louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05023187: Social and Cognitive Online Training: the SCOT Project
Official title: SCOT: An Online Intervention to Reduce Social Isolation and Promote Cognitive Well-being in the Elderly Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Cognitive Decline
Lead sponsor: Università degli Studi di Trento
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Social isolation and reduced involvement in cognitive activities are associated with repercussions on cognitive well-being and health status in elderly adults. In particular, loneliness and social isolation represent risk factors in favouring cognitive decline and dementia. The Social Cognition Online Training (SCOT) project aims to evaluate the beneficial effects of an online intervention on social-cognitive functioning in healthy elderly subjects.


Eligibility criteria: Inclusion Criteria:

* Cognitively healthy subjects aged above 65 years old
* Montreal Cognitive Assessment (MoCA) equivalent score \> 1 (Italian normative values)

Exclusion Criteria:

* Diagnosis of dementia, based on Diagnostic and Statistical Manual of Mental Disorders, FifthEdition (DSM-V)
* History of current or previous neuropsychiatric disorders;
* History of current or previous substance abuse;

Primary outcomes:
measure: The Tower of London test (Boccia et al. 2017)
timeFrame: Day 0 - Month 3
Secondary outcomes:
measure: Experimental task of emotion recognition
timeFrame: Day 0 - Month 3
measure: Italian Social and Emotional Loneliness Scale
timeFrame: Day 0 - Month 3
Other outcomes:
Locations:
city: Rovereto
country: Italy
facility: Centro Interdipartimentale Mente/Cervello - CIMeC
state: Trento
Study officials:
affiliation: Centro Interdipartimentale Mente/Cervello - CIMeC
name: Costanza Papagno
role: STUDY_DIRECTOR
affiliation: Centro Interdipartimentale Mente/Cervello - CIMeC
name: Alessandra Dodich
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03512587: Personalized Quantum Sonotherapy in Regional Anesthesia
Official title: Personalized Quantum Sonotherapy in Regional Anesthesia Peripheral Nerve Block: Randomized and Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Anxiety
Keywords: Personalized quantum sonotherapy
Regional anesthesia
Peripheral nerve block
Lead sponsor: CES University
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objetive of the study is to evaluate the effect of personalized quantum sonotherapy on the level of anxiety and pain in outpatients schedule for orthopedic surgery under regional anesthesia in a second level center. The investigators believed that personalized quantum sonotherapy could reduce the levels of anxiety and pain before and after surgery evaluated through hemodynamic variables and scales for pain (analogous visual scale) and anxiety (STAI Spielberger anxious state questionnaire).


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective orthopedic ambulatory surgery under regional anesthesia
* Age between 18 and 60 years.
* Patients with anesthetic risk ASA 1 and 2.
* Patients without contraindications for the administration of opioids and benzodiazepines.
* Patients living in the metropolitan area who have a telephone line and can be contacted by telephone within the first 48 hours through calls at 24 and 48 hours after surgery, made by the researchers at the number previously reported by the patient.
* Patients with an adequate level of understanding, who are able to communicate by telephone and understand a numerical scale.
* Patients who agree to participate in the work.

Exclusion Criteria:

* Patients with auditory and cognitive problems.
* Patients requiring general anesthesia at some time during the intraoperative period.
* Patients with morbid obesity.
* Patients consuming anxiolytics in the last month.
* Patients whose start of surgery is after 45 minutes of the blockade.

Primary outcomes:
measure: Pain
timeFrame: 48 hours (From the moment before surgery when the sonotherapy is apply until 48 hours after surgery)
measure: Anxiety
timeFrame: 48 hours (From the moment before surgery when the sonotherapy is apply until 48 hours after surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Instituto Colombiano del Dolor
state: Antioquia
Study officials:
affiliation: University CES
name: Mara P Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06549387: Topo-Pachymetric Customized Accelerated Epi-On Vs Accelerated Epi-Off Corneal Cross Linking in Keratoconus Management
Official title: Topo-Pachymetric Customized Accelerated Epithelium-On Versus Standard Accelerated Epithelium-Off Corneal Collagen Cross Linking in the Management of Keratoconus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Amount of Corneal Flattening (Kmax Flattening)
Change in the Endothelial Cell Count
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 55
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 objective of this study is to compare the clinical effectiveness and safety of Topo-Pachymetric Customized Accelerated Epithelium-On (aCFXL) to Standard Accelerated Epithelium-Off (aCXL) Corneal Collagen Cross-Linking in the management of keratoconus. The study aims to evaluate visual and structural outcomes, to provide valuable insights into optimizing treatment strategies.


Eligibility criteria: Inclusion Criteria:

1. Age: 18 years or older
2. Corrected distance visual acuity (CDVA) of ≥ 0.3 Snellen.
3. Central corneal thickness (de-epithelialized) of ≥ 400 micron.
4. Corneal endothelial count of ≥ 2000.

Exclusion Criteria:

1. Previous eye surgery
2. The presence of lesions other than keratoconus, central or paracentral scaring
3. History of Cross linking
4. History of viral keratitis
5. Connective tissue diseases
6. Pregnancy or lactation during the study.
7. The presence of nystagmus

Primary outcomes:
measure: Amount of corneal flattening
timeFrame: 6 months
measure: Change in the endothelial cell count.
timeFrame: 6 months
Secondary outcomes:
measure: Best corrected visual acuity
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al Ainy
Study officials:
References:
Clinical trial NCT01809587: IQP-PO-101 for the Regulation of Bowel Movement Frequency
Official title: Open Label Study to Assess the Safety and Efficacy of IQP-PO-101 in Regulating Bowel Movement Frequency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Constipation
Irregular Bowel Movement Frequency
Lead sponsor: InQpharm Group
Sponsor class: INDUSTRY
First posted: 2013-03-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and efficacy of IQP-PO-101 in regulating the bowel movement frequency


Eligibility criteria: Inclusion Criteria:

* A subject must have experienced 2 - 4 bowel movements per week and at least 2 of the following symptoms over the preceding 3 months (self-reported):

  * Excessive straining
  * Lumpy or hard stools
  * Sensation of anorectal obstruc-tion
  * A sense of incomplete evacua-tion of bowel movements
  * A need for digital manipulation to facilitate evacuation
* Recorded between 4 and 9 defecations in the 14-day bowel movement diary during the run-in period
* Subjects of childbearing potential must agree to use appropriate contraceptive methods during run-in and treatment period
* Commitment to avoid the use of any laxatives and/ or other medicinal products/ supplements that may interfere with bowel movement frequency during the run-in and treatment period
* Written informed consent.

Exclusion Criteria:

* Known sensitivity to the ingredients of the device
* Any organic gastrointestinal diseases, congenital or otherwise
* Presence of occult blood on screening
* Constipation that may have been drug-induced
* Use of any laxative/ products that help ease bowel movements within 7 days of the screening visit
* Constipation other than idiopathic constipation
* Presence of other factor(s) that, in the in-vestigator's judgement, should preclude subject participation

Primary outcomes:
measure: Bowel movement frequency
timeFrame: 6 weeks
Secondary outcomes:
measure: Bristol Stool Form Scale
timeFrame: 6 weeks
measure: Straining at the start/ end of defecation
timeFrame: 6 weeks
measure: Pain during defecation
timeFrame: 6 weeks
measure: Feeling of incomplete evacuation
timeFrame: 6 weeks
measure: Evaluation of efficacy by subjects
timeFrame: 4 weeks
measure: Evaluation of efficacy by investigator
timeFrame: 4 weeks
measure: Full blood count
timeFrame: 4 weeks
measure: Clinical chemistry
timeFrame: 4 weeks
measure: Safety evaluation by subjects
timeFrame: 4 weeks
measure: Safety evaluation by investigators
timeFrame: 4 weeks
measure: Adverse events
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Analyze & Realize Ag
Study officials:
References:
Clinical trial NCT04686487: SterEotactic AbLative Radiotherapy in PatiEnts With HypertrophiC ObstrucTive Cardiomyopathy
Official title: Stereotactic Ablative Radiotherapy in Patients With Hypertrophic Obstructive Cardiomyopathy: First in Man Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertrophic Obstructive Cardiomyopathy
Keywords: Hypertrophic Obstructive Cardiomyopathy
Stereotactic Ablative Radiotherapy
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 5
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: Hypertrophic obstructive cardiomyopathy (HOCM) is an inherited myocardial disease which leads to the muscle in the wall of the heart growing and thickening to the point that it blocks blood flow exiting the heart with increasing risk of sudden cardiac death, heart failure, and atrial fibrillation. Surgical septal myectomy and alcohol septal ablation are two invasive therapies for drug-refractory symptomatic patients with HOCM. Unfortunately, some patients may be unsuitable for both the two procedures. Recently, stereotactic ablative radiotherapy, usually used for the treatment of tumours, was confirmed to be feasible, safe and effective in destroying abnormal tissue in heart by targeting high energy heavy ion beams at a specific area of the body precisely. In this study we will determine whether radiation ablation, can be used to destroy the thick heart muscle at the point of obstruction safely and effectively.


Eligibility criteria: Inclusion Criteria:

* Male or female aged ≥ 18 years
* Drug-refractory symptomatic patients with HOCM
* Willing and able to give written informed consent

Exclusion Criteria:

* Enrolled in another clinical study.
* Patient unable to tolerate lying flat for one hour
* Pregnant Or Lactating Women
* With other contraindications for receive stereotactic ablative radiotherapy

Primary outcomes:
measure: Safety of stereotactic ablative radiotherapy
timeFrame: 3 months
Secondary outcomes:
measure: Assessment of MACE endpoints
timeFrame: 1, 3, 6 and 12 months
measure: Development of complete heart block, atrial or ventricular arrhythmias
timeFrame: 1, 3, 6 and 12 months
measure: Change in LVOT gradient
timeFrame: 1, 3, 6 and 12 months
measure: Change in exercise capacity
timeFrame: 1, 3, 6 and 12 months
measure: Change in LV wall thickness
timeFrame: 1, 3, 6 and 12 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
References:
Clinical trial NCT01752387: The Management of Sportsman's Groin Hernia in Professional and Amateur Soccer Players
Official title: A Study, Based on Medical Record and Questionnaire, Investigate the Management of Sportsman's Groin Hernia in Professional and Amateur Soccer Players -Results of the Follow-up in Our Department and a Comparison the Medical Literature
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sportsman's Groin Hernia
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2012-12-19
Enrollment: 246
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: soccer players with groin pain

Brief summary: The purpose of this study is to compare the surgical treatment for sportsman's hernia in our department to the current literature. Our hypothesis is that combined solution for the two major problems that cause pain in this syndrome - repair the weakness in the posterior wall of the inguinal canal with "tension free" technique (mesh repair) and reducing the muscle strain on the abdominal wall by cutting, partially, the tendon of the external oblique muscle, will shorten the time to return to full physical activity in soccer players.


Eligibility criteria: Inclusion Criteria:

* Soccer players who reffered to our clinic
* soccer players diagnosed with sportsman's hernia
* Failure of conservative treatment
* Underwent conventional surgery for sportsman's hernia in our department
* Completed the follow-up in our clinic
* age : 14-40
* male and female

Exclusion Criteria:

* soccer players who were diagnosed of had there surgery in other places
* soccer players who recover after conservative treatment

Primary outcomes:
measure: time to return to full physical activity
timeFrame: 2 month
Secondary outcomes:
measure: pain after the surgery
timeFrame: 1 week, 2 weeks and 4-6 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04120987: Ocular Inflammation in Cataract Patients and Response to Treatment With Xiidra
Official title: The Incidence of Ocular Inflammation as Defined by the Inflammadry Assay in 250 Consecutive Cataract Patients and Their Response to Treatment With Xiidra
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Dry Eye
Keywords: cataract
lifitegrast
dry eye syndrome
ocular surface inflammation
hyperosmolarity
MMP-9
Lead sponsor: Bucci Laser Vision Institute
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if the use of Xiidra® reduces ocular surface inflammation in preoperative and postoperative cataract patients.

Detailed description: Single-center, prospective, randomized, investigator-initiated study

250 cataract patients, aged 60 or older, will be tested for ocular surface inflammation with the InflammaDry® immunoassay

Patients with bilateral positive MMP-9 will be randomized into a group treated with Xiidra two weeks preoperatively and six weeks postoperatively or a group not treated with Xiidra

The investigator hypothesizes that treatment with Xiidra prior to routine cataract surgery will significantly improve the quality of keratometry readings and BCVA.

Eligibility criteria: Inclusion Criteria:

* Positive for MMP-9 bilaterally as assessed by the Inflammadry assay

Exclusion Criteria:

* Negative Inflammadry assay in either eye
* Active diabetic retinopathy, uncontrolled glaucoma, uncontrolled uveitic inflammation
* Ocular surface diseases that might confound the interpretation of the InflammaDry assay

Primary outcomes:
measure: Compare the conversion rates of bilateral positive MMP-9 to negative in pre-cataract and post-cataract patients receiving treatment with Xiidra versus no Xiidra
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Wilkes-Barre
country: United States
facility: Bucci Laser Vision
state: Pennsylvania
Study officials:
affiliation: Bucci Laser Vision
name: Frank A Bucci, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05047887: Socket Preservation Using Socket Shield Technique Comparison of Socket Preservation Using Socket Shield Technique With Autogenous Dentin Graft Versus Alloplast Graft Material
Official title: Comparison of Socket Preservation Using Socket Shield Technique With Autogenous Dentin Graft Versus Alloplast Graft Material (Clinical and Histological Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extraction Tooth Socket
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A single group in a split-mouth design, right and left sides are randomly allocated to the intervention group (16 sides in 8 patients)
Primary purpose: TREATMENT

Brief summary: Alveolar bone resorption and labial bone plate reduction follow teeth extraction due to the deficiency of blood supply, derived from the loss of periodontal ligaments, and hence the socket shield technique with autogenous dentine was introduced to preserve the periodontal ligaments.

this study aim to evaluate of socket preservation using alloplast with socket shield versus Autogenous dentin graft with socket shield through radiographic analysis of alveolar bone dimension change and mean bone density in addition to histological and histomorphometric analysis for the quality of the formed bone.


Eligibility criteria: Inclusion Criteria:

* One or more of non-restorable (fractured or decayed) tooth/teeth in the maxillary aesthetic regions (incisors, premolars) in both side
* Intact labial periodontal tissues.
* Ability to read and sign an informed consent form.

Exclusion Criteria:

* A medical history that contraindicates oral surgical treatment (uncontrolled/untreated diabetes mellitus, immunocompromised status, radio/chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous amino-bisphosponates).
* Untreated periodontal disease.
* Vertical root fractures on the labial aspect.
* Tooth /teeth with horizontal fractures below bone level.
* Tooth /teeth with external or internal resorptions.

Primary outcomes:
measure: post opertaive edema
timeFrame: after 7 days
measure: change in pain score
timeFrame: 1 week and 3 months
measure: Change in bone density
timeFrame: at baseline and 3 months
measure: Change in bone height
timeFrame: at baseline and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT02787187: Lymphadenectomy for Pancreatic Head Cancer: Standard or Extended?
Official title: A Prospective Randomized Controlled Study Comparing Standard and Extended Lymphadenectomy for Pancreatic Head Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Ductal Adenocarcinoma
Keywords: Standard lymphadenectomy
extended lymphadenectomy
pancreaticoduodenectomy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
First posted: 2016-06-01
Enrollment: 230
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: The purpose of this study is to compare outcomes of patients undergoing standard or extended lymphadenectomy in pancreaticoduodenectomy for pancreatic cancer


Eligibility criteria: Inclusion Criteria:

* Pathologic diagnosis of pancreatic ductal adenocarcinoma
* Signed the informed consents

Exclusion Criteria:

* Pathologic diagnosis of other pancreatic cancers
* Pre-operative anti-cancer treatment
* Recurrence patients
* Patients with contraindication(hepatic/ respiratory/ renal dysfunction, etc )
* Pre operative exam: Total bilirubin more than 250µmol/L
* AJCC stage IV
* Operation non radical

Primary outcomes:
measure: All-cause mortality
timeFrame: 3yrs post-operation
Secondary outcomes:
measure: all-cause mortality
timeFrame: 1yr post-operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Ruijin Pancreatic Disease Center
name: Baiyong SHEN
role: STUDY_DIRECTOR
References: