louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02694588: Clinical and Molecular Phenotyping in IBD
Official title: Systematic Profiling of Anti-inflammatory Drugs for the Detection of Drug- Specific Response Signatures in the Treatment of Chronic Inflammatory Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IBD
Keywords: Vedolizumab
Infliximab
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2016-02-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Inflammatory bowel disease (IBD) and psoriasis (Ps) are common, chronic, immune- mediated barrier diseases with shared inflammatory pathways. Current therapeutic interventions with anti-cytokine antibodies (TNF-α, IL-23/IL-12) reflect the intent to disrupt specific pathways of inflammatory immunopathology. Individual responses to biological treatment can be thereby be exploited in a systems biology approach that employs a targeted mechanism of action (MOA) to decipher molecular signatures of therapeutic responses in the context of a distinct disease entity. Using a translational approach to investigate clinical and molecular phenotypes during therapeutic interference with cytokine signaling and leukocyte trafficking, the investigators aim to trace common and unique signatures of drug- and therapy-specific responses.

Patients will undergo endoscopic evaluation of the mucosal surface and gastrointestinal wall by conventional HD-colonoscopy, endoscopic ultrasound and confocal laser endomicroscopy prior to and during specific therapies with biologicals. In parallel, mucosa samples will be obtained to define molecular phenotypes during the course of therapy.


Eligibility criteria: Inclusion Criteria:

* inflammatory bowel disease
* indication for biological therapy

Exclusion Criteria:

* pregnancy, breast feeding
* no written informed consent to participate in the study

Primary outcomes:
measure: Mucosal healing week 2
timeFrame: week 2
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Medical Department I, University Hospital Schleswig-Holstein
Study officials:
affiliation: 00494315971272
name: Stefan Schreiber, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zeissig S, Rosati E, Dowds CM, Aden K, Bethge J, Schulte B, Pan WH, Mishra N, Zuhayra M, Marx M, Paulsen M, Strigli A, Conrad C, Schuldt D, Sinha A, Ebsen H, Kornell SC, Nikolaus S, Arlt A, Kabelitz D, Ellrichmann M, Lutzen U, Rosenstiel PC, Franke A, Schreiber S. Vedolizumab is associated with changes in innate rather than adaptive immunity in patients with inflammatory bowel disease. Gut. 2019 Jan;68(1):25-39. doi: 10.1136/gutjnl-2018-316023. Epub 2018 May 5.
Clinical trial NCT02910388: LLETZ Under Direct Colposcopic Vision
Official title: Direct Colposcopic Vision and Large Loop Excision of the Transformation Zone in Women With Cervical Dysplasia: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Cervical Dysplasia
Keywords: conization
LLETZ
loop excision
randomized controlled trial
colposcopy
direct colposcopic vision
intraoperative colposcopy
Lead sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry
Sponsor class: OTHER
Collaborators: name: Ruhr University of Bochum
First posted: 2016-09-22
Enrollment: 150
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: To assess the benefits of large Loop excision of the transformation Zone (LLETZ) under direct colposcopic Vision.


Eligibility criteria: Inclusion Criteria:

* histologically proven cervical dysplasia
* colposcopy Prior to conization
* informed consent

Exclusion Criteria:

* significant language barrier
* a personal history of conization
* pregnancy
* the use of blood thinner
* unwillingness to participate

Primary outcomes:
measure: the resected cone mass
timeFrame: 10 minutes
Secondary outcomes:
measure: Margin status
timeFrame: 2 Days after conization
measure: Operation time
timeFrame: 20 minutes
measure: Operative complications
timeFrame: 14 days
measure: number of fragments of the surgical specimen
timeFrame: 10 minutes
measure: the dimensions of the surgical specimens
timeFrame: 2 Days after conization
measure: handling of the device
timeFrame: 30 minutes
measure: satisfaction with the device
timeFrame: 30 minutes
measure: Time to complete intraoperative hemostasis
timeFrame: 120 seconds
measure: Intraoperative blood loss
timeFrame: 5 hours
Other outcomes:
Locations:
city: Herne
country: Germany
facility: Department of Obstetrics and Gynecology of the Ruhr University Bochum
state: NRW
Study officials:
affiliation: Zydolab - Institute of Cytology and Immune Cytochemistry
name: Ziad Hilal, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01169688: Preoperative Cataract Pupillary Dilation: Inpatient At The Ambulatory Surgery Center vs Outpatient Dilation Prior To Arrival At The Ambulatory Surgery Center
Official title: Preoperative Cataract Pupillary Dilation: Inpatient vs Outpatient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pupil Dilation Prior to Cataract Surgery In-patient
Pupil Dilation Prior to Cataract Surgery Out-patient
Keywords: Cataract Surgery
Pupillary Dilation
Lead sponsor: Northwest Kansas Surgery Center
Sponsor class: OTHER
First posted: 2010-07-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study was done to compare efficacy, safety and efficiencies of various methods of pupil dilation prior to cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Ability to self administer eye or have a helper for the task of administering eye drops.
* Ability to follow and eye drop administration schedule.
* No noted ocular abnormalities.
* Bilateral cataract surgery anticipated.

Exclusion Criteria:

* Inability to self administer eye drops or have assistance with eye drop administration.
* Health problems that would contraindicate self administration of dilating eye drops such as poor cardiovascular or respiratory status.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06845488: Application of Virtual Reality Technology to Treatment of Social Anxiety
Official title: Application of Virtual Reality Technology to Treatment of Social Anxiety
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Social Anxiety Disorder
Keywords: Virtual reality
psychotherapy
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare CBT VR exposure + VR social skills treatment to CBT Imaginal exposure + mindfulness, in reducing the severity of social anxiety in adults with autism and social anxiety (SA), to identify characteristics associated with benefitting from the CBT-VR treatment and to assess acceptability and feasibility of the VR intervention for patients receiving it and use findings to improve methods and to prepare for a community based pragmatic trial.


Eligibility criteria: Inclusion Criteria:

* Autism Spectrum Disorder (ASD) (diagnosed by a qualified professional)
* verbal and literate in English or Spanish
* average or greater intellectual ability, based on history and interview
* able to operate a computer (Windows or Mac).

Exclusion Criteria:

* current or historical severe mental illness such as schizophrenia, bipolar disorder, or severe depression
* intellectual disability or a learning disability that would interfere with participating (e.g., unable to read)
* unable use the technology or do not have access to the technology
* unable to read

Primary outcomes:
measure: Change in anxiety as assessed by the Liebowitz Social Anxiety Scale (LSAS)
timeFrame: Baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, post treatment (about 4 weeks after end of treatment))
measure: Change in anxiety as assessed by the Social Interaction Anxiety Scale (SIAS)
timeFrame: Baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, post treatment (about 4 weeks after end of treatment)
measure: Change in anxiety as assessed by the Social Phobia Scale (SPS)
timeFrame: Baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, post treatment (about 4 weeks after end of treatment)
measure: Change in anxiety as assessed by the The Severity Measure for Social Anxiety Disorder (SMSAD) scale
timeFrame: Baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, post treatment (about 4 weeks after end of treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at Houstom
name: Katherine Loveland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03370588: The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Outcomes in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Cytoreductive Surgery; Double Blind Randomized Controlled Trial
Official title: The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Outcomes in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Cytoreductive Surgery; Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-12-12
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) has been reported to be an effective treatment approach for peritoneal cancer, however, the stress response to HIPEC is major neuroendocrine and cytokine response, which has been considered as the homeostatic defense mechanism. Recently, dexmedetomidine has been suggested to exhibit anti-inflammatory properties. This study was designed to evaluate the effect of perioperative administration of dexmedetomidine on inflammation response and postoperative outcomes in patients undergoing hyperthermic intraperitoneal chemotherapy (HIPEC) cytoreductive surgery.


Eligibility criteria: Inclusion Criteria:

* patients between 20 and 70 years old
* obtaining written informed consent from the patients who were undergoing hyperthermic intraperitoneal chemotherapy (HIPEC) cytoreductive surgery
* weights under 90 kg and BMI under 32

Exclusion Criteria:

* emergency operation
* re-operations
* combined surgery over 4 departments.
* cardiac disease (unstable angina, congestive heart failure, valvular heart disease)
* Ventricular conduction abnormality
* prior pacemaker insertion
* uncontrolled hypertension (diastolic blood pressure \> 110mmHg)
* bradycardia (HR \< 40 Bpm)
* cerebral vascular disease (cerebral hemorrhage, cerebral ischemia)
* hepatic or renal failure
* patients who take antiarrythmic agent
* neurological or psychiatric illnesses
* foreigner and patient who can not read the letter

Primary outcomes:
measure: IL-6 level
timeFrame: Up to 12 hours after surgery
Secondary outcomes:
measure: recurrence rate
timeFrame: up to 1 year after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Study officials:
References:
Clinical trial NCT05741788: The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain
Official title: The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Chronic Pain
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 15
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Spinal cord stimulation modulates the nervous system to effectively block pain signals originating from the back and legs. Spinal cord stimulation has been shown to improve chronic pain, improve quality of life, and reduce disability. Unfortunately, spinal cord stimulation has a high trial failure rate and a high long-term failure rate. This study consists of a prospective cohort of patients clinically scheduled to undergo spinal cord stimulation for the treatment of chronic back pain or radiculopathy. Participants will undergo a structured optimization evaluating existing types of stimulation (tonic, burst, and multistim). Each participant will try out all types of available stimulation but be blinded to the type. Over the course of four months, each participant will evaluate each type of stimulation by reporting daily pain scores. Thompson sampling will be used to identify which setting produces the biggest improvement in pain and recommend it for future use. Participants will follow up routinely to collect laboratory, behavioral, and survey responses to test for the feasibility of obtaining data explaining pain phenotype.


Eligibility criteria: Inclusion Criteria:

* 22 years of age or older
* Scheduled to undergo spinal cord stimulation
* English speaker
* Baseline pain rating (NRS/VAS) \>=6

Exclusion Criteria:

* Scheduled for permanent implantation only without trial
* Presence of pacemakers or other neurostimulators
* Pregnant
* Inability to read or use smart phone
* Individuals who are unable to consent
* Employees or students of PI
* Prisoners

Primary outcomes:
measure: Feasibility
timeFrame: 3 years
Secondary outcomes:
measure: Acceptability of procedure
timeFrame: 3 years
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: David Darrow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05782088: Single Versus Repeated Piezocision-assisted Orthodontic Tooth Movement
Official title: Single Versus Repeated Piezocision-assisted Orthodontic Tooth Movement: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Tooth Movement
Canine Retraction
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2023-03-23
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of the study is to evaluate the effect of single and repeated piezocisions on the rate of orthodontic tooth movement. Secondary aims are to evaluate the effect of both protocols on molar anchorage loss, as well as on canine root resorption.


Eligibility criteria: Inclusion Criteria:

* Malocclusion that requires at least the extraction of maxillary first premolars, such as Class I bimaxillary protrusion, and Class II division 1 cases.
* Normal shape and structure of the maxillary canines, with no history of root canal treatment

Exclusion Criteria:

* Patients who underwent previous orthodontic treatment.
* Patients currently receiving drug therapy that may affect orthodontic tooth movement, e.g. hormonal therapy and corticosteroids.

Primary outcomes:
measure: Measurement of canine retraction
timeFrame: 12 weeks
measure: Measurement of molar anchorage loss
timeFrame: 12 weeks
measure: Measurement of canine root resorption
timeFrame: 12 weeks
measure: Bone Microstructure (Fractal Dimension)
timeFrame: 12 weeks
measure: Alveolar bone density
timeFrame: 12 weeks
measure: Alveolar bone thickness
timeFrame: 12 weeks
measure: Alveolar bone volume
timeFrame: 12 weeks
measure: Maxillary canine tipping
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: Farah Y Eid, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Ahmed R El-Kalza, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06771388: Efficacy Evaluation of Avance QQ Collagen for Skin Beautification
Official title: Efficacy Evaluation of Avance QQ Collagen for Skin Beautification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Condition
Liposomal Encapsulation
Keywords: Avance QQ Collagen
Double Nutri
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-13
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess Avance QQ Collagen product on skin condition improvement


Eligibility criteria: Inclusion Criteria:

* Healthy male or female adults, age above 18 years old;
* The grade of crow's feet above 2 (Han et al. Sci Rep 13, 18903 (2023));
* Commitment not to use products having activity comparable with that of the product to be tested during the study period;
* Free of any dermatological or systemic disorder that would interfere with results.

Exclusion Criteria:

* Subject with obvious skin surface damage;
* Subject who had oral or topical medication which may affect skin condition within 1 month;
* Subject who is a vegetarian or likely to be acutely allergic to the listed ingredients in the product;
* Female who is pregnant, nursing or planning to become pregnant during the course of the study;
* Received facial laser therapy, chemical peeling in the past 2 months.

Primary outcomes:
measure: The change of skin collagen density
timeFrame: Change from Baseline skin collagen density at 8 weeks
measure: The change of skin wrinkles
timeFrame: Change from Baseline skin wrinkles at 8 weeks
measure: The change of skin elasticity
timeFrame: Change from Baseline skin elasticity at 8 weeks
Secondary outcomes:
measure: The change of wrinkles around the eyes
timeFrame: Change from Baseline wrinkles around the eyes at 8 weeks
measure: The change of skin hydration
timeFrame: Change from Baseline skin hydration at 8 weeks
measure: The change of skin lightness
timeFrame: Change from Baseline skin lightness at 8 weeks
measure: The change of skin tone
timeFrame: Change from Baseline skin tone at 8 weeks
Other outcomes:
measure: The change of self-assessment skin condition
timeFrame: Change from Baseline skin condition at 8 weeks
Locations:
city: Pingtung
country: Taiwan
facility: Chia Nan University of Pharmacy & Science
Study officials:
affiliation: Chia Nan University of Pharmacy ＆ Science
name: Chia-Hua Liang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03570788: HRQoL Among Patients Amputated Due to Peripheral Arterial Disease
Official title: Health-related Quality of Life Among Patients Amputated Due to Peripheral Arterial Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Amputation
Peripheral Arterial Disease
Prosthesis User
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients amputated at Södersjukhuset during 2014-2018 are reviewed based on criteria for inclusion and exclusion. All patients that meets the inclusion criteria during the period will be contacted by the researcher in connection with the amputation and informed about the study.

Brief summary: A prospective cohort study over the prosthetic use among patients amputated after vascular disease and the impact of their HRQoL.


Eligibility criteria: Inclusion Criteria:

* Patients amputated at femoral, knee or tibial level due to peripheral arterial disease

Exclusion Criteria:

* Patients not able to provide informed consent
* Patients not able to verbally express their experience of the amputation.
* Patients that not speak Swedish

Primary outcomes:
measure: Change in Health related quality of life according to EQ-5D
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of patients using prosthesis
timeFrame: 1 year after the amputation
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet
Study officials:
affiliation: Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet
name: Eva Torbjörnsson
role: PRINCIPAL_INVESTIGATOR
References: