louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00511316: Trial of Montelukast in Eosinophilic Esophagitis
Official title: A Randomized Placebo-Controlled Trial of Montelukast in Maintenance Therapy of Asymptomatic Eosinophilic Esophagitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Eosinophilic Esophagitis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2007-08-03
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate clinical effectiveness of oral montelukast compared to placebo on prevention of dysphagia and food impaction in patients with EE.

Also evaluate tolerance and safety of oral montelukast in treatment of EE.

Detailed description: We will randomize in a double blind manner 60 consecutive consenting patients being evaluated at the three Mayo Clinic Medical Centers with EE to montelukast 20mg daily or placebo daily for six months? time. Patients will be in remission after treatment with topical fluticasone therapy before enrollment. Patients will fill out a validated dysphagia and side effect questionnaire before, during, and at the end of therapy.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* \> 14 eosinophils / hpf on biopsies from mid esophagus within the 6 months.
* Abnormal dysphagia questionnaire (Question 1a yes, question 1c \>/= mild and question 2 \>/= less than once a week) prior to topical steroid treatment. This questionnaire has recently been validated.
* Normal dysphagia questionnaire after topical steroid treatment (Having an answer of no to question 1a: Have you had trouble swallowing, not associated with other cold symptoms? over the past two weeks since having completed the swallowed steroid treatment).

Primary outcomes:
measure: evaluate effectiveness of oral montelukast in treatment of EE.
timeFrame: 6 months
Secondary outcomes:
measure: evaluate safety of montelukast in eosinophilic esophagitis
timeFrame: 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jeffrey A. Alexander, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alexander JA, Ravi K, Enders FT, Geno DM, Kryzer LA, Mara KC, Smyrk TC, Katzka DA. Montelukast Does not Maintain Symptom Remission After Topical Steroid Therapy for Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2017 Feb;15(2):214-221.e2. doi: 10.1016/j.cgh.2016.09.013. Epub 2016 Sep 17.
Clinical trial NCT00396916: Hybrid PET/CT in Cancer Patients
Official title: The Value of Novel Imaging Modality, Hybrid PET/CT, Using F18-Flurodeoxyglucose(FDG) in the Assessment of Cancer Patients. Impact of PET/CT on Clinical Management of Patients With Rising Tumor Markers and no Other Evidence of Disease and in Patients With Metastatic Cancer of Unknown Origin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: cancer patients
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2006-11-08
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of the present study is to assess the role of hybrid PET/CT imaging diagnosis of active malignancy in cancer patients with rising tumor markers after treatment and in the diagnosis of primary tumor in patients with metastatic cancer of unknown origin. The clinical impact of PET/CT in the management and treatment of these two groups of cancer patients will be evaluated


Eligibility criteria: Inclusion Criteria:

* Cancer patients in complete remission after treatment, with serial elevation of serum tumor markers and negative CT or other conventional imaging test.
* Patients with newly diagnosed metastatic cancer with unknown primary tumor
* Glucose levels below 150-200
* Patient signed informed consent

Exclusion Criteria:

* Pregnant or lactating women
* Patient unable or not willing to tolerate the test until its completion
* One or more of the inclusion criteria is not fulfilled

Primary outcomes:
measure: the impact of the imaging modality on patient management
Secondary outcomes:
measure: the impact of the imaging modality on patient management
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Rachel Bar-Shalom, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01669616: Point of Service Diabetes Screening Evaluation
Official title: Point of Service Diabetes Screening Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Non-Insulin Dependent
Keywords: Type 2 Diabetes
Adults 18 years and older
Lead sponsor: VeraLight, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-21
Enrollment: 667
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Attendees of Blue Cross Blue Shield Wellness Event

Brief summary: The primary objective of the trial is to collect SCOUT DS, random capillary glucose and Hemoglobin A1c measurements from subject 18 years of age or older.

Detailed description: The objectives of this study are to compare the accuracy of SCOUT versus random capillary glucose and several diabetes risk assessment questionnaires for detection of HbA1C-defined dysglycemia.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older

Exclusion Criteria:

* Known to be pregnant (self-reported)
* Receiving dialysis or known renal compromise
* Known to have photosensitivity
* Taking medications that fluoresce
* Have scars, any tattoos, rashes or other disruption/discoloration on the left volar forearm

Primary outcomes:
measure: To compare the accuracy of SCOUT DS versus random capillary glucose and several diabetes risk assessment questionnaires for detection of HbA1c-defined dysglycemia.
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Blue Cross Blue Shield of Louisiana
state: Louisiana
Study officials:
affiliation: Blue Cross Blue Shield of Louisiana
name: Andrea Barrack, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00945516: Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture
Official title: Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture: Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bile Duct Disease
Keywords: Metal stent
Bile duct stricture
Stent migration
Feasibility
Safety
Removability
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2009-07-24
Enrollment: 60
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: The purpose of this study is to determine the feasibility, easy removability, safety, and migration rate of flared end fully covered self-expanding metal stent (FCSEMS) and anchoring FCSEMS for benign biliary stricture.

Detailed description: Benign biliary strictures (BBS) are usually managed with plastic stents, whereas placement of uncovered metallic stents has been associated with failure related to mucosal hyperplasia. Fully covered self-expanding metal stent(FCSEMS) placement was reported as a useful method for BBS. However, stent migration was a frequent complication of CSEMS placement. Recently, flared end FCSEMS was developed to decrease stent migration, and anchoring CSEMS was newly developed.

Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old
* Patient with benign bile duct stricture

Exclusion Criteria:

* No written informed consent
* Malignant biliary obstruction
* Patients with uncorrectable severe coagulopathy
* Patients with severe cardiopulmonary disease precluding sedation

Primary outcomes:
measure: Stent migration rate
timeFrame: one year
Secondary outcomes:
measure: Feasibility (Technical success rate and functional success rate)
timeFrame: one year
measure: Safety (Procedure related early complications occurred within one month and late complications occurred one month after the procedure)
timeFrame: one year
measure: Removability
timeFrame: one year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center
name: Do Hyun Park, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Park DH, Lee SS, Lee TH, Ryu CH, Kim HJ, Seo DW, Park SH, Lee SK, Kim MH, Kim SJ. Anchoring flap versus flared end, fully covered self-expandable metal stents to prevent migration in patients with benign biliary strictures: a multicenter, prospective, comparative pilot study (with videos). Gastrointest Endosc. 2011 Jan;73(1):64-70. doi: 10.1016/j.gie.2010.09.039.
Clinical trial NCT01014416: Pharmacokinetics/Pharmacodynamics (PK/PD) Characteristics of Tolvaptan Tablet in Korean Healthy Male
Official title: A Dose Block-randomized, Double-blind, Placebo-controlled, Single Dose, Dose-escalation Study to Investigate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Tolvaptan in Healthy Korean Male Subjects Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Korean male
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-11-17
Enrollment: 46
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate the safety, tolerance, pharmacokinetics and pharmacodynamics of tolvaptan 15, 30 and 60 mg after single oral administration in healthy Korean male subjects.


Eligibility criteria: Inclusion Criteria:

1. Healthy Korean male subjects between 20 and 45 years of age, inclusive.
2. Body Mass Index (BMI) of 20 to 26 kg/m2, body,weight ≥ 50kg BMI = weight (kg)/height2(m)
3. Informed consent from the subjects

Exclusion Criteria:

1. Clinically significant abnormality of respiratory, cardiovascular, hepatic, neurologic, endocrine, hematologic, urinary, psychiatric.
2. History of gastrointestinal disease or surgery which can affect intestinal absorption of the study drug.
3. History of any significant drug allergy or hypersensitivity.
4. AST or ALT \> 1.25 times upper normal limit at screening clinical laboratory test
5. Supine blood pressure after resting for ≥ 3 minutes, higher than 140/90 mmHg or lower than 100/50 mmHg, Supine pulse, after resting for ≥ 3 minutes, outside the range of 40 to 90 beats/minute.
6. Subjects who had history of drug abuse or alcohol addiction
7. Subjects who used of any prescription drug or herbal medication within 2 weeks prior to the first dosing of the study drug, or any over-the-counter or vitamin supplements within 1 week prior to the first dosing (However, investigators can judge the subject, who has taken the medications during those periods above, eligible for the trial if all other conditions are satisfied)
8. The investigator judges the subject not eligible for the study after reviewing clinical laboratory results or other reasons.

Primary outcomes:
measure: PK parameters: AUC, Cmax, Tmax
timeFrame: 1 day
measure: PD parameters: 24 hour fluid balance
timeFrame: 1 day
measure: Safety: adverse event, body weight, physical examination, vital sign, ECG, clinical laboratory test
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Sang Yu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03405116: Prediction Tool for Premature Labour and Neonatal Outcome
Official title: Neonatal and Long Term Outcomes of Preterm Born Children in Flanders
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Premature Birth
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 2037
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women visiting the maternity ward suffering from symptoms of preterm birth.

Brief summary: A register and prediction model will be developed to predict the outcome of preterm labour and birth.


Eligibility criteria: Inclusion Criteria:

* Gestational age of 24 weeks 0 days and 33 weeks and 6 days, and their preterm born children

Exclusion Criteria:

* Patients who choose not to participate in the research.
* Intra-uterine prelabour fetal death.
* Fetuses or neonates with a major congenital disorder. Major is defined as a disorder that has an impact on neonatal respiratory and cerebral outcome and/or long-term outcome.
* Postpartum transfer/outborn.

Primary outcomes:
measure: Register
timeFrame: 2017 - 2030
measure: Prediction model
timeFrame: 2017 - 2030
Secondary outcomes:
measure: The interval between starting corticosteroids and delivery
timeFrame: 2012-2020
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital - Women's Clinic
Study officials:
affiliation: University Hospital, Ghent
name: Kristien Roelens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dehaene I, Scheire E, Steen J, De Coen K, Decruyenaere J, Smets K, Roelens K. Obstetrical characteristics and neonatal outcome according to aetiology of preterm birth: a cohort study. Arch Gynecol Obstet. 2020 Oct;302(4):861-871. doi: 10.1007/s00404-020-05673-5. Epub 2020 Jul 3.
Clinical trial NCT03116516: Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1604 in Comparison to the Co-administration of Telmisartan/Amlodipine and Rosuvastatin
Official title: A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1604 in Comparison to the Co-administration of Telmisartan/Amlodipine and Rosuvastatin in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Hyperlipidemia
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-17
Enrollment: 62
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomized, open-label, single dose, crossover clinical trial
Primary purpose: TREATMENT

Brief summary: This is a phase 1, open label, single-dose, crossover study to investigate the pharmacokinetics of YHP1604 in comparison to the co-administration of telmisartan/amlodipine and rosuvastatin in healthy male volunteers

Hypothesis: "YHP1604" and "telmisartan/amlodipine and rosuvastatin" are showing equal pharmacokinetics.

Detailed description: This is a phase 1, open label, single-dose, crossover study to investigate the pharmacokinetics of YHP1604 in comparison to the co-administration of telmisartan/amlodipine and rosuvastatin in healthy male volunteers.

In ARM1, 30 subjects will be assigned and the subjects will be administered "telmisartan/amlodipine and rosuvastatin" at Day1 and "YHP1604" at Day22.

In ARM2, 30 subjects will be assigned and the subjects will be administered "YHP1604" at Day1 and "telmisartan/amlodipine and rosuvastatin" at Day22.

Eligibility criteria: Inclusion Criteria:

* Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2
* Who has not suffered from clinically significant disease
* Provision of signed written informed consent

Exclusion Criteria:

* History of and clinically significant disease
* A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
* Administration of other investigational products within 3 months prior to the first dosing
* Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs

Primary outcomes:
measure: Telmisartan/Amlodipine/Rosuvastatin Cmax, AUClast
timeFrame: 0 - 72 hrs, 0 - 168 hrs, 0 - 48 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
Study officials:
affiliation: Chonbuk National University Hospital
name: Mingul Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00143416: Long Term Study With B2036-PEG
Official title: Long-Term Study of B2036-PEG in Acromegaly - Long Term Study With B2036-PEG -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acromegaly
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary objective: To investigate the efficacy and safety of Pegvisomant in Japanese patients with acromegaly.


Eligibility criteria: Inclusion Criteria:

* Patients with acromegaly who have received at least one dose of B2036-PEG in the preceding study (A6291009).

Exclusion Criteria:

* Switching to other therapeutic methods for acromegaly

Primary outcomes:
measure: To evaluate the safety and efficacy of long-term B2036-PEG therapy in patients with acromegaly
Secondary outcomes:
measure: PK/PD evaluation
Other outcomes:
Locations:
city: Kobe City
country: Japan
facility: Pfizer Investigational Site
state: Hyogo Pref
city: Kozukue-cho, Kouhoku-ku, Yokohama-shi
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Hamamatsu-shi
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka-ken
city: Bonkyo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Gakuhara, Kishiwada, Osaka
country: Japan
facility: Pfizer Investigational Site
city: Kyoto
country: Japan
facility: Pfizer Investigational Site
city: Sannomaru-cho, Naka-ku, Nagoya-shi
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02287116: Continuous Positive Airway Pressure Via Binasal Prong vs Nasal Mask: a Randomised Controlled Trial
Official title: Continuous Positive Airway Pressure Via Binasal Prong vs Nasal Mask: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchopulmonary Dysplasia
Death
Keywords: preterm infants
CPAP
BPD
invasive mechanical ventilation
we aimed determine that affect the rate of BPD and death of NCPAP therapy with nasal prongs or nasal mask as the initial treatment for RDS.
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2014-11-10
Enrollment: 150
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators aimed to compare the effectiveness of nasal mask and prongs used in CPAP (nasal continuous positive airway pressure)as the initial respiratory support when using minimal ly invasive surfactant therapy (MIST) in preterm infants.

Detailed description: OBJECTIVE: To determine that affect the rate of (bronchopulmonary dysplasia) BPD and death of NCPAP therapy with nasal prongs or nasal mask as the initial treatment for respiratory distress syndrome (RDS).

METHODS: Inborn preterm infants of gestational age 26-32 weeks, with respiratory distress syndrome were enrolled in this single-centered, unblinded randomized prospective controlled trial. They were stabilized with T-piece device in delivery room. Immediately after admission of neonatal intensive care unit (NICU), infants were randomly assigned to receive NCPAP with either nasal prongs or mask. NCPAP was continued by setting at PEEP as 5 to 8 cm H2O .

RESULTS: 160 infants were assessed for eligibility 149 infants were randomized. Finally 75 infants in Group I (nasal prong) and 74 in Group II (nasal mask) were analyzed. Mean gestational ages were 29.3±1.6 vs 29.1±2.0 weeks (p=0.55) and birth weights were 1225±257 vs. 1282±312 grams (p=0.22) respectively in Group I and Group II. The frequency of NCPAP failure within 24 hours of life was higher in Group I compared to Group 2 (respectively 8%, %0 , p=0.09) but difference was not significant. The outcomes of BPD and death rates did not differ among the groups ( Group I 9.3% vs. Group II 9.4 %; p=0.96).

CONCLUSIONS: Applied nasal mask is a feasible method to deliver NCPAP and as effective as nasal prongs for the initial treatment of RDS in preterm infants.

Eligibility criteria: Inclusion Criteria:

* One hundred sixty infants born at 26-32 weeks' gestation not endotracheally intubated in the delivery room (DR)

Exclusion Criteria:

* Infants with major congenital anomalies, and who required intubation in the DR and no parental consent were excluded.

Primary outcomes:
measure: BPD
timeFrame: 7 months
Secondary outcomes:
measure: death
timeFrame: 7
Other outcomes:
Locations:
Study officials:
References: