louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01481792: Efficacy and Safety of ReLEx Smile for Laser Correction of Myopia
Official title: Use of the VisuMax Femtosecond Laser for the Correction of Myopia With Small Incision Lenticular Extraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Keywords: Keratorefractive Surgical Procedures
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2011-11-30
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to the Department of Ophthalmology, Aarhus University Hospital, for keratorefractive surgical correction of myopia

Brief summary: Evaluation of the safety and efficacy of the Carl Zeiss Meditec VisuMax femtosecond laser for lamellar resection (ReLEx smile) in the reduction of myopia.

Detailed description: Quality control study of patients treated with ReLEx smile for myopia at the Department of Ophthalmology, Aarhus University Hospital.

The patients will be followed with standard clinical techniques (slit-lamp examination, refraction, topography) during their normal follow-up up to 12 months after treatment.

Eligibility criteria: Inclusion Criteria:

* Indication for keratorefractive correction of myopia
* Patient consent to undergo keratorefractive correction of myopia

Exclusion Criteria:

* Pregnant or lactating women

Primary outcomes:
measure: Effectiveness
timeFrame: Refraction one year after surgery
measure: Safety
timeFrame: One year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Department of Ophthalmology, Aarhus University Hospital
Study officials:
References:
Clinical trial NCT04400292: Sentinel Lymph Node Mapping in Esophageal Cancer Using ICG Dye and NIR Imaging
Official title: Does the Concept of the Sentinel Lymph Node Apply to Esophageal Cancer? A Prospective Assessment of Near-infrared Image-guided Lymphatic Mapping and Sentinel Lymph Node Identification in Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Cancer
Keywords: Sentinel Lymph Node Mapping
lymphadenectomy
esophagectomy
ICG Injection
Intraoperative NIR Imaging
20-201
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This will be a prospective single-arm study.
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to find out whether sentinel lymph node (SLN) mapping with ICG dye and NIR imaging can be used to identify esophageal or esophagogastric junction cancer that has spread to the lymph nodes. If SLN mapping is successful in these types of cancer, surgeons in the future could identify the sentinel lymph nodes and only remove these instead of removing all the lymph nodes which is currently done.


Eligibility criteria: Inclusion Criteria:

* Pathological diagnosis of adenocarcinoma tumor located in distal 1/3 of esophagus or esophagogastric junction , with a plan to undergo minimally invasive esophagectomy.
* All patients with Stage IVA (AJCC Cancer Staging Manual, 8th edition) disease will be eligible
* ≥18 years of age.
* Documented, signed, and dated informed consent, obtained before any procedures, for the proposed research study and for standard surgical resection.

Exclusion Criteria:

* No plan to undergo surgical resection.
* Severe iodide or seafood allergy.
* Women of childbearing potential without a negative pregnancy test; or women who are lactating.
* Prior diagnosis of severe hepatic or renal dysfunction.
* Patients with Stage IVB or M1 disease (AJCC Cancer Staging Manual, 8th edition)
* Patients with local recurrence and planning to undergo salvage esophagectomy

Primary outcomes:
measure: The number of lymph nodes visualized to be fluorescent and nonfluorescent.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Daniela Molena, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06268392: A Comparative Study of AI Methods for Fetal Diagnostic Accuracy in Ultrasound
Official title: A Comparative Study of AI Methods for Fetal Diagnostic Accuracy in Ultrasound
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Fetal Growth Retardation
Fetal Macrosomia
Fetal Growth
Keywords: Artificial Intelligence
Fetal weight estimation
Ultrasound
Lead sponsor: Copenhagen Academy for Medical Education and Simulation
Sponsor class: OTHER
Collaborators: name: Slagelse Hospital
name: Technical University of Denmark
name: Rigshospitalet, Denmark
First posted: 2024-02-20
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical students are recruited from the Medical universities in Denmark (mainly Copenhagen University) Pregnant women are chosen from the fetal medical departement at Rigshospitalet, Copenhagen.

Brief summary: This study serves as a supplemental investigation to the randomized controlled SCAN-AID study (NCT0632187). This study will evaluate and compare the fetal growth estimation outcomes of AI-supported groups, expert sonographers, and control groups using a secondary AI predictive model.

Detailed description: The goal of this study is to compare the effects of two distinct AI methods on fetal ultrasound diagnostic accuracy. It serves as a supplementary investigation to the SCAN-AID study (NCT NCT06232187). This study aims will compare the diagnostic accuracy of two types of AI methods.

From the SCAN-AID study ultrasound novices were randomized into one of three groups with different levels of AI support: control group, AI feedback group 1 where the participants are presented with basic black box AI feedback, and AI feedback group 2 where the participants are presented with a more detailed explainable AI feedback. All the participants are tasked to perform an ultrasound fetal weight estimation (EFW) on pregnant women at gestational age 30-37. The outcomes were than compared to the expert sonographers measurements.

In this study an operator independent AI method that predicts the fetal weight is used on the SCAN-AID ultrasound examinations. .

Eligibility criteria: Pregnant women:

Inclusion Criteria:

* Singelton pregnant.
* Gestational age: 30-38 weeks
* Maternal age \< 40 years

Exclusion Criteria:

* Oligo hydramnion
* Severe fetal anomaly e.g. fetal heart anomaly, omphalocele etc.
* Severe fetal macrosomia or growth restriction.

Primary outcomes:
measure: Fetal weight
timeFrame: 10 minutes
measure: Ultrasound fetal weight estimation
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CAMES rigshopsitalet
name: Martin Tolsgaard
role: STUDY_DIRECTOR
References:
Clinical trial NCT00367692: Study Evaluating PSI-697 in Patients With Scleritis
Official title: An Exploratory, Double Blind, Placebo-controlled, Randomized, Single-dose, Cross-over, Proof of Mechanism Study of Orally Administered PSI-697 in Patients With Scleritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Scleritis
Keywords: Scleritis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To evaluate the safety of an orally administered single dose of PSI-697 in subjects with scleritis, as a model of inflammatory disease. To evaluate by in vivo confocal microscopy (IVCM) the effect of a single dose of PSI-697 on leukocyte rolling in the scleral blood vessels of subjects with scleritis.


Eligibility criteria: Inclusion: Age 18 or higher; A negative urine pregnancy test at screening for female subjects; Female subjects must be postmenopausal or surgically sterile.

Exclusion: Isolated episcleritis; Isolated posterior scleritis; Infectious scleritis.

Primary outcomes:
measure: To evaluate by IVCM the effect of a single dose of PSI-697 on leukocyte rolling in scleral blood vessels of subjects with scleritis.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00207792: Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation
Official title: Randomized Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Graft vs Host Disease
Keywords: Granulocyte colony stimulating factor
Lead sponsor: Centre National de Greffe de Moelle Osseuse
Sponsor class: OTHER_GOV
First posted: 2005-09-21
Enrollment: 160
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effect of haematopoietic growth factors on neutrophil recovery after allogeneic bone marrow transplantation is well recognized. Recent laboratory studies demonstrated that these cytokines may also modify T-cell and dendritic cell function, but whether the effect is strong enough to alter the risk of graft-versus-host disease (GvHD) is unclear.

The aim of this randomised study is to determine the effect of granulocyte colony-stimulating factor \[G-CSF\] (Neupogen; filgrastim) on the risk of acute GvHD after allogeneic bone marrow transplantation.


Eligibility criteria: Inclusion Criteria:

* Age: \> 16 years and \< 46 years
* Geno-identical allogeneic bone marrow transplantation
* Myeloablative conditioning regimen
* Haematological malignancies and acquired aplastic anemia
* Written and informed consent

Exclusion Criteria:

* ECOG performance score \> 2
* T-cell depletion
* Serum creatinine level \> 133 µmol/L
* Abnormal liver function
* Positive HIV test
* Pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Centre National de Greffe de Moelle Osseuse
Study officials:
affiliation: Centre National de Greffe de Moelle Osseuse
name: Tarek Ben Othman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02117492: A Randomized Trial Comparing Horizontal and Vertical Vaginal Cuff Closure
Official title: A Randomized Trial Comparing Horizontal and Vertical Vaginal Cuff Closure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysterectomy
Keywords: hysterectomy
vaginal cuff
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 70
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: The purpose of this study is to evaluate the possible impacts of two techniques of vaginal cuff closure during robotic hysterectomy. We aim to compare vertical vs horizontal vaginal cuff closure and the impact that these techniques have on vaginal length, sexual function, and overall complication rates.

Detailed description: A Validated questionnaire the Female Sexual Function Index (FSFI) and total vaginal lengths will be used to evaluate patients pre-operatively, at 4-6 weeks post-operatively, and 6 months post operatively. The FSFI will also be sent to the patient 12 months post operatively. These data will be used to assess sexual function and total vaginal length in patients undergoing minimally invasive hysterectomy. The study endpoint will occur after the 12 month follow-up questionnaire. Additionally, all complications following surgery will be tracked over the study period for comparison.

Eligibility criteria: Inclusion Criteria:

1. Female premenopausal patients undergoing robot assisted total laparoscopic hysterectomy

Exclusion Criteria:

1. Adults unable to consent
2. Children under the age of 18
3. Pregnant women
4. Prisoners
5. Post-menopausal women
6. Women with the known preoperative need for bowel or genitourinary surgery at the time of hysterectomy
7. Patients unable to consent to the procedure in the English language

Primary outcomes:
measure: Vaginal Length
timeFrame: up to 4-6 weeks post-operative
Secondary outcomes:
measure: Sexual Function
timeFrame: Pre-operative, 6 and 12 months post-operativey
Other outcomes:
measure: Complication Rates
timeFrame: up to 12 months post-operativey
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Timothy A Deimling, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06853392: Socket Preservation Using Dentin Graft Autogenous Dentin Graft With Collagen Sponge on Dental Implant Stability AUTOGENOUS TOOTH GRAFT WITH COLLAGEN SPONGE ON DENTAL IMPLANT STABILITY
Official title: Evaluation of Socket Preservation Using Autogenous Dentin Graft With Collagen Sponge on Dental Implant Stability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bone Loss
Bone Remodeling Disorder
Bone Resorption
Keywords: socket preservation
alveolar ridge defect
Dentin graft
Demineralized freeze dried allograft
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
Collaborators: name: Beni-Suef University
First posted: 2025-03-03
Enrollment: 16
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: test group :socket preservation by dentin graft covered with collagen sponge control group :socket preservation by demineralized freeze dried allograft covered by collagen sponge
Primary purpose: PREVENTION

Brief summary: The present study was performed to evaluate socket preservation using collagen sponge with autogenous dentin graft versus collagen sponge with de-mineralised freez-dried bone graft on dental implant stability

Detailed description: in our study we made socket preservation using two different grafts in two groups.

before grafting we took CBCT

we used autogenous dentin graft covered by collagen sponge in one group and demineralized freeze - dried allograft covered with collagen sponge in the other group.

after 6 months we Took another CBCT to assist the dimensional changes and bone density in the alveolar socket after grafting We inserted the implant and during insertion we took a core biopsy with trephine bur with external diameter 3 mm for histological analysis.

After implant insertion we assisted the stability using RFA.

Eligibility criteria: Inclusion Criteria:

* Patients are free from any systemic diseases.
* Patients with good oral hygiene.
* Age range from 25-50 years.
* Adequate inter arch space .

Exclusion Criteria:

* Medications that may affect bone turnover, and bone metabolic diseases.
* Smoker patients and alcoholics.
* Patients with parafunctional habits.
* Patients with active acute infection related to tooth of interest.
* Patients with a lack of compliance, and serious mental or psychological problems.
* Pregnant females.

Primary outcomes:
measure: change in radiographic Socket dimensions from base line to 6 months
timeFrame: 6 months following the end of treatment
measure: change in bone density from base line to 6 months
timeFrame: 6 months following the end of treatment
Secondary outcomes:
measure: new bone formation
timeFrame: after six months at the time of implant placement
measure: implant stability
timeFrame: after six months at the time of implant placement
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AL Azhar university for girls
Study officials:
References:
Clinical trial NCT04879992: Rifabutin-containing Triple Therapy for Treatment of Helicobacter Pylori
Official title: Rifabutin-containing Triple Therapy for Rescue Treatment of Helicobacter Pylori: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori Therapy
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 413
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rifabutin has good chemical stability and low drug resistance rate in acidic gastric environment. Therefore, it is often used in combination with amoxicillin proton pump inhibitor for the rescue treatment of Helicobacter pylori. The purpose of this study was to evaluate the efficacy and safety of rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori


Eligibility criteria: Inclusion Criteria:

* ability and willingness to participate in the study and to sign and give informed consent
* Confirmed H. pylori infection and with previous treatment experience

Exclusion Criteria:

* Less than 18 years old
* With previous gastric surgery
* Previous history of tuberculosis
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

Primary outcomes:
measure: Helicobacter pylori eradication rate
timeFrame: Six weeks after completion of therapy
Secondary outcomes:
measure: Compliance rate
timeFrame: Within 7 days after completion of therapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
References:
Clinical trial NCT01566292: Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy
Official title: Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy: a Randomised, Double-blind, Controlled Trial Using Subjective and Objective Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Benign Prostatic Hyperplasia (BPH)
Benign Prostatic Enlargement (BPE)
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2012-03-29
Enrollment: 33
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The injection of botulinum neurotoxin A into the prostate represents an alternative, minimal invasive treatment in patient with lower urinary tract symptoms (LUTS) associated to benign prostatic hyperplasia (BPH).

Objective: To evaluate the effectiveness of BTA in treating patients with symptomatic BPH and unsatisfactory response to combined medical therapy.


Eligibility criteria: Inclusion Criteria:

* Moderate-to-severe LUTS as determined by the International Prostate Symptom Score
* Mean peak urinary flow rate of no more than 15 mL/s with a voided volume of at least 150 mL, or postvoid residual urine volume (PVR) of more than 100 ml and urodynamic parameters indicative of bladder outlet obstruction (BOO) according to International Continence Society

Exclusion Criteria:

* Patients with neurogenic voiding disorders, prostate or bladder cancer, bladder stones, urethral stricture, chronic bladder catheterization were excluded from the study.

Primary outcomes:
measure: evaluation of symptomatic improvement after treatment as measured by the IPSS score. A successful outcome was defined as a reduction of IPSS score of > 50% from baseline.
timeFrame: 3 month
Secondary outcomes:
measure: safety and tolerability of treatment
timeFrame: 3 month
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University of Sacred Heart
Study officials:
affiliation: Catholic University of sacred Heart
name: PierFrancesco Bassi, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maria G, Brisinda G, Civello IM, Bentivoglio AR, Sganga G, Albanese A. Relief by botulinum toxin of voiding dysfunction due to benign prostatic hyperplasia: results of a randomized, placebo-controlled study. Urology. 2003 Aug;62(2):259-64; discussion 264-5. doi: 10.1016/s0090-4295(03)00477-1.
Clinical trial NCT01635192: Effects of Probiotic VSL#3 on Expression of Small Intestinal Renin-angiotensin System
Official title: Effects of Probiotic VSL#3 on Expression of Small Intestinal Mucosal Renin-angiotensin System and Glucose Absorption in Man - a Doubleblind, Randomized Parallel Arm Placebo Controlled Exploratory Study in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: the Local Renin-angiotensin System (RAS) in Small Intestinal Mucosa in Man
Keywords: renin
angiotensin
probiotic
glucose absorption
intestinal
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
First posted: 2012-07-09
Enrollment: 24
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: BASIC_SCIENCE

Brief summary: Probiotics have become very popular and are by WHO defined as "Live microorganisms which when administered in adequate amounts confer a health benefit on the host". For example, probiotics have been shown to contribute to improvements of abdominal discomfort and intestinal inflammation. The main hypothesis behind the present study is that probiotics influences mucosal regulatory systems, particularly the actions of the hormone Angiotensin II locally in the intestinal mucosa.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers of both sexes
* between 18 and 65 years of age.
* BMI between 18-25 kg/m2

Exclusion Criteria:

* Any drug abuse
* Use of prescription medication within the previous 14 days (with the exception of contraceptives)
* Pregnant or breast feeding woman or woman of childbearing potential not using adequate birth control (e.g. IUD, barrier method, oral contraceptive, abstinence)
* In the investigator's judgement, clinically significant abnormalities at the screening examination or in the laboratory test results.

Primary outcomes:
measure: The change in mucosal expression of components of renin-angiotensin (particularly ACE1, AT1-receptor, AT2-receptor)
timeFrame: Change from baseline in protein expressions after 2 weeks of treatment.
Secondary outcomes:
measure: Changes in epithelial permeability and glucose absorption capacity in vitro
timeFrame: Change from baseline at 2 weeks after start of treatment.
measure: Change in intestinal glucose absorption capacity in-vivo
timeFrame: Change from baseline at 2 weeks after start of treatment.
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dept of Gastrosurgical R&E, Sahlgrenska Universityhospital
Study officials:
affiliation: Göteborg University
name: Lars Fändriks, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: