louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01905904: Sevoflurane in Electroconvulsive Therapy
Official title: The Comparision of Different Doses of Sevoflurane for Induction of General Anesthesia in Electroconvulsive Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ECT
Anesthesia
Keywords: electroconvulsive therapy
seizures
sevoflurane
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to investigate the effects of different doses of sevoflurane used in electroconvulsive therapy (ECT) on duration of seizure, hemodynamic response and recovery profiles

Detailed description: Motor (EMG) and electroencephalography seizure duration (EEG), heart rate (HR) and mean arterial pressure (MAP) values, and recovery times were recorded.

Eligibility criteria: Inclusion Criteria:

* Study included 25 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-60 years who were scheduled for ECT sessions under general anesthesia

Exclusion Criteria:

* Pregnancy
* Cerebrovascular disease
* Epilepsy
* Unstable cardiovascular disease
* Chronic obstructive pulmonary disease; and
* Renal or hepatic failure

Primary outcomes:
measure: sevoflurane used in electroconvulsive therapy (ECT) on duration of seizure
timeFrame: taken prior to the seizure
Secondary outcomes:
measure: sevoflurane used in electroconvulsive therapy (ECT) on hemodynamic response.
timeFrame: taken prior to the seizure
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu Unıversity School of Medicine
Study officials:
affiliation: Inonu University
name: Huseyin Toprak, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03003104: DMT210 Topical Gel in the Treatment of Acne Rosacea
Official title: A Randomized, Double-Blind, Vehicle Controlled Study To Evaluate The Safety, Tolerability, And Efficacy Of DMT210 Gel In Adult Patients With Moderate To Severe Acne Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Rosacea
Keywords: Skin diseases
rosacea
Lead sponsor: Dermata Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-12-26
Enrollment: 107
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 evaluates the safety, tolerability, and efficacy of DMT210 Gel, 5% when applied twice daily for 12 weeks in adult patients with moderate to severe acne rosacea. Half of participants will receive DMT210 Gel while the other half will receive vehicle control.


Eligibility criteria: Inclusion Criteria:

* Patient is male or non-pregnant female at least 18 years of age.
* Clinical diagnosis of moderate to severe facial rosacea as determined by Investigator's Global Assessment (IGA) at Randomization
* Patient has at least ten inflammatory lesions of rosacea on the face at Randomization
* Patient is willing to apply the Investigational Product as directed
* Patient is willing and able to comply with the protocol

Exclusion Criteria:

* Patient is pregnant or planning to become pregnant
* Patient is taking a topical therapy which may affect the patient's rosacea

Primary outcomes:
measure: Efficacy as measured by Inflammatory lesion counts
timeFrame: 12 weeks
measure: Efficacy as measured by Investigator Global Assessment (IGA)
timeFrame: 12 weeks
measure: Efficacy as measured by 5-point Clinical Erythema Assessment (CEA)
timeFrame: 12 weeks
measure: Efficacy as measured by 5-point Patient Severity Assessment of Erythema (PSA)
timeFrame: 12 weeks
Secondary outcomes:
measure: Incidence of adverse events as a measure of safety and tolerability
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Dermata Investigational Site
state: California
city: Miami
country: United States
facility: Dermata Investigational Site
state: Florida
city: Fridley
country: United States
facility: Dermata Investigational Site
state: Minnesota
city: Omaha
country: United States
facility: Dermata Investigational Site
state: Nebraska
city: High Point
country: United States
facility: Dermata Investigational Site
state: North Carolina
city: Broomall
country: United States
facility: Dermata Investigational Site
state: Pennsylvania
city: Nashville
country: United States
facility: Dermata Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Dermata Investigational Site
state: Texas
city: Norfolk
country: United States
facility: Dermata Investigational Site
state: Virginia
Study officials:
References:
Clinical trial NCT05231304: Retrospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement
Official title: Retrospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Talus
Ankle Arthropathy
Keywords: Retrospective Study
Ankle Joint
Talus
Arthrodesis
Printing, Three-Dimensional
Joint Prosthesis
Prosthesis Design
Lead sponsor: Restor3D
Sponsor class: INDUSTRY
First posted: 2022-02-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients who underwent surgery involving a TTR implant with or without total ankle replacement and/or subtalar fusion between 1/1/2019 and 01/28/2022 will be will be included in this retrospective review. Patients with at least one postoperative follow-up visit will be included in this study. Only data in existence as of 01/28/2022 will be collected.

Brief summary: This study is a retrospective analysis of patients who underwent surgery using a total talus replacement (TTR) implant with or without concurrent total ankle replacement and/or subtalar fusion. This study seeks to analyze the clinical and radiographic outcomes of TTR implant recipients and generate additional data on the safety and benefit of the TTR implant.


Eligibility criteria: Inclusion Criteria:

* \>18 Years of Age
* Patient underwent surgery involving a total talus replacement implant between 1/1/2019 and 01/28/2022.

Exclusion Criteria:

* No available postoperative data

Primary outcomes:
measure: Improvement in pain from pre-operative baseline
timeFrame: 12-months
Secondary outcomes:
measure: Improvement in Patient Reported Outcomes
timeFrame: 3 months
measure: Improvement in Patient Reported Outcomes
timeFrame: 6 months
measure: Improvement in Patient Reported Outcomes
timeFrame: 12 months
measure: Improvement in Patient Reported Outcomes
timeFrame: 24 months
measure: Improvement in Patient Reported Outcomes
timeFrame: 36 months
Other outcomes:
measure: Subsequent Surgical Intervention
timeFrame: Up to 3 years.
measure: Adverse Events (AEs)/Serious Adverse Events (SAEs)
timeFrame: Up to 3 years.
Locations:
city: Paducah
country: United States
facility: Orthopaedic Institute of Western Kentucky
state: Kentucky
city: Bellevue
country: United States
facility: The Bellevue Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT03108404: Predictive Score for Neonatal Mortality for Women With Premature Rupture of Membranes Between 22 and 28 Weeks of Gestation
Official title: Predictive Score for Neonatal Mortality for Women With Premature Rupture of Membranes Between 22 and 28 Weeks of Gestation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perinatal Mortality
Premature Rupture of Fetal Membranes
Keywords: predictive score
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with premature rupture of membranes between 22 + 0 and 27 + 6 SA included

Brief summary: Pretern premature rupture of the membranes (PPROM) remains the leading cause of preterm deliveries and neonatal mortality and morbidity. PPROM is defined as rupture of the fetal membranes prior to 37 weeks' gestation. PPROM complicates 2-4% of all pregnancies and accounts for approximately 30 % of preterm births.

The etiology of PPROM remains elusive. PPROM is one of the main causes of prematurity and its complications, such as newborn respiratory distress syndrome, neonatal sepsis, necrotizing enterocolitis, intraventricular hemorrhage, perventricular leucomalacia, varying degrees of lung hypoplasia and bronchopulmonary dysplasia. All these factors contribute greatly to an increase in neonatal morbidity and mortality Management of PPROM followed actual guidelines. Conservative management to prolong a pregnancy is a classical approach to treat PPROM before 34 weeks' gestation in association with antibiotic therapy and corticosteroids.

Maternal and neonatal data were collected from maternal and newborns medical records.


Eligibility criteria: Inclusion Criteria:

* Women with PPROM between 22 weeks and 27 weeks and 6 days are eligible for this study

Exclusion Criteria:

* Therapeutic abortion / terminaison of pregnancy
* Intra uterine demise
* active labor with cervical dilatation of 3 cm with regular contractions.
* Triplet pregnancies

Primary outcomes:
measure: The purpose was to determine which antepartum criteria were efficient to predict neonatal death, in order to create a predictive prognostic antenatal index of mortality.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT00516204: Diabetic Under 70 (Diabetics Below 70)
Official title: Diabetic Under 70 (Diabetics Below 70)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Hyperlipidemia
Atherosclerosis
Keywords: Hyperlipidemia
Diabetics
NIS
Diabetics with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PAVK, etc.)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-08-15
Enrollment: 685
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: Male and female secondary prevention patients with: coronary disease with event: acute coronary syndrome, status post MI, PTCA, CABG, angiographically verified), PAVK (min. IIb or S.p. revascularization), stroke/TIA, carotis-plaque (asymptomatic min. 70% or S.p. revascularization), Diabetes Mellitus (type I, II)

Brief summary: A screening project of diabetics with a very high cardiovascular risk (e.g. diabetes plus coronary heart disease) who already receive cholesterol-lowering therapy. Lipid profile and rate of patients who are treated to target (which is \<70mg/dl for such patients with very high risk) are screened. The doctors therapy decisions after the screening will be documented and 8-10 weeks later the lipid profile of each patient will be evaluated again. Our aim is to evaluate dosing habits, to evaluate how many patients are treated to their LDL-C target and to underline the importance of treating patients to their cholesterol targets.


Eligibility criteria: Inclusion Criteria:

* Diabetics with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PAVK, etc.) who already receive cholesterol-lowering therapy

Exclusion Criteria:

* Diabetics w/o CVD; diabetics who do not receive cholesterol-lowering therapy

Primary outcomes:
measure: Cholesterol levels
timeFrame: After 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Research Site
Study officials:
affiliation: Chairs of the Austrian Diabetes Society
name: Michael Roden, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06215404: Fluid Management Strategies on Blood Loss in Liver Transplantation
Official title: Effects of Different Fluid Management Strategies on Blood Loss, Inflammatory Response, and Major Organ Sequelae in Liver Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Transplant
Keywords: fluid management
blood loss
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 60
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: PREVENTION

Brief summary: During liver transplantation, due to the complexity of the operation and abnormal coagulation function, there may be a large amount of bleeding and corresponding blood transfusion. Excessive blood transfusion will increase pulmonary complications and affect the prognosis. Infusion management to reduce bleeding is a very important issue in liver transplant surgery. Restrictive infusion management can effectively reduce the amount of bleeding in liver transplantation, but it remains unclear whether it will cause sequelae in other major organs.

The investigators plan to study different infusion goals and strategies in liver transplant surgery using a randomized group model, using the PiCCO (Pulse Contour Cardiac Output) cardiopulmonary volume monitor, and setting the stroke volume variation (SVV) as the macroscopic circulation.The purpose of this study was to divide it into restrictive and liberal groups to explore the impact on liver transplantation bleeding volume and inflammatory response as well as postoperative lung and renal function, and to collect statistics on clinical care and postoperative sequelae (pulmonary liver, renal function impairment, etc.) in order to develop the most appropriate infusion management strategy in liver transplantation.


Eligibility criteria: Inclusion Criteria:

* end stage liver disease
* age between 18y/o to 75 y/o
* expected to recieve to receive liver transplantation

Exclusion Criteria:

* arrythmia

Primary outcomes:
measure: blood loss intraoperatively
timeFrame: during the operation
Secondary outcomes:
measure: Lung injury biomarker
timeFrame: from biginning of the operation to postoprative day 1
measure: Kidney injury biomarker
timeFrame: from biginning of the operation to postoprative day 1
measure: Influammatory reponses
timeFrame: from biginning of the operation to postoprative day 1
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Anesthesiology, National Taiwan University Hospital
name: Kuang-Cheng Chan, M.D.,PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05903404: PCOS Indirect and Intangible Economic Burden
Official title: The PCOS Indirect and Intangible Economic Burden Study. A Sub-study of the PCOS Challenge Study: For the Collection of Information to Advance Research and Improve Care for PCOS Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polycystic Ovary Syndrome
Keywords: pcos
polycystic ovary syndrome
polycystic ovarian syndrome
stein leventhal syndrome
Lead sponsor: PCOS Challenge: The National Polycystic Ovary Syndrome Association
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population for the PCOS Indirect and Intangible Economic Burden will include individuals with a clinical diagnosis of PCOS, individuals self-diagnosed with PCOS, individuals with symptoms of PCOS (e.g., hirsutism, irregular menstrual cycles), and demographic-matched controls without PCOS.

Brief summary: The primary purpose of the PCOS Indirect and Intangible Economic Buren study is to estimate the economic costs of having PCOS in terms of quality of life and work productivity. The population will include individuals with a clinical diagnosis of PCOS, individuals self-diagnosed with PCOS, individuals with symptoms of PCOS (e.g., hirsutism, irregular menstrual cycles), and demographic-matched controls without PCOS. This study is a sub-study of The PCOS Challenge Study.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with PCOS by a health professional, self-diagnosed with PCOS or individuals with PCOS symptoms
* Willing to sign the consent form
* Able to understand the registry surveys or what is being asked

Exclusion Criteria:

* Unable to understand the surveys or what is being asked
* Unwilling to sign the consent form

Primary outcomes:
measure: Information
timeFrame: One Year
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: PCOS Challenge: The National Polycystic Ovary Syndrome Association
state: Maryland
Study officials:
affiliation: PCOS Challenge: The National Polycystic Ovary Syndrome Association
name: Sasha Ottey, MHA, MT (ASCP)
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Alabama at Birmingham
name: Ricardo Azziz, MD, MPH, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05087901: Multifocal Electroretinography Before and After Silicone Oil Removal
Official title: Multifocal Electroretinography Before and After Silicone Oil Removal
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Silicone Oil Filled Eyes
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 30
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: A total of 30 patients will be recruited. We will include patients 18 years of age or older who underwent PPV for the repair of rhegmatogenous retinal detachment (RRD) and received silicone oil as an intraocular tamponade. Patients will be excluded if they have a significant corneal opacity, uncontrolled intraocular pressure, a confounding macular pathology or optic nerve pathology or if silicone oil has been in the eye for longer than 6 months.

Brief summary: This is a prospective observational study to investigate the changes in multifocal electroretinogram signal before and after silicone oil removal in silicone-filled eyes.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older who underwent pars plana vitrectomy for the repair of rhegmatogenous retinal detachment (RRD) and received silicone oil as an intraocular tamponade.

Exclusion Criteria:

* Patients will be excluded if they have a significant corneal opacity, uncontrolled intraocular pressure, a confounding macular pathology or optic nerve pathology or if silicone oil has been in the eye for longer than 6 months.

Primary outcomes:
measure: Change in Amplitude
timeFrame: Preoperative and 1 month postoperative recordings
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University Hospital
Study officials:
References:
Clinical trial NCT05311501: Impact of Non-surgical Periodontal Therapy in the Management of Plaque Psoriasis.
Official title: Impact of Non-surgical Periodontal Therapy in the Management of Plaque Psoriasis. A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psoriasis Vulgaris
Psoriasis
Periodontitis
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Both periodontitis and plaque psoriasis are non communicable chronic inflammatory diseases. They share genetic polymorphysms (IL-1, IL-6 e TNFalfa) and risk factors (smoking, diabetes, obesity), as well as a great resemblance in terms of pathophysiological pathways. In fact, they are both characterized by an hyperactivation of the innate immune response which induces an excessive production of cytokines such as IL-17/TNFalfa. While non-surgical periodontal therapy consists in the mechanical removal of supra and subgingival calculus, psoriasis treatment involves the administration of either systemic or biologic drugs. Evidence is scarce regarding the effectiveness of non-surgical periodontal therapy in ameliorating the clinical outcomes of plaque psoriasis. The biological plausibility relies on the important reduction of systemic inflammation caused by periodontal treatment, which could ameliorate psoriasis phenotype.


Eligibility criteria: Inclusion Criteria:

* diagnosis of plaque psoriasis;
* diagnosis of untreated periodontitis;
* presence of at least 20 teeth;
* age between 18 and 70 years;
* ability and willingness to give informed consent.

Exclusion Criteria:

* inability of unwillingness to give informed consent;
* patients undergoing periodontal treatment within the last 6 months;
* patients undergoing immunosuppressive treatments for other systemic diseases;
* pregnancy or lactation;
* pts undergoing antibiotic therapy.

Primary outcomes:
measure: PASI (Psoriasis Area and Severity Index)- Baseline
timeFrame: PASI was registered at baseline.
measure: PASI (Psoriasis Area and Severity Index)- 10 weeks
timeFrame: PASI was registered 10 weeks after baseline.
Secondary outcomes:
measure: Body Surface Area (BSA)- Baseline
timeFrame: BSA was registered at baseline.
measure: Body Surface Area (BSA)- 10 weeks
timeFrame: BSA was registered 10 weeks after baseline.
Other outcomes:
measure: Salivary Concentration of miRNAs- Baseline
timeFrame: Salivary Concentration of miRNAs was registered at baseline.
measure: Salivary Concentration of miRNAs- 10 weeks
timeFrame: Salivary Concentration of miRNAs was registered 10 weeks after baseline.
Locations:
city: Siena
country: Italy
facility: Azienda Ospedaliero Universitaria Senese
Study officials:
References: