louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02037659: Dermabond Treatment for Gastric Variceal Bleeding
Official title: Endoscopic Ultrasound (EUS) Gastric Variceal Bleeding Database Repository
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Varices
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated with DermaBond for gastric varices.

Brief summary: The purpose of having a database is to collect data related to endoscopic ultrasound procedures performed by Indiana University EUS physicians; specifically, for the treatment of gastric variceal bleeding This data will be used for research purposes only to determine the clinical impact of endoscopic ultrasound treatment of gastric variceal bleeding. The physicians will also be able to better understand the patient's condition and disease process that may lead to improved standard of care and improved patient management.

Detailed description: Clinical outcomes research is one of the strengths of the EUS group. As a group, the physicians need a tracking system for specific treatment modalities, and data to determine the impact of endoscopic ultrasound for patients with gastric variceal bleeding. Gastric variceal bleeding is a severe complication of portal hypertension with significant morbidity and mortality with limited therapeutic options. Currently, there is no database in existence for endoscopic ultrasound clinical research for specific procedures. Also, there is limited data regarding the outcome of endoscopic sclerotherapy with cyanoacrylate in the United States.

Eligibility criteria: Inclusion Criteria:

Anyone receiving treatment with DermaBond for treatment gastric varices.

Exclusion Criteria:

No evidence of gastric varices.

-

Primary outcomes:
measure: To determine the clinical impact of endoscopic ultrasound treatment of gastric variceal bleeding.
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: John M. DeWitt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01223859: Pretreatment Assessment of Oropharynx Ans Soft Palate Radiofrequency Surgery - a Multi-center Study
Official title: The Impact of Pretreatment Assessment of Oropharynx on Interstitial Soft Palate Radiofrequency Surgery Outcome - a Multi-center Study in Patients With Habitual Snoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Snoring
Keywords: Radiofrequency, ablation, RFA, RFTA, RFITT, soft palate.
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Olympus Surgical Technologies Europe, Celon Ag Medical Instruments, Teltow, Germany
name: Helsinki University Central Hospital
First posted: 2010-10-19
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Interstitial radiofrequency (RF) surgery of the soft palate (SP) is an established option in the treatment of habitual snoring. The decision making process in the management of habitual snoring would benefit from diagnostic guidelines for oropharyngeal findings. The aim was to investigate the correlation of systematic clinical pretreatment oropharyngeal examination scores with the efficacy of interstitial RF surgery of SP in a multi-center study

Detailed description: TABLE 1. The inclusion and exclusion criterion used for the multicenter study.

Criteria Inclusion Exclusion _____________

Age (years) 18-65 \< 18, \> 65

Habitual snoring yes no Excessive daytime sleepiness no yes

BMI (kg/m2) \< 28 \> 28

AHI (events/hour) \< 15 \> 15

Overjet (mm) \< 5 \> 5 Clinical suspicion of obstruction no yes at base of tongue

Size of palatine tonsils (grade) 0-II III-IV

Nose breathing problems no yes

Pharyngeal tonsil hypertrophy no yes

A bed partner to assess snoring yes no

_____________

Abbreviations: BMI = body mass index, AHI = apnea-hypopnea index.

Eligibility criteria: TABLE 1. The inclusion and exclusion criterion used for the multicenter study.

Criteria Inclusion Exclusion _____________

Age (years) 18-65 \< 18, \> 65

Habitual snoring yes no Excessive daytime sleepiness no yes

BMI (kg/m2) \< 28 \> 28

AHI (events/hour) \< 15 \> 15

Overjet (mm) \< 5 \> 5 Clinical suspicion of obstruction no yes at base of tongue

Size of palatine tonsils (grade) 0-II III-IV

Nose breathing problems no yes

Pharyngeal tonsil hypertrophy no yes

A bed partner to assess snoring yes no

_____________

Abbreviations: BMI = body mass index, AHI = apnea-hypopnea index.

Primary outcomes:
measure: VAS
timeFrame: 3 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Helsinki University Dept of ORL HN Surg
name: Leif JJ Bäck, MD PhD
role: STUDY_DIRECTOR
References:
citation: Back LJ, Koivunen P, Pyykko I, Stene BK, Makitie AA. The impact of pretreatment assessment of oropharynx on interstitial soft palate radiofrequency surgery outcome--a multi-center study in patients with habitual snoring. Sleep Breath. 2012 Mar;16(1):199-204. doi: 10.1007/s11325-011-0490-4. Epub 2011 Feb 12.
Clinical trial NCT05400759: Clinical Outcomes of the Implementation of Diurnal IOP Curve to 1500 Patients - A Cohort Study.
Official title: Clinical Outcomes of the Implementation of Diurnal IOP Curve to 1500 Patients - A Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: To Present the Clinical Outcomes of Diurnal IOP Monitoring and Determine Its Value in Our Clinical Practice
Keywords: Tonometric curve, diurnal IOP, IOP phasing, IOP monitoring, glaucoma, glaucoma suspects, IOP peaks, hypertension, compliance, adherence,
Lead sponsor: George Papanicolaou Hospital
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients were retrieved from the eye clinic database. The records of all 1500 patients were retrospectively reviewed. We included the last 1500 patients who had undergone diurnal IOP monitoring in the clinic until the conduct of the study. All of them were hospitalized between November 2007 and December 2019, at the Eye Clinic of General Hospital "George Papanikolaou" in Thessaloniki, Greece.

Brief summary: To present the clinical outcomes of diurnal IOP monitoring and determine its value in our clinical practice.We reviewed the records of 1500 patients (glaucoma suspects or glaucoma patients), who were admitted for diurnal curve during almost 12 years.

Detailed description: We reviewed the records of 1500 patients, who were admitted for diurnal curve during almost 12 years. All patients were hospitalized because their within office-hours exams were considered inadequate and inconclusive for decision-making

744 patients needed change of treatment. 121 patients were programmed for interventional therapy (laser or surgery). 68 patients were declassified, as overdiagnosed and overtreated. In 250 patients hidden adherence problem revealed. In 720 patients peak IOP occurred out of office hours.

Eligibility criteria: Inclusion Criteria: IOP diurnal curve consisted of glaucoma patients with intraocular pressure higher than target pressure despite referred previously sufficient therapy and also patients with equal or lower than target pressure, but with disease progression. There were also included patients with advanced glaucoma with visual field defects on the visual field testing, as well as patients with normal tension glaucoma and labile secondary glaucomas (exfoliative, pigmentary and chronic angle closure glaucoma), for whom close monitoring and therapy reconsidering was judged appropriate.Glaucoma suspects, demonstrating findings consistent with increased risk for glaucoma development, were included.

-

Exclusion Criteria: Patients with missing data values for IOP

-

Primary outcomes:
measure: Diurnal IOP monitoring
timeFrame: 12 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05422859: Mobile and Digital Application in Heart Failure Networks Berlin/Brandenburg
Official title: Mobile and Digital Application in Heart Failure Networks Berlin/Brandenburg
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: German Heart Institute
Sponsor class: OTHER
Collaborators: name: Federal Ministry of Health, Germany
First posted: 2022-06-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The MobiDig trial is designed to evaluate an implementation of a mobile phone application with secondary preventive/rehabilitative modules for patients with heart failure in certified Heart Failure Unit centers in Berlin and Brandenburg.

The aim is to evaluate the effect on quality of life, symptoms and the course of the disease. In addition, the acceptance, adherence and user behavior as well as the implementation potential for a permanent introduction of the application in national heart failure networks will be analyzed.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of heart failure
* Treatment in a certified Heart Failure Unit center in Berlin or Brandenburg
* Written informed consent of the participants
* User of a mobile device with an iOS operating system

Exclusion Criteria:

* Addiction or other illnesses that do not allow the participants to assess the nature and scope as well as possible consequences of participation or its scientific evaluation
* insufficient knowledge of the German language, which is necessary to use the application

Primary outcomes:
measure: Acceptance of the application
timeFrame: 3 months
measure: Change in quality of life
timeFrame: Baseline and 3 months
measure: Patient reported outcomes
timeFrame: Baseline and 3 months
measure: Change in symptoms of heart failure
timeFrame: Baseline and 3 months
measure: Change in six-minute walk distance
timeFrame: Baseline and 3 months
measure: Change in daily walking distances
timeFrame: Baseline and 3 months
measure: Change in heart failure biomarker
timeFrame: Baseline and 3 months
measure: Number of hospitalizations
timeFrame: 3 months
measure: Length of hospitalizations
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Deutsches Herzzentrum der Charité - Universitätsmedizin Berlin
state: Deutschland
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin: Campus Virchow-Klinikum
city: Bernau
country: Germany
facility: Herzzentrum Berlin
Study officials:
References:
Clinical trial NCT04195659: Chest Dysphoria in Transmasculine Spectrum Adolescents
Official title: The Effect of Top Surgery on Chest Dysphoria in Assigned-Female-At-Birth, Transmasculine Spectrum Youth and Young Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gender Dysphoria
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Ann and Robert H. Lurie Children's Hospital of Chicago
name: University of Illinois at Chicago
First posted: 2019-12-12
Enrollment: 81
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Top surgery participants will be recruited from plastic surgery practices at Northwestern University, the Ann and Robert H Lurie Children's Hospital of Chicago, and the University of Illinois Chicago. Matched controls will be recruited from the Lurie Children's Hospital Gender and Sex Development Program.

Brief summary: The investigators hypothesize that masculinizing top surgery (e.g., mastectomy and chest masculinization) leads to an improvement in self-report chest dysphoria, gender dysphoria, and gender congruence in assigned-female-at-birth, transgender and non-binary youth and young adults. This is a prospective, observational study that will enroll assigned-female-at-birth, transmasculine spectrum individuals age 13 to 25 years old who are or are not undergoing top surgery. Participants will complete a set of standard of care questionnaires regarding their chest dysphoria (e.g., distress about the chest), gender dysphoria (e.g., distress about a gender identity that does not match assigned sex), and gender congruence (e.g., degree to which an individual feels they are living in their authentic appearance and gender identity). They will complete this same set of questionnaires either three months after their top surgery or three months after the initial set of surveys.


Eligibility criteria: Inclusion Criteria:

* Assigned the female sex at birth
* Affirmed gender identity of male, non-binary, or gender other than female
* English-speaking
* Undergoing top surgery or matches a top surgery participant on age and number of months on testosterone

Exclusion Criteria:

* Non English speaking
* Unable to complete self-report questionnaires

Primary outcomes:
measure: Chest Dysphoria
timeFrame: Three month
Secondary outcomes:
measure: Gender Dysphoria
timeFrame: Three month
measure: Gender Congruence
timeFrame: Three month
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann and Robert H Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
Study officials:
affiliation: Northwestern University
name: Sumanas W Jordan, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06926959: Tricuspid RegurgitAtion rIsk modeL Study (TRAIL Study)
Official title: Tricuspid RegurgitAtion rIsk modeL Study (TRAIL Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tricuspid Regurgitation
Keywords: Tricuspid Regurgitation
all-cause mortality
risk factor
prediction model
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Affiliated Hospital of Guangdong Medical University
name: Second Affiliated Hospital of Shantou University Medical College
name: Eighth Affiliated Hospital, Sun Yat-sen University
name: Zhongshan People's Hospital, Guangdong, China
name: Jieyang People's Hospital
First posted: 2025-04-15
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with tricuspid regurgitation (TR) during hospitalization were enrolled.

Brief summary: This study is a multicenter cohort study including patients diagnosed with tricuspid regurgitation during hospitalization. The primary outcome of the study is all-cause death, and the secondary outcome is cardiovascular events. The prognostic risk factors of patients with tricuspid regurgitation are evaluated, and the prognostic models are constructed through the follow-up observation.


Eligibility criteria: Inclusion Criteria:

* Aged over 18 yrs.
* Patients diagnosed with tricuspid regurgitation during hospitalization.

Exclusion Criteria:

* Patients unable to provide informed consent.

Primary outcomes:
measure: all-cause mortality
timeFrame: Through study completion, an average of 5 years
Secondary outcomes:
measure: Cardiovascular death
timeFrame: Through study completion, an average of 5 years
measure: Heart Failure Hospitalization
timeFrame: Through study completion, an average of 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen Univerity
state: Guangdong
city: Guangzhou
country: China
facility: Third Affiliated Hospital, Sun Yat-Sun University,
state: Guangdong
city: Jieyang
country: China
facility: Jieyang People's Hospital
state: Guangdong
city: Shantou
country: China
facility: Second Affiliated Hospital of Shantou University Medical College
state: Guangdong
city: Shenzhen
country: China
facility: Eighth Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Zhanjiang
country: China
facility: Affiliated Hospital of Guangdong Medical University
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan People's Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT01772459: Paper vs. Internet
Official title: Internet-administered Adolescent Scoliosis Questionnaires Compared With Traditional Pencil and Paper Versions: a Randomized Crossover Design
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Scoliosis
Adolescent
Keywords: Scoliosis
Adolescents
Questionnaire
Reliability
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: iACT - Innovations in Acute Care and Technology
First posted: 2013-01-21
Enrollment: 139
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents with idiopathic scoliosis will be asked to participate during visits to the orthopaedic spine clinic at BC Children's Hospital

Brief summary: Research has shown that questionnaires completed on the internet have the potential to provide more complete and honest data with fewer errors in a more efficient manner than questionnaires completed using the paper and pencil format. Despite the numerous advantages of internet-administered questionnaires, it is important to make sure that the internet questionnaires will yield comparable results to the well-established paper and pencil versions. No one has studied internet administration of scoliosis specific questionnaires in adolescents with scoliosis. The investigators will test whether the internet administration of scoliosis questionnaires is as reliable as the traditional paper and pencil version. The investigators predict that the internet-administered questionnaire will provide the same reliability as the paper-administered questionnaires.


Eligibility criteria: Inclusion Criteria:

* Aged 10-18
* Male or female
* Diagnosis of Adolescent or Juvenile Idiopathic Scoliosis
* Home access to computer and internet
* Capable or oral and written communication in English

Exclusion Criteria:

* Unable to communicate in English

Primary outcomes:
measure: To test the reliability of the internet-administered PODCI and SRS-30 questionnaires in adolescents with idiopathic scoliosis
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Chris Reilly, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05537259: BUMPP: A Study to Better Understand Mood During the Perinatal Period
Official title: BUMPP: A Study to Better Understand Mood During the Perinatal Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Postpartum
Mental Health Issue
Keywords: Pregnancy
Postpartum
Mental Health
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women and their infants

Brief summary: The overall goal of the BUMPP study is to improve our understanding of a range of moods, feelings, and thoughts that women can experience during pregnancy and soon after they give birth. This study will examine how these moods, feelings, and thoughts are related to changes in hormonal and immune health that women experience during and after pregnancy, and to mother-baby relationships and infant development in the early postpartum months.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* 35 weeks pregnant or less
* carrying only one baby (not twins or triplets)
* first time giving birth
* can speak/read/write in English

Exclusion Criteria:

* major medical health condition like a heart, kidney, or liver disease or HIV
* currently taking corticosteroids, progesterone, or immunosuppressive medications that might impact the samples we are taking in this research study
* have regularly used alcohol, tobacco, or recreational drugs (such as marijuana or prescription drugs for non-medical reasons) during pregnancy (regularly means more than a few times total, such as on a monthly, weekly, or daily basis)

Primary outcomes:
measure: Self-report questionnaire measure of depressive symptoms (Edinburgh Postnatal Depression Scale)
timeFrame: 35 weeks of pregnancy through 2 months postpartum
measure: Self-report questionnaire measure of anxiety symptoms (Generalized Anxiety Disorder-7)
timeFrame: 35 weeks of pregnancy through 2 months postpartum
measure: Self-report questionnaire measure of manic symptoms (Highs Scale)
timeFrame: 35 weeks of pregnancy through 2 months postpartum
measure: Self-report questionnaire measure of symptoms of psychosis (subscales of Symptom Checklist-90)
timeFrame: 35 weeks of pregnancy through 2 months postpartum
measure: Mother-infant behavior during 5 min play episode coded using Global Rating Scales
timeFrame: 2 months postpartum
measure: Bayley Scales of Infant Development, 4th edition, to assess infant cognitive development
timeFrame: 2 months postpartum
Secondary outcomes:
measure: Monthly cortisol levels determined from hair sample
timeFrame: 35 weeks of pregnancy through 2 months postpartum
measure: Cytokine levels determined from finger prick blood spot
timeFrame: 35 weeks of pregnancy through 2 months postpartum
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Megan Gunnar, PhD
role: PRINCIPAL_INVESTIGATOR
References: