louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05883709: A Real-world Study of Tafasitamab in Combination With Lenalidomide in Patients withR/R DLBCL
Official title: A Real-world Study Evaluating the Safety and Efficacy of Tafasitamab in Combination With Lenalidomide in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diffuse Large B-cell Lymphoma
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recurrent or refractory diffuse large B-cell lymphoma after systemic therapy

Brief summary: To evaluate the real-world efficacy of Tafasitamab combined with Lenalidomide base regimen in patients with relapsed or refractory DLBCL, with objective response rate as the primary end point.

Detailed description: This study retrospectively collected the data of patients previously treated with Tafa and divided them into two coords according to different protocols received. Cohort 1 was Tafa combined treatment group, which could include Tafa combined with lenalidomide, Tafa combined with Lenalidomide plus BTK inhibitor, Tafa combined with Lenalidomide plus chemotherapy (including ADC). Cohort 2 was treated with sequential CAR T or graft after Tafa combination therapy.

Eligibility criteria: Inclusion Criteria:

* Patients with pathological diagnosis of DLBCL, including but not limited to non-specific DLBCL (NOS-DLBCL); Large B-cell lymphoma (THRLBCL) rich in T cells/histiocytes; EBV positive DLBCL (EBV-positive DLBCL); According to the revised REAL/WHO classification, it was grade 3b follicular lymphoma, including DLBCL component, followed by DLBCL recurrence. In addition, patients with low-grade lymphomas such as follicular lymphoma, marginal zone lymphoma, and chronic lymphocytic leukemia have histological evidence of transformation to DLBCL and subsequent recurrence
* Patients who, as determined by the treating physician, would benefit from Tafa treatment

Exclusion Criteria:

* Known allergy or metabolic disorder to any drug in the regimen
* Those who refuse to use reliable methods of contraception during pregnancy, lactation or age-appropriate period
* Have a history of uncontrolled medical disease (including uncontrolled diabetes, severe heart, lung, liver, renal insufficiency), blood, endocrine system, and other malignancies
* Severe mental illness
* Patients deemed unsuitable for inclusion by the investigator

Primary outcomes:
measure: objective remission rate
timeFrame: at the end of Cycle 2 (each cycle is 28 days)
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 1year after induction therapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Study officials:
References:
Clinical trial NCT01341509: A Randomized Trial to Evaluate the Effectiveness of Transferring the Flexor Hallucis Longus Tendon
Official title: Insertional Achilles Tendinopathy: A Randomized Trial to Evaluate the Effectiveness of Transferring the Flexor Hallucis Longus Tendon
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Achilles Tendinopathy
Keywords: Surgical Treatment of Insertional Achilles Tendinopathy
Lead sponsor: OAD Orthopaedics
Sponsor class: OTHER
First posted: 2011-04-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The optimal surgical treatment for insertional Achilles tendinopathy remains unclear. The purpose of this study is to evaluate the long-term outcome of surgical treatment by comparing the patient reported outcomes of Insertional Achilles Tendinopathy; Achilles tendon debridement, excision calcaneal exostosis, Strayer procedure, secondary repair of Achilles with flexor hallucis longus (FHL) transfer and Achilles tendon debridement, excision calcaneal exostosis, Strayer procedure, secondary repair of Achilles without FHL transfer.


Eligibility criteria: Inclusion Criteria:

* Male and female 18 years or older
* Diagnosed with insertional Achilles tendinosis by history and physical exam
* Confirmed by x-ray and MRI
* Calcification at the Achilles insertion and gastrocnemius tightness.
* Failure of the following non-operative treatment for greater than 6 months: \*shoe modifications

  * physical therapy
  * immobilization
  * and home exercise program.
* In addition, participant must have an intact flexor hallucis longus tendon.

Exclusion Criteria:

* Patients who have failed surgery for the same and patients with diabetic neuropathy.

Primary outcomes:
measure: Statistical difference
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Warrenville
country: United States
facility: OAD Orthopaedics
state: Illinois
Study officials:
affiliation: OAD Orthopaedics
name: Gregory P Witkowski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01675609: Study Evaluating the Safety and Efficacy of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects
Official title: A Single-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ocular Redness
Lead sponsor: Eye Therapies, LLC
Sponsor class: INDUSTRY
First posted: 2012-08-30
Enrollment: 57
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of brimonidine tartrate 0.025% ophthalmic solution used four times daily in a population of adult and geriatric subjects


Eligibility criteria: Inclusion Criteria:

* Be at least 40 years of age
* Must have normal ocular health
* Must have history of redness relief drop use or desire to use

Exclusion Criteria:

* Must not have any ocular/systemic health problems
* Must agree to avoid disallowed medications

Primary outcomes:
measure: Ocular redness
timeFrame: at specified timepoints for up to 180 minutes
Secondary outcomes:
measure: Ocular Redness
timeFrame: up to 5 minutes post study medication instillation
Other outcomes:
Locations:
city: Andover
country: United States
facility: Ora, Inc.
state: Massachusetts
Study officials:
References:
Clinical trial NCT05865509: Comparison of the Escape Room and Storytelling Methods in Learning the Stress Response
Official title: Comparison of the Escape Room and Storytelling Methods in Learning the Stress Response: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Response
Keywords: Escape room
Storytelling
Nursing
Game-based learning
Lead sponsor: Ankara Medipol University
Sponsor class: OTHER
Collaborators: name: Atılım University
First posted: 2023-05-19
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this randomised controlled study is to evaluate the effects of storytelling and escape room methods on the level of learning about stress response of nursing students and students' opinions about these methods.

The main questions it aims to answer are:

* Is there a difference between the pretest-posttest scores of the students who received training on stress response with the escape room method?
* Is there a difference between the pretest-posttest scores of the students who were trained on the stress response with the storytelling method?
* Is the difference between the knowledge levels of the students who received stress response training with the escape room and storytelling methods statistically significant? The students, who received training on stressors, stress response and the long-term effects of stress through lecture, were divided into two groups four weeks after this training and were retrained on the same subject with escape room and storytelling methods. Before and after the Escape room and storytelling practices, the students' knowledge of the stress response was evaluated. After both applications, focus group discussions were held with the students and their opinions and feedbacks on the applications were evaluated.


Eligibility criteria: Inclusion Criteria:

Nursing students taking internal medicine course

Exclusion Criteria:

N/A

Primary outcomes:
measure: Knowledge levels of students about stress response before the application.
timeFrame: On intervention day, just before application
measure: Knowledge levels of students about stress response after the application
timeFrame: On intervention day, immediately after application
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Nilgün Doğu
Study officials:
References:
Clinical trial NCT01415609: Endoscopic Submucosal Dissection Registry
Official title: Establishment of Registry for Endoscopic Submucosal Dissection for Superficial Gastrointestinal Neoplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Neoplasms
Gastric Cancer
Keywords: Gastrointestinal neoplasia
Submucosal resection
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Olympus
First posted: 2011-08-12
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for endoscopic treatment of gastrointestinal neoplasia.

Brief summary: The purpose of this study is to monitor the success rates and completion rates for endoscopic submucosal dissection (ESD) for gastrointestinal (GI) cancers.


Eligibility criteria: Inclusion Criteria: Patients referred for endoscopic treatment of advanced gastrointestinal (colorectal, gastric, duodenal, esophagus) neoplasia, defined by any of the following procedures:

1. Flat dysplastic lesion greater than 2cm(IIa or IIb by Paris classification)
2. Flat depressed lesion \< 2cm in size (llc by Paris Classification)
3. Ulcerated lesion \< 2cm (Paris type lll) staged as T1N0 on endoscopic ultrasound
4. Upon resection, the criteria for curative ESD include:

   * Non-invasive neoplasia of differentiated carcinoma
   * No lymphovascular invasion
   * Intramucosal cancer or minute submucosal cancer \<1 mm invasion (sm1)
   * Negative deep and lateral margins.

Exclusion Criteria:

1. Use of antiplatelet(e.g. clopidrogel) or anticoagulation (e.g. Coumadin) agents that cannot be withheld for at least 7 days prior to the procedure. Aspirin use is accepted according to the American Society for Gastrointestinal Endoscopy for these procedures.
2. Patients who refuse or who are unable to consent.
3. Suboptimal colon prep, or solid gastric residual that precludes safe lesion resection at the time of endoscopy.
4. Lesion location in a segment of the colon not conducive to ESD, including significant narrowing, tortuosity and/or extensive diverticular disease, as determined by the endoscopist.

Primary outcomes:
measure: Ease of use of the overall procedure and Time of procedure.
timeFrame: 1 Year
Secondary outcomes:
measure: Complications and Rate of Completion
timeFrame: 1 Year
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Michael B Wallace, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02758509: Impact of Antiviral Therapy on Gastroesophageal Varices.
Official title: Efficacy and Safety of Interferon Based Therapy and Interferon-free Direct-acting Antivirals in Cirrhotic Patients With Hepatitis C. Impact of Antiviral Therapy on Gastroesophageal Varices.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C
Cirrhosis
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2016-05-02
Enrollment: 237
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: Patients with chronic hepatitis C by genotype 1 and liver cirrhosis

Brief summary: Hepatitis C virus (HCV) chronic infection affects 200 million people worldwide. HCV antiviral treatment has evolved rapidly since 2011. The use of pegylated interferon (PEG-INF) with ribavirin (RBV) has supposed high serious adverse events (SAEs) and low efficacy, especially in patients with cirrhosis. The introduction of 1st generation protease inhibitors (PIs) in genotype-1 (GT1) HCV, such as boceprevir (BOC) and telaprevir (TVR), improved the efficacy but increased the SAEs. Currently, interferon-free direct-acting antivirals (IF-DAAs) achieve great effectiveness with minimum SAEs. However, studies evaluating efficacy and safety of DAAs in cirrhotic patients are limited in real clinical practice. The aim of our study is to evaluate in HCV-cirrhotic patients the efficacy and safety of 3 treatment strategies (PEG-IFN/RBV, PEG-IFN/RBV/PIs, and IF-DAAs) in routine practice according to European guidelines from 2010 to 2015. The secondary aim is to evaluate the impact of sustained virological response on gastroesophageal varices (GOV).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Signed informed consent.
* Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA).
* Liver cirrhosis (transient elastography ≥ 14 kPa).
* Baseline upper gastrointestinal endoscopy to assess gastroesophageal varices

Exclusion Criteria:

* Negative to provide signed informed consent.
* Negative to perform gastrointestinal endoscopy

Primary outcomes:
measure: sustained virological response (SVR)
timeFrame: 12 weeks after treatment completion
Secondary outcomes:
measure: Number of patients with gastroesophageal varices
timeFrame: gastroesophageal varices (GOV) before antiviral treatment and 12-24 weeks after treatment completion
Other outcomes:
Locations:
Study officials:
References:
citation: Puigvehi M, Londono MC, Torras X, Lorente S, Vergara M, Morillas RM, Masnou H, Serrano T, Miquel M, Gallego A, Lens S, Carrion JA. Impact of sustained virological response with DAAs on gastroesophageal varices and Baveno criteria in HCV-cirrhotic patients. J Gastroenterol. 2020 Feb;55(2):205-216. doi: 10.1007/s00535-019-01619-0. Epub 2019 Sep 6.
Clinical trial NCT04091009: A Prospective, Randomized Trial of the Effect of Standard of Care Reduced Dose Versus Full Dose Buprenorphine/Naloxone in the Perioperative Period on Pain Control and Post-Operative Opioid Use Disorder Symptoms
Official title: A Prospective, Randomized Trial of the Effect of Standard of Care Reduced Dose Versus Full Dose Buprenorphine/Naloxone in the Perioperative Period on Pain Control and Post-Operative Opioid Use Disorder Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Opioid-use Disorder
Opioid Use Disorder, Mild
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 76
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: The purpose of this research study is to compare two ways of managing pain in people who are taking buprenorphine and are scheduled to undergo surgery. Buprenorphine (subutex) and buprenorphine/naloxone (suboxone) are effective long-term treatments for substance use disorders. The management of pain after surgery in adults taking buprenorphine can be challenging, as buprenorphine may interfere with the effectiveness of other medications used to treat pain.

We want to compare how well pain is managed after surgery ("post-op") in two groups:

The "Continue Group": those who continue taking their standard dose of buprenorphine before, during and after surgery.

The "Reduce Group": those who are placed on a lower dose of buprenorphine starting one day before surgery and during the time period after surgery until the pain from the surgery has decreased. Once the pain from the surgery has decreased, you will be put back on your full dose of buprenorphine.

We also want to find out if there is a difference in pain, opioid cravings, and relapse rates in the month following surgery.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) health class I-III
* Currently taking buprenorphine or buprenorphine/naloxone daily at a dose of at least 16mg per day for at least the prior 30 days for treatment of Opioid Use Disorder by Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria
* Scheduled for surgery at Massachusetts General Hospital where greater than 3/10 pain is expected on post-operative day 1

Exclusion Criteria:

* Participants unable to consent to the study
* Renal insufficency with a glomerular filtration rate \<30ml/min (participants would be unable to use ketorolac which is a part of the multimodal anesthetic plan)
* Liver cirrhosis with a Model for End-Stage Liver Disease (MELD) score \> 25 (participants would be unable to use Tylenol which is part of the multimodal anesthetic plan)

Primary outcomes:
measure: Pain scores at 24 hours post-operative procedure
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Zhang Yi, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06044909: Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance
Official title: Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatectomy
Laparoscopy
Keywords: Intraoperative
preoperative
multimodal data
registration
laparoscopy
hepatectomy
augmented reality
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 40
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: Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy

Brief summary: Multimodal intraoperative minimal-invasive (laparoscopic or robotic) liver surgery images will be registered to each other. Explicitly, these are the ultrasound and laparoscope images. Once they are registered, they will reveal the hidden tumor's location to the surgeon in real time through augmented reality. The intraoperative augmentation will also be enriched with the preoperative data (e.g., CT or MRI). This will simplify minimal invasive liver surgery, improve surgical safety and accuracy. It will also shorten hospital stays and contribute to an overall better quality of life for the patient, which in return will reduce the health-care costs.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing hepatectomy;
* Patients for whom good-quality imaging is available (CT scan and/or MRI and/or ultrasound);
* Patients over 18 years of age;
* Minimally invasive surgery by conventional or robot-assisted laparoscopy.

Exclusion Criteria:

* Surgery by laparotomy

Primary outcomes:
measure: Analysis accuracy of the augmented reality by aligned with the intraoperative measurements
timeFrame: 28 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Bertrand LE ROY, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00291109: An Examination of Predictors of Indicators of Response to Letrozole 2.5 mg
Official title: Quantitative Real Time PCR in Cytolytic Formalin Fixed Breast Cells Obtained by Periareolar Fine Needle Aspiration. An Ancillary Protocol to a Chemoprevention Trial of Letrozole
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast atypia
breast epithelial hyperplasia
Ki-67
RTPCR
microdissection
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2006-02-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: To assess the quantitative real time PCR results of oligonucleotide probes for a number of gene transcription products that may be useful as predictors or indicators of response to letrozole

Detailed description: To assess the quantitative real time PCR results of oligonucleotide probes for a number of gene transcription products (PCNA, cyclin-D1, ER alpha, PR, pS2, 450 aromatase, bcl-2, bax, caspase-3, and VEGFR) that may be useful as predictors or indicators of response to letrozole

Eligibility criteria: Inclusion Criteria:

* evidence of hyperplasia with/without atypia upon random periareolar fine needle aspiration of breast
* on hormone replacement therapy
* postmenopausal
* increased risk of developing breast cancer based on personal or family history
* never have taken aromatase inhibitors or selective estrogen receptor modulators in last six months
* women who have a high risk of breast cancer
* older than 18 years

Exclusion Criteria:

* no anticoagulants
* no marked breast tenderness
* not pregnant or within twelve months of breast feeding/childbirth

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Carol J Fabian, MD
role: PRINCIPAL_INVESTIGATOR
References: