louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03922295: Endoscopic Tympanoplasty: Single Versus Double Flap Technique
Official title: Endoscopic Tympanoplasty: Single Versus Double Flap Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tympanic Membrane Perforation
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of this study is to compare results of double and single flap techniques for tympanoplasty in chronic suppurative otitis media patients. Inclusion criteria include total or subtotal tympanic membrane perforations with limited anterior remnant and should be dry for at least 3 months. Patients with persistent discharge, cholesteatoma, ossicular affection or those with recurrent perforations after previous myringoplasty were excluded. Also, patients with uncontrolled diabetes, chronic liver and kidney diseases and immuno-compromised patients are not included in this study. Patients are divided into two groups, endoscopic double flap group and endoscopic single flap group. Healing and hearing outcomes were evaluated 3 months postoperative. Also, post-operative pain scores and complications were assessed.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic suppurative otitis media with total or subtotal tympanic membrane perforation with limited anterior remnant.
* dry perforation for at least 3 months.

Exclusion Criteria:

* Recurrent perforation after previous myringoplasty.
* Ossicular disruption or fixation.
* immune-compromised patients including uncontrolled diabetics, chronic liver and kidney diseases.

Primary outcomes:
measure: Healing or graft take rate
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University
state: ElDakahlia
Study officials:
affiliation: ORL-HNS department, Faculty of Medicine, Mansoura University
name: Noha A Elkholy
role: PRINCIPAL_INVESTIGATOR
affiliation: ORL-HNS department, Faculty of Medicine, Mansoura University
name: Mohammed A Salem
role: STUDY_DIRECTOR
affiliation: ORL-HNS department, Faculty of Medicine, Mansoura University
name: Abdelwahab M Rakha
role: STUDY_CHAIR
References:
citation: El-Kholy NA, Salem MA, Rakha AM. Endoscopic single versus double flap tympanoplasty: a randomized clinical trial. Eur Arch Otorhinolaryngol. 2021 May;278(5):1395-1401. doi: 10.1007/s00405-020-06212-3. Epub 2020 Jul 20.
Clinical trial NCT06527495: Clinical Pharmacogenetic Study of Sorafenib in Egyptian Patients With Hepatocellular Carcinoma
Official title: Clinical Pharmacogenetic Study of the Efficacy and Safety of Sorafenib in Egyptian Patients With Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: HCC
Hepatocellular Carcinoma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The current study will aim to maximize the therapeutic effect and to minimize the adverse effects of sorafenib in HCC through pharmacogenomic analysis of VEGFA and KDR genetic polymorphisms.


Eligibility criteria: Inclusion Criteria:

* Age of all studied subjects ≥ 18 years old
* All patients with hepatocellular carcinoma will be included in group I.
* Patients not treated with systemic TKIs

Exclusion Criteria:

* Patients presented with liver tumors other than HCC.
* Patients with Child-Pugh grade C for liver function.
* Patients with other malignancies.
* Patients with chronic inflammatory disorders.
* Patients with severe organ dysfunction such as heart, lung, and kidney.
* Patients who cannot tolerate or are allergic to sorafenib.
* Patients with severe coagulation dysfunction were uncorrectable.
* Age less than 18 years old.

Primary outcomes:
measure: Vascular Endothelial Growth Factor A (VEGFA) genotyping
timeFrame: At Baseline, 3 month, and 6 month after treatment.
measure: Kinase insert domain receptor (KDR) genotyping
timeFrame: At Baseline, 3 month, and 6 months after treatment.
Secondary outcomes:
measure: Tumor markers
timeFrame: At Baseline, 3 month, and 6 month after treatment.
measure: Complete blood culture
timeFrame: At Baseline 3 month, and 6 months after treatment.
measure: Kidney function tests
timeFrame: At Baseline 3 month, and 6 months after treatment.
measure: Liver function tests.
timeFrame: At Baseline 3 month, and 6 months after treatment.
measure: Safety outcome
timeFrame: At Baseline, 3 month, and 6 months after treatment.
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: NLI
state: Menoufia
Study officials:
References:
Clinical trial NCT05765695: Radiofrequency Ablation in TIR3A Nodules With Negative Genetic Evaluation
Official title: Radiofrequency Ablation for Treating Thyroid Nodules Classified as TIR3A, With a Negative Genetic Evaluation for Thyroid Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thyroid Nodule
Keywords: thyroid nodule
indeterminate
genetic
radiofrequency ablation
follow-up
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to demonstrate that TIR3A nodules with negative genetic test can be safely and effectively treated by radiofrequency ablation, with nodular shrinkage and improvement of clinical symptoms.

Fine needle aspiration cytology is the gold standard test for differential diagnosis of thyroid nodules, but sometimes the result can be indeterminate with a risk of malignancy of 10-30%. In these cases the ablation is not indicated and many patients with benign nodules that may benefit from the procedure are not treated.

All the patients enrolled must have a TIR3A cytology and negative genetic test for mutations associated with thyroid carcinoma. Before the ablation blood, evaluation of serum TSH, anti-thyroglobulin antibodies, anti-thyroid peroxidase antibodies and calcitonin levels will be performed.


Eligibility criteria: Inclusion Criteria:

* Patients with thyroid nodule eligible for radiofrequency ablation, with low-risk indeterminate lesion cytology (TIR3A) and negative genetic test for mutations associated with thyroid carcinoma

Exclusion Criteria:

* Patients who are not able to sign the informed consent
* Patients with contraindications to radiofrequency ablation
* Patients with cytology different from TIR3A
* Patients with positive genetic test for mutations associated with thyroid carcinoma

Primary outcomes:
measure: Thyroid nodule volume reduction rate
timeFrame: 1 month after the procedure
measure: Thyroid nodule volume reduction rate
timeFrame: 6 months after the procedure
measure: Thyroid nodule volume reduction rate
timeFrame: 12 months after the procedure
measure: Complication rate
timeFrame: When the procedure is performed
measure: Complication rate
timeFrame: 1 month after the procedure
measure: Complication rate
timeFrame: 6 months after the procedure
measure: Complication rate
timeFrame: 12 months after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano IRCCS
Study officials:
References:
Clinical trial NCT03907995: Peer-led Group Intervention for Coping With Disaster
Official title: Peer-led Group Intervention for Coping With Disaster
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorder
PTSD
Depressive Symptoms
Anger
Depressive Disorder
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: American National Red Cross
First posted: 2019-04-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present project partners with leading faith communities in Houston to provide expert-led educational workshops to a diverse sample of adults on normative and concerning response to disaster. Secondly implementing peer-led interventions where a trained adult leads others through an evidence-based manualized intervention. Lastly, identifying and referring individuals who require more intensive services to a higher level of care.

Detailed description: Approximately 20% of individuals have significant behavioral health concerns. Exposure to a disaster like Hurricane Harvey and its aftermath often exacerbates pre-existing issues and/or brings new issues, with post-traumatic stress presenting in manners such as anxiety, depression, conduct issues and/or somatic issues. Approaches are needed that educate community members about both normative and concerning responses to disaster focused on coping skills development. A particular approach, peer-led intervention groups have been shown effective at delivering these types of intervention. Brief, psycho-educational peer-led programs have shown effectiveness in a variety of forums including helping promote adjustment among those who have experienced trauma. There will be six group sessions every two weeks. Sessions will include how to teach appropriate coping techniques to respond to the distress, confronting distressing memories related to the disaster, and emotion regulation techniques. After the group sessions end, individuals who require a more intensive service will be referred to a higher level of care.

Eligibility criteria: Inclusion Criteria:

* 18 years and older and English speaking.

Exclusion Criteria:

* Individuals under the age of 18 and non-English speaking and participants who do not wish to participate in this study.

Primary outcomes:
measure: PTSD Symptom Scale - Adult
timeFrame: Post-treatment, which is 12 weeks after baseline.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine: Jamail Specialty Care Center
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Eric Storch, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03586414: MitoQ Supplementation and Cardiovascular Function in Healthy Men and Women
Official title: Mitochondrial Targeted Antioxidant Supplementation and Diastolic Function in Healthy Men and Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diastolic Dysfunction
Keywords: MitoQ
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of Colorado Nutrition Obesity Research Center (NORC)
First posted: 2018-07-13
Enrollment: 31
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: In this pilot study, the investigators will determine whether supplementation with a mitochondrial-targeted antioxidant (Mitoquinone (MitoQ)) improves mitochondrial function, left ventricular diastolic and vascular function.

Detailed description: Heart failure affects over 5 million American adults and the risk of heart failure increases with age. Diastolic function typically declines with age. Targeting age-related causal factors leading to the decline in diastolic function in both women and men is a major public health initiative. In this pilot study, the investigators will determine whether supplementation with a mitochondrial-targeted antioxidant (Mitoquinone (MitoQ)) improves mitochondrial function, left ventricular diastolic and vascular function in older adults. As an exploratory aim, the investigators will determine whether there are differences between men and women in response to this supplementation.

Eligibility criteria: Inclusion Criteria:

1. 50 - 75 years of age
2. sedentary-to-recreationally active (\<3 days of vigorous exercise);
3. nonsmokers;
4. healthy, as determined by medical history, physical examination, standard blood chemistries.

Exclusion Criteria:

1. history of cancer
2. history of cardiovascular disease
3. unwilling or unable to take MitoQ supplement;
4. taking antioxidant vitamins, corticosteroids, or anti-inflammatory medications (e.g., aspirin);
5. taking sex hormone therapy
6. presence of menses within last 1 year;
7. taking any other medications (e.g., antihypertensives, lipid lowering medications) that would interact with MitoQ or impact CV function

Primary outcomes:
measure: Changes in diastolic function
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Changes in arterial stiffness
timeFrame: Baseline and 4 weeks
measure: Changes in brachial artery flow-mediated dilation
timeFrame: Baseline and 4 weeks
measure: Changes in endothelial function
timeFrame: Baseline and 4 weeks
measure: Changes in arterial vascular coupling
timeFrame: Baseline and 4 weeks
measure: Changes in mitochondrial function
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Shauna Runchey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02586714: Maternal Body Composition Regulates Placental Function
Official title: Maternal Body Composition Regulates Placental Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Pregnancy
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Oregon Health and Science University
First posted: 2015-10-26
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy pregnant women at term with singleton gestation who were normal weight, overweight, or obese.

Brief summary: This study examined the relationships between maternal body composition, placental function, and fetal nutrition and body composition, and sought to determine the most accurate method of maternal body composition analysis in late pregnancy.

Detailed description: This study examined the relationships between maternal body composition, placental function, and fetal nutrition and body composition, and sought to determine the most accurate method of maternal body composition analysis in late pregnancy. This project integrates body composition analysis, nutrition, and metabolic factors to study the impact of maternal body composition and diet on placental function and fetal growth.

Research Project: The proposed enrollment of 41 pregnant women at term (\>37 weeks gestation) was completed in September 2013. The subjects underwent four body composition measurements (bioelectrical impedance, skin-fold thickness, BodPod, and deuterium dilution) and dietary surveys along with a fasting blood draw. The subjects returned 2 weeks postpartum for repeat measurements along with a DEXA scan.

Eligibility criteria: Inclusion Criteria:

Healthy pregnant women at term with singleton gestation

Exclusion Criteria:

Medical condition requiring daily medication Fetal congenital anomalies Diabetes

Primary outcomes:
measure: Compare maternal body fat measurement
timeFrame: 37 weeks gestation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Marshall NE, Murphy EJ, King JC, Haas EK, Lim JY, Wiedrick J, Thornburg KL, Purnell JQ. Comparison of multiple methods to measure maternal fat mass in late gestation. Am J Clin Nutr. 2016 Apr;103(4):1055-63. doi: 10.3945/ajcn.115.113464. Epub 2016 Feb 17.
Clinical trial NCT02615314: Clinical Aspects of Patients With Benign Paroxysmal Positional Vertigo (BPPV) and Migraine
Official title: Clinical Aspects of Patients With Benign Paroxysmal Positional Vertigo (BPPV) and Migraine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Positional Vertigo
Keywords: migraine
benign paroxysmal positional vertigo
Lead sponsor: Anadolu Medical Center
Sponsor class: OTHER
First posted: 2015-11-26
Enrollment: 232
Sex: ALL
Minimum age (years): 10
Maximum age (years): 84
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: BPPV patients only confirmed by VNG

Brief summary: The aim of this study is to analyze the clinical aspects of patients with BPPV associated with migraine. It is our purpose to clarify weather migraine is a risk factor for BPPV if the clinical aspect and the therapeutic outcome is different.

Detailed description: Two hundred and sixty-three patients with BPPV were enrolled in this retrospective study. All patients' charts were reviewed by independent observer. The type of BPPV and associated problems were noted. Patients with migraine were investigated in terms of age, gender, symptoms, affected side and the cure rate. Their data were compared with those having no migraine. Mean values and standard deviations (± SD) were calculated. One way ANOVA test was used for the analysis. Significance was set at p \< 0.005.

Eligibility criteria: Inclusion Criteria:

* Patients who had history of head-induced positional and brief vertigo and who have been confirmed by VNG were included

Exclusion Criteria:

* Patients with balance problem other than BPPV,
* Patients receiving any medication prior to therapeutic maneuver were excluded

Primary outcomes:
measure: Number of patients who had normal vestibular response to provocative tests 7 days after re-positioning maneuver
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dept of Neurology, Anadolu Medical Center
name: Meltem Hale Gokmen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uneri A. Migraine and benign paroxysmal positional vertigo: an outcome study of 476 patients. Ear Nose Throat J. 2004 Dec;83(12):814-5.
citation: Ishiyama A, Jacobson KM, Baloh RW. Migraine and benign positional vertigo. Ann Otol Rhinol Laryngol. 2000 Apr;109(4):377-80. doi: 10.1177/000348940010900407.
citation: Yetiser S, Ince D. Demographic analysis of benign paroxysmal positional vertigo as a common public health problem. Ann Med Health Sci Res. 2015 Jan-Feb;5(1):50-3. doi: 10.4103/2141-9248.149788.
citation: von Brevern M, Radtke A, Lezius F, Feldmann M, Ziese T, Lempert T, Neuhauser H. Epidemiology of benign paroxysmal positional vertigo: a population based study. J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):710-5. doi: 10.1136/jnnp.2006.100420. Epub 2006 Nov 29.
Clinical trial NCT02438514: Biological Biomarkers in MOMS Partnership
Official title: Biological Biomarkers in MOMS Partnership
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Psychological Stress
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Low-income, racially and ethnically diverse, un- or under-employed, biological mothers of children in New Haven.

Primary source of recruitment will be the screening/needs assessment from our affiliated MOMS Partnership protocol, however, we will actively respond to inquiries from any preliminarily eligible biological mother in the New Haven community who expresses interest in the study

Brief summary: The investigators propose to evaluate the potential utility of stress-related biomarkers obtained via dried blood spots (DBS) and retinal scans by collecting new data from mothers and children within the New Haven MOMS Partnership, a well-established community-partnered research setting. The proposed research could greatly advance the application of stress-related biomarkers within community-based research by increasing our understanding of how stress, trauma, and depression influence biology in childhood and adulthood, as measured using minimally-invasive approaches.


Eligibility criteria: Inclusion Criteria:

* English-speaking adult mothers (age 21 or older) of at least one biological child mothers must be able to answer three verification questions to confirm they are the biological parent of their child

Exclusion Criteria:

* Non-english speakers
* Women not able to provide informed consent and with no biological children
* Mothers under the age of 21

Primary outcomes:
measure: Number of Mother-Child Dyads Who Complete Assessments & Biological Samples
timeFrame: End of study (approximately 5 years)
measure: Telomere Length
timeFrame: At baseline-After 90 minutes
measure: Advanced Glycation End Products (AGEs)
timeFrame: At baseline-After 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
References: