louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00699777: Assess Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets in Healthy Subjects
Official title: A Randomized, Open-label, 2-period, Crossover Study to Assess the Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets Administered as a Single Oral Dose in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2008-06-18
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study is a randomized, open-label, crossover study to assess the bioequivalence of 1 risedronate 150 mg tablet versus 2 risedronate 75 mg tablets administered as a single oral dose. Approximately 320 subjects will be enrolled from 4 study centers in the U.S.

Detailed description: The data to support the interchangeability of one risedronate 150 mg tablet versus two risedronate 75 mg tablets as monthly dose forms is primarily based on the similarity of in vitro dissolution and an in vivo study, which showed risedronate absorption is not dissolution rate limited. These results suggest that monthly dosing of risedronate may be accomplished by administration of either one risedronate 150 mg tablet or two risedronate 75 mg tablets. The purpose of this study is to provide additional clinical data to support the interchangeability of these 2 dose regimens.

Eligibility criteria: Inclusion Criteria:

* be in good general health based on medical history, physical examination, and laboratory evaluation
* have a body mass index (BMI) ≤ 32 kg/m2 at screening

Exclusion Criteria:

* has clinically significant uncontrolled cardiovascular, hepatic, renal, or thyroid disease
* has any disease or surgery known to alter normal GI structure or function
* has a creatinine clearance of \< 60 mL/min, estimated by serum creatinine using the Cockcroft-Gault formula

Primary outcomes:
measure: The primary objective is to assess the bioequivalence of one risedronate 150 mg tablet versus two risedronate 75 mg tablets administered as a single oral dose.
timeFrame: 18-21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Miramar
country: United States
facility: Research Facility
state: Florida
city: Austin
country: United States
facility: Research Facility
state: Texas
city: Dallas
country: United States
facility: Research Facility
state: Texas
Study officials:
affiliation: Procter and Gamble
name: William S Aronstein, PhD/M/FACP
role: STUDY_DIRECTOR
References:
Clinical trial NCT04123977: Evaluation of Patient Analgesia After Bloc Serratus
Official title: Evaluation of Patient Analgesia After Bloc Serratus for the Management of Thoracic Trauma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thorax Traumas
Keywords: thorax trauma
head injury
Multi-modal analgesia
Paravertebral block
Thoracic epidural
Serratus Block
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-10-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient hospitalised in surgical intensive care or continuous trauma care with thorax trauma who received anterior Serratus block analgesia from January 1, 2018 to February 28, 2019

Brief summary: Thorax traumas are very common in severe traumatology, including road accidents, representing the second most frequent site (after head injury, according to the FIRST study). These thoracic lesions are the cause of many complications (pneumothorax, hemothorax, lung infections, atelectasis).

The national recommendations recommend the use of multi-modal analgesia with the use of regional loco anaesthesia for pain management and prevention of respiratory complications, including infectious complications. The loco-regional anaesthesia of choice is thoracic epidural or paravertebral block, but these techniques are not without risks, and are contraindicated in many situations (severe head trauma, patient under curative anticoagulation, pelvic trauma...).

The anterior Serratus block appears to be a quality localoregional anaesthesia in thoracic surgery, and a few cases in the literature have shown an interest in severe traumatology.

The investigators perform this anterior Serratus block almost systematically in patients with thoracic trauma in the Hautepierre surgical intensive care unit.


Eligibility criteria: Inclusion criteria:

* Adult patient (≥18 years old)
* Gender (Male and Female)
* Patient hospitalised in surgical intensive care or continuous trauma care with thorax trauma who received anterior Serratus block analgesia from January 1, 2018 to February 28, 2019
* Patient who has given his consent to the reuse of his data for the purposes of this research

Criteria for non-inclusion:

* Patient who has expressed opposition to participating in the study
* Impossibility of giving the subject informed information (difficulties in understanding the subject,...)
* Subject under the protection of justice
* Subject under guardianship or curatorship

Primary outcomes:
measure: Retrospective analysis of analgesia after Bloc serratus
timeFrame: Files analysed retrospectily from January 1st, 2018 to February 28, 2019 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Réanimation chirurgicale_ Hôpital de Hautepierre
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Julien POTTECHER, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03744377: Validation ( Endometriosis Health Profile) EHP-30 (Turkish Version) for Patients With Endometriosis
Official title: Validation ( Endometriosis Health Profile) EHP-30 (Turkish Version) for Patients With Endometriosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometriosis
Lead sponsor: V.K.V. American Hospital, Istanbul
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women referred to Obstetrics and Gynecological Department for the treatment of endometriosis.

Brief summary: Endometriosis can affect quality of life, including physical, psychological and social aspects. It is important to include quality of life measures in evaluating disease severity and response to any given treatment. The 30-item Endometriosis Health Profile (EHP-30) from in-depth interviews with patients with endometriosis is currently the most reliable questionnaire for the measurement of health-related quality of life in women with endometriosis. It includes specific questions addressing the problems faced by patients with endometriosis. The aim of the present study is to validate the Turkish version of EPH 30, a self reported questionnaiere already used internationally, in order to determine the quality of life in women with endometriosis, assess their psychological health and the effectiveness of therapies.


Eligibility criteria: Inclusion Criteria:

* Previous surgical and histological diagnosis of endometriosis

Exclusion Criteria:

* Severe underlying comorbidities (gynecological, cardiovascular, respiratory, renal, hematological, endocrine, hepatic, gastrointestinal, neurological)
* Psychiatric diseases
* Refusal or inability to sign the informed consent

Primary outcomes:
measure: Validation of Endometriosis health profile-30 (EHP-30) Turkish version
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: American Hospital
Study officials:
References:
Clinical trial NCT01960777: Chronic Pain After Inguinal Hernia Repair, the ONSTEP Technique Versus the Laparoscopic Approach
Official title: Chronic Pain After Inguinal Hernia Repair, ONSTEP vs. Laparoscopic Approach, A Randomised Observer Blinded Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, Inguinal
Chronic Pain
Keywords: Hernia, Inguinal
Laparoscopy
Onstep
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2013-10-11
Enrollment: 188
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate chronic pain after inguinal hernia repair involving mesh placement with the Onstep-technique compared to mesh placement using a laparoscopic approach. The study hypothesis is that an even or smaller proportions of patients operated the Onstep technique will have chronic pain that impairs daily function.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnose of a primary groin hernia that requires surgical intervention.
* Eligible for procedure performed under general anesthesia.
* Eligible for both laparoscopic and Onstep procedure.

Exclusion Criteria:

* Not able to understand Danish/Swedish, written and spoken.
* Emergency procedures.
* Previous inguinal hernia on ipsilateral side.
* ASA score more than 3.
* Irreducible inguinoscrotal hernia.
* Local or systemic infection.
* Contralateral hernia being operated at the same time or planned operated during follow-up.
* Other abdominal hernias being operated at the same time or planned operated during follow-up.
* Previous surgery that has impaired the sensation in the groin area.
* BMI \> 40 or \< 20.
* Daily intake of alcohol \>5 units, 1 unit = 12g pure alcohol.
* Known disease which impairs central or peripheral nerve function.
* Concurrent malignant disease.
* Impairment of cognitive function (e.g. dementia).
* Chronic pain that requires medication.
* Mental disorder that requires medication.

Primary outcomes:
measure: Proportion of patients with substantial pain related impairment of function
timeFrame: 6 month
measure: Early postoperative pain
timeFrame: 10 days
measure: Pain related impairment of function at 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Surgery, Herlev Hospital
Study officials:
affiliation: University of Copenhagen, Herlev Hospital
name: Jacob Rosenberg, Professor
role: STUDY_CHAIR
References:
citation: Andresen K, Burcharth J, Rosenberg J. ONSTEP versus laparoscopy for inguinal hernia repair: protocol for a randomised clinical trial. Dan Med J. 2015 Dec;62(12):A5169.
Clinical trial NCT01182077: A Study to Assess Drug Interaction of ASP015K and Midazolam
Official title: A Phase 1, Open Label, Crossover, Drug Interaction Study of the Pharmacokinetics of ASP015K and Midazolam After Separate and Concomitant Administration to Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Pharmacokinetics of ASP015K and Midazolam
Keywords: ASP015K
midazolam
healthy volunteers
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The objective of the study is to characterize the effect of multiple doses of ASP015K on the pharmacokinetics of a single dose of midazolam.


Eligibility criteria: Inclusion Criteria:

* Subject weighing at least 45kg and BMI of 18-32 kg/m2, inclusive
* If female, subject is at least 2 years post menopausal or is surgically sterile per documentation provided by a third party medical professional and the subject is not pregnant as documented by a negative serum pregnancy test
* If male, subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy during the study period

Exclusion Criteria:

* History of any clinically significant disorder, disease or malignancy excluding non-melanoma skin cancer
* Recent history (within 6 months) of drug or alcohol abuse or positive urine screen for drugs of abuse/illegal drugs
* Treatment with prescription drugs or complementary and alternative medicines (CAM) within 14 days prior to study drug administration, or over the counter medication within 1 week prior to study drug administration
* A symptomatic, viral, bacterial or fungal infection within 1 week prior to clinic check-in
* Positive test for hepatitis C antibody, or positive test for hepatitis B surface antigen (HBsAg)
* History of the human immunodeficiency virus (HIV) antibody
* Positive tuberculosis (TB) skin test or Quantiferon Gold test
* Vaccinated within the last 30 days prior to study drug administration
* Received an experimental agent within 30 days or five half-lives, whichever is longer, prior to study drug administration
* Any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission
* Absolute neutrophil count (ANC) \<2500 cells/mm3

Primary outcomes:
measure: Pharmacokinetic variables assessed through the analysis of blood and urine samples
timeFrame: Days 1-8 and Days 21-27
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
Study officials:
affiliation: Astellas Pharma Global Development
name: Use Central Contact
role: STUDY_DIRECTOR
References:
Clinical trial NCT05846945: Threshold Inspiratory Trainer Versus Trigger Sensitivity Adjustment on Weaning From Mechanical Ventilation
Official title: Effect of Threshold Inspiratory Trainer Versus Trigger Sensitivity Adjustment on Weaning From Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Ninety adult patients from both gender, with acute respiratory failure, intubated and mechanically ventilated. Their ages ranged from 50 to 70 years. They were selected from Intensive Care Unit (ICU), Department of Chest Diseases, Cairo University Hospitals. They have randomly assigned into three equal groups. Group (A): trained by threshold IMT device plus routine physical therapy. Group (B): trained by adjusting MV trigger sensitivity plus routine physical therapy. Group (C): only received routine physical therapy. (Negative inspiratory force NIF, arterial blood gases, P/F ration, respiratory rate RR, tidal volume VT, and rapid shallow breathing index RSBI) were measured before the study and at the end of the study (just before weaning for successfully weaned patients, or on the 10 day of intervention for failed weaning patients).


Eligibility criteria: Inclusion Criteria:

* Their age ranged from 50-70 years.
* The patients were diagnosed with acute respiratory failure duo to COPD exacerbation and need mechanical ventilation support for more than 48 hours.
* They were vitally stable and can tolerate pressure support
* PEEP less than 8Cm H2O , SpO2 more than 90).
* All patients were conscious and responded to verbal command.

Exclusion Criteria:

* Unstable hemodynamics,
* unstable neurological problems,
* lack of attention and cooperation
* skipping more than five training sessions.

Primary outcomes:
measure: partial pressure of oxygen(PaO2)
timeFrame: change from baseline at one week
measure: partial pressure of carbon dioxide(PaCO2)
timeFrame: change from baseline at one week
Secondary outcomes:
measure: Respiratory rate (RR)
timeFrame: change from baseline at one week
measure: tidal volume (TV)
timeFrame: change from baseline at one week
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
References:
Clinical trial NCT06756945: Low-dose Evaluation of Aspirin After STEMI Patients With PCI: A Multicenter, Double-blind, Randomized Controlled Clinical Trial
Official title: Low-dose Evaluation of Aspirin After STEMI Patients With PCI: A Multicenter, Double-blind, Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: ST-elevation Myocardial Infarction (STEMI)
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 3612
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: The study aims to optimize the dual antiplatelet therapy regimen for patients with STEMI after PCI, focusing on addressing the following key technical challenges: establishing an effectiveness evaluation system for a low-dose aspirin (50mg/day) antithrombotic treatment strategy based on ticagrelor, including the formulation of a scientific non-inferiority margin, assessment criteria, and composite endpoint determination standards; constructing a strict risk assessment system for major bleeding events, including bleeding event grading based on BARC standards and a blind evaluation process by an independent endpoint event adjudication committee; and developing a quality control system for multicenter clinical research to ensure patient follow-up compliance and data reliability. By solving the above technical challenges, the study provides evidence-based medical support and technical support for optimizing the antithrombotic treatment regimen for STEMI patients after PCI.


Eligibility criteria: Inclusion Criteria:

STEMI patients with clear diagnosis Has received PCI treatment (at least the culprit's blood vessels have been treated); 18 years old and above, regardless of gender; Received DAPT upon discharge: aspirin+ticagrelor; Signed informed consent form approved by the ethics committee

Exclusion Criteria:

Individuals with atrial fibrillation/DVT/valve surgery requiring anticoagulant medication; Combined cardiomyopathy (HCM/DCM/RCM); Combining severe ventricular arrhythmias requires ICD; Chronic obstructive pulmonary disease (bronchial asthma, chronic bronchitis, emphysema, pulmonary heart disease); Serious infectious diseases, including active hepatitis B, hepatitis C or AIDS patients; Diseases of the blood system, such as thrombocytopenia, severe anemia, leukemia, etc; Severe liver and kidney dysfunction; Malignant tumors; Cognitive impairment

Primary outcomes:
measure: Primary Endpoint 1 (composite ischemic events for non-inferiority testing)
timeFrame: 12 months
measure: Primary Endpoint 2 (bleeding events for superiority testing)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06511245: European, Multi-center, Exploratory Trial to Assess WEB Versus Other Endovascular Treatment in Ruptured Aneurysms.
Official title: WEB™ Embolization System in the Treatment of Acutely Ruptured Intracranial Aneurysms Versus Other Endovascular Techniques
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ruptured Aneurysm
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-19
Enrollment: 80
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: Comparison of efficacy and safety between WEB and other endovascular techniques


Eligibility criteria: Main Inclusion Criteria:

* Patient is above 18 years of age at the time of consent
* Patient has an identified acutely ruptured intracranial aneurysm requiring endovascular treatment (for the purposes of this study an acutely ruptured IA patient is defined as a patient with computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP) evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 30 days)
* Aneurysm dome diameter must be ≤ 10mm and within the diameter (and parent vessel diameter, as appropriate) range treatable by commercially available WEB devices as well as at least one other alternative commercially available endovascular treatment device used per hospital standard practice
* Aneurysm is located on the anterior communicating artery complex segment (ACom), internal carotid artery terminus (ICAt), anterior cerebral artery (ACA), middle cerebral artery (MCA), basilar apex, posterior communicating artery (PCom) or pericallosal artery
* Patient must be neurologically stable with a Hunt \& Hess score of I to III
* Patient or patient's legally authorized representative (LAR) has provided written informed consent

Main Exclusion Criteria:

* Aneurysm to be treated is unsuitable for endovascular treatment with commercially available WEB devices and/or all other available endovascular treatment techniques used per standard site practice
* Patient presenting as target aneurysm a blister like or dissecting aneurysm
* Patient has more than one aneurysm requiring treatment within 30 days of completion of treatment of the target aneurysm
* Patient with multiple aneurysms in whom ruptured aneurysm cannot be identified
* Patient has pre-morbid mRS \> 2

Primary outcomes:
measure: As exploratory design, one of the outcome will be the assessment of aneurysm occlusion at 12 months using Raymond-Roy scale.
timeFrame: 12 months (-3/+6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: CHU Reims
Study officials:
References: