louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02114216: Nociceptors, Neurotrophic Factors and Cytokine Expression in Gastroesophageal Reflux Disease
Official title: Symptomatic Gastroesophageal Reflux Disease is Associated With Increased TRPV1 and PAR2 mRNA Expression Levels in the Esophageal Mucosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro-esophageal Reflux Disease
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Transient receptor potential vanilloid-1 (TRPV1) receptor and proteinase-activated receptor 2 (PAR2) have been implicated in the mechanism of acid induced inflammation in gastroesophageal reflux disease (GERD). We aimed to evaluate TRPV1 and PAR2 mRNA expression levels in the GERD patients and their relationship with endoscopic findings and reflux symptoms.

Detailed description: All the subjects receive upper GI endoscopy and completed questionnaires about GERD symptoms under the supervision of a well-trained interviewer. Subjects are excluded if there was a history of gastrointestinal surgery, Barrett's esophagus, esophageal motility disorder, duodenal ulcer, benign gastric ulcer or gastroduodenal cancer and if he or she had any history of systemic disease requiring chronic medication (except for hypertension and diabetes mellitus).

The subjects are classified into 3 groups after upper GI endoscopy and completing questionnaires about GERDsymptoms ; ERD(erosive reflux disease), NERD(nonerosive reflux disease) and control group.

Eligibility criteria: Inclusion Criteria:

* subjects who completed upper GI endoscopy and questionnaires about GERD symptoms

Exclusion Criteria:

* a history of gastrointestinal surgery
* Barrett's esophagus
* esophageal motility disorder
* duodenal ulcer
* benign gastric ulcer
* gastroduodenal cancer
* if he or she had any history of systemic disease requiring chronic medication (except for hypertension and diabetes mellitus).

Primary outcomes:
measure: TRPV1, GDNF, and NGF mRNA Expression of Esophageal Mucosa
timeFrame: up to 24weeks
Secondary outcomes:
measure: PAR2 and IL-8 Expression of Esophageal Mucosa
timeFrame: up to 24weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Professor
name: Nayoung Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05851716: Upper Gastrointestinal Endoscopy Reporting System in Improving Report Quality
Official title: A Prospective, Single-arm, Single-center Observational Study to Evaluate the Clinical Effectiveness of an Intelligent Reporting System for the Upper Gastrointestinal Endoscopy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endoscopy, Gastrointestinal
Artificial Intelligence
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is not limited. Patients aim to undergo screening, surveillance, and diagnosis upper gastrointestinal endoscopy will be accessed for eligibility.

Brief summary: The goal of this observational study is to evaluate the effectiveness of an AI-based reporting system for upper gastrointestinal endoscopy. The main question it aims to answer is: Whether the AI-based reporting system can improve the completeness of the reports, which are drafted by endoscopists with the AI assistance. Participants will undergo upper gastrointestinal endoscopy examination as routine. The junior endoscopists will draft the report with the assiatance of the AI system. And the senior and expert endoscopists will draft the report using the traditional reporting system without AI assistance.


Eligibility criteria: Inclusion Criteria:

1. Aged 18 years
2. Aim to undergo screening, surveillance, and diagnosis
3. Undergo sedated EGD
4. Able to read, understand, and sign informed consent

Exclusion Criteria:

1. EGD contraindications
2. Not suitable for sedated endoscopy after anaesthesia evaluation
3. Biopsy contraindications
4. Active upper gastrointestinal bleeding or emergency oesophagogastroduodenoscopy (EGD)
5. Pregnancy
6. Upper gastrointestinal surgery or residual stomach
7. Not suitable for recruitment after investigator evaluation because of other high-risk conditions

Primary outcomes:
measure: Completeness of reporting lesions
timeFrame: one month
Secondary outcomes:
measure: Completeness of report drafting on lesion features
timeFrame: one month
measure: Accuracy of report drafting on lesion features
timeFrame: one month
measure: Reporting time
timeFrame: one month
measure: Completeness of reporting lesions of AI system
timeFrame: one month
measure: Accuracy of report drafting on lesion features of AI system
timeFrame: one month
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
References:
Clinical trial NCT00584116: Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement
Official title: Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Stenosis
Keywords: Aortic Valve Replacement
AVR
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 2
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: Any patient with severe symptomatic calcific aortic stenosis (AS) referred for elective surgical aortic valve replacement.

Brief summary: Prospective, two academic center, non-randomized pilot, acute in-patient study correlating pre-operative imaging studies, intra-operative measurements and intra-operative balloon aortic valvuloplasty (BAV) in patients with degenerative aortic stenosis undergoing surgical aortic valve replacement (SAVR) to understand the requirements (device size and radial strength) of emerging percutaneous heart valve technologies in the treatment of aortic stenosis.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Any patient with severe, symptomatic calcific aortic stenosis (AS) referred for elective surgical aortic valve replacement.

  * Severe AS: aortic valve area (AVA) ≤ 1.0 cm2
  * Symptoms: dyspnea on exertion, heart failure, angina or syncope believed to be secondary to AS

Exclusion Criteria:

* Emergent surgical aortic valve replacement.
* Inability to undergo TTE or TEE intra-operatively.
* Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.

Primary outcomes:
measure: aortic annulus size
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Jason Rogers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04716816: Stripping Massage After Thoracoscopy
Official title: Pain Relief Following Stripping Massage for Rhomboid Myofascial Trigger Points After Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chest Pain
Keywords: Chest pain; Stripping massage; thoracoscopy; trigger points
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital, Yun-Lin Branch
First posted: 2021-01-20
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigated the effects of stripping massage (SM) on myofascial trigger points in the rhomboid after thoracoscopic surgery.

Detailed description: This study investigated the effects of stripping massage (SM) on myofascial trigger points in the rhomboid after thoracoscopic surgery. Sixty patients with chest pain after thoracoscopic surgery were randomized divided into two equal groups (A and B). Group A (n = 100) received conventional analgesics. Group B (n = 100) received SM twice daily in the active trigger points of the rhomboid for two weeks. The visual analogue scale, a pressure algometer, will be used to evaluate patients' pre- and post-treatment statuses.

This study will compare differences between the current traditional method (using analgesics) and the SM for rhomboid myofascial trigger points for post-thoracoscopic chest pain, and analyze the variables generated by the two different methods including demand time of analgesics, acceptance, and differences of visual analogue scale. The results of the study will use scientific data to prove which way is a good way to take into account of the relief of patient's chest pain.

Eligibility criteria: Inclusion Criteria:

* Chest pain with visual analogue scale larger than 3 after thoracoscopic surgery

Exclusion Criteria:

* bleeding tendency

Primary outcomes:
measure: Change From Baseline in Pain Scores on the Visual Analog Scale
timeFrame: baseline, 3 days, one weeks, two weeks, one month
Secondary outcomes:
measure: demand time of analgesics
timeFrame: baseline, 3 days, one weeks, two weeks, one month
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital Research Ethics Committee
Study officials:
affiliation: National Taiwan University Hospital Yunlin Branch
name: Pei-Ming Huang, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04062916: Improvement in Quality of Life and Pain Scores After Laparoscopic Management of Deep Infiltrating Endometriosis
Official title: Improvement in Quality of Life and Pain Scores After Laparoscopic Management of Deep Infiltrating Endometriosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: endometriosis
Lead sponsor: Acibadem Fulya Hastanesi
Sponsor class: NETWORK
First posted: 2019-08-20
Enrollment: 65
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with endometriosis 65 women whose main symptom was pain and who did not respond to medical treatment and underwent endometriosis surgery

Brief summary: This is a retrospective cohort study that evaluates the postoperative pain findings of a consecutive series of laparoscopic surgeries for deep infiltrating endometriosis (DIE).

Detailed description: The study was carried out in university hospitals (Istanbul, Turkey). Patients diagnosed through bimanual gynecologic examination, gynecologic ultrasound or magnetic resonance imaging-confirmed endometrioma and DIE together; who underwent a laparoscopic surgery by a team of gynecologists, colorectal surgeons, and a urologist were retrospectively evaluated. The data were collected in a specific database and analyzed for postoperative pain outcomes through a comparison with preoperative symptoms scored using a visual analogue score (VAS), and the British Society of Gynecologic Endoscopy (BSGE) pelvic pain questionnaire.

Eligibility criteria: Inclusion Criteria:

* Patients with deep infiltration endometriosis and endometrioma diagnosed through bimanual gynecologic examination, gynecologic ultrasound or through laparoscopically confirmed endometrioma and DIE together;
* DIE with bowel involvement that required shaving or segmental resection for colorectal lesions and nodules;
* Who completed the VAS score and BSGE questionnaire;
* Follow-up period of at least 3 months;
* Patients resistant to medical therapy (NSAIDs, OCPs, levonorgestrel-releasing intrauterine device (IUD), and progesterone) or refuse to use medical therapy.

Exclusion Criteria:

\*Any other endometriosis patient that do no meet the inclusion criteria

Primary outcomes:
measure: Quality of Life after endometriosis surgery
timeFrame: 7 years
measure: Pain levels after endometriosis surgery
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Fulya Hospital
Study officials:
affiliation: Acibadem Fulya Hospital
name: Ercan Bastu, MSc, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00871416: Localisation of Potential Insulin Deposits in Normal Weight and Obese Diabetics Using 6 mm and 12 mm Long Needles
Official title: Localisation of Potential Insulin Deposits in Normal Weight and Obese Diabetics Using 6 mm and 12 mm Long Needles. Furthermore, the Thickness of Cutis/Subcutis Is Measured on Recommended Insulin Injection Sites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Delivery Systems
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-03-30
Enrollment: 48
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: This trial is conducted in Europe. The primary aim of this clinical trial is to locate and compare simulated insulin injections (injections of sterile atmospheric air) in normal weight and obese patients with diabetes mellitus. Injections are done with 6 mm and 12 mm needles with and without lifting of skin fold at different injection sites.


Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus
* Use NovoPen®, NovoPen® 1.5, NovoPen® 3, NovoLet® 1.5 or NovoLet® 3 for at least 3 months
* Body mass index (BMI) for normal weight between 19-25 kg/m2
* Body mass index (BMI) for obese between 25-33 kg/m2

Exclusion Criteria:

* Pregnancy or plans thereof
* Local reactions on injection sites
* Acute, severe infection diseases
* Coagulation disorders

Primary outcomes:
measure: Location of the injected sterile, atmospheric air
timeFrame: after 4 injections at visit 1 and 2, respectively
Secondary outcomes:
measure: Cutis/subcutis thickness on 14 recommended injection sites
Other outcomes:
Locations:
city: Århus
country: Denmark
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06526416: The Objective is to Evaluate the Anterior Chamber Angle After BANG Procedure, the Study Will Recruit 12 Patients Who Will Undergo Planned Goniectomy for Uncontrolled POAG, Anterior Segment OCT Scan Will Be Used to Evaluate the Anterior Chamber Postoperatively.
Official title: Anterior Chamber Angle Changes After Bent Angle Needle Goniectomy Procedure, Anterior Segment OCT Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Primary Open Angle Glaucoma
Glaucoma
Keywords: Bent angle needle goniectomy
anterior segment optical coherence tomography
Primary open angle glaucoma
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients presenting to Benha University Hospitals with open angle glaucoma.

Brief summary: Evaluation of anterior segment using anterior segment optical coherence tomography in patients undergoing planned bent angle needle goniectomy procedure for uncontrolled open angle glaucoma.


Eligibility criteria: Inclusion Criteria:

1. Patients who are being treated for primary open angle glaucoma using eye drops.
2. Patients with uncontrolled intraocular pressure \&gt;21 mm Hg
3. All recruited patients should have open anterior chamber angles demonstrated on gonioscopy examination.
4. Patients giving consent for operation and follow up

Exclusion Criteria:

* 1- Pseudophakic patients 2- Advanced glaucoma patients. 3- Patients who are to have trabeculectomy or laser trabeculoplasty. 4- Patients with secondary glaucoma. 5- Patients who are unable to give consent for surgery or follow up. 6- Patients with previous trauma to the eye

Primary outcomes:
measure: To detect the changes in anterior chamber angle using Anterior segment OCT after BANG goniectomy
timeFrame: 12 weeks after the day of surgery.
Secondary outcomes:
measure: To detect any correlation between the post-op anterior chamber angle changes and the intraocular pressure.
timeFrame: 12 weeks after the day of surgery.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00002416: Comparing FTC and Lamivudine in HIV-Infected Patients on a Stable Anti-HIV Drug Combination
Official title: A Randomized, Open-Label Equivalence Study of FTC Versus Lamivudine in Patients on a Stable Triple Antiretroviral Therapy Regimen Containing Lamivudine, Stavudine or Zidovudine, and a Protease Inhibitor or Non-Nucleoside Reverse Transcriptase Inhibitor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV-1
Zalcitabine
Zidovudine
Stavudine
HIV Protease Inhibitors
Lamivudine
RNA, Viral
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two anti-HIV drugs, FTC and lamivudine (3TC), when given with either stavudine (d4T) or zidovudine (ZDV) and one other anti-HIV drug.

Detailed description: Patients are randomized to one of two arms in a 2:1 ratio (weighted to Arm 1). Arm 1: Replace lamivudine with FTC while continuing on current background regimen. Arm 2: Continue on current lamivudine-containing regimen. Patients are further stratified based upon screening plasma HIV-1 RNA and background therapy. Stratum 1: Less than 50 copies/ml; PI (protease inhibitor) in treatment regimen. Stratum 2: Less than 50 copies/ml; NNRTI (nonnucleoside reverse transcriptase inhibitor) in treatment regimen. Stratum 3: 50-400 copies/ml; PI in treatment regimen. Stratum 4: 50-400 copies/ml; NNRTI in treatment regimen. Clinic visits occur at regular intervals throughout the 48-week study period to determine viral load.

Eligibility criteria: Inclusion Criteria

You may be eligible for this study if you:

* Are at least 18 years old.
* Are HIV-positive.
* Have a viral load below 400 copies/ml.
* Agree to use a barrier method of birth control (such as condoms) during the study.
* Have taken one of the following anti-HIV drug combinations: (1) 3TC plus d4T or ZDV plus a protease inhibitor (PI) for at least 8 weeks, or (2) 3TC plus d4T or ZDV plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) for at least 12 weeks. (You must show the date you started on this combination.)

Exclusion Criteria

You will not be eligible for this study if you:

* Have had severe diarrhea or have been unable to eat as much as you need due to nausea, vomiting, or stomachache within 30 days of study entry.
* Have had a serious medical event within 30 days prior to study entry.
* Are taking hydroxyurea.
* Have Grade 2 or higher peripheral neuropathy.
* Abuse alcohol or drugs.
* Are pregnant or breast-feeding.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Petersburg
country: United States
facility: Dr Robert Wallace
state: Florida
city: Great Neck
country: United States
facility: North Shore Univ Hosp
state: New York
Study officials:
name: Charles van der Horst
role: STUDY_CHAIR
References:
Clinical trial NCT00689416: Effects of Crestor on Inflammation of Atherosclerotic Plaques
Official title: Exploratory Study of New Imaging Biomarkers for Measurement of Carotid Plaque Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Atherosclerosis
Inflammatory Activity in Carotid Arteries
Keywords: imaging biomarkers
MRI
FDG-PET/CT scanning
Crestor
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary aim of this study is to investigate the effect of 40 mg dose of rosuvastatin on carotid plaque inflammation measured with MRI and PET scanning, to evaluate whether these techniques are promising for future proof of principle studies. A number of patients will receive placebo as a control.


Eligibility criteria: Inclusion Criteria:

* Subjects with a non-calcified plaque of at least 2 mm over an at least 6 mm length on first MR scan with an uptake of contrast agent on the dynamic MRI scan
* Signed written Informed Consent.
* Healthy men 18 - 70 years, women 60 - 70

Exclusion Criteria:

* Use of a statin within six months before randomization.
* Use of lipid altering medication other than statins within the last six months.
* Clinical evidence of metabolic or vascular disease requiring statin or other lipid lowering pharmacological or non-pharmacological treatment.
* Total cholesterol \> 8, LDL-C \> 6 or TG \> 6 mmol/L at enrolment

Primary outcomes:
measure: Comparison between the active and the placebo group regarding changes in MRI contrast enhancement in terms of the transfer constant (Ktrans) for the carotid region
timeFrame: MRI scan at enrolment visit and within group after 3 months.
Secondary outcomes:
measure: Comparison between the active and the placebo group regarding changes in MRI contrast enhancement measured as fractional plasma volume (Vp) and changes in 18FDG uptake in terms of standardised uptake value (SUV), respectively
timeFrame: MRI scan at enrolment visit and within group after 3 months. 18FDG at randomisation visit (baseline) and within group after 3 months treatment.
measure: Change in carotid MRI contrast enhancement in terms of Ktrans and Vp.
timeFrame: At enrolment visit and within group after 3 months treatment.
measure: Change in 18FDG uptake in terms of SUV.
timeFrame: At randomisation visit (baseline) and within group after 3 months treatment.
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: Uppsala University Sweden
name: Håkan Ahlström, MD, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D Mölndal
name: Maria Leonsson-Zachrissson, MD, Study Physician
role: STUDY_CHAIR
References: