louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02574208: Acceptability/Feasibility of HIV Testing by ELISA or Rapid Test to Adult Patients in Paris, France
Official title: Acceptability and Feasibility of HIV Testing by ELISA or Rapid Test to Adult Patients Consulting Their General Practitioner in Paris, France: A Multi-center Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Adult outpatients
Paris, France
Lead sponsor: Hopital Lariboisière
Sponsor class: OTHER
First posted: 2015-10-12
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: CDC recommends universal HIV testing in all adults, at least once during life, to reduce the pool of infected patients unaware of their status. Routine universal HIV testing can use "classical" ELISA tests from serum, or rapid tests, ideally from finger-stick whole blood (FSB), which have shown close predictive values from classical tests. The investigators will compare the acceptability and feasibility of the two methods.

Detailed description: The multi-center prospective randomized study will compare the acceptability and feasibility of routine universal HIV testing to adult patients consulting their general practitioner in Paris, France, using either the " classical " ELISA tests from serum or rapid tests from FSB (Insti®).

Eligibility criteria: Inclusion Criteria:

* adult patients consulting their general practitioner in Paris, France

Exclusion Criteria:

* patients previously known as HIV-positive,
* patients who declare having been tested HIV-negative less than three months ago,
* patients who can not give informed consent

Primary outcomes:
measure: acceptability of HIV testing
timeFrame: immediately after HIV testing proposal
Secondary outcomes:
measure: feasibility of HIV testing
timeFrame: one month after HIV testing proposal
Other outcomes:
Locations:
Study officials:
affiliation: Hopital Lariboisiere
name: Pierre O Sellier, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prost A, Griffiths CJ, Anderson J, Wight D, Hart GJ. Feasibility and acceptability of offering rapid HIV tests to patients registering with primary care in London (UK): a pilot study. Sex Transm Infect. 2009 Sep;85(5):326-9. doi: 10.1136/sti.2008.033233. Epub 2009 May 31.
Clinical trial NCT00174408: Treatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age
Official title: Growth Hormone Treatment in Short Children Born Small for Date (Genotonorm)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth Disorders
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 110
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to evaluate, if Genotonorm (Genotropin) increases linear growth in short children born SGA. Safety of the drug is a main objective as well. The growth promoting effect of two different dosages is compared. The effect of long-term treatment on final height is evaluated (according to several amendments)


Eligibility criteria: Inclusion Criteria:

* Birth length below -2 SD
* Height at start below - 2 Sd

Exclusion Criteria:

* Any endocrine or chronic disease
* Any known syndrome with short stature

Primary outcomes:
measure: Height, height velocity
Secondary outcomes:
measure: Side effects
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02086708: Ultrasound Method to Measure Fibrosis of the Liver in Children
Official title: Sonoelastography: Ultrasound Method to Measure Fibrosis of the Liver in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Liver Disease
Non-Alcoholic Fatty Liver Disease
HCV Coinfection
HBV
Drug-Induced Liver Injury
Keywords: Sonoelastography,
Diffuse liver disease,
chronic liver disease,
NASH,
NAFLD,
Elevated Transaminases,
Liver Biopsy,
Fibrosis,
METAVIR
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 24
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) provide accurate quantitative measurements that can be used to stage liver fibrosis in pediatric patients with chronic liver disease.

Specific Aims:

To measure liver stiffness with sonoelastography in pediatric and adolescents with suspect diffuse liver disease who will undergo nonfocal liver biopsy as part of their routine clinical care.


Eligibility criteria: Inclusion criteria:

* Patients scheduled for random liver biopsy for routine staging of liver fibrosis
* Pediatric patients patients (ages 1-21)
* Girls or boys
* Suspected liver disease
* Consent to participate in the study

Exclusion criteria:

* Pregnancy
* Acute illness/cognitive impairment resulting in inability to cooperate with ultrasound
* Patients that do not consent to ultrasound guided liver biopsy.
* Contraindications to liver biopsy (e.g. low platelets defined as a platelet count of less than 50,000, and hemophilia/coagulopathy as an INR higher than 1.5.)

Primary outcomes:
measure: Measure Liver Elasticity Value Using Sonoelastography.
timeFrame: Day one
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetss General Hospital
name: Uzma Shah, MD, FAAP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dhyani M, Gee MS, Misdraji J, Israel EJ, Shah U, Samir AE. Feasibility study for assessing liver fibrosis in paediatric and adolescent patients using real-time shear wave elastography. J Med Imaging Radiat Oncol. 2015 Dec;59(6):687-94; quiz 751. doi: 10.1111/1754-9485.12388. Epub 2015 Oct 27.
Clinical trial NCT03931408: Gentamicin Bladder Instillation in Individuals With Spinal Cord Injury Having Chronic Urinary Tract Infections
Official title: The Evaluation of Antimicrobial Bladder Instillation on the Prevalence of Chronic Urinary Tract Infections and Bladder Dysfunction in Persons With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neurogenic Bladder
Spinal Cord Injuries
Keywords: bladder
spinal cord injury
urinary tract infection
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Participants will undergo daily gentamicin bladder instillations to determine if its use will reduce the rate of symptomatic urinary tract infections (UTIs) as well as the use of oral and intravenous antibiotics in adults with chronic spinal cord injury (SCI) who have recurrent UTIs. Participants are randomized into one of three groups: 1) Gentamicin and saline instillation 2) Saline only instillation 3) Standard of care, no instillation.

Detailed description: The purpose of this study is to determine if twice daily bladder flushing with an antibiotic solution will decrease the rate of UTIs and the use of oral medications used to treat UTIs. The occurrence of UTIs in the SCI population is high, with a rate of about 2.5 episodes per year. The inability to effectively empty the bladder increases the risk of UTIs, which are the most common medical complication after SCI. This study will help us understand the effectiveness of a local bladder therapy on preventing UTIs and improving bladder function in individuals with SCI.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age;
* Non-progressive spinal cord injury;
* Stable medical condition;
* Bladder dysfunction as a result of spinal cord injury
* History of recurrent UTIs (defined as 3 or more within the past year or 2 or more within the past 6 months).

Exclusion Criteria:

* Signs or symptoms of serious UTI that requires the use of systemic antibiotics;
* Use of any urine-acidifying agent, bladder irrigant, or systemic antibiotic within the previous 2 weeks;
* Participants colonized with gentamicin-resistant bacteria on baseline urine culture or a gentamicin allergy/sensitivity;
* Participants with known hearing loss and/or renal disease;
* Pregnant at the time of enrollment or planning to become pregnant during the time course of the study.

Primary outcomes:
measure: Evaluate Bladder Storage Using Urodynamics
timeFrame: 1. Baseline (1 week) 2. Midpoint (2 months) 3. Post (4 months)
Secondary outcomes:
measure: Participants With Symptomatic Urinary Tract Infection
timeFrame: 1. Baseline (1 week) 2. Midpoint (2 months) 3. Post (4 months)
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Frazier Rehab
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Susan Harkema, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05950308: Assessment of Immune Response in Multiple Sclerosis Patients With COVID-19/Vaccination Treated With Ofatumumab and Other Disease Modifying Therapies
Official title: Assessment of Immune Response in Multiple Sclerosis Patients With COVID-19/Vaccination Treated With Ofatumumab and Other Disease Modifying Therapies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-07-18
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study

Brief summary: Vaccine responses in patients treated with anti-CD20 antibodies (ocrelizumab and ofatumumab) or S1P receptor modulators (fingolimod and siponimod) were evaluated before and after third SARS-CoV-2 vaccination as part of an ongoing longitudinal study. Total spike protein and spike receptor binding domain (RBD)-specific immunoglobulin G (IgG) responses were measured by Luminex bead-based assay. Spike-specific CD4+ and CD8+ T cell responses were measured by activation-induced marker expression.


Eligibility criteria: Inclusion Criteria

All Participants:

* Aged 18-75 years old MS Patients
* Diagnosed with MS based on 2017 McDonald criteria

Exclusion Criteria

All Participants:

* Participants with a known history of COVID-19 Healthy Adults
* Immunocompromised or on immunosuppressive therapy MS Patients
* None specified

Primary outcomes:
measure: Percentage of participants achieving humoral response (i.e. immune response) to an FDA-authorized COVID 19 vaccine in ofatumumab treated participants
timeFrame: varied up to 6 months
measure: Percentage of participants achieving T-cell response (i.e. immune response) to an FDA-authorized COVID 19 vaccine in ofatumumab treated participants
timeFrame: varied up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02377908: European Postgraduate Training in Geriatric Medicine
Official title: European Postgraduate Training in Geriatric Medicine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Education
Geriatrics
Lead sponsor: Klinikum Nürnberg
Sponsor class: OTHER
Collaborators: name: Medical University of Graz
First posted: 2015-03-04
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Experts in geriatric medicine and member of one of the organizations European Union of Medical Specialists (UEMS), European Academy for the Medicine of Ageing (EAMA) or European Union Geriatric Medicine Society (EUGMS).

Brief summary: The objective of the study is to give a structured update on geriatric postgraduate education throughout Europe. The study will be performed as a cross-sectional structured quantitative online survey with qualitative comments. The survey content covers structural items, content and educational aspects of geriatric specialty training in European countries.

Detailed description: The study is performed as a cross-sectional structured quantitative survey leaving space for qualitative comments. The survey content covers structural items, content and educational aspects of geriatric specialty training in European countries. To prove feasibility in the questionnaire setting and time management the survey will be piloted in five international experts in geriatric medicine. Questions in the survey are closed with the possibility to give a free comment.Validity of individual data collection will be controlled by repeated hidden content within different questions.

Experts in the field of geriatric medicine and members of one of the organizations European Union of Medical Specialists (UEMS), European Academy for the Medicine of Ageing (EAMA) or European Union Geriatric Medicine Society (EUGMS) and a strong personal focus of interest in postgraduate training are contacted by the survey coordinator and invited to participate in the survey personally and via E-mail. The survey will be performed online using the following software (http://www.surveyxact.com/) . To reassure data quality, the survey will be sent for double checks within nations.

Eligibility criteria: Inclusion Criteria:

Experts in geriatric medicine and member of one of the organizations European Union of Medical Specialists (UEMS), European Academy for the Medicine of Ageing (EAMA) or European Union Geriatric Medicine Society (EUGMS).

Exclusion Criteria:

none

Primary outcomes:
measure: situation of geriatric postgraduate education
timeFrame: until June 2014
Secondary outcomes:
Other outcomes:
Locations:
city: Nuremberg
country: Germany
facility: Insitute for Biomedicine of Aging
state: Bavaria
Study officials:
References:
Clinical trial NCT04318808: Effect of Laser Acupuncture on Constipation in Patients With Advanced Cancer
Official title: Effect of Laser Acupuncture on Constipation in Patients With Advanced Cancer: a Prospective Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Constipation
Advanced Cancer
Keywords: Constipation
Acupuncture
Laser acupuncture
Advanced Cancer
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Constipation is one of the most common complications in patients with advanced cancer.

The aim of this protocol designed as a double-blind randomized controlled trial is to investigate the efficacy of laser acupuncture (LA) therapy on constipation in patients with advanced cancer.


Eligibility criteria: Inclusion Criteria:

* Aged 20 years or older
* Principal diagnosis of advanced cancer
* Diagnosis of constipation
* Treat with laxatives for at least 1 week but still have symptoms of constipation

Exclusion Criteria:

* Intestinal obstruction
* Disturbance of consciousness
* Active gastrointestinal bleeding
* Active intraabdominal infection
* Local skin infection on the acupoints or limb amputees.

Primary outcomes:
measure: Complete spontaneous bowel movements (CSBM)
timeFrame: 1 week
Secondary outcomes:
measure: Comfort levels during defecation
timeFrame: 1 week
measure: Symptoms of constipation
timeFrame: 1 week
measure: Colonic motility
timeFrame: 1 week
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital
name: Chun-Ting Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01250808: Technology Platform and System Construction of Clinical Evaluation Studies on New Drugs of Hematological Malignancy
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Multiple Myeloma
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2010-12-01
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Multiple Myeloma (MM) is the second diagnosed malignancy of hematological malignancies. The previous study pointed out that the dosage and course of Bortezomib including the dose of concomitant drugs used to treatment MM patients did not get the preferred treatment program, so we are going to determine the optimal doses and course of Bortezomib through the prospective, multicenter clinical trial and evaluate the efficiency and safety of different program.


Eligibility criteria: Inclusion Criteria:

1. Obtain informed consent form (ICF) signed by patients or its relative.
2. Patients newly diagnosed multiple myeloma (MM). (Not include patients with multiple solitary extramedullary plasmacytoma and those atⅠstage of Durie-Salmon staging system)
3. Measurable serum protein:

   IgG type of MM: serum M-protein≥ 1.0g/dl or urine M-protein≥ 200mg/24h. IgA type of MM: serum M-protein≥0.5g/dl or urine M-protein≥200mg/24h. IgM type of MM: (IgM M-protein and osteolytic lesion showed in X-ray):serum protein≥ 1.0g/dl or urine M-protein≥ 200mg/24h. IgD type of MM: serum M-protein≥0.05g/dl or urine M-protein≥200mg/24h. Light chain type of MM: serum M-protein≥ 1.0g/dl or urine M-protein≥ 200mg/24h.
4. Physical score 0\~2 grade(WHO standard), and able to comply with the visit time and protocol requirements.

Exclusion Criteria:

1. Diagnosed with relapsed multiple myeloma.
2. Any serious diseases which may lead patients suffer from unaccepted risk.
3. Female patients who is pregnant or breast-feeding.
4. Histories of other malignant tumors other than MM, except those patients whose disease have been cured for at least 3 years. Exception: basal-cell carcinoma, squamous cell carcinoma, carcinoma in situ of uterine cervix, breast carcinoma in situ,occasionally prostatic cancer histological discovery(at stage T1a or T1B defined as TNM classification).
5. Not be able to understand or comply with the investigate protocol.
6. Patients with grade 2 or higher peripheral neuropathy before treatment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Peking
country: China
facility: Institute of Hematology,Peking University
Study officials:
References:
Clinical trial NCT04286308: Cortical-Basal Ganglia Speech Networks
Official title: Cortical-Basal Ganglia Speech Networks
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Essential Tremor
Dystonia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In this research study the researchers want to learn more about brain activity related to speech perception and production.

Detailed description: Speech production is disrupted in a number of neurological diseases that involve the basal ganglia, including Parkinson's disease (PD) and dystonia. The investigators will use a novel experimental approach and combination of analytic techniques to elucidate the contribution of neural activity in cortical-basal ganglia circuits to the hierarchical control of speech production, in subjects undergoing deep brain stimulation surgery.

Eligibility criteria: Inclusion Criteria:

1. Subjects scheduled for DBS implantation, as determined by the clinical multidisciplinary movement disorders board with definitive diagnosis of Parkinson's disease, essential tremor or dystonia.
2. Subjects able to provide informed consent and comply with task instructions.
3. Subjects 18-85 years old

Exclusion Criteria:

1. Subjects with reported hearing loss.
2. Non-English-speaking subjects

Primary outcomes:
measure: The number of subjects providing the interpretable speech related electrophysiological data collection.
timeFrame: Duration of single DBS surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT05995808: Cyclin D1 as a Prognostic Factor in Multiple Myeloma and Its Association With the Immunological Prognostic Factor PDL1 and Clinical and Biochemical Lab Tests
Official title: Cyclin D1 as a Prognostic Factor in Multiple Myeloma and Its Association With the Immunological Prognostic Factor PDL1 and Clinical and Biochemical Lab Tests
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Multiple myeloma (MM) is the most common bone marrow malignancy of terminally differentiated plasma cells. It accounts for about 1% of all malignant diseases and 10% of haematological malignancies and takes the second place after non-Hodgkin lymphoma .

There are some serological and clinical criteria that help to detect the stage of MM and predict the patients' prognosis. These criteria include the level of M protein, calcium, haemoglobin, albumin, creatinine, β2-microglobulin and glomerular filtration rate (GFR).


Eligibility criteria: Inclusion Criteria:

1. Patients older than 18 year with newly diagnosed MM.
2. Approval to sign an informed written consent.

Exclusion Criteria:

* 1. Patient younger than 18 years. 2.Refusal to sign an informed written consent.

Primary outcomes:
measure: Cycline D1 expression in bone marrow biopsy of multiple myeloma patient
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: