louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00441753: Cerebral Bloodflow and Carbondioxide Reactivity During Mild Therapeutic Hypothermia in Patients After Cardiac Arrest
Official title: Cerebral Bloodflow and Carbondioxide Reactivity During Mild Therapeutic Hypothermia in Patients After Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrest
Post-Anoxic Encephalopathy
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2007-03-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients after cardiac arrest, comatose and treated with therapeutic hypothermia

Brief summary: Survivors of a cardiac arrest frequently develop severe postanoxic encephalopathy. Derangements in cerebral blood after return of spontaneous circulation play an important role in the pathogenesis of postanoxic encephalopathy. In the present study we examine the effect of mild therapeutic hypothermia on cerebral blood flow and carbondioxide reactivity in patients after cardiac arrest.


Eligibility criteria: Inclusion Criteria:

* adult patients
* GCS after return of circulation \< 7
* Induced mild hypothermia for 24 hours
* primary rhythm ventricular fibrillation

Exclusion Criteria:

* Thrombolysis
* Cardiogenic shock with expected survival \< 24 hrs
* Pregnancy
* No informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: Cornelia Hoedemaekers, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Johannes van der Hoeven, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06562153: FMRI Accelerated TMS Depression
Official title: Tracking Brain Imaging Changes in Depression Over Clinical Accelerated Transcranial Magnetic Stimulation (TMS) Therapy At the Individual Level
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Depression
Keywords: Brain
Depression
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Foundation for the Advancement of Clinical TMS
First posted: 2024-08-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers with diagnosed MDD undergoing accelerated transcranial magnetic stimulation therapy (TMS).

Brief summary: This study aims to investigate whether phenotypic-related brain states revealed by a novel INSCAPE ("Individualized Network-based Single-frame Coactivation Pattern Estimation") neuroimaging method in Major Depressive Disorder (MDD) patients can track brain recovery of MDD patients over an accelerated antidepressant transcranial magnetic stimulation (TMS) treatment.

Detailed description: The aim of this study is to use magnetic resonance imaging (MRI) to capture images of participants' brains and apply an image processing method called INSCAPE to assess brain states. This study will recruit participants who are scheduled to receive accelerated Transcranial Magnetic Stimulation (TMS) therapy for Major Depressive Disorder (MDD). Participation in this study involves two visits, each including a 30-minute MRI scan. The interval between each visit is about one week. Depressed participants will also complete mood assessments at various intervals while they are receiving accelerated TMS for depression.

Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Have the capacity and ability to provide one's own consent in English and sign the informed consent document.
* DSM-IV diagnosis of MDD

Exclusion Criteria:

* Unable to speak English.
* Contraindicated for MRI.
* Any current or recent untreated medical, neurological, or psychiatric conditions
* Metal implant devices in the head, heart, or neck.
* History of brain surgery.
* History of cortisol medication use or electroconvulsive therapy.
* Comorbidity with other psychiatric/neurological illnesses or personality disorders
* History of myocardial infarction or arrhythmia, bradycardia.
* Personal history of head injury, concussion, or self-report of moderate to severe traumatic brain injury.
* Individuals suffering from frequent/severe headaches.
* Moderate to severe alcohol or substance use disorder.
* Pregnancy

Primary outcomes:
measure: Dynamic brain state change after 5-day transcranial magnetic stimulation (TMS) treatment compared to baseline
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: 30 Bee Street
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Xiaolong Peng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04109053: Ultrasensitive Electroanatomic Mapping to Adjudicate Endpoints for Ablation In Paroxysmal AF Patients Using Cryoballoon
Official title: Ultrasensitive Electroanatomic Mapping to Adjudicate Endpoints for Ablation In Paroxysmal AF Patients Using Cryoballoon
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: BayCare Health System
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing pulmonary vein isolation using cryoballoon at St. Joseph's Hospital in FL that sign informed consent

Brief summary: Ultrasensitive Electroanatomic Mapping to Adjudicate Endpoints for Ablation In Paroxysmal AF Patients Using Cryoballoon

Detailed description: Collected data include procedural parameters relevant to pulmonary vein isolation as outlined in the protocol section, DE identified patient demographics, follow up information including rhythm status, antiarrhythmic medication usage, and symptoms or signs to suggest procedural complications relevant to the pulmonary vein isolation procedure.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing pulmonary vein isolation using cryoballoon at St. Joseph's Hospital in FL that sign informed consent

Exclusion Criteria:

-

Primary outcomes:
measure: Frequency of acute pulmonary vein isolation as adjudicated by pacing catheter based entrance/exit block, and Orion derived activation and voltage map.
timeFrame: 12 months
Secondary outcomes:
measure: AT/AF free survival
timeFrame: 12 months
measure: Procedural endpoints including total procedure time, LA dwell time, total flouro time, total ablation time, and total mapping time.
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01107353: Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions
Official title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Imipramine Pamoate Capsules, 75 mg, Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-04-20
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Imipramine Pamoate 75 mg Capsules under fasting conditions


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to imipramine pamoate or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence Determined by Statistical Comparison Cmax
timeFrame: 33 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Novum Pharmaceutical Research Services
state: Texas
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: Soran Hong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01590953: A Study of the Effects of an Employee Wellness Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
First posted: 2012-05-03
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ochsner employees with a BMI greater than or equal to 30

Brief summary: Ochsner employees with a body mass index (BMI) greater than or equal to 30 will be enrolled in a fitness program consisting 90 days of a structured exercise program and dietary counseling. Measures of fitness including weight, BMI, cholesterol, HDL, blood pressure, and absenteeism rates will be measured at 0, 90 days, in one year.


Eligibility criteria: Inclusion Criteria:

* Ochsner employees with a BMI greater than or equal to 30

Exclusion Criteria:

* Failure to pass initial physical exam

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Harahan
country: United States
facility: Elmwood fitness center
state: Louisiana
Study officials:
References:
Clinical trial NCT00774553: To Evaluate Safety and Tolerability After Multiple Oral Doses of AZD1656 in Type 2 Diabetes Patients on Top of Metformin
Official title: A Randomized, Single-Blind, Placebo-Controlled, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in Subjects With T2DM Treated With Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-17
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess safety and tolerablility of AZD1656 after multiple repeated oral doses in patients with type 2 diabetes on top of metformin.


Eligibility criteria: Inclusion Criteria:

* Male or female (with non child-bearing potential)
* Diagnosed diabetes Mellitus patients treated with metformin alone or one other anti-diabetic drugs. Stable blood sugar control indicated by no changed treatment within 3 months prior to study start.t
* HbA1c \<11 % at screening (HbA1c value according to international DCCT standard)

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP
* History of ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease
* Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results.

Primary outcomes:
measure: Safety variables (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG)
timeFrame: Blood samples taken repeatedly during 24 hours on study day sessions
Secondary outcomes:
measure: Pharmacokinetic variables
timeFrame: Blood samples taken repeatedly during 24 hours on study day sessions
measure: Pharmacodynamic variables
timeFrame: Blood samples taken repeatedly during 24 hours on study day sessions
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Ahmedabad
country: India
facility: Research site
Study officials:
affiliation: AstraZeneca R&D Mölndal
name: Klas Malmberg, MD, PhD, Prof.,
role: STUDY_DIRECTOR
affiliation: Healthcare Discoveries LLC Icon Development Solutions
name: Dr Emanuel DeNoia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Veeda Clinical Research Pvt. Ltd
name: Sanjay Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06808451: Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture
Official title: Diagnosis and Treatment of Urinary Tract Infection Using DNA PCR Versus Urine Culture - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Urinary Tract Infections
Keywords: urine culture
DNA PCR
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Adults 18 years or older with urinary tract infection (UTI) symptoms. Participants will be assigned to either the urine culture group or the DNA PCR study group by randomization. At time of enrollment in the study they will be also asked to fill out two questionnaires. If prescribed antibiotics for treatment of a UTI, participants will then be called the day after they are scheduled to stop their antibiotics. Participants will be asked to fill out questionnaires the day after finishing antibiotics. Participants will be enrolled in the study for a maximum of 21 days.


Eligibility criteria: Inclusion Criteria:

* Adult men and women 18 years and older
* Presenting to clinic with symptoms of UTI or cystitis
* Patients with Medicare and Medicaid insurance

Exclusion Criteria:

* Urinary diversion of any type
* Chronic indwelling urinary catheter
* Diagnosed UTI within the previous 21 days
* Antibiotic therapy within the previous 21 days
* Use of phenazopyridine within the previous 21 days
* Commercial insurance
* Non-English speaking
* Pregnant patients

Primary outcomes:
measure: Change in symptoms as measured by UTI-SIQ-8 questionnaire
timeFrame: Baseline, one day after antibiotic completion
measure: Change in symptoms as measured by the UTI Symptom Assessment questionnaire
timeFrame: Baseline, one day after antibiotic completion
Secondary outcomes:
measure: Length of time from patient presentation to initiation of treatment as measured by medical record review
timeFrame: Up to 21 days
measure: Number of antibiotic changes as measured by medical record review
timeFrame: Up to 21 days
measure: Duration of antibiotic use as measured by medical record review
timeFrame: Up to 21 days
measure: Number of times participant represents with UTI symptoms as measured by medical record review
timeFrame: Up to 30 days
measure: Number of additional diagnostic procedures related to initial presenting symptoms as measured by medical record review
timeFrame: Up to 21 days
measure: Number of hospitalizations related to UTI as measured by medical record review
timeFrame: Up to 21 days
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
Study officials:
affiliation: University Hospitals
name: David Sheyn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05682651: Relationship Between Post-Intubation Tracheal Stenosis and Covid-19
Official title: Etiological Investigation of 'Post-Intubation Tracheal Stenosis' Cases Requiring Intervention: 2-year Case Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tracheal Stenosis
COVID-19
Post-Intubation Subglottic Stenosis
Intensive Care Unit
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 18 years of age and without a history of malignancy who developed post-intubation tracheal stenosis are included in the study.

Brief summary: Tracheal stenosis (TS) is a serious complication that occurs in approximately 6-22% of patients due to prolonged endotracheal intubation. Cuff hyperinflation of the endotracheal tube, use of large tubes, advanced age, female gender, smoking, obesity, and diabetes are risk factors for TS. The most common and serious complication in COVID-19 patients is acute respiratory distress syndrome (ARDS), which requires oxygen and ventilation treatments. In the literature, it is reported that 9.8-15.2% of patients need invasive mechanical ventilation (IMV). The concern of aerosol formation and prone position applications that emerged with the coronavirus pandemic caused delays in tracheostomy decisions and the use of uncontrolled high cuff pressures, paving the way for TS. The capillary perfusion pressure of the tracheal mucosa ranges from 20 to 30 mmHg. A cuff pressure of the endotracheal tube above 30 mmHg causes mucosal ischemia. Cartilage inflammation due to ischemic injury may be partial or full thickness. Depending on the degree of inflammation in the affected tracheal segments, stenosis and even perforation may develop.

It is aimed to determine the etiological causes, to determine how much of the total TS cases covid-related TS constitutes, to examine the treatments and patient results in covid/non-covid TS.

This study will contribute to the measures that can be taken during and after the care process in the intensive care unit.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years

Exclusion Criteria:

* Patients undergoing surgical procedures for malignancy

Primary outcomes:
measure: Intubation time
timeFrame: Up to 3 months
measure: Morbidity/mortality
timeFrame: Up to 2 months
measure: Length of hospital stay
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Çankaya
country: Turkey
facility: Ankara City Hospital
state: Ankara
Study officials:
References:
Clinical trial NCT05427851: Diode Laser Pulpotomy of Mature Permanent Molars With Irreversible Pulpitis
Official title: Effect Of Diode Laser And Platelet Rich Fibrin In Regenerative Pulpotomy Of Mature Permanent Molars With Irreversible Pulpitis (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irreversible Pulpitis
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Thirty six patients are included in this study. For each patient, a pulpotomy procedure is performed.

Detailed description: For each patient, a pulpotomy procedure is done. Group I (n=12) pulpotomy is performed and hemostasis is achieved by applying NaOCl, then the radicular pulp is covered with Platelet Rich Fibrin (PRF) and capped with Biodentine, Group II (n=12) pulpotomy is done as in group I and hemostasis is achieved using diode laser and remaining pulp is capped with Biodentine, Group III (n=12) pulpotomy is performed and hemostasis is achieved as in group II then radicular pulp is covered with PRF then capped with Biodentine, The teeth are then restored with Glass ionomer cement followed by composite restoration. Pain is recorded every 24 hours for 7 days after intervention. Clinical and radiographic follow-up are done at 1,3,6,9 and 12 months. Cone beam computed tomography (CBCT) is done immediate postoperative and will be used for the assessment of the outcome of the pulpotomy procedure at the end of the study period.

Eligibility criteria: Inclusion Criteria:

1. Patients between 18 and 40 years of age.
2. Deep caries in a permanent lower molar with mature roots.
3. Clinical diagnosis of symptomatic irreversible pulpitis
4. No signs of pulpal necrosis including sinus tract or swelling.
5. Vital bleeding pulp tissue should be present in all canals after complete pulpotomy.
6. The tooth is restorable.

Exclusion Criteria:

1. Patients with systemic disease.
2. Negative response to cold testing.
3. Presence of sinus tract or swelling.
4. No pulp exposure after caries excavation.
5. Bleeding could not be controlled
6. Absence of bleeding from any of the canals.
7. Teeth with radiographic signs of internal resorption.
8. Pulpal calcifications.
9. Non-restorable teeth

Primary outcomes:
measure: regenerative pulpotomy success
timeFrame: 12 months
Secondary outcomes:
measure: Postoperative pain
timeFrame: 7 days
Other outcomes:
measure: Dentine bridge formation
timeFrame: 12 months
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Professor of Endodontics, Faculty of Dentistry, Alexandria University
name: Raef A sherif, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00829751: The Physiological Consequence of Silicone-hydrogel Care-solution Bio-incompatibility
Official title: The Physiological Consequence of Silicone-hydrogel Care-solution Bio-incompatibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Solution Toxicity
Keywords: staining
toxicity
fluorometry
dye diffusion
anterior chamber
Lead sponsor: Southern California College of Optometry at Marshall B. Ketchum University
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2009-01-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to more objectively evaluate potential lens-material/care solution bio-incompatibilities. We will do this by measuring corneal staining and the amount of fluorescein dye diffusion into the eye.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age.
* Best correctable vision to 20/40 in each eye.
* Possess a functional spectacle prescription to allow adequate vision during the de-adaptation and fluorometry measurement period.
* No known ocular or systemic allergies, which may interfere with contact lens wear.
* No known systemic disease, or need for medication that may interfere with contact les wear (i.e. antihistamines, beta-blockers, steroids, ect.).

Exclusion Criteria:

* Subjects demonstrating any medical condition that may affect the results of this study SHOULD NOT be enrolled. The following are specific conditions that exclude subjects from enrollment in this study.
* Eye (ocular) or systemic allergies that may interfere with contact lens wear.
* Clinically significant corneal swelling (greater than 3 or 4 on a 0-4 scale), corneal blood vessel growth (vascularization), corneal staining, bulbar redness, tarsal redness, or any other abnormality of the cornea that may cause unsafe contact lens wear.
* Are taking part in any other study or have taken part in a study within the last 14 days.
* Are pregnant, or anticipating to become pregnant during the course of the study.

Primary outcomes:
measure: The level/amount of sodium fluorescein dye in the anterior chamber at post wear timepoints
timeFrame: On day of experiment
Secondary outcomes:
measure: Corneal staining level post lens wear
timeFrame: On day of study
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Southern California College of Optometry
state: California
Study officials:
affiliation: Southern California College of Optometry at Marshall B. Ketchum University
name: Jerry R Paugh, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References: