louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00356083: Opioid Rotation From Morphine to Methadone in Treatment of Non-malignant Pain
Official title: Opioid Switching From Oral Slow Release Morphine to Oral Methadone May Improve Pain Control in Chronic Non-malignant Pain: a Nine-month Follow-up Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-malignant Chronic Pain
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2006-07-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with non-malignant pain are switched from morphine to methadone with a nine-months' follow-up.

Detailed description: Twelve patients with poor pain control or unacceptable side effects during treatment with morphine were switched to methadone and followed for nine months in this open prospective study. Primary outcomes were patient preference for opioid and pain control while physical, cognitive and role functioning were secondary outcomes. The morphine dose was decreased by 1/3 daily and was replaced with an equianalgesic dose of methadone over a three-day period. During switching and a one-week dose titration period, patients were given additional methadone if required. During dose titration one patient experienced sedation requiring naloxone. Four patients were switched back to morphine due to poor pain control, drowsiness or sweating. Seven patients preferred long-term (\>nine months) treatment with methadone and reported reduced pain and improved functioning while cognition was not improved. This study brings novel information on the long-term consequences for pain control, health-related quality of life and cognitive functioning with a switch from morphine to methadone in the treatment of chronic non-malignant pain.

Eligibility criteria: Inclusion Criteria:

* 18-70 years of age
* non-malignant chronic pain
* morphine use

Exclusion Criteria:

* addiction
* kidney disorders

Primary outcomes:
measure: pain
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Norwegian University of Science and Technology
name: Petter C. Borchgrevink, PhD MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian University of Science and Technology
name: Petter C Borchgrevink, MD PhD
role: STUDY_CHAIR
References:
citation: Fredheim OM, Borchgrevink PC, Hegrenaes L, Kaasa S, Dale O, Klepstad P. Opioid switching from morphine to methadone causes a minor but not clinically significant increase in QTc time: A prospective 9-month follow-up study. J Pain Symptom Manage. 2006 Aug;32(2):180-5. doi: 10.1016/j.jpainsymman.2006.02.010.
citation: Fredheim OM, Kaasa S, Dale O, Klepstad P, Landro NI, Borchgrevink PC. Opioid switching from oral slow release morphine to oral methadone may improve pain control in chronic non-malignant pain: a nine-month follow-up study. Palliat Med. 2006 Jan;20(1):35-41. doi: 10.1191/0269216306pm1099oa.
Clinical trial NCT01422083: Glenohumeral Internal Rotation Deficit (GIRD)
Official title: Correlation Between Loss of Internal Rotation Range of Motion and Size of the Subacromial Space and the Influence of a Home Stretching Program.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glenohumeral Internal Rotation Deficit (GIRD)
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
First posted: 2011-08-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A loss of mobility in the shoulder in direction of internal rotation is associated with shoulder tendon pathology. Cause-effect relationship between these two is still not clear. It is suspected that this loss of mobility reduces the size of the tunnel in which this shoulder tendon is lying, namely the subacromial space. Overhead athletes frequently show glenohumeral internal rotation deficit (GIRD) while being healthy and free of shoulder pain. This makes this population interesting to investigate. This study wants to look at shoulders of overhead athletes with GIRD and measure the size of the subacromial space. After this, the athletes will be instructed to perform a home stretching program and at the end the effect of this on mobility and the size of the subacromial space will be measured.60 athletes will be recruited and randomly allocated to the control group and the stretching group. Before they start stretching, subacromial space size will be measured by use of ultrasound. This is a safe and non-invasive measuring tool. Mobility will be measured by use of a digital inclinometer. This also is safe and non-invasive. Patients will be instructed a stretching exercise, which they will be performing at home once a day during 6 weeks. At the end all outcome measures will be reassessed.


Eligibility criteria: Inclusion Criteria:

* overhead athletes: at least 3 hours/week training
* male and female
* 18-30 years of age
* No shoulder pain during last 3 months for which a doctor was consulted
* No shoulder surgery
* No neck diseases

Exclusion Criteria:

-

Primary outcomes:
measure: Size of the subacromial space and shoulder mobility.
timeFrame: at 0 weeks
measure: Size of the subacromial space and shoulder mobility.
timeFrame: after 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Ann Cools, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03704883: Behavior of Cyclists in Response to Pain
Official title: Behavior of Cyclists in Response to Pain: a Qualitative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Sport Injury
Athletic Injuries
Keywords: Cycling
Endurance
Pain
Injury
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Club-level cyclists, recruited from a local bike shop, who have an injury and either have or have not sought medical attention.

Brief summary: A qualitative study, as a follow-up to an earlier study, that provides an opportunity to develop a deeper understanding of the injured cyclist's behavior related to seeking medical attention and endurance of pain. This study includes 10 club-level cyclists who have an injury and either have or have not sought medical attention.


Eligibility criteria: Inclusion Criteria:

* Have at least one year of cycling experience and will not compete in multi-sport events such as a triathlon.
* Have had an injury currently or in the recent past associated with biking and experiencing pain related to cycling injury(s).
* Must read and speak English.

Exclusion Criteria:

* Non-English speaking

Primary outcomes:
measure: Self-reported experience of cycling-related pain
timeFrame: Up to 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
Study officials:
affiliation: Allina Health
name: Marie C Lesiz, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06888583: Fixation of Unstable Sacral Fractures by Transpedicular System
Official title: Fixation of Unstable Sacral Fractures by Transpedicular System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fixation
Unstable Sacral Fractures
Transpedicular Sacral Fixation
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This prospective case series study was conducted on 21 patients with unstable sacral fractures at Tanta and Assiut University Hospitals from May 2022 to August 2024.

Brief summary: This research aimed to assess the role of the transpedicular Fixation system in the management of unstable sacral fractures in adults.

Detailed description: Pelvic ring disruptions are high-energy injuries with a significant impact on quality of life and higher levels of mortality. Unstable sacral fracture is an unusual injury, and even though many studies implicate the surgical intervention as the treatment of choice, the purposes of surgery on sacral fractures include pelvic ring reconstruction, lumbopelvic stability restoration, fracture healing, early mobilization, fracture displacement prevention and improving the neurological deficiency. More and more surgeons are advocating for surgical management in the treatment of sacral fractures, and open reduction internal fixation (ORIF) has demonstrated marked benefits over conservative treatment.

Eligibility criteria: Inclusion Criteria:

* Adult patients over 18 years old age.
* Both sexes.
* Unstable AO sacral fracture type B and type C.
* Patient fit for surgery and hemodynamic stable patient.
* Closed fracture.

Exclusion Criteria:

* AO sacral fracture type A.
* Bedridden before the trauma.
* Patient unfit for surgery.
* Open sacral fractures.
* Sacral fractures with massive morel-lavallee lesions.

Primary outcomes:
measure: Functional outcome
timeFrame: 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT01026883: Evaluation of a Novel Method for Hematocrit Level Determination
Official title: Evaluation of a Novel Method for Hematocrit Level Determination
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Keywords: hematocrit
layered resonant piezoelectric sensors
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-12-07
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The hematocrit level is defined as the ratio of plasma volume and red blood cell mass. Determination of this level is important for the diagnosis and follow-up of various hematological and renal disorders. In clinical practice, automated hematology analyzers are commonly used.

Recently, a new method for hematocrit level determination has been introduced which employs layered resonant piezoelectric sensors. In the present study this technique will be applied in blood samples of healthy subjects and compared to a standard laboratory method.


Eligibility criteria: Inclusion Criteria:

* Men and women aged between 18 and 80 years
* Men and women will be included in equal parts
* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

* Symptoms of a clinically relevant illness in the 3 weeks before the study day
* Systemic treatment with anticoagulants
* Intake of any medication that could lead to spurious hematocrit values
* Presence of any medical condition that could lead to spurious hematocrit values
* Blood or plasma donation during the previous 3 weeks

Primary outcomes:
measure: Correlation of hematocrit level determined by two different techniques
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
affiliation: Department of Clinical Pharmacology, Medical University of Vienna
name: Gerhard Garhofer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04081883: Biosensors for Open and Closed-loop Glycemia Control in T1D Patients With Insulin Pump
Official title: Decoding Islet Algorithms in Biosensors for Open and Closed-loop Glycemia Control in T1D Patients With Insulin Pump Coupled to Sensors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Continuous Glucose Monitoring
Biosensor
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 1
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: In T1D, the destruction of beta-pancreatic cells causes insulin deficiency and requires insulin therapy whose control remains complex: even with recent technologies of continuous measurement and monitoring of blood glucose (CGM), current systems are electrochemical, insulin therapy algorithms do not are not optimal and cannot completely eliminate vital risks such as hypoglycemia. A new biosensor connected to the patient by microdialysis, will be tested in a clinical trial in CHU-Bdx on 10 T1D patients with an internal or external insulin pump. In various daily scenarios (meals, physical exercise) the biosensor DIABLO responses will be compared to the measurements of standard CGM systems.

Detailed description: Continuous monitoring and linked drug delivery is a novel approach to the treatment of chronic diseases that provides powerful means to improve therapeutic outcomes and quality of patient's life. Type 1 diabetes (T1D) concerns 5 to 10% of the estimated 415 million cases of diabetes worldwide in 2016, expected to rise to 642 million by 2040(1). Continuous glucose monitoring systems (CGMS) linked to insulin delivery has provided a major advance(2). T1D is a serious, currently chronic and costly disease in children or young adults. Indeed, the destruction of pancreatic beta-cells leads to absolute insulin deficiency in T1D.

Eligibility criteria: Inclusion Criteria:

* Patient over 18 years of age
* Patient with type 1 diabetes (T1D)
* Patient being equipped and trained with an external or internan insulin pump linked to a CGM
* Affiliated person or beneficiary of a social security scheme
* Free, informed and written consent

Exclusion Criteria:

* Patient under 18 years
* Patient not having T2D
* Pregnant or lactating patient
* No consent signed by the patient

Primary outcomes:
measure: Comparison between biosensor to CGMS responses
timeFrame: 2 days after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Saint-André
Study officials:
affiliation: University Hospital, Bordeaux
name: Bogdan CATARGI, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04300283: Pre-operative Hypnosis to Prevent Side Effects After Surgery
Official title: A Pilot Study Investigating the Feasibility of a Pre-operative Hypnosis Intervention to Prevent Post-operative Pain After Thoracic and Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Surgery
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot testing of a pre-operative hypnosis intervention.
Primary purpose: PREVENTION

Brief summary: The aim of the pilot study is to translate and feasibility test a brief hypnosis intervention in 8-10 patients that are about to undergo thoracic surgery and in 4-5 patients about to undergo breast cancer surgery.

Detailed description: The hypnosis intervention will be based on a protocol from Montgomery et al. They showed in a recent study that a brief 15-minute hypnosis intervention was effective in reducing a number of common side effects, including pain, fatigue and nausea. The scripted session includes a relaxation-based induction, suggestions for pleasant visual imagery, suggestions to experience relaxation and peace, and specific symptom-focused suggestions. The intervention will be professionally translated into Norwegian, and adapted and modified as necessary to the specific context of this study. The PI, who is a an experienced clinical psychologist, will hold the session in the pilot study. Patients will further be instructed to use hypnosis on their own following the intervention session.

The patients will further be invited to participate in semi-structured interviews upon completion of the intervention, either by phone or in person, to discuss their experiences with the intervention, and share any advice for modifications or changes to the interventions or procedures. Systematic text condensation will be applied in the analyses of the interviews.

Eligibility criteria: Inclusion Criteria:

* Patients about to undergo either breast cancer surgery or thoracic surgery

Exclusion Criteria:

* Insufficient Norwegian speaking or writing skills to participate in the intervention
* cognitive and psychiatric impairment
* other serious malignancies

Primary outcomes:
measure: Patient experiences of the intervention
timeFrame: 1 week post-surgery
Secondary outcomes:
measure: NRS Pain intensity one week after surgery
timeFrame: 1 week post-surgery
measure: Fatigue severity one week after surgery
timeFrame: 1 week post-surgery
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Silje E Reme, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lind SB, Jacobsen HB, Solbakken OA, Reme SE. Clinical Hypnosis in Medical Care: A Mixed-Method Feasibility Study. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211058678. doi: 10.1177/15347354211058678.
Clinical trial NCT00349583: Efficacy of Topical Cyclosporine Versus Tears for Improving Visual Outcomes Following Multifocal IOL Implantation
Official title: Efficacy of Topical Cyclosporine Versus Tears for Improving Visual Outcomes Following Multifocal IOL Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Dry Eye
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2006-07-07
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the efficacy on quality of vision and dry eye signs and symptoms in patients undergoing cataract surgery using the ReZoom® multifocal IOL.


Eligibility criteria: Inclusion Criteria:

* · Males or females \> 50 years old

  * Scheduled to undergo bilateral phacoemulsification with implantation of a multifocal IOL.
  * Likely to complete all study visits and able to provide informed consent
  * Visual potential of 20/25 or better

Exclusion Criteria:

* · Prior use of topical cyclosporine

  * Known contraindications to any study medication or ingredients
  * Active ocular diseases or uncontrolled systemic disease
  * Active ocular allergies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville Centre
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
Study officials:
affiliation: Ophthalmic Consultants of Long Island
name: Eric Donnenfeld, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04847583: A Phase 2 Study to Evaluate Biomarker Change, Efficacy, Pharmacokinetics, Safety and Tolerability of Telacebec (Q203) in Covid-19 Patients
Official title: A Phase 2 Open-Label, Randomized Controlled Trial to Evaluate the Biomarker Change, Efficacy, Pharmacokinetics, Safety and Tolerability of Telacebec in Participants With Moderate COVID-19 Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19 Virus Infection
Lead sponsor: Qurient Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-19
Enrollment: 1
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: This is a Phase 2, open-label, randomized controlled trial to determine the effects of Telacebec (Q203) on inhibition of leukotriene production, clinical change, pharmacokinetics, and safety in participants with moderate COVID-19 disease


Eligibility criteria: Inclusion Criteria:

1. Provide written, informed consent prior to all study-related procedures.
2. Provide written, informed consent to undergo Human Immunodeficiency Virus (HIV) testing.
3. Willingness and ability to attend scheduled visits and undergo study assessments.
4. Able and willing to measure their oxygen saturation level and temperature, record their COVID-19 symptoms and complete a patient diary.
5. Male or female aged 18 years or older.
6. Confirmed and documented SARS-CoV-2 infection, defined as RT-PCR laboratory confirmation.
7. Clinical and/or radiological findings indicative of moderate COVID-19 disease

Exclusion Criteria:

1. Severe or critical COVID-19 disease at enrollment (Day 1) (per NIH Treatment Guideline categorization) as determined by the Investigator.
2. Inability to swallow oral medication.
3. Concurrent known asthma, active tuberculosis or tuberculosis within the last 3 months, or any other condition that could compromise the well-being of the participant, or prevent, limit or confound protocol specified assessments, in the opinion of the Investigator.
4. Female Participant who is pregnant, breast-feeding, or planning to conceive a child within the anticipated period of participating in the study or within 6 months after last dose of study medication. Males planning to conceive a child during the study or within 6 months of cessation of treatment.

Primary outcomes:
measure: Biomarker change
timeFrame: Day 1 and 14
Secondary outcomes:
Other outcomes:
Locations:
city: Soweto
country: South Africa
facility: Chris Hani Baragwanath Academic Hospital
state: Gauteng
city: Durban
country: South Africa
facility: KwaPhila Health Solutions
state: Kwa-Zula Natal
city: George
country: South Africa
facility: TASK Eden
state: Western Cape
Study officials:
References: