louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01282138: Assessment of Alcon's Ocular Image Quantification System
Official title: A Study to Assess Alcon's Ocular Image Quantification Using Conjunctival Allergan Provocation Testing (CAPT) and Natural Allergen Exposure in an Environmental Exposure Chamber (EEC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Conjunctivitis
Keywords: Allergic conjunctivitis
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-01-24
Enrollment: 13
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: DIAGNOSTIC

Brief summary: The purpose of this study was to evaluate ocular responses with different allergen provocation methods.

Detailed description: Subjects demonstrating a successful allergen response to a common allergen received the first study treatment and used as instructed for 5 days, after which they entered the Environmental Exposure Chamber (EEC) for a 3-hour exposure to a known concentration of the allergen. After waiting at least 7 days, subjects received the second study treatment and used as instructed for 5 days, after which a 3-hour Conjunctival Allergen Provocation Test (CAPT) was performed with an escalating concentration of the allergen. Subjects dosed with study treatment approximately 15 minutes prior to each allergen provocation test.

Eligibility criteria: Inclusion Criteria:

* History of allergic conjunctivitis;
* Active signs and symptoms of ocular allergies;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* History of dry eye;
* Presence of ocular infection;
* Presence of severe or serious ocular conditions;
* Symptoms of allergic conjunctivitis;
* Use of topical or systemic ocular medications as specified in protocol;
* Ocular surgery or laser surgery within 6 months of study start;
* Unwilling to discontinue contact lens wear 72 hours prior to Visit 1 and during study period;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours
timeFrame: Baseline, 3 hours
measure: Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours
timeFrame: Baseline, 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT00974038: Cognitive Behavior Therapy for Adolescents With Bulimia
Official title: Cognitive Behavior Therapy for Adolescents With Bulimia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bulimia Nervosa
Keywords: Bulimia Nervosa, EDNOS, Adolescents
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2009-09-10
Enrollment: 8
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We are interested in studying two different psychological treatments for eating disorders for adolescents (ages 12-18). The study is designed to help adolescents who are having problems with binge eating and/or purging. The treatment consists of 14 sessions of approximately one-hour each over about three months.

Detailed description: Interested adolescents will have a phone screen and then come in for an in-person psychiatric evaluation. If eligible and interested, they will be randomly assigned to 4 months of outpatient treatment (free of charge) that is either 1) cognitive-behavioral therapy or 2) supportive psychotherapy.

Eligibility criteria: Inclusion Criteria:

* Current or prior DSM IV diagnosis of Bulimia Nervosa or Sub-threshold Bulimia Nervosa (those who meet all DSM-IV criteria for BN, but engage in subjective binge-eating episodes and binge/purge at a frequency of at least once per week for 3 months, whereas meeting full DSM-IV criteria for BN requires binge eating and purging twice per week for 3 months)
* Major Depression

Exclusion Criteria:

* Diagnosis of bipolar disorder, current psychosis, drug or alcohol abuse in past 3 months, acute suicidal risk, major depression producing significant functional impairment, significant medical illness, weight outside of normal weight range.

Primary outcomes:
measure: Binge-eating a purging (EDE scores)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Robyn Sysko, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05569564: Evaluation of Osseodensification Versus Osseodensification With Ridge Splitting in Horizontally Deficient Ridge
Official title: Evaluation of Osseodensification Versus Osseodensification With Ridge Splitting in Horizontally Deficient Ridge (A Randomized Clinical Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osseodensification
Keywords: Osseodensification
Alveolar ridge splitting
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osseodensification is a method of biomechanical bone preparation where specially designed burs increase density of bone as they expand an osteotomy. These osseodensifying burs combine advantages of osteotome bone preservation with the standard traditional drilling burs speed and tactile control. The investigators compared ridge splitting followed by osseodensification versus osseodensification in terms of buccolingual ridge expansion both clinically and radiographically.

Detailed description: Sixteen patients will be randomly allocated into two groups. Ridge splitting followed by osseodensification will be performed with simultaneous implant placement in group I.

Osseodensification will be performed with simultaneous implant placement in group II.

Alveolar ridge width and Implant stability will be assessed clinically. Alveolar ridge width and bone density will be assessed radiographically.

Eligibility criteria: Inclusion Criteria:

* Patients suffering from missing single or multiple maxillay anterior and /or premolar with at least 8 mm alveolar ridge height, with 4-6mm alveolar buccolingual (BL) ridge width.
* Patients should be systemically healthy.
* Patients available during follow up periods.

Exclusion Criteria:

* Pregnant females.
* Smokers.
* Poor oral hygiene.
* Vulnerable patients

Primary outcomes:
measure: assessment of gain in alveolar ridge width
timeFrame: before surgery and immediately after surgery
Secondary outcomes:
measure: primary implant stability
timeFrame: at the end of surgery
measure: bone density
timeFrame: before surgery and immediately after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Dentistry, Ain Shams University
name: Nevine H. El Din, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05748964: Different Surgical Approaches for Treatment of UPJ Obstruction in Children: Prospective Randomized Clinical Trial
Official title: Different Surgical Approaches for Treatment of UPJ Obstruction in Children: Prospective Randomized Clinical Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urologic Diseases
Surgery
Keywords: UPJ obstruction
pediatric urology
pyeloplasty
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children diagnosed with unilateral ureteropelvic junction obstruction

Brief summary: This study aimed to evaluate the clinical efficacy of laparoscopic pyeloplasty (LP) for ureteropelvic junction obstruction (UPJO) via retroperitoneal and transperitoneal approaches.

Detailed description: Ureteropelvic junction obstruction (UPJO) is the most common congenital abnormality of the kidney and is responsible for flank pain, recurrent urinary infections, hydronephrosis and the loss of renal function. Until recently, open pyeloplasty (OP) was the standard surgical treatment modality for UPJO.However, with the development of laparoscopic devices and surgical technology, laparoscopic pyeloplasty (LP) has become a more beneficial choice for the patients with UPJO than open surgery because of the advantages of excellent visualization, minimal trauma, rapid postoperative recovery, good cosmetic result, and a nearly successful rate compared with open pyeloplasty. The first LP in children was performed in 1995. It has gained popularity for older children. LP can be performed though retroperitoneal and transperitoneal approaches. Which surgical method is better is still controversial.

Eligibility criteria: Inclusion Criteria:

* Age above two years.
* Unilateral UPJO.

Exclusion Criteria:

* Age below two years.
* Bilateral UPJO.
* Recurrent UPJO.
* Malrotated kidneys and renal fusion anomalies.

Primary outcomes:
measure: Operative time
timeFrame: From April 1, 2023 to April 1, 2024
Secondary outcomes:
measure: Convergence rate
timeFrame: From April 1, 2023 to April 1, 2024
measure: Post operative complications
timeFrame: From April 1, 2023 to April 1, 2024
measure: Hospital stay
timeFrame: From April 1, 2023 to April 1, 2024
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00253864: Functional Outcomes Following Shoulder Surgery: A Prospective Database
Official title: Functional Outcome Following Shoulder Surgery: A Prospective Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tear
Keywords: shoulder surgery
prospective database
long term outcome
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2005-11-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who underwent an arthroscopic rotator cuff surgery between 2007-2009.

Brief summary: The purpose of this prospective database is to investigate the long-term functional status of patients who have undergone various types of rotator cuff repair surgery. Patients are asked to respond to questionnaires prior to surgery and at various post-operative visits in an attempt to quantify their functional outcomes. Responses are then linked to other data such as symptoms, prior treatments, previous surgery, complications, radiographic results, etc. These data may then be used as a basis for devising guidelines for future patients and surgeons. This particular project is interested in investigating long term results of arthroscopic rotator cuff repair techniques.

Detailed description: The purpose of the prospective database is to initiate data collection for a group of patients undergoing surgery of the shoulder. Long-term data collection will include information on the functional status of the patients' shoulder as well as quality of life information and radiographic results.

For the purposes of this study, we are interested in the long-term outcomes of participants who underwent a double row versus single row fixation in arthroscopic rotator cuff repair procedures.

Eligibility criteria: Inclusion Criteria:

* arthroscopic rotator cuff repairs that occurred between 2007-2009
* enrolled in previous study comparing single vs double-row fixation

Exclusion Criteria:

* withdrew from original study
* unable or unwilling to provide written informed consent
* excluded from original study

Primary outcomes:
measure: Western Ontario Rotator Cuff Index
timeFrame: 10 year post operative
Secondary outcomes:
measure: American Shoulder and Elbow Surgeons Score
timeFrame: 10 year post operative
measure: Constant Score
timeFrame: 10 year post operative
measure: Strength
timeFrame: 10 year post operative
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: OHRI
name: Peter Lapner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06734390: Bladder Neck Surgery in Children with Neurogenic Bladder
Official title: Management of Patients Under 18 Years of Age Who Have Had Bladder Neck Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incontinence
Bladder Dysfunction
Spina Bifida
Neurogenic Bladder Disorder
Child, Only
Keywords: Bladder Neck Surgery
Surgical Outcomes
Child
Retrospective Study
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 46
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with neurogenic bladder

Brief summary: Surgical outcomes of bladder neck surgery in children with neurogenic bladder. Consequences on bladder voiding.

Detailed description: Surgical outcomes of bladder neck surgery in children with neurogenic bladder:

Quality of voiding: spontaneous, need for catheterization, or incontinence. Other surgical complications.

Eligibility criteria: Inclusion Criteria:

* Patients with neurogenic bladder and younger than 18 years old , who underwent a bladder neck procedure

Exclusion Criteria:

* Patients, with neurogenic bladder and older than 18 years old ,who underwent a bladder neck procedure

Primary outcomes:
measure: Number of participants with delayed or incomplete opening of the bladder neck during the voiding phase of micturition impeding urine flow
timeFrame: Before surgery
measure: Long-term urinary continence
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Length of stay
timeFrame: From admission to discharge home, up to 20 days
measure: Complications after bladder neck procedure
timeFrame: Through study completion, an average of 2 years
measure: Follow-up
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: University Hospital, Clermont-Ferrand
state: Auvergne
Study officials:
References:
citation: Stein R, Bogaert G, Dogan HS, Hoen L, Kocvara R, Nijman RJM, Quaedackers J, Rawashdeh YF, Silay MS, Tekgul S, Radmayr C. EAU/ESPU guidelines on the management of neurogenic bladder in children and adolescent part II operative management. Neurourol Urodyn. 2020 Feb;39(2):498-506. doi: 10.1002/nau.24248. Epub 2019 Dec 3.
Clinical trial NCT01724190: Effect of Vitamin D on the Honeymoon Period in Children and Adolescents With Type 1 Diabetes
Official title: Effect of Vitamin D Supplementation on Rate of Partial Clinical Remission in Children and Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 Diabetes
Vitamin D
Clinical Remission
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2012-11-09
Enrollment: 38
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine if supplementation with Vitamin D in children and adolescents with newly diagnosed type 1 diabetes increases the number of patients who enter the honeymoon period.

Detailed description: Type 1 diabetes is an autoimmune disease characterized by destruction of the insulin secreting beta-cells of the pancreas. There is evidence that Vitamin D may play a role in the initial risk of development of autoimmune disease, including type 1 diabetes. However, Vitamin D may also play a role the natural progression of type 1 diabetes by altering innate insulin secretion and sensitivity and by influencing systemic inflammation, directly at the level of the beta-cell. Studies have shown that Vitamin D insufficiency or deficiency is frequently reported in children and adolescents with type 1 diabetes. A majority of newly diagnosed patients with type 1 diabetes enter a period of partial clinical remission, characterized by low or even absent insulin requirements, also known as a honeymoon period. This honeymoon period is associated with improved metabolic control, near normal insulin sensitivity, and recovery of beta-cell function leading to preservation of endogenous insulin secretion. We hypothesize that supplementation with Vitamin D in children and adolescents with newly diagnosed type 1 diabetes will halt the destructive process within the beta cell and improve beta-cell function by increasing endogenous insulin secretion and decreasing systemic inflammation, thereby increasing the rate of partial clinical remission.

Eligibility criteria: Inclusion Criteria:

* children and adolescents ages 4-18 years old with newly diagnosed type 1 diabetes.

Exclusion Criteria:

* age less than 4 years
* pregnant females
* previous or known history of Vitamin D deficiency or insufficiency
* current use of Vitamin D supplementation or multi-vitamin containing \>800 IU daily
* or concurrent development and/or history of other significant systemic illness or non-endocrine autoimmune disorder.

Primary outcomes:
measure: IDAA1c
timeFrame: 9 months disease duration
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Kathryn J Stephens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05646290: Validation of a Model for Predicting Anastomotic Leakage
Official title: Validation of a Machine Learning Model for Predicting Anastomotic Leakage of Esophagogastrostomy and Esophagojejunostomy: A Multicenter Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: machine learning
anastomotic leakage
total and proximal gastrectomy
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 512
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gastric cancer patients undergoing total or proximal gastrectomy in five medical centers (Tongji Hospital, Wuhan No. 1 Hospital, Xianning Central Hospital, Huanggang Central Hospital and Jingzhou Central Hospital) are included in this perspective study.

Brief summary: This study will validate a machine learning model for predicting anastomotic leakage of esophagogastrostomy and esophagojejunostomy.

Detailed description: Anastomotic leakage is a fatal complication after total and proximal gastrectomy in gastric cancer patients. Identifying patients with high-risk of AL is important for guiding the surgeons' decision making, such as a more rigorous anastomotic operation， placing a jejunal feeding tube and dual-lumen flushable drainage catheter. We have developed a high-performance machine learning model based on 1660 gastric cancer patients, which showed good discrimination of anastomotic leakage. Hence, this multi-center prospective study will validiate the usability of the model for predicting anastomotic leakage in gastric cancer patients who receive total and proximal gastrectomy.

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria:

1. Aged older than 18 years and younger than 85 years.
2. Primary gastric adenocarcinoma confirmed by preoperative pathology.
3. Expected curative resection via total or proximal gastrectomy.
4. American Society of Anesthesiologists (ASA) class I, II, or III.
5. Written informed consent.

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. Severe mental disorder or language communication disorder.
3. Other surgical procedures of gastrectomy is performed.
4. Interrupted of surgery for more than 30 minutes due to any cause.
5. Malignant tumors with other organs

Primary outcomes:
measure: Incidence of anastomotic leakage
timeFrame: Within 30 days after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
state: Hubei
Study officials:
References:
Clinical trial NCT05344690: SLMAP and EPO Genetic Polymorphism in Diabetic Retinopathy
Official title: Evaluation of the Relationship Between SLMAP and EPO Genetic Polymorphism and the Risk of Diabetic Retinopathy in Egyptian Diabetic Patients: A Case-Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 180
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All diabetic patients registered to the outpatient clinic of the Endocrinology Unit will be assessed for eligibility followed by screening for diabetic retinopathy by fundoscopic examination Those with diabetic retinopathy will be assigned to the case group while matched diabetic patients free from diabetic retinopathy will be assigned to the control group.

Brief summary: A case-control study to assess the association between the risk of diabetic retinopathy in Egyptians and genetic polymorphism of both EPO and SLMAP genes.

Detailed description: Traditional environmental risk factors, such as glycemic control and duration of diabetes, failed to fully explain why some individuals remain protected while others progress to severe diabetic retinopathy.

Several studies suggest variations in diabetic retinopathy prevalence depending on racial background and genetic polymorphism.

Eligibility criteria: Inclusion Criteria:

* Age \>30-60
* Type 2 DM
* Duration of diabetes from 5-10 years
* Egyptian patients

Exclusion Criteria:

* Other ophthalmic diseases not related to diabetes

Primary outcomes:
measure: Association of SLMAP gene polymorphism and the risk of confirmed diabetic retinopathy diagnosis
timeFrame: At baseline (upon confirmed diagnosis of diabetic retinopathy)
measure: Association of EPO gene polymorphism and the risk of confirmed diabetic retinopathy diagnosis
timeFrame: At baseline (upon confirmed diagnosis of diabetic retinopathy)
Secondary outcomes:
measure: The association of confounding factors on the incidence of diabetic retinopathy
timeFrame: At baseline
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
state: Abbasseya
Study officials:
affiliation: Faculty of Pharmacy, Ain Shams University
name: Lamiaa M El Wakeel, PhD
role: STUDY_CHAIR
References: