louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01136252: Intravitreal Adalimumab in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Official title: Open-label Clinical Trial to Evaluate Safety and Efficacy of Intravitreal Adalimumab in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration Non-responders to the Conventional Treatment With Ranibizumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Age-Related Macular Degeneration
Choroidal Neovascularization
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 5
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: Adalimumab is a humanized recombinant monoclonal antibody fragment targeted against tumor necrosis factor. This study will assess the safety and efficacy of intravitreal adalimumab administered in patients with choroidal neovascularization secondary to age-related macular degeneration non-responders to the conventional treatment with intravitreal ranibizumab.


Eligibility criteria: Inclusion Criteria:

- Choroidal neovascularization secondary to age-related macular degeneration non-responders to the conventional treatment with ranibizumab (active choroidal neovascularization after loading phase of one injection per month for three consecutive months, followed by a maintenance phase with 5 injections in the last 12 months or 3 injections in the last 6 months

Exclusion Criteria:

* Only one functional eye
* Hypersensitivity to adalimumab or any component of the formulation
* Previous systemic treatment with adalimumab
* Cancer
* Life expectancy \<1 year

Primary outcomes:
measure: Patients proportion with electroretinogram alterations
timeFrame: 6 months
Secondary outcomes:
measure: Changes in retinal thickness measured by ocular coherence tomography
timeFrame: once a month to 6 months
measure: Changes in best corrected visual acuity
timeFrame: once a month to 6 months
measure: Incidence of adverse events
timeFrame: until 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Servicio de Oftalmologia. Hospital Universitario Vall d'Hebron
Study officials:
affiliation: Hospital Vall d'Hebron
name: Miguel A Zapata, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04764500: Developing Microbials to Fight Extended-spectrum Beta-lactamase (ESBL)-Producing Escherichia Coli
Official title: Developing Microbials to Fight Extended-spectrum Beta-lactamase (ESBL)-Producing Escherichia Coli
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Extended Spectrum Beta Lactamases (ESBL) E. Coli
Keywords: Antibiotic resistance
pan-sensitive strains (non-ESBL E. coli)
multidrug resistant E. coli strains
ESBL E. coli displacement
multidrug resistant Enterobacteriaceae
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Gebert Rüf-Stiftung
First posted: 2021-02-21
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Clients planning to travel to Southeast Asia will be recruited while receiving pre-travel health advice at the travel clinic of the Swiss Tropical and Public Health Institute in Basel.

Brief summary: This study is to identify and isolate well-defined microbials (non-ESBL E. coli) in an observational setting exploring natural gastrointestinal decolonization of humans colonized with ESBL E. coli.

Detailed description: Antibiotic resistance is a severe threat to contemporary medicine. Effective approaches to fight multi-drug resistant pathogenic bacteria are needed.

This clinical observational study is to investigate whether express extended spectrum beta lactamases (ESBL) E. coli colonizing the human gut can be out-competed by other, ideally pan-sensitive strains (non-ESBL E. coli).

Eligibility criteria: Inclusion Criteria:

* travelling to Southeast Asia (India, Bhutan, Nepal, Bangladesh, Myanmar, Thailand, Laos, Cambodia, Vietnam) for a maximum of 4 weeks.

Exclusion Criteria:

* other travelling destinations than mentioned above
* antibiotic use at the first sampling time
* Participants who are not colonized will serve as a control group for microbiome comparison

Primary outcomes:
measure: proportion of patients being "naturally" decolonized from ESBL E. coli
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Division of Clinical Microbiology
Study officials:
affiliation: Division of Clinical Microbiology, University Hospital Basel
name: Adrian Egli, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04131400: Establishment of the National Registry for Inherited Retinal Dystrophy in Iran
Official title: Establishment of the National Registry for Inherited Retinal Dystrophy in Iran
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inherited Retinal Dystrophy Primarily Involving Sensory Retina
Inherited Retinal Dystrophy Primarily Involving Retinal Pigment Epithelium
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: An initial registration will be performed only for subjects who has a diagnosis of IRD based on clinical and retinal imaging by an expert retina specialist, but definite diagnosis will be confirmed by genetic testing.

Brief summary: Purpose: To establish of the national Inherited Retinal Dystrophy Registry (IRDR) in Iran.

Methods: This study is a community-based participatory research that is approved by the Ministry of Health and Medical Education of Iran in 2016. To provide the minimum data set (MDS), several focus group meetings will be held with participation of the faculty members of the Ophthalmic Research Center affiliated to Shahid Beheshti University of Medical Sciences (SBMU). Final MDS will be presented to the software engineering team to develop a web-based software. In the pilot phase, software will be set up in two referral centers including Labbafinejad Medical Center (Tehran) and Alzahra Eye Hospital (Zahedan) to discover the possible drawbacks. Final diagnosis will be made based on both clinical manifestations as well as genetic findings.The steering committee meetings are planned to be held each year with the presence of delegates of all centers.


Eligibility criteria: Inclusion Criteria:

* Patients with a definite diagnosis of IRD diagnoses based on clinical examinations and genetic testing.

Exclusion Criteria:

* Individuals who have a suspected diagnosis of IRD disease

Primary outcomes:
measure: prevalence and incidence of the different types of inherited retinal dystrophy in different regions of Iran.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References:
Clinical trial NCT02267200: The Screening and Analysis of Plasma Biomarkers in Irreversible PAH-CHD
Official title: The Screening and Analysis of Plasma Biomarkers in Irreversible Pulmonary Arterial Hypertension Associated With Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension,Pulmonary
Keywords: biomarkers，pulmonary arterial hypertension
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: those patients with systolic PAP (sPAP) \>65mmHg before surgery were included.

Brief summary: The purpose of this study is to analyse the sensitivity and specificity of circulating endothelial cells to predict irreversible pulmonary arterial hypertension associated with congenital heart disease.

Detailed description: predict to recruit 100 patients with pulmonary arterial hypertension (PAH)associated with CHD，under the commitment of the children's parents，take 3-4ml central venous blood before the corrective surgery，then calculate the number of the circulating endothelial cells by flow cytometer AND detect the expression of micro RNAs to screen out the biomarker，through the 6 months follow-up, separated the reversible and irreversible PAH,then to carry on the statistics.

Eligibility criteria: Inclusion Criteria:

* Only those patients with systolic PAP (sPAP) \>65mmHg before surgery were included.

Exclusion Criteria:

* Patients with trisomy 21 (Down syndrome) were not included

Primary outcomes:
measure: the number of Circulation endothelial cells and the detective count of microRNAs
timeFrame: 6 months after corrective surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Children's Medical Center
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Zhuoming Xu, Ph D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01969500: Development of a Mobile System for Self-management of Schizophrenia (SOS)
Official title: Development of a Mobile System for Self-management of Schizophrenia (SOS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
Schizoaffective Disorder
Self Management of Schizophrenia
SOS
Serious Mental Illness
Psychosis
Social Dysfunction
Medication Adherence
Mobile Application
EHealth
E-Health
Health Technology
mobile health
m-Health
electronic health
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2013-10-25
Enrollment: 51
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: This 2-arm clinical trial piloted a mobile Self-Management of Schizophrenia (SOS) system that administers interventions targeting persistent symptoms of psychosis, social dysfunction, and medication adherence. Researchers compared an intervention arm using the SOS system and an arm receiving treatment as usual on the outcomes of change in severity of psychotic symptoms and change in social functioning.


Eligibility criteria: Inclusion Criteria:

* DSM-IV (Diagnostic and Statistical Manual IV) criteria for schizophrenia or schizoaffective disorder based on a chart diagnosis;
* 18 years or older;
* Prescribed oral antipsychotic medication; and
* A rating of "3" or lower on one of the three items which comprise the Domination by Symptoms factor from the Recovery Assessment Scale, indicating patient-rated need for illness self-management

Exclusion Criteria:

* Hearing, vision, or motor impairment that make it impossible to operate a smartphone or respond to prompts (determined using demonstration smartphone for screening); and
* English reading level below 4th grade (determined using the Wide Range Achievement Test - 4th Edition)

Primary outcomes:
measure: Change in Severity of Psychotic Symptoms
timeFrame: Baseline, week 12
measure: Change in Social Functioning
timeFrame: Baseline, week 12
Secondary outcomes:
measure: Change in System Use
timeFrame: 4 weeks
measure: Usability and Satisfaction
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Manchester
country: United States
facility: The Mental Health Center of Greater Manchester
state: New Hampshire
Study officials:
affiliation: University of Washington
name: Dror Ben-Zeev, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06273800: Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients
Official title: Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Triple negative tumor
Stage I - III disease
Starting neo adjuvant treatment
Regular physiological menstrual cycle (premenopausal)
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: collection of serum sample blood at first day of neo adjuvant treatment
Primary purpose: DIAGNOSTIC

Brief summary: This study is a prospective, multicenter study in which a serum sample will be collected at the day of starting neo adjuvant treatment in breast cancer patients


Eligibility criteria: Inclusion Criteria:

* Women with a new diagnosis of triple negative breast cancer who have not yet started systemic treatment.
* Patients with stage I-III disease, patient with locoregional recurrence who have not been treated with chemotherapy before. ,
* Aged \< 60 years
* Women having a (regular) physiological menstrual cycle
* Patients who are assigned to receive neoadjuvant chemotherapy with or without immunotherapy, targeted therapy and endocrine therapy
* Patients must be systemic treatment naïve for current malignancy (e.g. no chemotherapy, hormonal therapy or targeted therapy)
* Signed written informed consent

Exclusion Criteria:

* current use of hormonal contraception or in the six weeks prior to start of neoadjuvant systemic treatment for breast cancer, such as:
* Oral contraception (OAC)
* Hormonal intra-uterine device (IUD, Mirena)
* No ovarian function suppression to preserve fertility
* Other forms of hormonal contraception, including but not limited to: nuva-ring, Implanon, prikpil
* Currently pregnant and / or breast feeding. In case of use of hormonal contraception or breast feeding in de last year: patients should have had at least 2 menstrual cycles since stopping hormonal contraception.

  - active other malignancy
* IVF-trajectory for egg cell preservation prior to start of neoadjuvant systemic treatment

Primary outcomes:
measure: pCR rate
timeFrame: At 6 months
Secondary outcomes:
measure: Radiological reduction on tumor size
timeFrame: At 6 months
measure: Pathological reduction on tumor size
timeFrame: At 6 months
measure: Residual cancer burden (RCB)
timeFrame: At 6 months
measure: Distant recurrence free interval (DRFI)
timeFrame: Up to 120 months
measure: Recurrence-free interval (RFI)
timeFrame: Up to 120 months
measure: Overall survival (OS)
timeFrame: Up to 120 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek
state: Noord-Holland
Study officials:
affiliation: Antoni van Leeuwenhoek
name: Marleen Kok, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02212600: Determinants of Function and Clinically Important Outcomes in Proximal Humerus Fractures
Official title: The DECIPHER Study: Determinants of Function and Clinically Important Outcomes in Proximal Humerus Fractures in the Elder Population: A National Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Humeral Fractures, Proximal
Lead sponsor: London Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
First posted: 2014-08-08
Enrollment: 500
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We will include male and female patients who are over 50 years of age and who have an acute, displaced or undisplaced proximal humerus fracture caused by low energy trauma and who provide written informed consent.

Brief summary: The proposed project will be a multi-centre, prospective observational study to determine the prognosis and determinants of functional outcomes of patients with proximal humerus fractures. Approximately 10 centres will participate in this observational cohort, each enrolling at least 50 patients over the course of 2 years.


Eligibility criteria: Inclusion Criteria:

males and females age 50 years or older (no uper age limit) presenting with an acute displaced or undisplaced proximal humerus fracture

Exclusion Criteria:

pathologic fractures patients likely to be lost before completing follow-up patients who do not provide consent patients who do not speak English and who do not have a translator that will be available during consent discussion and at each follow-up.

Primary outcomes:
measure: Disabilities of the Arm, Shoulder, and Hand (DASH)
timeFrame: 2 years
Secondary outcomes:
measure: Rate of complications
timeFrame: 2 years
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: London Health Scieneces Centre and St. Michael's Hospital
name: Emil Schemitsch, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03742700: Acute Health Effects of Short-term Use of E-cigarettes on Pulmonary and Cardiovascular System
Official title: Acute Health Effects of Short-term Use of E-cigarettes on Pulmonary and Cardiovascular System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: E-cigarette
Keywords: e-cigarette
health effects
cigarette smoking
exhaled nitric oxide
pulmonary function tests
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This was a laboratory-based intervention study: pre-post-post
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of our study was to assess acute, short term respiratory (airflow, FeNO, O2 saturation, exhaled air temperature) and cardiovascular (heart rate, blood pressure) responses to smoking an e-cigarette in exclusive e-smokers and dual users and to compare these effects with responses to smoking a tobacco-cigarette in exclusive tobacco smokers.


Eligibility criteria: Inclusion Criteria:

- smoking status (cigarette or e-cigarette smoking)

Exclusion Criteria:

* occurrence of any chronic diseases,
* history of lung conditions (eg.: asthma or bronchial hyperactivity in childhood),
* presence of any allergic diseases,
* medication intake within the last 2 weeks,
* acute illnesses or infections in the last 2 weeks,
* influenza vaccination in the last 2 weeks,
* or current pregnancy or lactation.

Primary outcomes:
measure: O2 saturation
timeFrame: pre - post (1 minute after exposure) - post (30 minute after exposure)
measure: Concentration of nitric oxide (FeNO)
timeFrame: pre - post (1 minute after exposure) - post (30 minute after exposure)
measure: exhaled carbon monoxide (CO)
timeFrame: pre - post (1 minute after exposure) - post (30 minute after exposure)
measure: temperature of exhaled air
timeFrame: pre - post (1 minute after exposure) - post (30 minute after exposure)
measure: spirometric testing
timeFrame: pre - post (1 minute after exposure) - post (30 minute after exposure)
measure: heart rate
timeFrame: pre - post (1 minute after exposure) - post (30 minute after exposure)
measure: blood pressure
timeFrame: pre - post (1 minute after exposure) - post (30 minute after exposure)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Epidemiology, School of Medicine in Katowice, Medical University of Silesia in Katowice, Poland
name: Grzegorz Brożek, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06108700: Ergonomic Risk Assessment for Musculoskeletal Disorders in Office Workers Turkish Version, Validity and Reliability Study
Official title: Ergonomic Risk Assessment for Musculoskeletal Disorders in Office Workers Turkish Version, Validity and Reliability Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Office workers at Tokat Gaziosmanpaşa University

Brief summary: Today, there is a relationship between the increase in the use of electronic devices such as smartphones or tablets and musculoskeletal disorders. Different usage styles of various electronic devices such as laptops, smartphones and tablets affect the risk factors that may be related to musculoskeletal disorders in office workers. In addition to the use of electronic devices, the posture of the office worker's head, waist and hands while sitting are among the risk factors. Parameters such as the features of the chair he is sitting on, the height and distance of the table affect the person's posture. Evaluation of these factors is important in preventing musculoskeletal disorders.

The Ergonomic Risk Assessment for Musculoskeletal Disorders in Office Workers was developed by Kluay-On et al. in 2022 and its validity and reliability were established. The aim of our study is to culturally adapt the Ergonomic Risk Assessment for Musculoskeletal Disorders in Office Workers into Turkish and to examine its validity and reliability.


Eligibility criteria: Inclusion Criteria:

* Being an employee of Tokat Gaziosmanpaşa University
* Being an office worker

Exclusion Criteria:

* Not being an office worker

Primary outcomes:
measure: Ergonomics Risk Assessment for Musculoskeletal Disorders in Office Workers
timeFrame: Baseline
measure: Ergonomics Risk Assessment for Musculoskeletal Disorders in Office Workers
timeFrame: After 1 week (retest)
measure: New York Posture Rating Chart
timeFrame: Baseline
measure: Short Form 36
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Faculty of Health Sciences, Tokat Gaziosmanpaşa University
Study officials:
References: