louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03685799: Impact of Histologic Concordance Between Biopsies and the Endoscopic Resection Specimen, in the Treatment of Barrett's Esophagus in Dysplasia, on the Recurrence of Dysplasia
Official title: Impact of Histologic Concordance Between Biopsies and the Endoscopic Resection Specimen, in the Treatment of Barrett's Esophagus in Dysplasia, on the Recurrence of Dysplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barretts Esophagus With Dysplasia
Keywords: Barretts Esophagus
Dysplasia
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 18
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 DHG on Barrett's esophagus on endoscopic biopsies followed by endoscopic resection.

Brief summary: Influence of histological concordance on the risk of recurrence:

the histological concordance being the comparison between the biopsies and the endoscopic resection piece and its concordant response rate.

Detailed description: Influence of histological concordance on the risk of recurrence:

the histological concordance being the comparison between the biopsies and the endoscopic resection piece and its concordant response rate.

Eligibility criteria: Inclusion Criteria:

* patients with DHG on Barrett's esophagus on endoscopic biopsies followed by endoscopic resection.

Exclusion Criteria:

-

Primary outcomes:
measure: Influence of histological concordance on the risk of recurrence
timeFrame: 1 day
Secondary outcomes:
measure: Identification of histological factors of recurrence.
timeFrame: 1 day
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
state: Bouches-du Rhône
Study officials:
References:
citation: Godat S, Caillol F, Autret A, Bories E, Pesenti C, Ratone JP, De Cassan C, Poizat F, Giovannini M. Endotherapy in case of relapse of neoplastic Barrett's esophagus after successful initial endoscopic resection. Surg Endosc. 2017 Sep;31(9):3703-3710. doi: 10.1007/s00464-016-5409-5. Epub 2017 Jan 11.
Clinical trial NCT06834399: TATE and KN046 in MCRC
Official title: Phase IIA Clinical Trial of Intra-arterial Administration of Tirapazamine Followed by Transarterial Embolization （TATE）and KN046 for the Treatment of Advanced Colorectal Cancer with Liver Metastasis (MSS/pMMR)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colorectal Cancer with Hepatic Metastases
Keywords: Colorectal Cancer
Liver Metastasis
Tirapazamine
KN046 (PD-L1/CTLA-4 Bispecific Antibody)
Lead sponsor: Zhejiang Raygene Pharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
First posted: 2025-02-19
Enrollment: 42
Sex: ALL
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 single-arm, multicenter, Phase IIA study of Intra-arterial Administration of Tirapazamine followed by Transarterial Embolization (TATE) and KN046 (recombinant humanized anti-PD-L1/CTLA-4 bispecific single-domain antibody Fc fusion protein injection) in patients with liver metastases from colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Liver metastatic MSS/pMMR-mCRC;
* mCRC progressed on at least two lines of standard chemotherapy;
* Measurable disease;
* ECOG 0-1;
* Adequate organ function

Exclusion Criteria:

* Prior organ transplantation;
* Oxygen saturation less than 92% in room air;
* Prior autoimmune disorder;
* Major GI bleeding in the last 2 months;
* Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody therapy, or any other antibody or drug that specifically targets T-cell co-stimulation or immune checkpoint pathways.

Primary outcomes:
measure: ORR
timeFrame: 24 months
measure: OS
timeFrame: 24 months
Secondary outcomes:
measure: DCR
timeFrame: 24 months
measure: PFS
timeFrame: 24 months
measure: survival rates
timeFrame: 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT01345799: A Study of TRK-170 for the Treatment of Crohn's Disease
Official title: A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Crohn's Disease Activity Index
Crohn's Disease
Inflammatory Bowel Disease
Lead sponsor: Toray Industries, Inc
Sponsor class: INDUSTRY
First posted: 2011-05-02
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In Crohn's Disease Patients

* To evaluate the efficacy of TRK-170
* To evaluate the PK characteristics of TRK-170
* To assess the safety of TRK-170


Eligibility criteria: Inclusion Criteria:

* Patient has a diagnosis of Crohn's Disease before screening
* Patient has stable disease activity

Exclusion Criteria:

* Patient has had a clinically significant illness prior to screening
* Patient with clinically significant deviations in laboratory values

Primary outcomes:
measure: Crohn's Disease Activity Index
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Belgium
country: Belgium
facility: Belgium
city: Bulgaria
country: Bulgaria
facility: Bulgaria
city: Czech Republic
country: Czech Republic
facility: Czech Republic
city: France
country: France
facility: France
city: Hungary
country: Hungary
facility: Hungary
city: Latvia
country: Latvia
facility: Latvia
city: The Netherlands
country: Netherlands
facility: The Netherlands
city: Norway
country: Norway
facility: Norway
city: Poland
country: Poland
facility: Poland
city: Romania
country: Romania
facility: Romania
city: Serbica
country: Serbia
facility: Serbia
city: Sweden
country: Sweden
facility: Sweden
city: Ukraine
country: Ukraine
facility: Ukraine
Study officials:
References:
Clinical trial NCT05765799: Evaluation of Patient Information in Interventional Radiology.
Official title: Evaluation of Patient Information in Interventional Radiology.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patient Satisfaction
Keywords: interventional radiology
Information
videos
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient who receives a consultation before an interventional procedure will be included.

Brief summary: Interventional radiology is developing. Patient information modalities are also evolving, in particular information videos.

The aim of this work is therefore the evaluation of patient information in interventional radiology


Eligibility criteria: Inclusion Criteria:

* Any patient who receives a consultation before an interventional procedure.

Exclusion Criteria:

* None

Primary outcomes:
measure: To evaluate effectiveness of each patient information tool by Consultation with the interventional radiologist
timeFrame: Year : 2
measure: To evaluate Effectiveness of each patient information tool by Consultation with another doctor who explained the procedure
timeFrame: Year : 2
measure: To evaluate Effectiveness of each patient information tool by Explanatory videos
timeFrame: Year : 2
measure: To evaluate Effectiveness of each patient information tool by Patient information sheet
timeFrame: Year : 2
measure: To evaluate Effectiveness of each patient information tool by Posters in the consultation room
timeFrame: Year : 2
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Sylvain GRANGE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01007799: Vitamin D for Chronic Sinusitis
Official title: A Randomized, Clinical Trial of a Novel Immunotherapy for Chronic Sinusitis: Vitamin D
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Sinusitis
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2009-11-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine if vitamin D improves the symptoms of chronic sinusitis.


Eligibility criteria: Inclusion Criteria:

* African American (4 grandparents with AA ancestry)
* Age\>18 years
* Diagnosis of chronic sinusitis

Exclusion Criteria:

* Women of childbearing potential not utilizing contraception
* Subjects with contraindications to vitamin D therapy
* History of nephrolithiasis, hypercalcemia, sarcoidosis, recent (3 month) hospitalization
* Use of immunosuppressants/medications that interfere with vitamin D metabolism (e.g., phenytoin and carbamazepine)
* Malignancy
* Kidney, gastrointestinal, or liver disorders
* Immunodeficiency
* Morbid obesity (BMI\>35 kg/m2)
* Changes to medications for 6 months prior to study entry

Primary outcomes:
measure: score on the Sinonasal Outcome Test-22 (SNOT-22)
timeFrame: study onset, mid-point and conclusion
Secondary outcomes:
measure: Quality of life as measured by SF-36
timeFrame: At entry and at completion of study
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Jayant Pinto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01982799: Local Anesthesia and Analgesics in Endodontic Pain
Official title: Local Anesthesia and Analgesics in Post-Operative Endodontic Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Odontalgia
Keywords: Endodontic treatment, analgesics, anesthesia, post-operative pain
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: For patients with a toothache, is pain relief after root canal procedure improved using long acting local anesthetic and analgesics? The purpose of this clinical trial is the investigate the effect of long acting local anesthetic with 1 of 4 oral medication groups, on post-operative endodontic pain.

Detailed description: Patients (n=220) presenting to the University of Minnesota Endodontic clinic, with moderate to severe pain from toothache requiring root canal treatment ,will be invited to participate in the study. The endodontic treatment is NOT part of the research. Patients will complete pain evaluation forms and take 2 doses of prescribed medication. Normally after a root canal procedure, patients will be suggested to take over-the-counter ibuprofen if needed, or prescribed an analgesic if they are having severe pain. We will be randomizing patients in double blind manner to receive regular or long acting local anesthesia and post-op medications (placebo or 1 of 3 analgesics), with the patient evaluating their pain before starting root canal (pre-treatment pain), after root canal, after analgesics and during the following day.

Eligibility criteria: Inclusion Criteria:

18-65 y.o. American Society of Anesthesiologists physical classification I or II Can understand and complete pain evaluation forms tooth pain (\>3 out of 10) needing root canal Ability to read and provide informed consent Must be able to swallow tablets

Exclusion Criteria:

Allergy/intolerance to analgesics (ibuprofen, naproxen, vicodin) Patients who are pregnant Patients currently on pain medications for an unrelated condition Patients unwilling to fill out pain scales Liver or kidney disease Unable to understand and complete consent form and pain evaluation forms

-

Primary outcomes:
measure: Effect of long acting anesthesia and analgesics on endodontic pain
timeFrame: 36 hours
Secondary outcomes:
measure: Effect of gender and age on post-operative endodontic pain treatment
timeFrame: 36 hours
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota School of Dentistry
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Walter Bowles, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05377099: Evaluation of the Change in the DA Ratio, IR and SSI as Parameters of Corneal Biomechanics Post Different LVC Procedures
Official title: Evaluation of the Change in the Deformation Amplitude Ratio, Integrated Radius and Stress Strain Index as Parameters of Corneal Biomechanics Post Different Laser Vision Correction Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Biomechanics
Keywords: CORVIS - Corneal Biomechanics
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the study, The Investigators will compare the participates' corneal biomechanical properties including:

Deformation Amplitude ratio (Da Ratio) Integrated Radius (IR) Stress strain index (SSI)

All measurements will be taken before and after 3 months of LVC.

Detailed description: Each Participant will undergo preoperative pentacam and corvis scan for his eyes and the 3 months post operative.

The participants are divided into 3 groups, one who underwent LASIK, one PRK and one Femto LASIK.

Collected data will before and after surgery will be compared in each arm and then the 3 arms will be compared together.

Eligibility criteria: Inclusion Criteria:

* • Age range 18 - 40 years.

  * Normal eyes with normal tomographic indices.
  * Patients with maximum mean refractive spherical equivalent (MRSE) of -7.00 diopters and with maximum astigmatism of -3.00 diopters.

Exclusion Criteria:

* • Patients with any other coexisting corneal diseases.

  * Keratoconus eyes.
  * Eyes with previous refractive corneal surgery.
  * Patients with increased intraocular pressure.

Primary outcomes:
measure: Evaluation of the changes in DA ratio, integrated radius and SSI before and after LVC
timeFrame: 3-6 months post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Mohamed Hosny
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Mohamed Anis
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Wessam Salem
role: STUDY_CHAIR
affiliation: Research institute of Ophthalmology
name: Mohamed ELnaggar
role: STUDY_DIRECTOR
References:
Clinical trial NCT04786899: Sleep & Postoperative Delirium in Hispanic/ Latino Patients After Cardiothoracic Surgery
Official title: Sleep & Postoperative Delirium in Hispanic/ Latino Patients After Cardiothoracic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium in Old Age
Sleep Disturbance
Circadian Rhythm Sleep Disorder
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 14
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hispanic/Latino patients scheduled for cardiothoracic surgery at the University of Miami.

Brief summary: The purpose of this research is to study pre-operative sleep problems and delirium in Hispanic/Latino patients after heart and lung surgery.


Eligibility criteria: Inclusion Criteria:

1. Self identify as Hispanic/Latino or preferred language as Spanish
2. Undergoing scheduled elective and urgent cardiothoracic surgery
3. 50 years of age and older

Exclusion Criteria:

1. Inability to consent
2. preferred language other than English, Spanish or Portuguese
3. emergency surgery
4. anticipated discharge \< 48 hours
5. Individuals \< 50 years of age
6. Pregnant women
7. Prisoners

Primary outcomes:
measure: Incidence of postoperative delirium in Hispanic/Latino patients after cardiothoracic surgery
timeFrame: Up to 7 days post surgery.
Secondary outcomes:
measure: Percentage of participants with preoperative sleep disturbance
timeFrame: Up to 7 days before surgery
measure: Pittsburgh Sleep Quality Index (PSQI) score
timeFrame: baseline
measure: Insomnia Severity Index (ISI) score
timeFrame: baseline
measure: Epsworth Sleepiness scale (ESS) score
timeFrame: baseline
measure: STOP-BANG Score
timeFrame: baseline
measure: Percentage of patients with risk allele of the melatonin receptor single nucleotide polymorphism.
timeFrame: baseline
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Elizabeth Mahanna Gabrielli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03489499: Genetic Variants and Postoperative Pain
Official title: Genetic Variants and Postoperative Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Pain
Analgesia
Surgical Procedure, Operative
Keywords: postoperative pain
analgesics
patient reported outcome
pain related impairment
genetic association study
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 5000
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 patients scheduled for elective surgery

Brief summary: Prospective observational study to analyse patients' pain related outcome after surgery and ist association to genetic variants and non-genetic variables.

Detailed description: Background

Severe acute pain as well as long-lasting pain after surgery and pain-related interference of daily activities are frequent. Some risk factors for severe pain after surgery in adults have been described, e.g. younger age and pre-existing chronic pain. The question arises whether a specific genetic background is related to an unfavorable pain outcome.

Objective

The aim of this study is to investigate clinical and genetic variables and their possible association to severe acute postoperative pain, higher analgesic consumption and the development of chronic postsurgical pain.

Methods

Prospective observational study investigating clinical, patient related, surgery related and anesthesia related variables as well as genetic variants and their possible association to patients' pain related outcome after surgery.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Written informed consent
* Elective surgery
* Patients' ability to understand the purpose of the study

Exclusion Criteria

* No informed consent
* Cognitive impairment

Primary outcomes:
measure: Pain related impairment after surgery and its association to genetic and non-genetic variables
timeFrame: day of surgery up to 1 year after surgery
Secondary outcomes:
measure: Association of genetic and non-genetic variables with analgesic consumption
timeFrame: day of surgery up to one year after surgery
measure: Association of genetic and non-genetic variables with pain related outcome of patients 1 year after surgery
timeFrame: Up to one year after surgery
measure: Association of genetic and non-genetic variables with chronic neuropathic postsurgical pain
timeFrame: up to one year after surgery
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
Study officials:
affiliation: Department of Anaestheisolpogy + Pain Medicine, Inselspital, University of Bern
name: Ulrike Stamer, Prof. MD
role: STUDY_CHAIR
affiliation: Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
name: Ulrike M Stamer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04612699: A Phase 2 Study of Jaktinib in Participants With Moderate to Severe Psoriasis
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Jaktinib in Patients With Moderate-to-Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate-to-Severe Plaque Psoriasis
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2020-11-03
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is study designed to investigate the efficacy and safety of Jaktinib in the treatment of participants with moderate to severe, chronic plaque psoriasis as assessed by the Psoriasis Area and Severity Index (PASI) score and routine safety assessments.


Eligibility criteria: Inclusion Criteria:

* 18\~65 years old (including lower limit), no gender limit；
* You must have active chronic plaque psoriasis for at least 6 months prior to entry into the study；
* You must have active plaque psoriasis covering at least 10% body surface area； You must have Psoriasis Area and Severity Index (PASI) score of at least 12；You must have Static Physician's Global Assessment (sPGA) score of at least 3；
* The patient can communicate well with the investigator and follow the research and follow-up procedures；
* Understand and voluntarily sign the informed consent form.

Exclusion Criteria:

* You must not have prior treatment with an oral Janus kinase (JAK) inhibitor；
* You must not have received a phototherapy within 4 weeks prior to entry into the study；
* You must not have a history of active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)；
* You must not have a history of chronic alcohol abuse or intravenous (IV) drug abuse

Primary outcomes:
measure: Percentage of Participants Achieving Psoriasis Area and Severity Index Score ≥75% (PASI 75) Improvement (Efficacy of Jaktinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Jaktinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])
timeFrame: Week 8、12、16、20、24
Other outcomes:
Locations:
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: First Hospital of China Medical University
name: Xinghua Gao, PhD
role: PRINCIPAL_INVESTIGATOR
References: