louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05822193: Incidence, Associated Factors, and Burden of Post COVID-19 Condition in Brazil
Official title: Incidence, Associated Factors, and Burden of Post COVID-19 Condition in Brazil
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post-Acute COVID-19 Syndrome
Lead sponsor: Inova Medical
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2023-04-20
Enrollment: 1694
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study target population is composed by adult participants with confirmed symptomatic COVID-19 during the SARS-CoV-2 omicron wave in Brazil (January 2022 to date, representing the period of time with absolute dominance of omicron as circulating variant). The study will include patients with distinct levels of acute illness severity (i.e., both outpatients and patients who required hospitalization for COVID-19).

Brief summary: This is a national retrospective cohort study with internet-based recruitment which intends to enroll 1,694 adult patients with COVID-19 diagnosis during the SARS-CoV-2 omicron wave in Brazil. Participants with confirmed symptomatic COVID-19 after january 2022 will be evaluated in order to assess incidence, potential risk factors and impact of post COVID-19 condition according to the WHO definition on health-related quality of life and other relevant patient-centered outcomes.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years;
* Brazilian resident;
* Symptomatica COVID-19 confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) or antigen test for SARS-COV-2 after January 2022, with diagnosis at least 90 days before recruitment.

Exclusion Criteria:

* No availability to participate in remote research appointments;
* Communication difficulty (aphasia, important hearing loss, non-portuguese speaker, severe dementia)
* Refuse to provide informed consent

Primary outcomes:
measure: Post COVID-19 condition according to the WHO definition
timeFrame: 3 to 24 months
measure: EQ5D-3L
timeFrame: 3 to 24 months
Secondary outcomes:
measure: Instrumental activities of daily living
timeFrame: 3 to 24 months
measure: Functional status
timeFrame: 3 to 24 months
measure: Cognition
timeFrame: 3 to 24 months
measure: Anxiety symptoms
timeFrame: 3 to 24 months
measure: Depression symptoms
timeFrame: 3 to 24 months
measure: Posttraumatic stress symptoms
timeFrame: 3 to 24 months
measure: Time to return to work or studies
timeFrame: 3 to 24 months
measure: Healthcare utilization
timeFrame: 3 to 24 months
measure: Costs
timeFrame: 3 to 24 months
Other outcomes:
Locations:
city: Cachoeirinha
country: Brazil
facility: Inova Medical
state: RS
Study officials:
References:
Clinical trial NCT01672593: Glue Sealing for Patients With Low-Output ECFs
Official title: A Randomized Controlled Trial to Evaluate Endoscopy Assisted Fibrin Glue Application in the Treatment of Low-Output ECFs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low-output External Gastrointestinal Fistula
Keywords: Autologous platelet rich fibrin glue;
Enterocutaneous fistulas;
Single low output GI fistulas;
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2012-08-27
Enrollment: 30
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: Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of low-output ECFs. The primary objectives of this study are to compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (PRFG) and a commercially available fibrin sealant Bioseal® in the management of patients with low-output volume ECFs.

Detailed description: * This is a prospective, randomized, single-centered study clinical, safety and economic outcome of ECFs patients.
* Subjects are randomized to one of 2 groups:

  * Group 1: Autologous PRFG-treatment (PRFG + SOC)
  * Group 2: Commercial FG-treatment (Bioseal® + SOC)
* Study will include three phases:

  * Phase 1: Screening, consent and enrollment
  * Phase 2: Patients will receive either PRFG, or Bioseal only for 14 days
  * Phase 3: Follow up: for patients with closed fistula within 14 days, we will follow up them for 6 months. For patients whose fistulas were still open will be treated with other therapeutic option and follow up for 6 months after closure.

Eligibility criteria: Inclusion Criteria:

* Patients with a single tubular ECF
* Low output volume (\<200 ml/24h)
* Tract length \>2cm
* Tract diameter \< 1cm

Exclusion Criteria:

* Cancer-infiltrated fistula
* Abscess
* Foreign bodies
* Distal bowel obstruction
* Inflammatory bowel disease

Primary outcomes:
measure: Clinical outcome
timeFrame: 14 days
Secondary outcomes:
measure: Safety outcome
timeFrame: up to 180 days
Other outcomes:
measure: Economic outcome
timeFrame: Upon enrollment, an expected average of 1 year
Locations:
city: Nanjing
country: China
facility: Department of Surgery, Jinling Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT00839293: Comparison of Fenofibric Acid Bioavailability From ABT-335 Capsules
Official title: Comparison of Fenofibric Acid Bioavailability From 45 mg and 135 mg Strength ABT-335 Capsules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioavailability
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2009-02-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
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 safety and compare the bioavailability of fenofibric acid from 2 different dosage strengths of ABT-335.


Eligibility criteria: Inclusion Criteria:

* A condition of general good health
* BMI 18 to 29

Exclusion Criteria:

* Currently enrolled in another clinical study
* Females who are pregnant or breast-feeding

Primary outcomes:
measure: To determine the bioavailability of ABT-335 in healthy subjects as measured by timed pharmacokinetic blood draws from pre-dose (0 hour) to 120 hours post dose
timeFrame: 14 Days
measure: To evaluate the safety and tolerability of ABT-335 in healthy adults after single dosage
timeFrame: 14 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Waukegan
country: United States
facility: Site Reference ID/Investigator# 16862
state: Illinois
Study officials:
affiliation: Abbott
name: Maureen Kelly, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03128593: A Study of JR-141 in Patients With Mucopolysaccharidosis Type II
Official title: A Phase I/II Study of JR-141 in Patients With Mucopolysaccharidosis Type II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Mucopolysaccharidosis II
Lead sponsor: JCR Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-04-25
Enrollment: 14
Sex: MALE
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study in patients with mucopolysaccharidosis type II (MPS II) is below,

* to collect the safety information of JR-141
* to evaluate the plasma pharmacokinetics of JR-141
* to explore the efficacy of JR-141 on MPS II-related central nervous system symptoms and general symptoms


Eligibility criteria: Inclusion Criteria:

* Patients aged 6 years or older at the time of informed consent.
* Patients diagnosed with MPS II.
* Patients who have received idursulfase (0.5 mg/kg/week) continuously for at least 12 weeks until the initial dose of JR-141.

Exclusion Criteria:

* Patients with a history of hematopoietic stem cell transplantation, excluding those who need enzyme replacement therapy even after hematopoietic stem cell transplantation.
* Patients in whom lumbar puncture cannot be performed.
* Patients who have developed serious drug allergy or hypersensitivity that is inappropriate for participation in the study.
* Patients who have received other investigational products within 4 months before enrollment in the study.

Primary outcomes:
measure: Number of participants with Adverse Events
timeFrame: 4 weeks
Secondary outcomes:
measure: Plasma Pharmacokinetic parameter [Maximum Plasma Concentration [Cmax]]
timeFrame: 4 weeks
measure: Plasma Pharmacokinetic parameter [Area Under the Curve [AUC]]
timeFrame: 4 weeks
measure: Urinary and serum heparan sulfate (HS) /dermatan sulfate (DS)
timeFrame: 4 weeks
measure: HS/DS in CSF
timeFrame: 4 weeks
measure: Urinary total GAG
timeFrame: 4 weeks
measure: Liver and spleen volumes
timeFrame: 4 weeks
measure: Cardiac function
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Gifu
country: Japan
facility: Gifu Clinical site
city: Kurume
country: Japan
facility: Fukuoka Clinical site
city: Minato
country: Japan
facility: Tokyo clinical site1
city: Osaka
country: Japan
facility: Osaka Clinical site1
city: Saitama
country: Japan
facility: Saitama Clinical site
city: Setagaya
country: Japan
facility: Tokyo clinical site2
city: Suita
country: Japan
facility: Osaka Clinical site2
city: Yonago
country: Japan
facility: Tottori Clinical site
Study officials:
References:
citation: Okuyama T, Eto Y, Sakai N, Minami K, Yamamoto T, Sonoda H, Yamaoka M, Tachibana K, Hirato T, Sato Y. Iduronate-2-Sulfatase with Anti-human Transferrin Receptor Antibody for Neuropathic Mucopolysaccharidosis II: A Phase 1/2 Trial. Mol Ther. 2019 Feb 6;27(2):456-464. doi: 10.1016/j.ymthe.2018.12.005. Epub 2018 Dec 8.
Clinical trial NCT04916093: Safety and Efficacy of Antidiabetic Drugs in Recently Diagnosed Patients With Type 2 Diabetes
Official title: Safety and Efficacy of Sitagliptin, Vildagliptin, and Metformin in Recently Diagnosed Drug-naïve Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
Collaborators: name: Minia University
First posted: 2021-06-07
Enrollment: 60
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 current study aims to investigate Sitagliptin and vildagliptin efficacy and safety compared to metformin as 1st line options for T2D patients.

Detailed description: This is a randomized case-controlled study in which drug-naive type-2 diabetic patients were divided into 3 groups and followed up for three months.

Eligibility criteria: Inclusion Criteria:

* Recently diagnosed type2 diabetic adult subjects who were not on an oral hypoglycemic drug (OHA) at the screening visit were eligible to participate.

Exclusion Criteria:

1. Type1 diabetes or ketoacidosis
2. End-organ failure as chronic renal failure (estimated serum creatinine level ≥ 1.5mg/dl in male and ≥ 1.4mg/dl in female)
3. Liver cell failure (elevated alanine transaminase (ALT ) and/or aspartate transaminase (AST) ≥ 2 folds)
4. Any stage of heart failure
5. Previous history of pancreatitis
6. Previous history of taking medication which may alter the efficacy of either drug eg: (other OHA drug, corticosteroids, and oral contraceptives)
7. Pregnant or lactating females

Primary outcomes:
measure: Changes in glycemic parameters
timeFrame: 3-months
measure: Changes in Serum insulin (IU/l)
timeFrame: 3-months
measure: Insulin resistance
timeFrame: 3-months
measure: Beta cell function (HOMA-B)
timeFrame: 3-months
measure: Changes in HbA1c (%)
timeFrame: 3-months
Secondary outcomes:
measure: Changes in Lipid profile
timeFrame: 3-months
measure: Changes in liver enzymes
timeFrame: 3-months
measure: Changes in Renal function tests
timeFrame: 3-months
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minya University Hospital
Study officials:
affiliation: BUC
name: Asmaa A Elsayed, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00828893: Navigation Guidance Gestures Carried Out Under CT
Official title: Interest of the Use of a Navigation Guidance Gestures Carried Out Under CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Drainage
Biopsy
Punction
Keywords: drain under scanner
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2009-01-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess the contribution of navigation systems recently developed to guide the punction needle.


Eligibility criteria: Inclusion Criteria:

* more or equal than 18 years old
* patient affiliated to social security or similarly regime
* patient sent to hospital for drain under CT

Exclusion Criteria:

* Pregnant women and lactating mothers
* Ward of court or under guardianship
* Adult unable to express their consent
* Person deprived of freedom by judicial or administrative decision
* Person hospitalized without their consent
* Person under legal protection
* Person participating in another clinical study

Primary outcomes:
measure: Maximum distance between the planned trajectory and trajectory achieved, defined for the needle of local anesthesia.
timeFrame: 2 hours
Secondary outcomes:
measure: Maximum distance between the planned trajectory and trajectory achieved by the needle puncture.
timeFrame: 2 hours
measure: Duration of intervention
timeFrame: 3 hours
measure: Dose irradiation and number of control scanners made
timeFrame: 3 hours
measure: overall satisfaction Score
timeFrame: 3 hours
measure: Success or failure of the final gesture made
timeFrame: 3 hours
measure: Number of attempts
timeFrame: 3 hours
measure: number of complications (per-operative, post-surgery)
timeFrame: 7 days
Other outcomes:
Locations:
city: Grenoble
country: France
facility: UniversityHospitalGrenoble
Study officials:
References:
citation: Robert AL, Chagnon G, Bricault I, Cinquin P, Moreau-Gaudry A. A generic three-dimensional static force distribution basis for a medical needle inserted into soft tissue. J Mech Behav Biomed Mater. 2013 Dec;28:156-70. doi: 10.1016/j.jmbbm.2013.07.023. Epub 2013 Aug 9.
Clinical trial NCT00367393: Reconstitution With Pimecrolimus Cream 1% of Steroid-damaged Skin in Adults With Atopic Dermatitis
Official title: An Open-label Multicenter 12-month Long Term Study on Skin Reconstitution With Pimecrolimus Cream 1% in Adult Patients With Atopic Eczema and Corticosteroid Induced Skin Damage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Keywords: Pimecrolimus, skin atrophy, dermoscopy, atopic dermatitis, eczema
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-08-22
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Topical steroid use may lead to skin deterioration and spider veins. This study will examine long-term management of atopic dermatitis (AD) over 12 months with pimecrolimus cream 1% and its effect on skin reconstitution of steroid-damaged skin and disease control.


Eligibility criteria: Inclusion Criteria:

* clinically diagnosed AD
* almost clear to mild AD (local IGA \[target lesions face and cubital areas\] score of 1-3)
* clinically (i.e. to the unaided eye) evident skin atrophy due to long-term topical steroid use
* Dermatophot Score (DPS - composed of skin atrophy and telangiectasia) of 4-6 on at least two target areas

Exclusion Criteria:

* Phototherapy or systemic therapy known or suspected to have an effect on AD within 4 weeks prior to study entry
* Topical therapy known or suspected to have an effect on AD within 7 days prior to study entry or systemic corticosteroids within 4 weeks prior to study entry
* Clinical conditions other than AD that according to investigator can interfere with the Dermatophot evaluation

Primary outcomes:
measure: • Decrease of the Dermatophot (a combination of a dermatoscope and a camera) score on skin deterioration and spider veins from baseline to end of the study
timeFrame: 48 weeks
Secondary outcomes:
measure: • Epidermal thickness by optical coherence tomography at selected investigational centers
timeFrame: 48 weeks
measure: Skin thickness by ultrasound at selected investigational centers
timeFrame: 48 weeks
measure: Epidermal thickness by 3mm punch biopsies (optional)
timeFrame: 48 weeks
measure: Skin metabolism by suction blisters.
timeFrame: 48 weeks
measure: Investigator's Global Assessment (IGA)
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Novartis
country: Germany
facility: Novartis
Study officials:
affiliation: Novartis
name: Novartis Pharm
role: STUDY_CHAIR
References:
citation: Reference: Thaci D et al TBD. CORTICOSTEROID-INDUCED SKIN DAMAGE IMPROVED WITH PIMECROLIMUS CREAM 1% TREATMENT: A 1-YEAR STUDY IN ADULTS WITH ATOPIC ECZEMA. European Academy of Dermatology and Venereology - 17th Congress. 2008; www.eadv.org
Clinical trial NCT00212693: Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in Japan
Official title: Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: ONO-2506PO, Parkinson's disease
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 165
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
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 efficacy and safety of ONO-2506PO in patients with Parkinson's Disease


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Parkinson's disease
2. Stage 2 - Stage 4 of revised Hoehn \& Yahr severity score
3. Taking L-dopa/DCI without changing dose and regimen
4. Having motor complication
5. Other inclusion criteria as specified in the study protocol

Exclusion Criteria:

1. Previous participation in ONO-2506PO or ONO-2506 protocol
2. Previous brain surgery for Parkinson's disease
3. Presence or history of serious cardiac disease
4. Other exclusion criteria as specified in the study protocol

Primary outcomes:
measure: Unified Parkinson's disease rating scale (Part III)
Secondary outcomes:
measure: Unified Parkinson's disease rating scale (Part I, II, IV and total), revised Hoehn & Yahr severity score and off time
Other outcomes:
Locations:
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader, Development Planning
role: STUDY_DIRECTOR
References:
Clinical trial NCT04805593: Clinical Investigation of the WaveLight® EX500 Excimer Laser
Official title: Clinical Investigation of the WaveLight® EX500 Excimer Laser for Hyperopic LASIK
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperopia
Hyperopic Astigmatism
Keywords: LASIK
Refractive errors
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2021-03-18
Enrollment: 44
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: The purpose of this study is to collect efficacy and safety data on the WaveLight EX500 excimer laser system for the correction of hyperopia with and without astigmatism by laser in situ keratomileusis (LASIK) treatment.

Detailed description: Qualified subjects will receive LASIK treatment in both eyes and be followed for 1 year. Subjects will be asked to attend a total of 9 visits (Screening, Surgery, Day 1, Week 1, Month 1, Month 3, Month 6, Month 9, and Month 12). Total expected duration of subject participation is approximately 1 year.

Eligibility criteria: Key Inclusion Criteria:

* Intended to treat bilaterally;
* Hyperopia with or without astigmatism as specified in the protocol;
* Stable vision as specified in the protocol;
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Glaucoma;
* Cataracts;
* Previous eye surgery;
* Intent to have monovision treatment;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within ±0.50 Diopter (D) at Refractive Stability
timeFrame: Up to Month 12 postoperative (Month 1 to Month 3, Month 3 to Month 6, Month 6 to Month 9, and Month 9 to Month 12)
measure: Percentage of Eyes With MRSE Within ±1.00 D at Refractive Stability
timeFrame: Up to Month 12 postoperative (Month 1 to Month 3, Month 3 to Month 6, Month 6 to Month 9, and Month 9 to Month 12)
measure: Percentage of Eyes Experiencing Ocular Adverse Events (AEs)
timeFrame: Up to Month 12 postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Durrie Vision
state: Kansas
city: Kansas City
country: United States
facility: Moyes Eye Center
state: Missouri
city: Greensboro
country: United States
facility: Physicians Protocol
state: North Carolina
city: W. Fargo
country: United States
facility: Vance Thompson Vision ND
state: North Dakota
city: Houston
country: United States
facility: Mann Eye Institute
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Sr. Clinical Trial Lead, Surgical
role: STUDY_DIRECTOR
References: