louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00189722: Inhaled Tacrolimus, Add-on to Inhaled Corticosteroids & Long Acting B2 Agonists in Moderate to Severe Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma, Bronchial
Bronchial Asthma
Keywords: Tacrolimus
Immunosuppressant
Anti-asthmatic drug
Administration, inhalation
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Europe B.V.
First posted: 2005-09-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of tacrolimus in patients with asthma.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of asthma
* Patients treated with inhaled corticosteroid and long acting beta 2 agonist
* FEV1(forced expiratory volume in 1 second)\>50% to 80%

Exclusion Criteria:

* Respiratory infection within 2weeks
* Asthma exacerbation within 6 weeks

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brno
country: Czech Republic
city: Krhanice
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Sumperk
country: Czech Republic
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Deggendort
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Munchen
country: Germany
city: Rudersdorf
country: Germany
city: Wiesbaden
country: Germany
city: Bialystok
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Tarnow
country: Poland
city: Wroclaw
country: Poland
city: Ekaterinburg
country: Russian Federation
city: Moscow
country: Russian Federation
city: Smolensk
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Dnepropetrovsk
country: Ukraine
city: Kiev
country: Ukraine
city: Zaporozhye
country: Ukraine
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: R. G. M. vom Amsterdam, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04751422: Medical Data Collection for the Evaluation of Radiofrequency Ablation and Cement Augmentation for the Treatment of Secondary Metastases to the Spine
Official title: A Single-Center Retrospective Study Evaluating Radiofrequency Ablation and Cement Augmentation for the Treatment of Secondary Metastases to the Spine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Malignant Neoplasm in the Spine
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent radiofrequency ablation with cement augmentation at the Department of Interventional Radiology at MD Anderson Cancer Center (MDACC) between 1/1/2017 and 9/26/2020

Brief summary: This study collects data on the use of radiofrequency ablation and cement augmentation for the treatment of cancer that has spread to the spine (metastases to the spine). Radiofrequency ablation with cement augmentation is a useful approach for the treatment of secondary metastasis to the spine. Information collected in this study may help doctors to learn the effectiveness of this therapy, and may help to evaluate optimal technique, appropriate patient selection, and management of complications.

Detailed description: PRIMARY OBJECTIVE:

I. To evaluate the use of radiofrequency ablation and cement augmentation for the treatment of secondary metastases to the spine.

OUTLINE:

Patients' medical data is collected retrospectively.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent radiofrequency ablation with cement augmentation at the Department of Interventional Radiology at MD Anderson Cancer Center (MDACC) between 1/1/2017 and 9/26/2020

Exclusion Criteria:

* None

Primary outcomes:
measure: Technical success
timeFrame: Up to 3 years
measure: Clinical success
timeFrame: Up to 3 years
measure: Complication rates
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Rahul A Sheth
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04809922: Accuracy of Cardiac Wearables Devices to Detect Atrial Fibrillation
Official title: Accuracy of Cardiac Wearables Devices to Detect Atrial Fibrillation in a Real-World Cohort of Patients; BASEL Wearable Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation (AF)
Keywords: Cardiac Wearables Devices
Sinus rhythm (SR)
Lead-intelligent Electrocardiogram (iECG)
heart rhythm device accuracy
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing electrophysiological study, pacemaker or implantable defibrillator (ICD) implantation or electric cardioversion at the University Hospital Basel.

Brief summary: Atrial fibrillation (AF) is the most common cardiac arrhythmia. This study is to assess the heart rhythm device accuracy of five cardiac wearable devices (Apple Watch, Kardia Mobile/Kardia Mobile 6L, Fitbit Sense, Samsung Galaxy Watch 3 and Withings Scanwatch, Withings SA, Model Number: HWA09) and its detection algorithms in identifying AF compared to a nearly simultaneously acquired physician-interpreted 12-lead ECG in a real world cohort of patients.


Eligibility criteria: Inclusion Criteria:

* All consecutive patients undergoing electrophysiological study, pacemaker or implantable defibrillator (ICD) implantation or electric cardioversion at the University Hospital Basel are eligible for study participation and will be asked to participate

Exclusion Criteria:

* Use of a radial artery graft for coronary artery bypass grafting
* Tattoos located on the skin of the wrist or forearm where wearable device will be placed
* Patients receiving hemodialysis through arteriovenous fistula in the upper extremities
* Patients with inability to communicate and comply with all study requirements
* Patients who refused to participate in the trial

Primary outcomes:
measure: Heart rhythm device accuracy of cardiac wearable devices
timeFrame: one time assessment at baseline
measure: Heart rhythm device accuracy of physician-interpreted iECG
timeFrame: one time assessment at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Cardiology, University Hospital Basel
Study officials:
affiliation: Department of Cardiology, University Hospital Basel
name: Patrick Badertscher, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06273722: D-OCT for Detection and Subtyping of BCC: a Diagnostic Cohort Study
Official title: Dynamic Optical Coherence Tomography for Detection and Subtyping of Basal Cell
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Basal Cell Carcinoma
Optical Coherence Tomography
Keywords: Basal cell carcinoma
Optical coherence tomography
Imaging
Non-melanoma skin cancer
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This diagnostic cohort study will include patients (18+ years) who underwent a biopsy and D-OCT scan for lesions suspect for BCC skin cancer. Patient data was retrieved from a pre-existing registry (METC: 2022-3555). All D-OCT scans were obtained at the outpatient dermatology clinic of Maastricht University Medical Center+ (MUMC+) using a Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner (Michelson Diagnostics Maidstone, Kent, UK; resolution \<7.5 µm lateral, \<5 µm axial; depth of focus 1.0 mm; scan area 6 × 6 mm). All scanned lesions were histopathologically examined by a dermatopathologist blinded to D-OCT scans and D-OCT assessment.

Brief summary: The current gold standard for diagnosing basal cell carcinoma (BCC) is the histopathological examination of biopsy specimen. However, non-invasive imaging modalities such as optical coherence tomography (OCT) may replace biopsy if BCC presence and its subtype can be established with high confidence. Subtype differentiation is crucial; while superficial BCCs (sBCC) can be treated topically, nodular (nBCC) and infiltrative BCCs (iBCC) require excision. Dynamic OCT (D-OCT) is a functionality integrated within the OCT device, enabling the visualization of vascular structures through speckle variance.

Descriptive studies have unveiled vascular shapes and patterns associated with BCC and its respective subtypes. These findings suggest that D-OCT could contribute to the accuracy of BCC detection and subtyping. Yet comparative clinical studies between OCT and D-OCT are lacking. In the proposed diagnostic cohort study, we aim to assess whether D-OCT assessment is superior to OCT in terms of accuracy for BCC detection and subtyping.


Eligibility criteria: Inclusion Criteria:

* 18+ years
* Lesions suspect for non-melanoma skin cancer or premalignancy
* Patient underwent D-OCT scan and biopsy conform regular care

Exclusion Criteria:

* Patient unable to sign informed consent.

Primary outcomes:
measure: Diagnostic accuracy for BCC detection on D-OCT assessment
timeFrame: Measured before December 31st 2024
Secondary outcomes:
measure: Diagnostic accuracy for BCC subtyping on D-OCT assessment
timeFrame: Measured before December 31st 2024
measure: Diagnostic value of vascular structures and patterns
timeFrame: Measured before December 31st 2024
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02391922: Better First Aid With First Aid Training and Dispatcher Central Instructions?
Official title: Bedre førstehjelp Med førstehjelpstrening og AMK-veiledning?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Injury
Keywords: out of hospital cardiac arrest
first aid
Lead sponsor: University of Tromso
Sponsor class: OTHER
Collaborators: name: Norway: Helgeland Hospital
First posted: 2015-03-18
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The study evaluates the effect of a first aid course on first aid skills compared to no training. The study also evaluates the effect of first-aid instructions given by emergency dispatch central over mobile phone on first aid performance to no instructions.

Half the participants will perform first aid in two scenarios prior to first aid training. Half the participants will perform first aid in two scenarios 4 to 5 months after attending a first aid course. Half the participants (overall) will receive first aid instructions by mobile phone during the scenarios.


Eligibility criteria: Inclusion Criteria:

* Students in high school/college

Exclusion Criteria:

-

Primary outcomes:
measure: First aid performance after first aid course
timeFrame: 4-5 months
measure: First aid performance during first aid instructions by phone
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University of Tromso
Study officials:
References:
Clinical trial NCT06953622: Establishment of a Clinical and Prognostic Follow-up Cohort of Migraine Patients With Patent Foramen Ovale
Official title: Establishment of a Clinical and Prognostic Follow-up Cohort of Migraine Patients With Patent Foramen Ovale
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Migraine
Patent Foramen Ovale
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 330
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All clinically confirmed migraine patients with PFO who met the inclusion criteria were included.

Brief summary: To establish a headache center in China that combines clinical, imaging and laboratory examinations, explore the feasible treatment options for migraine combined with patent foramen ovale, and search for the possible influencing factors, construct models that influence prognosis.


Eligibility criteria: Inclusion Criteria:

* Meet the diagnostic criteria for migraine in the International Classification of Headache (ICHD-3);
* Confirmation of patent foramen ovale through transthoracic echocardiography(TTE) or transesophageal echocardiography(TEE)/right heart contrast echocardiography
* Agree to participate in the study and sign the informed consent form.

Exclusion Criteria:

* Can not sign the informed consent form or cooperate with follow-up.

Primary outcomes:
measure: The changes of migraine attacks
timeFrame: 3 months, 6 months, 1 year, 2 years and 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
References:
Clinical trial NCT01705522: Multimodal Approach in IBD Patients
Official title: Multimodal Approach in IBD Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ulcerative Colitis
Crohn's Disease
Nonalcoholic Fatty Liver Disease (NAFLD)
Vitamin D Deficiency
Keywords: IBD
ulcerative colitis
Crohn's disease
NAFLD
biomarkers
vitamin D
Lead sponsor: Clinical Hospital Colentina
Sponsor class: OTHER
First posted: 2012-10-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients with IBD over 18 years of age, currently in clinical remission

Brief summary: The investigators intend to assess the role of several biomarkers in the prediction of relapse in IBD. Clinical, laboratory and endoscopic data will be gathered and a predictive score will be derived in order to assess the relapse risk at 1 year.

Detailed description: Patients with a confirmed diagnosis of IBD will be prospectively assessed on a yearly basis in order to assess relapse risk factors.

Disease activity will be assessed using the Mayo score for UC patients and CDAI for Crohn's disease and endoscopic activity will be assessed using the Mayo endoscopic subscore for UC patients and the Simple Endoscopic Score for Crohn's Disease for CD patients.

Serum and fecal biomarkers will be obtainted at each study visit (C-reactive protein, fecal calprotectin).

Data about current and past medication for IBD will also be gathered.

Eligibility criteria: Inclusion Criteria:

* ulcerative colitis or Crohn's disease
* age over 18
* clinical remission
* signed informed consent

Exclusion Criteria:

* pregnant women
* refusal to sign informed consent

Primary outcomes:
measure: Clinical relapse
timeFrame: 1 year
measure: Prevalence of NAFLD
timeFrame: 1 year
measure: prevalence of vitamin D deficiency
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Colentina Clinical Hospital
Study officials:
affiliation: Clinical Hospital Colentina
name: Theodor Voiosu, Md
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dionne S, Hiscott J, D'Agata I, Duhaime A, Seidman EG. Quantitative PCR analysis of TNF-alpha and IL-1 beta mRNA levels in pediatric IBD mucosal biopsies. Dig Dis Sci. 1997 Jul;42(7):1557-66. doi: 10.1023/a:1018895500721.
citation: Voiosu T, Bengus A, Dinu R, Voiosu AM, Balanescu P, Baicus C, Diculescu M, Voiosu R, Mateescu B. Rapid fecal calprotectin level assessment and the SIBDQ score can accurately detect active mucosal inflammation in IBD patients in clinical remission: a prospective study. J Gastrointestin Liver Dis. 2014 Sep;23(3):273-8. doi: 10.15403/jgld.2014.1121.233.thv.
Clinical trial NCT06694922: Turkish Validation of the Adult Nutrition Literacy Tool
Official title: Turkish Validity and Reliability Study of the Adult Food and Nutrition Literacy Assessment Tool
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutrition
Keywords: Validity and Reliability
Nutrition
Food
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 849
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample in Ankara and Elazığ, Turkey

Brief summary: This study evaluated the validity and reliability of the Food and Nutrition Literacy Assessment Tool (FNLAT) in a sample of 849 Turkish adults. Reliability was tested using Cronbach's alpha, test-retest, and Pearson correlation, while construct validity was analyzed via factor analysis. Data were processed with SPSS and AMOS software.

Detailed description: Aim: The aim of this study is to evaluate the validity and reliability of the Food and Nutrition Literacy Assessment Tool in Turkey.

Subject and Methods: The study included 849 individuals aged 19-64 years (316 males, 563 females). A questionnaire containing socio-demographic characteristics and the " Food and Nutrition Literacy Assessment Tool (FNLAT)" and " General Nutrition Knowledge Questionnaire (GNKQ)" were used as data collection tools. Test-retest was performed on 60 individuals at 3-week intervals. Cronbach's alpha, test-retest, and Pearson correlation analyses were conducted to assess the reliability of the scale. The construct validity of the scale was determined using explanatory factor analysis. The data were analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 25.0 and AMOS 21 programs.

Eligibility criteria: Inclusion Criteria:

* People aged 19 to 64 years

Exclusion Criteria:

* Individuals diagnosed with psychiatric or neurological diseases
* Individuals with alcohol or drug addiction.

Primary outcomes:
measure: General Nutrition Knowledge Questionnaire (GNKQ) Assessment
timeFrame: Basaline
measure: Food and Nutrition Literacy Assessment Tool (FNLAT) Assessment
timeFrame: Basaline
Secondary outcomes:
measure: Sociodemographic characteristics
timeFrame: Basaline
measure: Body Mass Index (BMI)
timeFrame: Basaline
measure: Body weight
timeFrame: Basaline
measure: Height
timeFrame: Basaline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University
Study officials:
References:
Clinical trial NCT06993922: Dexmedetomidine as an Adjuvant to Bupivacaine in Scalp Block Versus Bupivacaine Alone for Postoperative Pain Management in Patients Undergoing Craniotomy
Official title: Dexmedetomidine as an Adjuvant to Bupivacaine in Scalp Block Versus Bupivacaine Alone for Postoperative Pain Management in Patients Undergoing Craniotomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dexmedetomidine
Adjuvant
Bupivacaine
Scalp Block
Postoperative Pain
Craniotomy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 50
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: This study aims to compare dexmedetomidine as an adjuvant to bupivacaine in scalp block versus bupivacaine alone for postoperative pain management in patients undergoing craniotomy.

Detailed description: Scalp block is proposed as a multimodal approach to preventing postoperative pain and hemodynamic responses to previous noxious stimulation during the operation.

The use of adjuvants, such as dexmedetomidine, a highly selective alpha-2 adrenergic receptor agonist, has recently been studied for its analgesic effects. Dexmedetomidine acts additionally to local anesthetics, prolonging their duration of action.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 65 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status I or II.
* Undergoing supratentorial elective planned craniotomies.

Exclusion Criteria:

* Patients refusal.
* History of known allergy to the used local anesthetic or dexmedetomidine.
* Bleeding disorders.
* Evidence of local infection at the site of injection.
* Emergency craniotomy.
* Psychotic disorder.
* Patients who will not be extubated in the operating room after surgery.

Primary outcomes:
measure: Cumulative postoperative morphine consumption
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Mean arterial pressure
timeFrame: 24 hours postoperatively
measure: Heart rate
timeFrame: 24 hours postoperatively
measure: Degree of pain
timeFrame: 24 hours postoperatively
measure: Time for 1st rescue analgesia
timeFrame: 24 hours postoperatively
measure: Incidence of complications
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References: