louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02096497: Analysis of the Vascular Pattern of the Superficial Temporal Artery
Official title: In Vivo Analysis of the Vascular Pattern of the Superficial Temporal Artery Based on Digital Subtraction Angiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arteria Temporalis Superficialis
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: clinic patients who underwent digital subtractions angiographie

Brief summary: Retrospective analysis to the course and branching pattern as well as surgically relevant inner diameters and lengths of the superficial temporal artery (STA) by digital subtraction angiographies (DSA).


Eligibility criteria: Inclusion Criteria:

* good quality digital subtractions angiographies of the STA

Exclusion Criteria:

* bad quality digital subtractions angiographies of the STA

Primary outcomes:
measure: vessel diameters
timeFrame: up to 36 month
Secondary outcomes:
measure: vessel length
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Clinic for Hand, Plastic and Reconstructive Surgery with Burn Center BG Trauma Center
Study officials:
References:
citation: Pinar YA, Govsa F. Anatomy of the superficial temporal artery and its branches: its importance for surgery. Surg Radiol Anat. 2006 Jun;28(3):248-53. doi: 10.1007/s00276-006-0094-z. Epub 2006 Mar 28.
Clinical trial NCT01975597: Pilot Study of Bone Biopsy and Aspirate in Women With Metastatic Breast Cancer
Official title: Pilot Study of Bone Biopsy and Aspirate in Women With Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Metastatic Breast Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2013-11-03
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are receiving care for metastatic breast cancer at University of Michigan Rogel Cancer Center will be recruited for this study to donate samples.

Brief summary: This is a feasibility study to demonstrate the team's ability to collect bone marrow aspirates and biopsies for research purposes from women with metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

* Patients with metastatic breast cancer (any site) age 21 or older
* Patients willing and able to provide informed consent \& perform study procedures
* Patients may enroll with recently (with 2 months) progressive tumor burden
* Performance status of 0,1 or 2

Exclusion Criteria:

* Patients unable or unwilling to provide informed consent and or perform study procedures
* Patients with active, uncontrolled coagulopathy
* Patients on treatment dose anticoagulation or an International Normalised Ratio of 2 or greater if on warfarin
* Patients who are known to be pregnant are not eligible to participate in this study during the time of the pregnancy

Primary outcomes:
measure: Number of patient that agree to undergo 2 biopsy's strictly for research purposes.
timeFrame: At 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Catherine Van Poznak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00630097: A Dose Ranging Study of Modafinil for Methamphetamine Dependence
Official title: A Dose Ranging Study of Modafinil for Methamphetamine Dependence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Substance Dependence
Amphetamine Dependence
Keywords: methamphetamine addiction, meth dependence
Lead sponsor: California Pacific Medical Center Research Institute
Sponsor class: OTHER
First posted: 2008-03-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients treated for methamphetamine dependence have high rates of relapse, and no pharmacotherapy has yet been demonstrated to be efficacious. Modafinil (d, l-2-\[(diphenylmethyl)sulfinyl\]acetamide) is a novel wake- and vigilance-promoting agent that is chemically and pharmacologically dissimilar to CNS stimulants. It is well tolerated and has low abuse liability compared to CNS stimulants. Modafinil is FDA approved for a variety of sleep disorders, may relieve methamphetamine withdrawal symptoms, improves cognitive function, has been shown to reduce cocaine use in dependent users, and is safe when coadministered with intravenous methamphetamine. We will conduct a randomized dose ranging clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for methamphetamine dependence.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 50 years
2. Patient is agreeable to conditions of study and signs consent form

Primary outcomes:
measure: Methamphetamine-negative urine samples will be analyzed using a generalized estimating equation model
timeFrame: end of study
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: CPMC
state: California
Study officials:
affiliation: California Pacific Medical Center
name: Gantt Galloway, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05489497: Morbidity After Surgical Treatment of Perforated Ulcer
Official title: Postoperative Morbidity Risk Factors After Surgical Treatment of Perforated Peptic Ulcer: a Retrospective Study of 116 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peptic Ulcer Perforation
Keywords: Postoperative complication
Risk factor
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient who presented to tahar sfar hospital for perforated ulcer

Brief summary: The main objective of our study is to identify the risk factors for postoperative morbidity after surgical treatment of Perforated peptic ulcer

Detailed description: the investigators conducted a retrospective study of 116 patients, operated on for a perforated peptic ulcer, carried out in the General Surgery Department of Taher Sfar University Hospital in Mahdia over a period of 11 years 6 months.

Eligibility criteria: Inclusion Criteria:

* patients who underwent surgery for a perforated peptic ulcer in the General Surgery Department of Taher Sfar University Hospital in Mahdia, between January 1, 2010, and June 1, 2021, were included in this study.

Exclusion Criteria:

* patients who have medical treatment

Primary outcomes:
measure: postoperative medical or surgical complication
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05014997: TyG Index Levels in Klinefelter Syndrome
Official title: Triglyceride-Glucose Index Levels in Patients With Klinefelter Syndrome and Its Relationship With the Endothelial Dysfunction and Insulin Resistance: A Cross-sectional Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Event
Klinefelter Syndrome
Endothelial Dysfunction
Keywords: Klinefelter Syndrome, TyG Index, Cardiometabolic risk
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 30 male patients with treatment-naive Klinefelter syndrome and 30 control subjects without any chronic disease

Brief summary: It is well known that the frequency of cardiometabolic diseases are increased in patients with Klinefelter Syndrome. The triglyceride-glucose index (TyG index) is a simple surrogate marker of insulin resistance and is also associated with various cardiometabolic diseases. The aim of this study to investigate the TyG index levels and its relationship with insulin resistance and endothelial dysfunction in patients with KS.

Detailed description: From the patient database of our Endocrinology department we randomly included a total of 30 patients with KS and 32 healthy controls in the study. All the recorded data in the database were registered under the approval of Local Ethical Committee of Gulhane School of Medicine.

The clinical and laboratory parameters, TyG index, asymmetric dimethylarginine (ADMA), homeostatic model assessment of insulin resistance (HOMA-IR) and high-sensitivity C-reactive protein (hs-CRP) levels were gathered from the database and the triglyceride-glucose index was calculated by the help of pre-measured laboratory parameters.

Eligibility criteria: Inclusion Criteria:

* Patients with a verified Klifelter Syndrome karyotype (all subjects included were 47, XXY) and who were not previously given testosterone replacement.

Exclusion Criteria:

* age \<18 years,
* acute infection, malignancy, any visceral organ dysfunction, nutritional derangements, clinical history of cardiovascular disease, cerebrovascular disease, drug use such as antidiabetic or lipid-lowering medications, or those lacking complete clinical data.

Primary outcomes:
measure: Cardiometabolic risk
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Health Sciences University, Gulhane School of Medicine, dep. of Endocrinology and Metabolism, Turkey
name: Alper Sonmez, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02171897: Pertrochanter Arthroplasty Versus Osteosynthesis
Official title: Comparison of Functional Recovery After Pertrochanter Fracture Treated With Either Total Hip Replacement or Centromedullary Nailing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pertrochanter Fracture
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 70
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a single-centre, comparative, prospective randomised trial. It will include 70 patients over a period of 2 years randomized into two groups of 35 patients: one group of patients treated with osteosynthesis (plate, nail or screw) and the second group treated with total hip replacement.

The Harris and PMA functional scores will be assessed at 6 weeks, 3 months, 6 months and 1 year.

The time to recovery of weight-bearing, the subjective satisfaction score, the EQ5D quality of life questionnaire, the VAS score for pain at rest and when walking, the Parker score, the rate of complications and deaths will also be measured. Operating time, blood loss and scar size will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* Patients who have provided written informed consent
* Patients over 18 years old
* Patients less than 70 years old
* Patient presenting with a fracture of the trochanter (type 1 to 6 according to the Ender classification, and A1 and A2 according tyo the AO classification (Association suisse pour l'étude de l'Ostéosynthèse : classification internationale)

Exclusion Criteria:

* Adult under guardianship
* Patients not covered by national health insurance
* Pregnant or breast-feeding women
* Unable to walk independently before the trauma
* Patients with dementia

Primary outcomes:
measure: Harris Score
timeFrame: At 6 months after surgery
Secondary outcomes:
measure: PMA functional score
timeFrame: Up to 1 year after surgery
measure: Time to recovery of weight-bearing
timeFrame: Up to 1 year after surgery
measure: Subjective satisfaction score (EQ5D, VAS score for pain at rest and when walking)
timeFrame: Up to 1 year after surgery
measure: Parker score
timeFrame: Up to 1 year after surgery
measure: Rate of complications (loosening of implants, fractures around osteosynthesis devices or prostheses, infections, phlebitis-pulmonary embolism)
timeFrame: Up to 1 year after surgery
measure: Death rate
timeFrame: Up to 1 year after surgery
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de DIJON
Study officials:
References:
Clinical trial NCT00279097: Safety Study to Evaluate Intracranial Pressure During High Frequency Chest Wall Oscillation
Official title: A Safety Study to Evaluate Intracranial Pressure With the Utilization of High Frequency Chest Wall Oscillation (HFCWO) Using the Vest™ on Mechanically Ventilated Neurosurgical Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intracranial Pressure
Keywords: Intracranial pressure
High Frequency Chest Wall Oscillation
Neurosurgery
Lead sponsor: Hill-Rom
Sponsor class: INDUSTRY
First posted: 2006-01-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate changes in intracranial pressure (ICP) during or immediately following high frequency chest wall oscillation (HFCWO) treatment with the Vest™ in neurosurgical subjects.

Detailed description: This study is a single site safety study to evaluate changes in intracranial pressure during or immediately following HFCWO treatment with the Vest™ in neurosurgical subjects with intracranial pressure monitors having normal opening pressures and ICP less than or equal to 20 mmHg. The secondary objective of this study is to evaluate changes in arterial blood gases that may result with Vest™ therapy in ventilated patients.

Eligibility criteria: Inclusion Criteria:

* ICP monitor with normal opening pressure (greater than or equal to 20 mmHg)
* On ventilator
* Arterial line in place
* Age equal to or greater than 18
* Admitted to neurotrauma intensive care unit (ICU)

Exclusion Criteria:

* Inability to obtain informed consent
* Unstable spinal cord injury
* ICP \> 20 mmHg sustained for \> 5 minutes
* Hemodynamic instability within the prior 12 hours
* Active hemoptysis
* Hemothorax
* New onset, unstable arrhythmia
* Enrollment in another interventional study
* Aneurysm that has not been clipped or coiled
* Coagulopathic head injury subjects

Primary outcomes:
measure: Intracranial pressure
measure: SpO2
measure: Heart rate
measure: Mean arterial pressure (MAP)
measure: Arterial blood gases (ABGs)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas at Houston/Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: University of Texas
name: Robert L Levine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01722097: Recovery After Laparoscopic Hysterectomy With Deep Neuromuscular Blockade and Low Intra-abdominal Pressure
Official title: Recovery After Laparoscopic Hysterectomy With Deep Neuromuscular Blockade and Low Intra-abdominal Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuromuscular Blockade
Pain
Laparoscopy
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2012-11-06
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study on laparoscopic hysterectomy is to investigate postoperative pain. Patients are allocated to either deep neuromuscular blockade and low intra-abdominal pressure (8 mmHg) or moderate neuromuscular blockade and usual intra-abdominal pressure (12 mmHg).

Primary hypothesis:

Deep neuromuscular blockade and low intra-abdominal pressure (8 mmHg) reduces postoperative pain compared to moderate neuromuscular blockade and intra-abdominal pressure (12 mmHg).


Eligibility criteria: Inclusion Criteria:

* Elective laparoscopic hysterectomy (total/subtotal)
* Can read and understand Danish
* Informed consent

Exclusion Criteria:

* BMI \> 30 kg/cm2
* Known allergy to medications that are included in the project
* Severe renal disease, defined by S-creatinine \> 0,200 mmol/L, GFR \< 30ml/min or hemodialysis)
* Neuromuscular disease that may interfere with neuromuscular data
* Lactating
* Impaired liver function
* Indication for rapid sequence induction (esophageal reflux/ hiatus hernia/other cause)

Primary outcomes:
measure: Shoulder Pain
timeFrame: within 14 days
Secondary outcomes:
measure: Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain)
timeFrame: within 14 days
Other outcomes:
measure: Patient-movements
timeFrame: During surgery
Locations:
city: Søborg
country: Denmark
facility: Department of anesthesia and department of minimal invasive gynecology, Aleris-Hamlet
Study officials:
affiliation: Department of anesthesia, Herlev Hospital
name: Mona Gätke, MD, ph.d.
role: STUDY_CHAIR
affiliation: Department of anesthesia, Herlev Hospital
name: Matias Vested Maden, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Madsen MV, Istre O, Springborg HH, Staehr-Rye AK, Rosenberg J, Lund J, Gatke MR. Deep neuromuscular blockade and low insufflation pressure during laparoscopic hysterectomy. Dan Med J. 2017 May;64(5):A5364.
citation: Madsen MV, Istre O, Staehr-Rye AK, Springborg HH, Rosenberg J, Lund J, Gatke MR. Postoperative shoulder pain after laparoscopic hysterectomy with deep neuromuscular blockade and low-pressure pneumoperitoneum: A randomised controlled trial. Eur J Anaesthesiol. 2016 May;33(5):341-7. doi: 10.1097/EJA.0000000000000360.
Clinical trial NCT02568397: A Drug-drug Interaction Study of Lanabecestat (LY3314814) in Healthy Participants
Official title: Effect of LY3314814 on the Pharmacokinetics of Dabigatran in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2015-10-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to learn about the effect of lanabecestat on how the body absorbs and processes dabigatran etexilate and how dabigatran etexilate affects lanabecestat when they are taken together. This study will last about 28 days and participants will be asked to take an lanabecestat tablet daily for 19 days and a dabigatran etexilate tablet on 3 occasions. Screening is required within 30 days prior to the start of the study.


Eligibility criteria: Inclusion Criteria:

- Overtly healthy males and females

Exclusion Criteria:

* Eye abnormalities or disease
* History of vitiligo or any skin color disorder
* Have a history psychiatric or brain disease including seizures
* Have smoked within the last 3 months
* Are unwilling to avoid food and drinks containing grapefruit or Seville oranges for the duration of the study
* Have known allergies to dabigatran etexilate and related compounds

Primary outcomes:
measure: Pharmacokinetics (PK) : Maximum Concentration (Cmax) of Dabigatran
timeFrame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose
measure: Pharmacokinetics: Area Under The Dabigatran Pharmacokinetic (PK) Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity)
timeFrame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose
Secondary outcomes:
measure: Pharmacokinetics: Maximum Concentration (Cmax) of Lanabecestat
timeFrame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose
measure: Pharmacokinetics: Area Under the Lanabecestat Pharmacokinetic (PK) Concentration Versus Time Curve During One Dosing Interval (24 Hours) (AUCtau)
timeFrame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose
measure: Pharmacodynamics: Area Under the Effect Versus Time Curve (AUEC) of Thrombin Time
timeFrame: Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose
measure: Pharmacodynamics: Ratio of Maximum Effect to Baseline Effect (ERmax) of Thrombin Time
timeFrame: Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03969797: AED Log Analysis of 19 Cases in Out-of-hospital Environment
Official title: Quality Feedback of 19 Cases by AED Operation in Out-of-hospital Environment: a Prospective Randomized Log Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest, Sudden
Lead sponsor: RadianQbio
Sponsor class: INDUSTRY
First posted: 2019-05-31
Enrollment: 19
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients using AED HR-501

Brief summary: The study performed to demonstrate a reasonable assurance of safety and effectiveness of the Heart Guardian HR-501 when used in an out-of-hospital environment.

Detailed description: The defibrillation study was conducted by analyzing the logs of Heart Guardian HR-501 with Radian ECG Viewer. The product analysis was studied whether the device was operated normally in ECG analysis and electric shocks.

Eligibility criteria: Inclusion Criteria:

* out-of-hospital cardiac arrest
* \> 12 months

Exclusion Criteria:

* age under 12 months

Primary outcomes:
measure: Identification ECG from patients
timeFrame: during operating, approximately 2 hours
Secondary outcomes:
measure: Survival patients by electric shock
timeFrame: 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Radianqbio
Study officials:
References: