louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05810493: A Cohort of Patients With Phenotyped Diffuse Interstitial Lung Disease With Longitudinal Follow-up
Official title: A Cohort of Patients With Phenotyped Diffuse Interstitial Lung Disease With Longitudinal Follow-up
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Interstitial Lung Disease
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ≥ 18 years old; Patients with a formal diagnosis or a provisional diagnosis of interstitial lung disease according to the mutlidisciplinary monthly meeting for interstitial lung disease occuring at University hospital of Nice, France

Brief summary: The purpose of the study is to conduct a descriptive analysis of the population of patients with an interstitial lung disease received in the pulmonary department of University hospital of Nice (France). Analysis and documentation of clinical forms of the disease, therapeutics used and evolutions.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Diagnosis of interstitial lung disease according to the multidisciplinary monthly meeting for interstitial lung disease occuring at University hospital of Nice, France

Exclusion Criteria:

* Patient-led opposition to data collection

Primary outcomes:
measure: Build a retrospective cohort of patients with phenotyped interstitial Lung disease with longitudinal follow-up
timeFrame: 2 years
Secondary outcomes:
measure: Follow-up of progression criteria according to diagnosis
timeFrame: 2 years
measure: Follow-up of progression criteria according to diagnosis
timeFrame: 2 years
measure: Follow-up of progression criteria according to diagnosis
timeFrame: 2 years
measure: Follow-up of progression criteria according to diagnosis
timeFrame: 2 years
Other outcomes:
Locations:
city: Nice
country: France
facility: University Hospital of Nice
Study officials:
References:
Clinical trial NCT06062693: New Interactive Sensor-home-based Hand Training to Improve Dexterity
Official title: New Interactive Sensor-home-based Hand Training to Improve Dexterity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Multiple Sclerosis
Parkinson Disease
Keywords: dexterity
training
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: sensor-home-based hand training for MS, PD, stroke or control group
Primary purpose: TREATMENT

Brief summary: Primary objective of this study is to explore the impact of a 3-week upper limb hand function training in patients with PD, MS or stroke. The benefits on hand function of this training program will be evaluated. The hypothesize is that the 3-week upper limb hand function training improves finger dexterity.

Detailed description: Patients with Parkinson's disease (PD), multiple sclerosis (MS) or stroke often suffer from significantly decreased coordination and have difficulties with precise hand/finger movements during the performance of both basic activities of daily living (ADL), such as dressing, grooming as well as higher ADL, such as cooking, shopping and regular medication intake. The investigators explore the effects of a new, interactive, sensor-home-based upper limb hand training on upper limb related ADL in patients with PD, MS or stroke.

Eligibility criteria: Inclusion Criteria:

* Patients with confirmed PD, according to UK Brain bank Criteria (Hughes et al., 1992) or
* MS patients with relapsing-remitting MS (RRMS), secondary-progressive MS (SPMS) or primary progressive MS (PPMS) according to the revised McDonald's criteria or
* subacute stroke
* written and signed informed consent
* self-reported hand function problems

or

* healthy subject
* written and signed informed consent
* no self-reported hand function problems

Exclusion Criteria:

* MoCA \<21/30
* psychiatric disease
* participation on other interventional trials
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.

Primary outcomes:
measure: hand dexterity
timeFrame: 3 weeks
Secondary outcomes:
measure: fine finger movements
timeFrame: 3 weeks
measure: grip strength
timeFrame: 3 weeks
measure: cognition
timeFrame: baseline
measure: executive function
timeFrame: 3 weeks
measure: executive function
timeFrame: 3 weeks
measure: self-reported dexterity related problems in daily living for PD
timeFrame: 3 weeks
measure: self-reported arm and hand function related problems in patients with MS
timeFrame: 3 weeks
measure: Arm and hand function in stroke patients
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Lucerne
country: Switzerland
facility: Luzerner Kantonsspital
Study officials:
affiliation: Luzerner Kantonsspital, Universität Bern
name: Tim Vanbellingen, Prof. Dr. phil.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00590993: Magnetic Resonance Imaging and Spectroscopy of the Prostate
Official title: Magnetic Resonance Imaging and Spectroscopy of the Prostate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: MRSI
MRI
Prostate Cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-01-11
Enrollment: 1005
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Urology and Radiology prostate cancer patients seen at Memorial Sloan-Kettering Cancer Center

Brief summary: Past studies have shown that MRI is useful for staging prostate cancer. This study will use magnetic resonance spectroscopic imaging (MRSI) to obtain more information. MRSIs with MRIs help doctors locate prostate cancer and determine the extent of tumor before deciding on treatment. This study looks at structural and chemical properties of prostates in prostate cancer patients before and after treatment.


Eligibility criteria: Inclusion Criteria:

* prostate cancer patients willing to undergo a MRI and MRSI exam

Exclusion Criteria:

* patients with prostate cancer and bone or lymph node metastasis
* patients who can not have an MRI exam

Primary outcomes:
measure: Determine added value in combining MRSI and MRI in prostate cancer treatment
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Hedvig Hricak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03482193: Health Literacy and Overweight in Adolescents
Official title: The Association of Adolescents' Interactive and Critical Health Literacy With Their Overweight: a Study in a Medium Urban City in Belgium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight and Obesity
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 254
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents studying in 2nd or 4th year in one of the participating secondary school. Students in those years receive a medical examination, which facilitate the collect of data and made us chose to limit the participation to these 2 years.

Brief summary: Obesity in children and adolescents has become a major public health problem in recent years. In Belgium, 20% of people aged between 2 and 17 are overweight and 7% suffer from obesity. While studies often associate this overweight with socio-economic level, other factors, such as health literacy (HL), may also play a role. Among adolescents, some studies have shown an association between the level of HL and the Body Mass Index (BMI). Our study aims to investigate the association between HL of adolescents and their BMI.

This is a cross-sectional survey among 9 high schools in a medium city of Belgium, including 254 high school students aged between 12-17 years. Health literacy was assessed by the Health Literacy Measure for Adolescents (HELMA). Student's age, sex, weight, size and parental socio-economic status are gathered in the medical file during the medical examination organized by the schools after obtaining the informed consent of the students and their parents.


Eligibility criteria: Inclusion Criteria:

* Studying in one of the participating school
* Being in 2nd or 4th year
* Parental consent to participate

Exclusion Criteria:

* None

Primary outcomes:
measure: Health Literacy
timeFrame: 1 day (At the inclusion in the study)
measure: Body Mass Index
timeFrame: 1 day (At the inclusion in the study)
measure: Parents' socio-economic status
timeFrame: 1 day (At the inclusion in the study)
Secondary outcomes:
measure: Language spoken at home
timeFrame: 1 day (At the inclusion in the study)
measure: Education type
timeFrame: 1 day (At the inclusion in the study)
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: University of Liège
Study officials:
affiliation: Université de Liège
name: Isabelle Bragard
role: STUDY_DIRECTOR
References:
Clinical trial NCT00480493: STEP: Social Support To Empower Parents
Official title: STEP: Social Support To Empower Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2007-05-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This RCT intervention provides parental social support (informational, affirmational, and emotional) using parent mentors (experienced in the management of the chronic illness) for mothers and fathers of young children newly diagnosed with type 1 diabetes. The parent mentors provide both home visits and phone call support over the course of the first year after diagnosis. The hypothesis is that newly diagnosed parents who receive the intervention will perceive less parental concern and worry, less negative impact on the family, more perceived confidence and social support compared to those mothers and fathers not receiving the intervention.


Eligibility criteria: Inclusion Criteria:

* Mothers and fathers of children 12 years and younger with type 1 diabetes

Primary outcomes:
measure: Maternal Confidence Scale
timeFrame: 12 months
measure: Parent Concern
timeFrame: 12 months
measure: Worry
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts, Worcester
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester, Graduate School of Nurisng
name: Susan Sullivan-Bolyai, DNSc CNS RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02932293: Triple Combination DAAs for Treating HCV GT1b Subjects
Official title: Triple Combination DAAs for Ultra Short Duration Therapy for HCV Genotype 1b in Chinese (SODAPI II Study)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Chronic Hepatitis C Infection
Lead sponsor: Humanity and Health Research Centre
Sponsor class: OTHER
Collaborators: name: University of Maryland
name: Emory University
name: Beijing 302 Hospital
First posted: 2016-10-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is only one kind of treatment (simeprevir 150 mg + sofosbuvir 400 mg+daclatasvir 60 mg) in this study but the treatment duration may be different depending on patients' response to the antiviral therapy and whether patients have liver cirrhosis. If patients have no cirrhosis and the HCV viral load on day 2 is \<500 IU/ml, patients will receive sofosbuvir, daclatasvir and simeprevir for 3 weeks, otherwise the treatment duration is 4 weeks. If patients have cirrhosis and the HCV viral load on day 2 is \<500 IU/ml, patients will receive sofosbuvir, daclatasvir and simeprevir for 6 weeks, otherwise the treatment duration will be 8 weeks.


Eligibility criteria: Inclusion Criteria:

1. HCV RNA positive \>2000 IU/ml or NAT POC positive
2. Genotype 1b
3. CP score ≤6

Exclusion Criteria:

1. Pregnant or nursing female or male with pregnant female partner
2. Hematologic or biochemical parameters at Screening outside the protocol- specified requirements
3. Active or recent history (≤ 1 year) of drug or alcohol abuse
4. Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers)
5. History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.

Primary outcomes:
measure: Proportion of participants with plasma HCV viral load below the lower limit of quantification for 12 weeks after treatment completion (SVR12)
timeFrame: Post treatment Week 12
Secondary outcomes:
measure: Frequency and severity of adverse events
timeFrame: Baseline up to Week 24
measure: Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment
timeFrame: Baseline up to Week 24
measure: Kinetics of circulating HCV RNA during treatment and after treatment discontinuation
timeFrame: Baseline up to Week 24
measure: Proportion of participants with on-treatment virologic breakthrough and relapse
timeFrame: Baseline up to Week 24
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Humanity and Health Medical Centre
Study officials:
affiliation: Humanity & Health Medical Centre
name: George LAU, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02089893: Study of the Incidence of Cilioretinal Arteries in the Hungarian Population
Official title: Study of the Incidence of Cilioretinal Arteries in the Hungarian Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cilioretinal Arteries
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy young population

Brief summary: The purpose of this study is to analyze the retinal arteries, to investigate the incidence, number, types, distribution and localization of cilioretinal arteries in the Hungarian Caucasian population.


Eligibility criteria: Inclusion Criteria:

* Caucasian race
* Signed informed consent

Exclusion Criteria:

* Optical media opacities of the eye

Primary outcomes:
measure: Incidence of cilioretinal arteries
timeFrame: Through study completion, 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University, Department of Ophthalmology
Study officials:
affiliation: Semmelweis University
name: Miklos Schneider, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03993093: Prevalence of HIV +ve Cases With AIDS Defining Opportunistic Infections Among ART Naive Patients Attending ART Centre
Official title: AIDS Defining Opportunistic Infections in Naive HIV Cases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Tuberculosis
Candidiasis, Esophageal
Cryptococcosis
Leishmaniasis
Toxoplasmosis
Keywords: HIV
Opportunistic infection
CD4+ T cells
AIDS defining condition
Lead sponsor: Singh, Ranjan Kumar, M.D.
Sponsor class: INDIV
First posted: 2019-06-20
Enrollment: 257
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Antiretroviral treatment naive HIV patients

Brief summary: HIV patients are likely to suffer from opportunistic infections, in absence of highly active retroviral therapy. This happens due to lack of awareness of HIV status among patients or unresponsive to anti retroviral drugs. This study is for the prevalence of AIDS defining OIs among treatment naive HIV patients.

Detailed description: Oppotunistic infections (OIs) happen in persons with weakened immune system. HIV patients, who remain untreated due to lack of knowledge of existing HIV infections, often get OIs. HIV patients with AIDS defining OIs fall into stage 3 of HIV illness. Prevalence of OIs in resource poor settings are tuberculosis (pulmonary and extra pulmonary), toxoplasmosis, cryptococcosis, and oesophageal candidiasis. There are a few data to show AIDS defining OIs in treatment naïve HIV patients. Incidence of OIs among HIV patients in United States, and Canada between 2000 to 2019 was 9%. Leading OIs were peumocystis Jiroveci, oesophageal candidiasis and disseminated MAC or M. kansassi.

Minimal diagnoses at poor settings can be made by observation of symptoms, use of microscope, imaging and diagnostic therapy.

Eligibility criteria: Inclusion Criteria:

• HAART naïve HIV patient

Exclusion Criteria:

* Patients died during screening
* Transferred in HIV patients

Primary outcomes:
measure: Prevalence of AIDS defining OIs
timeFrame: Six months
Secondary outcomes:
measure: Compare CD4 cell in cases of HIV with OIs with CD4 cell of HIV patients without OIs
timeFrame: Six months
Other outcomes:
Locations:
city: Khagaria
country: India
facility: ART centre, Sadar Hospital
state: Bihar
Study officials:
affiliation: Singh, Ranjan Kumar
name: Ranjan K Singh, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00096811: Entecavir for Subjects With Chronic Hepatitis B Infection: An Early Access Program
Official title: A Treatment Use Protocol of Entecavir in Subjects With Chronic Hepatitis B Infection Who Have Failed or Who Are Intolerant of Available Therapies
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Hepatitis B
Chronic Disease
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2004-11-16
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this clinical research study is to provide entecavir to subjects with chronic Hepatitis B infection who have failed or who have demonstrated intolerance of marketed therapies or for those in whom use of these agents is contraindicated and that have no other available treatment options.


Eligibility criteria: Inclusion Criteria:

* Hepatitis B Early Access Program

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Local Institution
city: Nazareth
country: Israel
facility: Local Institution
city: Petach Tikva
country: Israel
facility: Local Institution
city: Tel Aviv
country: Israel
facility: Local Institution
city: Zefat
country: Israel
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02825693: Femtosecond Laser Assisted Cataract Surgery in The NHS
Official title: The Development of Surgical Pathways Using Femto-second Laser Technology to Increase the Efficiency and Safety of Cataract Surgery Within a Public Health Sector Setting - A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Surgery
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 400
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 study aims to examine the health economic impact of adopting femtosecond laser technology to assist high volume cataract surgery (FLACS) within a state-funded healthcare system, the National Health Service (NHS).


Eligibility criteria: Inclusion Criteria:

* Patients must have reduced visual acuity or visual symptoms attributed to the presence of cataract in one or both eyes by the examining ophthalmologist or else must require cataract surgery on clinical grounds other than visual symptoms.
* Patients must be willing to attend for follow-up at 1 month after cataract surgery.
* Patients must be sufficiently fluent in English for informed consent and self-completion of the patient reported outcome questionnaires.

Exclusion Criteria:

* Children below the age of 18
* Already enrolled in another study

The principle exclusion criteria relate to clinical contraindications for FLACS, such as:

* Significant corneal opacities
* Small pupils following pharmacological dilatation
* Patients unable to lie sufficiently flat so as to be positioned underneath the laser machine.

Primary outcomes:
measure: Cost-analysis: Healthcare resource use attributable to managing patients in this study will be collected.
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: