louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04507009: Clinical Investigation of the Efficacy of CGF and Ozone in the Treatment of Alveolar Osteitis
Official title: Clinical Investigation of the Efficacy of CGF (Concentrated Growth Factor) and Ozone in the Treatment of Alveolar Osteitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Osteitis
Keywords: Alveolitis
Dry socket
Ozone
CGF
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the efficacy of CGF and Ozone in the treatment of alveolitis and to develop a new treatment protocol that can enable a quick and effective solution of this clinical problem, which significantly affects patients' comfort of life.

Detailed description: In the present study, 60 healthy patients \> 18 years old and have alveolitis, will included. 60 patient will divided randomly into three groups as Control, Ozone and Ozone+CGF. After irrigation of the sockets alvogyl, ozone and ozone+CGF will applied to the sockets respectively. Post operative pain, will measured at 1st to 7th days. Post operative infection, and granulation tissue will measured at 1st, 3rd and 7th days. Oral hygiene will evaluated at first visit. Quality of life will evaluated at 7th day.

Eligibility criteria: Inclusion Criteria:

Patients who have one or more of the following in addition to severe pain, which occur within and around the socket 1-3 days after extraction and do not decrease with pain killers;

* With a partially or completely disintegrated blood clot in the socket
* With exposed bone that gives a dark gray appearance
* With bad odor

Exclusion Criteria:

* Who does not want to be volunteer for the study,
* Smokers,
* During pregnancy or lactation,
* Has a chronic systemic disorder that will affect recovery,
* Has hematological disorder
* Cooperation cannot be established,
* Previously received radiotherapy or chemotherapy,
* Patients using oral contraceptives

Primary outcomes:
measure: Change in post-operative pain assessed: visual analog (VAS) scale
timeFrame: 6th and 24th hour, 2nd day, 3rd day, 4th day, 5th day, 6th day and 7th day
Secondary outcomes:
measure: Granulation tissue health
timeFrame: postoperative 1st, 3rd, 7th days
measure: Inflamation severity
timeFrame: postoperative 1st, 3rd, 7th days
measure: Change in the quality of postoperative life after the procedures performed
timeFrame: postoperative 7th day
Other outcomes:
measure: Oral hygiene degree
timeFrame: Evaluation of the oral hygiene before operation
Locations:
city: Ordu
country: Turkey
facility: Ordu University
Study officials:
affiliation: T.C. ORDU ÜNİVERSİTESİ
name: Damla Torul, DDS PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06108609: Validation of the French Version of the Hearing Aid Benefit Measurement COSI and IOI-HA Questionnaires
Official title: Validation of the French Version of the Hearing Aid Benefit Measurement COSI and IOI-HA Questionnaires
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hearing Impairment
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2023-10-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 patients seen for consultation, with unilateral or bilateral hearing aids

Brief summary: Estimating patient satisfaction is essential in modern day-to-day medical practice. This is particularly true in the field of audiology where evaluating the benefit of patients' devices makes it possible to improve settings and increase patient satisfaction and therefore compliance. Questionnaires measuring hearing aid benefit such as the IOI-HA (International Outcome Inventory for Hearing Aids) and the COSI (Client Oriented Scale of Improvement) are used in everyday practice and promote cooperation between researchers by providing comparable data. Unlike other countries, these questionnaires have never been validated in French by psychometric studies. The objective of this study is to validate the translation of the IOI-HA questionnaire already used in the clinic and to adapt the COSI into French and statistically validate its translation.

Detailed description: Recruitment of cases via the otological consultation of the ENT department, among patients consulting for hearing aids. Inclusion will be suspended once 100 tests and at least 35 re-tests have been completed.

Inclusion (D0):

* Audiometry (as part of treatment)
* Clinical evaluation (as part of treatment)
* Passing the French version of the COSI and IOI-HA questionnaires Visit 1 (D0 +3±1 week): only for 35 patients Second administration of the French version of the COSI and IOI-HA questionnaires either by telephone, or during a second consultation or hospitalization, if this occurs within a compatible time frame.

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years old
* Diagnosis of deafness with unilateral or bilateral hearing aid
* Informed consent to participate in the study
* Good understanding of French
* Non-opposition to participation in the study

Exclusion Criteria:

* Comorbidity that may hamper the interpretation of results (e.g. disabling cognitive disorder)

Primary outcomes:
measure: Statistical validation of the French version of the IOI-HA and COSI questionnaires: Reproducibility, internal consistency, relevance and discriminatory performance of the tests
timeFrame: 3 +/- 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Fondation Adolphe de Rothschild
Study officials:
References:
Clinical trial NCT02060409: Prognostic Molecular Markers in Patients With Myelodysplastic Syndrome
Official title: Prognostic Molecular Markers Determined by Using Gene Expression Profiling in Patients With Myelodysplastic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelodysplastic Syndrome
Keywords: myelodysplastic syndrome
decitabine
spliceosome mutation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 58
Sex: ALL
Minimum age (years): 17
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: de novo MDS patients were included in the study who had received 1st line decitabine treatment and had adequate genomic DNA from pretreated bone marrow samples

Brief summary: In the era of hypomethylating agent in MDS treatment, the investigators aimed to investigate the prognostic impact of mutations in spliceosome machinery genes (SRSF2, U2AF1, and ZRSR2) on the outcomes of 1st line decitabine treatment in MDS.

Detailed description: A number of studies have tried to investigate clinical impact of mutations in spliceosomal machinery genes in MDS but they failed to demonstrate a consistent prognostic relevance. Moreover, the clinical impact of these mutations on the outcomes of hypomethylating agent treatment in MDS has never been explored yet. The investigators investigated the prognostic impact of mutations in spliceosome machinery genes (SRSF2, U2AF1, and ZRSR2) on the outcomes of 1st line decitabine treatment in MDS.

Eligibility criteria: Inclusion Criteria:

* de novo MDS patients were included in the study who had received 1st line decitabine treatment and had adequate genomic DNA from pretreated bone marrow samples

Exclusion Criteria:

* therapy-related MDS

Primary outcomes:
measure: overall survival
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jun Ho Jang, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hong JY, Seo JY, Kim SH, Jung HA, Park S, Kim K, Jung CW, Kim JS, Park JS, Kim HJ, Jang JH. Mutations in the Spliceosomal Machinery Genes SRSF2, U2AF1, and ZRSR2 and Response to Decitabine in Myelodysplastic Syndrome. Anticancer Res. 2015 May;35(5):3081-9.
Clinical trial NCT06405009: Prediction Model of Occult Omental Metastasis in Patients With Gastric Cancer
Official title: A Nomogram for Predicting Occult Omental Metastasis in Patients With Gastric Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Omental Metastasis
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: It included consecutive patients with a primary gastric adenocarcinoma (cT1-4N0-3M0) in whom a potentially curative total gastrectomy could be performed.

Brief summary: A complete omentectomy is typically recommended during radical total gastrectomy for gastric cancer, though its impact on survival remains unclear. This study aimed to assess the frequency and risk factors of metastases in the greater omentum in gastric cancer patients undergoing gastrectomy. It will involve a single prospective cohort of consecutive patients who underwent total gastrectomy with complete en bloc omentectomy and modified D2 lymphadenectomy. Post-surgery, the omentum will dissect from the gastrectomy specimen beyond the gastroepiploic vessels and examine separately for pathological assessment. The primary outcome will focus on the detection of omental metastases.


Eligibility criteria: Inclusion Criteria:

1. pathological confirmation of gastric cancer
2. eligibility for surgical intervention
3. undergoing first rectal cancer surgery
4. acquisition of written informed consent from patients and their families
5. no history of hypertrophic scar or allergic predispositions

Exclusion Criteria:

1. absence of postoperative pathology of the omentum
2. diagnosis of multiple primary malignancies
3. intraoperative discovery of widespread implant metastases within the abdominal cavity
4. severe comorbidities

Primary outcomes:
measure: patients with omental metastases
timeFrame: up to 2 weeks after gastric cancer surgery
measure: patients without omental metastases
timeFrame: up to 2 weeks after gastric cancer surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Yifan Cheng
state: Jiangsu
Study officials:
References:
Clinical trial NCT03594409: Frequency of Patho-morphological Classes of Gall Stones in Lahore, Pakistan
Official title: Frequency of Patho-morphological Classes of Gall Stones in Lahore, Pakistan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gallstone
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
First posted: 2018-07-20
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients selected from lahore and adjacent areas

Brief summary: It is a cross sectional study in which we are tying to determine frequency of type of gall stones in our setup(Lahore, Pakistan).


Eligibility criteria: Inclusion Criteria:

1. Patients with any sex age 1
2. 5 years and above
3. presenting to OPD with cholelithiasis -

Exclusion Criteria:

1. patients who develop gallstones after bariatric surgery
2. less than 15 years of age

Primary outcomes:
measure: Frequency of type of gallstones
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services hospital
state: Punjab
Study officials:
affiliation: Services Hospital, Lahore
name: Mahmmood Ayyaz, mbbs, fcps
role: STUDY_DIRECTOR
References:
Clinical trial NCT06975709: ASSOCIATION BETWEEN TEMPOROMANDIBULAR DISORDERS AND SLEEP DISORDERS
Official title: ASSOCIATION BETWEEN TEMPOROMANDIBULAR DISORDERS AND SLEEP DISORDERS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Temporomandibular Disorders (TMD)
Sleep
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population must include Female and Male over 18 y.o with sleep disorders that meet inclusion and exclusion criteria.

Brief summary: ASSOCIATION BETWEEN TEMPOROMANDIBULAR DISORDERS AND SLEEP DISORDERS

Detailed description: Temporomandibular disorders (TMD) are complex conditions, which can have a significant impact on patients' health and quality of life. Furthermore, they are unclearly associated with sleep disorders. The aim of the study is to investigate the prevalence of TMD in patients with sleep disorders.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Famale and Male
* Signature of the privacy information form
* Signature of the informed consent form of the protocol
* Subjects capable of understanding and wanting
* Subjects suffering from a sleep disorder (Insomnia,Hypersomnia,Restless legs syndrome,REM sleep behavior disorder,Narcolepsy,Obstructive sleep apnea syndrome (OSAS),Primary snoring, REM parasomnias,Nocturnal epilepsy)

Exclusion Criteria:

* Physical trauma to the head and neck area
* Painful oral pathologies (e.g. pulpitis, tooth fractures, tooth abscesses, tooth decay, canker sores and mucosal wounds)
* Recent dental treatments that may cause pain (e.g. tooth extraction, tooth root canal)
* Use of oral contraceptives
* Subjects not capable of understanding and wanting
* Patients suffering from neurological pathologies that may interfere with the completion of the questionnaires (ES dementia) or psychiatric pathologies or drug use as per DSM-5 criteria (including schizophrenia, bipolar, major depression, substance abuse, personality disorders).

Primary outcomes:
measure: Primary Outcome
timeFrame: at enrollment
Secondary outcomes:
measure: Secondary Outcome
timeFrame: at enrollment
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele Turro
city: Milan
country: Italy
facility: IRCCS San Raffaele Hospital
Study officials:
References:
Clinical trial NCT02208609: Zinc Bioavailability From Amaranth-enriched Maize Tortillas
Official title: Absorption of Zinc (Zn) From Traditional Maize Tortillas and Amaranth-enriched Tortillas by Toddlers in the Indigenous Post-Mayan Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Deficiency
Keywords: Zinc Absorption
Maize
Amaranth
Guatemala
Stable isotopes of Zn
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: International Atomic Energy Agency
name: Universidad Francisco Marroquín
First posted: 2014-08-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Young children in Guatemala are at risk for nutrient deficiencies due to plant-based diets and poor sanitation. Stunting, frequent diarrhea, and respiratory infections are common. Supplementation of Zn to children during diarrhea episodes has been shown to diminish duration and severity of illness. Poor Zn absorption due to high fiber and phytate in this diet might play a role in these processes. Supplementation of this micronutrient in the diet might be beneficial. The investigators will compare absorption of Zn from white maize tortillas enriched with 20% amaranth to traditional white corn tortillas in preschool children in Guatemala.

Detailed description: This is a randomized cross-over study of zinc absorption in young children living in the Western Highlands of Guatemala. Absorption of zinc will be measured from maize tortillas and maize tortillas fortified with 20% amaranth as the major food staple which provides at least 70% energy and at least 90% zinc and phytate of the diet. Participants will be randomized as to which type of tortilla they receive on the first and second day. Fractional absorption of zinc (FAZ) from all meals in one day for one type of tortilla and one day for the other will be measured by extrinsic labeling with stable isotopes of zinc. FAZ will be measured by a dual isotope tracer ratio (DITR) technique based on ratio of urine enrichment of orally versus intravenously administered zinc stable isotopes. Measurement of total zinc in duplicate diets on test days allow for determination of quantities of this micronutrient absorbed.

Eligibility criteria: Inclusion Criteria:

* 2-3 years of age
* apparently healthy
* eats \>2-3 tortillas at each meal of the day.

Exclusion Criteria:

* Chispitas or macrovital supplementation
* breastfeeding
* birth weight \< 2,500 g
* birth defect affecting growth and development
* chronic infection
* twin or triplet
* sibling enrolled in study

Primary outcomes:
measure: Zinc Absorption
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Guatemala City
country: Guatemala
facility: Universidad Francisco Marroquin
Study officials:
affiliation: University of Colorado, Denver
name: Michael Hambidge, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02365909: Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH)
Official title: A Prospective Randomized Double-Blind Placebo Controlled Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Postdural Puncture Headache
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2015-02-19
Enrollment: 6
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: Postdural puncture headaches (PDPH) are a consequence of spinal and epidural anesthesia in approximately 1% of cases when performed in obstetric patients. The gold standard treatment for a PDPH is currently an epidural blood patch (EBP), which involves placing a needle back into the epidural space of the neuraxium and then injecting 20 ml of the patient's own blood through the needle and into the epidural space to form a clot over the insult in the tissue layer that causes the headaches. The investigators want to test the efficacy of using a less invasive procedure, called a sphenopalatine block (SPGB), for treatment of PDPH. SPGB has been used for many years in the treatment of migraines and cluster headaches, and there are several case reports of its use to successfully treat PDPH as well. SPGB simply involves applying a local anesthetic to the mucosa in the back of each nostril to numb the nerves that cause the headache. The investigators hope that the SPGB will reduce the number of PDPH patients that require and EBP.


Eligibility criteria: Inclusion Criteria

* Active postdural puncture headache within 7 days after neuraxial analgesia/anesthesia
* Age ≥ 18 years.
* ASA physical status ≤ 3

Exclusion Criteria

* Known coagulopathy
* Known nasal septal deviation or abnormalities
* Medical conditions contraindicated to bupivacaine or the nasal applicator (according to the product labeling)

Primary outcomes:
measure: Headache verbal pain score
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
References:
Clinical trial NCT04904809: Perclose Multi-Access Duplex Ultrasound (DUS) Study
Official title: Perclose Multi-Access DUS Study: Assess the Safety and Performance of the Perclose ProGlide™ Suture-Mediated Closure (SMC) System and the Perclose™ ProStyle™ Suture-Mediated Closure and Repair (SMCR) System in Managing Multiple Venous Access Sites (Evaluation by DUS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmia
Keywords: ABT-CIP-10410
Ablation
DUS
Femoral DUS
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2021-05-27
Enrollment: 36
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: The aim of this prospective, single-arm, United States (US) multi-center, descriptive clinical study is to evaluate the safety of multiple access site closure in a single vein with the SMC System by scheduled DUS at discharge and at 30 days (if vascular complications observed at discharge) in asymptomatic or non-visible subjects.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Subject is planned to have an ablation procedure that requires multiple sheaths insertion in a single femoral vein
* All the access sites are planned to be treated with Perclose SMC
* Written informed consent is obtained prior to the procedure

Exclusion Criteria:

* Visible vascular thrombus (angiographic or ultrasound) in the ipsilateral leg prior to the ablation procedure
* Prior ipsilateral deep vein thrombosis within 6 months
* International Normalization Ratio \>3.5 for patients on warfarin
* Subject who is not able to ambulate pre-procedure
* Women who are pregnant (based on site standard pre-procedure pregnancy test)
* Has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the prior 2 months

Primary outcomes:
measure: Number of Subjects With Major Vascular Complications by DUS Detection at Discharge
timeFrame: Within 24 hours of procedure.
measure: Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge
timeFrame: Within 24 hours of procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
Study officials:
affiliation: St. Luke's Hospital
name: Sanjaya K Gupta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Soroosh Kiani, MD
role: PRINCIPAL_INVESTIGATOR
References: