louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01804127: Interim PET/CT Guided Cycle Numbers of R-CHOP in DLBCL
Official title: Interim PET/CT Guided Cycle Numbers of R-CHOP in Patients With Diffuse Large B-cell Lymphoma: a Exploratory Phase II Study Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diffuse Large B-cell Lymphoma
Keywords: DLBCL
R-CHOP
PET/CT
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2013-03-05
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to optimize the number of cycles of R-CHOP in patients with diffuse large B-cell lymphoma based on the interim results of PET/CT.

Detailed description: R-CHOP is the standard regimen for patients with diffuse large B-cell lymphoma (DLBCL). However, the standard number of cycles is uncertain. Recently, interim PET/CT was found to predict prognosis in DLBCL. The hypothesis of this study is to optimize the number of cycles based on the interim results of PET/CT in order to avoid treatment exposure.

Eligibility criteria: Inclusion Criteria:

* Previously untreated diffuse large B-cell lymphoma
* Age range 18-80 years old
* Eastern Cooperative Oncology Group performance status 0-2
* Life expectancy of more than 3 months
* Adequate organ function

Exclusion Criteria:

* Primary or secondary central nervous system involvement
* Previous serious cardiac disease
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection

Primary outcomes:
measure: 3-year progression-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Objective response rate
timeFrame: 6 months
measure: 3-year overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Ye Guo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jin J, Ji D, Xia Z, Xue K, Zhang Q, Liu Y, Cao J, Hong X, Gu JJ, Guo Y, Lv F. Four cycles of R-CHOP followed by two applications of rituximab based on negative interim PET/CT: an analysis of a prospective trial. BMC Cancer. 2022 Apr 13;22(1):403. doi: 10.1186/s12885-022-09486-4.
Clinical trial NCT01792427: Mortality in Non-cystic Fibrosis Bronchiectasis
Official title: Mortality in Non-cystic Fibrosis Bronchiectasis: a Long-term Cohort Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-cystic Fibrosis Bronchiectasis
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 253
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: non-cystic fibrosis bronchiectasis

Brief summary: In this study we analyzed the overall survival for all newly diagnosed patients with non-cystic fibrosis bronchiectasis from June 2006 onwards. The investigators wanted to confirm the known risk factors such as age, gender, smoking history and Pseudomonas aeruginosa and evaluate the impact on survival of etiology, number of different bacteriological species in retrospective and prospective sputa, azithromycin use and presence/development of pulmonary hypertension.


Eligibility criteria: Inclusion Criteria:

* Patients with clinically significant and radiologically proven bronchiectasis
* Chest CT scan confirming the presence of bronchiectatic lesions and had symptoms of chronic productive cough
* Bronchiectasis was deemed to be present if there was one or more of the following criteria: a bronchoarterial ratio greater than 1, lack of tapering of the bronchi and visualization of bronchi within 1 cm of costal or paravertebral pleura or abutting the mediastinal pleura

Exclusion Criteria:

* diagnosis of cystic fibrosis
* underlying tumoral problem causing the bronchiectatic lesions (postradiotherapy, secondary immunodeficiency due to chemotherapy or postinfectious due to tumoral obstruction)
* patients with asymptomatic traction bronchiectasis caused by interstitial lung disease

Primary outcomes:
measure: overall survival
timeFrame: 6 years 4 months
Secondary outcomes:
measure: risk factor identification for NCFB
timeFrame: 6 years 4 months
Other outcomes:
measure: Identify cause of death
timeFrame: 6 years 4 months
measure: risk factor identification for the survival of NCFB
timeFrame: 6 years 4 months
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Pieter Goeminne, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01921127: Comparative Effectiveness of Symbicort vs. Advair Among COPD Patients
Official title: A U.S. Retrospective Database Analysis Evaluating the Comparative Effectiveness of Budesonide/Formoterol (BFC) vs. Fluticasone/Salmeterol (FSC) Combination in Patients With COPD.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: COPD, Comparative effectiveness, Symbicort
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: HealthCore, Inc.
First posted: 2013-08-13
Enrollment: 3000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health plan members with COPD aged 40 years or older receiving one or more prescriptions of BFC or FSC during 3/1/2009 and 3/31/2013 who are naive to ISC/LABA combinbination therapy.

Brief summary: This study is intended to evaluate treatment effectiveness of BFC compared to FSC in COPD patients new to ICS/LABA combination therapy.


Eligibility criteria: Inclusion Criteria:

* Continuous health plan enrollment for 12 months before and after index Rx, at least one prescription for BFC or FSC during intake period, naive to ICS/LABA therapies in year prior to first prescription claim, COPD diagnosis, aged 40 or over at time of first prescription.

Exclusion Criteria:

* ICS/LABA combination during pre-index period, patients with a claim for BFC and FSC on the same day, patients diagnosed with cancer, patients with long-term OCS medication use during pre-index period.

Primary outcomes:
measure: Rate of COPD exacerbation
timeFrame: 12 months
Secondary outcomes:
measure: COPD exacerbation rate sensitivity and subgroup analyses
timeFrame: 12 months
measure: COPD respiratory medication use
timeFrame: 12 months
measure: COPD related healthcare utilization
timeFrame: 12 months
measure: All-cause utilization
timeFrame: 12 months
measure: All- cause and COPD related healthcare costs
timeFrame: 12 months
measure: Treatment patterns and adherence
timeFrame: 12 months
measure: Treatment modification
timeFrame: 12 months
measure: COPD exacerbation rate sensitivity analysis
timeFrame: up to 4 years
Other outcomes:
measure: Pneumonia diagnosis validation
timeFrame: 12 months
Locations:
Study officials:
References:
citation: Kern DM, Davis J, Williams SA, Tunceli O, Wu B, Hollis S, Strange C, Trudo F. Comparative effectiveness of budesonide/formoterol combination and fluticasone/salmeterol combination among chronic obstructive pulmonary disease patients new to controller treatment: a US administrative claims database study. Respir Res. 2015 Apr 23;16(1):52. doi: 10.1186/s12931-015-0210-x.
Clinical trial NCT00249327: Online HIV Prevention Vignette Evaluation
Official title: Online HIV Prevention Vignette Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV testing
HIV disclosure
HIV Seronegativity
Lead sponsor: Public Health Solutions
Sponsor class: OTHER
Collaborators: name: Van Ameringen Foundation Inc
name: The New York Community Trust
First posted: 2005-11-07
Enrollment: 1000
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

Brief summary: This is an evaluation of the effect that an online live action, dramatic vignette about four gay men, two HIV positive and two HIV negative, struggling with the responsibility for safer sex has on the sexual behavior and HIV testing intentions of the gay/bisexual men who watch the vignette and participate in the evaluation study. The primary hypothesis is that men will be more likely to: 1)express the intent to have an HIV test and 2) to express the intent to inform their sex partners of their HIV status after watching the vignette. The secondary hypothesis is that men will be more likely to follow through on these intentions in the three months following the intervention than they were in the three months before viewing the vignette. This is a one group pre-posttest intervention in which each man serves as his own control.

Detailed description: * Men over 18 years of age will be recruited for the study through a banner posted on the exit page of manhunt.net an internet gay hook-up site. Those clicking on the banner will go to the evaluation website (www.hivbigdeal.org)
* asked to read the consent and click agreement.
* asked to complete a relatively brief questionnaire about their sexual behavior, HIV testing and HIV disclosure in the preceding three months
* watch the 8 minute dramatic vignette
* complete a brief questionnaire that elicits their response to the video and their HIV testing and disclosure intentions.
* if they agree to provide the study with their e-mail address, participants will be re-contacted in three months and asked to complete a second behavioral survey online that asks about sexual behavior, HIV testing and HIV disclosure in the three months since watching the vignette.Behavior before and after watching the vignette will be compared.
* The entire study will be conducted online.

Eligibility criteria: Inclusion Criteria:

* English-speaking
* Gay/bisexual men
* Age \> 18

Exclusion Criteria:

* Women
* Men under 18
* Men who do not have sex with other men

Primary outcomes:
measure: Increase in HIV testing
measure: Increase in disclosure of HIV status to sex partner
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Medical and Health Research Association of New York City, Inc.
state: New York
Study officials:
affiliation: Medical and Health Research Association of New York City Inc.
name: Mary Ann Chiasson, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03643627: A Study of SYNT001 in Healthy Volunteers
Official title: A Phase 1a, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study of SYNT001 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Lead sponsor: Syntimmune, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-23
Enrollment: 31
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being done to compare the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of an intravenous (IV) formulation of SYNT001. This is the first-in-human (FIH) study of SYNT001.


Eligibility criteria: IInclusion Criteria:

Subjects must meet the following criteria to be included:

* Healthy as determined by comprehensive clinical assessment and clinical laboratory investigations
* Body mass index 18.5 to 30.0 kg/m2
* Must use medically acceptable contraception
* Willingness to complete all study measurements and assessments in compliance with the protocol

Exclusion Criteria:

Subjects meeting any of the following criteria are to be excluded:

* Past or present disease that is judged by the investigator to have the potential to interfere with the study procedures, compromise safety or affect the PK evaluations
* Subject unable or unwilling to comply with the protocol
* Any exposure to an investigational drug within the 30 days prior to screening
* Use of any tobacco or nicotine-containing products
* Abuse of alcohol
* Positive drug test or history of drug abuse

Primary outcomes:
measure: assessment of safety data (counts and percentages of adverse events)
timeFrame: Day 0 - Day 28
Secondary outcomes:
measure: Pharmacokinetics (serum concentration of SYNT001)
timeFrame: Pre-dose and 0.08, 2, 4, 6, 8, 12, 16, 20, 24, 48, 72, and 120 hours post dose
measure: Pharmacodynamics
timeFrame: Days 1 (pre dose), 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 21 and 28
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami
state: Florida
Study officials:
References:
Clinical trial NCT01455727: Pharmaceutical Care of Ambulatory Elderly Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Pharmaceutical care
Diabetes Mellitus
Lead sponsor: Nantou Hospital
Sponsor class: OTHER_GOV
First posted: 2011-10-20
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will try to perform pharmaceutical care on ambulatory elderly diabetes patients. To provide appropriate diabetes education administration, identify and resolve drug-related problems, assess the appropriateness of their medications, establish the mechanism of medication consultations. Each patient will be assessed by the MMSE(Mini-Mental State Examination) and GDS(Geriatric Depression Scale). The effectiveness of pharmacist's intervention will be assessed by lab data and some questionnaires.


Eligibility criteria: Inclusion Criteria:

* Age 65 years or older
* A1c greater than or equal to 9.0

Exclusion Criteria:

* Not expected to live for the duration of the study
* Unwillingness to participate and attend pharmacist visits
* Unwillingness to participate the questionnaires(MMSE, GDS)

Primary outcomes:
measure: Hgb A1c change
timeFrame: 12 month
Secondary outcomes:
measure: Mini-Mental State Examination(MMSE) Score change
timeFrame: 1 year
measure: Taiwan Geriatric Depression Scale(GDS) Score change
timeFrame: 1 year
Other outcomes:
Locations:
city: Nantou
country: Taiwan
facility: Nantou Hospital
Study officials:
References:
Clinical trial NCT06819527: Medication Reconciliation in Hospitalized CKD Patients : a Quasi-Experimental Study
Official title: The Impact of Medication Reconciliation on Discrepancies and All-cause Readmission Among Hospitalized Patients with Chronic Kidney Disease: a Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease(CKD)
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This was a quasi-experimental trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to evaluate the impact of combining medication reconciliation with medication review on reducing medication discrepancies at discharge and all-cause readmissions among CKD patients, in comparison to a retrospective control group that received usual care, which may or may not have included medication reconciliation.


Eligibility criteria: Inclusion Criteria:

Adult (18 years or older) admitted patients with CKD (stages 2-5 ), who were using at least three chronic medicines at home, and were hospitalized for at least 48 hours.

Exclusion Criteria:

Patients with kidney transplantation . Patients who have difficulties in responding to interviews and did not have family member or caregiver on behave, and those who refused to provide a written informed consent.

Primary outcomes:
measure: all-cause 90-day readmission
timeFrame: 90 days after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: King Abdullah University Hospital and Princess Basma Hospital
Study officials:
References:
citation: Abu Farha R, Yousef A, Gharaibeh L, Alkhalaileh W, Mukattash T, Alefishat E. Medication discrepancies among hospitalized patients with hypertension: assessment of prevalence and risk factors. BMC Health Serv Res. 2021 Dec 14;21(1):1338. doi: 10.1186/s12913-021-07349-5.
Clinical trial NCT00142727: Opioid Agonist and Antagonist Effects on Opioid Dependence
Official title: The Variability of Agonist and Antagonist Effects as a Function of Level of Physical Dependence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Johns Hopkins University
First posted: 2005-09-02
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the acute agonist and antagonist effects of a full opioid agonist medication, an opioid antagonist medication, and a partial opioid agonist medication in individuals who have different levels of physical opioid dependence.

Detailed description: The pharmacological effects of opioids in opioid dependent individuals can vary as a function of the characteristics of the opioid being studied (e.g., whether it is an agonist, partial agonist, or antagonist; the dose administered; and the route of administration). Another important set of factors influencing the effects produced by opioids is the characteristics of the organism to which the opioid is being administered. One such characteristic is the level of physical dependence in individuals.

Participants in this study will be maintained on different dose levels of an opioid agonist (methadone). The participant will be challenged with a prototypic opioid agonist, antagonist, and a mixed agonist-antagonist with partial agonist features in order to determine the effects that each has on the human body.

Eligibility criteria: Inclusion Criteria:

* Active opioid dependence
* Qualifies for opioid agonist treatment (e.g., methadone or buprenorphine)
* Fulfills DSM-IV diagnostic criteria for opioid dependence

Exclusion Criteria:

* Significant medical problems, including insulin dependent diabetes mellitus
* Non-substance use psychiatric disorders (e.g., schizophrenia)
* Currently seeking treatment for substance abuse

Primary outcomes:
measure: Opiate withdrawal
timeFrame: up to one day
measure: Opiate agonist symptoms
timeFrame: up to one day
measure: Physiologic measures
timeFrame: up to one day
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University (BPRU) Bayview Campus
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Eric C. Strain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00541827: Skeletal Muscle and Platelet Mitochondrial Dysfunction During Sepsis
Official title: Skeletal Muscle and Platelet Mitochondrial Dysfunction During Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Sepsis
Septic Shock
Keywords: Sepsis. Shock, septic. Mitochondria.
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
Collaborators: name: European Society of Intensive Care Medicine
First posted: 2007-10-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult ICU-admitted severely septic and septic shock patientes; adult ICU-admitted cardiogenic shock patients; surgical patients

Brief summary: The primary aim of the study is to demonstrate that mitochondrial dysfunction occurs in both skeletal muscle and circulating platelets of severely septic and septic shock ICU-admitted patients. Secondary aims are to clarify the pathogenesis and the clinical relevance of mitochondrial damage during sepsis.

Detailed description: The primary aim of the study is to demonstrate that mitochondrial dysfunction occurs in both skeletal muscle and circulating platelets of severely septic and septic shock ICU-admitted patients, as compared to otherwise healthy surgical ones. In order to better clarify the pathogenesis of mitochondrial dysfunction during sepsis, cardiogenic shock patients (suffering from systemic hypoperfusion) will act as additional controls. Markers of oxidative stress will be measured in tissue samples from septic patients. The clinical relevance of mitochondrial dysfunction during sepsis will be assessed in terms of both skeletal muscle and platelet function.

Eligibility criteria: Inclusion Criteria:

* Consecutive ICU-admitted severely septic or septic shock patients.

Exclusion Criteria:

* Severe thrombocytopenia.
* Severe coagulopathy.
* Pre-existing mitochondrial disease

Primary outcomes:
measure: Mitochondrial respiratory chain enzyme activity
timeFrame: On day one and seven from admission to ICU
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
Study officials:
affiliation: Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
name: Luciano Gattinoni, MD
role: STUDY_CHAIR
affiliation: Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
name: Alessandro Protti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Protti A, Fortunato F, Artoni A, Lecchi A, Motta G, Mistraletti G, Novembrino C, Comi GP, Gattinoni L. Platelet mitochondrial dysfunction in critically ill patients: comparison between sepsis and cardiogenic shock. Crit Care. 2015 Feb 11;19(1):39. doi: 10.1186/s13054-015-0762-7.