louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05628194: ASSESSING THE GAY MALE EXPERIENCE WITH ANAL CANCER PREVENTION STRATEGIES
Official title: SAVE THE BOTTOMS!!!: ASSESSING THE GAY MALE EXPERIENCE WITH ANAL CANCER PREVENTION STRATEGIES
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anal Cancer
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-11-28
Enrollment: 5000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSM population, which may include individuals who may identify as having a sexual orientation of gay, bisexual, or gender-queer. They may identify as any gender, including trans-gender or non-binary (but limited to those born with sex assigned at birth as male).

Brief summary: The purpose of this study is to describe current knowledge and opinions about anal cancer screening among men who have sex with men (MSM), as well as their experience receiving guideline-compliant care aimed at anal cancer risk reduction using a large-scale survey disseminated via social media.


Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* Current resident of the U.S.
* Engage in anoreceptive intercourse with male partners
* Fluent in English or Spanish

Exclusion Criteria:

* Under the age of 18 years old
* Not living in the United States
* Not born with sex assigned at birth as male
* Does not engage in sex with male partners

Primary outcomes:
measure: MSM awareness of anal cancer risk
timeFrame: 2 months
measure: MSM awareness of strategies to decrease anal cancer risk
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Elliot Arsoniadis, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05485194: Ridge Preservation Following Tooth Extraction
Official title: Use of a Titanium Bone Screw for Ridge Preservation Following Tooth Extraction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alveolar Bone Resorption
Tooth Extraction
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: An animal study and our pilot human study demonstrated that placing a smooth-surface titanium bone screw (TBS) over the buccal plate of an extraction socket resulted in less dimensional changes of the alveolar ridge along with no adverse effects. The purpose of this randomized clinical trial is to investigate the effectiveness of TBS application for ridge preservation in comparison to (1) unassisted/non-interventional socket healing and (2) alveolar ridge preservation (ARP) approach using allografts and a membrane.

Detailed description: The participants will be randomized to one of the three groups: the non-intervention, titanium bone screw (TBS), and alveolar ridge preservation (ARP) groups. The sockets in the non-intervention group will be filled with blood clots only. One TBS will be placed over the labial/buccal plate of the extraction socket in the TBS group on the same day of the extraction. Allograft and resorbable collagen membrane will be used for the ARP group.

Eligibility criteria: Inclusion Criteria:

* age ≥18 years
* a tooth, which is in the area from the central incisor to the second premolar bounded by teeth (or implants) mesiodistally
* a tooth requiring extraction

Exclusion Criteria:

* thyroid dysfunctions
* diabetes mellitus
* history of a chronic use of corticosteroids (\>6 months)
* history of oral/intravenous bisphosphonates within the past 2 years
* smoking
* history of other systemic conditions that could affect bone integrity.

Primary outcomes:
measure: The width of the alveolar bone
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Maryland School of Dentistry
name: Se-Lim Oh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joseph S, Oh SL, Pae EK, Joshi S. Use of transcortical miniscrews for alveolar ridge preservation following tooth extraction: A pilot study. Clin Oral Implants Res. 2022 Feb;33(2):150-157. doi: 10.1111/clr.13875. Epub 2021 Nov 16.
citation: Melsen B, Huja SS, Chien HH, Dalstra M. Alveolar bone preservation subsequent to miniscrew implant placement in a canine model. Orthod Craniofac Res. 2015 May;18(2):77-85. doi: 10.1111/ocr.12058. Epub 2014 Nov 18.
Clinical trial NCT03451994: Exploratory Study of Volatile Organic Compounds in Alveolar Breath
Official title: Retrospective Analysis of Volatile Organic Compounds in Alveolar Breath as Biomarkers of Idiopathic Malodor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutritional and Metabolic Diseases
Lead sponsor: Mebo Research, Inc.
Sponsor class: OTHER
Collaborators: name: Menssana Research, Inc.
name: Aurametrix
First posted: 2018-03-02
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals self-reporting idiopathic malodor production as a consequence of a systemic disorder

Brief summary: The purpose of this secondary analysis is to identify breath signatures associated with idiopathic malodor conditions.

Detailed description: Individuals with metabolic disorders may sporadically produce malodors despite good hygiene. Analysis of volatile organic compounds (VOCs) helps to gain insights into medical conditions arising due to metabolic dysfunction as different metabolic pathways emit and or consume various VOCs. These VOCs can be detected via the exhaled breath collected and analyzed with a portable breath collection apparatus. VOC profiles will be compared with self-reported symptoms and other observations of participating subjects.

Eligibility criteria: Inclusion Criteria:

* good general health
* willing and able to travel to one of the participating sites

Exclusion Criteria:

* medical conditions that, in the opinion of the investigator, would prevent participation
* elect not to participate in the study

Primary outcomes:
measure: VOCs detected
timeFrame: 2 years
Secondary outcomes:
measure: Correlations between breath biomarkers and self-reported observations (questionnaires)
timeFrame: 1 year
Other outcomes:
Locations:
city: Miami
country: United States
facility: MeBO Research
state: Florida
city: London
country: United Kingdom
facility: MeBO Research LTD
state: England
Study officials:
affiliation: MeBO Research
name: Irene Gabashvili, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Phillips M. Method for the collection and assay of volatile organic compounds in breath. Anal Biochem. 1997 May 1;247(2):272-8. doi: 10.1006/abio.1997.2069.
Clinical trial NCT01335594: Evaluation of Swallowing in Patients With Obstructive Sleep Apnea
Official title: Clinical, Endoscopical and Manometric Evaluation of Swallowing in Obstructive Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: Sleep apnea, obstructive
Deglutition Disorders
Manometry
Endoscopy
Lead sponsor: Hospital do Servidor Publico Estadual
Sponsor class: OTHER
First posted: 2011-04-14
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to test the hypothesis that obstructive sleep apnea syndrome is associated with deviant pharyngeal swallowing function, using clinical, endoscopical and manometric evaluation.


Eligibility criteria: Inclusion Criteria:

* diagnosis of obstructive sleep apnea syndrome

Exclusion Criteria:

* other causes of dysphagia
* pharyngeal surgery
* prior treatment for obstructive sleep apnea

Primary outcomes:
measure: Clinical evaluation of swallowing in obstructive sleep apnea
timeFrame: within the first 3 months after diagnostic
Secondary outcomes:
measure: Manometric evaluation of swallowing in obstructive sleep apnea
timeFrame: within the first 3 months after diagnostic
measure: Endoscopic evaluation of swallowing in obstructive sleep apnea
timeFrame: within the first 3 months after diagnostic
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto de Assistência Médica ao Servidor Público Estadual
Study officials:
affiliation: Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
name: Luciana A M da Paz Oliveira
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02561494: Postoperative Analgesic Effect of Nefopam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stomach Neoplasms
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2015-09-28
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Nefopam will be administered to the patients undergoing laparoscopic gastrectomy under the total intravenous anesthesia (TIVA).

The investigators will evaluate whether the nefopam can decrease the total amount of remifentanil administered during the operation, which will reduce the acute opioid tolerance and following consumption of fentanyl during postoperative period.


Eligibility criteria: Inclusion Criteria:

* Early or advanced gastric cancer

Exclusion Criteria:

* Refusal
* Use of preoperative analgesic drugs
* Pregnancy
* Recurred gastric cancer
* Seizure
* Cardiac disease
* Monoamine oxidase inhibitor
* Urologic disease
* Previous intrabdominal surgery
* Body mass index \> 30 or \< 16

Primary outcomes:
measure: Change of the administered fentanyl dose from postoperative 6 h to postoperative 5 day
timeFrame: postoperative 6 h, postoperative 1 day, postoperative 2 day, postoperative 3 day, postoperative 5 day
Secondary outcomes:
measure: Change of the pain score from postoperative 6 h to postoperative 5 day
timeFrame: postoperative 6 h, postoperative 1 day, postoperative 2 day, postoperative 3 day, postoperative 5 day
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
References:
Clinical trial NCT06493994: Myval TransAXillary Transcatheter Aortic Valve Replacement Multicenter Clinical Registry
Official title: Myval TransAXillary Transcatheter Aortic Valve Replacement Multicenter Clinical Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Stenosis
Lead sponsor: University of Luebeck
Sponsor class: OTHER
Collaborators: name: University Hopsital Schleswig Holstein Campus Lübeck
First posted: 2024-07-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were treated with Myval TAVR via TAX access are included in the registry.

The participating centers also provide a retrospective cohort of TAX-TAVR implantations with other TAVR prothesis (e.g. Edwards Sapien XT/3/Ultra, Medtronic Evolut R/Pro, Accurate Neo, Allegra, Portico) to compare the results and outcomes of the MYVAL-TAX-TAVR registry using the Myval THV with other TAVR bioprothesis used for TAX-TAVR. To further improve comparability between groups propensity score matching between the groups will be performed using the following parameters (age, sex, STS score, peripheral artery disease, atrial fibrillation, minimum axillary diameter, moderate/severe axillary tortuosity and moderate/severe axillary, calcification).

Brief summary: Study goal is to determine the feasibility, procedural success, safety and potential benefit of the Myval transcatheter heart valve (THV) in patients undergone transaxillary (TAX) transcatheter aortic valve replacement (TAVR).


Eligibility criteria: Inclusion Criteria:

* Patient has been treatet transaxillary (TAX) with Myval transcatheter aortic valve replacement
* BMI \<35 kg/m2
* Ability to give informed consent

Exclusion Criteria:

* History of coronary artery bypass graft and a patent left internal mammary artery (LIMA)
* Age ≤18 years
* Patients presenting with pregnancy
* Patients without informed consent
* Expected life expectancy \<2 years

Primary outcomes:
measure: Time until first occurrence
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: Universität zu Lübeck
state: Schleswig-Holstein
Study officials:
References:
Clinical trial NCT04125394: Efficacy and Tolerance of Hypertonic Sodium Chloride (NaCl 5%) Eye Drops Without Preservatives in Corneal Edema
Official title: Unicentric Clinical Trial on the Clinical Efficacy and Tolerance of the Treatment With an Ophthalmic Solution of Hypertonic Sodium Chloride (NaCl 5%) Without Preservatives in Patients Suffering From Symptomatic Corneal Edema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Corneal Edema
Keywords: corneal edema
sodium chloride
single-dose
Lead sponsor: Tiedra Farmacéutica SL
Sponsor class: INDUSTRY
Collaborators: name: Hospital Universitario Principe de Asturias
First posted: 2019-10-14
Enrollment: 30
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: Corneal edema is frequently found in clinical practice as a common sign of acute corneal disease due to different etiologies that cause an accumulation of extracellular fluid in the cornea. The present unicentric clinical trial aims to evaluate the efficacy and tolerance of an ophthalmic solution of hypertonic sodium chloride (NaCl 5%) without preservatives in participants suffering from symptomatic corneal edema.


Eligibility criteria: Inclusion Criteria:

* Age over 18 years
* Clinical diagnosis of symptomatic corneal edema related to chronic epithelial, secondary to corneal dystrophies, controlled infectious and inflammatory pathologies and surgical trauma already resolved.
* No need for keratoplasty in the 6 months following the start of the study

Exclusion Criteria:.

* Visual acuity less than 1/20 in both eyes
* Corneal edema caused by the following acute etiologies: trauma, infection, inflammation or Stevens-Johnson syndrome.
* Glaucoma or uncontrolled hypertension.
* Known allergy to any of the ingredients of the product.

Primary outcomes:
measure: Mean Change from Baseline in Visual acuity
timeFrame: Baseline, Day 7 and Day 28
Secondary outcomes:
measure: Mean Change from Baseline in Corneal Thickness
timeFrame: Baseline, Day 7 and Day 28
Other outcomes:
measure: Number of Participants with Treatment-Related Adverse Events (Objective Tolerance)
timeFrame: Baseline, Day 7 and Day 28
measure: Score in Subjective Tolerance Test
timeFrame: Day 7 and Day 28
Locations:
city: Alcalá De Henares
country: Spain
facility: Hospital Universitario Príncipe de Asturias
Study officials:
References:
Clinical trial NCT06382194: Decision Making Tool for Firearm Storage
Official title: Shared Decision Making for Firearm Safety Among Older Adults With Early Changes Associated With Alzheimer's Disease/Alzheimer's Disease-Related Dementias (AD/ADRD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia, Mild
Depression
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-04-24
Enrollment: 5
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a one-arm pilot study testing the feasibility and acceptability of a decision aid about safe firearm storage.

Detailed description: This pilot study will test the feasibility and acceptability of a decision aid about safe firearm storage with firearm-owning persons with early dementia and/or depression

Eligibility criteria: Inclusion Criteria:

* Medical record documentation of early dementia and/or depression
* Internet or mobile device access
* Access to firearm(s)

Exclusion Criteria:

• Active suicidality

Primary outcomes:
measure: Firearm storage (adapted from the National Firearm Survey)
timeFrame: Assessed at 4 weeks post enrollment
Secondary outcomes:
measure: Low-Literacy Decisional Conflict Scale
timeFrame: Assessed at 4 weeks post enrollment
measure: Knowledge Questionnaire
timeFrame: Assessed at 4 weeks post enrollment
measure: Feasibility of intervention delivery
timeFrame: Assessed at 4 weeks post enrollment
measure: Acceptability of Intervention Measure
timeFrame: Assessed at 4 weeks post enrollment
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Elizabeth Phelan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01979094: Spinal Arthrodesis and Spinal Arthroplasty Database Study
Official title: General Spinal Arthrodesis and Spinal Arthroplasty Database
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Spine Condition
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 1296
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Spinal arthrodesis and/or spinal arthroplasty can be performed through either anterior, posterior, or lateral approaches for a variety of traumatic, degenerative, or deformity conditions.

Brief summary: To collect and organize data into a repository for future research.

Detailed description: To collect and organize data into a repository from the Principal Investigator's (H. Francis Farhadi, MD, PhD) patients who are undergoing spinal arthrodesis and/or spinal arthroplasty procedures at Ohio State University for future research, as yet to be identified. This comprehensive database of patients will allow for gathering of relevant information for potential future research use.

Eligibility criteria: Inclusion Criteria:

* Must have had or will undergo a spinal arthrodesis and/or spinal arthroplasty procedure at Ohio State University

Exclusion Criteria:

* N/A

Primary outcomes:
measure: clinical prospective review- Prospective Database study for future studies
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State Unviersity
state: Ohio
Study officials:
affiliation: Ohio State University
name: H. Francis Farhadi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06354894: Percutaneous Pinning Versus Plate and Screws for Surgical Fixation of Proximal Humeral Fractures
Official title: Riduzione e Sintesi Delle Fratture Del Terzo Prossimale d'Omero: Confronto Prospettico Tra Placca e Viti e Pinning Percutaneo
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Proximal Humeral Fractures
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 120
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: Patients affected by proximal humeral fractures who consent to participate the study and whose fracture was considered to be treated with surgical fixation either with percutaneous pinning or with plate and screws

Brief summary: The aim of this multicenter nonrandomised study is to prospectively compare the clinical and radiographic results of two different techniques of surgical fixation of proximal humeral fractures: percutaneous pinning versus plate and screws.


Eligibility criteria: Inclusion Criteria:

* \&gt; 18 year old
* proximal humeral fracture
* both X-rays and CT scan available

Exclusion Criteria:

* dementia
* psychiatric disease

Primary outcomes:
measure: Oxford Shoulder Score (OSS)
timeFrame: 1 year
measure: Quick Disabilities of the arm, shoulder and hand (DASH) score
timeFrame: 1 year
measure: Subjective Shoulder Value (SSV)
timeFrame: 1 year
measure: Radiographic outcomes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Orbassano
country: Italy
facility: San Luigi Gonzaga Hospital
state: Turin
Study officials:
References:
Clinical trial NCT01674894: Study of the Cleavage of the Egg in Relation to the Stimulation Treatment
Official title: Kinetics in Time-lapse Culture of Human Preembryos
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Female Infertility
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-08-29
Enrollment: 356
Sex: FEMALE
Minimum age (years): 38
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women suffering from infertility

Brief summary: This post-marketing, single-center prospective study will be conducted in an open-label, non-interventional setting, for women seeking fertility treatment and will describe cleavage dynamics in relation to the age of the oocyte and gonadotrophin treatment.


Eligibility criteria: Inclusion Criteria:

1. IVF/ICSI treatment
2. Regular cycles of 25-35 days
3. Follicle stimulation with Bravelle and/or Menopur
4. Women aged 38-35 years
5. Long agonist or short antagonist treatment
6. Willing and able to understand a Danish, English or German patient information form
7. Willing and able to provide written Informed Consent

Exclusion Criteria:

1. BMI more than 35
2. Presence of hydrosalpinx on ultrasound
3. FSH more than 13 or antral follicle count (AFC) less than 4 at fertility investigation
4. Known allergic reactions to the planned medications
5. Use of testicular sperm

Primary outcomes:
measure: Time to 2. polar body extrusion in transferred embryos (only Intracellular Sperm Injection)
timeFrame: Week 1 after oocyte retrieval
measure: Time for disappearance of pronuclei in transferred embryos
timeFrame: Week 1 after oocyte retrieval
measure: Time for first cleavage in transferred embryos
timeFrame: Week 1 after oocyte retrieval
measure: Time for cleavage to 3-cell embryo and 4-cell embryo in transferred embryos
timeFrame: Week 1 after oocyte retrieval
measure: Scoring of blastomere even-size, fragmentation and multinucleation at 4-cell stage
timeFrame: Week 1 after oocyte retrieval
Secondary outcomes:
measure: Total dose of gonadotrophin used
timeFrame: 1 month
measure: Gonadotrophin dose per oocyte retrieved
timeFrame: 1 month
measure: Number of oocytes retrieved
timeFrame: 1 month
measure: Number of fertilized and cleaved oocytes
timeFrame: 1 month
measure: Number of preembryos with top quality
timeFrame: 1 month
measure: Implantation rate
timeFrame: 2 months
measure: Ongoing pregnancy rate week 7
timeFrame: 3 months
measure: Live birth rate
timeFrame: 9 months
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Danish Fertility Clinic
state: Copenhagen
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: