louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05767203: Genetic Markers and Biomarkers in Patients With Intellectual Disabilities of Genetic Origin
Official title: Search for Genetic Markers and Biomarkers to Follow Patients With Intellectual Disabilities of Genetic Origin and to Understand Its Origin and Associated Comorbidities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Down Syndrome
Intellectual Disability
Lead sponsor: Institut Jerome Lejeune
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Analyze genetic and biological markers in patients with Intellectual Deficiencies (ID) of genetic origin in order to better understand the mechanisms of modified genes, cellular mechanisms, pathways involved in different disorders , complications and pathologies associated with ID of genetic origin.

Detailed description: Blood and skin samples will be taken from patients coming at the outpatients clinic of the Institut Jérôme Lejeune and who consent to participate to the study. Search and identification of markers will be then done from the collected samples.

Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with an intellectual disability of genetic origin
* Patient of all ages coming for consultation at the Institut Jérôme Lejeune
* Patient whose parents or legal representative have received and understood the information document and signed the informed consent for a sample for the research project.
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Parents unable to find out about the constraints related to the study
* Refusal of informed patient participation
* Pregnant, parturient and nursing mothers
* Persons deprived of their liberty by judicial or administrative decision

Primary outcomes:
measure: Identification of biomarkers in blood
timeFrame: 10 years
measure: Identification of biomarkers from skin samples
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Jérôme Lejeune
Study officials:
References:
Clinical trial NCT02424903: European Prosthetic Joint Infection Cohort Study- Hip, Knee and Shoulder Prosthetic Joint Infection
Official title: European Prosthetic Joint Infection Cohort Study (EPJIC): Evaluation of the Treatment Approach for Hip, Knee and Shoulder Prosthetic Joint Revision Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prosthesis-related Infections
Keywords: infection
prosthesis
hip
knee
shoulder
Lead sponsor: Pro-Implant Foundation
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
First posted: 2015-04-23
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitted to hospital

Brief summary: The purpose of the study is to compare different approaches for the treatment of prosthetic joint revisions and to optimize the outcomes in patients with prosthetic joint infections (PJI) by improving the treatment concept of PJI.

Detailed description: The aim of the study is to assess the impact of different surgical and antibiotic therapies on patients admitted for a septic or aseptic revision of the hip, knee or shoulder prosthesis. The decision whether the implant will be retained or removed or antimicrobial treatment is based on criteria of each participating center specialists.The success of different treatment algorithms will be measured in terms of infection free interval, functional outcome and quality of life. All consecutive patients who need a revision surgery to the hip, knee or shoulder will be included. Furthermore the study will investigate different diagnostic tests (microbiological and histological) for the diagnosis and the discrimination of septic and aseptic causes in prosthesis failures. Pathogens (microorganisms isolated from puncture of the joint, tissue samples sonication fluid and blood) will be collected to establish a biobank.The samples are obtained preoperatively and intraoperatively as part of routine care practice. The study is not randomized.

Eligibility criteria: Inclusion Criteria:

* subject is older than 18 years of Age
* written informed consent has been obtained
* subject Needs a Revision surgery of the hip, knee or shoulder prosthesis

Exclusion Criteria:

* subject is currently enrolled in another investigational study
* inability to read and understand the participant's Information
* subject is younger than 18 years of age

Primary outcomes:
measure: Infection outcome
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Functional outcome
timeFrame: 12 months after surgery
measure: lifequality evaluation
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité, Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Andrej Trampuz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01907503: Adaptation of Locomotor Activity in Patients Suffering From Hip OA - Analysis of This Adaptation as a Prognostic Criterion for Future Disease Progression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Hip Osteoarthritis
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 200
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To assess the prognostic value of a characteristic evaluation of gait in persons suffering from hip OA for subsequent indications for THR.


Eligibility criteria: Inclusion Criteria:

* Men or women aged between 45 and 75 years Suffering from primary hip osteoarthritis defined according to ACR criteria who presented pain in the hip for at least one month in the preceding 3 months Radiological stage II, III or IV hip OA according to the Kellgren and Lawrence classification Patients able to understand simple instructions des packaging instructions, to give their written informed consent.

Exclusion Criteria:

* Indication for THR at the time of inclusion. Pregnant or breast-feeding women Alzheimer's disease Chronic respiratory insufficiency with clinical manifestations Parkinson's disease Motor neuron disease Major musculo-skeletal disorder (other than hip OA) Severe non-stabilised diabetes Non-stabilised hypertension Hip OA inflammation flare Rapidly-destructive hip OA Radiography to evaluate structural evolution of the disease done more than 12 months previously Presence of OA in another joint, or another osteoarticular or periarticular disease of the lower limbs with, in the opinion of the patient, disability due to this other disease that is greater than the disability caused by the hip OA.

Spine disease causing gait disturbance (radiculalgia, lumbar canal stenosis,... with, in the opinion of the patient, disability due to this other disease that is greater than the disability caused by the hip OA.)

Primary outcomes:
measure: locomotor activity
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de Dijon
Study officials:
References:
citation: Moissenet F, Naaim A, Ornetti P, Bourredjem A, Binquet C, Morisset C, Gouteron A, Maillefert JF, Laroche D. Is the Pelvis-Thorax Coordination a Valuable Outcome Instrument to Assess Patients With Hip Osteoarthritis? Front Bioeng Biotechnol. 2020 Jan 23;7:457. doi: 10.3389/fbioe.2019.00457. eCollection 2019.
Clinical trial NCT00753103: Anti-Cytokine Therapy for Vasculitis
Official title: Phase II Pilot Cohort Study to Investigate the Safety and Efficacy of Infliximab as Additional Therapy in the Treatment if Anti-Neutrophil Cytoplasm Antibody Associated Vasculitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Wegener's Granulomatosis
Renal Limited Vasculitis
Microscopic Polyangiitis
Keywords: Infliximab
Vasculitis
antitnf monoclonal antibody
Lead sponsor: University Hospital Birmingham NHS Foundation Trust
Sponsor class: OTHER
First posted: 2008-09-16
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Infliximab (monoclonal anti-tumour necrosis factor alpha antibodies) are safe and effective in the treatment of anti-neutrophil cytoplasm antibody (ANCA) associated vasculitis.

Detailed description: Anti-neutrophil cytoplasm antibody (ANCA) associated vasculitis is a life-threatening systemic inflammatory autoimmune disease. Current treatment regimes using corticosteroids and cyclophosphamide have improved patient survival but are associated with treatment associated morbidity and mortality. Tumour necrosis factor alpha (TNF) is a proinflammatory cytokine which has been implicated in the pathogenesis of ANCA vasculitis. Anti-TNF therapies have been used successfully in the management of other inflammatory autoimmune diseases. This phase II cohort study has been designed to investigate the safety and efficacy of anti-TNF monoclonal antibody (Infliximab) therapy for patients with ANCA associated vasculitis when used in addition to standard immunosuppressive therapy.

Eligibility criteria: Inclusion Criteria:

* Either newly diagnosed or relapsed ANCA associated vasculitis (Wegener's granulomatosis, microscopic polyangiitis, renal limited vasculitis)

Exclusion Criteria:

* Active infection
* Malignancy
* Pregnancy
* Diagnosis of Churg-Strauss syndrome or anti-glomerular basement membrane antibody disease

Primary outcomes:
measure: Time to clinical remission (Birmingham Vasculitis Activity Score 0 or 1)
timeFrame: 0, 6, 10, 14, 26, 39 and 52 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: Weeks 2, 6, 10, 14, 26, 39, 52
measure: Vasculitis Damage Index Score
timeFrame: Weeks 0, 14, 26, 39, 52
measure: Renal function
timeFrame: Weeks 0, 2, 6, 10, 14, 26, 39, 52
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
state: West Midlands
Study officials:
affiliation: University of Birmingham
name: Lorraine Harper, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04300803: Expanded Access Program for Tafasitamab (MOR00208) in R/R DLBCL
Official title: An Expanded Access Protocol to Provide Intermediate Access to Tafasitamab (MOR208) for the Combination Treatment With Lenalidomide to Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL)
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: DLBCL
Keywords: Tafasitamab
MOR00208
MOR208
monoclonal anti-CD19 antibody
Diffuse large B-cell lymphoma
Lead sponsor: MorphoSys AG
Sponsor class: INDUSTRY
Collaborators: name: Clinigen Healthcare Ltd
First posted: 2020-03-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Expanded Access Program (EAP) to provide Tafasitamab (MOR208) to eligible patients with relapsed or refractory Diffuse Large B Cell Lymphoma. Access to MorphoSys´ EAP can be requested by contacting the respective CRO Clinigen (tafasitamab@clinigengroup.com).

Detailed description: This program is intended to provide access to patients with relapsed and/or refractory DLBCL who had at least one prior anti-CD20 containing regimen. Patients with primary refractory disease and double/triple hit status are also eligible. Patients considering this access program should have no other therapeutic option, and are not eligible for other clinical trials. The expanded access program (MOR208N001) is currently available in the United States only.

Eligibility criteria: Major Inclusion Criteria :

1. Age ≥ 18 years
2. Patient able to provide written informed consent
3. Histologically-confirmed diagnosis of DLBCL, including transformation from an earlier diagnosis of indolent lymphoma.
4. Patients must have relapsed and/or refractory DLBCL, including primary refractory disease and double/triple hit status, after at least 1 prior anti-CD20 containing regimen.
5. Patients with a serious, life-threatening illness in which conventional therapies have failed, are unsuitable and/or are unavailable and participation in ongoing relevant clinical trials is not feasible.

Major Exclusion Criteria:

1. Patients who have other histological type of lymphoma, e.g. indolent Non-Hodgkin lymphoma (NHL), Primary mediastinal B-cell lymphoma (PMBL) or Burkitt Lymphoma
2. Patients who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period with lenalidomide
3. Patients with:

   1. Known active bacterial and viral and fungal infections
   2. Serology of chronic active viral Hepatitis B and/or C-Hepatitis
   3. Known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV)
4. Patients who are unable to participate in the lenalidomide REMS program

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04662203: Can Frailty Inform the Management of Hypertension in Older People?
Official title: Is Frailty a Prognostic Factor for Relevant Outcomes in the Management of Hypertension in Older People, and is There Evidence That the Association of Blood Pressure and Outcomes is Different in the Context of Frailty?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Frailty
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: Swansea University
name: University of Oxford
name: Dalhousie University
First posted: 2020-12-10
Enrollment: 145598
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients living in the community registered with a general practitioner in Wales.

Brief summary: The purpose of this study was to investigate in large scale routine primary care data whether frailty is a prognostic factor for relevant outcomes in the management of hypertension in older people and whether frailty causes effect modification of the association of blood pressure or blood pressure lowering treatment and outcomes in older people.

Detailed description: A retrospective cohort study used linked electronic health records from the Welsh Secure Anonymised Information Linkage (SAIL) databank. All patients had hypertension in the absence of established cardiovascular disease, and were over the age of 65 years in 2007. Systolic blood pressure and frailty, measured using the electronic frailty index were recorded. Patients were followed up for ten years. Time to event analysis measured first ever major adverse cardiovascular or cerebrovascular event (MACCE), all-cause mortality and injurious falls. Adjustment was made for established cardiovascular risk factors.

Eligibility criteria: Inclusion Criteria:

* Patient registered with a general practitioner contributing to SAIL database for at least 1 year
* Patient with blood pressure measured and recorded at any time after 1st January 2007 and before 1st January 2008, was used as the individual's index start date.
* Patient aged 65 years or older at the time of study entry.

Exclusion Criteria:

* Patient did not have a diagnosis of hypertension or did not have blood pressure meeting criteria for hypertension;
* Patient had an established history of cardiovascular disease (previous stroke, heart failure or myocardial infarction) prior to the start date.

Primary outcomes:
measure: Major adverse cardiovascular and cerebrovascular events
timeFrame: 10 years
Secondary outcomes:
measure: All-cause mortality
timeFrame: 10 years
measure: Injurious falls
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06154603: Upper Gastrointestinal Perforations: a Nationwide Registry-based Study
Official title: Risk Factors for and Survival After Oesophageal, Gastric and Small Intestinal Perforations: a National Observational Registry-based Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Abdomen
Keywords: Clinical outcomes
General surgery
Upper gastrointestinal perforation
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
First posted: 2023-12-04
Enrollment: 2000
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: All adult patients with an upper gastrointestinal perforation between 2005-2023 in Sweden.

Brief summary: The primary aim of this project is to increase the knowledge about how perforations in the esophagus, stomach and small intestine are treated on a national level. Furthermore, secondary aims include assessment of how different treatment options and type of treating facilities relate to patient survival. This will be done by studying information about all adult patients with an upper GI perforation treated in Sweden during 2005-2023.


Eligibility criteria: Inclusion Criteria:

* age of at least 18 years
* perforation in either oesophagus, stomach or small intestine
* treatment carried out in Sweden
* diagnosis set between January 2005 and August 2023

Exclusion Criteria:

* children

Primary outcomes:
measure: Mortality
timeFrame: One year after diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Rebecka Ahl Hulme, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03802903: Efficacy and Safety of Remo-Wax for Removal of Impacted Earwax
Official title: Efficacy and Safety of Remo-Wax for Removal of Impacted Earwax; an Open, Single-arm, Non-randomised, Multicentre Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerumen Impaction of Both Ears
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2019-01-14
Enrollment: 52
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study evaluates if Remo-Wax ear drops can soften impacted earwax.

Detailed description: This is an open, single-arm multicentre study to confirm the efficacy and safety of a commercially available Remo-Wax ear drops containing allantoin for dissolving and removing impacted earwax. Subjects that qualify for enrollment and provide informed consent wil be treated with topical earwax softening product.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent obtained.
2. Male or female patients over 1 year old who have cerumen impaction.
3. Presence of excessive or impacted cerumen \[excessive or impacted cerumen is identified as causing partial (\> 50%) or complete occlusion of at least one ear canal when attempting to visualize the tympanic membrane.

Exclusion Criteria:

1. Hypersensitivity to any product ingredient(s) or history of anaphylactic/anaphylactoid reactions.
2. History of tympanic membrane perforation, tympanostomy tubes, or otitis externa in the previous 6 months.
3. External ear infection.
4. Middle ear infection
5. Past ear surgery.
6. Otorrhea.
7. Temporal bone neoplasm.
8. Presence of known or suspected mastoiditis.
9. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data (e.g. ear eczema or seborrhoea, ear canal stenosis, exostoses).
10. Deafness in the contralateral ear (single sided deafness).
11. Use of any ototopical drug or cerumen-removal product (with the exception of water or physiologic saline) during the preceding 3 days.
12. Use of hearing aids.
13. Participation in another drug study within 60 days prior to the start of the present study.
14. Predictable poor compliance or inability to communicate well with the investigator.

Primary outcomes:
measure: Tympanic membrane visuality
timeFrame: 20-60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: LOR Clinic
Study officials:
References:
Clinical trial NCT05418803: BE Study of Two Formulations of Rivaroxaban 2.5 mg in Healthy Subjects
Official title: An Open-label, Randomized, 2-sequence, 2-period, Fasted, Single Dose, Oral Administration, Crossover Study to Evaluate the Bioequivalence of YHP1807 Tablets 2.5 mg and YHR1901 Tablets 2.5 mg in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2022-06-14
Enrollment: 34
Sex: ALL
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 objective of this study was to compare the pharmacokinetic profiles and bioequivalence of rivaroxaban after a single oral dose of rivaroxaban 2.5 mg tablet in healthy Korean subjects.

Detailed description: This study was a randomized, open-label, single-dose, two-period, crossover study which included 34 healthy adult male and female subjects under fasting conditions. A single dose of experimental drug or comparator was administered in each of the two study periods (separated by a washout period of 1 week). Serial blood samples were collected up to 36 hours post-dose. Plasma drug concentrations were measured by liquid chromatography/tandem mass spectrometry (LC-MS/MS). Pharmacokinetic parameters, including maximum plasma concentration (Cmax) and area under the plasma concentration versus time curve from dosing to the last measurable concentration (AUCt), were determined by non-compartmental analysis. The geometric mean ratios and associated 90% confidence intervals (CIs) of log-transformed Cmax and AUCt were calculated to evaluate pharmacokinetic equivalence.

Eligibility criteria: Inclusion Criteria:

* Healthy male/female aged 19 to 55 with body mass index(BMI) between 18.5 and 30kg/m2
* Acceptable medical history, physical examination, laboratory tests and EKG, during screening
* Subjects who has signed a written informed consent voluntarily

Exclusion Criteria:

* History of clinically significant medical history or current disease
* Hypotension (SBP ≤ 90 mmHg or DBP ≤ 60 mmHg) or hypertension (SBP

  ≥ 140 mmHg or DBP ≥ 90 mmHg).
* AST(SGOT) or/and ALT(SGPT) \> 1.5 times of normal upper limit
* Total bilirubin \> 2.0 mg/dl
* Volunteers considered not eligible for the clinical trial by the investigator
* Administration of other investigational products within 6 month prior to the first dosing.

Primary outcomes:
measure: AUCt
timeFrame: 0-36 hours
measure: Cmax
timeFrame: 0-36 hours
Secondary outcomes:
measure: AUCinf
timeFrame: 0-36 hours
measure: Tmax
timeFrame: 0-36 hours
measure: t1/2
timeFrame: 0-36 hours
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References: