louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00705289: A Study to Observe Characteristics of Rheumatoid Arthritis in Patients Using Infliximab (Study P04250)
Official title: Epidemiology, Correlation and Predictive Value of Disease Activity and Biomarkers in RA Patients Initiated on Infliximab in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-06-26
Enrollment: 728
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be patients with rheumatoid arthritis in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European SPC of Remicade®).

Subjects will be recruited from approximately 12 countries, including: Austria, Belgium, Denmark, France, Greece, the Netherlands, Norway, Poland, Portugal, Sweden, Switzerland and Turkey.

Brief summary: This 14-week non-interventional study will observe patients with rheumatoid arthritis (RA) who are being treated with infliximab for the first time, in order to learn about their disease characteristics. Patients in this study will be treated for RA with infliximab and in a usual manner as decided by their physician.


Eligibility criteria: Inclusion Criteria:

* Subject has been diagnosed with RA
* Physician has decided, with the subject's consent, to begin treatment with infliximab
* Written informed consent form signed by both the subject and the physician.

Exclusion Criteria:

* Subjects who have previously been exposed to infliximab

Primary outcomes:
measure: Baseline Raw Disease Activity Score for 28 Joint Swollen and Tender Joint Count (DAS28) by Age
timeFrame: At Baseline
measure: Baseline Raw DAS28 by Time Since Diagnosis
timeFrame: At Baseline
measure: Baseline Raw DAS28 by Gender
timeFrame: At Baseline
measure: Baseline Raw DAS28 by Country of Residence
timeFrame: At Baseline
measure: Baseline Raw DAS28 by Previous Anti-Tumor Necrosis Factor (Anti-TNF) Therapy
timeFrame: At Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Westhovens R, van Vollenhoven RF, Boumpas DT, Brzosko M, Svensson K, Bjorneboe O, Meeuwisse CM, Srinivasan S, Gaudin P, Smolen JS, Rahman MU, Nelissen RL, Vastesaeger N. The early clinical course of infliximab treatment in rheumatoid arthritis: results from the REMARK observational study. Clin Exp Rheumatol. 2014 May-Jun;32(3):315-23. Epub 2014 Feb 11.
Clinical trial NCT04285489: A Study on the Safety of Hakim Programmable Shunt System
Official title: A Multi-center, Retrospective Registry Study on the Safety of Hakim Programmable Shunt System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hydrocephalus
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2020-02-26
Enrollment: 130
Sex: ALL
Minimum age (years): 2
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an implanted Hakim catheter due to Hydrocephalus (HCP)

Brief summary: This study aimed to collect safety information from subjects implanted with a shunt system (trade name: Hakim Shunt Programmable System) produced by Codman \& Shurtleff, Inc. of the United States. Device safety would be assessed based on all the adverse events that occurred within one year after the subjects implanted the catheter.


Eligibility criteria: Inclusion Criteria:

1. The informed consent was exempted by the Ethics Committee of a research center. Either a subject or his/her legal representative signed the informed consent form (ICF) prior to enrollment.
2. Subject had an indication suitable to use Hakim Shunt Programmable System.
3. Subject received a Hakim Shunt Programmable System at least one year ago.

Exclusion Criteria:

1. Subject didn't have an indication suitable to use the product.
2. Subject was known to be allergic to a component or ingredient of the product to be implanted, including silicone tubing and other components.
3. According to the comprehensive judgment of an investigator, subject had an infection of the implant site when the shunt system was implanted, such as ventriculitis, meningitis, peritonitis, and local implant skin infection.
4. Subject was simultaneously implanted with another shunt system different from Hakim Shunt Programmable System.
5. Subject had a contraindication of the shunt operation.
6. Subject had uncorrected coagulopathy or any bleeding disorder.

Primary outcomes:
measure: Number of Participants With Non-infection Within One Year
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
city: Guangzhou
country: China
facility: Guangzhou Women and Children Medical Center
state: Guangdong
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Nanjing
country: China
facility: Nanjing Brain Hospital Affiliated to Nanjing Medical University
state: Jiangsu
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
affiliation: Integra LifeSciences Corporation
name: Hua Tang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03994289: Motor-assisted Cycling and FES Cycling for Postprandial Glucose in Diabetic Patients With ADL Disability
Official title: Effects of Motor-assisted Cycling and Functional Electrical Stimulation Cycling on Postprandial Glucose in Type 2 Diabetic Patients With Activities of Daily Living Disability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Disability Physical
Keywords: exercise
FES
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2019-06-21
Enrollment: 9
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Exercise has been the cornerstone of diabetes management. However, many diabetic patients have ADL disabilities and experience substantial difficulty in performing usual exercises, such as brisk walking and upright cycling. There is an urgent need to provide alternative exercise modalities for diabetic patients with ADL disabilities. In this study, investigators will investigate the effects on the glucose of three exercise modalities, including motor-assisted cycling (i.e., cycling on a motor-driven bike) and functional electrical stimulation (FES) cycling, during which the investigators will use electrical current to facilitate cycling movements.


Eligibility criteria: Inclusion Criteria:

* Age above 60 years.
* Physician-diagnosed type 2 diabetes.
* ADL disability (self-reported).

Exclusion Criteria:

* Fasting glucose ≥ 250 mg/dL.
* Symptomatic hypoglycemic events in the past three months.
* Insulin injection or infusion
* Systolic blood pressure ≥ 160 mmHg OR Diastolic blood pressure ≥ 100 mmHg
* Diagnosis of NYHA class I-IV heart failure
* Myocardial infarction in the past 6 months
* Recent or current angina, shortness of breath, or other symptoms suggestive of heart failure
* Diagnosed Cancer
* Unable to consent due to impaired cognitive function
* Bone fracture, joint dislocation, or joint stiffness
* Local skin disorders at the FES cuff area or CGM sensor area
* Implantable electronic or metallic devices, such as cardioverter defibrillator and pacemaker

Primary outcomes:
measure: Postprandial glucose AUC
timeFrame: The glucose will be measured using CGM during the 2-hour postprandial period.
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Brookdale Senior Living Central Chandler
state: Arizona
Study officials:
References:
Clinical trial NCT06040489: Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly
Official title: Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Leishmaniasis; Brazilian
Leishmaniasis, Mucocutaneous
Keywords: Elderly
Miltefosine
Leishmaniasis
Pentoxifylline
Liposomal amphotericin b
Treatment
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomised clinical trial comparing oral miltefosine associated with pentoxifylline to intravenous liposomal amphotericin b for the treatment of cutaneous and mucosal leishmaniasis


Eligibility criteria: Inclusion Criteria:

* Active confirmed cutaneous leishmaniasis ou mucosal leishmaniasis
* Use of highly effective contraceptive method and a negative serologic pregnancy test (beta - HCG), if female in fertile phase
* Agree and sing informed consent form

Exclusion Criteria:

* Previous treatment with leishmanicidal drugs in the last 6 months
* Pre-treatment electrocardiographic changes that contraindicate the use of liposomal amphotericin B (QTc greater than 450ms)
* Serum creatinine or urea 1.5 times the upper limit of normal
* Patients with severe or decompensated liver, kidney, heart disease, Diabetes Mellitus
* history of any hypersensitivity reaction to liposomal amphotericin B, miltefosine and/or pentoxifylline
* Pregnant and breastfeeding women
* Patients with Acquired Immunodeficiency Syndrome (AIDS) or other immunodeficiency

Primary outcomes:
measure: Cure
timeFrame: 90 days after the begin of treatment
Secondary outcomes:
measure: Adverse effects
timeFrame: 30 days after drug interruption
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Hospital Universitario de Brasilia
state: DF
Study officials:
References:
Clinical trial NCT05435989: Extended High-frequency Hearing and Speech Perception
Official title: Extended High-frequency Hearing and Speech Perception
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low-pass Filtering Speech
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2022-06-28
Enrollment: 480
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study examines the effects of low-pass filtering speech on speech perception.


Eligibility criteria: Inclusion Criteria:

* native speakers of American English
* normal hearing 250-8000 Hz

Exclusion Criteria:

* non-native speakers of American English
* hearing loss

Primary outcomes:
measure: Speech recognition or localization score
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Champaign
country: United States
facility: University of Illinois Urbana-Champaign
state: Illinois
Study officials:
References:
Clinical trial NCT00993889: Virtual Reality Analgesia During Pediatric Physical Therapy
Official title: Virtual Reality Analgesia During Pediatric Physical Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burn
Keywords: Virtual Reality Peds
Lead sponsor: National Institute of General Medical Sciences (NIGMS)
Sponsor class: NIH
First posted: 2009-10-14
Enrollment: 18
Sex: ALL
Minimum age (years): 5
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We would like to determine whether Virtual Reality (VR) analgesia continues to be effective for reducing pain when administered for a clinically relevant treatment duration over multiple, repeated exposures (i.e., up to ten sessions of physical therapy per patient).

Detailed description: This study is done in a hospital for inpatients pediatrics. By randomization some subjects will immersive Virtual Reality (VR) during a painful procedure on daily basis up to 10 days to see whether this will reduce the pain and anxiety.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 8 years up to 20 yrs old
* Compliant and able to complete subject evaluation
* A minimum of 3 days of physical therapy, one physical therapy session per day
* No history of psychiatric (DSM-IV-R Axis I) or developmental disorder that would interfere with decisional capacity
* Not demonstrating delirium, psychosis, or any form of Organic Brain Disorder that would interfere with decisional capacity
* Able to communicate verbally
* Able to take oral medications
* English-speaking

Exclusion Criteria:

* - Age less than 8 years, or greater than 20 years.
* Not capable of indicating pain intensity
* Not capable of filling out study measures
* Hospitalization of fewer than 3 days
* Evidence of traumatic brain injury
* History of psychiatric (DSM-IV-R Axis I) disorder as evidenced in the admitting RN and MD admission notes, if interfering with decisional capacity
* Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems that would interfere with decisional capacity
* Unable to communicate verbally
* Unable to take oral medications
* History of sig. cardiac, endocrine, neurologic, metabolic, respiratory, gastrointestinal or genitourinary impairment that would interfere with treatment or decisional capacity
* Receiving prophylaxis for alcohol or drug withdrawal
* Developmental disability that would interfere with decisional capacity
* Face/head/neck injuries preventing helmet use
* Non-English-speaking
* Extreme susceptibility to motion sickness
* Seizure history

Primary outcomes:
measure: Pain and anxiety
timeFrame: pre and post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: David R Patterson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00534989: Use of FDG PET as Predictor of Residual Disease and Subsequent Relapse in Patients With NHL and HD Undergoing HDC and ASCT
Official title: Use of FDG PET as Predictor of Residual Disease and Subsequent Relapse in Patients With NHL and HD Undergoing HDC and ASCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoma, Non-Hodgkin
Hodgkin Disease
Keywords: NHL and HD
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2007-09-26
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cytogenetic Analysis of Bone Marrow Specimen Prior to High Dose Chemotherapy and Autologous Stem Cell Transplantation in Patients with Non-Hodgkin's Lymphoma or Hodgkin's Disease


Eligibility criteria: Inclusion Criteria:

* Patients with NHL and HD undergoing HDC and ASCT

Primary outcomes:
measure: Prognosis
timeFrame: overall
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: KFSH & RC
name: Syed Akhtar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03207789: T-cell Brazil: Prospective Collection of Data in T-cell Lymphomas Patients
Official title: Prospective Collection of Data in Patients With T-cell Lymphomas Distributed in the Five Distinct Macro Regions of Brazil
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: T-cell Lymphoma
NK-Cell Lymphoma
T-cell Lymphoma Adults
Lead sponsor: Grupo de Estudos Multicentricos em Onco-Hematologia
Sponsor class: NETWORK
Collaborators: name: Takeda
First posted: 2017-07-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with confirmed histologically diagnosis of T-cell or NH-cell lymphoma in any of 5 macro region of Brazil

Brief summary: The designed study follows up on the previous one by the international T-cell project (Bellei et al,, 2012) and its purpose is to verify whether a prospective collection of data would permit access to more accurate information permitting a better definition of prognosis and investigation of more adequate treatment strategies for these neoplasms.

The analysis of patients distributed in all five macro regions of the country and a comparison among them will provide a real picture of the disease in Brazil, limiting the bias probably found in the previous projects.

Detailed description: Patients with diagnosis histologically confirmed T-cell or NK-cell lymphoma will be registered in the study, despite of their planned treatment. Registration will be made on-line on a key restricted accessible web-database after obtaining the informed consent dated and signed by the patient. Every registered patient has as well to undergo a central histopathology review by a panel of experts. The referring pathologist will collect and review the patological material sent by the participating centers, without knowing the clinical outcome of the patient. Validated cases have to be supplied of information regarding treatment procedures and follow up updating for at least 5 years. The primary endpoint is the overall survival and other endpoints such as event free survival; progression free survival, complete and partial response rates.

Eligibility criteria: Inclusion Criteria:

* Dated and signed informed consent;
* T-cell or NK-cell diagnosis;
* Tissue biopsies adequate for diagnosis and classification and available for centralized review;
* clinical, laboratory, image data available and registred in the website.

Exclusion Criteria:

-

Primary outcomes:
measure: Descriptive analysis during the first year of T-cell Brazil Registry
timeFrame: 12 months of registring
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Grupo de Estudos Multicentricos em Onco-Hematologia
name: Eliana CM Miranda, M.Ed.; Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03465189: Validation of a Seizure Monitoring System
Official title: Validation of a Seizure Monitoring System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Lead sponsor: St Vincent's Hospital Melbourne
Sponsor class: OTHER
Collaborators: name: University of Melbourne
name: Seer Medical
First posted: 2018-03-14
Enrollment: 10
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 with epilepsy

Brief summary: The investigators aim to determine the feasibility of using the Medtronic LINQ device for epilepsy diagnosis, monitoring and management. The feasibility will be determined by comparing EEG signals from the LINQ system to the gold standard clinical recordings. If seizures can be identified using the LINQ device with the same level of accuracy as adjacent scalp EEG recording electrodes, then the LINQ will be deemed feasible.


Eligibility criteria: Inclusion Criteria:

* Patients with epilepsy

Exclusion Criteria:

* Women that are pregnant
* Patients that are highly dependant on medical care
* Patients that cannot give informed consent for themselves

Primary outcomes:
measure: Verify feasibility of using the LINQ device for epilepsy diagnosis, monitoring and management
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
Study officials:
References:
Clinical trial NCT00412789: Efficacy and Safety of Patupilone in Patients With Advanced Solid Tumors in Japan
Official title: A Phase IA, Open-label, Dose Escalation Study of Patupilone Administered Intravenously Every 3 Weeks in Adult Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumors
Keywords: Advanced solid tumor
Patupilone
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-12-18
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will evaluate the safety and efficacy of Patupilone in adult patients with advanced solid tumors.


Eligibility criteria: Inclusion criteria:

* Patients with a histologically/cytologically confirmed diagnosis of advanced solid tumors refractory to or unsuitable for standard therapy, or for whom no standard therapy exists
* Patients with WHO Performance Status of 0-1 ( Karnofsky Performance Status of 80-100)
* At least one measurable lesion

Exclusion criteria:

* Patients with any peripheral neuropathy
* Patients with unresolved diarrhea
* Patients with severe and/or uncontrolled medical conditions or infections that require systemic therapy

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Dose-limiting Toxicity
timeFrame: 18 months
Secondary outcomes:
measure: Safety and tolerability of patupilone assessed by CTCAE
timeFrame: 18 months
measure: Pharmacokinetic profile of patupilone
timeFrame: 18 months
measure: Anti-tumor activity of patupilone according to the RECIST guidelines
timeFrame: 18 months
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: