louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01703858: Study to Investigate the Relative Bioavailability, Influence of Pantoprazole Coadministration and Food Effect of Different Oral Formulation of BI 113608
Official title: An Open Label, Randomised, Single Dose, 3-way Cross Over Study to Investigate Relative Bioavailability and Food Effect on Different Formulations of BI 113608 in Healthy Male Subjects, Followed by Fixed Sequence Periods Investigating Influence of Pantoprazole Coadministration and Food Effect on Pharmacokinetics of Different Formulations of BI 113608
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-10-11
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the trial is to investigate the relative bioavailability, influence of pantoprazole coadministration and food effect of different oral formulations of BI 113608 in healthy male subjects


Eligibility criteria: Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Primary outcomes:
measure: Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
timeFrame: PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.
measure: Maximum Measured Concentration of the Analyte BI-113608 in Plasma (Cmax)
timeFrame: PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.
Secondary outcomes:
measure: Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)
timeFrame: PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.
Other outcomes:
Locations:
city: Ingelheim
country: Germany
facility: 1314.3.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT06582758: Does Choice Improve the Pain Relief Derived From a Brief Intervention
Official title: Brief (&lt;10 Minute) Behavioral Interventions for Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Acute Pain
Keywords: mindfulness
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project is a single-site, four-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room the ability to choose which pain management intervention the receive impacts the degree of pain relief they experience.

Detailed description: This project is a single-site, four-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room the ability to choose which pain management intervention the receive impacts the degree of pain relief they experience. Participants will be randomized to one of three conditions: 1) a 4-minute pain psychoeducation recording, 2) a 4-minute mindfulness recording, or 3) choice. In the choice condition, participants will be able to choose which recoding (i.e., pain psychoeducation or mindfulness) they would like to listen to.

Eligibility criteria: Inclusion Criteria:

* Receiving pain treatment at Tallahassee Orthopedic Center
* Understanding English instructions fluently
* Being 18 years of age or older

Exclusion Criteria:

* Unable to consent because of physical or mental incapacity.

Primary outcomes:
measure: Change in Pain Unpleasantness Numeric Rating Scale
timeFrame: Immediately before to after 7 to 10-minute audio recording
Secondary outcomes:
measure: Change in Pain Intensity Numeric Rating Scale
timeFrame: Immediately before to after 7 to 10-minute audio recording
measure: Change in Anxiety Numeric Rating Scale
timeFrame: Immediately before to after 7 to 10-minute audio recording
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Tallahassee Orthopedic Clinic (TOC)
state: Florida
Study officials:
References:
Clinical trial NCT00562458: Non-interventional Study to Evaluate Arimidex in Postmenopausal Women With Advanced Breast Cancer
Official title: ARIMIDEX Study ( Non-interventional Study to Evaluate Arimidex in Adjuvant Therapy in Partial or Complete Response or Stabilized Disease After First Line Chemotherapy in Postmenopausal Women With Advanced Breast Cancer)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Breast Cancer
Keywords: Advanced breast cancer
Advanced breast cancer in postmenopausal women
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-11-22
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal patients with advanced breast cancer in whom a partial or complete response or stabilized disease were obtained with first line chemotherapy, by tumoral response assessment.

Brief summary: To evaluate Arimidex 6 month therapy as an adjuvant treatment in postmenopausal patients with advanced breast cancer in whom a partial or complete response or stabilized disease were obtained with first line chemotherapy, by tumoral response assessment.


Eligibility criteria: Inclusion Criteria:

* Patients to be included in the program are that ones according to the indications specified in the Romanian anastrozole (Arimidex) approved SmPC (attached to the protocol)and who are already treated with anastrozole for at least 1 month before inclusion in this program/non-interventional study.

Exclusion Criteria:

* Patients not to be included in the programme: patients who have a known hypersensitivity to anastrozole (Arimidex®) or any of its excipients.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06420258: Deeper Intubation Make Effects on Cervical Esophageal ESD
Official title: A Study on the Effectiveness and Safety of Intratracheal Deep Intubation Compared to Traditional Tracheal Intubation in Endoscopic Submucosal Dissection for Early Esophageal Cancer in the Cervical Esophagus: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Carcinoma in Situ of Cervical Part of Esophagus
Keywords: Deep tracheal intubation
Cervical esophageal cancer
ESD
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy and safety of intratracheal deep intubation with traditional intubation in endoscopic submucosal dissection for early esophageal cancer in the cervical esophagus, and to follow up and assess their short-term clinical outcomes.

Detailed description: Forty patients with early esophageal cancer in the cervical esophagus scheduled for endoscopic submucosal dissection will be included. They will be randomly divided into two groups using sealed envelopes: approximately 20 patients in the intratracheal deep intubation group and 20 patients in the traditional intubation group. By comparing the operation time, perioperative complications, postoperative short-term complications, and other outcomes, we aim to elucidate the effectiveness and safety of deep intubation in endoscopic submucosal dissection for early esophageal cancer in the cervical esophagus.

Eligibility criteria: Inclusion Criteria:

1. The lesions mainly involve superficial esophageal squamous cell carcinoma or high-grade intraepithelial neoplasia (HGIN) in the cervical esophagus;
2. There is no evidence of regional lymph node or distant metastasis on endoscopic ultrasound (EUS) or CT/MRI imaging;
3. Participants have a thorough understanding of this study and voluntarily sign the informed consent form.

Exclusion Criteria:

* 1. Patients who have received radiotherapy or chemotherapy before endoscopic submucosal dissection surgery; 2. Patients with severe comorbidities who are not suitable for endoscopic submucosal dissection surgery.

Primary outcomes:
measure: the rate of complete resection and postoperative stricture
timeFrame: Seven days and three months after ESD procedure
Secondary outcomes:
measure: ESD procedural time and other procedure-related complications
timeFrame: During procedures and just after ESD procedure.
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provintial Hospital
state: Fujian
Study officials:
affiliation: Fujian Provintial Hospital
name: Wei Liang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06474858: Effects of Obesity on COPD
Official title: A Prospective Observational Study on the Effects of Obesity on Symptoms, Health Related Quality of Life and Pulmonary Function in COPD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Obesity
Chronic Obstructive Pulmonary Disease
Keywords: COPD
Obesity
Chronic Obstructive Pulmonary Disease
Dyspnea
HRQoL
Symptoms
Dynamic hyperinflation
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with a diagnosis of COPD who visit a Pulmonologist at Rijnstate Hospital.

Brief summary: The purpose of this study is to investigate whether obese COPD patients experience more or less discomfort in daily life. Furthermore the investigators will evaluate if body composition or body fat distribution has effects on symptoms and performance.

Detailed description: Chronic Obstructive Pulmonary Disease (COPD) and Obesity are two major health problems. The prevalence of both is growing and there is a complex interaction between COPD and obesity. On the one hand obesity impairs lung function, with decreasing static lung volumes being the most significant effect. On the other hand there seems a beneficial role of obesity on lung function in COPD patients. This is because obese COPD patients tend to have less hyperinflation than non-obese COPD patients . An interesting question is what the net effect of these changes in lung function is on respiratory symptoms and quality of life.

In this observational study, the investigators will compare obese and non-obese COPD patients. Pulmonary function, dyspnea and quality of life will be compared between the two groups.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with COPD by a Pulmonologist defined as an obstructive lung function test with FEV1/FVC \< 0.7 and FEV1 \< 80% predicted
* No exacerbation of COPD at time of inclusion
* Age \> 18 years
* Able to perform lung function tests and fill in the questionnaires.

Exclusion Criteria:

* Not able to perform lung function tests or fill in the questionnaires
* Diagnosis of Asthma
* Diagnosis of neuromuscular disease
* Diagnosis of heart failure
* Treatment for lung Malignancy in the past
* Active Malignancy

Primary outcomes:
measure: Dyspnoea - mMRC
timeFrame: At inclusion
measure: Dyspnoea - NCSI
timeFrame: At inclusion
measure: Change in dyspnoea
timeFrame: Before and after the 6 minute walking test
Secondary outcomes:
measure: 6 minute walking test
timeFrame: At inclusion
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Department Of Pulmonology, Rijnstate Hospital, The Netherlands
Study officials:
affiliation: Rijnstate Hospital, Arnhem, The Netherlands
name: Safir Zewari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00810758: Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691
Official title: A Phase 1, Randomized, Placebo Controlled, Blinded (3rd Party Open), Sequential, Multiple-Dose Escalation Study To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691 In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C Virus
Keywords: HCV
Toll-like receptor 7
Multiple oral dose escalation study of PF-04878691
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of PF-04878691.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18-55, inclusive.
* Body Mass Index (BMI) of 18-30 kg/m2; total body weight \>50kg (110lbs).

Exclusion Criteria:

* Pregnant or nursing females.
* Females of child-bearing potential.
* Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic or autoimmune disease or clinical findings at screening.
* Smoking within the previous 6 months.

Primary outcomes:
measure: To assess the safety and toleration of multiple ascending oral doses of PF-04878691
timeFrame: 3 weeks
Secondary outcomes:
measure: To assess the pharmacokinetics and pharmacodynamics with regards to specific biomarkers of immune stimulation of PF-04878691
timeFrame: 3 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02472158: Chlorhexidine-Impregnated Sponge Dressing: A Clinical Trial
Official title: Use of Chlorhexidine-gel-Impregnated Dressing Compared to Transparent Polyurethane Film Dressing as Coverage of the Site of Insertion of Central Venous Catheter, in the Evaluation of Catheter Colonization in Critically Ill Adults Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Catheter-Related Infections
Keywords: Bandages
Central Venous Catheters
Catheter-Related Infections
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the use of chlorhexidine-gel-impregnated dressing and the transparent polyurethane film dressing as coverage of the site of insertion of central venous catheter, in the evaluation of catheter colonization in critically ill adults patients.


Eligibility criteria: Inclusion Criteria:

Critically ill patients hospitalized carrying a short-term central venous catheter

Exclusion Criteria:

* Use of a central venous catheter with antimicrobial coating
* Suspected or confirmed bacterial infection at randomization
* Known allergic/hypersensitivity reaction to any compounds of the treatment
* Active lesions in the skin where the CVC is located and / or where the dressing of CVC is being conducted;

Primary outcomes:
measure: Catheter Colonization
timeFrame: Participants will be followed from placement until the withdraw of the central venous catheter, an expected average of 3 weeks.
Secondary outcomes:
measure: Microbiological Exit site Infection
timeFrame: Participants will be followed from placement until the withdraw of central venous catheter, an expected average of 3 weeks
measure: Clinical Exit Site Infection
timeFrame: Participants will be followed from placement until the withdraw of central venous catheter, an expected average of 3 weeks
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Clinical Hospital of Ribeirão Preto Medical School (HCFMRP-USP)
state: São Paulo
Study officials:
affiliation: University of São Paulo at Ribeirão Preto College of Nursing
name: Amanda Salles Margatho, PhD student
role: STUDY_CHAIR
References:
Clinical trial NCT01017458: Safety and Tolerability of MK0773 in Healthy Older Men (0773-004)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Double-Dummy, Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Endpoints of MK0773 in Healthy Older Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Adults
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-11-20
Enrollment: 68
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK0773 in healthy older men.


Eligibility criteria: Inclusion Criteria:

* Subject is in good general health
* Subject agrees to avoid excess alcohol and strenuous physical activity during the study
* Subject who is sexually active with partners of reproductive potential agrees to use two forms of appropriate contraception during the study

Exclusion Criteria:

* Subject has significant drug allergies
* Subject has donated blood within the last 8 weeks or has taken an investigational drug in another clinical trial within the last 4 weeks
* Subject is a regular user or past abuser of any illicit drug (including alcohol)
* Subject drinks excessive amounts of caffeinated beverages
* Subject has a history of cancer
* Subject has a history of prostate or testicular surgery

Primary outcomes:
measure: Number of subjects with Clinical Adverse Events (CAE)
timeFrame: 12 weeks
measure: Number of subjects with Serious CAEs
timeFrame: 12 weeks
measure: Number of subjects with drug-related CAEs
timeFrame: 12 weeks
measure: Number of subjects with serious drug-related CAEs
timeFrame: 12 weeks
measure: Number of subjects that discontinued with CAEs
timeFrame: 12 weeks
measure: Number of subjects with Laboratory Adverse Events (LAE)
timeFrame: 12 weeks
measure: Number of subjects with drug-related LAEs
timeFrame: 12 weeks
measure: Number of subjects with serious LAEs
timeFrame: 12 weeks
measure: Number of subjects with serious drug-related LAEs
timeFrame: 12 weeks
measure: Number of subjects that discontinued with LAEs
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01605058: Visual Performance With a Trifocal Intraocular Lens
Official title: Visual Performance Adn Quality of Vision Evaluation After Implantation of a Trifocal Intraocular Lens
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Lead sponsor: BMI Southend Hospital
Sponsor class: OTHER
First posted: 2012-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from a private ophthalmology clinic

Brief summary: The purpose of this study is to evaluate the visual performance of a trifocal intraocular lens at distance, near and intermediate viewing, by way of visual acuity measurement, contrast sensitivity.

Patient satisfaction and quality of vision will also be assessed by way of a questionnaire.

Detailed description: Monocular and Binocular Unaided (UCVA) and Best Corrected Visual Acuity (BCVA) will be measured at 6m in LogMAR units under photopic conditions (85cd/m2).

Subjective Refraction will be performed to establish any residual refractive error will for distance, intermediate and near.

Defocus Profiles (visual acuity over imposed defocus) are measured for each patient. The patient observes the 6m LogMAR chart through best distance correction, then defocusing is achieved by the addition of pairs of lenses from +2.00D to -4.00D in 0.50D steps.. The LogMAR acuity will be recorded and the data plotted.

Contrast Sensitivity will be evaluated monocularly under photopic (85cd/m2) conditions and mesopic (4cd/m2) using the Pelli-Robson Contrast Sensitivity Chart.

Near and intermediate performance will be evaluated using the Radner Reading Charts to assess acuity (LogRAD units) and reading speed in photopic conditions 85cd/m2

Eligibility criteria: Inclusion Criteria:

* Age 40-70yrs
* Bilateral implantation of a trifocal intraocular lens

Exclusion Criteria:

* existing ocular pathology
* surgical complications
* corneal astigmatism \> 1.50DC

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Westclifff-on-Sea
country: United Kingdom
facility: BMI Southend Hospital
state: Essex
Study officials:
affiliation: BMI Southend
name: Elizabeth M Agrippa, BSc
role: PRINCIPAL_INVESTIGATOR
References: