louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00000222: Alternate-Day Buprenorphine Administration. Phase II - 4
Official title: Alternate-Day Buprenorphine Administration. Phase II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opioid-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Vermont
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 28
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if two times a subject's daily maintenance dose will hold for 48 hours without changes in agonist and antagonist effects.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Drug use
measure: Opioid withdrawal
measure: Opioid agonist effects
measure: Dose identification
measure: Pupil diameter
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Treatment Research Center
state: Vermont
Study officials:
affiliation: University of Vermont
name: Warren Bickel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amass L, Bickel WK, Crean JP, Blake J, Higgins ST. Alternate-day buprenorphine dosing is preferred to daily dosing by opioid-dependent humans. Psychopharmacology (Berl). 1998 Apr;136(3):217-25. doi: 10.1007/s002130050559.
Clinical trial NCT00898222: Effect of Daily Low Dose Aspirin on Exhaled Inflammatory Mediators in Normal Subjects
Official title: Effect of Daily Low Dose Aspirin on Exhaled Inflammatory Mediators in Normal Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: healthy volunteers
aspirin
Normal healthy subjects
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2009-05-12
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Hypothesis: Low dose aspirin does not change exhaled inflammatory breath mediators in normal subjects.

Detailed description: Aim:

1. To study the effect of low dose aspirin on exhaled breath inflammatory mediators
2. To compare the change to that seen in diseased states such as asthma and Lymphangioleiomyomatosis (LAM)

We will interview healthy volunteers to confirm that they do not have any major underlying medical conditions such as heart disease, diabetes, stroke and bleeding disorders. We will collect breath condensate before and after two weeks of low dose over the counter enteric coated aspirin 81 mg/day therapy. Side effects are extremely rare at this dose, but include bleeding, heart burn and allergic reaction.

Eligibility criteria: Inclusion Criteria:

* healthy adults

Exclusion Criteria:

* any underlying major medical conditions such as heart disease, hypertension, stroke, diabetes, bleeding disorders

Primary outcomes:
measure: Change in Exhaled Inflammatory Mediator Levels
timeFrame: baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Asthma Research Center, Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Shamsah Kazani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01494922: Safety and Efficacy of EXC 001 in Subjects Who Have Participated in Prior Studies of EXC 001
Official title: A PHASE 2, OPEN-LABEL STUDY TO PROVIDE REVISION OF SCARS RESULTING FROM SURGERY IN PRIOR STUDIES OF EXC 001
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Reduction in Severity of Skin Scarring
Keywords: Skin scarring
cicatrix
hypertrophic scar
hypertrophic scar prevention
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-12-19
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide subjects who participated in prior studies of EXC 001 the opportunity to have their hypertrophic scars surgically revised and treated with EXC 001.


Eligibility criteria: Inclusion Criteria:

* Healthy adults who have participated in previous studies of EXC 001.
* Healthy adults who have chosen to have their scars revised.

Exclusion Criteria:

* Currently pregnant or pregnant during the 6 months prior to inclusion in the study, or breast feeding.
* Participation in another clinical trial within 30 days prior to the start of the study.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Week 2 to Week 24
measure: Number of Participants With Positive Skin Sensitivity Reaction
timeFrame: Day 1 up to Week 24
measure: Number of Participants With Clinically Significant Findings in Laboratory Examinations
timeFrame: Day 1 up to Week 24
measure: Number of Participants With Clinically Significant Change in Vital Signs
timeFrame: Day 1 up to Week 24
measure: Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) Abnormalities
timeFrame: Day 1 up to Week 24
measure: Number of Participants With Abnormalities in Physical Examinations
timeFrame: Day 1 up to Week 24
Secondary outcomes:
measure: Physician Observer Scar Assessment Score: Individual Sub Scores and Composite Score
timeFrame: Week 24
measure: Participant Observer Scar Assessment Score: Individual Sub Scores, Composite Score, Scar Appearance Composite Score
timeFrame: Week 24
measure: Number of Scars Classified According to Physician Photonumeric Guide Score Severity Category
timeFrame: Week 24
measure: Number of Scars Classified According to Subject Participant Photonumeric Guide Score Severity Category
timeFrame: Week 24
Other outcomes:
Locations:
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Chicago
country: United States
facility: Northwestern University,Division of Plastic Surgery
state: Illinois
city: Eugene
country: United States
facility: Jewell Plastic Surgery Center
state: Oregon
city: Tualatin
country: United States
facility: Connall Consmetic Surgery
state: Oregon
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02707822: The Influence of ABCB1、CYP3A4、CYP3A5、POR Genetic Polymorphism and Other Factors on Tacrolimus Blood Concentration
Official title: The Influence of ABCB1、CYP3A4、CYP3A5、POR Genetic Polymorphism and Other Factors on Tacrolimus Blood Concentration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Transplantation
Liver Transplantation
Keywords: tacrolimus
pharmacokinetics
gene polymorphism
clinical factors
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-03-14
Enrollment: 440
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: PROBABILITY_SAMPLE
Study population: Renal or liver transplant recipients who underwent transplantation at National Taiwan University Hospital, and were treated with tacrolimus.

Brief summary: The purpose of the study is to identify factors that may influence tacrolimus (TAC) pharmacokinetics, and the impact of gene polymorphism (ABCB1, CYP3A4, CYP3A5, POR) on pharmacokinetics of TAC in Taiwanese.

Detailed description: TAC is one of the most important immunosuppressive agents for organ transplantation. In some patients the dose and concentration of TAC are difficult to adjust because of its narrow therapeutic index and variable pharmacokinetics.

Many factors affect the pharmacokinetics of TAC. Literature suggests that ABCB1, CYP3A4, CYP3A5, POR gene polymorphisms may affect the pharmacokinetics of TAC. In addition, the distribution of TAC is affected by hematocrit and albumin concentrations. The pharmacokinetics of TAC may also be affected by total protein, total bilirubin, creatinine, AST, ALT, gender, age, drug interactions, and so on.

This study intends to analyze the influence of various factors, including drugs, on the pharmacokinetics of TAC.

Eligibility criteria: Inclusion Criteria:

* kidney transplants or liver transplants
* 20 - 65 years old
* receiving tacrolimus as immunosuppressive drugs

Exclusion Criteria:

* Human immunodeficiency virus-positive status
* Retransplantation or multiorgan transplantation
* non-Asian

Primary outcomes:
measure: Dose-normalized tacrolimus concentration
timeFrame: Within the first 6 months post-transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Meng-Kun Tsai
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00967122: Band Holiday Study
Official title: The Effect of Lap Band Adjustment on Satiety Peptides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Famine
Keywords: adjustment, hunger
Hunger/satiety changes before and after gastric band adjustment
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2009-08-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: AIMS: Our aims are to measure BMI and plasma concentrations of representative hormones before and after a band holiday, in addition to surveying hunger/satiety and behavior changes.

Detailed description: AIMS: Our aims are to measure BMI and plasma concentrations of representative hormones before and after a band holiday, in addition to surveying hunger/satiety and behavior changes.

Materials and Methods:

Adults ≥ 18 years of age who previously underwent LAGB at New York University Medical Center and have lost sufficient excess body weight and agree to have their band temporarily loosened for a 2 week period will be invited by the health care provider to participate. Patients of both genders and all races are eligible for participation. Patients will need to consent to complete a questionnaire and to have blood drawn when the band is loosened and refilled. Patients will only be excluded if they are not willing to have their band loosened or if they will not present for follow-up.

Sample size:

For this pilot program we plan to enroll 15 patients. Since patients will serve as their own controls before and after meals as well as before and after band adjustments, we anticipate adequate power to assess for significant variations.

Eligibility criteria: Inclusion Criteria:

* Adults ≥ 18 years of age
* who previously underwent LAGB at New York University Medical Center and have lost sufficient excess body weight and
* agree to have their band temporarily loosened for a 2 week period will be invited by the health care provider to participate.

Exclusion Criteria:

* \< %35 Excess weight loss

Primary outcomes:
measure: plasma concentrations of representative hormones of hunger and satiety
timeFrame: 2 weeks
Secondary outcomes:
measure: surveying hunger/satiety and behavior changes.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: NYUSOM
state: New York
Study officials:
affiliation: NYUSOM
name: Francois Fritz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03751722: Genetic an Functional Studies of Patient With Inflammatory Bowel Disease
Official title: Genetic an Functional Studies of Patient With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Keywords: Crohn disease
Ulcerative colitis
genetic makers
cytokines
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 630
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All outpatients and inpatients from gastroenterology units of adulte and pediatric references centers

Brief summary: The objective of this study is to study the response of macrophages, isolated from patients with ulcerative colitis (Crohn's disease) or Crohn's disease (CD), to 6 candidate enterogenous and their derivatives, depending on the genotype for associated polymorphisms. to the development of IBD


Eligibility criteria: Inclusion Criteria:

* patient with definite crohn's disease or ulcerative colitis

Exclusion Criteria:

* patient receiving anti-TNF therapy during 14 days before inclusion.

Primary outcomes:
measure: Isolated macrophage response measured by PCR
timeFrame: Baseline: one session
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU, Hôpital Claude Huriez
Study officials:
affiliation: University Hospital, Lille
name: Corinne Gower-Rousseau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01232322: Pulmicort Respules 0.25/0.5 Specific Clinical Experience Investigation
Official title: Pulmicort Respules 0.25/0.5 Specific Clinical Experience Investigation for Long-term Use in Pediatrics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchial Asthma
Keywords: bronchial asthma
Pulmicort Respules
long term use
pediatrics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-11-02
Enrollment: 633
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with Pulmicort respules for the first time due to bronchial asthma and children of \>=6months and \<5 years old age at the start of study treatment

Brief summary: The purpose of this study is to investigate the safety and efficacy for long term treatment of the drug in children aged 6 months and \< 5 years on bronchial asthma in daily clinical usage.


Eligibility criteria: Inclusion Criteria:

* Patients treated with Pulmicort Respules for the first time due to bronchial asthma
* Children of \>= 6 months and \< 5 years old age at the start of study treatment

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: Range of 3 years
measure: Effects on growth rate
timeFrame: Range of 3 years
measure: Effects on the adrenal cortical function.
timeFrame: Range of 3 years
measure: Effects on development of infections.
timeFrame: Range of 3 years
Secondary outcomes:
measure: Clinical course under Pulmicort long-term use
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Yoshida Shigeru, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03126422: Effects of Different Doses of Dexmedetomidine on Fentanyl-induced Cough
Official title: Effects of Different Doses of Dexmedetomidine on Fentanyl-induced Cough
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Fentanyl-induced Cough
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The investigators aimed to investigate the effects of pretreatment with different doses of dexmedetomidine on the cough caused by fentanyl during anesthetic induction.

Patients undergoing elective surgeries under general anesthesia will be randomly allocated to 4 groups (n = 60, each group). Dexmedetomidine 0, 0.03, 0.06, and 0.09 μg/kg/min will be pump-administered in 10 mins to groups I, II, III, and IV, respectively, followed by the induction of general anesthesia with intravenous fentanyl 4 μg/kg. The incidences and severity of cough that occurred within 2 min after the injection of fentanyl will be recorded, and the incidences of cardiovascular adverse events that occurred between the administration of the dexmedetomidine infusion and 2 min after tracheal intubation will be recorded.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective surgeries under general anesthesia.

Exclusion Criteria:

* Patients with contraindications of dexmedetomidine.
* Patients younger than 18 years old and older than 65 years old.

Primary outcomes:
measure: The incidence of cough
timeFrame: After the infusion of dexmedetomidine up to 10 minutes
measure: The time of cough
timeFrame: After the infusion of dexmedetomidine up to 10 minutes
measure: The severity of cough
timeFrame: After the infusion of dexmedetomidine up to 10 minutes
measure: The occurence of adverse effects of dexmedetomidine
timeFrame: After the infusion of dexmedetomidine up to 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: the Affiliated Hospital of Yangzhou University, Yangzhou University
state: Jiangsu
Study officials:
References:
citation: Zhou W, Zhang D, Tian S, Yang Y, Xing Z, Ma R, Zhou T, Bao T, Sun J, Zhang Z. Optimal dose of pretreated-dexmedetomidine in fentanyl-induced cough suppression: a prospective randomized controlled trial. BMC Anesthesiol. 2019 Jun 1;19(1):89. doi: 10.1186/s12871-019-0765-z.
Clinical trial NCT05820022: Scientific Research Barriers by Gender and Other Characteristics in Physiatry
Official title: Evaluating Scientific Research Barriers by Gender and Other Characteristics From the Perspective of Physiatrists in Turkey: A Multicenter Survey Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gender Bias
Researcher-Subject Relations
Lead sponsor: Uskudar State Hospital
Sponsor class: OTHER_GOV
First posted: 2023-04-19
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physical medicine and rehabilitation physicians who consented to participate in the study.

Brief summary: The ever-increasing population and life expectancy worldwide lead to a higher prevalence of physical disabilities and diseases, which increases the need for physical medicine and rehabilitation research. In our study, we aimed to evaluate various aspects of the barriers, particularly gender disparities, faced by physical medicine and rehabilitation professionals who wish to conduct scientific research.

Detailed description: Physicians in physical medicine and rehabilitation must also put in tremendous effort and manage their time meticulously to contribute to scientific research (SR). Research requires knowledge, experience, and institutional support, such as financial incentives, technical facilities, and trained personnel. In this field, research productivity is increasingly important due to the rising prevalence of conditions such as age-related disability and chronic pain, which put pressure on the healthcare system and affect people's quality of life. Turkey's publication productivity in physical medicine and rehabilitation has also increased steadily in recent years, with a significant number of articles published between 2015 and 2020. However, gender disparities in academic leadership positions persist in this field as well, with women lagging behind men in the number of scientific publications. While bibliometric studies are useful for assessing the current state of scientific performance, survey studies are necessary to identify obstacles that deter researchers and increase research productivity. Unfortunately, few studies have used this approach in physical medicine and rehabilitation, and no such study has been conducted in Turkey.

Eligibility criteria: Inclusion Criteria:

* Being a physical medicine and rehabilitation physician.
* Giving consent to participate in the study.

Exclusion Criteria:

- Not giving consent to participate in the study.

Primary outcomes:
measure: Research Barriers Scale
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Üsküdar State Hospital
state: Üsküdar
Study officials:
affiliation: Uskudar State Hospital
name: Mustafa H Temel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03951922: Occupational Therapy and Horticulture for Cancer Survivors With Chronic Pain
Official title: Exploring the Effect of Occupational Therapy and Horticulture for Cancer Survivors With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivor
Chronic Pain
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this quasi-experimental study is to explore the impact of a therapeutic horticulture program as an occupation-based intervention to address chronic pain symptoms for cancer survivors. The main objectives are to assess participants' perceptions of pain, physical and psychosocial wellness, stress management, and quality of life at pre-, post-, and 3-month follow-up. Quantitative and qualitative data will be synthesized and analyzed to explore this phenomenon.


Eligibility criteria: Inclusion Criteria:

* 18 - 64 years of age
* History of cancer diagnosis
* Chronic pain longer than 3 months
* Have interest in therapeutic horticulture and exercise
* Able to participate in a moderate physical activity in sitting and/or standing for at least one hour twice a week
* Able to provide own transportation to the horticulture site or the supervised exercise program
* Able to comprehend, speak and write in English

Exclusion Criteria:

* Uncontrolled seizure disorder
* Pregnancy

Primary outcomes:
measure: Salivary Cortisol Test
timeFrame: Change between baseline and three months
Secondary outcomes:
measure: Lower body strength
timeFrame: Change between baseline and three months
measure: Upper body strength
timeFrame: Change between baseline and three months
measure: Endurance
timeFrame: Change between baseline and three months
measure: Lower body flexibility
timeFrame: Change between baseline and three months
measure: Upper body flexibility
timeFrame: Change between baseline and three months
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University Health
name: Julie Kugel, OTD
role: PRINCIPAL_INVESTIGATOR
References: