louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06902818: The Study Compare and Evaluate the Safety and PK Data of a Single Dose Administration of 'AD-115A' or 'AD-1151'
Official title: A Randomized, Open-label, Single-dose, Two-sequence, and Two-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of AD-115A and the Administration of AD-1151 for Healthy Subjects in Fasting State
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Gastric Ulcer
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-30
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study compare and evaluate the safety and pharmacokinetic characteristics of a single dose administration of 'AD-115A' or 'AD-1151' in healthy adults.

Detailed description: A randomized, open-label, single-dose, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of AD-115A and the administration of AD-1151 for healthy subjects in fasting state

Eligibility criteria: Inclusion Criteria:

* The Age equal to or greater than 19 in healthy volunteers at the time of screening visit
* Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit

Exclusion Criteria:

* Individuals who have taken drugs that induce (e.g., barbiturates) or inhibit drug-metabolizing enzymes within 30 days prior to the start of the study (first dosing day), or have taken drugs that may affect this study within 10 days prior to the start of the study (first dosing day)
* Other exclusions applied

Primary outcomes:
measure: Maximum concentration of drug in plasma (Cmax)
timeFrame: pre-dose to 24 hours
measure: Area under the plasma concentration-time curve during dosing interval (AUCt)
timeFrame: pre-dose to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04154618: Continuous Vital Sign Monitoring in Newborns
Official title: Continuous Vital Sign Monitoring in Newborns
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Newborn Complication
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: New York State Department of Health
First posted: 2019-11-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy newborn infants \< 12 hours of age admitted to the Well Baby Nursery

Brief summary: This study evaluates the feasibility and usability of continuous wireless vital sign monitoring of well newborns during their birth hospitalization.

Detailed description: This study is conducted for the purposes of understanding the feasibility and acceptability of routine wireless continuous monitoring on healthy newborns as a standard practice \& its effect on existing workflows and as a future tool for the early detection of undiagnosed problems. All infants will receive routine newborn nursing care .

Once alarm limits have been determined, the monitoring data will be analyzed in real time and out of range vital signs will alert the nurse to perform standard assessment of the newborn.

Nurse and parents will complete surveys regarding their experience with continuous vital sign monitoring.

Eligibility criteria: Inclusion Criteria:

* Healthy infants \<12 hours of age
* Expected to be admitted to the Well Baby Nursery
* 36 or more weeks gestation at birth
* Mother at least 18 years of age

Exclusion Criteria:

* Infants requiring any non-routine medical care or observation
* Neonatal Intensive Care Unit (NICU) or Special Care Nursery admission
* Multiple birth

Primary outcomes:
measure: Assessment of feasibility by questionnaires to nurses and mothers using the using the Technology Acceptance Model (TAM).
timeFrame: Up to 3 days
Secondary outcomes:
measure: Accuracy assessed by comparison to conventional vital sign measurements within a 2-minute window
timeFrame: Up to 3 days
measure: Clinical Utility as measured by false alerts
timeFrame: Up to 3 days
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Cohen Children's Medical Center of New York
state: New York
city: Sleepy Hollow
country: United States
facility: Phelps Hospital
state: New York
Study officials:
References:
Clinical trial NCT00952718: Effects of Inspiratory Muscle Training in Patients With Bronchiectasis
Official title: Effects of Inspiratory Muscle Training in Patients With Bronchiectasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiectasis
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 38
Sex: ALL
Minimum age (years): 40
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 whether inspiratory muscle training could improve and/or prevent the deterioration of inspiratory muscle strength, clinical cardiopulmonary outcome, systemic immunologic responses and quality of life in patients with bronchiectasis.

Detailed description: Inspiratory muscle training is reportedly beneficial in patients with diverse chronic cardio-pulmonary diseases. It can increase inspiratory muscle strength and endurance, improves exercise capacity and quality of life (QOL), and decreases the perception of dyspnea (POD) for adults with stable chronic obstructive pulmonary disease (COPD). Though the pathophysiology in COPD and bronchiectasis are different, there are some similarities in clinical presentation. In COPD patients, lung hyperinflation induces functional weakness of the inspiratory muscle and increases elastic load to breathing and intrinsic positive end expiratory pressure. Patients with bronchiectasis shows reduced ratio of FEV1/FVC, reduced FEV1, and normal or slightly reduced FVC, which indicate that airways are blocked by mucus. However, there has been no study that used IMT as a training modality to determine its effect in bronchiectasis. The clinical relevance of increased respiratory muscle strength per se by IMT alone is unknown. This study tried to evaluate the feasibility and effectiveness of home-based threshold training and examined if the effects of IMT extends to clinical outcomes such as activities of daily living and QOL in bronchiectasis patients.

Eligibility criteria: Inclusion Criteria:

* Bronchiectasis confirmed by clinical history, pulmonary function test, and high resolution computed tomography

Exclusion Criteria:

* Had recent exacerbation within six weeks
* Use of corticosteroid
* With poor consciousness level
* Have cerebro-vascular or neuro-muscular disorders

Primary outcomes:
measure: Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) at 8 Weeks
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: Six Minutes Walking Distance
timeFrame: baseline and 8 weeks
measure: 6 Minute Work
timeFrame: baseline and 8 weeks
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital-Kaohsiung Medical Center
Study officials:
affiliation: Chang Gung Memorial Hospital-Kaohsiung Medical Center
name: Meng-Chih Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04831541: 68Ga-PSMA-11 PET/CT in Patients With Various Types of Cancer
Official title: 68Ga-PSMA-11 PET/CT in Patients With Various Types of Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Prostate Cancer
Positron-Emission Tomography
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the potential usefulness of 68Ga-PSMA-11 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions, efficacy assessment and recurrence monitoring in various types of cancer.

Detailed description: Subjects with various types of cancer underwent 68Ga-PSMA-11 PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-PSMA-11 PET/CT were calculated.

Eligibility criteria: Inclusion Criteria:

(i) adult population (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled 68Ga-PSMA-11 PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

(i) patients with pregnancy; (ii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Primary outcomes:
measure: Standardized uptake value (SUV)
timeFrame: 30 days
Secondary outcomes:
measure: Diagnostic efficacy
timeFrame: 30 days
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
References:
Clinical trial NCT00960141: A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Montelukast in Patients With Seasonal Allergic Rhinitis-Fall Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-08-17
Enrollment: 829
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study of the ability of montelukast to improve signs and symptoms of seasonal allergic rhinitis compared with placebo. Loratadine is included in the study as an active control.


Eligibility criteria: Inclusion Criteria:

* Patient has a documented clinical history of seasonal allergic rhinitis symptoms that become worse during the study season
* Patient is a non-smoker
* Patient is in good mental and physical health

Exclusion Criteria:

* Patient is hospitalized
* Patient is a woman who is \<8 weeks postpartum or is breast feeding
* Patient intends to move or vacation away during the study
* Patient is a current or past abuser of alcohol or illicit drugs

Primary outcomes:
measure: Mean Change From Baseline in Daytime Nasal Symptoms Score
timeFrame: Baseline and Week 2
Secondary outcomes:
measure: Mean Change From Baseline in Nighttime Symptoms Score
timeFrame: Baseline and Week 2
measure: Mean Change From Baseline in Daytime Eye Symptoms Score
timeFrame: Baseline and Week 2
measure: Patient's Global Evaluation of Allergic Rhinitis
timeFrame: Week 2 (or upon discontinuation)
measure: Physician's Global Evaluation of Allergic Rhinitis
timeFrame: Week 2
measure: Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score
timeFrame: Baseline and Week 2
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Chervinsky P, Philip G, Malice MP, Bardelas J, Nayak A, Marchal JL, van Adelsberg J, Bousquet J, Tozzi CA, Reiss TF. Montelukast for treating fall allergic rhinitis: effect of pollen exposure in 3 studies. Ann Allergy Asthma Immunol. 2004 Mar;92(3):367-73. doi: 10.1016/S1081-1206(10)61576-1.
Clinical trial NCT01459341: Near Infrared Spectroscopy and Transcutaneous Oxygen Pressure in Critical Limb Ischemia Before and After Treatment
Official title: Comparison of Near Infrared Spectroscopy (NIRS) and Transcutaneous Oxygen Pressure (TCPO2) Measurements in Critical Limb Ischemia (CLI) Patients After Invasive Treatment (Endovascular or Surgery)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Vascular Disease
Critical Limb Ischemia
Keywords: CLI Critical limb ischemia
PVD peripheral vascular disease
NIRS near infrared spectroscopy
TCPO2 - transcutaneous oxygen pressure
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2011-10-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 10 patients admitted to the vascular surgical department and undergoing invasive treatment (surgical or endovacular)

Brief summary: Comparison of two non-invasive methods for measuring tissue oxygenation. One is Transcutaneous Oxygen Pressure (TCPO2) and the other is the new method of Near Infrared Spectroscopy (NIRS) - near infrared spectroscopy in patients with critical limb ischemia (CLI) undergoing invasive treatment (surgical or endovascular).

Detailed description: Comparison of two non-invasive methods for measuring tissue oxygenation. One is TCPO2 and the other is the new method of NIRS - near infrared spectroscopy in patients with critical limb ischemia (CLI) undergoing invasive treatment (surgical or endovascular).

The NIRS probe has been used to measure tissue oxygenation in the cerebral circulation up to now. While TCPO2 is the established method for measuring tissue oxygenation in patients with CLI to evaluate the potential for wound healing.

Eligibility criteria: Inclusion Criteria:

* 10 patients admitted to the vascular surgical department and undergoing invasive treatment (surgical or endovascular)

Exclusion Criteria:

* pregnancy allergy to iod advanced renal failure CCT\<50 active peptic ulcer recent bleeding

Primary outcomes:
measure: tissue oxygenation
timeFrame: the outcome will be assessed during the hospital stay up to a week
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: department of vascular surgery, Carmel medical center
Study officials:
affiliation: Carmel Medical Center
name: Dallit Mannheim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murkin JM, Arango M. Near-infrared spectroscopy as an index of brain and tissue oxygenation. Br J Anaesth. 2009 Dec;103 Suppl 1:i3-13. doi: 10.1093/bja/aep299.
Clinical trial NCT01903941: Anti-inflammatory Effect of Aerobic Exercise in Individual With Increased Cardiovascular Risk
Official title: Anti-inflammatory Effect of Aerobic Exercise in Individual With Increased Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Inflammation
Keywords: exercise
Lead sponsor: Escola Bahiana de Medicina e Saude Publica
Sponsor class: OTHER
First posted: 2013-07-19
Enrollment: 68
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aerobic physical activity attenuates systemic inflammatory activity in individuals with cardiovascular risk.

Detailed description: Background: Observational studies suggest that exercise has anti-inflammatory effect, however this idea has not been definitively confirmed by randomized clinical trials.

Objective: To test the hypothesis that aerobic exercise attenuates systemic inflammatory activity in individuals with cardiovascular risk.

Methods: Randomized controlled trial, which included 68 sedentary individuals, with at least two risk factors for coronary heart disease or established cardiovascular disease. The volunteers were randomized to 3 months of supervised aerobic training or just advice when healthy lifestyles. C-reactive protein (CRP) was measured by the method of high sensitivity before and after 3 months of intervention.

Eligibility criteria: Inclusion Criteria:

- Individuals with are between 40 to 70 years, no regular exercise, and at least two risk factor for cardiovascular disease (diabetes, hypertension, dyslipidemia, smoking) or documented cardiovascular disease.

Exclusion Criteria:

- Incapacity to exercise.

Primary outcomes:
measure: C-reactive protein
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00555841: Safety and Efficacy of ALC in Breast Cancer in Subjects With Fatigue
Official title: Safety and Efficacy of Oral Acetyl-l-carnitine (ALC) in Non-anemic Potentially Curable Breast Cancer Subjects Undergoing Adjuvant Radiation Therapy Who Have Moderate to Severe Fatigue
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
Lead sponsor: Sigma-Tau Research, Inc.
Sponsor class: INDUSTRY
First posted: 2007-11-09
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy and safety of ALC in the treatment of non-anemic, breast cancer subjects who develop moderate or severe fatigue during adjuvant radiotherapy.

Detailed description: The objective of this study is to evaluate the efficacy and safety of ALC in the treatment of non-anemic, breast cancer subjects who develop moderate or severe fatigue during adjuvant radiotherapy

Eligibility criteria: Inclusion Criteria:

* Stage 0-III breast cancer in which adjuvant radiation is indicated;
* Qualifying Brief Fatigue Inventory (BFI) score 6. -

Exclusion Criteria:

* Medication to treat or manage fatigue and pain
* Use of erythropoietin to control anemia
* Clinical evidence of hypothyroidism or hyperthyroidism

Primary outcomes:
measure: Change of BFI as evaluated from Baseline to Final Visit
timeFrame: 16 weeks
Secondary outcomes:
measure: Changes in Health-Related Quality of Life (HQoL) outcomes using Medical Outcomes Study Short Form Health Status Profile 12 items (MOS-SF 12
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: The University of Texas MD Anderson Cancer Center
name: Carmen Escalante, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03129841: Effects of Late Dinner Against Early Dinner on Weight Loss Healthy Obese Women
Official title: Effects of Late Dinner Against Early Dinner on Weight Loss Healthy Obese Women in a Weight-loss Program: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: weight loss
dietary pattern
late dinner
early dinner
Lead sponsor: Novindiet Clinic
Sponsor class: OTHER
Collaborators: name: University of Nottingham
name: Tehran University of Medical Sciences
First posted: 2017-04-26
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to test whether late eating dinner could affect the amount of weight loss in healthy obese women in a weight-loss program.


Eligibility criteria: Inclusion Criteria:

* Must have Body mass index (BMI) between 27-35 kg/ m².
* Must be able to have moderate exercise.
* Must be interested to have weight loss.

Exclusion Criteria:

* Participating in a research project involving weight loss or physical activity in the previous six months.
* Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
* Taking medication that could affect metabolism or change body weight.
* Report heart problems, chest pain, and cancer within the last five years.
* Smoking
* Menopause
* Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.

Primary outcomes:
measure: weight loss
timeFrame: 12 Weeks
Secondary outcomes:
measure: waist circumference
timeFrame: 12 Weeks
measure: fasting plasma glucose
timeFrame: 12 Weeks
measure: insulin level
timeFrame: 12 Weeks
measure: insulin resistance (HOMA-IR)
timeFrame: 12 Weeks
measure: glycosylated hemoglobin (HbA1c)
timeFrame: 12 Weeks
measure: lipid profiles
timeFrame: 12 Weeks
measure: Liver Enzyme (SGOT, SGPT)
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: NovinDiet Clinic
Study officials:
References:
Clinical trial NCT01833741: A Study of LUMIGAN® RC in the Clinical Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma, Primary Open Angle
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-04-17
Enrollment: 1137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate bimatoprost 0.01% (LUMIGAN® RC) in patients with elevated intraocular pressure (IOP) due to primary open angle glaucoma (POAG) or ocular hypertension (OHT) in a clinical setting.


Eligibility criteria: Inclusion Criteria:

* Elevated IOP due to either primary open-angle glaucoma or ocular hypertension
* Determined by the treating physician to require treatment with LUMIGAN® RC

Exclusion Criteria:

* None

Primary outcomes:
measure: Percentage of Treatment-Naive Patients With Ocular Hyperemia
timeFrame: Week 12
measure: Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia
timeFrame: Week 12
measure: Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia
timeFrame: Week 12
Secondary outcomes:
measure: Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients
timeFrame: Baseline, 12 Weeks
measure: Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients
timeFrame: Baseline, 12 Weeks
measure: Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy
timeFrame: Baseline, 12 Weeks
measure: Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients
timeFrame: Baseline, Week 6, Week 12
measure: Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients
timeFrame: Baseline, Week 6, Week 12
measure: Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy
timeFrame: Baseline, Week 6, Week 12
measure: Percentage of Patients Discontinuing Due to Ocular Adverse Events
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Barrie
country: Canada
state: Ontario
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: