louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01737385: Examination of Microcirculation of the Caput Humeri After Proximal Humerus Fracture
Official title: Intraoperative Examination of Microcirculation of the Caput Humeri After Traumatic Proximal Humerus Fracturation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proximal Humeral Fractures
Keywords: microcirculation
proximal humeral fractures
O2C
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that are treated for proximal humeral fratures in the University hospital of the RWTH Aachen University.

Brief summary: This study examines the microcirculation of the caput humeri after proximal humeral fracturation using O2C light probes.

During the operation the blood circulation is measured at four points (tuberculum majus, tuberculum minus, neck and head of the humerus) directly on the bone. The O2C light probes are a none-invasive technique of measuring blood flow, velocity and oxygen concentration. The data is analysed in respect to the fracture type according to the classification of Neer.

Valuable additional information for the correct treatment and prognosis of humeral fractures is expected.


Eligibility criteria: Inclusion Criteria:

* traumatic fractures of the proximal humerus
* surgical treatment
* over eighteen years of age

Exclusion Criteria:

* pathological fractures
* conservative treatment
* soft tissue damage
* delay of surgery more than three days
* immunological defects
* multiple trauma

Primary outcomes:
measure: microcirculation of the caput humeri
timeFrame: during surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: RWTH Aachen University Hospital
state: Nordrheinwestfalen
Study officials:
affiliation: Dpt. of Orthopedic Trauma, RWTH Aachen University
name: Hans-Christoph Pape, Univ.-Prof MD
role: STUDY_CHAIR
References:
Clinical trial NCT01869985: Partial Replicated Crossover Clinical Study to Compare Pharmacokinectic Characteristics of Eperisone Hydrochloride and Aceclofenac With HCP1104 Treatment to Those of Co-administration of Eperisone Hydrochloride 50mg Tablet and Aceclofenac 100mg Tablet in Healthy Adult Male Volunteers
Official title: A Randomized, Open-label, Single Dose, 3-sequence and 3-period Partial Replicated Crossover Clinical Study to Compare Pharmacokinectic Characteristics of Eperisone Hydrochloride and Aceclofenac With HCP1104 Treatment to Those of Co-administration of Eperisone Hydrochloride 50mg Tablet and Aceclofenac 100mg Tablet in Healthy Adult Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: HCP1104
Eperisone Hydrochloride
Aceclofenac
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2013-06-05
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1104 and Eperisone Hydrochloride plus Aceclofenac.

Detailed description: The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1104 and Eperisone Hydrochloride plus Aceclofenac.

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers, age between 20 and 45
* BMI of \>20kg/m2 and \<28kg/m2 subject
* Informed of the investigational nature of this study and voluntarily agree to participate in this study

Exclusion Criteria:

* Use of any prescription medication within 14 days prior to Day 1
* Use of any medication within 7 days prior to Day 1
* Participation in another clinical study within 60 days prior to start of study drug administration

Primary outcomes:
measure: Area Under Curve(AUC) last
timeFrame: 0, 20, 40min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24h hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT00062985: Obesity Treatment in a Managed Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
Keywords: obesity treatment
weight management
managed care
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2003-06-19
Enrollment: 1801
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 aim of the present study is to evaluate the effectiveness of two different delivery formats for weight management in a managed care setting. Mail-based weight counseling and phone-based weight counseling will be compared to each other and a control condition. Primary outcomes are participation rates in programs, weight change, and cost.


Eligibility criteria: * at least 18 years of age
* BMI ≥ 27.8 kg/m2 for men
* BMI ≥ 27.3 kg/m2 for non-pregnant or lactating women

Primary outcomes:
measure: Change in body weight
timeFrame: 6 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota, Division of Epidemiology
state: Minnesota
Study officials:
affiliation: University of Minnesota, Division of Epidemiology
name: Robert W. Jeffery, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeffery RW, Sherwood NE, Brelje K, Pronk NP, Boyle R, Boucher JL, Hase K. Mail and phone interventions for weight loss in a managed-care setting: Weigh-To-Be one-year outcomes. Int J Obes Relat Metab Disord. 2003 Dec;27(12):1584-92. doi: 10.1038/sj.ijo.0802473.
Clinical trial NCT03107585: Intermediate Cervical Block Under Ultrasound for Thyroid Surgery: Impact on Per and Postoperative Opioid Consumption
Official title: Bilateral Intermediate Cervical Plexus Block Under Ultrasound for Thyroid Surgery: Impact on Perioperative Opioid Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Local Anesthesia
Analgesia Disorder
Keywords: cervical plexus block
thyroidectomy
opioid consumption
Lead sponsor: University Hospital, Mahdia
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators included prospectively 35 patients undergoing an intermediate cervical block under ultrasound (GP1) before a thyroidectomy ,compared to a group of 35 patients without a block (GP2).

Detailed description: The investigators performed prospective trial with 70 patients randomized in two groups each of 35:

* Group 1 (GP1): bilateral echo-guided intermediate cervical plexus bloc (ICB) by 10 ml of isobaric Bupivacaine (0.25%).
* Group 2 (GP2): control.

Ten minutes after ICB, general anesthesia was realised. Total dose of Remifentanil is calculated upon awakening, the postoperative pain is determined by visual analog scale from 0 to 10 (VAS) statements to H0, H2, H4, H6, H12 and H24. Whenever VAS is greater than or equal to 4, a morphine titration was administered.

Total dose consumption, side effects and satisfaction are noted at the end of protocol.

Eligibility criteria: Inclusion Criteria:

* candidate for thyroidectomy
* reoperation l

Exclusion Criteria:

* no consent
* BMI\> 34
* allergy to any of the products used
* reoperation

Primary outcomes:
measure: peroperative opioid consumption
timeFrame: opioid consumption during surgery
Secondary outcomes:
measure: postoperative opioid consumption
timeFrame: first 24 hours after surgery
Other outcomes:
Locations:
city: Mahdia
country: Tunisia
facility: Mahdia University Hospital
Study officials:
affiliation: tunisian ministery of health
name: ali majdoub, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02499185: Study Evaluating Novel Biomarkers of AKI (Acute Kidney Injury) in Post-operative Patients
Official title: A PILOT Study Evaluating Novel Biomarkers of AKI in Post-operative Patients Undergoing Major Intra-Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Kidney Injury
Arterial Hypertension
Obesity
Cardio Vascular Disease
Diabetes Mellitus
Chronic Liver Disease
Hypercholesterolemia
Keywords: Biomarker
Intra Abdominal Surgery
AKI
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2015-07-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To validate the use of \[TIMP-2\]●\[IGFBP-7\] to predict AKI in patients undergoing major intra abdominal surgery.

Detailed description: A prospective pilot single center study to investigate the potential of \[TIMP-2\].\[IGFBP-7\] to predict AKI (Acute Kidney Injury) in patients undergoing major abdominal surgery. The investigators will measure the biomarker once preoperatively and 4-times postoperatively starting at arrival on PACU (post anesthesia care unit).The primary endpoint of this study is the development of AKI stage 2 or 3 within the first 72 postoperative hours.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years
* High risk patients: General Surgery AKI Risk Index Class III, IV or V
* Major abdominal surgery

Exclusion Criteria:

* Ongoing acute kidney injury Stage 2/3
* History of kidney transplant

Primary outcomes:
measure: Number of participants diagnosed with AKI stage 2 or 3 using the updated rifle "KDIGO" guidelines
timeFrame: 72 Hours
Secondary outcomes:
measure: Number of participants who need renal replacement therapy
timeFrame: 30 Days
Other outcomes:
measure: 30-day mortality
timeFrame: 30 days
measure: persistence of renal dysfunction at 30 days
timeFrame: 30 days
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussels
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Lien Torisaen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Brussel
name: Jan Poelaert, Prof.Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT05706285: Comparing Intrathecal Morphine With Erector Spina Plane Block in Open Gastrectomy Surgery
Official title: Comparing Postoperative Analgesic Effects of Intrathecal Morphine With Erector Spina Plane Block in Open Gastrectomy Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Use
Post Operative Pain
Pain Assessment Scales
Keywords: erector spina plane block
intrathecal morphine
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years old undergoing open gastrectomy surgery in Marmara University Training and Research Hospital

Brief summary: Open gastrectomy causes severe postoperative pain due to wide surgical incisions, retraction of the abdominal wall and direct manipulation of the visceral organs. It leads to delayed postoperative recovery, increased medical expenses and poor surgical outcomes. Epidural analgesia, intrathecal morphine and patient-controlled analgesia are frequently used in the postoperative pain management of abdominal surgeries. Intrathecal morphine is applied as a standard protocol in many centers due to its ease of application and effective pain control. However; it has undesirable effects such as postoperative nausea-vomiting, itching and most importantly respiratory depression. Regional interfascial plane blocks, such as erector spina plane block, have recently been popular in clinical practice to provide postoperative pain control. Erector spina plane block, when placed preoperatively, is expected to reduce opioid consumption and improve outcomes. The primary implication of this study is to compare postoperative pain scores and opioid consumption. It is also aimed to compare the effectiveness of Numeric Rating Scale and Clinically Aligned Pain Assessment Tool used in postoperative pain assesment.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old
* Patients undergoing open gastrectomy surgery

Exclusion Criteria:

* Patients with solid organ dysfunction
* Patients who receive opioid or corticosteroid medication prior to surgery
* Patients with bleeding diathesis
* Patients with psychiatric disorders
* Patients who can not be contacted after surgery

Primary outcomes:
measure: Postoperative pain assessment with Numeric Rating Scale (NRS)
timeFrame: 48 hours
measure: Postoperative pain assessment with Clinically Aligned Pain Assessment (CAPA) Tool
timeFrame: 48 hours
measure: Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device
timeFrame: 48 hours
Secondary outcomes:
measure: Comparison of the frequency of treatment related complications
timeFrame: 48 hours
measure: Participant satisfaction
timeFrame: 48 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine
Study officials:
References:
Clinical trial NCT00806585: Dose-ranging Study to Evaluate the Effectiveness and Tolerability of MK0736 in Patients With Type 2 Diabetes Mellitus (T2DM) and Hypertension (0736-007)
Official title: A Worldwide, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy & Tolerability of MK0736 When Added to Ongoing Therapy With Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) in Patients With T2DM and Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Hypertension
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-12-11
Enrollment: 620
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: TREATMENT

Brief summary: The study will assess the efficacy and tolerability of MK0736 in patients with Type 2 Diabetes Mellitus and Hypertension who are on ongoing therapy with Angiotensin-Converting Enzyme or Angiotensin Receptor Blocker. After a 3 to 5 week pre-randomization phase, patients will be randomized to either MK0736 (3 doses), placebo, or hydrochlorothiazide (HCTZ). The study will also include a 3 week, posttreatment follow-up period.


Eligibility criteria: Inclusion Criteria:

* Must be 18 to 75 years of age
* Type 2 Diabetes Mellitus (Glycohemoglobin \[A1CHbA1c\]: 7 to 10%)
* Hypertension: Diastolic blood pressure (DBP; 85 to 99 mm Hg) and systolic blood pressure (SBP; 120 to 159 mm Hg)
* LDL-C \< 140 mg/dL
* On stable treatment with an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB)

Exclusion Criteria:

* History of Type I Diabetes mellitus or ketoacidosis
* Patients taking 3 or more blood pressure lowering medications
* Have severe chronic heart failure
* History of certain diseases or conditions such as cardiac arrhythmias, heart attack, stroke, unstable angina, or decompensated vascular disease
* History of cancer within the last 5 years
* Human immunodeficiency virus (HIV) Positive
* Have received treatment with any investigational drugs within the past 30 days
* History of alcohol or drug abuse within the past 3 years
* Body Mass Index ( BMI) \>= 41 kg/m2

Primary outcomes:
measure: Change From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Sitting Systolic Blood Pressure (SiSBP) at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Body Weight at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05239585: Remote EEG Device for Identification of Risk for Neonatal Seizures
Official title: Pilot Study on the Use of a Wearable Remote Electroencephalography Device to Identify Neonates at Risk for Neonatal Seizures and Status Epilepticus
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Neonatal Encephalopathy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 0
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to see if the use of wireless brain wave monitoring can be helpful for newborns and help their medical providers identify seizures earlier and to monitor for the risk for seizures.

Detailed description: Our goals are to evaluate the effectiveness of the Epilog device in identification of neonates who are at risk for seizures and need formal EEG monitoring or cooling. The current process for these patients would be transfer from Rochester Methodist Hospital to the St. Mary's level 3 NICU for EEG monitoring. Given that in case of neonatal encephalopathy, there is 6-hour window in which to make the critical decision of whether to initiate therapeutic hypothermia or not, rapid access to EEG data is crucial. We would like to perform a pilot study on use of wireless EEG technology in neonates with mild neonatal encephalopathy and neonates with spells to see if this device can be used to determine the risk for neonatal seizure and need for escalation of care and full scalp EEG.

Eligibility criteria: Inclusion Criteria:

* Age 28 days old or less (postnatal age)
* Neonatal encephalopathy as judged by clinical team or symptoms concerning for subtle seizures
* Patient currently in level 1 newborn nursery or level 2 or 3 NICU

Exclusion Criteria:

* Medical comorbidity which would result in prolonged need for sedation
* Prolonged EEG monitoring is medically indicated

Primary outcomes:
measure: Evaluate the effectiveness of the Epilog device in identification of neonates who are at risk for seizures and need formal EEG monitoring or cooling
timeFrame: Approximately 2 to 72 hours
measure: Evaluate time to formal long-term EEG monitoring in neonates monitored with the Epilog device compared to a historical control cohort of neonates undergoing EEG evaluation.
timeFrame: Approximately 2 to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Anthony L Fine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03380585: Postoperative Pain and PTN and Reciproc
Official title: Postoperative Pain Assessment After Foraminal Enlargement Using Protaper Next and Reciproc File Systems.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apical Periodontitis
Dental Pulp Necrosis
Lead sponsor: Isparta Military Hospital
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this clinical trial, the researchers will investigate the effect of single-file reciprocating file system (Reciproc) versus multi-file rotational file systems (ProTaper Next) on the postoperative pain in adult patients who have necrotic pulp and apical periodontitis. The participants will be assigned by chance to separate groups that compare 2 different treatments, reciprocating single-file system (Reciproc) and rotational multi-file system (ProTaper Next).

Detailed description: The infected root canal treatments will be performed using one-visit approach with either a reciprocating single-file system or a continuous rotational multi-file system. Foraminal enlargement will be perfomed using either Reciproc or ProTaper Next file systems. The root canals will be completed in single-visit. The patients will record their postoperative pain during the follow-up period using a VAS scale.

Eligibility criteria: Inclusion Criteria:

Participants who have in their mandibular or maxillary molar teeth necrotic pulp and apical periodontitis.

Exclusion Criteria:

Pregnancy, drug hypersensitivity, cardiac problems, previously performed endodontics treatment.

Primary outcomes:
measure: 4-step pain intensity measures using a Visual Analog Scale (VAS).
timeFrame: 7 days
Secondary outcomes:
measure: The number of patients taking an analgesic following the endodontics treatment.
timeFrame: 7 days
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Isparta Military Hospital
Study officials:
affiliation: Isparta Military Hospital
name: Ibrahim E YAYLALI, PhD
role: STUDY_DIRECTOR
References: