louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06280508: Chemotherapy Combined With Adebrelimab and Apatinib as the Perioperative Treatment in Patients With Biliary Tract Cancer
Official title: A Prospective, Single-arm Exploratory Trail of Chemotherapy Combined With Adebrelimab and Apatinib as the Perioperative Treatment in Patients With Biliary Tract Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Resectable Intrahepatic Cholangiocarcinoma With High Risk of Recurrence
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 40
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: This is a prospective, single-arm exploratory study to evaluate the efficacy and safety of chemotherapy combined with Adebrelimab and Apatinib as the perioperative treatment in Patients With Biliary Tract Cancer.


Eligibility criteria: Inclusion Criteria:

* confirmed intrahepatic cholangiocarcinoma
* with Resectable tumor lesion
* no contraindications to surgery
* with high risk of tumour recurrence
* No prior systemic therapy for intrahepatic cholangiocarcinoma.
* ECOG Performance Status of 0 or 1
* Child-Pugh Class: Grade A

Exclusion Criteria:

* History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
* Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
* Known genetic or acquired hemorrhage or thrombotic tendency
* Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
* Cardiac clinical symptom or disease that is not well controlled
* Hypertension that can not be well controlled through antihypertensive drugs

Primary outcomes:
measure: 1-year EFS rate
timeFrame: Up to approximately 3 years
Secondary outcomes:
measure: R0 Resection rate
timeFrame: Up to approximately 3 years
measure: EFS
timeFrame: Up to approximately 3 years
measure: RFS
timeFrame: Up to approximately 3 years
measure: OS
timeFrame: Up to approximately 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
state: China/Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Yajin Chen
role: STUDY_DIRECTOR
References:
Clinical trial NCT03919708: Amblyopia and Strabismus Detection Using Retinal Birefringence Imaging
Official title: Deploying Retinal Birefringence Imaging in to the Clinic for Pediatric Vision Screening
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Amblyopia
Strabismus
Lead sponsor: Rebiscan, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Retina Foundation of the Southwest
First posted: 2019-04-18
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children between the ages of 2-8, with no gender, race, or ethnicity restricted from enrollment.

Brief summary: The purpose of this project is to compare the accuracy of two products at detecting amblyopia and strabismus in children. The devices will be Rebiscan's "blinq" (Pediatric Vision Scanner; PVS) and Rebiscan's RBI (Retinal Birefringence Imager).

Detailed description: Rebiscan is proposing a two-cohort study. The first cohort will include a population enriched for pathology in amblyopia to best assess device sensitivity, while a second cohort will be based in a primary care setting to best assess device specificity. The study will be conducted in busy, ethnically and economically diverse cites affiliated with the Retina Foundation of the Southwest (RFSW) in greater Dallas, TX area. Each child will be screened with Rebiscan's RBI device and it's PVS device in sequence, with results compared to the PVS as well as a comprehensive ophthalmic examination performed by a certified pediatric ophthalmologist in a statistically appropriate subset of screened subjects. Testing times will be assessed to compare the efficiency of the PVS and the RBI screening experiences. The percentage of children successfully completing the screening process will also be measured.

The RBI is expected to identify children with amblyopia and strabismus, without referring children who will not benefit from early treatment

Eligibility criteria: Inclusion Criteria:

* Children who present to the participating clinics
* Provide assent
* Guardian provides informed consent

Exclusion Criteria:

- Developmental delay or cognitive deficit

Primary outcomes:
measure: Presence of amblyopia / strabismus
timeFrame: 1 single day
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
Study officials:
affiliation: Retina Foundation of the Southwest
name: Eileen Birch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05833308: Association Between Fibrinogen-to-albumin Ratio and Delirium After Deep Brain Stimulation Surgery in Parkinson's Disease
Official title: Association Between Fibrinogen-to-albumin Ratio and Delirium After Deep Brain Stimulation Surgery in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Deep Brain Stimulation
Postoperative Delirium
Keywords: postoperative delirium
fibrinogen-to-albumin ratio
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 226
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson's disease were scheduled to undergo elective subthalamic nucleus deep brain stimulation surgery for the first time under total intravenous anesthesia. Delirium was evaluated at the preoperative visit, then twice daily for 3 days following surgery. Cognition assessment was conducted at preoperative visit, 24 h after surgery and 72 h after surgery. Delirium assessments were performed before 10 AM and after 5 PM in the ward. The CAM questionnaire and cognition assessment method for MMSE were performed by the qualified doctor who trained with CAM and MMSE training manual.

Brief summary: Postoperative delirium (POD) remains one of the most common neuropsychiatric complications after deep brain stimulation (DBS) surgery. The fibrinogen-to-albumin ratio (FAR) has been shown to significantly correlate with prognosis of many diseases associated with inflammation, but the relationship between FAR and POD is unclear. The investigators aimed to investigate the association between POD and FAR in Parkinson's disease (PD) patients receiving DBS surgery. For this aim, the present study was conducted to provide a new method for the early recognition and perioperative management of delirium after DBS surgery in PD patients.


Eligibility criteria: Inclusion Criteria:

* Over 55 years old
* American Society of Anesthesiologists (ASA) physical status I-III
* Bilateral subthalamic nucleus deep brain stimulation surgery

Exclusion Criteria:

* Preoperative delirium
* Missing preoperative laboratory parameters on fibrinogen or albumin
* Persistent infectious diseases
* Coagulopathy and autoimmune-illness or malignancies

Primary outcomes:
measure: CAM score
timeFrame: Before surgery
measure: CAM score
timeFrame: Postoperative day 1
measure: CAM score
timeFrame: Postoperative day 2
measure: CAM score
timeFrame: Postoperative day 3
Secondary outcomes:
measure: Mini-mental State Examination (MMSE) score
timeFrame: Before surgery
measure: MMSE score
timeFrame: Postoperative 24 hour
measure: MMSE score
timeFrame: postoperative 72 hour
measure: The level of fibrinogen-to-albumin ratio (FAR) in peripheral blood.
timeFrame: Before surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT06574308: Clinical Evaluation of the Scopio Cell Morphology Technology
Official title: Clinical Evaluation of the Scopio Cell Morphology Technology on Pre-classification of Blood Cells in Peripheral Blood (PB) and Bone Marrow (BM)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Blood Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pazienti affetti da emopatie

Brief summary: Digital morphology is currently expanding and developing new applications based on artificial intelligence software. We recently published a study comparing screen validation and microscopic reading of bone marrow aspirates. The aim of the current research will be the comparison between optical microscope reading and automatic pre-classification (AI based)


Eligibility criteria: Inclusion Criteria:

* Patients suffering from hemopathies with bone marrow aspirate assessable under the optical microscope

Exclusion Criteria:

* Patients not affected by blood disorders
* Patients suffering from hemopathies with bone marrow aspirate that cannot be assessed under the optical microscope

Primary outcomes:
measure: Optical microscope reading and automatic pre-classification
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Patrizia Chiusolo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03139708: The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients
Official title: The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients, Pressure Control and Pupil Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Intraocular Pressure
Keywords: Mydriasis
Cycloplegics
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This an interventional study looking at two different sequences of pre-operative eye drops, to determine which order is more effective in reducing intraocular pressure with pupil dilation.

Detailed description: Twenty healthy participants will be separated into two groups of 10 volunteers each. In both groups, the participant's right eye will serve as a control with only Tropicamide/phenylephrine given. In one group of 10 participants the left eyes will receive Alphagan prior to Tropicamide/phenylephrine. In the other group of 10 eyes, the left eyes will have Tropicamide/phenylephrine administered prior to Alphagan. The investigator will observe the intraocular benefits of the addition of Alphagan over the Tropicamide/phenylephrine alone and determine if pre-treating is any better than post-treating. In addition, the investigator will monitor pupil response, as it is known that Alphagan may have some effect on the pupil dilation.

Eligibility criteria: Inclusion Criteria:

* Healthy with no major medical conditions. Contact lens wear is ok but must be not worn on the day of the study

Exclusion Criteria:

* Diabetic, history of glaucoma
* history of iris trauma
* history of eye surgery except LASIK or Photorefractive keratectomy laser eye surgery
* Anisocoria
* pregnancy

Primary outcomes:
measure: Change in intraocular pressure from baseline to 15 min after last drop given, 30 min, 1 hour, and 4 hours.
timeFrame: 5 time points all occuring during one time visit: Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours.
Secondary outcomes:
measure: Change in pupil size pupil size from baseline to 15 min after last drop given, 30 min, 1 hour, and 4 hours.
timeFrame: 5 time points all occuring during one time visit: Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours.
measure: Change in pupil's reaction to light from baseline to 15 min after last drop given,30 min, 1 hour, and 4 hours.
timeFrame: 5 time points all occuring during one time visit: Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours.
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Eye Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Keith Walter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02752308: Effectiveness of Caudal Epidural Block on Intraoperative Blood Loss During Hypospadias Repair
Official title: Effectiveness of Caudal Epidural Block on Intraoperative Blood Loss During Hypospadias Repair; A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hypospadias
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-04-26
Enrollment: 60
Sex: MALE
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: From September 2014 to March 2015, 57 consecutive patients with hypospadias who are candidate for surgery will be enrolled in this randomized clinical trial.

Regional ethics committee of Isfahan University of Medical Sciences approved the protocol of the study and all parents will sign a written informed consent.

Inclusion criteria are age between 6 months to 15 years and hypospadias with any severity. Exclusion criteria are coagulopathy, history of previous failed surgery, skin infection , parents' disagreement with the protocol and any cardiac problem that made epinephrine injection contraindicated.

All selected patients will randomly allocate to one of the two groups: group A will receive caudal epidural block (CEB) plus general anesthesia before surgery and group B will receive general anesthesia before surgery and CEB afterwards. The surgical procedures will be performed by a single pediatric urologist (FA). The surgical technique will be tubularized incised plate in all cases.

Intraoperative blood loss will be determined by weighing all surgical gauzes used during procedure with a digital scale measure to the nearest 0.01 gram, every 10 minutes to minimize the effect of water vaporization on gauzes weights.

In addition to blood loss, operation time, dose of fentanyl used during procedure and length of the urethral plate defect will be recorded for each patient by trained nurses.

Demographics and disease characteristics as well as operation details will be compared in the two studied groups.


Eligibility criteria: Inclusion Criteria:

age between 6 months to 15 years and hypospadias with any severity

Exclusion Criteria:

coagulopathy, history of previous failed surgery, skin infection , parents' disagreement with the protocol and any cardiac problem that made epinephrine injection contraindicated

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: During procedure
Secondary outcomes:
measure: Dose of fentanyl used
timeFrame: during the operation
measure: operation time
timeFrame: during procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01698008: Effect of Mobile Phone Telemedicine on Diabetes Care
Official title: Effect of Mobile Phone Telemedicine on Diabetes Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2012-10-02
Enrollment: 5
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group is standard of care. The other is given the opportunity to use a new mobile app for reporting blood sugars.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Adult patients with diabetes on insulin are eligible for the study. They will be randomized to a group using standard of care communication and a group using an I phone intervention.

Detailed description: Type 1 or type 2 diabetes mellitus subjects who know how to operate and own an iPhone, are between the age of 19 to 75, and are on a basal/bolus insulin regimen will be included in the study. Subjects will be randomized to two groups - iPhone versus standard of care and seen in our clinic at an initial/baseline and three month clinical visit. The control group will e-mail, fax, or call their blood glucose log results once a month for an insulin regimen adjustment through verbal communication with a certified diabetic educator once a month as is already implemented at the Diabetes Center. This group will be compared to the intervention group who will submit their blood glucose log results through an iPhone mobile application, called Diabetes Doctor, once a month for an insulin regimen adjustment by a physician with a text message response. The two groups will have their HbA1c, hypoglycemic events, blood glucose dispersion compliance, quality of life, usability and satisfaction with the use of a mobile application will be assessed at each visit with surveys.

Eligibility criteria: Inclusion Criteria:

* Type 1 or type 2 Diabetes Mellitus on insulin basal/bolus injection
* Own and are able to operate an iPhone

Exclusion Criteria:

* Type 2 diabetics using only oral medications
* Do not own or know how to operate an iPhone

Primary outcomes:
measure: Evidence for Improved Diabetic Care With Mobile Phone Application Use
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: The University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Whitney S Goldner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01539408: Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion in Nigeria
Official title: Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Incomplete Abortion
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2012-02-27
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Women diagnosed with incomplete abortion in this health facility will be randomized to receive one of the following regimens: 400 mcg sublingual misoprostol in one dose or standard surgical treatment (MVA). The investigators hypothesize that treatment of incomplete abortion with misoprostol using 400 mcg administered sublingually will be as effective as surgical evacuation.


Eligibility criteria: Inclusion Criteria:

* no contraindications to misoprostol
* uterine size was not larger than 12 weeks
* there were no signs of severe infection
* haemodynamically stable
* in general good health
* willing to provide contact information

Exclusion Criteria:

* an IUD in place
* ectopic pregnancy
* aged below 18 years and had no accompanying adult to provide informed consent

Primary outcomes:
measure: Complete abortion without recourse to surgical intervention
timeFrame: follow up visit 7 days after initial treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Ibadan
country: Nigeria
facility: Adeoyo Maternity Hospital
city: Ibadan
country: Nigeria
facility: University College Hospital, Ibadan
Study officials:
References:
citation: Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
citation: Shochet T, Diop A, Gaye A, Nayama M, Sall AB, Bukola F, Blandine T, Abiola OM, Dao B, Olayinka O, Winikoff B. Sublingual misoprostol versus standard surgical care for treatment of incomplete abortion in five sub-Saharan African countries. BMC Pregnancy Childbirth. 2012 Nov 14;12:127. doi: 10.1186/1471-2393-12-127.
citation: Fawole AO, Diop A, Adeyanju AO, Aremu OT, Winikoff B. Misoprostol as first-line treatment for incomplete abortion at a secondary-level health facility in Nigeria. Int J Gynaecol Obstet. 2012 Nov;119(2):170-3. doi: 10.1016/j.ijgo.2012.06.012. Epub 2012 Aug 27.
Clinical trial NCT06168708: The Safety and Efficacy of Addition of Gentamicin on Irrigation Fluid in Prevention of Post-Transurethral Resection of the Prostate Infectious Complications.
Official title: The Safety and Efficacy of Addition of Gentamicin on Irrigation Fluid in Prevention of Post-Transurethral Resection of the Prostate Infectious Complications: A Prospective Randomized Double Blinded Placebo Controlled Pilot Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-TURP Infectious Complications
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 220
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical study is to evaluate the safety and efficacy of addition of gentamicin on irrigation fluid during trans-urethral resection of the prostate (TURP) and its role in reduction of post-TURP infectious complications.

the participants will be randomly divided into two groups: Group A (gentamicin group) and group B (Placebo).

Detailed description: 220 patients scheduled for TURP for the management of urinary retention or LUTS will be included and divided into two groups; "Group A" includes 110 patients who will undergo TURP with addition of one ampoule of gentamicin 80 mg (2ml) /3L of irrigation solution (the first 9 Liters during resection and the first 6 Liters during post-operative irrigation) and "Group B" includes 110 patients who will undergo TURP with addition of normal saline (2 ml) as a placebo on the irrigation solution. Determination of Gentamicin in human serum using HPLC/UV after Chemical Derivatization will be done using the method of Barends et al (Barends, Brouwers, \& Hulshoff, 1987). Both groups will be compared as regards the demographic data, post-operative pyuria and bacteruria (1 week after removal of urethral catheter), fever, and/or sepsis.

Eligibility criteria: Inclusion Criteria:

* adult patients with enlarged prostate presenting with LUTS or urine retention

Exclusion Criteria:

* Unfit patients
* Renal impairment
* active UTI
* urethral strictures

Primary outcomes:
measure: infectious complications
timeFrame: 1 week and 1 month after removal of urethral catheter
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Urolgy Departement, Faculty of Medicine, Tanta University
state: Outside U.S./Canada
Study officials:
References: