louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00315237: Phase III Trial of Vinflunine Plus Best Supportive Care vs. Best Supportive Care in Patients With Transitional Cell Carcinoma (TCC) of the Urothelial Tract
Official title: Prospective, Randomized Phase III Trial of I.V. Vinflunine Plus Best Supportive Care as Second Line Therapy Versus Best Supportive Care After a Platinum-containing Regimen, in Patients With Advanced Transitional Cell Carcinoma of Urothelial Tract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Transitional Cell Carcinoma of the Urothelial Tract
Bladder Cancer
Bladder Neoplasms
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2006-04-18
Enrollment: 364
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: The purpose of this clinical research study is to learn if patients who receive vinflunine plus best supportive care live longer than patients who receive best supportive care alone. This study will also investigate patient benefit, safety and whether or not vinflunine shrinks or slows the growth of the cancer.


Eligibility criteria: Inclusion Criteria:

* Bladder cancer
* Progressed after 1st line platinum-chemotherapy
* \>= 18 years old
* Adequate hematologic, hepatic \& renal function

Exclusion Criteria:

* CNS disease
* Moderate neuropathy
* More than 1 previous chemotherapy

Primary outcomes:
measure: duration of Overall Survival after Randomization
timeFrame: 30-March-07
Secondary outcomes:
measure: patient benefit
timeFrame: 30-Mar-07
measure: safety
timeFrame: 30-Mar-2007
measure: response rate
timeFrame: throughout the study
measure: time to response
timeFrame: upon occurrence
measure: response duration
timeFrame: throughout the study
measure: progression free survival
timeFrame: throughout the study
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Victoria
country: Canada
facility: Local Institution
state: British Columbia
city: Brampton
country: Canada
facility: Local Institution
state: Ontario
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: Kingston
country: Canada
facility: Local Institution
state: Ontario
city: London
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Rassy EE, Bakouny Z, Aoun F, Haddad FG, Sleilaty G, Assi T, Kattan J. A network meta-analysis of the PD(L)-1 inhibitors in the salvage treatment of urothelial bladder cancer. Immunotherapy. 2018 Jun;10(8):657-663. doi: 10.2217/imt-2017-0190. Epub 2018 Mar 22.
Clinical trial NCT00200837: Ethnopharmacological Studies in Oral Medicine
Official title: Ethnopharmacological Studies in Oral Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Pain
Oral Ulcers
Oral Tumors
Keywords: oral mucosal pain
oral inflammations
anisillo
cordonsillo
Piperaceae
oral ulcers
oral tumors
mucosal pain
mucosal inflammations
cordoncillo
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
Collaborators: name: University of Illinois at Chicago
name: Latin University of Costa Rica
First posted: 2005-09-20
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY
Time perspective: PROSPECTIVE

Brief summary: These are ethnomedicine studies of plants used by rural and indigenous peoples for pain and oral inflammation relief.

Detailed description: These are ethnomedicine studies of plants used by rural and indigenous peoples for pain relief in Central and South America.

Eligibility criteria: Inclusion Criteria:

* Patients who use plants to relieve oral pain, inflammations, ulcers, and tumors

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Medellin
country: Colombia
facility: Universidad Nacional
city: San Jose
country: Costa Rica
facility: Universidad Latina de Costa Rica
Study officials:
affiliation: University of Illinois at Chicago
name: Michael D Colvard, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colvard MD, Ashrafi SH, Alonge OK, Cordell GA. Smokeless tobacco-induced lamellar body abnormalities. Oral Dis. 2006 May;12(3):343-8. doi: 10.1111/j.1601-0825.2005.01211.x.
citation: Alonge OK, Ashrafi SH, Colvard MD. Mitochondrial volume densities in the smokeless tobacco-treated hamster cheek pouch epithelium. Oral Dis. 2003 May;9(3):138-43. doi: 10.1034/j.1601-0825.2003.01814.x.
citation: Colvard MD, Cordell GA, Villalobos R, Sancho G, Soejarto DD, Pestle W, Echeverri TL, Perkowitz KM, Michel J. Survey of medical ethnobotanicals for dental and oral medicine conditions and pathologies. J Ethnopharmacol. 2006 Aug 11;107(1):134-42. doi: 10.1016/j.jep.2006.04.005. Epub 2006 Apr 18.
citation: Cordell GA, Colvard MD. Some thoughts on the future of ethnopharmacology. J Ethnopharmacol. 2005 Aug 22;100(1-2):5-14. doi: 10.1016/j.jep.2005.05.027.
Clinical trial NCT02665637: Study Comparing Pharmacokinetics, Safety and Immunogenicity of CT-P6 and US-licensed Herceptin
Official title: A Randomized, Double-blind, Two-arm, Parallel-group, Single Dose Study to Compare the Pharmacokinetics, Safety and Immunogenicity of Two Formulations of Trastuzumab (CT-P6 and US-licensed Herceptin) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2016-01-28
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a double-blind, two-arm, parallel-group, single-dose study.

Detailed description: This is a double-blind, two-arm, parallel-group, single-dose study. A total of 70 healthy male subjects will be enrolled.

Eligibility criteria: Inclusion Criteria:

1. Healthy male subject
2. Subject voluntarily agrees to participate in this study

Exclusion Criteria:

1. Female.
2. Subject has a medical condition of disease including one or more.
3. Smoker

Primary outcomes:
measure: Pharmacokinetics will be assessed by AUC
timeFrame: up to week 10
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Phase I Clinic
state: Texas
Study officials:
affiliation: PPD Phase I Clinic
name: Rebecca Wood-Horrall, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06137937: Intradialytic Aerobic Exercise in CKD Patient
Official title: Intradialytic Aerobic Exercise in CKD Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: chronic kidney disease
intradialytic aerobic exercise
physical performance
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 34
Sex: ALL
Minimum age (years): 25
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Thirty-four participants receiving hemodialysis were randomized to the intervention and control groups.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Intradialytic aerobic exercise is not effective in increasing hemodialysis adequacy but is effective in improving physical performance in twice-weekly hemodialysis patients.

Detailed description: Uremic myopathy occurs in 60-75% of Chronic Kidney Disease (CKD) patients undergoing hemodialysis, which causes a decrease in muscle strength and physical performance. Increasing dialysis adequacy is beneficial in reducing the impact of uremia on muscles. Intradialytic aerobic exercise in thrice-weekly hemodialysis patients has improved dialysis adequacy and physical performance. This study aims to determine the effect of intradialytic aerobic exercise on improving dialysis adequacy and physical performance in twice-weekly hemodialysis patients.

Eligibility criteria: Inclusion Criteria:

* End Stage Renal Disease Patient stage 5 with Glomerular Filtration Rate \<15mL/minute/1.73m2 aged 25-54 years undergoing hemodialysis two times per week for three months to five years
* Hemoglobin levels \> 8mg/dl
* Mini-Mental State Examination (MMSE) score of ≥24
* Hamilton Depression Rating Scale (HDRS) score \<25

Exclusion Criteria:

* Received aerobic exercise in the last 3 months
* History of hospitalization in the last 3 months
* Access for hemodialysis circulation via the femoral vein.
* IMT \<18,5 (underweight) dan ≥35 (obese class II)
* Non-stable cardiovascular disease, uncontrolled glucose, acute infection disease

Primary outcomes:
measure: Kt/V
timeFrame: eight weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Al Ihsan Hospital
state: West Java
Study officials:
affiliation: Universitas Padjadjaran
name: Irma Ruslina Defi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rhee SY, Song JK, Hong SC, Choi JW, Jeon HJ, Shin DH, Ji EH, Choi EH, Lee J, Kim A, Choi SW, Oh J. Intradialytic exercise improves physical function and reduces intradialytic hypotension and depression in hemodialysis patients. Korean J Intern Med. 2019 May;34(3):588-598. doi: 10.3904/kjim.2017.020. Epub 2017 Aug 25.
citation: Yabe H, Kono K, Yamaguchi T, Ishikawa Y, Yamaguchi Y, Azekura H. Effects of intradialytic exercise for advanced-age patients undergoing hemodialysis: A randomized controlled trial. PLoS One. 2021 Oct 22;16(10):e0257918. doi: 10.1371/journal.pone.0257918. eCollection 2021.
Clinical trial NCT06592937: Harmonized and Pooled Database, Named PRIME.
Official title: Potentially Modifiable Ventilation Factors Associated With Outcome in Neurocritical Care vs Non-Neurocritical Care Patients - Rational and Protocol for a Patient-Level Analysis of PRoVENT, PRoVENT-iMiC and ENIO (PRIME)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Ventilation
Keywords: ICU
Invasive ventilation
Respiratory support
Mortality
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 3270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PROVENT, PROVENT-iMiC and ENIO included various types of patients, receiving ventilation for different reasons. For this first analysis we will select patients receiving invasive ventilation for acute brain injury.

Brief summary: We merged the dataset of three large observational studies of invasive ventilation in critically ill patients.

Detailed description: PRIME contains the individual patient data of 3 large observational studies of ventilation, 'PRactice of VENTilation in critically ill patients without ARDS' (PRoVENT), 'PRactice of VENTilation in critically ill patients in Middle-income Countries' (PRoVENT-iMiC) and 'Extubation strategies and in neuro-intensive care unit patients and associations with outcomes' (ENIO).

Eligibility criteria: All patients in the PRIME database are eligible for participation in the initial analysis presented here. We will exclude patients receiving ventilation fir another reason than acute brain injury.

Primary outcomes:
measure: ICU morality
timeFrame: ICU stay, anticipated average 15 days
Secondary outcomes:
measure: Mechanical Power
timeFrame: During the first 7 days of invasive ventilation
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study officials:
affiliation: Amsterdam UMC
name: Marcus J Schultz, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05126537: Co-inhibitory Molecules on Treg and miR-155-5p in Patients With Sepsis
Official title: An Observational Study on the Relationship Between Expression of Co-inhibitory Molecules on Treg and miR-155-5p Expression in the Peripheral Blood of Patients With Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: 28 Day Mortality
Keywords: sepsis immunosuppression Treg
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with sepsis

Brief summary: there is high mortality rate of sepsis, 36% in 90-days of sepsis in China, and there is no effective treatment. Immunosuppression mediated by sepsis is an important cause of death in patients. Treg cells are important immunomodulatory cell. Treg's over-differentiation is involved in the development of sepsis induced immunosuppression. In sepsis patients, the expression of PD-1、CTLA-4 and TIGIT on Treg cell surface increased, and Treg cells with high expression of co-inhibitory molecules showed stronger immunosuppressive characteristics. MiR-155-5p is an unencoded RNA transcript from a proto-oncogene B cell integration cluster. In sepsis, the expression of miR-155 increased in peripheral blood and correlated with the patient's prognosis. Recent studies have shown that miR-155-5p promotes co-inhibitory molecules expressed on T cells in LCMV infected animal models. However, the relationship between the expression of peripheral blood miR-155-5p in sepsis patients and the expression of co-inhibitory molecules on Treg cell surface is not clear.

Detailed description: 1. peripheral blood Treg cells and their surface PD-1、CTLA-4 and TIGIT levels in sepsis patients were measured by flowcytometry. SOFA score、APACHE II score were recorded
2. the level of miR-155-5p were measured by RT-qPCR in patients with sepsis on day 0-1 and day 3-5, and the correlation between the expression of the co-inhibitory molecules and miR-155-5p were evaluated

Eligibility criteria: Inclusion Criteria:

* sepsis 3.0 diagnositic criteria are met. older than 18 years old. total course is less than 7 days. Informed consent is obatained.

Exclusion Criteria:

* pregnancy. patients with active malignant tumors. chronic hepatitis or HIV. patients under treatment with immunosuppressive drugs (except patients with glucocorticosteroid prednisone or equivalent dose\<10 mg/d per day)

Primary outcomes:
measure: 28 day mortality
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital, Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Qingxiang Liu, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00549237: Perioperative Nutrition in Gastric Bypass Surgery
Official title: Perioperative Nutrition in Gastric Bypass Surgery for Morbid Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Gastric Bypass
Keywords: RYGBP
Early nutrition
Lean body mass
Length of stay
Body Composition
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2007-10-25
Enrollment: 200
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: The aim of this study is to demonstrate the influence of peri-operative nutrition on the preservation of lean body mass after gastric bypass, as well as it's influence on postoperative complications.

Detailed description: Outcome measures:

* Lean body mass
* Length of hospital stay
* Weight loss
* Postoperative complications
* Cost

Eligibility criteria: Inclusion Criteria:

* RYGBP surgery planned
* Age over 18
* Informed consent

Exclusion Criteria:

* Previous bariatric surgery

Primary outcomes:
measure: Post-operative body mass composition
timeFrame: 2 years
Secondary outcomes:
measure: Post-operative complications
timeFrame: 30 days
measure: Length of stay
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires Genève
Study officials:
affiliation: University Hospital, Geneva
name: Dan E Azagury, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00540137: The CogNaive Study: Assessing Changes in Neurocognitive Function in Treatment Naïve HIV-1 Positive Subjects
Official title: A Randomised Prospective Study Assessing Changes in Neurocognitive Function, Using a Computerised Test Battery, in Treatment Naïve HIV-1 Positive Subjects Commencing Two Different Antiretroviral Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: Antiretroviral therapy
Neurocognitive function
Magnetic resonance spectroscopy
HIV disease
Treatment Naive
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2007-10-05
Enrollment: 21
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the possibility of an association between changes in neurocognitive function, as measured by a computerised test battery, and the use of two different highly active antiretroviral therapy (HAART) regimens in treatment naïve HIV-1 infected subjects commencing antiretroviral therapy.


Eligibility criteria: Inclusion Criteria:

* HIV-1 infected males or females
* Signed informed consent
* No previous antiretroviral treatment
* Males with CD4+ lymphocyte count \< 400 cells/ųL and females with CD4+ lymphocyte count \< 250 cells/ųL
* Susceptible to all currently licensed nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs)

Exclusion Criteria:

* Existing neurological disease
* Hepatitis B or hepatitis C co-infection
* Current history of major depression or psychosis
* Recent head injury
* Current alcohol abuse or drug dependence
* Active opportunistic infection or significant co-morbidities

Primary outcomes:
measure: To assess changes in simple reaction time as measured by a computerised test battery
timeFrame: over study period
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Heart of England NHS Foundation Trust
city: London
country: United Kingdom
facility: St. Mary's Hospital
Study officials:
affiliation: Imperial College London
name: Alan Winston
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01181037: Bipolar H.A Versus Trochanteric Antegrade Nail for Treatment of Displaced Subcapital Femoral Fractures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Displaced Subcapital Femoral Fracture
Keywords: Displaced subcapital femoral fracture
Bbipolar H.A.
CRIF with Ttrochanteric Antegrade Nail
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-08-13
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 patients sustained a displaced subcapital femoral fracture and were operated on by colsed reduction and internal fixation with T.A.N nail or Bipolar hemiarthroplasty

Brief summary: A retrospective study to compare clinical results of patients that were treated by Bipolar H.A. vs. closed reduction and internal fixation with Trochanteric Antegrade Nail for displaced femoral subcapital fracture.


Eligibility criteria: Inclusion Criteria:

* Displaced femoral subcapital fracture.
* Active patient.
* Age 40-85.
* Patient was treated by one of the two methods.

Exclusion Criteria:

* Age out of range.

Primary outcomes:
measure: describe treatment of patients that were treated by Bipolar H.A. vs. closed reduction and internal fixation
timeFrame: 6month to 3 years following operation
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar - Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT02163837: Effect of Rifaximine on Sleep Disorders in Patients Suffering From Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Encephalopathy
Keywords: sleep quality
physical activity
daytime sleepiness
actigraphy
quality of life
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2014-06-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hepatic encephalopathy is responsible for sleep disturbances and daytime sleepiness. The purpose of our study is to assess sleep quality, quantity, sleep schemes and physical activity in patients suffering from HE, before and after a 2 weeks treatment with rifaximine, which is currently given to lower blood ammoniac levels.

Detailed description: Hepatic encephalopathy (HE) is a complex neuropsychiatric syndrome related to chronic/acute hepatic failure. Sleep architecture is disturbed in this syndrome, and patients complain mainly of excessive daytime sleepiness and sleep disturbances. Hypothesis to explain these symptoms is, among others, disturbed melatonin metabolism. Few studies have been conducted in order to study sleep disorders during HE, and effect of treatment is unknown. Recently, rifaximine, an oral broad spectrum antibiotic, have been proved to decrease ammoniac production in patients with HE. The purpose of our study is to assess sleep quality, quantity, sleep schemes and physical activity in patients suffering from HE, before and after a 2 weeks treatment with rifaximine.

Eligibility criteria: Inclusion Criteria:

* \>18y hepatic encephalopathy: positive Conn score

Exclusion Criteria:

* \<18y pregnancy inability to fulfil questionnaires acute infection unstable clinical condition bone or articular disease resulting in significant disability

Primary outcomes:
measure: Percentage of Slow Wave Sleep and REM Sleep
timeFrame: 28 days
Secondary outcomes:
measure: Sleep Efficiency
timeFrame: 28 days
Other outcomes:
measure: Quality of Sleep
timeFrame: 28 days
measure: Total Sleep Time
timeFrame: 28 days
measure: Number of Steps Walked Daily
timeFrame: 28 days
Locations:
city: Brussels
country: Belgium
facility: CHU St Pierre
Study officials:
affiliation: CHU St Pierre
name: Marie Bruyneel, MD
role: PRINCIPAL_INVESTIGATOR
References: