louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00966641: Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults
Official title: "A Single-Dose Crossover Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adult Volunteers in the Fasted State"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy Volunteers
Lead sponsor: PLx Pharma
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2009-08-27
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the single-dose pharmacokinetics of the investigational drug PL 3100 following oral administration to healthy volunteers and to compare the pharmacokinetic profiles of PL 3100 and naproxen at a prescription dose.


Eligibility criteria: Inclusion Criteria:

* Age 18-75 years, inclusive.
* Subject has a Body Mass Index (BMI) between 20 and 32, inclusive.
* Normal physical examination as determined by the Investigator.
* Normal clinical laboratory test results or clinically insignificant results as determined by the Investigator during the screening visit.
* If female and of child-bearing potential, the subject must have a negative pregnancy test and is not nursing.
* If female and of child-bearing potential, the subject must agree to use adequate birth control for the duration of the study.

Exclusion Criteria:

* Subject has a history of chronic alcohol consumption or abuse of narcotics or alcohol.
* Subject has had an acute illness within 5 days of study medication administration.
* Subject is currently participating, or has participated within 30 days prior to study entry, in an investigational drug study.
* Subject has hypersensitivity or contraindications to naproxen, ibuprofen, or other NSAID.

Primary outcomes:
measure: Area Under the Curve of Plasma Naproxen From 0 to t
timeFrame: 30 minutes prior to administration; 30, 60, and 90 minutes post drug administration; and 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, and 48 hours post drug administration.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Institute for Clinical Research
state: Texas
Study officials:
affiliation: PLx Pharma Inc.
name: Upendra K. Marathi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05542641: T-mult: Exploring the Impact of TMS Induced Virtual Lesions on the Multimodal Brain Network and Cognition
Official title: T-mult: Exploring the Impact of TMS Induced Virtual Lesions on the Multimodal Brain Network and Cognition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Cognition
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 102
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: T-mult is an experimental study using low-frequency (1Hz) single-sesson rTMS to the DLPFC (versus sham rTMS) to explore the effect of virtual lesions on the brain network and cognition in 100 healthy adults (20-65 years old).


Eligibility criteria: Inclusion Criteria:

* Age between 20 and 65 years old
* Native Dutch speaker
* Able to provide written informed consent

Exclusion Criteria:

* History of diagnosed neurological or psychiatric disease (including traumatic head injury)
* Current and regular use of centrally acting drugs (recreational or prescribed, including analgesics), including the use of alcohol \~8 hours prior to an appointment
* Presence of any contraindications for MRI, MEG, or TMS (including resting motor threshold \>75% of maximum stimulator output or no useful motor-evoked potential elicitable)
* Previous rTMS treatment

Primary outcomes:
measure: Cognitive change
timeFrame: baseline versus directly post-intervention (max. 8 weeks after baseline)
Secondary outcomes:
measure: Brain network change
timeFrame: baseline versus directly post-intervention (max. 8 weeks after baseline)
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU University Medical Centers, location VUmc
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Linda Douw, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06911541: Clinical Validation of a Novel, Accelerometer Based, Continuous Respiratory Rate Sensor
Official title: Clinical Validation of a Novel, Accelerometer Based, Continuous Respiratory Rate Sensor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Rate Accuracy Test
Capnography
Wireless Vital Signs Monitoring System
Respiratory Rate
Keywords: Respiratory rate
wireless monitoring
accelerometer
Lead sponsor: Eupnea AS
Sponsor class: INDUSTRY
Collaborators: name: Haraldsplass Deaconess Hospital
First posted: 2025-04-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Comparing a wireless accelerometer-based sensor that continuously measure breathing rate with the gold standard capnography. The aim is to evaluate if both methods are equivalent.


Eligibility criteria: Inclusion Criteria:

* Admitted to the Hospital
* Expected to remain undisturbed for at least one hour

Exclusion Criteria:

* Not able to give informed consent
* Use of high flow oxygen therapy
* Skin disease preventing proper attachment of the sensor
* Implanted electronic medical device.
* Known infection or colonisation with microbes necessitating protective measures above routine care

Primary outcomes:
measure: Validation of correctness of the sensor
timeFrame: one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haraldsplass Deaconess Hospital
Study officials:
References:
Clinical trial NCT00383617: Referral Recommendations for Axial Spondyloarthritis
Official title: Performance of Referral Recommendations in Patients With Chronic Back Pain and Suspected Axial Spondyloarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spondyloarthropathy
Ankylosing Spondylitis
Spondyloarthritis
Keywords: pre-radiographic
screening
early diagnosis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2006-10-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: The purpose of this study is to determine which of the proposed screening parameters or which combination of screening parameters perform best in daily clinical practice for making the diagnosis of axial Spondyloarthritis (SpA)in patients with chronic low back pain.

Detailed description: Ankylosing spondylitis (AS) and its early form accounts for up to 5% of all patients with chronic back pain. Shortening the delay of 5-10 years between first symptoms and making a diagnosis of AS has become a challenge especially because effective treatments have become available. Easy to apply referral parameters for physicians in primary care may contribute to make the diagnosis earlier.

Methods: Orthopedists and primary care physicians were offered to refer patients with i) chronic low back pain (duration \>3 months) and ii) onset of back pain at an age \< 45 years to a specialized rheumatology outpatient clinic for further diagnostic work-up if at least one of the following screening parameters was present: 1) inflammatory back pain (IBP), 2) positive HLA-B27, 3) sacroiliitis as detected by imaging. The final diagnosis was made according to expert opinion.

It was analyzed, which parameters or combination of parameters performed best in making a diagnosis of axial SpA.

Eligibility criteria: Inclusion Criteria:

* chronic back pain with a duration of more than 3 months
* onset of back pain before age of 45 years

Exclusion Criteria:

* age younger than 18 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Rheumatology, Medical Clinic I, Charite Campus Benjamin Franklin, Hindenburgdamm 30
Study officials:
affiliation: Department of Rheumatology, Medical Clinic I, Charité University Medicine Berlin, Campus Benjamin Franklin, Berlin, Germany
name: Joachim Sieper, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rudwaleit M, Khan MA, Sieper J. The challenge of diagnosis and classification in early ankylosing spondylitis: do we need new criteria? Arthritis Rheum. 2005 Apr;52(4):1000-8. doi: 10.1002/art.20990. No abstract available.
citation: Sieper J, Rudwaleit M. Early referral recommendations for ankylosing spondylitis (including pre-radiographic and radiographic forms) in primary care. Ann Rheum Dis. 2005 May;64(5):659-63. doi: 10.1136/ard.2004.028753. Epub 2004 Nov 4.
Clinical trial NCT00434317: Assessment of Pain and Quality of Life in Breast and Prostate Cancer Patients With Bone Metastases
Official title: A Multicenter, Open-label Study to Determine the Effect of iv. Zoledronic Acid on Pain and Quality of Life in Patients With Bone Metastases With or Without Skeletal Related Events (SRE) Resulting From Breast Cancer and Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neoplasm Metastasis
Keywords: Metastasis
Neoplasm
pain
breast cancer
prostate cancer
bone metastasis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-02-13
Enrollment: 80
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: This study will evaluate the safety, tolerability and efficacy of zoledronic acid administered intravenously every 3-4 weeks in patients with bone metastases from either breast cancer or prostate cancer.


Eligibility criteria: Inclusion criteria:

* Ambulatory patients \>18 years
* Proof of breast cancer or prostate cancer
* Diagnosis of at least one cancer-related bone lesion that is detectable on conventional radiographs or bone scan at screening
* Negative pregnancy test
* ECOG performance status of 0,1 or 2

Exclusion criteria:

* Patients with abnormal renal function
* Patients with clinically symptomatic brain metastases
* Known hypersensitivity on zoledronic acid or other bisphosphonates
* Pregnancy or lactation

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Measurement of pain assessed by a Visual Analogue Scale (VAS)
timeFrame: throughout the study
Secondary outcomes:
measure: Quality of Life assessment at baseline and last visit
timeFrame: throughout the study
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Pecs
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Szekesfehervar
country: Hungary
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT03391817: FAECAL MICROBIOTA TRANSPLANTATION IN OBESITY
Official title: FAECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF MORBID OBESITY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity, Morbid
Lead sponsor: Joint Authority for Päijät-Häme Social and Health Care
Sponsor class: OTHER
Collaborators: name: University of Helsinki
name: Helsinki University Central Hospital
First posted: 2018-01-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 40 patients meeting the criteria for obesity surgery are enrolled. Fecal microbiota transplantation (FMT) will be administered in gastroscopy 6 months before obesity surgery. 20 of the patients will receive a fecal transplant of a thin donor and 20 will receive placebo - a transplant made of their on feces. Changes in weight, laboratory values, general well being and stool microbiota will be measured up to one year after the surgery; one and a half years after FMT. The hypothesis is that FMT and the change in gut microbiota will help to reduce and maintain lower weight.


Eligibility criteria: Inclusion Criteria:

• Candidates for the bariatric surgery

BMI ≥ 40 or BMI ≥35 and at least two obesity-related co-morbidities such as type II diabetes (T2DM), hypertension, sleep apnea and other respiratory disorders, non-alcoholic fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease.

* Availability of consecutive fecal samples during one year
* Compliance to attend gastroscopy and FMT
* 18-65 years

Exclusion Criteria:

* Unable to provide informed consent
* Pregnancy
* Type I Diabetes Mellitus
* Severe renal insufficiency, GFR\<30%
* Chronic or recurrent bacterial infection needing antimicrobial treatment
* Large hiatal hernia

Primary outcomes:
measure: Reduction of weight
timeFrame: 1,5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Lahti
country: Finland
facility: Päijät-Häme Central Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Perttu Arkkila, PhD MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04294017: CellAdhesionMolecule EndometriosisRatio - CAMERA
Official title: The Soluble VCAM-1 / Soluble ICAM-1 Ratio as a Non-invasive Biomarker for Diagnosing Endometriosis - a Prospective Multicenter Validation Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometriosis (Diagnosis)
Identification of Biomarkers in Serum
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Medical-Scientific Fund of the Mayor of the Federal Capital Vienna
First posted: 2020-03-03
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women in reproductive age undergoing a diagnostic laparoscopy

Brief summary: Background: Endometriosis, which is characterized by the growth of endometrial stroma and glands outside of the uterine cavity, is estimated to occur in 6-10% of women of reproductive age. Clinical presentation of endometriosis can vary widely, often significantly reducing quality of life, and the mean interval between the onset of symptoms and obtaining a definitive diagnosis is approximately 10 years. Currently, laparoscopy is the gold standard for diagnosing endometriosis; however, this procedure is invasive, carries surgery-related risks, and contributes to diagnostic delay. Therefore, the field has an urgent need for an efficient, sensitive, non-invasive tool for diagnosing endometriosis.

Recently, it was shown that sVCAM-1/sICAM-1 ratio is a promising serum biomarker, which may lead to the development of a new, efficient, sensitive, non-invasive tool for diagnosing endometriosis, thereby potentially avoiding surgical interventions.

Primary aim: To determine whether the serum sVCAM-1/sICAM-1 ratio can be used todiagnose endometriosis.

Study design: Prospective multicenter validation study


Eligibility criteria: Inclusion Criteria:

* unfulfilled desire for children
* chronic pelvic pain
* suspicion of endometriosis
* cysts
* myomas

Exclusion Criteria:

* acute infections
* malign diseases
* drug abuse
* pregnancy
* infectious diseases

Primary outcomes:
measure: sICAM and sVCAM in serum
timeFrame: up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
References:
Clinical trial NCT05038917: Sedation for Endoscopic Procedures
Official title: Sedation for Endoscopic Procedures - a Follow-up Study of Efficiency and Safety
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endoscopic Surgical Procedure
Keywords: Quality of recovery
Health Literacy
Moderate sedation
Deep sedation
Anesthesia
Lead sponsor: Ostergotland County Council, Sweden
Sponsor class: OTHER
First posted: 2021-09-09
Enrollment: 500
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: Adult patients (≥18 years) scheduled for ERCP or/and EUS

Brief summary: Endoscopic procedures for biliary strictures, stenting or drainage (ERCP) and ultrasonic imaging or biopsies (EUS) are performed under sedation or anesthesia. The main purpose of the study is to evaluate aspects of procedure treatability and patients´ quality of recovery.

Detailed description: The main aim of this study is to evaluate the effects on treatability and procedure failur; also aspects of post-procedure quality of recovery from patients cognitive function and from the choice of sedation/anesthesia for ERCP and EUS-procedures.

Before endoscopic procedures, patients do not always read the written information sent to them. That´s a problem since patients tend to be insufficient prepared for the procedures. Therefore, evaluation of patients' health literacy was performed.

Patients are sedated (patient-controlled sedation or by nurse anesthetists) or in general anesthesia. No randomisation.

Eligibility criteria: Inclusion Criteria:

* Adult patients (≥18 years)
* Patients cheduled for ERCP or/and EUS
* Patients who have given their informed and written concent to participate

Exclusion Criteria:

Patients with

* confusion
* dementia
* communication problems.

Primary outcomes:
measure: Dimensions of recovery recorded by Quality of Recovery 15 swedish version
timeFrame: Baseline (Day 0)
measure: Dimensions of recovery recorded by Quality of Recovery 15 swedish version
timeFrame: Day 1
measure: Dimensions of recovery recorded by Quality of Recovery 15 swedish version
timeFrame: Day 5
Secondary outcomes:
measure: Health literacy measured by the use of FHL (swedish version)
timeFrame: Before procedure (Day 0)
measure: Aborted or increased difficulty to performed the planned procedure
timeFrame: From start of procedure to the end of it (Day 0)
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: University hospital of Linköping
state: Östergötland
Study officials:
affiliation: Ljungsborg Haga 1
name: Andreas o Nilsson, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01017341: Hip Protector for Prevention of Hip Fracture
Official title: PSU Hip Protector for Prevention of Hip Fracture From Falling
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hip Fracture
Keywords: hip fracture
back support
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2009-11-20
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the efficacy of the investigators PSU hip protector for prevention of fracture in elderly.The eligible patients include those with previous diagnosed as unilateral hip fracture. They will be randomized into 2 groups;psu hip protector and no protector. The patients will be instructed to wear the protector fulltime.The inceidence of hip fracture will be compared between both group at the end of 1 year.


Eligibility criteria: Inclusion Criteria:

* Patients with previous diagnosed as unilateral hip fracture

Exclusion Criteria:

* Poor communicative ability
* Cannot independently ambulate
* Local skin problem at trocahnteric area

Primary outcomes:
measure: incidence of new hip fracture
timeFrame: 6 months, 1 ,2 and 3 yrs
Secondary outcomes:
measure: SF 36
timeFrame: 6 months, 1 ,2 and 3 yrs
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Prince of Songkla University
state: Songkhla
Study officials:
affiliation: Department of Othropaedic Surgery, Faculty of Medicine, Prince of Songkla university, Hat Yai, Songkhla,Thailand
name: Boonsin Tangtrakulwanich, MD.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02815241: Sun Protection Factor Assay
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-06-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose).

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
References: