louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06661447: Bone Augmentation Techniques in the Mandible Posterior Region
Official title: Comparison of Bone Augmentation Techniques in the Mandible Posterior Region: a Randomized Split-mouth Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bone Substitutes
Alveolar Bone Grafting
Keywords: Alveolar Bone Atrophy
Bone Substitutes
Bone Resorption
Lead sponsor: Universidad de Especialidades Espiritu Santo
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split mouth randomized clinical trial will performed in 40 patient with bilateral edentulous atrophic posterior region.
Primary purpose: TREATMENT

Brief summary: This study aims to compare the efficacy of two bone augmentation techniques in the posterior mandible. Twenty participants will undergo 40 surgical procedures at Espíritu Santo University (UEES) in Samborondon, Ecuador. Each patient will receive two types of bone grafts: one side will use autogenous cortical bone plates with a 50/50 mixture of autogenous bone and biomaterial (as described by Dr. Fouad Khoury), while the other side will use xenogenous cortical bone plates with the same mixture.


Eligibility criteria: Inclusion Criteria:

* Patients with Bilateral Mandibular Posterior Edentulous with atrophy in 4, 5 or 6 Cawood and Howell stages.
* Patients who have good plaque control of less than 20%
* Patients between 18-64 years old

Exclusion Criteria:

* Systemically compromised patients
* Smoker patients
* Pregnant women, breastfeeding or use of oral contraceptives
* Patients who are taking medication that may affect healing and coagulation
* Patients with periodontal disease
* Patients who have undergone chemotherapy and radiotherapy

Primary outcomes:
measure: To evaluate bone formation Across Different Graft Techniques
timeFrame: The evaluation will occur from enrollment through the end of treatment at 12 months. Assessments will be conducted preoperatively, 7 days post-surgery, as well as at 3, 6, and 12 months following the surgery.
Secondary outcomes:
measure: To evaluate the surgery duration of across different bone grafting techniques.
timeFrame: To record the duration of surgery for both techniques, from the administration of anesthesia to the final suture
measure: To evaluate bone quality across different bone grafting techniques.
timeFrame: From enrollment, to the end of treatment at 12 months; evaluating at 3 days, 30 days, 3 months, 6 months and 12 months
measure: To evaluate postoperative inflammation across different bone grafting techniques.
timeFrame: The evaluation will occur prior to surgery, immediately postoperatively, on the 3rd day, 7th day, and at 14 days
Other outcomes:
Locations:
Study officials:
References:
citation: Khoury F, Hanser T. Three-Dimensional Vertical Alveolar Ridge Augmentation in the Posterior Maxilla: A 10-year Clinical Study. Int J Oral Maxillofac Implants. 2019 Mar/Apr;34(2):471-480. doi: 10.11607/jomi.6869.
Clinical trial NCT03046147: The Effect of Roux-en-Y Gastric Bypass on Bone Turnover
Official title: Bone Mineral Density and Markers of Bone Turnover After Roux-en-Y Gastric Bypass
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Bypass Surgery
Obesity
Bone Loss
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from a previously investigated cohort of 20 subjects undergoing Roux-en-Y gastric bypass surgery (NCT 01202526). The previous study aimed at investigating acute and long term changes in insulin sensitivity and secretion, whereas the present follow-up study investigates changes in bone metabolism as the primary outcome.

Brief summary: Bone mineral density (BMD) is decreased after Roux-en-Y gastric bypass (RYGB) but whether RYGB induces changes in BMD beyond adaptation to major weight loss is not known. We aim to investigate BMD changes in weight bearing (hip, lumbal columna) and in non-weight bearing (forearm) regions before and after maximal weight loss at 1 year and after weight stabilisation at 4 years after RYGB. Moreover, plasma markers of bone turnover will be studied at fasting and during oral glucose tolerance test.


Eligibility criteria: Inclusion Criteria:

* Participation in previos study ((NCT 01202526)

Exclusion Criteria:

* Treatment of osteoporosis

Primary outcomes:
measure: Changes in bone mineral density of non-weight bearing bone
timeFrame: 1 year, 4 years
measure: Changes in bone mineral density of weightbearing bone
timeFrame: 1 year, 4 years
Secondary outcomes:
measure: Plasma markers of bone turnover
timeFrame: 1 week, 3 months, 1 year, 4 years
measure: Plasma markers of bone turnover
timeFrame: 3 months, 1 year, 4 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University hospital Hvidovre
Study officials:
References:
Clinical trial NCT01007747: EPT 100: Geranium Oil for the Relief of Neuropathic Pain
Official title: EPT 100: Geranium Oil for the Relief of Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Keywords: Geranium oil
Neuropathy
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2009-11-04
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if Geranium oil will relieve a variety of neuropathic pain and some pain relief will last more than 48 hours.

Detailed description: EPT 100 study is designed to identify the percentage of people who experience neuropathic pain relief from topical geranium oil from Reunion Island, determine which neuropathic pain conditions respond best and define the time course of the pain relief.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or oler
* Neuralgia or neuropathy with daily pain
* At least moderate intensity pain
* Signed informed consent

Exclusion Criteria:

* Pregnant or nursing
* Known allergies to geranium oil or geranium oil fractions

Primary outcomes:
measure: Pain relief
timeFrame: 3 times in 30 to 60 minutes post-application
Secondary outcomes:
measure: Response to therapy at 30 to 60 minutes, they will be asked to apply the oil to painful area daily
timeFrame: Daily over 1 week
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
Clinical trial NCT07005947: Long COVID Cutaneous Signatures: An ARPA Funded Research Project
Official title: Long COVID Cutaneous Signatures: An ARPA Funded Research Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Long COVID
Acute COVID-19
Postural Orthostatic Tachycardia Syndrome (POTS)
Diabetic Neuropathy
Keywords: COVID
Diabetic Neuropathy
Postural orthostatic tachycardia syndrome
POTS
Lead sponsor: CND Life Sciences
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and females ages 18-80 who have been diagnosed with one of the following:

1. Long COVID defined by NIH PASC criteria OR 2. Acute COVID who tested positive for COVID without persistent symptoms OR 3. Postural orthostatic tachycardia syndrome (POTS) OR 4. Diabetic neuropathy

Brief summary: This is a prospective, longitudinal study involving 300 participants for a single visit to compare Long COVID neurocutaneous biosignatures with those of other disorders affecting the sensory and autonomic nervous system.

Detailed description: This is a prospective, longitudinal study involving 300 participants for a single visit to compare Long COVID neurocutaneous biosignatures with those of other disorders affecting the sensory and autonomic nervous system. The evaluations will include clinical assessments, neurologic exams, patient reported outcome surveys, and skin biopsies from three locations. Data will be collected on the amount of P-SYN in cutaneous nerve fibers. The cohorts of interest are as follows:

1. 100 participants with Long COVID defined by NIH PASC criteria
2. 100 participants with acute COVID who tested positive for COVID without persistent symptoms defined WHO criteria
3. 50 participants with postural orthostatic tachycardia syndrome (POTS)
4. 50 participants with diabetic neuropathy

There are no plans for additional visits at this time.

If interested to learn more about this study, please complete the form here for someone to contact you. "here" would take you to the said form.

Eligibility criteria: Inclusion Criteria:

1. Long COVID defined by NIH PASC criteria OR 2. Acute COVID who tested positive for COVID without persistent symptoms OR 3. Postural orthostatic tachycardia syndrome (POTS) OR 4. Diabetic neuropathy

Exclusion Criteria:

1. Clinical evidence of severe peripheral vascular disease 2. History of ulceration, poor wound healing or vascular claudication 3. History of allergic reaction to local anesthesia (for biopsy collection) 4. Use of oral anticoagulants (aspirin or Plavix alone is allowed) 5. History of a bleeding disorder

Primary outcomes:
measure: Pathology and nervous system changes that occur in patients suffering from sensory and autonomic function changes
timeFrame: Current - December 31,2025
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: CND Life Sciences
state: Arizona
Study officials:
References:
Clinical trial NCT03241147: Pharmacokinetics of Lu AF35700 in Subjects With Renal Impairment
Official title: Interventional, Open Label, Reduced/Staged, Single Dose Study Investigating the Pharmacokinetic Properties of Lu AF35700 in Subjects With Renal Impairment and in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Renal Failure
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2017-08-07
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the pharmacokinetics of Lu AF35700 after a single dose tablet to subjects with renal impairment (kidney insufficiency) and compare that with healthy subjects

Detailed description: If the initial data shows a substantial effect in subjects with severe renal impairment, the study will be expanded to include subjects with intermediate level (mild and moderate) of renal impairment.

Eligibility criteria: Inclusion Criteria:

-Healthy subjects: The subject has a Glomerular Filtration Rate as based on creatinine clearance (CLCr) ≥90 mL/min (estimated by the Cockcroft-Gault method)

-Subjects with renal impairment: The subject has any form of renal dysfunction which includes polycystic kidney disease

The subject is classified as having renal impairment at Screening according to Cockroft-Gault method for estimating creatinine clearance:

Severe: CLCr ≤ 29 mL/min Moderate: 30 mL/min ≤ CLCr ≤ 59 mL/min Mild: 60 mL/min ≤ CLCr ≤ 89 mL/min

Exclusion Criteria:

-The subject has previously been dosed with Lu AF35700

Primary outcomes:
measure: AUC0-inf
timeFrame: Predose to day 57 postdose
measure: Cmax
timeFrame: Predose to day 57 postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: APEX
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT04191447: Efficacy and Safety of Flamboyant 200/12 Association in the Treatment of Adults With Severe Asthma
Official title: Multicenter, Randomized, Double-blind, Double-dummy, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Flamboyant 200/12 Association in the Treatment of Adults With Severe Asthma .
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2019-12-09
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Flamboyant 200/12 association in adults with asthma.


Eligibility criteria: Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Participants aged 18 years or more;
* Diagnosis of uncontrolled severe asthma;
* Participants with Forced expiratory volume in 1 second (FEV1) \> 60% of predicted;

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* Known hypersensitivity to the formula components used during the clinical trial;
* History of alcohol and/or substance abuse within 12 months prior to Screening Visit.
* Current smoking or smoking history equivalent to "10 pack years"
* Participants with untreated oral candidiasis;
* Pulmonary disease history (e.g., chronic obstructive pulmonary disease \[COPD\], cystic fibrosis, bronchiectasis, tuberculosis);
* Participants with a history of acute asthma exacerbation, respiratory tract infection or hospitalization for asthma in the last 4 weeks;
* Known HIV-positive status or active hepatitis B or C virus test result
* Participants with current evidence or history of uncontrolled coronary artery disease, congestive heart failure, myocardial infarction or cardiac arrhythmia;
* Participants with a current medical history of cancer and/or cancer treatment in the last 5 years;
* Participants using medications that would have an effect on bronchospasm and / or lung function.

Primary outcomes:
measure: Change from baseline in Forced expiratory volume in 1 second (FEV1), obtained through espirometry.
timeFrame: 12 weeks
Secondary outcomes:
measure: Incidence and severity of adverse events recorded during the study.
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Tatuí
country: Brazil
facility: IMC Tatuí
state: São Paulo
Study officials:
References:
Clinical trial NCT02951247: Quality Control of CE-Certified Phonak Hearing Aids - 2016_05
Official title: Quality Control of CE-Certified Phonak Hearing Aids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2016-11-01
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: OTHER

Brief summary: A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of hearing participants to grant quality control prior to product launch. The aim of the investigation series is to ensure zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding Phonak Hearing Systems.

Detailed description: Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials in the way as planned for this study ("phase of final inspection"). This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Eligibility criteria: Inclusion Criteria:

* Adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids
* Good written and spoken (Swiss) German language skills
* Healthy outer ear
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* Informed Consent as documented by signature

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Central hearing disorders

Primary outcomes:
measure: Zero-defect performance in daily life
timeFrame: Four weeks
Secondary outcomes:
measure: Speech intelligibility in noise as signal to noise ration in dB (dB SNR)
timeFrame: Two weeks
measure: Visibility
timeFrame: Four weeks
measure: Wearing Comfort
timeFrame: Four weeks
Other outcomes:
measure: Initial first fit acceptance (pre-calculation) in lab
timeFrame: Two weeks
Locations:
city: Stafa
country: Switzerland
facility: Sonova AG
state: Zürich
Study officials:
References:
Clinical trial NCT01599845: The Differential Pattern of Deposition of Nano Particles in the Airways of Exposed Workers
Official title: The Differential Pattern of Deposition of Nano Particles in the Airways of Exposed Workers (Nanoexposure)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inadequate or Impaired Respiratory Function
Keywords: Lung
Alveoli
Nanoparticles
Particulate matter
Exhaled breath condensate
Induced sputum
Forced expiratory volume
Force vital capacity
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients

Brief summary: Investigation of the differences between the levels of extracellular and intracellular nano-particles in workers exposed to environmental particles during their employment to enhance understanding the process of penetration of the particles to respiratory epithelial cells.

Detailed description: This study investigates the following questions:

Does occupational exposure to nanoparticles influence permeation of such particles to respiratory airways? Is there a correlation between the levels of nanoparticles in sample biological fluids of the patients and their pulmonary functions.

Is there a correlation between the levels of nanoparticles in sample biological fluids of the patients and respiratory tract infections.

The study protocol includes the following steps:

Initial interview of the patient Measurement of nanoparticles in samples of exhaled breath condensate using NanoSight LM 20 Measurement of nanoparticles in induced sputum. And finally examination of the relationship between the measured parameters and the indices of pulmonary infection, and pulmonary function as measured by the pulmonary department of the TASMC.

Eligibility criteria: Inclusion Criteria:

* Adults over 20 years of age who visit Ichilov Hospital for medical complaints/inquiries regarding respiratory tract.
* Study population is composed of people who are exposed to environmental particles form industrial sources.
* Informed consent is requested from each subject.

Exclusion Criteria:

* Unemployed individuals.
* Individuals who are not working in industrial jobs, such as office workers and secretaries.

Primary outcomes:
measure: Analysis of the size distribution of nano-particles in exhaled breath condensate
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tel Aviv Sourasky Medical Center (TASMC, Ichilov)
name: Yehuda Schwarz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06552845: Consistency of LGE-MRI Fibrosis and EAM Low-voltage Area
Official title: Exploratory Study of Consistency of Bi-Atrial Fibrosis Detected by Late Gadolinium Enhancement Magnetic Resonance Imaging and Low Voltage Area of Electroanatomic Mapping
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2024-08-14
Enrollment: 50
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: Adult AF patients who are planned to receive catheter ablation and have no contraindications of LGE-MRI

Brief summary: This study aims to:

1. Assess the consistency of LGE-MRI bi-atrial fibrosis and electroanatomical mapping of bi-atrial low voltage region
2. To evaluate the electroanatomical characteristics of different types of fibrosis (dense fibrosis, patchy fibrosis, etc.) in different locations of the left and right atrium;
3. To explore the correlation between preoperative and postoperative bi-atrial fibrosis and long-term recurrence in patients with atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

1. Adult patients (≥18 years old) who are willing to participate in this study and can sign informed consent;
2. Atrial fibrillation was diagnosed and catheter ablation was proposed

Exclusion Criteria:

1. Left atrial thrombus or left atrial appendage thrombus;
2. Severe chronic obstructive pulmonary disease (FEV1/ FVC\<70%, FEV1\<50% predicted value);
3. Absolute contraindications of anticoagulation therapy;
4. Currently pregnant;
5. Contraindications for LGE-MRI (claustrophobia, pacemaker implantation, eGFR\<30ml/min for renal insufficiency, severe obesity, pregnancy, gadolinium chelating agent allergy, etc.);
6. refuse to participate in the study;
7. other physical or mental incapacity to participate in the study.

Primary outcomes:
measure: Consistency of LGE-MRI fibrosis and EAM low-voltage area
timeFrame: Baseline (at recruit time point)
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, CAMS&PUMC
state: Beijing
Study officials:
References: