaction by most of the students. They are also reassured because they know that they will easily find an employment at the end of their studies. However, the clinical activity can also create a stress among the students, which varies with their progress in their studies (Polychronopoulou et Divaris, 2009). Other sources of stress could also be identified. This multifactorial stress can influence their well-being, their practices and their relationships with patients. The stress and satisfactions of the dental students have mainly been studied by some questionnaires (Inquimbert et al., 2017). The main objective of this study is to investigate the experience of Brest dental students through a qualitative methodology, with individual interviews, followed by an analysis by grounded theory (Paillé, 1994). This type of research can enable us to keep a broad approach of students' experience and to stay faithful to it.

Eligibility criteria: Inclusion Criteria:

* volunteer students of Brest Dental University Hospital, having given his/her consent
* adult students of Brest Dental University Hospital, in fourth, fifth and sixth academic year

Exclusion Criteria:

* students in work-stoppage
* students in Erasmus program
* non-volunteer students or students refusing to give his/her consent

Primary outcomes:
measure: Evaluation of the hospital student (4th, 5th, 6th years) in odontology
timeFrame: 1 to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: CHRU de Brest
name: Valérie Chevalier
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01588600: Effects of Fiber on Satiety
Official title: Effects of Fiber on Satiety and Food Intake in Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: food intake, satiety, fiber
Lead sponsor: Ingredion Incorporated
Sponsor class: INDUSTRY
First posted: 2012-05-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The effects of a dietary fiber on hunger and food intake will be tested in men and women. Participants will receive fiber as part of a breakfast meal on two occasions. On another occasion, participants will receive the same breakfast, without added fiber. Their feelings of hunger and fullness will be measured over the day. They will be offered lunch, dinner and an evening snack and how much they eat will be recorded. It is expected that the fiber supplement will enhance their feelings of satiety and reduce the amount they eat over the day.


Eligibility criteria: Inclusion Criteria:

* normal-weight adults

Exclusion Criteria:

* eating disorders,
* on medications that affect food intake,
* pregnant or lactating,
* non-breakfast eaters

Primary outcomes:
measure: Food intake
timeFrame: 24-hr food intake, on three occasions within 3 weeks
Secondary outcomes:
measure: Subjective appetite ratings
timeFrame: Hourly, over 8 hrs, on 3 days within a 3-week period
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Kissileff Laboratory for the Study of Human Ingestive Behavior
Study officials:
affiliation: University of Liverpool
name: Jason Halford, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00244400: Examine the Possible Association of Hepatic CYP3A Activity and the Susceptibility to Femur Head Necrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femur Head Necrosis
Keywords: Femur Head Necrosis
CYP3A
Lead sponsor: Osaka City University
Sponsor class: OTHER
First posted: 2005-10-26
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of the present study was to examine the possible association of hepatic CYP3A activity and the susceptibility to femur head necrosis in patients treated with corticosteroids.

Detailed description: Femur head necrosis is one of the major side effects of corticosteroid therapy. Since corticosteroids are metabolized by hepatic cytochrome P-450 (CYP) 3A, a low endogenous activity of this enzyme may contribute to the pathogenesis of ONFH. The purpose of the present study was to examine the possible association of hepatic CYP3A activity and the susceptibility to femur head necrosis in patients treated with corticosteroids.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of avascular necrosis of the femur

Exclusion Criteria:

* Old age (\> 70 years)
* Severe hepatic or renal dysfunction
* Heart disease
* Current use of known CYP3A-inducing or -inhibiting drugs
* Morbid obesity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Graduate School of Medicine, Osaka City University
Study officials:
affiliation: Department of Orthopedic Surgery, Graduate School of Medicine, Osaka City University
name: Yasunori Kaneshiro, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00319800: Second-Line Irinotecan or Gefitinib in Docetaxel Pretreated NSCLC
Official title: A Phase II Study of Second-Line Therapy With Irinotecan or Gefitinib in Docetaxel Pretreated Patients With Non-Small Cell Lung Cancer: a New Treatment Strategy According to Clinical Predictors for Response
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2006-04-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine whether in docetaxel pretreated advanced NSCLC patients with favorable clinical parameter(s) gefitinib can produce different outcomes from patients without favorable clinical parameter treated with irinotecan.

Detailed description: It has been suggested that some clinical parameters, including women, no smoking history and a histologic diagnosis of adenocarcinoma, are associated with favorable outcomes of gefitinib therapy. We will conduct a phase II study in docetaxel pretreated advanced NSCLC patients treated with gefitinib or irinotecan according to these clinical parameters in order to determine whether in patients with favorable clinical parameter(s) gefitinib will produce difference outcomes from patients without favorable clinical parameter treated with irinotecan.

Eligibility criteria: Inclusion Criteria:

* aged 75 years or less
* histologically or cytologically confirmed non-small cell lung cancer
* advanced, metastatic or recurrent
* ECOG performance status 0 to 2
* one prior palliative chemotherapy including docetaxel
* measurable or evaluable indicator lesion(s)
* normal marrow, hepatic and renal function
* provision of written informed consent

Exclusion Criteria:

* active infection and/or severe comorbidities
* pregnant or breastfed women
* active CNS metastasis
* active bleeding in GI tract or elsewhere

Primary outcomes:
measure: Objective response rate
measure: Progression-free survival
Secondary outcomes:
measure: Overall survival
measure: Toxicity
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
Study officials:
affiliation: Gachon University Gil Medical Center, Incheon, Korea
name: Se Hoon Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06951100: Mechanisms of Myocardial Injury and Ischemia in Patients With Rapid Atrial Fibrillation
Official title: Mechanisms of Myocardial Injury and Ischemia in Patients With Rapid Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation (AF)
Keywords: Atrial Fibrillation
Cardiology
Emergency Medicine
Myocardial Infarction
Myocardial Ischemia
Coronary Artery Disease
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
name: NHS Lothian
First posted: 2025-04-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to an Emergency Department or Acute Medical Unit with rapid atrial fibrillation

Brief summary: The goal of this observational study is to better understand the role of measuring troponin (a protein measured by a blood test) and coronary imaging in patients presenting with rapid atrial fibrillation (AF)

The main questions this study aims to answer are:

1. Are patients with a fast, irregular heartbeat (rapid AF) and damage to the heart (myocardial injury) more likely than those without damage to the heart to have blocked heart arteries (obstructive coronary artery disease)
2. Are patients with a fast, irregular heartbeat (rapid AF) and damage to the heart (myocardial injury) with further evidence that their heart hasn't been getting enough oxygen (myocardial ischemia) more likely to have imaging evidence of myocardial infarction than those without myocardial ischemia

To do this, we will measure troponin in patients with rapid AF and then carry out further investigations of the heart (electrocardiogram, echocardiogram, CT scan and cardiac MRI)


Eligibility criteria: Inclusion Criteria:

1. Age 18 years and over
2. Primary presentation with symptoms related to atrial fibrillation
3. Atrial fibrillation with a ventricular rate \>100 bpm on a 12-lead electrocardiogram
4. Able to provide informed consent

Exclusion Criteria

1. Previous myocardial infarction
2. Previous coronary revascularisation procedure
3. Patients in renal failure (eGFR \<30ml/min/1.73m2) or major allergy to contrast media
4. Pregnancy or breast feeding
5. Deemed unsuitable for participation in the study by the attending clinician
6. Previous enrolment in the trial

Primary outcomes:
measure: Presence of obstructive coronary artery disease
timeFrame: within 4 weeks of presentation
Secondary outcomes:
measure: Imaging evidence of new myocardial infarction
timeFrame: within 4 weeks of presentation
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
state: East Of England
Study officials:
References:
Clinical trial NCT01175200: Double the Dose of Clopidogrel or Switch to Prasugrel to Antagonize Proton Pump Inhibitor Interaction.
Official title: Double the Dose of Clopidogrel or Switch to Prasugrel to Antagonize Proton Pump Inhibitor Interaction. A Prospective, Mono-center, Placebo- and Active Treatment-controlled, Randomized, Cross Over Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anti Platelet Effects
Lead sponsor: Ascopharm Groupe Novasco
Sponsor class: OTHER
Collaborators: name: Groupe Hospitalier Pitie-Salpetriere
name: Medco Health Solutions, Inc.
First posted: 2010-08-04
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will establish the optimal therapeutic strategy for patients with a coronary artery disease (CAD) and chronically treated with clopidogrel 75 mg/day requiring co-administration of an anti-platelet treatment with P2Y12 antagonist and a PPI for treatment/prevention of GI ulceration.


Eligibility criteria: Inclusion Criteria :

* patient with stable Coronary Artery Disease (\< 3 months) treated with clopidogrel (75mg/d)
* Between 18 and 75 years of age
* Body Mass Index between 18 and 30 kg/m2 and body weight not less than 60 kg
* No major bleeding according to ISTH definition
* Subjects who signed an informed consent document
* Subjects who signed a separate pharmacogenomic informed consent document
* Subjects registered to the French national welfare system

Exclusion Criteria:

* Personal or family history of coagulation or bleeding disorders
* Use of known inhibitors or inducers of CYP2C19 and CYP3A including grape fruit juice intake
* Known hypersensitivity to lansoprazole, its excipients, or substituted benzimidazoles,
* Known hypersensitivity to clopidogrel / prasugrel
* Anti-platelet treatment other than clopidogrel + aspirin within 7 days before inclusion
* Any formal indication to maintain PPI treatment
* PPI within 15 days before inclusion in the study
* Active pathology with 10 days before inclusion
* Prior history of stent thrombosis
* Prior history of Stroke
* Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.

Primary outcomes:
measure: Change in antiplatelet effect of clopidogrel
timeFrame: 14 days
Secondary outcomes:
measure: high on-treatment platelet reactivity Clopidogrel pharmacokinetics responses
timeFrame: 14 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitié Salpétrière Hospital
Study officials:
References:
Clinical trial NCT04624100: Quality Control of Ventral Hernia Surgery by Prospective Registration
Official title: Quality Control of Ventral Hernia Surgery in 21 Belgian Hospitals by Prospective Registration in Close Collaboration With the Danish Hernia Database.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ventral Incisional Hernia
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Belgian Section for Abdominal Wall Surgery, section of the Royal Belgian Society for Surgery
First posted: 2020-11-10
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients undergoing primary ventral/incisional hernia repair

Brief summary: Quality Control of ventral hernia surgery in 21 Belgian hospitals by prospective registration in close collaboration with the Danish Hernia Database.


Eligibility criteria: Inclusion criteria

* Consecutively all patients with an elective or emergency repair of every ventral/incisional hernia (including parastomal hernia)
* Male and female
* 18 years or older
* Operated of supervised by a participating surgeon (participating in this study is not necessarily by a whole surgical department of one of the 18 participating Belgian hospitals, but by specific surgeons)
* Elective and emergency surgery
* Signed informed consent form

Exclusion criteria

* Younger than 18 years
* Not operated or supervised by participating surgeon
* Pregnant at inclusion in the registry
* No signed informed consent form

Primary outcomes:
measure: Reoperation
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: