louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01595711: Prediction of Chronic Pain by the Pain Monitor
Official title: Prediction of the Occurrence of Chronic Pain After Thoracotomy by Measuring Preoperative Skin Conductance (Pain Monitor Device)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Surgery
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2012-05-10
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo a lung surgical procedure (thoracotomized patients)

Brief summary: The skin conductance algesimeter (Pain Monitor™, Med-Storm Innovation AS, NO-0264 Oslo, Norway)) reflects the sympathetic nervous system by the measurement of the skin conductance of the palm of the hand. SCA detects nociceptive pain fast and continuously, specific to the individual, with higher sensitivity and specificity than other available objective methods.

The skin conductance response to a calibrated noxious stimulus varies among patients. It defines two types of people depending on its magnitude.

The investigators assume that the importance of skin conductance response to a noxious stimulus predicts the occurrence of chronic pain in patients operated by thoracotomy.


Eligibility criteria: Inclusion Criteria:

* adult patients of both sexes
* planned pulmonary resection for cancer performed by a posterolateral thoracotomy
* thoracic epidural analgesia

Exclusion Criteria:

* pregnancy,
* morbid obesity,
* insulin-dependent diabetes with dysautonomia,
* inability to proceed with anesthesia using the BIS signal,
* known allergy to remifentanil, propofol, atracurium or to levobupivacaine,
* contra-indication to nefopam
* contra-indication to ketoprofen

Primary outcomes:
measure: Prediction of chronic pain
timeFrame: one year after surgery
Secondary outcomes:
measure: Prediction of the postoperative pain
timeFrame: 5 days postoperatively
measure: Prediction of the postoperative antalgic requirement
timeFrame: 5 days postoperatively
measure: Prediction of the postoperative antalgic requirement by the genetic study
timeFrame: One year after surgery
measure: Effect of remifentanil on skin conductance
timeFrame: One hour after anesthesia
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
state: Ile De France
city: Strasbourg
country: France
facility: CHU Strasbourg
Study officials:
affiliation: Hopital Foch
name: Morgan Le Guen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Storm H. Changes in skin conductance as a tool to monitor nociceptive stimulation and pain. Curr Opin Anaesthesiol. 2008 Dec;21(6):796-804. doi: 10.1097/ACO.0b013e3283183fe4.
Clinical trial NCT05978011: 2014TP001 - Assessing the Biology of the Injured Lung - Version 1
Official title: Assessing the Biology of the Injured Lung - Version 1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Diseases
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2023-08-07
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Respiratory disorders - lung transplantation

Brief summary: Respiratory diseases are very common and are the third leading cause of death in England. As such, there is strong interest in understanding how respiratory disease occurs.

This study intends to understand the changes that occur within diseased/injured lungs obtained from humans. The end goal of this will be to create new drugs to help treat these disorders.

Diseased lungs will be obtained from patients receiving a lung transplant. Lungs will either be placed onto a heart-lung machine, or surgically cut in order to create a model of the lung that can be used experimentally in the laboratory. Using a heart-lung machine, lungs can be maintained outside of the human body for a maximum of 12 hours, allowing the direct assessment of the organ. Using this procedure, we aim to understand the processes that occur within a disease, as well as during repair. Using the model of the lung, we will look at how the body's immune system interacts within a diseased lung.


Eligibility criteria: Inclusion Criteria:

* Patients must be able to provide informed consent
* Patients must be aged between 18-80 years of age

Exclusion Criteria:

-Patients under 16 or over 70 years of age

Primary outcomes:
measure: To identify the mechanisms that occur during lung inflammation, injury and repair and the contribution of immune cells to these processes.
timeFrame: Prior to lung transplantation.
Secondary outcomes:
measure: Characterise the migration and functional profile of immune cells within the inflamed/damaged lung.
timeFrame: Prior to lung transplantation
measure: Assess the effectiveness of therapeutic agents that can repair lung damage.
timeFrame: Prior to lung transplantation
measure: Trial therapeutic agents that can modulate the effect of immune cells in response to lung tissue injury.
timeFrame: Prior to lung transplantation
measure: Identify new therapeutic targets/agents that can reduce the incidence/severity of inflammatory respiratory conditions.
timeFrame: Prior to lung transplantation
measure: Cut sections of the lung to culture in an in vitro lung model to assess the effect of various different mechanisms of injury on the function and characteristics of immune cells.
timeFrame: Prior to lung transplantation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00463411: Study of Male Osteoporosis and Aging
Official title: Study on Male Osteoporosis and Aging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Keywords: osteoporosis
male
fracture risk
genetical epidemiology
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
name: AP Moeller Foundation
First posted: 2007-04-20
Enrollment: 30000
Sex: MALE
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: NATURAL_HISTORY
Time perspective: PROSPECTIVE

Brief summary: The aim of this study is to identify potential risk factors for fragility fractures in men.

Detailed description: Osteoporosis is a disease characterized by decreased bone mass and pathological changes in the microarchitecture of the bones. The clinical significance of osteoporosis is the association with fragility fractures and, consequently, increases in both morbidity and mortality.

In men, genetical and life-style factors are known to affect the risk of fractures, however, data relating these factors with measures of bone mineral density and fracture risk are limited.

30.000 men aged 60-70 were randomly selected from the Central Office of Civil Registration in Denmark. Each receive a questionnaire addressing demographics, potential risk factors of osteoporosis, past medical history and medication by mail. In case of consent, the participants will complete a full medical examination including DXA and sampling of DNA if they have a fragility fracture. At the same time, 2 participants from the study population will be selected as control. The study period is 10 years.

Eligibility criteria: Inclusion Criteria:

* Men aged 60-70 being able to consent in writing

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Endocrinology
Study officials:
affiliation: Odense University Hospital
name: Kim T Brixen, MD. Ph.d
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05296811: Lateral Arm Free Flap for Reconstruction of the Oral Cavity and Head and Neck Soft Tissue Defects.
Official title: Lateral Arm Free Flap for Reconstruction of the Oral Cavity and Head and Neck Soft Tissue Defects.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oral Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 15
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The excision of oral cancers causes extensive impairment of the oral cavity soft tissue. Complete excision of the tumors is vital, and the reconstruction of the resected area influences not only the postoperative recovery period of patients but also physiological functions such as swallowing, phonation function ,daily activities and psychosocial impact.

Oral and maxillofacial surgeons are faced with the task of reconstructing the affected area to reduce these problems as much as possible.

In 1982, Song introduced the lateral arm flap (LAF). Since this time, its used in surgical repairs of oral defects, But the specific subject of publications generally restricted to a small number of cases.

LAF is a thin and pliable flap with consistent anatomy and a high success rate. It is also claimed that there is no risk of vascular compromise to the arm

Detailed description: reconstruction of oral , head and neck defects with Lateral Arm Free Flap

Eligibility criteria: Inclusion Criteria:

1. All patients post glossectomy.
2. Patients post maxillectomy with malignant maxillary swelling with no distant metastases.
3. All patients which defect after surgery for head and neck neoplasia.

Exclusion Criteria:

* 1. Small defect post excision can be closed directly 2. medically unfit patients

Primary outcomes:
measure: Early detection of recurrence
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Assiut University
name: hassan harby
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nahabedian MY, Deune EG, Manson PN. Utility of the lateral arm flap in head and neck reconstruction. Ann Plast Surg. 2001 May;46(5):501-5. doi: 10.1097/00000637-200105000-00008.
Clinical trial NCT01034111: A Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178)
Official title: An Open-label Study to Assess the Safety and Tolerability of JANUVIA (Sitagliptin) in 30 Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-12-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess, over a 4-week treatment period, the safety and efficacy of the addition of sitagliptin to metformin in participants with type 2 diabetes mellitus (T2DM) who failed to achieve glycemic control on metformin monotherapy.


Eligibility criteria: Inclusion Criteria:

* Participants with T2DM failing metformin monotherapy
* Between the ages of 18 and 79

Exclusion Criteria:

* Participants has a history of type 1 Diabetes Mellitus or ketoacidosis

Primary outcomes:
measure: Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment
timeFrame: 4 weeks
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose at Week 4
timeFrame: Baseline and Week 4
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00817011: Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness
Official title: Phase 4 Study of Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Antidepressant Drug Adverse Reaction
Keywords: depression
pharmacogenomics
antidepressant response
biological markers
clinical variables
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2009-01-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Purpose of this study is to predict antidepressant response in advance using pharmacogenomics and peripheral biological markers in depressed patients.

Detailed description: The difficulties to treat depressed patients are 1)the patients don't respond to antidepressant is about 40% of which, and 2) The time lag is existed until the patients respond to antidepressant and show the treatment effects.

If it is predicted the response of antidepressant in advance, it would be overcome such problems. Drug response generally is known to be related to the individual genetic information and the environmental factors. We are going to investigation about antidepressant response using these approaches.

Eligibility criteria: Inclusion Criteria:

1. 25 \< age \<85
2. major depressed patients satisfied with the diagnosis criteria depression of DSM-IV
3. interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians

Exclusion Criteria:

1. received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks
2. potential study participants for pregnancy, significant medical conditions, abnormal laboratory baseline values, unstable psychiatric features(eg.suicidal), history of alcohol of drug dependence, seizures, head trauma with loss of consciousness, neurological illness, or concomitant Axis I psychiatric disorder.

Primary outcomes:
measure: all pharmacogenetic and biological marker variables cause drug response
timeFrame: 24weeks
Secondary outcomes:
measure: all clinical cause drug response
timeFrame: 24weeks
Other outcomes:
Locations:
city: Kangnam
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul
Study officials:
affiliation: Samsung Medical Center
name: Doh Kwan Kim, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00147511: Time To Efficacy and Onset Of Action Of Linezolid
Official title: Time To Efficacy and Onset Of Action Of Linezolid In Skin and Soft Tissue Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gram-Positive Bacterial Infections
Skin and Connective Tissue Diseases
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-07
Enrollment: 118
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: To assess the onset of action of linezolid


Eligibility criteria: Inclusion Criteria:

* suspected grampositive infection
* fever \> 38 C

Exclusion Criteria:

* Infections to be treated successfully by surgical procedures

Primary outcomes:
measure: Time to defervescence
Secondary outcomes:
measure: Reduction of CRP levels Reduction of leucocyte count
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02977611: The Safety of a High-Dose, Rapid Infusion of Iron Sucrose
Official title: The Safety of a High-Dose, Rapid Infusion of Iron Sucrose in a Non-Dialysis Dependent Population
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Iron Deficiency
Lead sponsor: The Guthrie Clinic
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Iron sucrose infusion is an iron replacement used to treat iron deficiency anemia (not enough iron in the body to make hemoglobin). Iron is a mineral that the body needs to produce hemoglobin, which carries oxygen in the blood. When the body does not get enough iron, it cannot produce enough hemoglobin and you become anemic.

The research study is looking at the side effects of using a higher dose and faster rate of iron sucrose infusion than what is used in standard of care. The purpose of this study is to see if infusion with 500 mg of iron sucrose over a one hour time period can be done safely. If this can be done safely, it may reduce the total number of infusions required and the time for each infusion. This may be less costly and less burdensome to patients.


Eligibility criteria: Inclusion Criteria:

* Any patient requiring iron infusion

Exclusion Criteria:

* Patients will be excluded from enrollment if they are under the age of 18, unable to give signed consent, are pregnant, have end-stage renal disease, are on hemodialysis (HD), or have a history of clinically significant adverse reactions to iron sucrose.

Primary outcomes:
measure: incidence of adverse events in the study population attributed to drug administration.
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sayre
country: United States
facility: Robert Packer Hospital
state: Pennsylvania
Study officials:
affiliation: The Guthrie Clinic
name: Bradley Lash, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01304511: Post-Marketing Surveillance of the Safety and Efficacy of Orgalutran (Ganirelix)®
Official title: Post-Marketing Surveillance Orgalutran (Ganirelix)®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fertilization in Vitro
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2011-02-25
Enrollment: 711
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing COH for ART

Brief summary: The purpose of this post-marketing surveillance is to identify problems and questions regarding the safety and efficacy of Orgalutran (Ganirelix)® when used for the prevention of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).


Eligibility criteria: Inclusion Criteria:

* Must be undergoing COH for ART

Exclusion Criteria:

* Hypersensitivity to the active substance or to any of the excipients
* Hypersensitivity to gonadotropin-releasing hormone (GnRH) or any other GnRH analogue
* Moderate or severe impairment of renal or hepatic function
* Pregnancy or lactation

Primary outcomes:
measure: Number of retrieved oocytes by COH based on Per stage approach
timeFrame: Baseline to End of Study
measure: Number of Serious Adverse Events
timeFrame: Baseline to End of Study
measure: Number of Unlabeled (Unexpected) Adverse Drug Reactions
timeFrame: Baseline to End of Study
measure: Number of Labeled Adverse Drug Reactions
timeFrame: Baseline to End of Study
measure: Number of Non-serious Adverse Events
timeFrame: Baseline to End of Study
measure: Number of Adverse events by drug misuse/abuse or drug-drug interaction
timeFrame: Baseline to End of Study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06222411: Leadership Training Affect Physician Career Satisfaction
Official title: Does Leadership Training Affect Physician Career Satisfaction?
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Leadership
Personality
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of the study is to evaluate the impact of organizational interventions for physician development on wellbeing, and investigate wellbeing and other characteristics of physicians with and without formal leadership roles.

Detailed description: 1. Compare the incidence of job satisfaction, stress, and burnout overall between physicians who have undergone some sort of leadership training and those who have not.
2. Compare the incidence of job satisfaction, stress, and burnout overall between physicians with and without formal leadership roles.
3. Determine additional factors associated with job satisfaction, stress, and burnout levels.
4. Evaluate intrinsic and extrinsic motivating factors associated with physicians currently in formal leadership roles and those interested in pursuing formal leadership roles in the future.
5. Determine whether more satisfied physicians seek leadership roles or whether seeking leadership roles leads to greater satisfaction.

Eligibility criteria: Inclusion Criteria:

* Age: ≥18 years
* Be a current licensed physician practicing at Methodist Health System( MHS )
* Literate in English
* Able and willing to provide consent

Exclusion Criteria:

* \<18 years of age
* Not a current licensed physician at MHS
* Illiterate in English
* Unable or unwilling to provide consent

Primary outcomes:
measure: Number of incidence
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Clinical Research Institute at Methodist Health System
state: Texas
Study officials:
References: