louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04642690: Nitrates and IL-8 in Barrett's Esophagus
Official title: The Association Between Nitrates, Nitrosylated Proteins, and Interleukin-8 in Barrett's Esophagus and Esophageal Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Barrett Esophagus
Esophageal Adenocarcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult individuals scheduled for clinically indicated EGD procedure. Subjects with normal squamous epithelium, erosive esophagitis, or varying degrees of Barrett's Esophagus may be enrolled.

Brief summary: The purpose of this study is to determine if nitrates and IL-8 (which are found in food and throughout the body regulating stomach acidity) play a role in Barrett's Esophagus and/or Esophageal Adenocarcinoma severity and if screening for these biomarkers can help predict patients that are more at risk for developing worsening disease.


Eligibility criteria: Inclusion Criteria:

- Patients undergoing a clinicallly-indicated Esophagogastroduoedoscopy (EGD).

Exclusion Criteria:

* Comorbid inflammatory medical condition.
* Use of antiinflammatory (aspirin and NSAIDs) or immunosuppressants over the past 1 week.
* Use of nitrate containing medication in the past 1 week.
* Consumption of nitrate rich foods in preceding 24 hours.
* Known allergy to meat or nitrates

Primary outcomes:
measure: Nitrate Levels
timeFrame: Baseline
measure: Serum and Tissue Biomarkers
timeFrame: Baseline
Secondary outcomes:
measure: Biomarkers and disease progression
timeFrame: Baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Cadman Leggett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05901090: Comparing the Effects of M-TAPA and TAP Block on Postoperative Analgesia in TAH
Official title: Comparing the Effects of Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) and Transerversus Abdominis Plane Block (TAP) on Postoperative Pain Scores and Total Analgesic Consumption in Patients Ongoing Total Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: m-tapa
tap block
total abdominal hysterectomy
regional anesthesia
postoperative pain
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 45
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Aim is to compare the postoperative analgesic efficacy of M-TAPA block and TAP block and their effect on opioid consumption in patients undergoing open total abdominal hysterectomy (TAH) surgery.

Detailed description: There were three randomized groups: Group M (M-TAPA block) (n=15), Group T (TAP block) (n=15) and Group C (no block) (n=15). All patients had standard general anesthesia. Group M had bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery. Group T patients had TAP block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery. Group Control had only tramadol for postoperative pain. Numerical rating scale (NRS) was used to assess postoperative pain on 1st, 6th, 12th and 24th hour after the surgery. Total tramadol consumption was calculated.

Eligibility criteria: Inclusion Criteria:

* Adult patients older than 35 years of age who underwent open total abdominal hysterectomy under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

Exclusion Criteria:

* Patients who did not give consent,
* patients with coagulopathy,
* patients with signs of infection at the block application site,
* patients using anticoagulants,
* patients with local anesthetic drug allergies,
* patients undergoing laparoscopic surgery,
* patients with unstable hemodynamics,
* patients who could not cooperate during postoperative pain assessment

Primary outcomes:
measure: Comparing the numerical rating scale scores
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Comparing total tramadol consumption
timeFrame: Postoperative 24 hours
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Sivas Cumhuriyet University
Study officials:
affiliation: Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
name: Oğuz Gündoğdu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01139190: Clinical Trial Evaluating Gastrointestinal Damage Following Administration PL3100 or Naproxen in At-Risk Adults
Official title: A Phase 2 Clinical Trial Evaluating the Incidence of Upper Gastrointestinal Mucosal Damage Following Administration of Either PL3100 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated GI Damage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastroduodenal Ulcerations
Erosion
Keywords: NSAID-induced gastroduodenal ulcerations or erosion
Lead sponsor: PLx Pharma
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2010-06-08
Enrollment: 77
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of PL3100 versus Naproxen in normal healthy volunteers.


Eligibility criteria: Inclusion Criteria (Selected)

* Male and female healthy adult subjects

Exclusion Criteria (Selected)

* Subject has protocol specified significant medical history.
* Subject is currently participating, or has participated within 30 days prior to study entry, in an investigational drug study.
* Subject has hypersensitivity or contraindications to naproxen, ibuprofen, or other NSAID.

Primary outcomes:
measure: Degree of GI Injury at Day 15
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Center For Clinical Research
state: Texas
Study officials:
References:
Clinical trial NCT06508190: Free Walking Exercise in Obstructive Sleep Apnea Patients With Non-alcoholic Fatty Liver
Official title: Impact of Free Walking Exercise on Obstructive Sleep Apnea Patients With Non-alcoholic Fatty Liver on Liver Enzymes, Degree of Exhaustion, and Quality of Sleep
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Non-alcoholic Fatty Liver
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Forty patients suffering from obstructive sleep apnea are divided into two groups: one for CPAP and the other for CPAP and free walking program.
Primary purpose: TREATMENT

Brief summary: Research evaluating the impact of continuous positive airway pressure (CPAP) \& walking exercise on fatigue severity, liver enzymes and sleeping quality in patients with non-alcoholic fatty liver disease who also have obstructive sleep apnea. Forty patients are divided into two groups: twenty patients CPAP and other twenty patients for CPAP and walking program .

Detailed description: Research evaluating the impact of continuous positive airway pressure (CPAP) \& walking exercise on fatigue severity, liver enzymes and sleeping quality in patients with non-alcoholic fatty liver disease who also have obstructive sleep apnea. Forty patients are divided into two groups: twenty patients CPAP and other twenty patients for CPAP and walking program .

Eligibility criteria: Inclusion Criteria:

* The body mass index (BMI) \< 35 kg/m2.
* obstructive sleep apnea patients with fatty liver

Exclusion Criteria:

* liver transplantation , alcoholic fatty liver, antipsychotic medications, bariatric surgery; cardiac , renal problem , liver cancer ; pregnancy,orthopedic problems, systemic diseases, respiratory dysfunctions, neurological dysfunctions.

Primary outcomes:
measure: Alanine tranaminase
timeFrame: it will be measured after 12 weeks
Secondary outcomes:
measure: Asparatate transamianse
timeFrame: it will be measured after 12 weeks
measure: Body mass index
timeFrame: it will be measured after 12 weeks
measure: triglycerodes
timeFrame: it will be assessed after 12 weeks
measure: Pittsiburg sleeping quality index
timeFrame: it will be assessed after 12 weeks
measure: fatigue severity scale
timeFrame: it will be assessed after 12 weeks
measure: Epworth sleepness scale
timeFrame: it will be assessed after 12 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ahram canadian university
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University (ACU), Giza, Egypt
name: El-Hadidy Hagar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04130490: The Heidelberg Engineering ANTERION Anterior Segment Cornea and IOL Precision and Agreement Study
Official title: The Heidelberg Engineering ANTERION Anterior Segment Cornea and IOL Precision and Agreement Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Healthy Eye
Cornea Abnormality
Post-Keratorefractive Surgery
IOL
Lead sponsor: Heidelberg Engineering GmbH
Sponsor class: INDUSTRY
First posted: 2019-10-17
Enrollment: 176
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eyes with normal anterior segment and crystalline lens; eyes with cataract of grade 1.5 or higher; eyes with abnormal corneal shape; eyes with status post-keratorefractive surgery and eyes without a crystalline lens

Brief summary: This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess anterior segment parameters with the ANTERION


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 the following eye pathology status for the individual eye population:

   * A. Eye with normal anterior segment and crystalline lens
   * B. Eye with a cataract of grade 1.5 or higher
   * C. Eye with abnormal corneal shape
   * D. Eye with status post-keratorefractive surgery
   * E. Eye without a crystalline lens

Exclusion Criteria:

1. Subjects which were enrolled in the B-2018-1 clinical study
2. Active infection or inflammation in the study eye
3. Insufficient tear film or corneal reflex
4. Physical inability to be properly positioned at the study devices or eye exam equipment
5. Rigid contact lens wear 2 weeks prior to imaging
6. Soft lenses worn within one hour prior to imaging
7. With the following eye pathology status for the individual eye population:

   * A. Eye meets eligibility criteria for eye populations B, C, D or E
   * B. Eye meets eligibility criteria for eye populations C,D or E
   * C. Eye meets eligibility criteria for eye populations D or E
   * E. Eye with abnormal corneal shape (except status post-keratorefractive surgery)

Primary outcomes:
measure: Precision and Agreement 1
timeFrame: 1 day
measure: Precision and Agreement 2
timeFrame: 1 day
measure: Precision and Agreement 3
timeFrame: 1 day
measure: Precision and Agreement 4
timeFrame: 1 day
measure: Precision and Agreement 5
timeFrame: 1 day
measure: Precision and Agreement 6
timeFrame: 1 day
measure: Precision and Agreement 7
timeFrame: 1 day
Secondary outcomes:
measure: Adverse Events Rate
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:
Clinical trial NCT04909190: Saline Flush to Reduce the Amount of Residual Air Inside a Stentgraft Delivery System
Official title: A Randomized Trial of an Increased Saline Flush Protocol to Reduce the Amount of Residual Air Inside a Stentgraft Delivery System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Aneurysm
Aortic Aneurysm, Thoracic
Aortic Diseases
Aortic Arch Aneurysm
Stroke
Keywords: endovascular
evar
tevar
stentgraft
de-airing
Lead sponsor: Semmelweis University Heart and Vascular Center
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Non-randomized studies have shown that de-airing of the delivery system with an increased volume of saline may be associated to a decrease in periprocedural stroke during thoracic endovascular aortic repair. This study is designed to provide evidence that 4xIFU-dose volume of saline flush vs. standard IFU-dose saline flush is associated to a decrease in the amount of intra-sac air detected on the first follow-up imaging after EVAR.


Eligibility criteria: Inclusion Criteria:

* endovascular aortic repair of an abdominal aortic aneurysm using either of these devices: Terumo/Bolton Treo, Terumo Anaconda, Cook Zenith Alpha Abdominal

Exclusion Criteria:

* concomitant use of an iliac bifurcation device due to insufficient common iliac landing zone on either side

Primary outcomes:
measure: Air volume
timeFrame: within 7 days after index procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Heart and Vascular Center
Study officials:
affiliation: Dept. of Interventional Radiology, Heart and Vascular Center, Semmelweis University
name: Csaba Csobay-Novák, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04086290: National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients
Official title: Oligomet-DK. National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer Metastatic
Keywords: radiotherapy
prostatectomy
androgen deprivation therapy
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective, open label phase 2 clinical trial assessing safety, complications and feasibility of radical prostatectomy (RARP) plus local stereotactic body radiotherapy (SBRT) to bone metastases in combination with short-term medical castration to a select population of prostate cancer patients with oligometastatic disease.


Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older and willing and able to provide informed consent;
2. Stage cT1 ≤ cT3b, Clinical resectable
3. Gleason score ≥ 6
4. M1

   1. ≤ 3 bone metastases localized to the spine, pelvis or humeral/femoral bones as evaluated by 68Ga-PSMA PET/CT and magnetic resonance imaging (MRi)
   2. Absence of PSMA uptake in retroperitoneal lymph nodes, (outside the anatomical region of extended pelvic lymph node dissection as described in the European Association of Urology (EAU) guidelines.
   3. No visceral metastasis
   4. Metastases suitable for stereotactic body radiotherapy
   5. Non symptomatic bone lesions
5. Eligible for surgery

Exclusion Criteria:

1. Prior curative intended treatment for prostate cancer
2. Prior androgen deprivation therapy (ADT)
3. History of another invasive cancer within 3 years of screening, with the exception of fully treated cancers with a remote probability of recurrence. The medical monitor and investigator must agree that the possibility of recurrence is remote for exceptions.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status \> 1
5. Evaluated not able to fulfil the study protocol.
6. Contraindications against MRI

Primary outcomes:
measure: Proportion of men with Grade ≥ 3 adverse events the first year
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of men achieving prostatic specific antigen (PSA) < 0.1 ng/ml
timeFrame: 1 year
measure: Feasibility of radical prostatectomy in the oligometastatic setting
timeFrame: 1 year
Other outcomes:
measure: Time to castrate resistance (TCR)
timeFrame: 5 yrs
measure: Quality of life (FACT-P-DK)
timeFrame: 5 yrs
measure: Number of participants with Interventions on lower or upper urinary tract
timeFrame: 5 yrs
Locations:
city: Herlev
country: Denmark
facility: Herlev and Gentofte Hospital
Study officials:
affiliation: Herlev and Gentofte Hospital
name: Peter B Østergren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06626490: Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant Variants
Official title: Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant Variants
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Revision Total Hip Arthroplasty
Periprosthetic Fracture of Hip
Keywords: Patient-reported outcomes
Clinical performance and safety
Total hip arthroplasty implantation
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2024-10-03
Enrollment: 120
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: Patients with indication of a hip revision

Brief summary: The study design is confirmative for non-inferiority of the functional outcome of the implants and is intended to examine the safety and performance of the Prevision hip stem. The study is an observational post-market clinical follow-up study, and the study sites chose the stem variant depending on their own routine and indication.

Detailed description: Generally, the advantage of the Prevision implant family is that all implant variants can be implanted with basically the same instrumentation, which makes it easier to switch to another variant. All implant variants will be available at the study sites and switching between the variants in the study will be encouraged.

The aim of the study is to prove the non-inferiority of the OHS functional outcome after two years to the predecessor implant generation, and comparable revision hip stems. In addition, the patient groups treated with the different variants, and outcome of these subgroups will be descriptively compared.

Eligibility criteria: Inclusion Criteria:

* Revision hip arthroplasty patients treated with a Prevision hip stem
* Written patient informed consent
* Patients are able to attend at follow-up examinations

Exclusion Criteria:

* Patients \< 18 years at surgery
* Pregnancy at implantation
* Patients held in a custodial setting
* Patients in a relationship of dependence on the sponsor, the clinic or the investigator

Primary outcomes:
measure: Functional outcome of the hip revision surgery
timeFrame: after two years
Secondary outcomes:
measure: Kaplan-Meier survival
timeFrame: after two years
measure: EQ-5D-5L Quality of Life
timeFrame: visits after 2 and 5 years
measure: Complications
timeFrame: visits after 2 and 5 years
measure: Patient satisfaction
timeFrame: visits after 2 and 5 years
measure: Pain (VAS Score)
timeFrame: visits after 2 and 5 years
measure: Radiology: Hip stem subsidence
timeFrame: visits after 2 and 5 years
measure: Qualitative radiologic assessment
timeFrame: visits after 2 and 5 years
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Orthopädische Kliniken im Annastift, MHH, Anna-von-Borries-Str. 1-7
Study officials:
affiliation: Orthopädische Kliniken im Annastift, MHH
name: Henning Windhagen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00795990: Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants
Official title: Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patent Ductus Arteriosus
Keywords: Efficacy of early vs late use of ibuprofen for PDA closure
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2008-11-24
Enrollment: 350
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature infants born weighing less than 1200 gms with echo confirmed PDA

Brief summary: This is a retrospective chart review to look at the timing of using indomethacin and ibuprofen for PDA closure for infants admitted into the NICU of the University of Utah Hospital from 1/2007-8/2008. The purpose is to compare the outcomes of medical intervention in preterm infants if intervention occurs day of life 4 or less, or day of life 5 or greater, with the birthdate being counted as day of life 1.

Detailed description: This is a retrospective chart review to look at the timing of using indomethacin and ibuprofen for PDA closure for infants admitted into the NICU of the University of Utah Hospital from 1/2007-8/2008. The purpose is to compare the outcomes of medical intervention in preterm infants if intervention occurs day of life 4 or less, or day of life 5 or greater, with the birthdate being counted as day of life 1. All infants born less than 1200 gms will be evaluated for whether or not an echocardiogram was done. If an echocardiogram was done that showed a PDA, data will be collected as to what medical interventions were done, at what age, and what were the results of the medical intervention. Infants will be stratified into birthweights \<800 gm and 800-1200 gm.

Eligibility criteria: Inclusion Criteria:

* birth weight less than 1200 gm

Exclusion Criteria:

* none

Primary outcomes:
measure: Early versus Late Medical Treatment of PDA
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Gary M Chan, MD
role: PRINCIPAL_INVESTIGATOR
References: