louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00566761: Treatment of Bevacizumab and Triamcinolone in Treatment or Macular Edema Secondary to CRVO
Official title: Combined Treatment of Intravitreous Bevacizumab and Triamcinolone for the Treatment or Macular Edema Secondary to Central Retinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Macular Edema
Central Retinal Vein Occlusion
Keywords: Macular edema
central retinal vein occlusion
bevacizumab
triamcinolone
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2007-12-04
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of macular edema secondary to central retinal vein occlusion is more effective with combined therapy of bevacizumab and triamcinolone than bevacizumab alone.

Detailed description: Comparison of two groups with different treatment with registrations of outcome in BCVA and complications

Eligibility criteria: Inclusion Criteria:

* Macular edema secondary to central retinal vein occlusion
* BCVA worse than 20/40
* Central macular \>250 mc with OCT

Exclusion Criteria:

* Diabetic retinopathy or other retinopathy
* Media opacity that does not allow following
* steroid responder
* diagnosed glaucoma or IOP \> 21 mmHg

Primary outcomes:
measure: Changes in Best corrected visual acuity and macular edema measured with OCT
timeFrame: Follow up to 3 , 6 and 12 months
Secondary outcomes:
measure: Report treatment complications
timeFrame: 12 month
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: Asociacion Para Evitar la Ceguera en Mexico
state: Coyoacan
Study officials:
affiliation: Asociación para Evitar la Ceguera en México
name: Carmen Gonzalez-Mijares, Physician
role: PRINCIPAL_INVESTIGATOR
affiliation: Asociación para Evitar la Ceguera en México
name: Hugo Quiroz-Mercado, Retinologyst
role: STUDY_DIRECTOR
affiliation: Asociación para Evitar la Ceguera en México
name: Juan Manuel Jimenez Sierra, Retinologyst
role: STUDY_CHAIR
affiliation: Asociación para Evitar la Ceguera en México
name: MA Martinez-Castellanos, Physician
role: STUDY_CHAIR
affiliation: Asociación para Evitar la Ceguera en México
name: Octavio Burgos Vejar, Physician
role: STUDY_CHAIR
affiliation: Asociación para Evitar la Ceguera en México
name: Raul Velez-Montoya, Physician
role: STUDY_CHAIR
affiliation: Asociación para Evitar la Ceguera en México
name: Ma de Lourdes Lopez Ramos, Physician
role: STUDY_CHAIR
affiliation: Asociación para Evitar la Ceguera en México
name: Omar Honerlager, preresident
role: STUDY_CHAIR
References:
Clinical trial NCT05558761: Pentoxifylline as Adjunctive Therapy in Patients With Ulcerative Colitis
Official title: Clinical Study to Evaluate the Possible Efficacy of Pentoxifylline in Patients With Ulcerative Colitis Treated With Mesalamine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The exact underlying mechanisms of ulcerative colitis (UC), an idiopathic, chronic inflammatory disease marked by diffused inflammation of the colon and rectum mucosa, are still unknown. Due to genetic, immune, and environmental factors, UC is highly dependent on cellular immune reactions and exaggerated inflammatory responses. The release of several cytokines, kinins, leukotrienes, platelet-activating factor (PAF), and reactive oxygen species is connected to immunological activity (ROS). Additionally, many of the cytokines will start an acute phase response, making the inflammation worse.


Eligibility criteria: Inclusion Criteria:

Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception

Exclusion Criteria:

- Breastfeeding Significant liver and kidney function abnormalities Colorectal cancer patients Patients with severe UC Patients taking rectal or systemic steroids Known allergy to the studied medications

Primary outcomes:
measure: Improvement in health related quality of life
timeFrame: 6 months
Secondary outcomes:
measure: changes in the level of measured biomarkers.
timeFrame: 6 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Medicine, Mansoura University
Study officials:
affiliation: Pharmacy Practice Department, Faculty of Pharmacy, Horus University, New Damietta, Egypt
name: Mostafa M Bahaa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04834661: Performing Laparoscopic Surgery for Colorectal and Gastric Cancer Outside the Primary Registered Medical Institution
Official title: Safety and Feasibility of Performing Laparoscopic Surgery for Colorectal and Gastric Cancer Outside the Primary Registered Medical Institution Under Multi-sites Practice (MSP) Policy, a Retrospective Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Gastric Cancer
Lead sponsor: Shanghai Minimally Invasive Surgery Center
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 1130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: colorectal cancer and gastric cancer

Brief summary: This study investigates the safety and feasibility of performing laparoscopic surgery for colorectal and gastric cancer inside versus outside the primary registered medical institution under multi-sites practice (MSP) policy. This is a single practitioner, retrospective comparative study. The endpoints are peri-operative outcomes, pathological results, and medical costs.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 100 years
* diagnosed as colorectal cancer or gastric cancer
* undergoing laparoscopic surgery between 2016-2020 performed by Dr Feng

Exclusion Criteria:

* Emergency procedure
* without histopathological result of malignancy
* conventional open surgery

Primary outcomes:
measure: overall postoperative complication rate
timeFrame: 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Zhenghao Cai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03723161: Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population
Official title: Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Conductive Hearing Loss
Atresia
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
Collaborators: name: Karolinska University Hospital
First posted: 2018-10-29
Enrollment: 15
Sex: ALL
Minimum age (years): 30
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients eligible for a bone anchored solution.

Brief summary: The purpose of this study is to in a proactive manner collect high quality data from a pediatric patients who have undergone a bone anchored hearing solution, using the Ponto BHX implant, in clinical practice. This to further increase the knowledge of using the system.


Eligibility criteria: Inclusion Criteria:

* Patients who have decided to undergo a Bone Anchored Hearing Surgery
* Diagnosed with atresia
* Signed informed consent
* Patients between 2,5 - 18 years of age
* Patients eligible for one stage surgery

Exclusion Criteria:

* Not fluent in Swedish or English; subject and/or legal guardian
* Unwillingness to participate in follow up visits

Primary outcomes:
measure: Stability 12 months
timeFrame: 12 months post surgery
Secondary outcomes:
measure: Stability 24 months
timeFrame: 24 months post surgery
measure: Implant survival rate
timeFrame: 24 months post surgery
measure: Performance audibility PTA4
timeFrame: 1 month post surgery
measure: Performance audibility
timeFrame: 1 month post surgery
measure: Performance speech intelligibility
timeFrame: 1 month post surgery
measure: Functional assessment
timeFrame: 12 months, 24 months
measure: Skin conditions Holger
timeFrame: 7-10 days,12 months, 24 months post surgery
measure: Skin conditions IPS evaluation
timeFrame: 7-10 days,12 months, 24 months post surgery
measure: Sustainability of audibility PTA4 performance
timeFrame: 1 month, 12 months, 24 months post surgey
measure: Sustainability of audibility performance
timeFrame: 1 month, 12 months, 24 months post surgey
measure: Sustainability of speech intelligibility performance
timeFrame: 1 month, 12 months, 24 months post surgey
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References:
Clinical trial NCT05160961: US-Guided SAPB Versus ESPB on Acute and Chronic Pain After VATS
Official title: Comparison of the Effects of Ultrasound-guided Serratus Anterior Plane Block and Erector Spinae Plane Block on Postoperative Acute and Chronic Pain for Patients Who Underwent Video-assisted Thoracoscopic Surgery.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Video-Assisted Thoracoscopic Surgery
Serratus Anterior Plane Block
Erector Spinae Plane Block
Acute Pain
Chronic Pain
Keywords: Serratus anterior plane block
Erector spinae plane block
Acute Pain
Chronic Pain
Lead sponsor: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 60
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: Postoperative acute and chronic pain is frequently observed in patients undergoing video assisted thoracoscopic surgery (VATS). This prolongs the discharge time of patients and increases the frequency of postoperative pulmonary complications. Recently, alternative analgesic methods such as thoracic paravertebral block (TPVB), erector spinae plane block (ESPB), and serratus anterior plane block (SAPB) which are thought to have less side effects than thoracic epidural analgesia, have been used. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In addition, ESPB and SAPB application is increasing in patients undergoing VATS. In the literature, the number of cases performed with ESPB and SAPB and randomized controlled prospective studies with ESPB and SAPB are increasing. In this study, it is planned to compare the effects of US-guided SAPB and ESPB on postoperative acute and chronic pain in patients undergoing VATS.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years
* American Society of Anesthesiologists physical status I-II-III
* Body mass index between 18-30 kg/m2
* Patients undergoing elective video assiste thoracoscopic surgery

Exclusion Criteria:

* Advanced cancer
* History of chronic analgesic therapy
* History of local anesthetic allergy
* Infection in the intervention area
* Patients with bleeding disorders

Primary outcomes:
measure: Pain scores
timeFrame: First 24 hours after surgery
Secondary outcomes:
measure: Chronic pain
timeFrame: 3rd month and 6th month
Other outcomes:
Locations:
city: Kecioren
country: Turkey
facility: Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
state: Ankara
Study officials:
affiliation: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
name: Musa Zengin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03881761: CD19/20 Bispecific Nanobody-derived CAR-T Cells in B Cell Lymphoma
Official title: Clinical Study of CD19/CD20 Bispecific Nanobody-derived CAR-T Cells in Refractroy/Relasped B Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: B-Cell Lymphoma Stage I
Refractory
Relapsed
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Henan Hualong Biotechnology Company
First posted: 2019-03-19
Enrollment: 50
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: transfusion of CD19/CD20 bispecific CAR-T cells 24-72 hours after completion of FC regimen pretreatment
Primary purpose: TREATMENT

Brief summary: Evaluation the safety and efficacy of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma

Detailed description: CART cell therapy has become the treatment of choice for patients with relapsed/ refractory B cell lymphoma. Currently, CAR-T cells approved for relapsed/refractory B-cell lymphoma are mainly CAR19-T cells. Nearly half of patients who relapse after treatment with CAR19-T cells are caused by tumor cell antigen escape. Dual-target CAR-T cells targeting CD19 and CD20 may reduce the recurrence rate after treatment. This study was to evaluate the efficacy and safety of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma.

Eligibility criteria: Inclusion Criteria:

* expected lifetime\>3 months
* CD19/CD20 positive relapsed/refractory B cell lymphoma
* KPS\>70
* at least one measurable lesion according to RECIST 1.1
* enough function of hear, liver, kidney and bone marrow
* no history of severe allergies
* no other history of malignancy
* no other diseases that conflict with this regimen
* no serious mental illness
* patient or family member sign informed consent

Exclusion Criteria:

* Pregnant or lactating women
* Severe infectious or viral disease
* Active B or C viral hepatitis
* Patients who have used large amounts of glucocorticoids or other immunosuppressive agents during the last 4 weeks
* participated in other clinical studies in the last 3 months, or have been treated with other gene products
* Others not appropriate to participate in this study examined by the investigators

Primary outcomes:
measure: occurrence of study related adverse events
timeFrame: one year
Secondary outcomes:
measure: objective response rate
timeFrame: three months
measure: survival time of CAR-T cells in vivo
timeFrame: one year
measure: progression-free survival
timeFrame: one year
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Yongping Song, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT06364761: Assesment of Intermediate Vision After BIL Cataract Surgery
Official title: Assesment of Intermediate and Near Vision After Bag in the Lens Cataract Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cataract
Keywords: bag in lens
Intermediate vision
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent bilateral bag in the lens cataract surgery in the University Hospital Brussels at least 3 months before inclusion

Brief summary: The goal of this observational study is to learn about the intermediate and near vision in patiënts who underwent cataract surgery with a specific technique, called "bag in the lens".

The main question it aims to answer is whether patiens who underwent this type of cataract surgery have better intermediate vision without spectacle correction than patients who underwent the classic lens in the bag cataract surgery.

Participants will:

* Have to read with and without spectacle correction at different distances (4 meters, 66 centimeters, 40 centimeters)
* Have to fill in 2 questionnaires about visual functioning and spectacle independance

Researchers will compare these values to the same values from the standard population who underwent the classic lens in the bag cataract surgery with a monofocal intraocular lens .


Eligibility criteria: Inclusion Criteria:

* Patients of at least 18 years old
* Must have underwent bilateral bag in the lens cataract surgery in the University hospital Brussels at least 3 months before inclusion
* Must not meet any exclusion criteria

Exclusion Criteria:

* Prior refractive surgery (other than bag in the lens)
* Glaucoma
* Corneal opacities
* Moderate non proliferative diabetic retinopathy or worse
* Optic neuropathy
* History of uveitis
* Amblyopia
* Residual post-operative astigmatism higher than 1.5 Diopters (D)
* Best corrected visual acuity \< 1.0
* Patients unable to cooperate or sign the informed consent

Primary outcomes:
measure: Intermediate vision
timeFrame: During the only hospital visit required in the study, between april and december 2024
Secondary outcomes:
measure: Near vision
timeFrame: During the only hospital visit required in the study, between april and december 2024
Other outcomes:
Locations:
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Jorgos Koulalis, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06044961: Radiomics-based Models for the Prediction of Pathological Response to Neoadjuvant Therapy in Gastric and Gastroesophageal Cancer
Official title: Radiomics-based Models for the Prediction of Pathological Response to Neoadjuvant Therapy in Gastric and Gastroesophageal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With Locally Advanced Carcinoma of the Stomach and Oesophagogastric Junction
Keywords: stomach cancer
esophagogastric junction.
locally advanced carcinoma of the stomach
radiomics
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with locally advanced stomach cancer

Brief summary: Identifying predictors of response to neoadjuvant therapy in gastric and gastro-oesophageal cancer early in the history of the disease would ensure optimal treatment planning.

The study aims to apply radiomics for the prediction of response to neoadjuvant therapy.


Eligibility criteria: Inclusion Criteria:

* Patients with locally advanced stomach cancer undergoing neoadjuvant chemotherapy and gastrectomy between January 2005 and August 2022

Exclusion Criteria:

* Siewert 1 tumors;
* Patients who have received neoadjuvant with the addition of a biological drug;
* Patients who have received radiotherapy;
* Patients without staging CT scan or with insufficient image quality in terms of phases performed, pixel spacing, slide thickness (mandatorily: \> 5 mm) or artefacts.

Primary outcomes:
measure: Use of radiomics
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00839761: The Use of Ultra Rice Compared to Iron Drops Consumed by Anemic Children
Official title: Efficacy of Iron Fortified Ultra Rice Compared to Supplemental Iron Drops in Infants and Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Iron Deficiency Anemia
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do estado de Minas Gerais
First posted: 2009-02-10
Enrollment: 175
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: How best to improve iron status among infants in low-income settings is of continued concern in many countries, including Brazil

Objective:

Design: In a double blind, 5-mo, home-based trial in Brazil, mildly anemic 6 - 24 month-old children (n=175) were randomly assigned to receive either Ultra Rice (URG) fortified with 23,4, mg Fe as micronized ferric pyrophosphate (MFP) and a placebo solution of iron drops, or identical non-fortified rice (CG) and a solution of iron drops. Parents were instructed on the correct dosage of iron drops and to feed their children (including whether and how much rice) as they normally would. Iron status and hemoglobin (Hb) were measured at baseline and at 5 mo.


Eligibility criteria: Inclusion Criteria:

* anemia

Exclusion Criteria:

* non anemic

Primary outcomes:
measure: Before, the prevalence of ID and anemia in sample were 73.1% and 100%, respectively. At 5-mo, increases occurred in serum ferritin (SF) and hemoglobin (Hb). SF and Hb were observed in both groups. Increases in both measures were seen in the URG group.
timeFrame: Before and after 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Federal University of Minas Gerais - UFMg
state: Minas Gerais
Study officials:
References:
citation: Moretti D, Zimmermann MB, Muthayya S, Thankachan P, Lee TC, Kurpad AV, Hurrell RF. Extruded rice fortified with micronized ground ferric pyrophosphate reduces iron deficiency in Indian schoolchildren: a double-blind randomized controlled trial. Am J Clin Nutr. 2006 Oct;84(4):822-9. doi: 10.1093/ajcn/84.4.822.
Clinical trial NCT03678961: The Effect of Leg Position on the Sciatic Nerve on Sonogram
Official title: Influence of Lower Extremity Positioning During Anterior-approach Ultrasound-guided Sciatic Nerve Block: Depth and Visibility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sciatic Nerve Block
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2018-09-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing knee surgery requiring peripheral nerve block

Brief summary: Little is known about which posture of lower extremity makes it easier to access to the sciatic nerve. In this study, the investigators aimed to identify the most appropriate positioning of the lower extremity during anterior-approach ultrasound-guided sciatic nerve block.


Eligibility criteria: Inclusion Criteria:

* ASA PS 1-3
* patients undergoing knee surgery requiring peripheral nerve block

Exclusion Criteria:

* patients who refuse to participate in the study
* BMI \> 40 kg/m2
* patients who have congenital abnormality on leg
* patients who have surgery or trauma on hip/knee
* patients who cannot move freely due to the contracture
* patients who are judged ineligible by the medical staff to participate in the study for other reasons

Primary outcomes:
measure: Visibility of sciatic nerve
timeFrame: during 10 minutes of anesthesia induction
Secondary outcomes:
measure: Depth of sciatic nerve
timeFrame: during 10 minutes of anesthesia induction
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: University of Ulsan, College of Medicine, Asan Medical Center
name: Won Uk Koh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: