louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05292976: Pharmacodynamic Bioequivalence Study of Albuterol Sulfate Inhalation Aerosol, 0.09 mg Albuterol Base/ Inhalation
Official title: Multi-center, Randomized, Double Blind, Double Dummy, Placebo and Active Controlled, Crossover Pharmacodynamic Bioequivalence Study of Albuterol Sulfate Inhalation Aerosol, 0.09 mg in Stable Mild Asthma Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Bronchial Asthma
Lead sponsor: Aurobindo Pharma Ltd
Sponsor class: INDUSTRY
First posted: 2022-03-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Pharmacodynamic bioequivalence study of Albuterol Sulfate Inhalation Aerosol 0.09 mg

Detailed description: To assess the pharmacodynamic bioequivalence of Albuterol Sulfate Inhalation Aerosol 0.09 mg base/ INH \[Aurobindo Pharma, USA, Inc\] compared to authorized generic drug Albuterol Sulfate HFA Inhalation Aerosol 0.09 mg per actuation \[Teva Pharmaceuticals USA, Inc\] in stable mild asthma patients, under Methacholine induced bronchoprovocation.

Eligibility criteria: Inclusion Criteria:

1. Male and non-pregnant female subjects (18-65 years of age).
2. Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines.
3. FEV1 ≥ 80% of predicted.
4. Airway responsiveness to methacholine demonstrated by a pre-albuterol dose (baseline) PC20 ≤ 8 mg/mL or equivalent PD20.
5. Nonsmokers for at least six months prior to the study and a maximum smoking history of five pack-years (the equivalent of one pack per day for five years).
6. Written informed consent.

Exclusion Criteria:

1. Evidence of upper or lower respiratory tract infection (e.g., pneumonia, bronchitis, sinusitis) within six weeks prior to the study.
2. History of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season.
3. History of cystic fibrosis, bronchiectasis or other respiratory diseases.
4. History of cardiovascular, renal, neurologic, liver or endocrine dysfunction, including ECG with evidence of ischemic heart disease.
5. Treatment in an emergency room or hospitalization for acute asthmatic symptoms or need for daily oral corticosteroids within past three months.
6. Known intolerance or hypersensitivity to any component of the albuterol MDI

Primary outcomes:
measure: Post-dose PD20
timeFrame: Over a period of 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Investigational site #1
state: California
Study officials:
affiliation: Aurobindo Pharma Ltd
name: Joseph Marialouis, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03649776: Training Church Leaders in Mental Health First Aid
Official title: Training Community Members in Mental Health First Aid
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stigma
Keywords: Disparities
Lead sponsor: Research Foundation for Mental Hygiene, Inc.
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 324
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This protocol primarily targets African Americans who live in Central Harlem, New York.

Community members will also include church leaders and lay participants from local churches, health care organizations, and other community-based organizations. This will include any adult who meets study eligibility criteria and consents to take the MHFA training at one of our approved study sites. Examples of community study sites are First Corinthian Baptist Church, New York State Psychiatric Institute, and the Columbia University Wellness Center

Brief summary: The purpose of this study is to train Church Leaders and other community members in Mental Health First Aid (MHFA), which is an evidence-based public mental health education program. MHFA has been found to improve people's recognition of emotional and mental health challenges and to increase people's confidence in providing help to others. Information about MHFA can be accessed at http://www.mentalhealthfirstaid.org.

MHFA consists an 8-hour training program in which participants will be provided a manual, learn the signs and symptoms of common mental health problems, and learn a 5-step action plan to help someone in an emotional crisis.

Participants ware recruited from faith-based organizations (i.e., churches), health care organizations (i.e., hospitals), and other community based organizations. There will be no treatment directly provided as part of this study.


Eligibility criteria: Inclusion Criteria:

* Fluent in English
* Able to provide signed formed consent

Exclusion Criteria:

* Any circumstances limiting participant's ability to complete the 8-hour training
* Inability to provide informed consent

Primary outcomes:
measure: Change from Baseline Confidence in Providing Help at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Change from Baseline in Stigma at 3 months
timeFrame: 3 months
measure: Change from Baseline in Functional Health Status at 3 months
timeFrame: 3 months
Other outcomes:
measure: Semi structured Interviews at 3 months
timeFrame: 3 months
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Sidney H Hankerson, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00186576: Non-Myeloablative Allogeneic Transplant for Myelodysplastic Syndromes and Myeloproliferative Disorders
Official title: Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation for Treatment of Myelodysplastic Syndromes and Myeloproliferative Disorders (Except CML)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myelodysplastic Syndromes
Myeloproliferative Disorders
Blood and Marrow Transplant (BMT)
Myelodysplastic Syndromes (MDS)
Myeloproliferative Disorders (MPD)
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-09-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
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: To improve survival outcomes for patients with MDS and MPD with a nonmyeloablative allogeneic hematopoietic cell transplant.

Detailed description: Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation for Treatment of Myelodysplastic Syndromes and Myeloproliferative Disorders (Except CML)

Eligibility criteria: Inclusion Criteria:- Myelodysplastic Syndromes

* Myeloproliferative Disorders
* HLA matched donor available Exclusion Criteria:- organ dysfunction
* HIV positive

Primary outcomes:
measure: Efficacy of transplant
timeFrame: 1 year
Secondary outcomes:
measure: safety profile of nonmyeloablative transplant, graft versus host disease, graft rejection, non-relapse mortality, use of donor lymphocyte infusion
timeFrame: 1 year
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Ginna Laport
role: PRINCIPAL_INVESTIGATOR
References:
citation: Laport GG, Sandmaier BM, Storer BE, Scott BL, Stuart MJ, Lange T, Maris MB, Agura ED, Chauncey TR, Wong RM, Forman SJ, Petersen FB, Wade JC, Epner E, Bruno B, Bethge WA, Curtin PT, Maloney DG, Blume KG, Storb RF. Reduced-intensity conditioning followed by allogeneic hematopoietic cell transplantation for adult patients with myelodysplastic syndrome and myeloproliferative disorders. Biol Blood Marrow Transplant. 2008 Feb;14(2):246-55. doi: 10.1016/j.bbmt.2007.11.012.
citation: Cooper JP, Storer BE, Granot N, Gyurkocza B, Sorror ML, Chauncey TR, Shizuru J, Franke GN, Maris MB, Boyer M, Bruno B, Sahebi F, Langston AA, Hari P, Agura ED, Lykke Petersen S, Maziarz RT, Bethge W, Asch J, Gutman JA, Olesen G, Yeager AM, Hubel K, Hogan WJ, Maloney DG, Mielcarek M, Martin PJ, Flowers MED, Georges GE, Woolfrey AE, Deeg JH, Scott BL, McDonald GB, Storb R, Sandmaier BM. Allogeneic hematopoietic cell transplantation with non-myeloablative conditioning for patients with hematologic malignancies: Improved outcomes over two decades. Haematologica. 2021 Jun 1;106(6):1599-1607. doi: 10.3324/haematol.2020.248187.
Clinical trial NCT05844176: Intracranial Arterial Stenosis in Young Patients
Official title: Intracranial Arterial Stenosis in Young Patients: a Multicenter Longitudinal Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracranial Arterial Stenosis
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 500
Sex: ALL
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with intracranial arterial stenosis

Brief summary: The goal of this study is to evaluate the characteristic of intracranial arterial stenosis among young patients.


Eligibility criteria: Inclusion Criteria:

* age \< 45 years.
* stenosis of a major intracranial artery.

Exclusion Criteria:

-

Primary outcomes:
measure: Ischemic stroke in territory of qualifying artery
timeFrame: 1 year
Secondary outcomes:
measure: Ischemic stroke in other territory
timeFrame: 1 year
measure: Any stroke
timeFrame: 1 year
measure: Death
timeFrame: 1 year
measure: Stenosis of the intracranial artery
timeFrame: 1 year
Other outcomes:
measure: Ischemic stroke in the territory of qualifying artery
timeFrame: 3 year
measure: Ischemic stroke in other territory
timeFrame: 3 year
measure: Any stroke
timeFrame: 3 year
measure: Death
timeFrame: 3 year
measure: Stenosis of the intracranial artery
timeFrame: 3 year
measure: Ischemic stroke in the territory of qualifying artery
timeFrame: 5 year
measure: Ischemic stroke in other territory
timeFrame: 5 year
measure: Any stroke
timeFrame: 5 year
measure: Death
timeFrame: 5 year
measure: Stenosis of the intracranial artery
timeFrame: 5 year
Locations:
city: Suzhou
country: China
facility: Suzhou Municipal Hoapital
state: An Hui
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
References:
Clinical trial NCT02760576: 18612 - Sun Protection Factor Assay
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-05-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing; Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA Form (Health Insurance Portability and Accountability Act).
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose).

Exclusion Criteria:

* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03484676: Adequacy of One Point Fixation of Displaced Zygomatic Complex Fracture
Official title: Adequacy of One-Point Fixation of Displaced Zygomatic Complex Fractures Using a Customized Plate pre_post Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Zygomatic Fractures
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 18
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with unilateral non-comminuted zygomatic complex fracture undergo fixation of the complex by a customized plate at one point after 3D virtual simulation and reduction of the complex using Mimics software.

Detailed description: History data will be gathered including personal data, medical and surgical history, and family history.

Clinical examination and photographic records will be carried out to evaluate the magnitude and direction of the displaced zygoma, degree of facial asymmetry, neurosensory affection and functional disturbances.

Computed tomography (CT) scan:

Patients will receive a preoperative computed tomography (CT) scan of the facial bones \[ Axial cuts, DICOM file, Gantry tilt zero and minimal thickness of 1 mm\]. The radiographic data will be imported into a surgical simulation software to virtually reduce the fractured zygoma and custom design the plate for fixation.

General operative procedures:

* All cases will undergo surgery under general anesthesia with nasotracheal intubation.
* Intraoral maxillary vestibular approach will be used to gain access to the fractured zygomatic complex. Reduction of the fractured segment would be achieved using the appropriate techniques and instrumentation. One point ORIF would be accomplished using the customized plate.

Eligibility criteria: Inclusion Criteria:

* Patients' age range from 15-65 years.
* Patients with unilateral zygomatic complex fracture
* Displaced fracture
* Dentulous or edentulous patients.
* Patients should be free from any systemic disease that may affect normal healing of bone and predictable outcome.

Exclusion Criteria. Patients with systemic diseases as history of radiation therapy or chemotherapy, hematological disorders, neuromotor disorders and autoimmune diseases (may affect normal healing).

* Patients with comminuted fractures .
* Delayed presentation 3 weeks or more after the date of trauma.

Primary outcomes:
measure: Patient satisfaction. Measuring device visual analogue scale. Measuring unit 0-10
timeFrame: One week
Secondary outcomes:
measure: Adequacy of reduction compared to the preoperative virtual simulation measuring device mimics software Ware. Measuring unit millimeters
timeFrame: Immediately post operative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01919476: Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women
Official title: Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes, Gestational
Keywords: Postprandial
Insulin resistance
Lipids
Satiety
Almonds
Lead sponsor: UCSF Benioff Children's Hospital Oakland
Sponsor class: OTHER
First posted: 2013-08-09
Enrollment: 18
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Currently, about one third of all women entering pregnancy are obese. The prevalence of metabolic disorders during pregnancy has increased concurrently with the rise in maternal obesity. Although dietary interventions are used routinely to reduce metabolic disease in non-pregnant obese individuals, no specific dietary advice is provided to obese, pregnant women unless they develop gestational diabetes mellitus. In this study, the investigators will specifically assess the effect of replacing dairy fats with almonds in a breakfast meal on the postprandial metabolic response. This cross-over, randomized control trial will examine the postprandial metabolic response to 0 or 2 oz of almonds in standardized test meals in pregnant Hispanic women with prepregnancy BMI between 25 and 40. Hispanics are at higher risk for gestational diabetes and the metabolic syndrome. The investigators hypothesize that consuming almonds in place of dairy fat reduces the glycemic response and improves the postprandial lipid profile in these high-risk women.


Eligibility criteria: Inclusion Criteria:

* Pregnant Hispanic women
* Between 30 and 36 weeks gestation
* Prepregnancy BMI between 25 and 40

Exclusion Criteria:

* Diagnosis of gestational diabetes mellitus
* Preexisting diabetes mellitus
* Renal disease
* Thyroid disease
* Cardiovascular disease
* History of drug abuse
* Nut allergies

Primary outcomes:
measure: Change in markers for glucose intolerance.
timeFrame: 0, .5, 1, 2, 3, 4, 5 hours following a meal
Secondary outcomes:
measure: Change in metabolic markers
timeFrame: 0, .5, 1, 2, 3, 4, 5 hours following a meal
Other outcomes:
measure: Change in satiety markers
timeFrame: 0, .5, 1, 2, 3, 4, 5 hours following a meal
Locations:
city: Oakland
country: United States
facility: Children's Hospital Oakland Research Institute
state: California
Study officials:
affiliation: Children's Hospital & Research Institute Oakland
name: Janet C King, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02206776: Randomized Controlled Trial of Intranasal Ketamine vs. Intranasal Midazolam in Individuals With OCD
Official title: Randomized Controlled Trial of Intranasal Ketamine vs. Intranasal Midazolam in Individuals With Obsessive Compulsive Disorder (OCD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2014-08-01
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obsessive-compulsive disorder (OCD) is a common illness that causes significant distress and impairment. Currently, serotonin reuptake inhibitors (SRIs) are the only medications that are FDA-approved to treat OCD. Unfortunately, SRIs can take a long time to work (2-3 months), and even then they usually only partially reduce OCD symptoms. The present study, will test if intranasal ketamine is feasible to use and can reduce OCD symptoms significantly more than a comparison medication called midazolam. Therefore, you may or may not receive ketamine as part of this study. Results from this study will allow doctors and researchers to better understand if you and others with OCD may respond to this class of medications.


Eligibility criteria: Inclusion Criteria:

* Age 18-55
* Physically healthy and not currently pregnant
* Primary diagnosis of OCD
* Sufficient severity of symptoms
* For all patients on medications, medications dose must be stable for at least 6 weeks prior to enrollment. Must discuss with Dr. current medications and doses.
* Able to provide consent

Exclusion Criteria:

* First degree relative with schizophrenia
* Psychiatric conditions that would make participation unsafe determined by study doctor
* Female patients who are either pregnant or nursing
* Planning to start EX/RP during the period of the study or those who have completed an adequate dose of EX/RP (defined as 8 or more sessions within 2 months) within 8 weeks prior to enrollment.
* Nasal obstruction or history of nasal surgery
* Currently on psychotropic medication or other medication likely to interact with the glutamate system
* Medical conditions that make participation unsafe
* Allergy or intolerance to ketamine or midazolam

Primary outcomes:
measure: Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.
timeFrame: Baseline and 1 Week
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Stanford University
name: Carolyn I Rodriguez, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00410176: A Randomized, Controlled, Unblinded, Clinical Trial of the Acceptability and Efficacy of Non-Pharmaceutical Methods in Preventing Spread of Influenza Within the Family
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Influenza
Lead sponsor: Ministry of Health, Israel
Sponsor class: OTHER_GOV
First posted: 2006-12-12
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed study will evaluate whether the use of non-pharmaceutical methods, such as surgical masks, isolation of patients and personal hygiene, are acceptable and effective in preventing the spread of influenza within the family.This will be achieved by conducting a randomized, controlled, unblinded, clinical trial. Family members of an index case with influenza like illness, will be randomly allocated to two groups. In the intervention group, family members will receive comprehensive guidance about sanitation and hygiene, as well as surgical masks to wear whenever in close contact (3 feet / 1 meter) with the index case. In addition, they will be asked to isolate the index case as much as possible. In the control group, family members will receive only standard guidance about sanitation and hygiene relevant for reducing the transmission of influenza. The primary end-point of the study will be secondary infection of influenza of at least one of the family members in order to asses the efficacy of the interventions. In addition, the compliance to those interventions will be evaluated.

The study hypothesis is that use of non-pharmaceutical methods will be acceptable and will reduce the secondary infection rate among them by 50%.


Eligibility criteria: Inclusion Criteria:

* Family members of an index case with influenza-like illness (ILI) during the first two days of his illness.
* No limitations will be given regarding the number of family members.

Exclusion Criteria:

* Presence of another household member with ILI during the previous two weeks.

Primary outcomes:
measure: secondary infection of influenza within the family
Secondary outcomes:
measure: compliance of non-pharmaceutical interventions
Other outcomes:
Locations:
Study officials:
affiliation: ICDC
name: Manfred S Green, PhD, M.D
role: PRINCIPAL_INVESTIGATOR
References: