louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06675656: Predictive Role of Microbiome in Patients With Urothelial Carcinoma
Official title: Predictive Role of Microbiome in Patients With Urothelial Carcinoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Urinary Bladder Cancer
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with diagnosis of NMIBC, both first diagnosis or relapsing NMIBC.

Brief summary: This study aims to establish the microbiota composition as a predictive tool for the response to the intravesical immunotherapy with Bacillus Calmette-Guérin (BCG) and 2 different chemotherapies schemes.

In this prospective cohort study patients with low/intermediate/high risk non muscle invasive bladder carcinoma (NMIBC) that undergo BCG/chemo treatment will be enrolled to collect urine stool and blood at different endpoints. Microbiota, short-chain fatty acids and immunophenotype will be quantified to develop a predictive screening platform, which might also integrate traditional urinary cytology and FISH data.

Detailed description: The purpose of this research is to understand the possible use of microbial profile from catheterized urine and feces of patients with NMIBC to categorize patients in two groups: those likely to respond positively and those unlikely to respond to the therapy. Goal of this study is to identify the predictive role of the microbiome to therapy response, thus allowing clinicians to deliver the most appropriate treatment based on the microbiome (microbiome-personalized therapy).

Eligibility criteria: Inclusion Criteria:

* Adults aged ≥ 18 years, all able to signed informed consent form;
* Diagnosis of NMIBC provided by an experience pathology, by using tissue specimens that were staged according to the TNM classification and morphoarchitectural criteria according to the WHO classification.

Exclusion Criteria:

* Participants with ongoing urinary tract infection;
* Antibiotic treatment within the last month;
* Immuno-/chemo- therapy within the past 3 months;
* Chronic immunosuppressive therapy;
* Additional major diagnosis known to affect the gut or bladder microbiota;
* Use of probiotics;
* Uncontrolled diabetes;
* Participants with other malignancy or previous history of oncological or autoimmune diseases.

Primary outcomes:
measure: Establish the change of microbial profile in high-grade NMIBC patients after BCG administration
timeFrame: 2 years
Secondary outcomes:
measure: The predictive role of microbiome in BCG responsiveness
timeFrame: 11 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00529256: Evaluation of Organisational Changes to Promote Smoking Cessation
Official title: Evaluation of Organisational Changes to Promote Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Smokers
Keywords: Adult smokers
Lead sponsor: Great Lakes Research Into Practice Network
Sponsor class: NETWORK
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2007-09-14
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Department of Family Practice at Michigan State University partnered with BCBSM with a grant from the Robert Wood Johnson Foundation to recruit primary care practices for a 3 year study designed to assess smoking cessation referral rates by primary care physicians in Michigan.

Detailed description: There are two main research questions to our study: 1) Whether provider referral rates to smoking cessation services and quitline counseling are enhanced by comparative feedback profiles to individual providers and provider groups (Study 1) and 2) Whether health plan members who receive pharmacotherapy for smoking cessation have higher participation rates in smoking cessation services if they receive proactive, invitational phone calls (Study 2).

Eligibility criteria: Inclusion Criteria:

* Primary care practice and thier Adult smokers

Exclusion Criteria:

* Non somkers

Primary outcomes:
measure: evaluate and provide a model of smoking cessation interventions
Secondary outcomes:
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: William Wadland
state: Michigan
Study officials:
affiliation: Michigan State University
name: William Wadland, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holtrop JS, Malouin R, Weismantel D, Wadland WC. Clinician perceptions of factors influencing referrals to a smoking cessation program. BMC Fam Pract. 2008 Mar 28;9:18. doi: 10.1186/1471-2296-9-18.
Clinical trial NCT00956956: A Multiple Dose Study To Determine Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Healthy Adult Subjects
Official title: A Phase I, Randomized, Placebo Controlled, Multiple Dose Study To Determine Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: An investigator and subject blinded (sponsor open)
multiple dose
dose escalation design with PF 04455242 and matching placebo.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-08-11
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goals of this study are to evaluate the safety and tolerability of multiple ascending doses of PF-04455242 administered orally to healthy adult subjects. In addition, the plasma and urine pharmacokinetics of multiple ascending doses of PF 04455242 administered orally to healthy adult subjects will be evaluated. Finally, the effect of multiple-doses of PF-04455242 on serum prolactin concentration will be explored.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects without childbearing potential between the ages of 21 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies).

Primary outcomes:
measure: Safety and tolerability of multiple ascending doses of PF 04455242 administered orally to healthy adult subjects.
timeFrame: 10 days
measure: Plasma and urine pharmacokinetics of multiple ascending doses of PF 04455242 administered orally to healthy adult subjects.
timeFrame: 10 days
Secondary outcomes:
measure: Effect of multiple-doses of PF 04455242 on serum prolactin concentration.
timeFrame: 10 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00550056: Treatment of Posttraumatic Stress Disorder by Trained Lay Counsellors in an African Refugee Settlement
Official title: Talking About Traumatic Events - A Randomized Controlled Dissemination Study of the Treatment of PTSD in an African Refugee Settlement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD, Posttraumatic Stress Disorder, refugees, war
Lead sponsor: University of Konstanz
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2007-10-26
Enrollment: 277
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 study is a pragmatic trial to study the efficacy of two active methods of psychotherapy for the treatment of posttraumatic stress disorder in a refugee camp in Africa. Treatment was administered by lay counsellors.

Detailed description: Traumatic stress due to conflict and war causes major mental health problems in many resource-poor countries, especially those coping with displaced populations. There is a lack of intervention research in these populations.

Te purpose of this study was to examine whether trained lay counsellors can carry out effective treatment of PTSD in a refugee settlement.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of posttraumatic stress disorder

Exclusion Criteria:

* Drug abuse
* Psychosis
* Mental retardation

Primary outcomes:
measure: Posttraumatic Stress Symptoms measured with the Posttraumatic Diagnostic Scale
timeFrame: 9 months
Secondary outcomes:
measure: Expert diagnosis of PTSD established with CIDI interview
timeFrame: 9 months
measure: Physical health symptoms assessed with a checklist
timeFrame: 9 months
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Nakivale Refugee Camp
Study officials:
affiliation: University of Konstanz
name: Thomas Elbert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06158256: Effects of Static Apnea at Low Lung Volume on Hypoalgesia, Cardiovascular Function and Respiratory Function
Official title: Effects of Static Apnea at Low Lung Volume on Hypoalgesia, Cardiovascular Function and Respiratory Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pain
Hypoxia
Hypercapnia
Apnea
Lead sponsor: Centro Universitario La Salle
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled study is to explore the hypoalgesic response of a 6 minutes of intermittent static apneas training session at low lung volume in healthy subjects; also, as secondary objectives, to analyze the cardiovascular and respiratory response produced during the intervention


Eligibility criteria: Inclusion Criteria:

- Asymptomatic subjects aged between 18 and 64 years.

Exclusion Criteria:

* Cardiovascular, respiratory, metabolic, neurological or osteomuscular signs or pathologies.
* History of epilepsy.
* Pregnant
* Pharmacological treatment.
* Participants who present any type of pain on the day of the measurements or who have frequently suffered pain during the previous 4 weeks.

Primary outcomes:
measure: Pain pressure threshold (PPT) on thumb, anterior tibial and spinous process of C7
timeFrame: before and after intervention (up 30 minutes)
Secondary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: before intervention (up 5 minutes)
measure: Pittsburg Sleep Quality Index (PSQI)
timeFrame: before intervention (up 5 minutes)
measure: Global Physical Activity Questionnaire (GPAQ)
timeFrame: before intervention (up 5 minutes)
measure: Heart rate
timeFrame: during intervention (up 6 minutes)
measure: Oxygen saturation
timeFrame: during intervention (up 6 minutes)
measure: Blood pressure
timeFrame: before, during and after intervention (up 10 minutes)
measure: Rate of perceived exertion (RPE)
timeFrame: immediately after intervention (up 10 seconds)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU LaSalle
Study officials:
References:
Clinical trial NCT04793256: Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Sealant (Part 2)
Official title: Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Sealant in Newly Erupted Permanent Molars in Group of Egyptian Children: A Randomized Clinical Trial(Part 2).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cost Effectiveness
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 91
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be randomized, allocation-blinded, two-arm, parallel-group trial.

The participants will be randomized on a 1: 1 allocation ratio to receive one of the following interventions:

* Resin-based fissure sealant FS.
* Fluoride varnish FV
Primary purpose: PREVENTION

Brief summary: The aim of the present study is determine the cost-effectiveness, clinical- effectiveness, acceptability and adverse effect of resin sealants versus the fluoride varnish for the prevention of dental caries on newly erupted permanent molars.

Detailed description: A Cochrane systematic reviews found low quality evidence supporting Current practice guidelines that recommend the use of Resin based fissure sealant over Fluoride varnish in prevent dental caries. However, they did not address the cost-effectiveness, A more recent systematic review and meta-analysis concluded that no statistical significance difference between Resin based fissure sealant and Fluoride varnish with a high-quality evidence in prevent dental caries.

This trial will measure cost effectiveness and clinical effectiveness for resin fissure sealant and fluoride varnish.

Eligibility criteria: Inclusion Criteria:

* • Healthy children with no physical or mental disorders. Children with newly fully erupted permanent molars (PMs).

Exclusion Criteria:

* Teeth will be excluded from the study if they had any of the following:

  * Dental caries in dentine
  * History of pain or swelling. Parents refused their children participate in the trial

Primary outcomes:
measure: Clinical-effectiveness (will be measured with DFS
timeFrame: Through study completion, an average of one year
Secondary outcomes:
measure: Cost-effectiveness (will be measured with Incremental cost effective ratio ICER
timeFrame: through study completion, an average of one year
Other outcomes:
measure: Time of application (continuous outcome, (minutes) will be measured with stopwatch.
timeFrame: Through application of interventions in treatment visit( baseline)
measure: acceptability will be measured by questionnaire
timeFrame: through study completion, an average of one year
measure: adverse effect will be measured by questionnaire
timeFrame: through study completion, an average of one year
Locations:
Study officials:
References:
Clinical trial NCT04975256: Adagrasib in Combination With BI 1701963 in Patients With Cancer (KRYSTAL 14)
Official title: A Phase 1/1b Trial of MRTX849 in Combination With BI 1701963 in Patients With Advanced Solid Tumors With KRAS G12C Mutation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Cancer
Metastatic Cancer
Malignant Neoplasm of Colon
Malignant Neoplasm of Lung
Malignant Neoplastic Disease
Keywords: KRAS G12C
SOS1 Inhibitor
NSCLC
CRC
Non Small Cell Lung Cancer
Colon Cancer
Advanced Solid Tumor
Metastatic Cancer
Pancreatic Cancer
adagrasib
Lead sponsor: Mirati Therapeutics Inc.
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
First posted: 2021-07-23
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study will evaluate safety, tolerability, drug levels, molecular effects and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with advanced solid tumors that have a KRAS G12C mutation.

Detailed description: This study will evaluate safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and BI 1701963 is a SOS1 pan-KRAS inhibitor.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation (phase 1b must be either Non-Small Cell Lung Cancer or Colorectal Cancer)
* Unresectable or metastatic disease
* No available treatment with curative intent
* Adequate organ function

Exclusion Criteria:

* History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow
* Other active cancer
* Cardiac abnormalities

Primary outcomes:
measure: Characterize the number of patients with treatment emergent adverse events of the combination regimen in patients with advanced solid tumor malignancies with KRAS G12C mutation
timeFrame: 20 months
measure: Evaluate Pharmacokinetics of the combination regimen
timeFrame: 20 months
measure: Establish Maximum Tolerated Dose
timeFrame: 12 months
Secondary outcomes:
measure: Evaluate preliminary clinical activity of the combination regimen
timeFrame: 20 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Next Oncology
state: Texas
Study officials:
affiliation: Mirati Therapeutics
name: Richard Chao, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00226356: Natural Supplements for Unipolar Depression
Official title: Phase 4 Study: An Open Study of the Efficacy and Tolerability in Unipolar Depression of Augmentation of the One-carbon Cycle With L-methionine, Betaine and Folate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Unipolar Depression
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2005-09-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being conducted to determine the clinical response rate for the regimen of L-methionine, betaine and folate for unipolar depression.

Detailed description: The study is 6 weeks long, with 9 clinical visits. All visits will take place at our location in Massachusetts.

Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of a MDD or DDNOS; clinical indication for treatment of current depressive symptoms; HDS \> 18; women of reproductive potential must use an acceptable method of birth control

Exclusion Criteria:

* Treatment with another psychotropic drug; history of mania or hypomania; history of bipolar illness in first-degree relatives; active homicidality; pregnant; trying to become pregnant, or nursing; unstable medical condition; current substance abuse in the past month; history of sulfa allergy

Primary outcomes:
measure: Depressive symptoms
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
Study officials:
affiliation: Cambridge Health Alliance
name: Robert T Dunn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00076856: Temozolomide for Treatment of Brain Metastases From Non-Small Cell Lung Cancer (Study P03247)
Official title: A Randomized, Open-Label Phase 2 Study of Temozolomide Added to Whole Brain Radiation Therapy Versus Whole Brain Radiation Therapy Alone for the Treatment of Brain Metastasis From Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Brain Neoplasms
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-02-06
Enrollment: 95
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 study is to demonstrate improvement in overall survival for the combination of whole brain radiation therapy (WBRT) plus temozolomide (TMZ) versus WBRT alone. Secondary objective is to demonstrate an improvement in the time to radiological CNS progression with the addition of TMZ to WBRT.


Eligibility criteria: * Age greater than or equal to 18
* Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC)
* At least one brain metastasis diagnosed within 30 days of randomization
* Brain metastases must not have been previously treated with WBRT or radiosurgery
* No more than 2 sites of extracranial metastases
* May have received prior radiation therapy to the primary tumor and/or systemic metastatic sites
* Meets protocol requirements for specified laboratory values.
* Written informed consent and cooperation of patient
* Appropriate use of effective contraception if of childbearing potential.
* Karnofsky Performance Status KPS greater than 70
* Score less than 2 on all criteria of the Comprehensive Neurological Outcome Scale (CNOS)

Primary outcomes:
measure: Overall Survival
Secondary outcomes:
measure: Time to radiological CNS progression
Other outcomes:
Locations:
Study officials:
References:
citation: Chua D, Krzakowski M, Chouaid C, Pallotta MG, Martinez JI, Gottfried M, Curran W, Throuvalas N. Whole-brain radiation therapy plus concomitant temozolomide for the treatment of brain metastases from non-small-cell lung cancer: a randomized, open-label phase II study. Clin Lung Cancer. 2010 May;11(3):176-81. doi: 10.3816/CLC.2010.n.022.