louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06130345: Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran
Official title: Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran Vaccines in the United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2
Keywords: Elasomeran
Davesomeran
Andusomeran
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
Virus Diseases
Messenger RNA
COVID-19
COVID-19 Vaccine
Moderna
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Aetion, Inc.
First posted: 2023-11-14
Enrollment: 15196685
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be identified using HealthVerity's aggregated medical and pharmacy claims database between September 1, 2022 and February 29, 2024.

Brief summary: The main objective of the study is to evaluate the safety of the elasomeran/davesomeran and andusomeran vaccines as used in routine clinical practice.


Eligibility criteria: Inclusion Criteria:

Cohort 1: Influenza vaccinated concurrent comparator

Eligible vaccine episodes must meet the following inclusion criteria within the protocol-specified time windows:

* Non-missing sex: (start of available data, 1 day prior to index)
* No receipt of elasomeran/davesomeran and andusomeran vaccine: (90 days prior to index, 1 day prior to index)
* No receipt of influenza vaccine: (90 days prior to index, 1 day prior to index)
* No receipt of any other COVID-19 vaccine: (90 days prior to index, index date)
* Continuous enrollment in closed medical and pharmacy claims (365 days prior to index, index date)

Cohort 2: Medically attended COVID-19 concurrent comparator

Eligible vaccine and disease episodes must meet the following inclusion criteria within the specified time windows:

* Non-missing sex: (start of available data, 1 day prior to index)
* No receipt of elasomeran/davesomeran and andusomeran vaccine: (180 days prior to index, 1 day prior to index)
* No evidence of medically attended COVID-19: (180 days prior to index, 1 day prior to index)
* No receipt of any other COVID-19 vaccine: (180 days prior to index, index date)
* Continuous enrollment in closed medical and pharmacy claims (365 days prior to index, index date)

Exclusion Criteria:

* Vaccine and disease episodes with a prior AESI within the washout window will be excluded from the analytic cohort.
* For the influenza vaccinated concurrent comparator cohort, individuals who receive an elasomeran/davesomeran and andusomeran vaccine and an influenza vaccine on the same day or within a minimum number of days will be excluded from the primary analysis.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants With Adverse Events of Special Interest (AESI)
timeFrame: Day 2 up to Day 60 after vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Aetion, Inc
state: New York
Study officials:
References:
Clinical trial NCT02157545: The Dose-Response Relationship of Rocuronium in Patients Taking Pyridostigmine
Official title: The Dose-response Relationship of Rocuronium in Patients Taking Pyridostigmine Preoperatively Compared With Age and Sex Matched Controls
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Muscle Relaxants
Keywords: muscle relaxants
pyridostigmine
pharmacodynamics
potency
Lead sponsor: University of Toledo
Sponsor class: OTHER
First posted: 2014-06-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects taking pyridostigmine for any reason who are scheduled for surgery under general anesthia.

Brief summary: Pyridostigmine is a medication that is used in certain heart rate and blood pressure conditions. This medication, as a side effect, is known to also cause changes in the junction between a nerve and muscle. The changes caused at the nerve muscle junction by pyridostigmine could alter the effect of muscle relaxants (a medication used during surgery and anesthesia). The investigators are conducting this study to see whether patients taking pyridostigmine are more or less sensitive to rocuronium (a muscle relaxing medication used during surgery).

Detailed description: No subjects enrolled. No data collected.

Eligibility criteria: Inclusion Criteria:

* Patients who take pyridostigmine for any reason or those who are matched by age, sex and weight to subjects taking pyridostigmine
* Patients who will be administered rocuronium during elective procedures as standard clinical care.

Exclusion Criteria:

* Allergy to rocuronium
* Known neuromuscular disorder, patients suffering from myasthenia gravis
* Subjects taking medications known to impact neuromuscular transmission (ex. gentamicin).

Primary outcomes:
measure: Dose of the muscle relaxant rocuronium that will lead to 50% decrease in the force of the evoked muscle contraction in patients taking pyridostigmine.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: United States
facility: University of Toledo, Health Science Campus
state: Ohio
Study officials:
affiliation: University of Toledo Health Science Campus
name: Shashi Bhatt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00177645: Inhaled Bicarbonate Therapy in Cystic Fibrosis
Official title: Inhaled Bicarbonate Therapy in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
mucus clearance
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2005-09-15
Enrollment: 16
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to see if inhaled bicarbonate will increase the ability to cough up mucus in a person with cystic fibrosis.

Detailed description: There is evidence that people with CF may have differences in the liquid that lines the surface of their lungs from people without CF. There are two things that are known to be different. One is called bicarbonate secretion, which is the movement of a salt called bicarbonate that is normally present in the blood and lung fluid in all people. The abnormal movement of bicarbonate appears to cause a second abnormality - the liquid in the breathing tubes has more acid than the liquid in patients without CF. These differences may affect the stickiness and thickness of the mucus and limit how well the hairs that line the breathing tubes (cilia) move mucus out of the lungs.

Recent studies in a group of patients with chronic cough looked at the effects of giving an inhaled bicarbonate solution (sodium bicarbonate instead of sodium chloride) on the study subjects' ability to cough up mucus. Compared to the group given inhaled saline, the patients given inhaled bicarbonate were able to cough up approximately three times as much mucus. No clinical studies have looked at whether inhaled bicarbonate improves the ability of the lung in a person with CF to move mucus out of the lung or how this treatment affects lung function in patients with CF.

Eligibility criteria: Inclusion Criteria:

* age 12 or older
* Forced expiratory volume in one second (FEV1) \>40% predicted
* Ability to expectorate sputum

Exclusion Criteria:

* pregnancy
* pulmonary exacerbation or initiation of inhaled or oral antibiotics, steroids, or aerosol treatments within the last four weeks
* oxygen saturation \<92%, or requirement for supplemental oxygen

Primary outcomes:
measure: Determine the acute effects of increasing doses of inhaled bicarbonate on mucociliary clearance after a single inhalation
timeFrame: single dose escalation
Secondary outcomes:
measure: comparison of pre- and post-bicarbonate exhaled breath condensate pH values at a single inhalation
timeFrame: two doses in single day
measure: Safety as determined by pre- and post-clearance assay pulmonary function tests (FEV1) at a single visit
timeFrame: two doses in single day
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Joseph M Pilewski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01489345: Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects
Official title: A Double-Blind, Placebo-Controlled, Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: ONO-2952
Healthy adult subjects
Multiple dose
Safety
Tolerability
Pharmacokinetics
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2011-12-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the safety and tolerability of ONO-2952 across ascending multiple doses in healthy adult male and female subjects. The secondary objective is to characterize the pharmacokinetic (PK) profile of ONO-2952.


Eligibility criteria: Inclusion Criteria:

* Healthy non-smoking male or female subjects (18-55 inclusive)
* Body mass index (BMI) of 19-35 kg/m2 (inclusive)
* For females, surgically sterilized, postmenopausal, or who are non- lactating and agree to use a double barrier method of contraception

Exclusion Criteria:

* History or presence of clinically significant disease

Primary outcomes:
measure: Safety and tolerability of ONO-2952 using vital signs, ECGs, laboratory tests, physical examinations, and incidence/severity of adverse events
timeFrame: 36 days
Secondary outcomes:
measure: Characterization of PK of ONO-2952 in plasma samples
timeFrame: 36 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: Austin Clinical Site
state: Texas
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Ono Pharma USA, Inc
role: STUDY_DIRECTOR
References:
citation: Suto F, Wood AT, Kobayashi M, Komaba J, Duffy K, Bruce M. Safety, Tolerability, and Pharmacokinetic Profile of the Novel Translocator Protein 18 kDa Antagonist ONO-2952 in Healthy Volunteers. Clin Ther. 2015 Sep;37(9):2071-84. doi: 10.1016/j.clinthera.2015.07.010. Epub 2015 Aug 4.
Clinical trial NCT00584545: Simultaneous Fluoroscopic and Manometric Measures of the Oropharyngeal Phase of Deglutition
Official title: Simultaneous Fluoroscopic and Manometric Measures of the Oropharyngeal Phase of Deglutition
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Dysphagia
Keywords: pharyngeal manometry
videofluoroscopy
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: UCDMC otolaryngology primary clinic

Brief summary: To validate the pharyngeal constriction ration, a surrogate measure of pharyngeal strength on fluoroscopy by comparing it with simultaneous pharyngeal manometry.

Detailed description: The specific aim of this study is to validate the pharyngeal constriction ration, a surrogate measure of pharyngeal strength on fluoroscopy by comparing it with simultaneous pharyngeal manometry. Combined videofluoroscopic swallowing studies with pharyngeal manometry are commonly used in the evaluation of dysphagia. However, no published study has compared the results of simultaneous pharyngeal manometry with objective timing and displacement measures on videofluoroscopy. These objective measures, such as the pharyngeal constriction ratio, were developed here at UCD and are not yet routinely used by other practitioners. A secondary aim of this study will be to corroborate recent data in the literature suggesting that the presence of feeding tube through the upper esophageal sphincter does not affect the oropharyngeal phase of deglutition. This topic is currently under hot debate in the speech language pathology realm and has important implications for the evaluation of hospitalized patients with dysphagia.

Eligibility criteria: Inclusion Criteria:

* undergone pharyngeal manometry with simultaneous videofluoroscopy during the period 1/1/06 to 4/30/07

Exclusion Criteria:

* those who do not meet the inclusion criteria; pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Peter Belafsky, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06538545: The Effect Of Sitting Position On The Labor Process
Official title: The Effect Of Sitting Position On The Labor Process
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Bleeding
Pain
Keywords: Bleeding
pregnant
labor duration
pain
Sitting Position
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 160
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted to determine the effect of sitting position on the labor process. The randomized controlled experimental study was conducted in the delivery room of Sivas Numune Hospital.


Eligibility criteria: 1. Inclusion Criteria:

   * Age range: 19-35
   * 38-42 weeks of pregnancy
   * No health problems that would prevent the use of sitting position
   * -Amniotic membranes not ruptured
   * Having a singleton pregnancy
   * Fetus in vertex position
   * Labor occurs with normal spontaneous vaginal delivery
   * No diagnosed chronic physical disease
   * No diagnosed psychiatric disease
   * No risky pregnancy, risky delivery and newborn/fetus
   * No communication problems
   * Voluntarily participating in the research
2. Exclusion Criteria:

   * Only women who gave birth at Sivas Sample Hospital were included in the study
   * Women who gave birth more than two times were not included in the study

Primary outcomes:
measure: Visual analog scale is applied starting from the 1st stage of labor and until the end of the 2nd stage.If the VAS value is 10, it means there is a lot of pain, and if it is 0, it means there is no pain.
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Hilal Güveri
state: Sivas Merkez
city: Sivas
country: Turkey
facility: Cumhuriyet Üniversitesi
Study officials:
References:
Clinical trial NCT06340945: The Outcomes of Ultrasound-guided Thermal Ablation for Benign Thyroid Nodules
Official title: The Clinical Outcomes and Artificial Intelligence Prediction Model of Ultrasound-guided Thermal Ablation for the Treatment of Benign Thyroid Nodules：A Multicenter Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thyroid Nodules
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 1. To evaluate the clinical outcomes of ultrasound-guided thermal ablationfor the treatment of benign thyroid nodules;
2. To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of benign thyroid nodules


Eligibility criteria: Inclusion Criteria:

* \[1\]confirmation of benign nodule status on two separate fine- needle aspiration (FNA) or core-needle biopsy (CNB) \[2\]no suspicious malignant features on ultrasound examination \[3\]report of cosmetic and/ or symptomatic problems or concern of nodules growing rapidly or malignant transformation \[4\]refusal or ineligibility for surgery \[5\]follow-up time ≥6months

Exclusion Criteria:

1. follicular neoplasm or malignancy findings on biopsy
2. nodules with benign result on biopsy had suspicious of malignancy in US, including marked hypoechoic, ill-defined margins, taller-than-wide shape or microcalcifications
3. patients with cystic nodules
4. patients with contra-lateral vocal cord par- alysis
5. previous radiation to the head and neck
6. ; follow- up time less than 6 months

Primary outcomes:
measure: volume reduction rate
timeFrame: through study completion, an average of 6 months
measure: rate of nodule regrowth
timeFrame: through study completion, an average of 1 months
Secondary outcomes:
measure: rate of complications
timeFrame: 1 week
measure: cosmetic score
timeFrame: through study completion, an average of 6 months
measure: symptom score
timeFrame: through study completion, an average of 6 months
measure: vital volume
timeFrame: through study completion, an average of 6 months
measure: total volume
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
References:
Clinical trial NCT01749345: Social Determinants of Health in Diabetes Outcomes
Official title: Social Determinants of Health as Explanatory Factors for Ethnic Disparities in Diabetes Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Ralph H. Johnson VA Medical Center
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-12-13
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pimary care and internal medicine clinics

Brief summary: This is a cross-sectional study of six hundred adults with type 2 diabetes, (300 White and 300 African-American) who will be recruited from two primary care sites to determine how social determinants of health impact diabetes outcomes. The first aim is to investigate the role of psychosocial factors and SES on diabetes care processes and outcomes. The second aim is to investigate the influence of community and neighborhood characteristics on diabetes care processes and outcomes. Finally, we will examine the contribution of social determinants of health to ethnic differences in diabetes care processes and outcomes. Clinical and metabolic measures will be abstracted from the electronic medical records. Outcome variables include hemoglobin A1c, blood pressure, LDL-Cholesterol and quality of life.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes
* Able to communicate in English

Exclusion Criteria:

* Mental confusion on interview suggesting significant dementia
* Alcohol or drug abuse/dependency
* Active psychosis or acute mental disorder

Primary outcomes:
measure: HbA1C
timeFrame: Within 3 months prior to the assessment
measure: Quality of life
timeFrame: Within a month of completely the assessment
Secondary outcomes:
measure: Blood pressure
timeFrame: Most recent to assessment date
measure: Low density lipoprotein (LDL) Cholesterol
timeFrame: Most recent to assessment date
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Leonard E Egede, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04393545: Efficacy of Splinting, Exercise and Electrotherapy on Hallux Valgus
Official title: A Comparison of the Effectiveness of Splinting, Exercise and Electrotherapy in the Management of Hallux Valgus: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hallux Valgus
Keywords: hallux valgus
Night splint
Exercise
High voltage galvanic stimulation
Radiographic angular degree
Foot-specific health-related quality of life
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the effects of splinting, exercise and electrotherapy on the hallux valgus (HV) angle, and foot-specific health-related quality of life. Sixty women (120 feet) with bilateral HV deformity were randomly assigned to one of three groups - an HV night splint (SP) group, an exercise (EX) group, and a high-voltage galvanic stimulation (EL) group. Angular degrees (hallux interphalangeal, HV, and intermetatarsal angles expressed as angles A, B and C, respectively) were determined before enrollment (t0) and three months after treatment (t2). Foot-specific quality of life was assessed using the Manchester-Oxford Foot Questionnaire (MOFQ) at t0, after one month (t1), and at t2. All groups exhibited significant changes in the A, B, and C angles and outcome measures (p ≤0.001). Decreases in the A and C angles, and MOFQ-Pain subscale scores, were higher in the SP group than in the other two groups (p\<0.05). C angle at t2, MOFQ-Walking score at t1 and t2 and MOFQ-Pain subscale score at t1 were lower in the SP group (p\<0.05).


Eligibility criteria: Inclusion Criteria:

* a diagnosis of HV confirmed by an orthopedist experienced in foot surgery
* female gender
* bilateral HV deformity
* aged 18-60 years.
* Patients were then selected based on an HV deformity degree of '2' or '3' on the Manchester scale before randomization

Exclusion Criteria:

* Patients with HV deformity degrees less than '2' or more than '3' according to the Manchester scale
* Patients with systemic disease, cognitive or mental disturbance, a history of surgery to the lower extremity, or previous use of any foot splints were excluded.

Primary outcomes:
measure: Manchester Scale
timeFrame: used once before enrollment for the inclusion
measure: change in hallux valgus angle
timeFrame: were taken before enrollment and at three-month follow-up controls
measure: change in Manchester-Oxford Foot Questionnaire score
timeFrame: were assessed three times: before enrollment, at 1st and 3rd months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kulunkoglu BA, Akkubak Y, Celik D, Alkan A. A comparison of the effectiveness of splinting, exercise and electrotherapy in women patients with hallux valgus: A randomized clinical trial. Foot (Edinb). 2021 Sep;48:101828. doi: 10.1016/j.foot.2021.101828. Epub 2021 May 25.