louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00725218: Flurbiprofen Axetil for Uterine Contraction Pain
Official title: Phase IV Study of Flurbiprofen Axetil for Uterine Contraction Pain After Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: NSAIDs
Postoperative pain
Analgesia
Abortion
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2008-07-30
Enrollment: 97
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Uterine contraction pain is a common problem after abortion. Optimal analgesic for such suffering is still needed to be guaranteed. Flurbiprofen Axetil is a target-distributable non-steroidal anti-inflammatory drug (NSAID) functioning via block the synthesis of prostaglandin E (PGE). The investigators hypothesized that Flurbiprofen Axetil could suppress the uterine contraction pain after abortion effectively.


Eligibility criteria: Inclusion Criteria:

* ASA status I-II
* Performing abortion operation (medical- or drug-induced
* Requiring painless abortion

Exclusion Criteria:

* \< 19yrs, and \>= 45yrs
* History of central active drugs administration
* Drug abuse
* Hypertension
* Diabetes
* Any other chronic diseases
* Allergy to the study drugs
* Habit of over-volume alcohol drinking
* Records of history of centrally active drug use and psychiatry
* Any organic disorders

Primary outcomes:
measure: VAS pain scorings
timeFrame: At the end of the operation, 0,5,15,30,60min after operation
Secondary outcomes:
measure: Anesthetic consumptions
timeFrame: At the end of the operation
measure: Overall VAS satisfaction scorings with analgesia
timeFrame: At the end of the study
measure: Side effects
timeFrame: During the whole period of the study
measure: Volume of bleeding
timeFrame: At the end of the study
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06663618: Short-term Glucocorticoid Combined with MMF for IgG4-RD
Official title: Comparison of Short-term Glucocorticoid Monotherapy and Short-term Glucocorticoid Combined with Mycophenolate Mofetil in the Treatment of IgG4 Related Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: IgG4-related Disease
Keywords: IgG4-related disease
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 63
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: Comparison of short-term glucocorticoid monotherapy and short-term glucocorticoid combined with MMF in the treatment of IgG4 Related Disease

Detailed description: This is a monocenter, 72-week prospective, randomized controlled study to compare short-term glucocorticoid monotherapy and short-term glucocorticoid combined with MMF in the treatment of IgG4 Related Disease.

Eligibility criteria: Inclusion Criteria:

1. 18-80 years old;
2. All patients must meet the comprehensive diagnostic criteria of IgG4-RD revised in Japan in 2020 or the classification criteria of IgG4-RD formulated by ACR/EULAR in 2019;
3. Active IgG4-RD (at least one organ has an IgG4-RD reaction score \>=2 at the time of enrollment.)；
4. No previous medication or recurrence after withdrawal.

Exclusion Criteria:

1. Combined with other autoimmune diseases as the main diagnosis.
2. Pregnant or lactating women
3. Patients with malignant tumor
4. Active bacterial, fungal, viral or mycobacterial infections.
5. Severe complications of important organs, and the expected survival time is less than 6 months.

Primary outcomes:
measure: The difference of recurrent rate of IgG4-RD between the two groups
timeFrame: 72 weeks
Secondary outcomes:
measure: The time of recurrence
timeFrame: 0-72 weeks
measure: The changes of IgG4-related disease Responder Index
timeFrame: 72 weeks
measure: The changes of serum IgG4 levels
timeFrame: 72 weeks
measure: The percentages of adverse events
timeFrame: 72 weeks
measure: The changes of PGA
timeFrame: 72 weeks
measure: The difference of remission rate of IgG4-RD between the two groups
timeFrame: 72 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Wen Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01639118: Prospective Study Of A Size Tailored Approach To Repair Umbilical And Epigastric Primary Ventral Hernias
Official title: Prospective Observational Cohort Study Of A Size Tailored Approach To Repair Umbilical And Epigastric Primary Ventral Hernias
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ventral Hernia
Umbilical Hernia
Epigastric Hernia
Keywords: primary ventral hernia repair with mesh
umbilical hernia repair
epigastric hernia repair
C-Qur V-patch
Size tailored repair
preperitoneal repair
abdominal hernia
dual sided mesh
Lead sponsor: Algemeen Ziekenhuis Maria Middelares
Sponsor class: OTHER
First posted: 2012-07-12
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: community sample

Brief summary: Primary ventral hernias, such as umbilical and epigastric hernias, are best repaired with abdominal wall reinforcement by mesh implantation. Mesh-devices using a dual-sided mesh technology have been developed for the specific indication of small ventral hernias; this technique is very attractive because the mesh can be introduced through a nearly invisible scar in the umbilicus. The dual layer of the mesh inhibits the formation of adhesions of the viscera to the mesh so, if wanted, it can be positioned in a intraperitoneal position. No literature is available on the adequate size of mesh needed to repair a hernia defect of an umbilical or epigastric hernia. Very small hernias are now often enlarged for repair with a large mesh device. Small hernias might benefit of repair with a small mesh device so no enlargement of the defect is necessary Larger hernias might benefit from a larger mesh size to have more overlap of the mesh beyond the hernia defect.

With this prospective cohort study the investigators want to explore the efficacy of C-QUR V-Patch of different sizes for the different sizes of hernia defects.


Eligibility criteria: Inclusion Criteria:

* all adult patients that are planned for surgical repair of a primary umbilical or epigastric hernia will be considered to enter the study.

Exclusion Criteria:

* patients refusing to participate at the follow up visits
* pregnancy
* age \< 18 years
* life expectancy less than 12 months
* recurrent umbilical or epigastric hernia
* incisional or trocar site hernias
* emergency operations
* liver cirrhosis or ascites
* cancer patients
* concomitant surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: AZ Maria Middelares
state: Oost Vlaanderen
Study officials:
affiliation: Algemeen Ziekenhuis Maria Middelares
name: Stijn De Sutter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Algemeen Ziekenhuis Maria Middelares
name: Filip Muysoms, MD
role: STUDY_DIRECTOR
affiliation: Algemeen Ziekenhuis Maria Middelares
name: Iris Kyle-Leinhase, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03745118: Development of a Practical, Minimally Invasive Seizure Gauge
Official title: Development of a Practical, Minimally Invasive Seizure Gauge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Keywords: Seizure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-11-19
Enrollment: 95
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The researchers are trying to assess changes in physiological signals before and during seizures.

Detailed description: Subjects that are undergoing video EEG monitoring in the hospital for their epilepsy at Mayo Clinic will be consented to participate in this study for a minimum of two days and/or the duration of their hospital stay for their clinical care. Subjects will be asked to wear up to 4 different commercially available seizure detection devices and complete surveys.

In the second year of the study patients who have implanted devices capable of recording or detecting seizures will be recruited to wear a noninvasive biosensor for multiple months. This data will be used to develop algorithms capable of detecting and/or forecasting seizures.

When the subjects clinical EEG monitoring is completed data scientists will analyze the data to identify patterns.

Eligibility criteria: Inclusion Criteria:

* Patients with epilepsy- scalp EEG or invasive EEG monitoring for clinical care, or an implanted device capable of monitoring brain activity and identifying seizures (e.g. NeuroPace RNS, Medtronic PC+S, Medtronic RC+S)
* Pediatric subjects 7 years of age or older.

Exclusion Criteria:

* Cognitive or psychiatric condition rendering patient unable to cooperate with data collection, or manage and recharge smart watch and tablet computer devices.
* Presence of open or healing wounds near monitoring sites (infection risk).

Primary outcomes:
measure: Assessment of Physiological Signals Measurable with Wearable Sensors
timeFrame: 2-10 days approximately
measure: Pattern Analysis
timeFrame: 2-10 days approximately
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Benjamin (Ben) H. Brinkmann, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03513718: Acute Kidney Injury After Cardiac Surgery on CPB
Official title: Incidence of Acute Kidney Injury After Cardiac Surgery on Cardiopulmonary Bypass in the Pediatric Intensive Care Unit of Lausanne. A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Congenital Heart Disease
Surgery
CBP
Child, Only
Keywords: Acute kidney injury, AKI
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 250
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective inclusion of all pediatric patients (0-16 years) admitted in our PICU after cardiac surgery with CPB between January 2014 and December 2016

Brief summary: The purpose of this retrospective study is to determine the incidence and severity of acute kidney injuries (AKI) after heart surgery on cardiopulmonary bypass (CPB) in the pediatric intensive care unit (PICU) in Lausanne, Switzerland.

Detailed description: The investigators will review in a retrospective way, all patients aged between 0 and 16 years, admitted in the PICU after cardiac surgery on CPB from 01.01.2014 to 31.12.2016. They will asses for AKI. The first step is to determine the incidence and severity, the second step is to determine the risk factors for AKI and/or protecting factors.

Eligibility criteria: Inclusion Criteria:

- all pediatric patients (0-16 years) admitted to PICU after cardiac surgery with CPB.

Exclusion Criteria:

* Preexisting kidney injury,
* no preoperative creatinine lab value

Primary outcomes:
measure: Presence and severity of an AKI occurring during stay in the PICU
timeFrame: up to 3 month
Secondary outcomes:
measure: PICU stay and ventilation time
timeFrame: up to 3 month
measure: Persisting AKI after release from PICU according to RIFLE score
timeFrame: more than 3 month
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Marie-Hélène Perez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03205618: A Retrospective, Observational Study on the Effectiveness of Daclatasvir-Containing Regimens in Patients in KSA, UAE and Qatar
Official title: Effectiveness of Daclatasvir-Containing Regimens in Patients Treated in Real-Life Setting in Kingdom of Saudi Arabia (KSA), United Arab Emirates (UAE) and Qatar
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-07-02
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll all patients initiating a new daclatasvir-containing HCV treatment, regardless of treatment history and previous treatment response from availability of the drug on country markets up to 01-Oct-2015.

Brief summary: The study will provide safety and efficacy information among patients receiving daclatasvir. It will describe daclatasvir prescribing patterns and provide a clinical profile of patients receiving the treatment in KSA, UAE, and Qatar.


Eligibility criteria: Inclusion Criteria:

* Adult patients greater than or equal to 18 years of age
* Diagnosed with chronic hepatitis C
* Ended treatment with daclatasvir-containing regimen no later than 01-Oct-2015

Exclusion Criteria:

* Use of a daclatasvir-containing regimen in a clinical trial setting

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Number of participants achieving sustained virological response 12 weeks post-treatment (SVR12)
timeFrame: 12 weeks after the last dose of study treatment
Secondary outcomes:
measure: Distribution of SVR12 by Treatment Regimen
timeFrame: 12 weeks after the last dose of study treatment
measure: Distribution of SVR12 by Country
timeFrame: 12 weeks after the last dose of study treatment
measure: Distribution of SVR12 by Genotype
timeFrame: 12 weeks after the last dose of study treatment
measure: Distribution of SVR12 by HCV-Treatment Experience
timeFrame: 12 weeks after the last dose of study treatment
measure: Distribution of SVR12 by HIV co-infection
timeFrame: 12 weeks after the last dose of study treatment
measure: Distribution of SVR12 by previous liver transplantation
timeFrame: 12 weeks after the last dose of study treatment
measure: Incidence of Serious Adverse Events (SAE)
timeFrame: Up to 12 months
measure: Incidence of Adverse Events leading to discontinuation
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Doha
country: Saudi Arabia
facility: Local Institution
city: Jeddah
country: Saudi Arabia
facility: Local Institution
city: Riyadh-11211
country: Saudi Arabia
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01284218: Retrospective Database Study of Real World Abilify Outcomes in Major Depressive Disorder (MDD)
Official title: Retrospective Database Study of Real World Abilify Outcomes in Major Depressive Disorder (MDD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Disorder, Major
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: i3 Innovus
First posted: 2011-01-26
Enrollment: 23514
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Commercial health plan members

Brief summary: To examine the differences in health care utilization and costs between MDD patients on adjunctive aripiprazole therapy and MDD patients on other augmentation therapies.


Eligibility criteria: Inclusion Criteria:

* ≥1 fill for an augmentation therapy medication from Table 1 during the identification period of 01 January 2005 - 30 November 2008.
* 12 months of continuous enrollment with medical and pharmacy benefits each before the index date (pre-index period) and after the index date (post-index period).
* ≥1 medical claim with a primary International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) diagnosis for MDD (296.2x, 296.3x, 311.xx) during the pre-index period.
* Age ≥18 years as of the year of the pre-index period.

Exclusion Criteria:

* No pharmacy claims for atypical antipsychotics, mood stabilizers, anxiolytics, anticonvulsants, or stimulants, during the pre-index period.
* No medical claims with primary or secondary diagnoses for non-MDD episodic mood disorders or schizophrenia during the pre-index or post-index periods.

Primary outcomes:
measure: All cause health care costs
timeFrame: 12 months
Secondary outcomes:
measure: Health care costs: MDD related, mental health related
timeFrame: 12 months
measure: Health care resource utilization: All cause, MDD related, mental health related
timeFrame: 12 months
measure: Duration of index therapies
timeFrame: 12 months
measure: Medication possession ratio to evaluate adherence
timeFrame: 12 months
measure: Discontinuation of index therapies
timeFrame: 12 months
measure: Therapy switches to a non-index antidepressant or non-index augmentation therapy
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03294018: Heart Rate Changes Following the Administration of Sugammadex
Official title: Heart Rate Changes Following the Administration of Sugammadex
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradycardia
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 276
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female 0-18 years old undergoing surgery with anesthetic plan with sugammadex.

Brief summary: This a prospective study when the clinician decides to use sugammadex, heart rate will be recorded every minute for 15 minutes following its administration. If bradycardia occurs and a clinical decision is made to treat it, the medications and doses used will be recorded.


Eligibility criteria: Inclusion Criteria:

* Patient age 0-18 years
* Anesthetic plan includes NMB reversal with sugammadex

Exclusion Criteria:

* Sugammadex not used during the case

Primary outcomes:
measure: Bradycardia during sugammadex administration
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT04068818: The Heidelberg Engineering ANTERION Imaging Agreement Study
Official title: The Heidelberg Engineering ANTERION Imaging Agreement Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eye Abnormalities
Normal Eyes
Lead sponsor: Heidelberg Engineering GmbH
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 87
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A: normal eyes B: eyes with anterior segment abnormalities

Brief summary: This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess image quality of acquired biometry images of the eye

Detailed description: The conducted study is a non-interventional study for an imaging device used in the aid of ophthalmology diagnosis. Because the study is not interventional, the study is not an Applicable Clinical Trial per Clinicaltrials.gov definition.

Eligibility criteria: Inclusion Criteria:

1. Age 22 years or older
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions
3. Able to fixate
4. With eye pathology status for each of the two eye populations. A. Eye with normal anterior segment

B. Eyes with anterior segment abnormalities identified with the slit lamp exam including but not limited to:

* glaucoma surgeries: trabeculectomy, laser peripheral iridotomy and drainage devices
* corneal surgeries: corneal inlays and corneal transplants
* pterygium and corneal scar

Exclusion Criteria:

1. Subjects which were enrolled in the B-2018-1 Study
2. Physical inability to be properly positioned at the study devices or eye exam equipment
3. Contact lenses worn during imaging

Primary outcomes:
measure: Image quality
timeFrame: 30 days
measure: Agreement in identification of abnormality
timeFrame: 30 days
Secondary outcomes:
measure: Adverse Events
timeFrame: 1 day
Other outcomes:
Locations:
city: New York
country: United States
facility: State University of New York College of Optometry
state: New York
Study officials:
affiliation: State University of New York College of Optometry
name: Mitchell Dul
role: PRINCIPAL_INVESTIGATOR
References: