louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00636207: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Montelukast (MK-0476) in Participants With Mild or Moderate Asthma (MK-0476-380 AM3)(COMPLETED)
Official title: A Sequential, 3-Part, Double-Blind, Randomized, Placebo-Controlled, Single-Rising-Dose and Rising-Multiple-Dose Study in Healthy Subjects and Mild or Moderate Asthmatic Patients to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled MK-0476
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-03-14
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast (MK-0476) in participants with mild or moderate asthma.


Eligibility criteria: Inclusion Criteria:

* Male or female between the ages of 18 and 65
* Must have mild or moderate asthma (Part III only)
* Nonsmoker for at least 6 months

Exclusion Criteria:

* History of stroke, chronic seizures or major neurological disorder
* You are nursing
* Drink more than 3 glasses of alcohol a day
* Have allergy to or not able to tolerate lactose
* Have a history of drug abuse in the last 5 years
* Drink more than 6 beverages containing caffeine a day
* Have had surgery, donated blood or participated in another investigational study in the last 4 weeks

Primary outcomes:
measure: Number of Participants Who Experienced At Least One Adverse Event
timeFrame: Up to 14 days after last dose of study drug
measure: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
timeFrame: Up to 7 days after last dose of study drug
measure: Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose
timeFrame: Up to 24 hours postdose
measure: AUC 0-24hr of Montelukast - Multiple Doses
timeFrame: Up to 24 hours postdose
measure: Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose
timeFrame: Up to 24 hours postdose
measure: Cmax of Montelukast - Multiple Doses
timeFrame: Up to 24 hours postdose
measure: Time to Cmax (Tmax) of Montelukast - Single Dose
timeFrame: Up to 24 hours postdose
measure: Tmax of Montelukast - Multiple Doses
timeFrame: Up to 24 hours postdose
measure: Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose
timeFrame: Up to 24 hours postdose
measure: t1/2 of Montelukast - Multiple Doses
timeFrame: Up to 24 hours postdose
measure: AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses
timeFrame: up to 10 days after first dose of study drug
measure: Cmax Accumulation Ratio of Montelukast - Multiple Doses
timeFrame: up to 10 days after first dose of study drug
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06708507: Tissue-resident Immune Cell Subsets in aGVHD
Official title: A Prospective Study on the Correlation Between Tissue-resident Immune Cell Subsets and Graft-versus-host Disease Following Hematopoietic Stem Cell Transplantation.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Graft-versus-Host Disease
Hematopoietic Stem Cell Transplantation
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients develop acute graft-versus-disease after hematopoietic stem cell transplantation.

Brief summary: This is a prospective study investigating the role of tissue-resident immune cell subsets in the occurrence and progression of graft-versus-host disease following hematopoietic stem cell transplantation. Approximately 40 subjects(including 20 grade 3-4 aGVHD patients and 20 grade 1-2 aGVHD patients ).

Detailed description: This study was a single-center, observational, prospective cohort study. The study lasted for 3 months, from 2024.11 to 2025.02.It is planned to enroll 40 subjects, divided into 20 grade 3-4 aGVHD patients and 20 grade 1-2 aGVHD patients. No randomization or any protocol-driven treatment will be performed or provided to subjects during the course of the study. Treatment decisions and selection of treatment options are left to the discretion of the treating physician, if clinically appropriate. All recipients will be followed for aGVHD evaluation,overall survival(OS) ,disease-free survival (DFS). aGVHD were graded according to published guidelines. All recipients will be monitored every month until the study is completed.

Eligibility criteria: Inclusion Criteria:

1. Voluntarily sign the informed consent form;
2. Age 16-65 years old
3. Clinically diagnosed with GVHD for the first time/receiving GVHD treatment.

Exclusion Criteria:

1. Have a history of other tumors
2. With poor compliance or mental disorders
3. Infected with HIV and HCV
4. With uncontrolled HBV infection
5. With other autoimmune diseases
6. Those who are judged by the researcher to be unsuitable to participate in this study

Primary outcomes:
measure: Association between tissue-resident Immune cell subsets in organ and acute graft-vs-host disease (aGVHD) outcomes.
timeFrame: 100days
Secondary outcomes:
measure: Association between tissue-resident Immune cell subsets in organ and overall survival(OS).
timeFrame: 100days
measure: Association between tissue-resident Immune cell subsets in organ and disease-free survival (DFS)
timeFrame: 100days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Other (Non U.s.)
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Hua Jin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06309407: Dosimeter Location in Pain Physicians
Official title: Dosimeter Location and Measured Effective Radiation Dose in Pain Management Physicians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: RAD
Keywords: Dosimeter
Radiation
Pain Medicine
Physician
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomized to wear either chest dosimeters only or chest and hand dosimeters for the duration of the study in order to measure differences in radiation readings by each dosimeter location.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary objective is to determine if there is a significant difference in radiation readings between dosimeters worn on the chest versus the hand of interventional pain management physicians and elucidate which dosimeter had higher readings.

The secondary objective is to track incidences of physician glove breaches in both groups to assess if wearing hand dosimeters is associated with an increased risk of this event.


Eligibility criteria: Inclusion Criteria:

* Physicians actively performing fluoroscopy procedures at the Comprehensive Pain Center.

Exclusion Criteria:

* Those that do not want to participate in the quality improvement project.

Primary outcomes:
measure: Radiation Readings
timeFrame: 6 months
Secondary outcomes:
measure: Total Number of Glove Breach Events
timeFrame: 6 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Associate Professor
name: Sandy Christiansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01853007: Communicating About Choices in Transplantation
Official title: Communicating About Choices in Transplantation (COACH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease and Kidney Transplantation
Keywords: End stage renal disease
Kidney transplantation
Transplant options (living and deceased donor)
Patient education
Communication skills training
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
First posted: 2013-05-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to test the impact of a newly developed educational program on kidney transplant candidates' communication about living and deceased donor kidney transplantation.

Detailed description: The Communicating about Choices (COACH) in Transplantation program educates patients with end stage renal disease, who are waitlisted for kidney transplantation, about kidney disease and the risks, benefits and processes for both living and deceased donor transplantation. The program also teaches key communication skills needed to effectively initiate and manage conversations about transplantation.

Eligibility criteria: Inclusion Criteria:

* Wait listed for kidney transplantation in active status
* Adult (at least 18 years of age)
* English speaking
* Capable of making medical decisions (i.e., not cognitively impaired)
* Non-institutionalized

Exclusion Criteria:

* Not listed for kidney transplantation

Primary outcomes:
measure: Change in engagement in discussion of living and deceased donor transplantation
timeFrame: Baseline (upon enrollment); 1 month post; 3 months post
measure: Change in knowledge of living and deceased donor transplant
timeFrame: Upon enrollment (baseline); 1 month post; 2 months post
Secondary outcomes:
measure: Change in intentions to discuss living and deceased donor transplantation
timeFrame: Upon enrollment (baseline); 1 month post; 3 months post
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Heather M Traino, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02811107: Evaluation of Anxiety in Surgery Preoperative Area (ASDT)
Official title: Evaluation of Anxiety in Surgery Preoperative Area (ASDT)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preoperative Area
Keywords: anxiety
pain
preoperative area
premedication
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 1000
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: Patient in preoperative area before surgery or interventional procedure

Brief summary: Anxiety is associated with discomfort but also with an increased risk of pain and/or analgesic consumption. A prescription of anxiolytics is very common in pre-anesthetic consultation but without considering the real anxiety level of the patients. The objective of this premedication is mainly to improve patient comfort, to reduce patient anxiety and to improve patient cooperation.

According to a study conducted in the 1990s, 40 to 80% of patients are anxious before surgery.

Consequences of anxiety are somatic (tachycardia, hypertension, difficulty to falling asleep), behavioural (aggressiveness, regression, fight against anaesthesia induction) and postoperative pain.

Preoperative area is a place of convergence for patients who need surgery or an interventional procedure.

Staying in the preoperative area may be a source of anxiety and may affect the patient management.

The investigators will interview patients undergoing surgery or interventional procedure to assess their level of anxiety, pain and their experiences during their stay in preoperative area. The objective is to analyse the level of anxiety and / or pain and their clinical consequences, and then to assess the relationship with any potential premedication.


Eligibility criteria: Inclusion Criteria:

* Patient in preoperative area before surgery or interventional procedure
* Patient to receive general anesthesia, local, locoregional, sedation,
* Agreeing to participate in the study after receiving information note,
* ≥ 18 years of age.

Exclusion Criteria:

* \< 18 years

Primary outcomes:
measure: Evaluation of anxiety in preoperative area, by using 3 questionnaires.
timeFrame: Day 0
Secondary outcomes:
measure: Evaluation of sedation
timeFrame: Day 0
measure: Evaluation of pain
timeFrame: Day 0
measure: Experiences of patient
timeFrame: Day 0
measure: Evaluation of patient premedication
timeFrame: Day 0
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03311607: Safety and Effectiveness of Short-course AmBisome in the Treatment of PKDL in Bangladesh
Official title: Safety and Effectiveness of Short-course AmBisome in the Treatment of Post-Kala-azar Dermal Leishmaniasis (PKDL): a Prospective Cohort Study in Bangladesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-kala-azar Dermal Leishmaniasis
Keywords: Post-kala-azar Dermal Leishmaniasis
Visceral Leishmaniasis
AmBisome
Liposomal amphotericin B
Bangladesh
Kala azar
Lead sponsor: Medecins Sans Frontieres, Netherlands
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 280
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort study
Primary purpose: TREATMENT

Brief summary: The safety and effectiveness of AmBisome 15 mg/kg, given over 15 days in 5 biweekly infusions of 3 mg/kg on an outpatient basis, is evaluated in clinically diagnosed PKDL patients of 12 years and older in a highly endemic area in Bangladesh. This is a prospective study, with the objective to assess final cure 12 months after treatment.

Detailed description: The safety and effectiveness of AmBisome 15 mg/kg, given over 15 days in 5 biweekly infusions of 3 mg/kg on an outpatient basis, was evaluated in clinically diagnosed PKDL patients of 12 years and older in a highly endemic area in Bangladesh. This was a prospective study, with the objective to assess final cure 12 months after treatment. Clinical response was monitored at 1, 3, 6, and 12 months after treatment, and safety during and up until one month after treatment. A total of 280 patients recruited between 8 April and 25 November 2014 received AmBisome. Of these, 272 were assessed at 12 months.

Eligibility criteria: Inclusion Criteria:

-Patients of 12 years and older with probable PKDL (skin lesions strongly suggestive of PKDL with exclusion of other skin diseases, a history of VL treatment and a positive serological rK39 test)

Exclusion Criteria:

* PKDL and concurrent VL
* Prior treatment for PKDL
* On medication with a side effect profile overlapping with that of AmBisome
* A known hypersensitivity to AmBisome
* Pregnant and lactating women,
* Known cardiac disease, hepatic impairment or another severe chronic underlying disease -Renal impairment (baseline serum creatinine \> 1.3 mg/dL)
* Serum potassium \<3.5mmol/L at baseline

Primary outcomes:
measure: Final outcome
timeFrame: 12 months
Secondary outcomes:
measure: Safety
timeFrame: 7 weeks
measure: Hypokalaemia
timeFrame: 7 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Medecins Sans Frontieres, Netherlands
name: Koert Ritmeijer, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00376207: Physical Activity After Stroke: How Does it Effect Chronical Inflammation and Insulin Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Infarction
Keywords: Cerebral infarct
physical exercise
insulin sensitivity
low grade chronic inflammation
intervention
HOMA
PASE
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2006-09-14
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Decreased insulin sensitivity is and independent risk factor for stroke despite glycemic control. It is known that physical exercise increases insulin sensitivity in healthy subjects. Wether stroke patients can increase insulin sensitivity via physical exercise is not known.

Chronic low-grade inflammation is associated with an increased risk of stroke. Physical exercise has shown to increase IL-6 directly after exercise in untrained subjects. When fitness is increased in each subject then the peak IL-6 concentration after exercise decreases and so does the basal level of IL-6. It is not known whether stroke patients can increase physical activity level to a degree where chronic inflammation are decreased.

This study is designed to evaluate if physical exercise after stroke will increases insulin sensitivity and reduce low-grade chronic inflammation.

Stroke patients have been randomized to intervention with physical exercise or control in the ExStroke pilot trial and followed for 2 years. Using the study population from the ExStroke pilot trail blood samples will be obtained at the last control. Insulin sensitivity can be measured from fasting glucose and insulin using the Homeostasis Model Assessment (HOMA). Interleukin-6, TNF-alfa and CRP is measured to estimate chronic inflammation.


Eligibility criteria: Inclusion Criteria:

* participated in the ExStroke Pilot trail

Exclusion Criteria:

* Diabetes Mellitus
* Not able to give informed consent

Primary outcomes:
measure: Association between PASE and HOMA
measure: Association between PASE and IL-6
Secondary outcomes:
measure: IL-6 concentration is lower in the intervention group than control group.
measure: TNF-alfa and IL-6 is positively associated.
measure: IL-18 is associated to HOMA
measure: Correlation between PASE and HOMA in the intervention group vs. controls
measure: HOMA mean value in the 2 groups
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Lars-Henrik Krarup, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00484107: Tolerability & Safety of Premarin Vaginal Cream in Indian Postmenopausal Women
Official title: A Postmarketing Surveillance Study Evaluating the Tolerability and Safety of PREMARIN VAGINAL CREAM in Indian Postmenopausal Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postmenopause
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-08
Enrollment: 200
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This post-marketing study will provide local safety and tolerance data on the use of Premarin® vaginal cream.


Eligibility criteria: Inclusion Criteria:

* Patients in whom Premarin vaginal cream is indicated.
* In the opinion of the investigator, sufficient intelligence and motivation for the patient to continue throughout the study.
* Provide signed informed consent.

Exclusion Criteria:

* Patients not willing to give informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03047707: S-Shearwave Elastography for Assessment of Hepatic Fibrosis
Official title: Diagnostic Performance of S-Shearwave Elastography for Hepatic Fibrosis Evaluation: a Multicenter Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Fibroses
Keywords: ultrasound elastography
S-Shearwave
liver
fibrosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Samsung Medison
First posted: 2017-02-09
Enrollment: 634
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this multi-center prospective study is to evaluate the diagnostic performance of S-Shearwave, a newly developed ultrasound shear wave elastography, for the assessment of hepatic fibrosis.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic liver disease or cirrhosis, or living-donor candidates for liver transplantation, or volunteers
* Signed informed consent

Exclusion Criteria:

* Acute hepatitis or bile duct obstruction
* Serum ALT\> 5 times the upper limit of normal within 3 months
* s/p Rt. hemihepatectomy
* s/p liver transplantation
* Large mass or infiltrative lesion in the right lobe of the liver

Primary outcomes:
measure: Diagnostic performance to detect severe hepatic fibrosis (F3)
timeFrame: 3 months
Secondary outcomes:
measure: Determination of cut-off values of S-Shearwave measurements for fibrosis grades according to causes
timeFrame: 3 months
measure: Intra-observer and inter-observer agreement of S-Shearwave measurements
timeFrame: same day
measure: Comparison of diagnostic performance: Shearwave vs. Transient elastography
timeFrame: 3 months
measure: Usefulness of auto-profile function in S-Shearwave measurements
timeFrame: 3 months
measure: Diagnostic value of B-mode ultrasound information for assessing hepatic fibrosis
timeFrame: 3 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References: