louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03102554: Genetics of Differences of Sex Development and Hypospadias
Official title: Utilizing Whole Exome Sequencing and Genomics to Improve Our Understanding of Differences of Sex Development (DSD) and Hypospadias
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Disorders of Sex Development
Hypospadias
Keywords: Exome Sequencing
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Longitudinal cohort
Primary purpose: DIAGNOSTIC

Brief summary: This study seeks to identify genetic causes of conditions that affect the gonads and genitals, and to study the impact on families of receiving genetic results.

Detailed description: This study seeks to understand the genetic causes of conditions that affect the development of the genitals, such as differences of sex development (DSD) and hypospadias, and the impact on families of receiving genetic results. The investigators are recruiting individuals with DSD and/or hypospadias without a clear genetic cause along with their family members for our research study. The investigators will collect samples for genetic studies. The investigators will review the clinical record for history, labs and physical exam information. The investigators will return results of genetic testing to parents/guardians of children with DSD/hypospadias and have them complete questionnaires to assess the impact of receiving these results.

Eligibility criteria: Inclusion Criteria:

* Genital or gonadal abnormalities as evidenced by physical examination or imaging (including but not limited to hypospadias, microphallus, clitoromegaly, ambiguous genitalia), with no cause identified by standard clinical evaluation

Exclusion Criteria:

* Inability to provide informed consent

Primary outcomes:
measure: Decision Regret
timeFrame: 3 months after return of genetic results
Secondary outcomes:
measure: Parenting-Related Stress
timeFrame: 3 months after return of genetic results compared to baseline
measure: Child Health-Related Stress
timeFrame: 3 months after return of genetic results compared to baseline
measure: Anxiety
timeFrame: 3 months after return of genetic results compared to baseline
measure: Depression
timeFrame: 3 months after return of genetic results compared to baseline
measure: Partner Relationship
timeFrame: 3 months after return of genetic results compared to baseline
measure: Partner Blame
timeFrame: 3 months after return of genetic results compared to baseline
measure: Stigma
timeFrame: baseline, 3 months after return of genetic results
measure: Quality of Life score
timeFrame: baseline, 3 months after return of genetic results
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Yee-Ming Chan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06703554: The Impact of Sage Extract on GTS B and D Gene Expression in S. Mutans
Official title: The Impact of Natural Sage Extract on Glucosyltransferase B and D Gene Expression in Streptococcus Mutans: A Randomized Clinical Trial Using Real Time Polymerase Chain Reaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries,Dental
Dental Caries
Dental Diseases
Keywords: High caries risk
Chlorohexidine
Real-time PCR
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sage Extract Natural product
Primary purpose: PREVENTION

Brief summary: Glucosyltransferases (Gtfs) play a crucial role in the pathogenesis of dental caries caused by Streptococcus mutans. Gtfs is recognized as an attractive target for effective therapeutic interventions aimed at inhibiting cariogenic biofilms.

Objective: This study evaluates the antibacterial effects of sage extract compared to chlorhexidine mouthwashes on the expression of Gtf genes in S. mutans from salivary samples of high caries risk patients over a one-month follow-up, utilizing real-time polymerase chain reaction.

Methodology: This clinical trial involves 42 participants with a high risk for caries, who are randomly divided into two groups of 21 subjects each.

Detailed description: Glucosyltransferases (Gtfs) are essential in the development of dental caries caused by Streptococcus mutans. They are currently recognized as promising targets for effective therapeutic strategies aimed at disrupting cariogenic biofilms.

Objective: This study investigates the antibacterial effects of sage extract in comparison to chlorhexidine mouthwashes on the expression of Gtf genes in S. mutans from the saliva of patients at high risk for caries, over a one-month follow-up period, using real-time polymerase chain reaction.

Methodology: This clinical trial includes 42 high caries risk participants, who are randomly assigned to two groups, each consisting of 21 subjects.

Eligibility criteria: Inclusion Criteria:

* medically free, high caries patient with DMFT

Exclusion Criteria:

* pregnant and smokers

Primary outcomes:
measure: real-time PCR
timeFrame: 1 week
measure: real-time PCR
timeFrame: 2 weeks
measure: real-time PCR
timeFrame: 3 weeks
measure: real-time PCR
timeFrame: 4 weeks
measure: Gene Expression
timeFrame: 1 week
measure: Gene Expression
timeFrame: 2 weeks
measure: Gene Expression
timeFrame: 3 weeks
measure: Gene Expression
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT01068054: Efficacy Study of FK-506 and Cyclosporine in Vernal Keratoconjunctivits (VKC)
Official title: A Double-blind Comparison of 0.1% Tacrolimus Ophthalmic Ointment and 2% Cyclosporine Eye Drops in the Treatment of Vernal Keratoconjunctivits (VKC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Keratoconjunctivitis, Vernal
Keywords: vernal keratoconjunctivitis
FK-506
tacrolimus
cyclosporine
children
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2010-02-12
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was a double-blind, parallel study to compare efficacy of 0.1% tacrolimus ophthalmic ointment vs 2% cyclosporine eye drops in children with vernal keratoconjunctivitis. The duration of the blinded period was 8 weeks followed with 4 weeks of open-period of tacrolimus ointment. The hypothesis was that tacrolimus was as effective as cyclosporine for the treatment of this condition.

Detailed description: Background: Vernal keratoconjunctivitis (VKC) is a serious, sight-threatening ocular disease, occurring mainly in children. Prolonged use of ophthalmic corticosteroids is usually required in severe cases which could lead to serious complications such as glaucoma and cataract. Cyclosporine and tacrolimus are among newer treatments for VKC.

Objective: To compare the efficacy of 0.1% tacrolimus (FK-506) ophthalmic ointment with 2% cyclosporine eye drops in the treatment of VKC.

Methods: Twenty-four patients with VKC were recruited. After a 2 week-washout period, they were randomized into 2 groups in a double-blinded, parallel fashion. The first group received 0.1% FK-506 eye ointment with placebo eye drops and the second group received 2% cyclosporine eye drops with placebo ointment for 8 weeks. Thereafter, all patients received an open-treatment with 0.1% FK-506 eye ointment for another 4 weeks. Subjective ocular symptoms and side effects were scored by patients at the entry, and at the end of the 1st, 4th, 8th and 12th weeks. Objective ocular signs were evaluated by an ophthalmologist (PK) at all follow up visits.

Eligibility criteria: Inclusion Criteria:

* patients with clinical diagnosis of vernal keratoconjunctivitis

Exclusion Criteria:

* coexisting ocular diseases such as glaucoma, other corneal disease, ocular infections, other coexisting systemic diseases

Primary outcomes:
measure: overall subjective ocular symptom scores
timeFrame: 8 weeks
Secondary outcomes:
measure: overall objective ocular signs
timeFrame: 8 weeks
measure: overall side-effect scores
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
Study officials:
affiliation: Siriraj Hospital
name: Pakit Vichyanond, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00891254: Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh
Official title: Randomized Study of Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh Versus On-lay Mesh Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Incisional Hernia
Keywords: Incisional hernia
Intraperitoneal mesh repair
On-lay repair
Prosthetic mesh
First repair (no recurrent hernia will be included)
Recurrence
Complications
Lead sponsor: Cirujanos la Serena
Sponsor class: OTHER
First posted: 2009-05-01
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The intraperitoneal repair has been proven safe for the repair of incisional hernia and is accepted, together with the subfascial or retromuscular repair as the "gold-standard" for the repair of incisional hernia. However no studies have convincingly proven that this approach is better than the on-lay repair.

The authors believe that the intraperitoneal repair performs better than the on-lay repair for incisional hernia.


Eligibility criteria: Inclusion Criteria:

* Patients with incisional hernia 5 cm of diameter or with an area of 25 square cm (cm2)
* First repair
* Older than 35 years of age and younger than 75 years of age
* Both genders
* Any BMI
* Only upper abdominal midline incisional hernias (supraumbilical)
* Patients submitted only to elective repair

Exclusion Criteria:

* Recurrent incisional hernia
* Emergency surgery
* Hernias with a diameter higher than 5 cm or more than 25 cm2 of area
* Lower midline abdominal incisional hernias
* Other hernias rather than midline incisional hernias
* Non-incisional hernias

Primary outcomes:
measure: Long-term recurrence
timeFrame: 5 years
Secondary outcomes:
measure: Short-term complications
timeFrame: 1 year
Other outcomes:
Locations:
city: La Serena
country: Chile
facility: Hospital de La Serena
state: Iv Region
Study officials:
affiliation: Hospital de La Serena
name: MARCELO A BELTRAN, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04086654: Psychometric Properties of the International Trauma Interview (ITI) for ICD-11 PTSD and CPTSD
Official title: Psychometric Properties of the International Trauma Interview (ITI) for ICD-11 PTSD and CPTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder (PTSD)
Complex Post-Traumatic Stress Disorder (CPTSD)
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the project is to evaluate the psychometric properties (e.g. validity, reliability) of the International Trauma Interview (ITI) - German version. The ITI is a structured clinical interview that corresponds to the ICD-11 criteria for diagnosing both posttraumatic stress disorder (PTSD) and complex posttraumatic stress disorder (CPTSD).

Eligible participants from psychiatric inpatient and outpatient facilities in Switzerland who have provided informed will complete various self-report measures about trauma-related mental health complaints. In addition, the ITI will be conducted by a trained clinician. Lastly, information from the medical chart will be further used for scientific purpose. The overall assessment will take approximately 1-2 hours to complete.


Eligibility criteria: Study-specific Inclusion criteria

* Structured diagnostic procedures upon hospital entry not yet started, except for orienting assessments
* Able to give informed consent as documented by signature
* Able to understand and communicate in German Exclusion criteria
* Clinical signs for impaired cognitive abilities
* Other contraindications to undergo the clinical interview

Primary outcomes:
measure: International Trauma Interview (ITI)
timeFrame: Up to two weeks upon psychiatric ward entry
measure: Life Event Checklist DSM-5
timeFrame: Up to two weeks upon psychiatric ward entry
Secondary outcomes:
measure: Beck Depression Inventory II
timeFrame: Up to seven days upon psychiatric ward entry
measure: Brief Symptom Checklist
timeFrame: Up to seven days upon psychiatric ward entry
measure: Impact of Event Scale Revised Version
timeFrame: Up to seven days upon psychiatric ward entry
measure: PTSD Checklist for DSM-5
timeFrame: Up to seven days upon psychiatric ward entry
measure: Borderline Symptom List
timeFrame: Up to seven days upon psychiatric ward entry
Other outcomes:
Locations:
city: Winterthur
country: Switzerland
facility: Integrierte Psychiatrie Winterthur, Spezialstation für Traumafolgestörungen
state: Zurich
Study officials:
References:
Clinical trial NCT00263354: Oxaliplatin in Gastric Cancer
Official title: Oxaliplatin Phase II Trial in Association With 5FU and Folinic Acid in the Treatment of Advanced Unresectable or Metastatic Gastric Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stomach Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-12-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the objective response to oxaliplatin/5FU/leucovorin combination chemotherapy in patients with advanced unresectable or metastatic gastric cancer.


Eligibility criteria: Inclusion Criteria:

* ECOG performance status of 0-2.
* Histologically proven gastric or gastro-esophageal junction adenocarcinoma.
* At least unidimensional measurable disease. If a unique metastasis constitutes the only disease sign, it requires histological confirmation.
* First line locally unresectable or metastatic gastric cancer.
* Relapsing gastric cancer after local and/or systemic treatment with a post-surgical period of at least 4 weeks, a post-adjuvant or neoadjuvant chemoradiotherapy period of at least 6 months.
* Serum bilirubin \< 2 mg/dl
* Serum creatinine \< or = 2 mg/dl
* Hemoglobin \> or = 10 g/dl
* Absolute neutrophil count \> or = 2000/dl
* Platelet count \>or = 100, 000/dl
* AST/ALT \< or = 2.5 time-fold the institutional normal upper limit
* Alkaline phosphatase \< or = 5 time-fold the institutional normal upper limit
* Imagenological evaluation of the patient at least 2 weeks prior to the drug infusion
* Laboratory tests at least 1 week prior to the first infusion
* Patient available for follow up and able to answer to the quality of life questionnaire

Exclusion Criteria:

* Symptomatic sensorial peripheral neuropathy
* Uncontrolled concomitant disease
* Another malignant neoplastic disease diagnosed within the previous 5 years to the diagnosis of advanced or metastatic gastric cancer, with the exception of 'in situ' cervix carcinoma or non-melanoma skin cancer
* Concomitant antitumoral treatment
* Cerebral metastases
* Unstable heart disease, even though in treatment
* Myocardial infarction within the last 6 months
* Radiotherapy within the last 6 weeks, surgery within the last 4 weeks, or chemotherapy within the last 6 months.
* Pregnancy or nursing ( or women in reproductive life without adequate contraception)
* Significant neurological or psychiatric disorders.

Primary outcomes:
measure: To evaluate response rate according to RECIST criteria
measure: To evaluate the progression-free survival in the ITT population
Secondary outcomes:
measure: To evaluate the overall survival in the ITT population
measure: To investigate safety using NCI-CTC criteria version 2
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Jesus M. Ruiz, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06986954: Beacon Tip Sizing Catheter and Slip-Cath Beacon Tip Catheter Study
Official title: Beacon Tip Sizing Catheter and Slip-Cath Beacon Tip Catheter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stenosis
Bleed Intracranial
Stroke
TIA
Vascular Malformation
Pseudoaneurysm
Keywords: Catheter
Beacon
Diagnostic imaging
Device sizing
Beacon tip slip cath
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2025-05-23
Enrollment: 588
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient population for this study will be patients receiving care at the 8 office-based labs (OBLs) consisting of 14 sites, all part of the Data Collection Center, Vascular Breakthroughs. These patients will not be constrained to a specific demographic, but rather will be any person who undergoes a procedure using a Beacon Tip Catheter(s).

Brief summary: This prospective observational post-market clinical study will collect data in the United States to primarily support the re-launch of the re-designed Beacon Tip Sizing Catheter and Slip-Catheter Beacon Tip Catheter \& Shuttle Select Slip-Catheter (Visceral and Cerbral) for a Conformité Européenne (CE) Mark application in the European Union (EU). Additionally, the data from this study may be used to support regulatory approval in other countries/regions.

The purpose of this clinical study is to evaluate the safety and performance of these catheters in accordance with the Intended Use through the end of index procedure, and through 30 days post procedure, (as applicable as data is available) to ensure an acceptable benefit:risk ratio.


Eligibility criteria: Inclusion Criteria:

* A patient is deemed suitable for inclusion in this study if the patient undergoes a procedure using an applicable Beacon Tip Catheter.

Exclusion Criteria:

* Patient or his/her legally authorized representative objects to collection and processing of his/her data, or not willing to accept the use of an Informed Consent waiver or the data protection notice (if utilized).

Primary outcomes:
measure: Successful navigation to the intended location
timeFrame: Duration of the procedure (approx. 1 hour)
measure: Successful intended use
timeFrame: Duration of the procedure (approx. 1 hour)
measure: Freedom from catheter-related major complications
timeFrame: up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Darien
country: United States
facility: Vascular Breakthroughs
state: Connecticut
Study officials:
References:
Clinical trial NCT03856554: Unilateral Versus Bilateral TLIF for Degenerative Lumbar Spondylolisthesis
Official title: Comparison of Radiologic and Clinical Outcome of Single Level Lumbar Interbody Fusion Between Unilateral or Bilateral Facetectomy : Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Degenerative Spondylolisthesis
Transforaminal Lumbar Interbody Fusion
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Transforminal lumbar interbody fusion

: unilateral versus bilateral facetectomy
Primary purpose: TREATMENT

Brief summary: A prospective randomized controlled trial for comparison of radiologic outcomes of "single level transforaminal interbody fusion(TLIF) technique via unilateral versus bilateral facetectomy for the treatment of lumbar degenerative spondylolisthesis

Detailed description: Traditionally many spine surgeons prefer single level TLIF surgery via bilateral facetectomy for increasing union rate. Our hypothesis - "Single level TLIF via unilateral facetectomy is sufficient for achieve successful fusion rate"

Eligibility criteria: Inclusion Criteria:

* lumbar degenerative spondylolisthesis
* indicated for surgery

Exclusion Criteria:

* not agreed for the study

Primary outcomes:
measure: Sagittal balance
timeFrame: through study completion, an average of 1 year
measure: Interbody fusion(union) failure
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Pain scores
timeFrame: through study completion, an average of 1 year
measure: Functional scores
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Spine Center, Kyoungpook National University Hospital
Study officials:
References:
Clinical trial NCT01361854: Comparison of 2 Different Hook-up Protocols to Perform Home-based Polysomnography
Official title: Comparison of 2 Different Hook-up Protocols to Perform Home-based Polysomnography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disordered-breathing
Keywords: polysomnography
portable monitoring
sleep
sleep disordered breathing
home based polysomnography
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2011-05-27
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Comparison of 2 hook-up protocols to perform home-based sleep studies in patients suspected of sleep-disordered breathing.

First one: hook-up is performed in the hospital, around 4 PM, and the patient go home with the portable monitoring.

Second one: hook-up is performed home, around 7 PM, and the patient has not to move after hook-up.

Detailed description: All the patients will undergo 2 polysomnographies, according to two different hook-up protocols, within 2 weeks. Order of the exams will be randomized.

We hypothesised that quality of recording is better when hook-up is performed at home.

Final polysomnographic diagnosis, with the 2 different techniques, must be similar.

Eligibility criteria: Inclusion Criteria:

* adult,
* suspects of SDB,
* leaving home,
* at maximum 30km around the hospital

Exclusion Criteria:

* suspicion of other sleep disorders
* children

Primary outcomes:
measure: Failure Rate of Sleep Study
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Saint Pierre
Study officials:
affiliation: CHU St Pierre
name: marie Bruyneel, MD
role: PRINCIPAL_INVESTIGATOR
References: