louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00239291: Safety Study to Explore Combination of Gefitinib (ZD1839, Iressa) and Radiotherapy in Non-Metastatic Prostate Cancer
Official title: A Phase I/II Study of ZD1839 (Iressa) Given Concurrently With Radiotherapy in Patients With Non-Metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-Metastatic Prostate Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To estimate the safety and tolerability of 250 mg ZD1839 given concurrently with 3D-CRT in patients with non-metastatic prostate cancer


Eligibility criteria: Inclusion Criteria:

* Biopsy confirmation of localised (T2) or locally advanced (T3) prostate cancer
* PSA below 20 ng/mL
* Lymph node negative
* Non-metastatic
* Written informed consent

Exclusion Criteria:

* Well differentiated stage T2 prostate cancer (Gleason score 2 to 4)
* Distant or nodal metastases
* Prostatectomy
* Concomitant LHRH analog treatment
* Previous or concomitant anti-androgens
* Active ILD

Primary outcomes:
measure: Part A: Safety (incidence of DLTs)
measure: Part B: Tolerability
Secondary outcomes:
measure: EGFR-1 expression and activation status (autophoshorylation; p-EGFR-1) at diagnosis
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Research site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Finland Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04546191: Symptoms and Wellbeing of People Infected With Covid-19 Virus in Iceland
Official title: Symptoms and Wellbeing of People Infected With Covid-19 Virus in Iceland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Covid19
Symptoms
Well being
Survey
Lead sponsor: Landspitali University Hospital
Sponsor class: OTHER
First posted: 2020-09-11
Enrollment: 1580
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients receiving care from the COVID-19 outpatient clinic at LUH during the first wave of the pandemic

Brief summary: The purpose of this cross-sectional study is to explore symptoms and well being of people diagnosed with COVID-19 from the outset of the pandemic until June 2020.

Detailed description: All patients diagnosed with COVID-19 in Iceland were referred to the COVID-19 outpatient clinic at Landspitali National University Hospital in Iceland. In the clinic risk assessment was conducted and the patients were accordingly provided with individualized care be it telephone surveillance, onsite examination and treatment, or admission to the hospital. As the the first wave of the pandemic was curbing the necessity of exploring how the patients did and continue to fare after being infected became apparent.

The research questions are:

What were the symptoms that patients expressed during and about three months after being diagnosed with COVID-19? What is the prevalence and intensity of the symptoms that patients expressed during and about three months after being diagnosed with COVID-19 ? How do patients value their health related quality of life, what is their health literacy and sense of security in care during and about three months after being diagnosed with COVID-19 ? How do patients value the nursing care in the outpatient COVID-19 clinic? What are the patients' perception of having caught COVID-19?

Eligibility criteria: Inclusion Criteria:

* Patients receiving care from the COVID-19 outpatient clinic at LUH during the first wave of the pandemic

Exclusion Criteria:

* Young than 18 y.o.
* Do not understand Icelandic
* Died

Primary outcomes:
measure: Symptoms
timeFrame: 2 months
Secondary outcomes:
measure: Wellbeing - HRQL
timeFrame: 2 months
Other outcomes:
measure: Anxiety and depression (HADS)
timeFrame: 2 months
Locations:
city: Reykjavík
country: Iceland
facility: Landspitali National University Hospital
state: Ísland
Study officials:
affiliation: Faculty of Nursing
name: Brynja Ingadottir, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06969391: Representation of Diet in the Management of Type 2 Diabetes in Migrant Patients at CHSD
Official title: Representation of Diet in the Management of Type 2 Diabetes in Migrant Patients at CHSD
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Centre Hospitalier de Saint-Denis
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study participants will be selected from patients diagnosed with type 2 diabetes who are attending the Centre Hospitalier St Denis. Specifically, the target population includes:

Adults aged 18 years or older.

Migrants who have arrived in France within the past 7 years.

Type 2 diabetes diagnosis for at least 3 months.

French or English language proficiency to facilitate communication during interviews.

The population will primarily consist of migrants from socioeconomically disadvantaged backgrounds, including those who may face barriers such as language differences, cultural challenges, and limited access to healthcare. Participants will have a range of cultural backgrounds, as the study aims to explore how migration and cultural factors influence their understanding and management of type 2 diabetes, particularly in relation to food and diet.

This population is chosen to address the knowledge gap regarding how migrant populations perceive and integrate dietary advice in the

Brief summary: This observational and monocentric study aims to explore how migrant patients with type 2 diabetes perceive and represent food in the context of their diabetes care. Conducted at the Centre Hospitalier de Saint-Denis, the study investigates the cultural, social, and personal factors that influence dietary habits and how these perceptions affect the management of their condition. The goal is to improve the understanding of patient behaviors and support more culturally adapted care strategies.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic for at least 3 months
* Arrived in France less than 7 years ago
* Adult patient (age 18)
* Speaking French or English

Exclusion Criteria:

* Minor patient (age \< 18 years)
* Type 1 diabetes
* Does not speak French or English
* Patient who has expressed opposition to the use of his data, or his refusal to participate

Primary outcomes:
measure: Representation of food in the care of diabetes in migrants Description
timeFrame: enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Denis
country: France
facility: Centre Hospitalier (CH) de Saint-Denis
Study officials:
References:
Clinical trial NCT02319291: PS150 Total Knee Arthroplasty Outcomes Registry
Official title: Outcomes of Total Knee Arthroplasty (TKA) Using the Sigma PS150 Primary Total Knee System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Rheumatoid Arthritis
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2014-12-18
Enrollment: 175
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 may be considered for inclusion in the registry if they meet the inclusion criteria below.

Brief summary: This registry is intended to evaluate the clinical outcomes of the DePuy P.F.C. Sigma PS150 RP Total Knee System. 200 participants will be enrolled prospectively or retrospectively and the follow up period will be 5 years. Data collection will include Radiographic Analysis, Knee Society Evaluation and Adverse Events.


Eligibility criteria: Inclusion Criteria:

* Primary total knee replacement for any indication in accordance with the Instructions For Use accompanying the SIGMA PS150 implant.
* Signed Informed Patient Consent

Exclusion Criteria:

* There are no exclusion criteria for this registry.

Primary outcomes:
measure: Implant Survivorship
timeFrame: 5 years
Secondary outcomes:
measure: Knee Society Score - Knee Score
timeFrame: 1, 3 & 5 years
measure: Knee Society Score - Function
timeFrame: 1, 3 & 5 years
measure: Pain sub-question of the Knee Society Score
timeFrame: 1, 3 & 5 years
measure: Flexion
timeFrame: 1, 3 & 5 years
measure: Extension
timeFrame: 1, 3 & 5 years
measure: Radiographic Analysis
timeFrame: 1, 3 & 5 years
measure: Adverse Events
timeFrame: 1, 3 & 5 years
Other outcomes:
Locations:
city: Greenslopes
country: Australia
facility: Greenslopes Private Hospital
city: Sydney
country: Australia
facility: Northern Orthopaedics
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital
Study officials:
affiliation: Greenslopes Private Hospital, Brisbane
name: Mark Dekkers, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05237791: Effect of Magnesium on Remifentanil Induced Cough
Official title: Effect of Magnesium Sulfate on Remifentanil Induced Cough and Chest Wall Rigidity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cough
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The hypothesis of this study is that Magnesium sulfate pretreatment (50mg/kg) will reduce the incidence of cough and chest wall rigidity caused by remifentanil administration.

The purpose of this study was to investigate the effect of magnesium sulfate administered before induction of anesthesia on thoracic stiffness and cough response caused by opioid analgesics administered for general anesthesia.


Eligibility criteria: Inclusion Criteria:

* Patients aged 20-75 years of age who are undergoing surgery under general anesthesia using a laryngeal mask and who have consented to participate in this study among American Society of Anesthesiologists body grade 1 or 2

Exclusion Criteria:

* When coughing may occur due to an underlying disease (upper respiratory infection, rhinitis, post nasal drip, asthma, chronic obstructive pulmonary disease, pneumonia, bronchitis, current smokers, etc.)
* If you have kidney disease that can affect magnesium metabolism (glomerular filtration rate less than 60)
* If you are taking opioid analgesics or magnesium for other reasons
* Patients with hypermagnesemia
* Patients with atrioventricular block (stages I-III) or other cardiac conduction disorders
* Pregnant or lactating women
* Patients with myasthenia gravis
* Patients taking drugs that are contraindicated or interact with magnesium (barbitalates, aminoglycoside antibiotics, isoniazid, chlorpromazine, digoxin)
* In case of hypersensitivity to magnesium
* Patients with a history of hypersensitivity to propofol and any of its components
* Patients with a history of hypersensitivity to remifentanil and other fentanyl analogues

Primary outcomes:
measure: remifentanil induced cough
timeFrame: from preoperative 20 minutes to induction of anesthesia
Secondary outcomes:
measure: severity of cough
timeFrame: from preoperative 20 minutes to induction of anesthesia
measure: laryngeal mask airway (LMA) insertion compliance
timeFrame: from preoperative 20 minutes to induction of anesthesia
measure: lung compliance
timeFrame: from induction of anesthesia to finish of surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03948191: 99Tc-MDP for Thyroid-Associated Ophthalmopathy
Official title: A Double-masked, Methylprednisolone-control, Efficacy and Safety Study of 99Tc-MDP for Thyroid Associated Ophthalmopathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thyroid-Associated Ophthalmopathy
Keywords: 99Tc-MDP
TAO
efficacy
safety
Lead sponsor: Dalian University
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy，safety and tolerability of 99Tc-MDP in comparison to Methylprednisolone, in the treatment of participants suffering from active moderate to severe TAO.


Eligibility criteria: Inclusion Criteria:

* The patient age 18 Years to 76 Years;
* Fewer than 6 months from onset of TAO;
* Clinical diagnosis of Graves' disease associated with active TAO and a clinical activity score of ≥ 3;
* Moderate to severe TAO;
* No previous medical or surgical treatment, excluding local supportive measures and oral steroids if the maximum cumulative dose is less than 1000 mg methylprednisolone or equivalent with at least 6 weeks between last administration of oral steroids and randomization.

Exclusion Criteria:

* Optic neuropathy, severe orbital appearance and surgical;
* Extra-thyroid disease;
* Pregnant and children;
* Severe impairment of cardiac, hepatic and renal functions;
* Allergies;
* Other contraindications.

Primary outcomes:
measure: Responder Status at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Overall Average Continuous Change in CAS From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Overall Average Continuous Change in Proptosis From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Overall Average Change in Diplopia grading From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Overall Average Change in extra-ocular muscular thickening From Baseline in thickening extra-ocular muscular improvement in Orbital CT to Week 24
timeFrame: Baseline to Week 24
measure: Overall Average Change in Graves' Ophthalmopathy Quality of Life (GO-QOL) Scale From baseline to Week 24 follow-up
timeFrame: Baseline to Week 24
measure: Overall Average Change in GO-QOLScale - Visual Functioning From baseline to Week 24 follow-up
timeFrame: Baseline to Week 24
measure: Overall Average Change in GO-QOLScale - Appearance From baseline to Week 24 follow-up
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Dalian
country: China
facility: Affiliated Zhongshan Hospital of Dalian University
state: Liaoning
Study officials:
References:
Clinical trial NCT01990391: Brazil Nut Consumption in Microvascular Endothelial Function, Oxidative Stress and Metabolic Abnormalities
Official title: Effect of Brazil Nut Consumption in the Microvascular Endothelial Function, Oxidative Stress and Metabolic Abnormalities in Hypertensive and Dyslipidemic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemia
Oxidative Stress
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
Collaborators: name: Instituto Nacional de Cardiologia de Laranjeiras
name: Oswaldo Cruz Foundation
name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
First posted: 2013-11-21
Enrollment: 125
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose this research is to check the effect of Brazil Nuts consumption in oxidative stress, metabolic abnormalities and microvascular endothelial function dyslipidemic and hypertensive patients.


Eligibility criteria: Inclusion Criteria:

* adults \> 20 years old
* Dyslipidemic
* Hypertensive

Exclusion Criteria:

* Allergy to nuts
* Consumption of nuts or vitamins/minerals supplement
* Loss weight before the research
* pregnancy
* Kidney chronic disease

Primary outcomes:
measure: Antioxidant biomarker
timeFrame: Change from Baseline at 12 weeks.
Secondary outcomes:
measure: Oxidative stress biomarker
timeFrame: Change from Baseline at 12 weeks.
measure: microvascular endothelial function
timeFrame: Change from baseline at 12 weeks
Other outcomes:
measure: Anthropometric measures
timeFrame: Change from baseline at 12 weeks
measure: Blood lipids
timeFrame: Change from baseline at 12 weeks
Locations:
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Grazielle V B Huguenin, Nutricionist
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carvalho RF, Huguenin GV, Luiz RR, Moreira AS, Oliveira GM, Rosa G. Intake of partially defatted Brazil nut flour reduces serum cholesterol in hypercholesterolemic patients--a randomized controlled trial. Nutr J. 2015 Jun 16;14:59. doi: 10.1186/s12937-015-0036-x.
citation: Huguenin GV, Oliveira GM, Moreira AS, Saint'Pierre TD, Goncalves RA, Pinheiro-Mulder AR, Teodoro AJ, Luiz RR, Rosa G. Improvement of antioxidant status after Brazil nut intake in hypertensive and dyslipidemic subjects. Nutr J. 2015 May 29;14:54. doi: 10.1186/s12937-015-0043-y.
Clinical trial NCT03316391: Association Between Pococyturia and Pre-eclampsia Severity
Official title: Prospective Study : Association Between Pococyturia and Pre-eclampsia Severity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pre-Eclampsia
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in hospital for pre-eclampsia at the Hopital Femme-Mère-Enfant

Brief summary: Pre-eclampsia is an hypertensive disorder appearing during pregnancy, inducing serious maternal, fetal and neonatal mortality and morbidity. Twenty four hours proteinuria is a key element to define pre-eclampsia severity but is delaying the result by 24 hours and constraining for the patient. A simple and rapid indicator for severe preeclampsia would help clinicians to make appropriate decision in patient management. We hypothesized that urinary podocyturia is correlated to preeclampsia severity. This is a prospective, non-interventional, monocentric study.


Eligibility criteria: Inclusion Criteria:

* women aged 18 years or more
* single pregnancy
* admission for pre-eclampsia
* patient receiving information and non-opposition to participate

Exclusion Criteria:

* multiple pregnancy
* in utero fetal demise excepted if associated with pre-eclampsia
* antecedent of nephropathy
* fetal malformation, chromosomal anomalies
* inability to understand information provided
* prisoner or under administrative supervision

Primary outcomes:
measure: Severity of pre-eclampsia
timeFrame: at childbirth (maximum 10 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service de gynécologie-obstétrique
state: Rhône
city: Bron
country: France
facility: Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France
Study officials:
References:
Clinical trial NCT03187691: Safety and PK of Oral Encochleated Amphotericin B (CAMB/MAT2203) for Antifungal Prophylaxis in Patients Undergoing Induction Chemotherapy for Acute Myelogenous and Lymphoblastic Leukaemia
Official title: An Open Label Phase II Clinical Study to Evaluate the Safety and Pharmacokinetics of Oral Encochleated Amphotericin B (CAMB/MAT2203) for Antifungal Prophylaxis in Patients Undergoing Induction Chemotherapy for Acute Myelogenous (AML) and Lymphoblastic Leukaemia (ALL)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Lead sponsor: Matinas BioPharma Nanotechnologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Cologne
name: The Clinical Trials Centre Cologne
First posted: 2017-06-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-randomized, open uncontrolled
Primary purpose: PREVENTION

Brief summary: A Non-randomized, prospective , multicenter, open uncontrolled study in patients with acute myelogenous (AML) or lymphoblastic leukaemia (ALL)

Detailed description: This is an open label phase II clinical study to evaluate the safety and pharmacokinetics of oral encochleated Amphotericin B (CAMB/MAT2203) for prevention of invasive fungal infections in approximately 30 patients undergoing induction therapy for AML/ALL.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed AML/ALL receiving chemotherapy inducing neutropenia \< 500 cells/mm3
* Able to have all screening tests done to allow for study drug administration no later than 5 days after start of chemotherapy
* Sign informed consent
* ≥ 18 years of age

Exclusion Criteria:

* Known hypersensitivity to amphotericin B, specifically anaphylactic reaction
* Fungal induced fever (≥ 38°C)
* Proven, possible or probably invasive fungal infection in previous 12 months
* Serum galactomannan index (GMI)≥ 0.5 at screening
* Pulmonary infiltrates at screening
* Current treatment with amphotericin B
* Sever comorbidity other than underlying haematological disease
* Prolongation of corrected QT interval
* History of convulsion
* Pregnant or breastfeeding
* Females of childbearing potential who do not practice sexual abstinence or who do not agree to use appropriate contraceptive methods
* Presence of hepatic disease
* Total bilirubin \> 3 x upper limit of normal
* Age-adjusted creatinine clearance \< 30 mL/minute
* Participating in any other clinical study

Primary outcomes:
measure: Incidence of treatment emergent adverse events
timeFrame: 35 days
Secondary outcomes:
measure: Population pharmacokinetic (PK) analysis
timeFrame: 35 days
measure: Population pharmacokinetic (PK) analysis
timeFrame: 35 days
measure: Population pharmacokinetic (PK) analysis
timeFrame: 35 days
measure: Efficacy analysis for time to clinical symptoms of fungal infection
timeFrame: 35 days
Other outcomes:
Locations:
Study officials:
affiliation: University of Cologne
name: Oliver Cornely, MD
role: PRINCIPAL_INVESTIGATOR
References: