louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00716924: CASTLE (Clopidogrel And Serum Troponin Level Elevation)
Official title: Clopidogrel 600 mg and 300 mg as a Loading Dose Prior to Percutaneous Coronary Intervention And Serum Troponin Level Elevation: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thrombosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2008-07-16
Enrollment: 155
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: Primary Objective: To test if 600 mg of clopidogrel loading dose administered ≥ 6 and ≤ 24 hours prior to PCI produce a greater decrease of periprocedural release of biochemical markers (CK, CK-MB, and troponin-T and/or I) of myocardial necrosis, compared to 300 mg loading dose, given ≥ 6 and ≤ 24 hours prior to PCI or 600 mg loading dose of clopidogrel, administered immediately (≤ 45 minutes) before PCI.


Eligibility criteria: Inclusion Criteria:

* Patients having symptomatic coronary artery disease with objective evidence of ischemia (eg, symptoms of angina pectoris, positive stress test results or dynamic electrocardiographic (ECG) changes).
* Patients undergoing stent implantation

Exclusion Criteria:

* Any known contraindication to the use of aspirin or clopidogrel.
* Patients receiving clopidogrel within 10 days, thrombolytics within 24 hours or receiving oral anticoagulation therapy
* Elective administration of IIb/IIIa inhibitors.
* Cardiogenic shock
* Acute MI\< 24 hours
* BP systolic \<100 mmHg
* Left ventricular ejection fraction \< 30%
* Heart failure, NYHA class III or IV
* Severe renal insufficiency (creatinine \> 3.0 mg/dL)
* Platelet count \<100,000/mm³
* Target lesion in a venous bypass graft
* Target lesion in a chronic occlusion

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Incidence of post-percutaneous coronary intervention elevation of troponin T.
timeFrame: At 6 and 12 months post-PCI
Secondary outcomes:
measure: Adverse events.
timeFrame: From the beginning to the end of the study
measure: Standard hematology and blood chemistry.
timeFrame: At 6 and 12 months post-PCI
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Sanofi aventis administrative office
Study officials:
affiliation: Sanofi
name: Judith Diaz, Md
role: STUDY_DIRECTOR
References:
Clinical trial NCT01669824: Pharmacy Based Pharmacoepidemiological Observational Study With Aspirin Protect 100 mg
Official title: Tolerability, Compliance and Indications of Aspirin Protect 100 mg in Longterm Use (12 Months) Under Everyday's Conditions - Data Collection With Questionnaires Handed Out in Pharmacies to Aspirin Protect 100 mg Consumers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aspirin
Drug Safety
Effects, Longterm
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-08-21
Enrollment: 4235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who buy Aspirin protect 100 mg with or without prescription in German pharmacies and who are willing to participate in the study.

Brief summary: In this non-interventional one year study, data about overall and particularly gastrointestinal tolerability, indications, cardiovascular risk factors and compliance are collected by basic questionnaires, which are handed out by pharmacists to patients who acquire (in Germany no prescription is needed) Rx (Prescription) or OTC (Over-The-counter) Aspirin protect (enteric coated aspirin) 100 mg and are willing to participate in the study. After 3, 6, 9 and 12 months follow-up questionnaires are sent out. Aim of the study is to get information about safety, usage and compliance under everyday's conditions, because in Germany low-dose aspirin is an OTC product with Rx indication.


Eligibility criteria: Inclusion Criteria:

* Patients who buy Aspirin protect 100 mg in a pharmacy and are willing to participate in the study.

Exclusion Criteria:

Primary outcomes:
measure: Overall and gastrointestinal tolerability assessed by questionnaire
timeFrame: After 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03653624: Collection of Anonymised Blood Pressure Data During High Risk Surgery
Official title: Collection of Fully Anonymised Blood Pressure Data From Patients Undergoing Elective High Risk Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perioperative Hypertension
Lead sponsor: Directed Systems Limited
Sponsor class: INDUSTRY
Collaborators: name: University Hospital Birmingham
First posted: 2018-08-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective high risk surgery at Queen Elizabeth Hospital, Birmingham, UK.

Brief summary: This is a single centre, prospective, non-randomised clinical investigation to be undertaken at the Queen Elizabeth Hospital, Edgbaston, Birmingham.

The clinical investigation will collect fully anonymised perioperative blood pressure data from patients undergoing elective high risk surgery.

The Sponsor of this clinical investigation, Directed Systems Limited, is developing a new medical device, BP Assist, which provides guidance to anaesthetists in relation to the real-time management of patient cardiovascular physiology.

Detailed description: This clinical investigation is designed to collect fully anonymised perioperative blood pressure data from patients undergoing high risk surgical procedures.

It is increasingly being recognised that in high risk surgery, the perioperative incidence and duration of hypotensive episodes (MAP \<60mmHg) can adversely impact postoperative outcome.

Collecting continuous perioperative blood pressure data will enable hypotensive episodes to be recorded. Such data will be used to aid the development and testing of algorithms involved in generating the guidance provided by BP Assist.

Eligibility criteria: Inclusion Criteria:

* Male or female, 18 years of age or older; undergoiing elective high risk surgery

Exclusion Criteria:

* \<18 years of age

Primary outcomes:
measure: Perioperative blood pressure
timeFrame: Duration of each patient's surgery, up to 6 hours.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06113224: Characterization of Anti-HLA Alloimmunization After Pulmonary Valve Homograft Insertion
Official title: Characterization of Anti-HLA Alloimmunization After Pulmonary Valve Homograft Insertion (CAssIOPé)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Graft Dysfunction
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 53
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a prospective, monocentric, observational cohort study whose main objective is to describe the number and rate of patients who developed DSAs (Donor Specific Antibody) at 6 months post-surgery with implantation of a cryopreserved lung homograft.

Detailed description: Lung homograft is used in a large number of complex malformations. It is accepted that homografts may induce immune reactions in the recipient, but no immunological studies have been carried out to characterize the recipient's immune reactions to the homograft and their potential impact on valve function. In this project, the authors propose to study the immunizing character of cryopreserved lung homografts by identifying the appearance of antibodies directed against the HLA, DSA (Donor Specific Antibodies) molecules of the graft (lung homograft) at 1 month and 6 months after its surgical implantation.The primary objective will be analyzed by describing the rate of patients who developed DSA at 6 months post-surgery with implantation of a cryopreserved lung homograft.

Eligibility criteria: Inclusion Criteriafor control patients:

* Patient receiving a cryopreserved pulmonary valve homograft
* Patient aged 14 or over
* Signature of consent by adult patients/parents/guardians and assent by children

Inclusion Criteriafor patients with lung homograft :

* Patientsreceiving a cardiac surgery with extracorporeal circulation and without lung homograft

Exclusion Criteria for both group

* Emergency surgery patient
* Pregnant women or childbirth within the last 6 months
* Transfusion during the surgery or within the last 6 months
* Patient with DSAs detected before the surgery
* Patient with anti-HLA antibodies (non-DSAs) detected before the surgery

Primary outcomes:
measure: Detection of DSA at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: DSA Quantification
timeFrame: 6 months
measure: antibody anti-HDLA (non DSA) detection
timeFrame: 6 months
measure: Early degeneration of the homograft
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02503124: Effect of a Single Nights' Wake Followed by Bright Light Therapy for Severe Depression
Official title: Wake and Bright Light Therapy for Depression Among Admitted Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2015-07-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial comparing wake therapy (single night) followed by bright light therapy to treatment as usual.


Eligibility criteria: Inclusion Criteria:

* Depressive episode requiring admission to a psychiatric hospital (including unipolar and bipolar depression).

Exclusion Criteria:

* Psychotic symptoms/agitation
* Compulsory admission
* Confusion
* Active substance use disorder
* Eye disease preventing bright light therapy

Primary outcomes:
measure: MADRS-S score reduction of 50%
timeFrame: One week
Secondary outcomes:
measure: MADRS-S score at discharge
timeFrame: Participants will be followed at discharge, an expected average of 2-3 weeks
measure: MADRS-S score at follow-up
timeFrame: 10-14 weeks
measure: ISI score score at discharge
timeFrame: Participants will be followed at discharge, an expected average of 2-3 weeks
measure: ISI score score at follow-up
timeFrame: 10-14 weeks
measure: ISI score reduction of 50%
timeFrame: One week
measure: Length of stay
timeFrame: The number of days between admission and discharge
measure: Re-admission
timeFrame: 10-14 weeks
measure: CGI score
timeFrame: One week
measure: CGI score
timeFrame: 10-14 weeks
measure: Medication use
timeFrame: 10-14 weeks
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
state: Västra Götaland
Study officials:
affiliation: Sahlgrenska University Hospital
name: Steinn Steingrimsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06557824: Pulmonary Rehabilitation Combined With Speleotherapy in Children With Bronchial Asthma
Official title: Efficacy of Pulmonary Rehabilitation Combined With Speleotherapy in Children With Bronchial Asthma: a Retrospective Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma in Children
Keywords: asthma
children
subterranean therapy
6MWT
exhaled nitric oxide
Lead sponsor: University School of Physical Education, Krakow, Poland
Sponsor class: OTHER
Collaborators: name: Andrzej Frycz Modrzewski Krakow University
name: Sanatorium Edel
name: Health Resort "Wieliczka" Salt Mine
First posted: 2024-08-16
Enrollment: 415
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical records of 415 patients with clinical diagnosis of bronchial asthma (J45.9, J45.0, J45, J45.8, J45.1) were analysed.

Brief summary: The goal of this retrospective study is to learn about the effects of rehabilitation and treatment stays combined with speleotherapy in children with asthma. Medical records of 415 patients with this clinical diagnosis were analyzed and the main question was:

• Does speleotherapeutic intervention increase distance in 6-Minute Walk Test (6MWT) and influence spirometry parameters and fractional exhaled nitric oxide concentration (FeNO) in children with asthma?

Detailed description: Background: Bronchial asthma is the leading cause of chronic disease and missed school days in children. The aim of the study was to evaluate pulmonary function and exercise tolerance in children with asthma who underwent speleotherapeutic intervention (STI) between January 2022 and October 2023 at Sanatorium Edel in Zlaté Hory.

Methods: Medical records of 415 patients with clinical diagnosis of bronchial asthma (J45.9, J45.0, J45, J45.8, J45.1) were analysed. The patients attended rehabilitation and treatment stays with a median length of 32 days combined with an average number of 15 speleotherapy sessions. The spirometry parameters, fractional exhaled nitric oxide concentration (FeNO), and 6-Minute Walk Test (6MWT) distance were measured before and after STI.

Eligibility criteria: Inclusion Criteria:

- Children with asthma who partcipated in speleotherapeutic intervention in Sanatorium Edel in Zlate Hory

Exclusion Criteria:

* Patients with incomplete data

Primary outcomes:
measure: Forced expiratory flow in 1 second
timeFrame: January 2022 and October 2023
measure: 6-Minute Walk Test (6MWT)
timeFrame: January 2022 and October 2023
measure: Peak expiratory flow (PEFR [pp])
timeFrame: January 2022 and October 2023
Secondary outcomes:
measure: Fractional exhaled nitric oxide concentration (FeNO)
timeFrame: January 2022 and October 2023
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: University of Physical Education in Krakow
Study officials:
affiliation: University of Physical Education in Krakow
name: Sylwia Mętel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03119324: Low Level Laser Therapy in the Treatment of Temporomandibular Joint Disorders (TMJDs) Related Pain
Official title: Evaluation of the Efficacy of a New Low Level Laser Therapy (LLLT) Home Protocol in the Treatment of the Temporomandibular Joint Disorders Related Pain. A Randomized, Double Blind Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Disorders
Keywords: Biomodulation
LLLT
Temporomandibular Joint Disorders
Pain management
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 90
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 Low Level Laser Therapy (LLLT) has been recently introduced with success in the management of the pain associated to this condition. This double blind placebo controlled clinical trial analyzes a new home LLLT protocol to verify whether it was possible to avoid to the repeated presence at dental chair required by traditional LLLT protocols.

Detailed description: 90 patients with pain deriving from mono- or bi-lateral TMJDs were enrolled in the study. Randomly subdivided in 3 groups. The Study Group (SG n=30) receive a LLLT by the B-cure Dental Pro 808nm diode low level laser (Biocare Enterprise Ltd, Good Energies, Haifa, IL). The therapeutic protocol previews 2 applications a day for 7 consecutive days performed at 5 Joules/min, 250 milliWatts and 15 KiloHertz for 8', (40 Joules total each) in contact mode over the painful area.

The first application is performed at the Department of Oral Sciences of Sapienza University of Rome, by a laser expert blinded examiner and serves as instruction. The remnants applications must be performed at home by the patients themselves.

The Placebo Group (PG n=30) follows the same protocol by a sham device, seemingly identical to the effective ones, including the pointer light, but devoid of the main diode source.

The Drug Control Group (DG n=30) follows the conventional drug treatment for TMJDs related pain, 2 non-consecutive cycles of 5 days of nimesulide (100mg a day), interspersed with one 5 days cycle of cyclobenzaprine hydrochloride (10 mg a day) Two pain evaluation are registered, before and after treatment.

Eligibility criteria: Inclusion Criteria:

* TMJD diagnosed clinically and by CT and MRI; presence of pain in the TMJ area or radiating to the face, jaw, or neck; reduced mouth opening or jaw locks, painful clicking, popping or grating when opening or closing mouth, occlusal alterations

Exclusion Criteria:

* Muscle tenderness; NSAIDs assumption within 3 weeks before the treatment; pregnancy; neurocognitive diseases; autoimmune diseases; connective diseases

Primary outcomes:
measure: Pain reduction laser groups
timeFrame: 7 days
measure: Pain reduction drug control
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Roma La Sapienza
name: Umberto Romeo, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03073824: A Long-term Evaluation of a Novel Intravaginal Device
Official title: An Open-label Long-term Evaluation of a Novel Intravaginal Device in Female Patients Experiencing Sexual and Bladder Function Issues
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Floor Disorders
Sexual Dysfunction
Stress Incontinence
Lead sponsor: Joylux, Inc.
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 65
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label long-term evaluation of a novel intravaginal device in female patients experiencing sexual and bladder function issues.

Detailed description: To determine the long-term clinical efficacy of the vSculpt therapy on treating the pelvic floor area and vaginal tissue for females who experience bladder and sexual dysfunction.

Eligibility criteria: Inclusion Criteria:

* All study participants are required to be biological females (genotype XX) to participate
* Female participants will be of adult age, over 18
* Female participants with self-reported concerns with bladder and sexual function
* Female participants who have reliable and consistent computer and internet access on a daily basis

Exclusion Criteria:

* Female participants shall not have an active sexually transmitted disease and/or infection
* Female participants who are actively undergoing chemotherapy or radiation
* Female participants who are currently taking any cancer-related or photosensitivity drugs
* Female participants who are pregnant, who may think they are pregnant, and/or actively trying to get pregnant during the clinical study

Primary outcomes:
measure: Improvement in Patient Quality of Life as Measured by Female Sexual Response Index
timeFrame: 365 days
measure: Improvement in patient quality of life as measured by the Female Sexual Distress
timeFrame: 365 days
measure: Improvement in patient quality of life as measured by the Urogenital Distress Inventory, Short Form (UDI-6)
timeFrame: 365 days
measure: Improvement in patient quality of life as measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7)
timeFrame: 365 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bellevue
country: United States
facility: Egrari Non Invasive Center
state: Washington
city: Seattle
country: United States
facility: Seattle Obstetrics and Gynecology Group
state: Washington
Study officials:
affiliation: Seattle OB/GYN Group
name: Sarah De La Torre, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06222424: Emergency Medicine Pharmacist Prescriptive Authority for Resolution of Outpatient Prescription Issues
Official title: Emergency Medicine Pharmacist Prescriptive Authority for Resolution of Outpatient Prescription Issues: a Descriptive Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Outpatient Prescription Issues
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aims to document the utility of Methodist Charlton Medical Center (MCMC's)Emergency Medicine Pharmacist (EMP) Collaborative Practice Agreement (CPA )utilization for the resolution of outpatient prescription issues. Evaluation of utility will involve describing all EMP-written prescriptions pursuant to resolution of prescription issues realized after discharge.

Detailed description: Use of an EMP CPA, which allows for broad prescriptive authority, will assist Emergency Department (ED )workflow by preventing a significant volume of new prescriptions needing to be sent by physician and mid-level providers. Will improve rates of ED re-visits. In addition, this Collaborative Practice Agreement (CPA) will not be associated with a large volume of new prescription errors.

Eligibility criteria: Inclusion Criteria:

* Patients at MCMC who had a prescription sent by an EMP between November 1, 2021 and June 30, 2023 and a progress note and documenting the reason for the call and action taken by the EMP.

Exclusion Criteria:

* CPA actions were misclassified as discharge prescription issue resolutions.
* Patients with prescriptions pursuant to late culture review, formulation changes not requiring a new prescription, prescription transfers to another pharmacy, or simple retransmission of prescriptions.
* Patients documented to have left the ED against medical advice.

Primary outcomes:
measure: Number of prescriptions and medication types sent to outpatient pharmacies
timeFrame: 2 years
Secondary outcomes:
measure: Number of patients returning with complaint or diagnosis related to EMP generated prescriptions
timeFrame: 2 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Clinical Research Institute at Methodist Health System
state: Texas
Study officials:
affiliation: Methodist Health System
name: Kevin Burnham, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References: