louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05415189: Lifetime Incidence and Socio-economic Implications of Mental Illness
Official title: Lifetime Incidence and Socio-economic Implications of Mental Illness - a Nationwide Population-based Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Illness
Keywords: Mental Illness
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2022-06-13
Enrollment: 1500000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study was based on a randomly selected 1,500,000 sample of all persons who were registered in Statistics Denmark on the 1st of January 1995.

Brief summary: The purpose of the present study is to estimate the lifetime incidence of any mental disorder in a nationwide population-based register linkage study for the Danish population and to estimate the influence on socio-economic functioning.

Detailed description: The purpose of the present study is to estimate the lifetime incidence of any mental disorder in a nationwide population-based register linkage study for the Danish population in total and according to gender and to estimate the influence on socio-economic functioning. The investigaters hypothesised that the lifetime incidence of any mental disorder is substantially higher than hitherto believed.

Eligibility criteria: Inclusion Criteria:

* The study was based on a randomly selected 1,500,000 sample of all persons who were registered in Statistics Denmark on the 1st of January 1995.

Exclusion Criteria:

* None

Primary outcomes:
measure: Any psychiatric disorder or any psychotropic medication according to data in Danish nationwide registers
timeFrame: January 1, 1995 to December 31, 2020
Secondary outcomes:
measure: Diagnosis of any psychiatric disorder according to data in Danish nationwide registers
timeFrame: January 1, 1995 to December 31, 2020
Other outcomes:
measure: Socio-economic functioning in relation to individuals recorded with the primary outcome according to data in Danish nationwide registers
timeFrame: January 1, 1995 to December 31, 2020
Locations:
city: Copenhagen
country: Denmark
facility: Psychiatric Center Copenhagen
Study officials:
affiliation: Psychiatric Center Copenhagen
name: Lars V Kessing, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01236989: Prognostic Impact of Anatomical Resection Vs. Non-anatomical Resection for HCC
Official title: Anatomical Liver Resection by Means of Ultrasound-guided Vessel Compression Versus Non-anatomical Resection for Hepatocellular Carcinoma: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients Affected by Hepatocellular Carcinoma
Disease-Free Survival
Overall Survival
Keywords: anatomical resection
non-anatomical resection
IOUS-guided finger compression
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2010-11-09
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prognostic impact of AR vs NAR

Detailed description: Whether anatomical is better than non anatomical resection for HCC is still debated. This prospective randomized study aimed to address which approach is better in terms of patients prognosis.

Eligibility criteria: Inclusion Criteria:

* patient affected by single HCC
* patients in whom liver resection is indicated
* HCC without vascular invasion and/or thrombosis

Exclusion Criteria:

* multinodular HCC
* metastatic disease
* spontaneous tumor rupture

Primary outcomes:
measure: the prognostic impact of anatomical resection by means of intraoperative ultrasound (IOUS) guided vessel compression versus nonanatomical resection in terms of disease free and overall survival
timeFrame: 5-years
Secondary outcomes:
measure: the impact of anatomical resection versus non-anatomical resection in terms of postoperative mortality and morbility
timeFrame: 30 and 90 days
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas
state: Milan
Study officials:
affiliation: IRCCS Istituto Clinico Humanitas, Milan, Italy
name: Guido Torzilli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hasegawa K, Kokudo N, Imamura H, Matsuyama Y, Aoki T, Minagawa M, Sano K, Sugawara Y, Takayama T, Makuuchi M. Prognostic impact of anatomic resection for hepatocellular carcinoma. Ann Surg. 2005 Aug;242(2):252-9. doi: 10.1097/01.sla.0000171307.37401.db.
citation: Torzilli G, Procopio F, Cimino M, Del Fabbro D, Palmisano A, Donadon M, Montorsi M. Anatomical segmental and subsegmental resection of the liver for hepatocellular carcinoma: a new approach by means of ultrasound-guided vessel compression. Ann Surg. 2010 Feb;251(2):229-35. doi: 10.1097/SLA.0b013e3181b7fdcd.
citation: Torzilli G, Makuuchi M. Ultrasound-guided finger compression in liver subsegmentectomy for hepatocellular carcinoma. Surg Endosc. 2004 Jan;18(1):136-9. doi: 10.1007/s00464-003-9024-x. Epub 2003 Nov 21.
Clinical trial NCT03827889: Efficacy of Two Protocols for Applying Fluorine Varnish to Deciduous Teeth
Official title: Efficacy of Two Protocols for Applying Fluorine Varnish to Initial Active Lesions of Deciduous Teeth: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Dental Caries
Keywords: dental caries
Tooth, Deciduous
Fluorides, Topical
Lead sponsor: Universidade Ibirapuera
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 168
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evidence that the data flow analysis tests, there are still no studies that show the clarity of the protocols of its application, including the interval and execution factors of applications, concentration of fluoridation and previous prophylaxis. That is, there are still large gaps regarding fluoride varnish applications. Thus, the objective of the present project is the selection of two protocols for application of fluid applications in active drugs in primary tooth enamel. The longitudinal follow-up will be performed in a period of 3, 6, 12, 18 and 24 months after the procedure. The progression of a subject will be evaluated clinically through the transition of ICDAS scores and assessment of the lesions (sound examination with superficial measurements) by visual examination, and the physician evaluates the efficacy and the ability to evaluate the therapeutic techniques and evaluation. treatment, cost and quality of life of participants


Eligibility criteria: Inclusion Criteria:

* Children with active carious lesions scores 1, 2 or 3 of the ICDAS in deciduous teeth

Exclusion Criteria:

* Patients with special needs;
* Patients using orthodontic appliances;
* systemic diseases;
* Teeth that present restorations, sealants, formation defects, deep caries lesions that may lead to pulp involvement, fistulae and / or abscesses;
* teeth with spontaneous painful symptomatology.

Primary outcomes:
measure: PROGRESSION OF CARIES LESIONS (caries lesions inactivation assessment)
timeFrame: Every 6 months up to 24 months
Secondary outcomes:
measure: Number of surfaces with NEW CARIES LESIONS
timeFrame: Up to 24 months
measure: Children self-reported discomfort
timeFrame: baseline (Immediately after procedure)
measure: COST-EFFICACY of each protocol
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade Ibirapuera
Study officials:
References:
Clinical trial NCT03480789: the Influence of Sleep Improvement Through Different Methods on Patients in ICU
Official title: the Influence of Sleep Improvement Through Different Methods on Patients in ICU
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Problems
Sleep
Lead sponsor: Chinese Medical Association
Sponsor class: NETWORK
First posted: 2018-03-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the research, we enroll 120 postoperative patients in the ICU and they will be assigned to four group: the eye patch group, the Dexmedetomidine(DEX) group, the eye patch+DEX group and the usual group. The sleep quality would be evaluated by the EEG monitor and the metabolic level, the inflammation and nutrition status would be detected.

Detailed description: In the research, we enroll 120 postoperative patients in the ICU and they will be assigned to four group: the eye patch group, the Dexmedetomidine(DEX) group, the eye patch+DEX group and the usual group. The sleep quality would be evaluated by the EEG monitor and the metabolic level, the inflammation and nutrition status would be detected. The research aims to confirm that the sleep quality could have a great influence on patients in the ICU and different interventions would make various changes.

Eligibility criteria: Inclusion Criteria:

* the postoperative patients that admission to icu is more than 48h

Exclusion Criteria:

* pregnant or breastfeeding
* sleep disorders before operation
* poor liver or kidney function
* post craniocerebral operation

Primary outcomes:
measure: the total time of sleep
timeFrame: the first 24hours in the icu
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affliated Drum Tower Hospital, Medical School of Nanjing University
state: Jiangsu
Study officials:
References:
Clinical trial NCT02140489: Evaluating a Pharmacokinetic Drug Interaction Between Amlodipine/Losartan and Rosuvastatin
Official title: An Open-label, Randomized, Single-dose Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Amlodipine/Losartan and Rosuvastatin in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2014-05-16
Enrollment: 30
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the drug-drug interaction between amlodipine/losartan and rosuvastatin in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male
* Age between 19 and 55
* Signed informed consent

Exclusion Criteria:

* Presence of medical history or a concurrent disease
* Has a history of hypersensitivity to IP ingredients

Primary outcomes:
measure: Cmax
timeFrame: 0-72h
measure: AUClast
timeFrame: 0-72h
Secondary outcomes:
measure: tmax
timeFrame: 0-72h
measure: t1/2
timeFrame: 0-72h
measure: AUCinf
timeFrame: 0-72h
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samgsung Seoul Hospital
Study officials:
affiliation: Samsung Seoul Hospital
name: JaeWook Ko, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01847989: Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers
Official title: A Randomized, Placebo-controlled Single-dose, Double-blind Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Congenital Bleeding Disorder
Congenital FXIII Deficiency
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-05-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial was conducted in Europe. The aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Normal platelet count and clotting parameters
* Adequate renal and hepatic function
* If female and of child-bearing potential, negative serum pregnancy test within 21 days of enrollment and a negative urine pregnancy test on admission to the clinical research unit
* If a sexually active male or a sexually active female of child-bearing potential,agreement to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits
* Negative drug and alcohol screens

Exclusion Criteria:

* Known antibodies or hypersensitivity to FXIII
* Known bleeding or hematologic disorder
* Known allergy to yeast
* Receipt of blood products within 30 days of screening
* Donation of blood within 30 days prior to enrollment
* Any surgical procedure in the 30 days prior to enrollment
* Previous history of autoimmune disorders involving autoantibodies, e.g., systemic lupus erythematosus
* Receipt of treatment with any experimental agent within 30 days of study enrollment

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Days 0-28
Secondary outcomes:
measure: Incidence of clinically significant changes from baseline in physical examination or laboratory measurements
timeFrame: Days 0-28
measure: Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay)
timeFrame: Days 0-28
measure: Incidence of yeast antibodies
timeFrame: Days 0-28
Other outcomes:
Locations:
city: Berkshire
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Visich JE, Zuckerman LA, Butine MD, Gunewardena KA, Wild R, Morton KM, Reynolds TC. Safety and pharmacokinetics of recombinant factor XIII in healthy volunteers: a randomized, placebo-controlled, double-blind, multi-dose study. Thromb Haemost. 2005 Oct;94(4):802-7. doi: 10.1160/TH05-04-0292.
Clinical trial NCT06738589: The Inflate Study; Defining the Soft Palate in the Upper Airway Flow Pathway
Official title: The Inflate Study; Defining the Soft Palate in the Upper Airway Flow Pathway
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Focus of the Study is the Anatomy of the Soft Palate
Non-invasive Ventilation
Keywords: Soft Palate
MRI
NIV
Airway
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
Collaborators: name: The University of Auckland
First posted: 2024-12-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to understand the impact of the size and shape of the soft palate on gas airflow in the upper airway in healthy volunteers. Utilizing Magnetic Resonance Imaging (MRI), this study aims to investigate:

* How does soft palate anatomy change in different body positions?
* What is the impact of positive pressure therapy, in the form of non-invasive ventilation (NIV) on soft palate anatomy? Researchers will compare MRI data without positive pressure to with positive pressure imaging to see if the addition of positive pressure impacts the size and shape of the soft palate.

Researchers will also utilize measures of upper airway resistance to assess the impact of soft palate anatomy of airflow dynamics.

Participants will be asked to:

* Lie inside an MRI scanner for up to 90 minutes (including breaks), in different body positions
* Undergo NIV therapy for 5-10 minutes while breathing normally inside an MRI scanner
* Have their upper airway resistance measured, in different body positions


Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 18+
* Willing and able to consent to the study

Exclusion Criteria:

* Contraindications for MRI (such as metal implants)
* Contraindications for NIV (such as pneumothorax)
* No history of lung or upper airway disease
* Claustrophobia
* Symptoms of a cold, flu, or significant congestion, within the last 3 days
* Self-reported confirmed or suspected pregnancy
* Palatal abnormalities or previous upper airway surgery (such as cleft palate and/or UPPP)
* Prior major head or neck surgery with or without irradiation (such as radiotherapy of cutaneous cancers, robotic surgery for an oropharyngeal cancer)

Primary outcomes:
measure: Volumetric change of soft palate airway size in delta millimeters cubed,
timeFrame: Single 2 hour visit
Secondary outcomes:
measure: Impact of positive pressure ventilation on airway volume in millimeters cubed,
timeFrame: Single 2 hour visit
measure: Upper airway resistance measurements
timeFrame: Single 2 hour visit
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: University of Auckland
Study officials:
affiliation: University of Auckland, New Zealand
name: Alys Clark
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00311389: A 12-Month Study to Evaluate the Efficacy and Safety of Once-Daily Instillation of Combination Glaucoma Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official title: A 12-Month Study to Evaluate the Efficacy and Safety of Once-Daily Instillation of Combination Glaucoma Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma, Open-angle
Ocular Hypertension
Keywords: Glaucoma
POAG
OAG
OHT
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-04-06
Enrollment: 408
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: The purpose of this study is to evaluate the intraocular pressure(IOP)-lowering efficacy of a combination IOP-lowering therapy in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

- As specified in protocol

Exclusion Criteria:

- As specified in protocol

Primary outcomes:
measure: Mean Intraocular Pressure (IOP)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Puurs
country: Belgium
facility: European Facilitiies
Study officials:
References:
Clinical trial NCT02275689: Radiofrequency Microtenotomy for Treatment of Rotator Cuff Tendinopathy
Official title: Alternative Treatment of Rotator Cuff Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Impingement Syndrome
Keywords: Rotator cuff
Tendinosis
Impingement
radiofrequency
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2014-10-27
Enrollment: 34
Sex: ALL
Minimum age (years): 30
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 compare the outcome (pain, function) after Radiofrequency microtenotomy (group I) and acromioplasty (group II) for treatment of rotator cuff tendinosis in the shoulder.

The outcome of both methods will be compared to the physical therapy treatment (groupIII)

Detailed description: Rotator cuff tendinosis cause pain and disability of the shoulder. Tendinosis, sometimes complicated by partial rupture, appears to be the major lesion in chronic rotator cuff tendinopathy. Important features is a poor intrinsic ability to heal.

Several patients receive treatment for shoulder tendinosis each year. Conservative treatments options include rest, stretching, strengthening, ice and/or physical therapy are used with difference results. A traditional surgical treatments (acromioplasty) have been reported with variable results..

The aim of this study is to evaluate improvement of VAS and functionality using Constant score before and after treatment of rotator cuff tendinosis using radiofrequency-plasma based microtenotomy in comparison to traditional acromioplasty and physical therapy.

Eligibility criteria: Inclusion Criteria:

* Impingement pain in the shoulder at least 3 months
* MRI of shoulder reveal tendinosis
* Classification of Acromion morphology by RTG and or MRI
* daily pain

Exclusion Criteria:

* inflammatory joint disease
* Other comorbidity in the shoulder as instability, osteoarthritis or rotator cuff tear
* serious illness

Primary outcomes:
measure: Change from baseline in VAS for pain
timeFrame: every 2 weeks. during 6 months
measure: Change from baseline in VAS for pain,
timeFrame: 6 weeks, 6 months, and 12 months
Secondary outcomes:
measure: Change from baseline in functionality measured by constant score
timeFrame: 6 weeks, 6 months and 12 months
Other outcomes:
Locations:
city: Tromsoe
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: University Hospital of North Norway. 9038-Tromsø. Norway
name: Khaled Meknas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06607289: National Longitudinal Cohort of Hematological Diseases (NICHE) - CART
Official title: National Longitudinal Cohort of Hematological Diseases (NICHE) - CART
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematological Malignancies
Keywords: Chimeric antigen receptors (CAR) T cell
hematological malignancies
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hematologic malignancies treated with Chimeric antigen receptors (CAR) T therapy in China

Brief summary: This is a multicenter, ambispective, longitudinal, observational cohort study investigating CAR-T cell therapy in Chinese patients with hematological malignancies. A consortium of Phase IV clinical trials and real-world studies of Chimeric antigen receptors (CAR) T cell therapy will be established in China. Patient-level data from these studies will be collected to create a large real-world cohort. In addition, patients receiving CAR-T cell therapy for hematological malignancies identified from an existing hematology longitudinal cohort study, the National Longitudinal Cohort of Hematological Diseases (NICHE), will also be included in the study.


Eligibility criteria: Inclusion Criteria:

* Patients with clinically diagnosed hematologic malignancies
* Patients treated with CAR-T cell therapy
* Signed the informed consent form

Primary outcomes:
measure: Long-term overall remission rate
timeFrame: 5 years
Secondary outcomes:
measure: Complete remission rate
timeFrame: 1 year, 2 years, 5 years
measure: Partial remission rate
timeFrame: 1 year, 2 years, 5 years
measure: Long-term safety
timeFrame: 5 years or more
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital
state: Tianjin
Study officials:
References: