louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00739297: The Safety and Effectiveness of MK0476 (Montelukast) in Patients With Chronic Asthma (0476-388)
Official title: A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Bronchodilatory Effect of MK0476 in Patients With Chronic Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Asthma
Keywords: Chronic asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-08-21
Enrollment: 68
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will test the safety and effectiveness of a range of doses of MK0476 (montelukast) compared to placebo on improved lung function in patients with chronic asthma.


Eligibility criteria: Inclusion Criteria:

* A person is 15 to 65 years of age. A person has had chronic asthma for at least one year

Exclusion Criteria:

* A person is a smoker or has smoked more that a pack a day for more than 10 years before stopping
* A person has other lung disorders such as COPD (chronic obstructive pulmonary disorder)

Primary outcomes:
measure: Change From Baseline in FEV1 Over 4 Hours
timeFrame: 0 (=baseline) to 4 hours after treatment with montelukast
Secondary outcomes:
measure: Change From Baseline in FEV1 Over 90 Minutes After Albuterol/Placebo Administration
timeFrame: 4 hours (equals time point at which albuterol or albuterol placebo is administered) to 5.5 hours after treatment with montelukast
Other outcomes:
measure: Change From Baseline in FEV1 at 8 Hours After Treatment With Montelukast
timeFrame: 0 (baseline) and 8 hours after treatment with montelukast
measure: Change From Baseline in FEV1 at 24 Hours After Treatment With Montelukast
timeFrame: 0 (baseline) and 24 hours after treatment with montelukast
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Philip G, Pedinoff A, Vandormael K, Tymofyeyev Y, Smugar SS, Reiss TF, Korenblat PE. A phase I randomized, placebo-controlled, dose-exploration study of single-dose inhaled montelukast in patients with chronic asthma. J Asthma. 2010 Dec;47(10):1078-84. doi: 10.3109/02770903.2010.520100. Epub 2010 Nov 3.
Clinical trial NCT01372683: Oat Breakfast Satiety Study
Official title: The Effect of Oat Based Breakfast Cereals on Satiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Subjective Appetite and Satiety
Subjective Energy Levels
Keywords: Appetite
Satiety
Subjective energy
Oats
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
Collaborators: name: Pennington Biomedical Research Center
First posted: 2011-06-14
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to test the hypothesis that on an equivalent calorie basis, oat based breakfast cereals do not provide the same satiety benefit. The study will also demonstrate the satiety comparison of the cereals related to product density.

Detailed description: This study is designed to test the hypothesis that on an equivalent calorie basis, oat based breakfast cereals do not provide the same satiety benefit. The study will also demonstrate the satiety comparison of the cereals related to product density. Ninety-six healthy men and women 18 years of age or older will be enrolled into this study and divided into 2 groups of 48 each to investigate the satiety impact of two oat based breakfast cereals compared to the leading ready-to-eat (RTE) oat based breakfast cereal. Each subject will participate in two test sessions (1 test cereal vs the leading RTE cereal). Subjects will come to the Ingestive Behavior Laboratory between 8 and 10 am after having nothing to eat for 10 hours prior to the scheduled visit time and be given one of the three cereals. The second session will be scheduled at least 1 week after the first. Visual analogue scales of hunger, satiety and subjective energy will be completed at baseline, 30, 60, 120, 180, and 240 minutes. Subjects will return on another day separated by at least a week to repeat the breakfast. Area under the curves of appetite and satiety will be compared with a mixed model.

Eligibility criteria: Inclusion Criteria:

* Male or female
* 18 years of age or older
* Healthy
* Willing to use an effective contraceptive during the study, if sexually active and capable of bearing children

Exclusion Criteria:

* Women who are pregnant or nursing
* Gain or loss of \> 4kg in the last 3 months.
* Diabetes mellitus (fasting glucose \>126 mg/dL)
* Dietary restraint on the Three Factor Eating Questionnaire score greater than or equal to 14
* Allergy to any of the foods used for the test breakfasts (oats or milk)

Primary outcomes:
measure: Area under the curve (AUC) of appetite and satiety
timeFrame: 4 hours
Secondary outcomes:
measure: Area under the curve for subjective energy measures
timeFrame: 4 hours
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Frank Greenway, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03435783: Brief Electronic Intervention for Heavy Drinking and Sex Risk Among MSM Seeking HIV Testing
Official title: Brief Electronic Intervention for Heavy Drinking and Sex Risk Among MSM Seeking HIV Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Alcohol Abuse
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Randomized controlled trial where participants are assigned to either a treatment or control group.
Primary purpose: PREVENTION

Brief summary: The overall objective of this research is to use both qualitative and quantitative data to inform the development of a technology-based intervention for heavy drinking and sexual risk behavior among men who have sex with men (MSM) who are seeking free HIV testing. Investigators will be conducting a randomized-controlled pilot test of the intervention among MSM seeking HIV testing in community-based settings to explore its potential impact on alcohol and HIV-related behavioral outcomes. This research will ultimately produce a combined, theory-based, and technology- delivered intervention for heavy drinking and sex risk that is fully portable and has been preliminarily tested for efficacy in community settings where high-risk MSM engage with prevention services.


Eligibility criteria: Inclusion Criteria:

1. Biologically male
2. Aged 18 or older
3. Fluent English speaker
4. Unprotected anal sex with a casual male partner at least once in the past 3 months
5. Heavy alcohol use during the past 2-weeks (\>14 drinks per week, or at least one occasion of 5+ drinks on a given occasion)
6. Breath alcohol concentration (BrAC) of .000 at the time of enrollment
7. No history of complex alcohol withdrawal
8. HIV-negative

Exclusion Criteria:

1. Individuals who are HIV-positive
2. Individuals who participated in other phases of the research
3. Individuals who report being coerced to participate

Primary outcomes:
measure: Number of New Sex Partners, Past 30 Days
timeFrame: Past 30 days
measure: Number of Condomless Anal Sex Events, Past 30 Days
timeFrame: Past 30 days
measure: Number of Drinking Days, Past 30 Days
timeFrame: Past 30 days
measure: Number of Heavy Drinking Days (5 or More), Past 30 Days
timeFrame: Past 30 days
measure: Average Number of Drinks Per Drinking Day
timeFrame: Past 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University School of Public Health
state: Rhode Island
Study officials:
References:
Clinical trial NCT01557283: An Observational Study of the Real Life Management of the Psoriasis Patients Treated With Enbrel According to the New Reimbursement Criteria
Official title: An Observational Study of the Real Life Management of the Psoriasis Patients Treated With Enbrel According to the New Reimbursement Criteria - Beflex Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plaque Psoriasis Patients
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-03-19
Enrollment: 140
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: All subjects enrolled should meet the usual prescribing criteria for Enbrel as per local reimbursement criteria and should be entered into the study at the investigator's discretion. It is requested to include patients in a consecutive manner as much as possible.

Brief summary: With the new reimbursement criteria, we want:

To describe the average treatment duration of patients with Enbrel expressed as a number of weeks/year.

To describe the number of patients who receive continuous treatment To describe the number of patients who receive intermittent treatment To describe the number of weeks off treatment

Detailed description: 100 patients will be followed for at least 1 year

Eligibility criteria: Inclusion Criteria:

* Patient restarts or is starting treatment with Enbrel for his/her psoriasis in alignment with reimbursement criteria
* Patients ≥18 year
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

N/A

Primary outcomes:
measure: Number of Weeks of Etanercept Treatment
timeFrame: Baseline up to end of study (90 weeks)
Secondary outcomes:
measure: Number of Weeks of Off-Treatment
timeFrame: Baseline up to end of study (90 weeks)
measure: Psoriasis Area and Severity Index (PASI) Score
timeFrame: Start and end of cycle 1, 2, 3
measure: Percentage of Body Surface Area (BSA) Affected by Psoriasis
timeFrame: Start and end of cycle 1, 2, 3
measure: Number of Participants With Reasons for Treatmant Discontinuation
timeFrame: Baseline up to end of study (90 weeks)
Other outcomes:
measure: Number of Participants Who Received Continuous Treatment
timeFrame: Baseline up to end of study (90 weeks)
measure: Number of Participants Who Received Intermittent Treatment
timeFrame: Baseline up to end of study (90 weeks)
Locations:
city: Leuven
country: Belgium
facility: Herestraat 49
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04885283: Factors Affecting the Time to Start Postoperative Chemotherapy in Colorectal Cancer
Official title: Factors Affecting the Time to Start Postoperative Chemotherapy in Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: the Time to Start Postoperative Chemotherapy
Keywords: Laparoscopy
overall survival
local recurrence
tumor
chemotherapy
colorectal cancer
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent colorectal resection at General Surgery Clinic in Kayseri state hospital between January 2013 and July 2020

Brief summary: Colorectal cancers are common tumors and have undergone a great change in the last 20 years in terms of treatment principles. Significantly improved results in local recurrence and overall survival have begun to be obtained with chemotherapy protocols given after surgery, which is the main element of the treatment system (1). It is known that postoperative chemotherapy protocols are commonly given within 6-8 weeks and this period is optimal. However, it was found that this period was prolonged in approximately 20% of these patients in the methanalysis performed (2). It has been shown that delay in applied chemotherapy causes a decrease in overall survival (3,4). The factors causing this delay have not been adequately examined in the literature. It is necessary to investigate these factors that affect the overall survival outcomes, which are the main pillars of treatment principles, and to regulate the factors that have the opportunity to improve.

In this study, our aim is to investigate the perioperative (preop-perop-postop) factors affecting the duration of postoperative chemotherapy initiation in patients with colorectal cancer treated in our hospital.


Eligibility criteria: Inclusion Criteria:

patients who underwent colorectal resection

Exclusion Criteria:

patients with missing data

Primary outcomes:
measure: Time to Start Postoperative Chemotherapy
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kocasinan
country: Turkey
facility: Health science University - Kayseri State Hospital
state: Kayseri
Study officials:
affiliation: Health Science University- Kayseri State Hospital
name: ersin Gundogan, Assoc Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT05882383: Changes of Optical Quality During the Peak of the Covid-19 Pandemic
Official title: Changes of Optical Quality During the Peak of the Covid-19 Pandemic From November 2022 to January 2023 in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal Wavefront Aberration
SARS-CoV-2
Keywords: optical quality
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitted to refractive center of Tianjin Eye Hospital

Brief summary: To explore whether cornea structure, and optical quality are affected by the covid-19 infection.

Detailed description: Participants with healthy corneas admitted to Tianjin Eye Hospital from November 25 to January 20, 2022 were followed up . At the end of the follow-up, the investigators recorded in detail whether the patients had undergone real-time reverse transcriptase polymerase chain reaction (covid-19 RT-PCR tests) testing, testing time and results. The presence of PCR-positive during follow-up is considered to be covid-19 infection; PCR-Negative and no symptoms of infection during the follow-up period are considered not infected; participants with symptoms but no PCR test were excluded from the study.Participants were divided into three groups according to the RT-PCR results and the presence or absence of symptoms of infection during follow-up. pentacam (Pentacam HR, Oculus, Wetzlar, Germany) was performed during follow-up and the results were recorded,and the data was statistically managed and compared.

Eligibility criteria: Included Criteria

1. Best corrected visual acuity (BCVA) ≥ 20/20;
2. No other eye diseases except myopia and astigmatism;
3. The cornea was transparent, and there was no cloud or pannus;
4. No clinical manifestation of Eye disease or systemic disease;

Exclusion Criteria:

1. corneal disease;
2. ocular trauma;
3. Pregnant and lactating women;

Primary outcomes:
measure: The value of cornea aberration
timeFrame: 1 months
measure: The value of cornea backscatter
timeFrame: 1 months
measure: The value of cornea thickness
timeFrame: 1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital
state: Tianjin
Study officials:
affiliation: Tianjin eye hosipital
name: Yan Wang, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT04753983: A Study to Evaluate fMRI of Active DBS Stimulation in Epilepsy
Official title: fMRI of Active DBS Stimulation in Epilepsy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Refractory Epilepsy
Keywords: Deep Brain Stimulation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to use functional imaging to study the mechanisms of the anterior nucleus of the thalamus (ANT) deep brain stimulation (DBS).

Detailed description: Researchers are testing how changing the settings on deep brain stimulation device (DBS) can help reduce the number and severity of seizures. Functional imaging will be used to study the mechanisms of ANT DBS to optimize the device settings to improve the degree of seizure reduction.

Eligibility criteria: Inclusion Criteria:

- Patients who have previously undergone anterior thalamic nucleus deep brain stimulation (DBS) for refractory epilepsy.

Exclusion Criteria:

- Contraindication to MRI; prior brain resective surgery or large area of brain tissue loss (e.g., large area infarction).

Primary outcomes:
measure: Document brain activation networks with ANT stimulation
timeFrame: Results would be available immediately following processing of the imaging data after each scan
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Steven A Messina, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00077883: TLK286 (Telcyta) in Combination With Cisplatin for Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
Official title: Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Cisplatin as First-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Telik
Sponsor class: INDUSTRY
First posted: 2004-02-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to study the efficacy and safety of the combination of TLK286 with cisplatin as first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Histologically confirmed non-small cell lung cancer
* Stage IV or IIIB
* Measurable disease by RECIST
* ECOG performance status of 0-1
* Adequate liver and renal function
* Adequate bone marrow reserve

Exclusion Criteria:

* History of bone marrow transplantation or stem cell support
* Pregnant or lactating women

Primary outcomes:
measure: Primary Objectives of the Study
timeFrame: Every 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Univ. of MD, Greenbaum Cancer Center
state: Maryland
city: Nashville
country: United States
facility: The Sarah Cannon Cancer Center
state: Tennessee
city: Houston
country: United States
facility: Univ. of TX, MD Anderson Cancer Center
state: Texas
Study officials:
References:
Clinical trial NCT01398683: Comparison Epidural Anesthesia and General Anesthesia in Laparoscopic Cholecystectomy
Official title: Comparison Epidural Anesthesia and General Anesthesia in Laparoscopic Cholecystectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epidural Anesthesia
Laparoscopic Cholecystectomy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-07-20
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Underwent laparoscopic cholecystectomy in patients

Brief summary: Comparison of epidural anesthesia and general anesthesia for laparoscopic cholecystectomy, patients in the surgery and the effectiveness of anesthesia after surgery, the incidence of side effects or complications, and postoperative recovery of the body of the differences


Eligibility criteria: Inclusion Criteria:

* Underwent laparoscopic cholecystectomy in patients

Exclusion Criteria:

* Unconsciousness or can not express their own feelings of the patient

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Yao Ming Wu, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03474783: To Explore the Factors Affecting the Effectiveness of Smoking Cessation
Official title: To Explore the Factors Affecting the Effectiveness of Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Cathay General Hospital
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 155
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Objectives:

Promoting quitting smoking and training smoking cessation educators in hospital, school, community, and workplace was being vigorously pushed by Health Promotion Administration. Since the implementation of the second-generation smoking cessation program by Health Promotion Administration, both the general public and medical institutions have worked with greater vitality to practice and promote quitting smoking. However, studies on smoking cessation in the inpatient remain inadequate. Increasing cessation motivation for inpatient smokers and evaluating their nicotine dependence are essential. In this study, we aimed to explore the factors that might influence the smoking cessation in the inpatients.

Method: A cross-sectional questionnaire survey was conducted on inpatients participants at the smoking cessation.

Questionnaire comprising（1）Demographic characteristics: age, sex, marital status, education, （2）physiological factors（concentration of carbon monoxide, nicotine dependence, disease severity）,（3）psychological factors（psychological dependence on smoking , smoking cessation stages of behavior change, smoking cessation self-efficacy）, （4）Social Factor: social support,（5）smoking Behavior indicators: smoked, daily cigarette consumption, smoking experience. After giving health education cessation of treatment one month, three months and six months, interviewed by telephone quitting behavior index contains daily cigarette consumption, quit rates point.


Eligibility criteria: Inclusion Criteria:

* being a current smoker (who had smoked more than 100 cigarettes in their lifetime),
* aged \> 20 years,
* with clear consciousness,
* being able to communicate using Mandarin or Taiwanese

Exclusion Criteria:

* with acute psychiatric disorders,
* inability to complete the questionnaire

Primary outcomes:
measure: point prevalence abstinence
timeFrame: 1 month after intervention
Secondary outcomes:
measure: point prevalence abstinence
timeFrame: 3 months after intervention
measure: point prevalence abstinence
timeFrame: 6 months after intervention
Other outcomes:
Locations:
Study officials:
References: