louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01332409: Special Drug Use Investigation for ADOAIR DISKUS COPD (Salmeterol and Fluticasone)
Official title: Special Drug Use Investigation for ADOAIR DISKUS COPD (Salmeterol and Fluticasone)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-04-11
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are diagnosed as having a chronic obstructive pulmonary disease (bronchitis chronic / emphysema)

Brief summary: To investigate possible problems or questions in safety and effectiveness of salmeterol and fluticasone in patients with chronic obstructive pulmonary disease (bronchitis chronic / emphysema). In this special drug use investigation, onset of pneumonia shall be handled as the priority investigation item.


Eligibility criteria: Inclusion Criteria:

* Must use salmeterol and fluticasone for the first time

Exclusion Criteria:

* Patients with hypersensitivity to salmeterol and fluticasone
* Patients with infection which salmeterol and fluticasone is not effective
* Patients with deep mycosis

Primary outcomes:
measure: The incidence of adverse events in Japanese patients treated with salmeterol and fluticasone based on prescribing information under the conditions of general clinical practice.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Yoriko Morioka, Hiroharu Abe, Terufumi Hara, Pascal Yoshida. Post-marketing Surveillance of Salmeterol Xinafoate / Fluticasone Propionate (Adoair®250Diskus®) - Interim Report -. Resp Med - Kokyuki Naika. 2013;23(1):111-122.
Clinical trial NCT02824809: Association Between Testosterone Levels and COPD Severity
Official title: Association Between Testosterone Levels and COPD Severity Measured by BODE Index in Men
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Hypogonadism
Keywords: hypogonadism
Chronic Obstructive Pulmonary Disease
Severity of Illness Index
Testosterone
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
Collaborators: name: Asociacion Argentina Medicina Respiratoria (AAMR)
First posted: 2016-07-07
Enrollment: 150
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients with stable COPD that consult in a tertiary academic teaching hospital in Buenos Aires, Argentina

Brief summary: The Aims of the study are estimate the association between the severity of COPD and free testosterone level and the prevalence of hypogonadism in adult men with stable COPD


Eligibility criteria: Inclusion Criteria:

* Adults Men ≥ 45 years
* COPD defined according to clinical diagnosis and spirometry American thoracic society ( ATS) criteria
* Stable COPD without recent acute exacerbation (less than 2 weeks)

Exclusion Criteria:

* Refusal to participate or informed consent process
* Those who are under treatment with testosterone replacement or anti-androgens
* Comorbidities: Cirrhosis, Alcoholism, cryptorchidism, panhypopituitarism, Pituitary adenoma.
* Orchiectomy
* Systemic glucocorticoids (equivalent dose ≥ 4 mg of prednisone in the last 3 weeks).
* Relative and absolute contraindications for spirometry.

Primary outcomes:
measure: Free testosterone Level
timeFrame: One day
Secondary outcomes:
measure: Prevalence of Hypogonadism
timeFrame: One day
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Buenos Aires
Study officials:
affiliation: HIBA, Buenos Aires Argentina
name: Horacio M Castro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00623909: Laser Therapy in the Treatment of Post Thoracotomy Pain; A Pilot Study
Official title: Laser Therapy in the Treatment of Post Thoracotomy Pain; A Pilot Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Laser Therapy
Post Thoracotomy Pain
Keywords: Laser Therapy
Post Thoracotomy Pain
AvicennaTM laser
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2008-02-26
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the safety of the AvicennaTM class IV laser for application over the skin of human subjects. In addition, we seek to measure the effectiveness and utility of this class 4 laser therapy in the treatment of post-thoracotomy pain syndrome.

Detailed description: This study was terminated prior to enrollment and closed.

Eligibility criteria: Inclusion Criteria:

* Men and women age 25-65 years old with chest wall pain after lung surgery lasting more than 2 months after surgery.
* Subjects shall have failed conservative treatment which may include rest, physical therapy, braces, and over the counter anti-inflammatory medications. All those enrolled will be native English speakers and have at least a high school degree

Exclusion Criteria:

* Subjects will be excluded if they are pregnant (which will be confirmed by a urine pregnancy test if they are of childbearing age)
* Have previous history of other pain syndromes or psychiatric disorders.
* We will exclude the morbidly obese (BMI \>30) because the laser may not be able to penetrate deep enough through adipose tissue. In addition, subjects who have had previous back surgery, or are on antidepressants for the treatment of depression in the preceding 6 weeks will be excluded as these may represent potential confounding factors.

Primary outcomes:
measure: The McGill pain questionnaire
timeFrame: 6 Treatments/6 Weeks
Secondary outcomes:
measure: The visual analog scale
timeFrame: 6 Weeks
measure: An infrared thermometer will measure skin temperature before and after the treatment
timeFrame: 6 Treatments/6 Weeks
measure: A 4-point Likert scale (none, mild, moderate, and severe) will be used to document skin redness.
timeFrame: 6 Treatments/6 Weeks
measure: A 4-point Likert scale (none, mild, moderate, and severe) will be used to document skin tenderness
timeFrame: 6 Treatments/6 Weeks
measure: At the end of the study patients will rate their satisfaction with the treatment using an 11 point Likert scale where 0 means completely dissatisfied and 10 means completely satisfied.
timeFrame: 6 Treatments/6 Weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College/New York Presbyterian Hospital
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Edward Rubin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05924009: Characterization of Gastric Evoked Potentials
Official title: Characterization of Gastric Evoked Potentials
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2023-06-29
Enrollment: 155
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is an exploratory study that will determine and standardize how best to record gastric evoked potentials (GEPs) elicited by a non-invasive method of brain stimulation (Transcranial Magnetic Stimulation, TMS), by optimizing the TMS parameters and cortical sites necessary to evoke GEPs.

Detailed description: The overall goal of this exploratory study is to determine the optimal conditions to elicit gastric evoked potentials (GEPs) with Transcranial Magnetic Stimulation (TMS).

Aim 1: Determine the optimal stimulation parameters and the optimal location for eliciting GEPs in cortical motor areas.

Aim 2: Determine whether various modes of repetitive TMS (rTMS) neuromodulation targeted to GEP hotspots shape gastric motor responses to a water load.

The investigators will record some clinical, demographic, and autonomic data (i.e. EKG) in our enrolled subjects. Secondary analyses will use these variables as covariates to investigate any systematic impact on the measures from Aims 1 and 2.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* psychosis or altered cognitive status
* history of head injury, metal in the skull, stroke, or a history of seizures, loss of consciousness or syncope
* implantable devices, such as a pacemaker or nerve stimulator
* current use of antiepileptic medications or current use of the following medications or substances which are known to lower the seizure threshold: Clozapine (Clozaril), Chlorpromazine (Thorazine), amphetamines or methamphetamine, Ecstasy, Ketamine, Angel Dust/PCP, cocaine, or 3 or more alcoholic drinks per day
* pregnancy
* BMI \> 30
* history of bariatric surgery such as sleeve gastrectomy or Roux-en-Y gastric bypass
* diabetes
* suffering from a neurodegenerative disorder.

Primary outcomes:
measure: Change in GEP hotspot location
timeFrame: Multiple study sessions spanning up to 12 months
measure: Change in optimal stimulation parameters at GEP hotspot
timeFrame: Multiple study sessions spanning up to 12 months
Secondary outcomes:
measure: Effect of satiety
timeFrame: Multiple study sessions spanning up to 12 months
measure: Effect of neuromodulation
timeFrame: Multiple study sessions spanning up to 12 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: David J Levinthal, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03002909: Continuous Pre-peritoneal Wound Infiltration Versus Epidural Analgesia in Cancer Surgery
Official title: Effect of Continuous Pre-peritoneal Wound Infiltration Versus Epidural Analgesia on Inflammatory Response and Pain Following Radical Cytsectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Neoplasms
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-12-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: the investigators aim is to investigate the effect of continuous preperitoneal bupivacaine wound infiltration versus epidural analgesia on the inflammatory cytokines response following radical cytectomy


Eligibility criteria: Inclusion Criteria:

* ASA I-III patients
* aged 18-60 yr
* undergo open abdominal cancer surgery

Exclusion Criteria:

* general contraindications for epidural analgesia,
* recent history (8 weeks) of, chemotherapy or radiation,
* chronic opioid use

Primary outcomes:
measure: changes in the level of inflammatory cytokines in pg /ml
timeFrame: 24 hours
Secondary outcomes:
measure: Visual Analog Scale at rest and on coughing
timeFrame: 24 hours
measure: opioid side-effects
timeFrame: 24 hours
measure: patient satisfaction
timeFrame: 24 hours
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: South Egypt Cancer instIitute
Study officials:
affiliation: south Egypt cancer institute - assuit university
name: fatma el sherif, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of anesthesia, icu, and pain management
name: Ahmad M Abd El-Rahman, M.D
role: STUDY_DIRECTOR
References:
citation: Othman AH, Ahmed DG, Abd El-Rahman AM, El Sherif FA, Mansour S, Aboeleuon E. Effect of Preperitoneal Versus Epidural Analgesia on Postoperative Inflammatory Response and Pain Following Radical Cystectomy: A Prospective, Randomized Trial. Clin J Pain. 2019 Apr;35(4):328-334. doi: 10.1097/AJP.0000000000000679.
Clinical trial NCT01758809: Pain Control of Thoracoscopic Major Pulmonary Resection
Official title: Pain Control of Thoracoscopic Major Pulmonary Resection: Is Pre-emptive Local Bupivacaine Injection Able to Replace the Intravenous Patient Controlled Analgesia?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Video Assisted Thoracic Surgery
Postoperative Pain
Intravenous Patient Controlled Analgesia
Bupivacaine
Major Pulmonary Resection
Post Pulmonary Resection
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2013-01-01
Enrollment: 86
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether pre-emptive local bupivacaine injection is a better alternative pain control modality than the conventional intravenous patient controlled analgesia.

Detailed description: Despite less postoperative pain from Video Assisted Thoracic Surgery (VATS) than thoracotomy, pain is still an important issue in its recovery period. After VATS procedure, intravenous patient controlled analgesia (IV PCA) is being used for pain control. However, the side effects of IV PCA are nausea, vomiting, sleepiness, and urination difficulty which interrupt the early recovery. It is established that pre-emptive local bupivacaine injection is more economical, has almost no side effects, and finally, it is effective for the postoperative 24 hours. The purpose of this study is to evaluate whether pre-emptive local bupivacaine injection is a better alternative pain control modality than the conventional intravenous patient controlled analgesia.

Eligibility criteria: Inclusion Criteria:

* patients that are expected to receive VATS segmenectomy or lobectomy regardless of disease entity

Exclusion Criteria:

* not done by VATS anatomical resection
* patient does not agree to the study
* postoperative hospital stay exceeds 7 days due to postoperative complications
* existence of preoperative renal insufficiency (Cr \> 1.5)
* OT/PT \> 120
* history of Lidocaine hypersensitivity

Primary outcomes:
measure: The change in postoperative pain confirmed by Visual Analogue Pain Scale
timeFrame: Operation day, Postoperative Day 1, 2, 3 and 2 week, 1 month, 2 months
Secondary outcomes:
measure: number of participants with adverse events related to fentanyl or bupivacaine drug
timeFrame: 2 months
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Sanghoon Jheon, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Seoul National University Bundang Hospital
name: Hee Chul Yang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04412109: Optic Nerve Sheath Diameter Difference Between Different Injection Volume
Official title: Effect of Normal Saline Injection Volume on Epidural Pressure and Optic Nerve Sheath Diameter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Optic Nerve Sheath Diameter
Keywords: Optic Nerve Sheath Diameter, Different volume
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Valid method of indirect measurement of intracranial pressure is using optic nerve sheath diameter. Different volume of injection is known to affect the degree of increase of intracranial pressure.

This study is desinged to measure the changes of optic nerve sheath diameter and cerebral oxygenation when different volume of normal saline was injected.

Detailed description: Previous study showed that different volume of injections (1.0 ml/kg vs. 1.5 ml/kg) during caudal anesthesia showed siginifiant increase of optic nerve sheath diameter in group of high volumes. Increase of ICP can result in harmful effect including reduced cerebral flow and oxygen saturation. Also, increase of ICP can cause headache, syncope and transient loss of visual acuity. The proven and valid method of measuring ICP indirectly is using optic nerve sheath diameter.

This study was designed to examine the changes of optic nerve sheath diameter and cerebral oxygenation when different volume of normal saline was injected.

Eligibility criteria: Inclusion Criteria:

* lung cancer
* liver cancer
* stomach cancer
* pancreas cancer
* gallbladder cancer

Exclusion Criteria:

* coagulopathy
* infection
* previous spine fusion at thoracic level
* previous brain lesion causing increased intracranial pressure

Primary outcomes:
measure: optic nerve sheath change during 4 time period
timeFrame: Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention
Secondary outcomes:
measure: cerebral oxygenation change during 4 time period
timeFrame: Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Hong ji HEE
Study officials:
affiliation: Keimyung University
name: Ji Hee Hong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hong J, Kim JS, Lee YH. The Effect of Normal Saline Injection Volumes on the Optic Nerve Sheath Diameter during Thoracic Epidural Analgesia. Pain Physician. 2021 Nov;24(7):E1007-E1013.
Clinical trial NCT04785209: Mean Platelet Volume and STEMI Clinical Risk Scores in Prediction of Impaired Myocardial Perfusion In Acute STEMI Patients Undergoing Primary Percutaneous Coronary Intervention.
Official title: Mean Platelet Volume and STEMI Clinical Risk Scores in Prediction of Impaired Myocardial Perfusion In Acute STEMI Patients Undergoing PPCI.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: No-Reflow Phenomenon
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 640
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All STEMI patients presenting within 24 hrs of onset of symptoms

Brief summary: Predicting no reflow in ppci of STEMI patients using mean platelet volume together with STEMI clinical risk scores


Eligibility criteria: Inclusion Criteria:

* patients presenting with acute STEMI, within 24 hours of symptoms, fulfilling criteria for PPCI protocol in our facility

Exclusion Criteria:

* patients presenting more than 24 hours of symptoms onset
* patients not eligible for PPCI program in our facility

Primary outcomes:
measure: Number of participents with No reflow after PPCI and in hospital mortality
timeFrame: Within 48 hours from admission
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
Study officials:
affiliation: Assiut University
name: Hamdy Shams elddin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06993909: Clinical Approaches to Stretching Intensity in Post-Operative Knee Rehabilitation
Official title: Clinical Approaches to Stretching Intensity in Post-Operative Knee Rehabilitation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Physiotherapist
Keywords: Stretching
Post-Operative
Rehabilitation
Clinical Decision-Making
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Licensed physiotherapists in Türkiye with at least one year of clinical experience who have worked with post-operative knee rehabilitation patients within the past year.

Brief summary: This study aims to examine how physiotherapists determine stretching intensity during knee flexion exercises in post-operative rehabilitation. It will also explore professional and clinical factors influencing these decisions, with the goal of informing standardized rehabilitation protocols.

Detailed description: This study aims to comprehensively evaluate the approaches of physiotherapists actively involved in post-operative knee rehabilitation in determining stretching intensity during knee flexion exercises. It also seeks to identify the professional and clinical factors influencing these decisions. By revealing the variations between physiotherapists' perceptions and their actual clinical practices regarding stretching intensity, the study aims to contribute to the development of standardized clinical protocols and enhance the specificity of existing rehabilitation guidelines.

Eligibility criteria: Inclusion Criteria:

* Physiotherapists with at least 1 year of clinical experience
* Involved in post-operative knee rehabilitation in the past year
* Willing to participate voluntarily

Exclusion Criteria:

* Refusal to participate
* Incomplete or inconsistent questionnaire responses

Primary outcomes:
measure: Stretching Intensity in Post-Operative Knee Rehabilitation
timeFrame: At time of questionnaire completion (single time point)
Secondary outcomes:
Other outcomes:
Locations:
city: Atasehir
country: Turkey
facility: Acıbadem University
state: Istanbul
Study officials:
References:
Clinical trial NCT02697409: Education Against Tobacco Randomized Trial
Official title: Medical-student-delivered Smoking Prevention Program for Secondary Schools: The Education Against Tobacco Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tobacco
Prevention
Adolescents
Schools
Lead sponsor: University of Giessen
Sponsor class: OTHER
Collaborators: name: University Hospital Tuebingen
name: Universities of Giessen and Marburg Lung Center
First posted: 2016-03-03
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A two armed randomized trial is evaluating the effect of the medical-student-delivered school-based intervention Education Against Tobacco on the smoking behavior of adolescents in 7th grade of secondary school. The primary endpoint is the change in smoking prevalence between the two groups.


Eligibility criteria: Inclusion Criteria:

* Pupils of 7th grade of regular secondary schools in Germany

Exclusion Criteria:

* Not fulfilling the inclusion criteria

Primary outcomes:
measure: Smoking prevalence measured via questionnaire.
timeFrame: 24 months post baseline
Secondary outcomes:
measure: Relevant differences due to the theory of planned behaviour between the two groups measured via questionnaire.
timeFrame: 24 months follow-up
measure: Changes in smoking behavior
timeFrame: 24 months post baseline
Other outcomes:
Locations:
city: Bünde
country: Germany
facility: Titus Brinker
Study officials:
References: