louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05406128: The Effect of Erector Spina Plan Block Application Time on Postoperative Anxiety
Official title: The Effect of Erector Spina Plan Block Application Time on Postoperative Anxiety in Cases of Lumbar Disc Hernioplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Recovery of Postoperative
Keywords: block timing
quality of recovery
erector spina plan block
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: we aimed to compare the effect of preoperative awake or post-induction erector spina plane block on patient anxiety and recovery quality in patients who will undergo elective lumbar disc hernioplasty.

Detailed description: Postoperative recovery quality can be tested with the Quality of Recovery-40 (QoR-40) questionnaire. Preoperative anxiety can be detected through structured and standardized screening with the State-Trait Anxiety Inventory (STAI) I and II. In our study, 108 patients between the ages of 18-70 who were planned for lumbar disc hernioplasty will be included. Preoperative Quality of Recovery-40 (QoR40), STAI I and II scores (anxiety questionnaire) will be administered to each patient.The patients will be divided into two groups as preoperative ve intraoperative group. Erector spina plane block will be applied to preoperative group patients in the preoperative period. In the intraoperative group, erector spina plane block will be applied after anesthesia induction. The STAI and Quality of Recovery-40 (QoR40) questionnaire will be repeated postoperatively, the Numerical Rating Scale (NRS) and postoperative patient satisfaction will be measured.

Eligibility criteria: Inclusion Criteria:

* 18-70 years old
* American Society of Anesthesiologists score I-II-III
* Patients who can read and write
* Can speak Turkish language clearly

Exclusion Criteria:

* Visual and hearing impaired
* Those with dementia
* Known serious heart, kidney and liver diseases
* Life-threatening hematological diseases
* Central and peripheral neurological diseases
* Psychiatric disorders
* History of allergy to amide type local anesthetics
* Infection in the block area
* Bleeding diathesis
* Morbidly obese (patients with BMI 40 and above)
* A history of narcotic drug use within 24 hours before the operation
* Those with narcotic substance and alcohol addiction related to chronic pain
* Patients who refused to participate in the study

Primary outcomes:
measure: The quality of postoperative functional recovery (QoR-40) score
timeFrame: 24 hours
Secondary outcomes:
measure: Spielberg State-Trait Anxiety Inventory (STAI) score
timeFrame: 4 hours
measure: Numerical Rating Scale (NRS)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
References:
Clinical trial NCT05446428: Evaluation of Type I IFN Level and Disease Activity in SLE Patients
Official title: Evaluation of Type I IFN Level and Disease Activity in SLE Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Elevated Level of IFN Type I in SLE Patients
Lead sponsor: V.A. Nasonova Research Institute of Rheumatology, Moscow
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2022-07-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 70 adult patients with SLE who receive inpatient or outpatient саre from 01.06.2022 (1 stage) 30 of them with moderate to severe disease activity (SLEDAI 2К ≥6) will be included in prospective observation (2 stage 01.06.2022-25.12.2023)

Brief summary: Elevated level of IFN type I in SLE patients associated with certain serum biomarkers (galectin -1,-3,-9; cytokine profile - 20 plex panel - GM-CSF, IFN-γ, IL-2, -4,-5,-6,-7,-8,-10,-13,-15,-17,-18, IP-10. MCP-1, MIG, MIP-1α, MIP-1β, RANTES, TNF-α, TNF-RII, BAFF, APRIL), clinical and laboratory manifestations, activity and duration pf the disease and SLE patients quality of life. Standard immunosuppressive and anti-B-cell therapy can reduce the IFN type I and associated biomarkers levels in patients with high and moderate disease activity (SLEDAI-2К ≥6).


Eligibility criteria: Inclusion Criteria:

1. Age 18-60 years old
2. Patients with SLE (SLICC/ACR 2012) confirmed by rheumatologist
3. Provided written informed consent before any study-related procedures are performed.
4. Ability to attend scheduled visits
5. No positive changes in the course of standard of care SLE therapy (glucocorticoids in stable doses, hydroxychloroquine and/or immunosuppressant therapy) at least 30 days before screening.

Exclusion Criteria:

1. Participation in any other clinical study
2. Pregnancy or pregnancy planning in next 12 months, lactation
3. Acute infectious disease or relapse of chronic infectious disease.
4. Receiving any of biologic agent or Janus-kinases inhibitors during 24 months prior to screening.
5. Active severe or unstable neuropsychiatric SLE manifestations (convulsion, psychosis, delirium, hallucinations, coma, transverse myelitis).

Primary outcomes:
measure: Pathogenetic, clinical and prognostic significance of IFN stimulated genes expression - IFNGS biomarkers in SLE patients
timeFrame: Sept 1 2022 - Nov 1 2022
Secondary outcomes:
measure: Rate of IFN stimulated genes
timeFrame: Nov 1 2022 - Oct 31 2024
measure: IFN stimulated genes hyper-expression and serum biomarkers level
timeFrame: Nov 1 2022 - Oct 31 2024
measure: IFNGS
timeFrame: Nov 1 2022 - Oct 31 2024
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04403828: Impact of COVID-19 on Personal Protection Among Dentist in Egypt
Official title: Impact of COVID-19 on Personal Protection Among Dentist in Egypt: A Quick Online Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID 19
Keywords: COVID-19
Personal Protection
Dentist
Egypt
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: dentist

Brief summary: Dentist exposed to coronavirus (COVID-19) may not have adequate access to personal protective equipment (PPE), safety procedures, and diagnostic protocols. Our objective will be to evaluate the reality and perceptions about personal safety among dentist in Egypt

Detailed description: This is a cross-sectional, online survey-based study administered to Dentist in Egypt. A 20-item questionnaire will be developed and distributed using Google Forms.

Participants were recruited through social networking websites and applications (Twitter, Instagram, Facebook, LinkedIn, and WhatsApp). The questionnaire will be conducted from 24 May 2020 and until 30 june 2020.

The survey will be delivered in Enlish. Participants will be able to complete the survey only once and will be allowed to terminate the survey at any time they desired. The survey will be anonymous and confidential. An introductory paragraph outlining the purpose of the study will be posted along with the survey.

Eligibility criteria: Inclusion Criteria:

All dentist actively working in Egypt

Exclusion Criteria:

* non dentist
* resident outside egypt

Primary outcomes:
measure: Personal protection measures
timeFrame: one week
Secondary outcomes:
measure: impact of Covid-19 pandemic on type of face masks used in dental clinic
timeFrame: one week
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
citation: Odeh ND, Babkair H, Abu-Hammad S, Borzangy S, Abu-Hammad A, Abu-Hammad O. COVID-19: Present and Future Challenges for Dental Practice. Int J Environ Res Public Health. 2020 Apr 30;17(9):3151. doi: 10.3390/ijerph17093151.
citation: Ather A, Patel B, Ruparel NB, Diogenes A, Hargreaves KM. Coronavirus Disease 19 (COVID-19): Implications for Clinical Dental Care. J Endod. 2020 May;46(5):584-595. doi: 10.1016/j.joen.2020.03.008. Epub 2020 Apr 6.
citation: Alharbi A, Alharbi S, Alqaidi S. Guidelines for dental care provision during the COVID-19 pandemic. Saudi Dent J. 2020 May;32(4):181-186. doi: 10.1016/j.sdentj.2020.04.001. Epub 2020 Apr 7.
Clinical trial NCT00615628: Inheritance of Osteosarcoma & Paget's Disease Through Chromosome 18:
Official title: Inheritance of Osteosarcoma & Paget's Disease Through Chromosome 18: Examination of Osteosarcoma Tissue Samples From Two Family Members for Loss of Heterozygosity in the Chromosome 18 Region, Genetically Linked With Paget's Disease of Bone
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteosarcoma
Paget's Disease
Keywords: Inheritance of Osteosarcoma & Paget's Disease through Chromosome 18
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2008-02-14
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a familial study therefore the only inclusion/exclusion criteria would be that subjects must be a blood relative and over the age of 18. The subjects are proband and father along with unaffected blood relatives. Their peripheral blood will act as a control and provide information to delineate the inheritance from the father, as seen in the son.

Brief summary: Researchers have previously demonstrated loss of heterozygosity in a region on chromosome 18q, associated with osteogenic sarcomas in bone affected by Paget's disease. The loci used in this study are specifically described by those authors as showing loss of heterozygosity in 6 of 7 affected families.

Detailed description: As above, no additional information

Eligibility criteria: Inclusion Criteria:

* This is a familial study therefore the only inclusion/exclusion criteria would be that subjects must be a blood relative and over the age of 18.
* The subjects are proband and father along with unaffected blood relatives. Their peripheral blood will act as a control and provide information to delineate the inheritance from the father, as seen in the son.

Exclusion Criteria:

* Not part of the family

Primary outcomes:
measure: Loss of heterozygosity
timeFrame: January, 2000 through February 2009
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
affiliation: State University of New York - Upstate Medical University
name: Timothy A Damron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04229628: Hypertension and Diabetes Mellitus Community Management Center(HAD-COME) Project
Official title: Establishment of Hypertension and Diabetes Mellitus Community Management Center(HAD-COME) Project
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Diabetes Mellitus
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 100000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypertension Diabetes mellitus

Brief summary: To develop and implement quality improvement programs for the treatment and management of hypertension and diabetes,and preventing and controlling hypertension and diabetes-related diseases in Chinese community. This program will use data collection, analysis, feedback, and process improvement to extend the use of evidence-based guidelines throughout the healthcare system and improve patient care of hypertension and diabetes in Chinese community.

Detailed description: The aim of this project was to improving care for hypertension and diabetes mellitus in Chinese community. Study population including subjects who are hypertension and/or diabetes mellitus, of any race or ethnicity, any age.

Eligibility criteria: Inclusion Criteria:

* In accordance with the diagnosis of essential hypertension;
* In accordance with the diagnosis of type 2 diabetes mellitus.

Exclusion Criteria:

* Non-type 2 diabetes patients
* Secondary hypertension
* Non-hypertensive patients
* Type 1 diabetes or other types of diabetes

Primary outcomes:
measure: Proportion of community hypertension patients receiving treatment as Chinese guideline recommended
timeFrame: at the time of enrollment
measure: Proportion of community diabetes mellitus patients receiving treatment as Chinese guideline recommended
timeFrame: at the time of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Feng Ying-qing, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00139828: Post Marketing Study in Haemophilia B Patients Using Nonafact® (Human Coagulation Factor IX)
Official title: Post Marketing Study in Haemophilia B Patients Using Nonafact® 100 IU/ml Powder and Solvent for Solution for Injection(Human Coagulation Factor IX)(Human Plasma Derived Factor IX Product, Freeze Dried)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemophilia B
Keywords: haemophilia B
factor IX
Product Surveillance, Postmarketing
plasma products
Lead sponsor: Prothya Biosolutions
Sponsor class: INDUSTRY
First posted: 2005-08-31
Enrollment: 12
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this postmarketing study, the safety of Nonafact® (human coagulation factor IX) is evaluated in previous treated and untreated patients with severe, moderate or mild haemophilia B.

Detailed description: The clinical efficacy and safety of Nonafact® has been shown in two pre-authorisation studies. Marketing authorisation for the EU was granted 3 July 2001. The Post Marketing Study, which evaluates the clinical efficacy, immunogenicity and safety of Nonafact®, is set up according to CPMP/BPWG /198/95, rev. 1 (Final, London, 19 October 2000) 'Note for guidance on the clinical investigation of human plasma derived factor VIII and IX products'

Eligibility criteria: Inclusion Criteria:

* Haemophilia B (mild, moderate or severe), Haemophilia B Leyden or symptomatic carriers of Haemophilia B and Haemophilia B Leyden
* Above the age of six, at the moment of inclusion
* Tested positive for HAV and HBV antibodies, induced by infection or vaccination, and negative for HBsAg
* Informed consent signed by the patients or his legally accepted representative

Exclusion Criteria:

* Under the age of six, at the moment of inclusion
* Tested negative for HAV and HBV antibodies

Primary outcomes:
measure: Number of bleeding episodes (efficacy after administration)
timeFrame: 24 months
measure: Haematological variables and clinical chemistry (safety)
timeFrame: 24 months
measure: Adverse events (safety)
timeFrame: 24 months
Secondary outcomes:
measure: Occurrence of antibodies to factor IX
timeFrame: 24 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre
city: Haarlem
country: Netherlands
facility: Kennemer Gasthuis
city: Leiden
country: Netherlands
facility: LUMC
city: Nijmegen
country: Netherlands
facility: UMC St. Radboud
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Centre
city: The Hague
country: Netherlands
facility: Leyenburg Hospital
city: Utrecht
country: Netherlands
facility: Van Creveldkliniek
Study officials:
affiliation: UMC Utrecht, Van Creveldkliniek, Utrecht, The Netherlands
name: E P Mauser-Bunschoten, MD, PdD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05861128: Extension Study to Evaluate Safety and Efficacy of Jaktinib in Patients With Active Ankylosing Spondylitis(AS)
Official title: An Open-Label, Multicenter, Extension Study to Assess the Long-Term Safety and Efficacy of Jaktinib in Patients With Active Ankylosing Spondylitis(AS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Ankylosing Spondylitis
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2023-05-16
Enrollment: 258
Sex: ALL
Minimum age (years): 18
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 determine if Jaktinib is safe and effective in participants with active ankylosing spondylitis.


Eligibility criteria: Inclusion Criteria:

* The investigators concluded that the participants continued to benefit from treatment with Jaktinib.
* The participants have been fully informed and voluntarily signed informed consent.
* The participants completed the ZGJAK029 study for 16 weeks of treatment and visitation and had good compliance.
* The interval between the participants' first dose and the last dose of ZGJAK029 ≤ 4 weeks.

Exclusion Criteria:

* There were any grade ≥3 adverse events within 4 weeks prior to enrollment and no return to grade 1 or normal.
* Within 4 weeks prior to enrollment, participants had the following infectious diseases: tuberculosis infection requiring treatment; HIV-positive, syphilis, HBV infection, HCV infection.
* The investigators considered participants unsuitable for this study.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Related Discontinuations at 32 Weeks
timeFrame: Baseline up to Week 32
Secondary outcomes:
measure: Percentage of Participants Achieving ASAS20 Response at Week 4, 8, 12, 16，20，24，28 and 32
timeFrame: Baseline, Week 4, 8, 12, 16，20，24，28 and 32
measure: Percentage of Participants Achieving ASAS40 Response at Week 4, 8, 12, 16，20，24，28 and 32
timeFrame: Baseline, Week 4, 8, 12, 16，20，24，28 and 32
measure: Change From Baseline in Patient's Assessment of Spinal Pain: Total Back Pain at Week 4, 8, 12, 16，20，24，28 and 32
timeFrame: Baseline, Week 4, 8, 12, 16，20，24，28 and 32
measure: Percentage of Participants Achieving ASAS 5/6 Response at Week 4, 8, 12, 16，20，24，28 and 32
timeFrame: Baseline, Week 4, 8, 12, 16，20，24，28 and 32
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Chunde Bao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03998228: Association Between Dermatoporosis and Fractural Risk
Official title: Association Between Dermatoporosis and Fractural Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dermatoporosis
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2019-06-26
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Major patients who are to perform dual X-ray absorptiometry (DMO) densitometry.

Brief summary: There is a need for new tools to identify patients who may have osteoporosis before a fracture occurs.


Eligibility criteria: Inclusion Criteria:

* Patient aged between 40 and 90 years old who has to undergo a bone densitometry (BMD) examination by dual X-ray absorptiometry
* Affiliate or beneficiary of a Social Security scheme
* Express consent to participate in the study.

Exclusion Criteria:

* Patient benefiting from a legal protection measure
* Pregnant or nursing woman.

Primary outcomes:
measure: compare fracture risk between patients with dermatoporosis and those without dermatoporosis
timeFrame: BASELINE
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation Adolphe de Rothschild
Study officials:
affiliation: Hôpital Fondation Adolphe de Rothschild
name: Thomas SENE, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01234428: Esophageal Dysmotility and Dilatation After Laparoscopic Gastric Banding
Official title: Esophageal Dysmotility Disorders Following Laparoscopic Gastric Banding - An Underestimated Complication.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Motility Disorders
Keywords: laparoscopy
adjustable gastric banding
morbid obesity
esophageal motility
esophageal dilatation
Lead sponsor: Spital STS AG
Sponsor class: INDUSTRY
Collaborators: name: Department of Medicine, Spital STS AG Thun
First posted: 2010-11-04
Enrollment: 167
Sex: ALL
Minimum age (years): 18
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 determine whether esophageal dysmotility and dilatation is an important complication in the long term follow-up following laparoscopic gastric banding for morbid obesity.

Detailed description: Using a yearly barium swallow the diameter of the esophagus will be monitored over the period.

Eligibility criteria: Inclusion Criteria:

* BMI more than 40

Exclusion Criteria:

* BMI below 40

Primary outcomes:
measure: esophageal dilatation
timeFrame: yearly follow-up over 12 year period
Secondary outcomes:
Other outcomes:
Locations:
city: Thun
country: Switzerland
facility: Department of Surgery, Spital STS AG Thun
Study officials:
affiliation: Spital STS AG Thun, Switzerland
name: Markus Naef, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Naef M, Mouton WG, Naef U, van der Weg B, Maddern GJ, Wagner HE. Esophageal dysmotility disorders after laparoscopic gastric banding--an underestimated complication. Ann Surg. 2011 Feb;253(2):285-90. doi: 10.1097/SLA.0b013e318206843e.
Clinical trial NCT02655328: Diagnosis et Treatment of Asthma in Athlete : Boundary Between Disease and Doping
Official title: Diagnosis et Treatment of Asthma in Athlete : Boundary Between Disease and Doping
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: asthma
athlete
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will determine the pharmacokinetic profile of the salbutamol concentration in the urine while athletes are resting or during exercise.


Eligibility criteria: Inclusion Criteria:

* patient who hold a license in a sport federation, and do at least 8 hours of sport each week
* asthmatic patient

Exclusion Criteria:

-

Primary outcomes:
measure: impact of exercise on pharmacokinetics profile
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: UH Toulouse
Study officials:
affiliation: UH Toulouse
name: Daniel Rivière, MD
role: PRINCIPAL_INVESTIGATOR
References: