louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02428010: Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study
Official title: Evaluation of Safety and Performance of the Twelve Transcatheter Mitral Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mitral Valve Insufficiency
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2015-04-28
Enrollment: 3
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: Study to evaluate the safety and performance of the Twelve TMVR System

Detailed description: The study is a prospective, multi-center, non-randomized trial to evaluate the safety and performance of the Twelve TMVR System in very high risk patients with severe, symptomatic mitral regurgitation.

Eligibility criteria: Key Inclusion Criteria:

* Severe mitral regurgitation (MR Grade 3-4+)
* Symptomatic mitral regurgitation (NYHA Class II-IV)
* Trans-apical access deemed feasible by the treating physician
* Native mitral valve geometry and size compatible with the Twelve TMVR

Key Exclusion Criteria:

* Left ventricular ejection fraction (LVEF) \< 20
* Evidence of intracardiac mass, thrombus, or vegetation
* Prior valve surgery or need for other valve surgery
* Prior stroke within 4 weeks
* Need for coronary revascularization
* History of, or active, endocarditis
* Renal insufficiency (Creatinine \> 2.5 mg/dL)

Primary outcomes:
measure: Adverse Events
timeFrame: 30 days
Secondary outcomes:
measure: Procedural Success
timeFrame: Through 5 years
measure: Reduction of MR
timeFrame: Through 5 years
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: John Paul II Hospital
Study officials:
affiliation: Medtronic
name: Sonia Diaz de Leon
role: STUDY_DIRECTOR
References:
Clinical trial NCT03577210: The Degree of Accuracy of Patient-specific PEEK Implant to Restore Chin Deficiency
Official title: The Degree of Accuracy of Patient-specific PEEK Implant to Restore Chin Deficiency. Accuracy Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chin Microgenia
Keywords: chin deficiency
chin asymmetry
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 20
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: computer guided patient-specific PEEK implant will be used to augment patients with chin deficiency or chin asymmetry.

Detailed description: augmentation genioplasty will be done to patients with chin deficiency or asymmetry. using cone beam CT for each patient and special soft ware "MIMICS 15" , patient-specific implant design can be done. PEEK will be milled as CAD-CAM technique to finally get patient specific PEEK implant. with patient is under General anesthesia, the implant will inserted and fixed with titanium screws. closure in two layers will be done.

Eligibility criteria: Inclusion Criteria:

* Adult male or female patients.
* Patients with retruded chin or with chin asymmetry.
* Patients with good oral hygiene.

Exclusion Criteria:

* Patients that need skeletal procedure in the mandible, other than genioplasty, at the same time of surgery or was done within time period less than 6 months.
* Patients with medical condition that may compromise the healing process.
* Patients with medical condition that is contraindicated for general anaesthesia.
* Presence of pathological lesion related to chin area.

Primary outcomes:
measure: degree of accuracy of patient specific peek implant in chin augmentation as virtually planned using Mimics software, measuring unit (mm) mm
timeFrame: two weeks postoperative
Secondary outcomes:
measure: patient satisfaction with postoperative chin appearance and pain: Face-Q questionnaire
timeFrame: 6 months postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Salma Hassan
Study officials:
affiliation: Cairo University
name: Ghada abd el-monim, phd
role: STUDY_DIRECTOR
References:
citation: Alonso-Rodriguez E, Cebrian JL, Nieto MJ, Del Castillo JL, Hernandez-Godoy J, Burgueno M. Polyetheretherketone custom-made implants for craniofacial defects: Report of 14 cases and review of the literature. J Craniomaxillofac Surg. 2015 Sep;43(7):1232-8. doi: 10.1016/j.jcms.2015.04.028. Epub 2015 May 8.
citation: Bertossi D, Galzignato PF, Albanese M, Botti C, Botti G, Nocini PF. Chin Microgenia: A Clinical Comparative Study. Aesthetic Plast Surg. 2015 Oct;39(5):651-8. doi: 10.1007/s00266-015-0518-4. Epub 2015 Jul 1.
citation: Hsu SS, Gateno J, Bell RB, Hirsch DL, Markiewicz MR, Teichgraeber JF, Zhou X, Xia JJ. Accuracy of a computer-aided surgical simulation protocol for orthognathic surgery: a prospective multicenter study. J Oral Maxillofac Surg. 2013 Jan;71(1):128-42. doi: 10.1016/j.joms.2012.03.027. Epub 2012 Jun 12.
Clinical trial NCT05261295: Comparison of PEEP Effect on Perioperative Oxygenation and Postoperative Pulmonary Complications in Lithotomy Position
Official title: Comparison of PEEP Applying in Terms of Perioperative Oxygenation and Postoperative Pulmonary Complications in the Use of Classical LMA and I-gel in Urological Surgery Procedures in Lithotomy Position
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Positive End Expiratory Pressure
Lung Ultrasound
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who will undergo transurethral resection of the bladder and prostate taken in the lithotomy position, ureter and kidney stone operations with ureteroscopy

Brief summary: The main purpose of the study is to compare the effectiveness of PEEP application in terms of perioperative oxygenation level in the use of classical LMA and i-gel, which is often preferred. The secondary aim is to compare parameters such as gastric insufflation and the rate of postoperative pulmonary complication development in the case of PEEP with two supraglottic airway devices.


Eligibility criteria: Inclusion Criteria:

* ASA I-III
* Patients who will undergo transurethral resection of the bladder and prostate taken in the lithotomy position, ureter and kidney stone operations with ureteroscopy

Exclusion Criteria:

* Heart failure (ejection fraction \< 40%),
* unstable hemodynamic conditions
* Having neck or upper respiratory tract pathology,
* have an increased risk of aspiration (gastroesophageal reflux disease, full stomach, acidity),
* obesity (body mass index≥30 kg m-2)
* Patients with poor tooth structure will also be excluded.

Primary outcomes:
measure: LUS score preop
timeFrame: Baseline
measure: LUS score postoperative
timeFrame: postoperative 1.hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: ankara ch bilkent
name: canan ün, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00780195: Metabolic Adaptations to Diabetes in African Americans
Official title: Metabolic Adaptations to Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: hypoglycemia
African Americans
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2008-10-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: We do not know why diabetic patients cannot protect themselves against low blood sugar. Therefore, in this study, we will perform a comprehensive assessment of the body's response to low blood sugar by measuring changes in blood hormones, blood sugar production, and nerve signals.

Detailed description: Morning and afternoon hypoglycemic episodes of 70, 60, or 50 mg/dl produce increased blunting of subsequent counterregulation dependent upon the depth of preceding hypoglycemia. We wanted to test this hypothesis in healthy African American individuals to determine if there is a difference in their responses to varying depths of hypoglycemia.

Eligibility criteria: Inclusion Criteria:

* Healthy males and females aged 18-40 yrs with no family history of diabetes mellitus.
* All prospective volunteers will have routine blood tests to screen for biochemical, hormonal and hematological abnormalities.
* Female volunteers will also undergo an HCG urine pregnancy test.

Exclusion Criteria:

* Prior or current history of poor health
* Abnormal results following blood and physical examination
* Pregnancy

Primary outcomes:
measure: catecholamines
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University
name: Stephen N. Davis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05778695: Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Ketones
Official title: Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Ketones
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson Disease
Lewy Body Dementia
Parkinson Disease Dementia
Keywords: ketone ester
ketosis
functional neuroimaging
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Farmer Family Foundation
First posted: 2023-03-21
Enrollment: 16
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Small exploratory open-label pilot study to assess supplementation of a ketone ester (KetoneAid) as a potential therapy for persons with Parkinson disease (PD), Parkinson Disease Dementia/Lewy Body Dementia (PDD/LBD), and healthy controls.

Detailed description: The overarching goal of this study is to investigate glucose metabolic, cognitive, clinical and imaging changes in persons with PD and PDD/LBD before and after a month supplementation of a ketone ester (KetoneAid) in a small open label exploratory clinical trial. Positive findings in this small exploratory pilot trial may support future target engagement studies of ketone supplementation in PD and normal adults.

Eligibility criteria: Inclusion Criteria:

* Healthy control volunteers over 45 years of age
* People with Parkinson Disease over 45 years of age
* People with Parkinson's Disease Dementia or Lewy Body Dementia over 45 years of age

Exclusion Criteria:

* Participants with contra-indications to MR imaging, including pacemakers or claustrophobia;
* Evidence of large vessel stroke or mass lesion on MRI
* Regular use of anti-cholinergic, benzodiazepines, high dose (\>100mg QD) of quetiapine, or neuroleptic drugs
* History of significant GI disease
* Significant metabolic or uncontrolled medical comorbidity
* Poorly controlled diabetes
* Pregnancy or breast feeding
* Current excessive alcohol use
* Suicidal ideation

Primary outcomes:
measure: Glucose Metabolism
timeFrame: Pre and post approximately 30 days of intervention
measure: Clinical Dementia Rating Scale Score
timeFrame: Pre and post approximately 30 days of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Domino's Farms
state: Michigan
city: Ann Arbor
country: United States
facility: University Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Nicolaas Bohnen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05841095: Evaluation of the Novel Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104
Official title: Phase I/II Study to Determine the Safety, Immunogenicity and Efficacy of the Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Chronic Hepatitis b
Keywords: Immunotherapy
Therapeutic Vaccination
Hepatitis B cure
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: ISA Pharmaceuticals B.V.
First posted: 2023-05-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test ISA104 in patients with chronic hepatitis B. The main question\[s\] it aims to answer are:

* How safe is ISA104?
* Does ISA104 induce immunity against hepatitis B virus?

Different doses of the vaccine ISA104 will be administered to participants. These participants are chronic HBV patients being actively treated with antiviral drugs.

Researchers will compare the ISA104 vaccine to a placebo.


Eligibility criteria: Inclusion Criteria:

* cHBV
* Active treatment with NUCs and HBV DNA \< limit of quantification

Exclusion Criteria:

* Immune-compromised
* Evidence of liver cirrhosis

Primary outcomes:
measure: Safety according to AEs, SAEs
timeFrame: 6 months
Secondary outcomes:
measure: HBV specific Immunogenicity- following ISA104 vaccination
timeFrame: 6 months
measure: Efficacy of ISA104 vaccination by using conventional biomarkers
timeFrame: 6 monts
Other outcomes:
measure: To study novel HBV disease markers in the study patient population to assist with treatment decisions and/or therapy response monitoring in general
timeFrame: 6 months
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Erasmus Medical Center
name: Dave Sprengers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02310295: Prospective, Randomized Clinical Trial Comparing Macular Photocoagulation With or Without Intravitreal Bevacizumab or Triamcinolone for the Treatment of Diabetic Macular Edema
Official title: Bevacizumabe e Acetato de Triancinolona Intra-vítreo Associados à Laserterapia em Pacientes Com Edema Macular diabético (IBeTA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Macular Edema
Keywords: Diabetic retinopathy
Macular edema
Anti-VEGF
Triamcinolone
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 45
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: Purpose: To compare the effects of macular photocoagulation with or without intravitreal bevacizumab (IVB) or triamcinolone (IVTA) for the treatment of diabetic macular edema (DME). Casuistic and Methods: 58 eyes of 44 patients with diffuse DME were randomized to receive either IVB + focal/grid laser (IVB-Laser, n=19), IVTA + focal/grid laser (IVTA-Laser, n=16) or focal/grid laser alone (Laser, n=23). Ophthalmic evaluation, including best-corrected visual acuity (BCVA), intraocular pressure (IOP) and central macular thickness (CMT) were performed at baseline and monthly for 12 months.


Eligibility criteria: Inclusion Criteria:

1. clinically significant diabetic macular edema (DME) with diffuse leakage involving the center of the fovea, with DME greater than 275 microns in OCT examination
2. BCVA between 0.3 LogMAR (logarithm of smaller angle of visual resolution) (20/40) and 1.6 LogMAR (20/800)
3. signed of inform Consent.

Exclusion Criteria:

1. HbA1c levels greater than 10%
2. thromboembolic event history (including myocardial infarction and stroke)
3. vitreo-macular traction on OCT
4. coagulation disorders
5. macular ischemia on fluorescein angiography examination
6. proliferative diabetic retinopathy that required treatment
7. eye surgery
8. history of ocular hypertension or glaucoma
9. any ocular pathology which in the opinion of the investigator, could macular edema or change the visual acuity during the study period (for example, retinal vascular occlusion, uveitis or other inflammatory eye disease, neovascular glaucoma)
10. systemic corticosteroid therapy
11. any conditions that could affect the documentation
12. any previous treatment for diabetic macular edema.

Primary outcomes:
measure: Central subfield macular thickness
timeFrame: 12 months
measure: Visual acuity
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04911595: Evaluation of Muscle Ischemia in Arterial Claudication (Tsingtao)
Official title: Evaluation de l'Ischemie Musculaire au Cours de l'Artériopathie Oblitérante Des Membres Inférieurs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Arterial Disease
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2021-06-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for claudication of suspected arterial

Brief summary: The goal is to compare the results observed in patients that had both an exercise oximetry and a thallium scintigraphy for lower limb claudication

Detailed description: On our routine pratice, patients suffering claudication (specifically atypical claudication or claudication of doubful vascular origin) have exercise oximetry to prove the vascular origin of pain. If still doubtful (inconsistency of pain and oximetry results) patients are referred for thallium scintigraphy. Our goal is to compare the results issued from these two test

Eligibility criteria: Inclusion Criteria:

* Claudication suspected of arterial origin

Exclusion Criteria:

* missing endopoint value

Primary outcomes:
measure: Correlation of thallium scintigraphy to oximetry results
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre hospitalier universitaire
Study officials:
affiliation: UH Angers
name: pierre abraham, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06009081: Interventions For Neck Pain In Relation to Internet Usage
Official title: A Comparıson Of Different Interventions For Neck Paın In Relation to Internet Usage Rates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Internet Addiction
Keywords: addiction
internet
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After the rapid increase in the use of the Internet in the world, it has brought some negativities.People with internet addiction describe all the time they spend without internet as worthless and they want to be on the internet with an increasing desire.

Detailed description: Under all this information, the exercise program and walking programs that are easily added to people's lives in the study; The effects on stress and sleep levels were investigated by reducing neck pain symptoms in people with internet addiction.

Eligibility criteria: Inclusion Criteria:

* 20 and 25 years old, have internet addiction
* have neck pain complaints for more than three months
* low category according to the International Physical Activity Index.

Exclusion Criteria:

* Participants who had mobility limitations and neurological problems -had spinal surgery, had a traffic accident in the last three months and were injured by whiplash injury mechanism- visual and hearing impairments,
* refused to participate in the study.

Primary outcomes:
measure: internet addiction scale
timeFrame: 8 weeks
measure: Disability Index
timeFrame: 8 weeks
measure: Physical Activity Index
timeFrame: 8 weeks
measure: stress scale
timeFrame: 8 weeks
measure: Sleep Quality Index
timeFrame: 8 weeks
measure: anxiety scale
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: HAZAL genç
state: None Selected
Study officials:
References:
citation: Zhang X, Yang H, Zhang K, Zhang J, Lu X, Guo H, Yuan G, Zhu Z, Du J, Shi H, Jin G, Hao J, Sun Y, Su P, Zhang Z. Effects of exercise or tai chi on Internet addiction in college students and the potential role of gut microbiota: A randomized controlled trial. J Affect Disord. 2023 Apr 14;327:404-415. doi: 10.1016/j.jad.2023.02.002. Epub 2023 Feb 6.
Clinical trial NCT01056081: Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease
Official title: Inspiratory Muscle Training for Patients With Chronic Obstructive Pulmonary Disease Undergoing a Pulmonary Rehabilitation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
inspiratory muscles
diaphragm
Lead sponsor: Faculdade Evangelica do Parana
Sponsor class: OTHER
First posted: 2010-01-26
Enrollment: 19
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Uncertainty persists regarding the usefulness of incorporating inspiratory muscle training (IMT) in pulmonary rehabilitation programs for patients with chronic obstructive pulmonary disease. In this study the investigators investigate whether IMT associated with exercise training would be better than exercise training alone, with regard to exercise capacity, inspiratory muscle strength and dyspnea.

Detailed description: Study design: A double-blind parallel controlled trial Setting: outpatient clinic Inclusion criteria: Subjects between 40 and 75 years of age referred by a physician to the Pulmonary Rehabilitation Program, with a clinical and spirometric diagnosis of moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD).

Outcome measurements: Inspiratory muscle strength (using maximal inspiratory pressure, MIP), exercise capacity (using six-minute walk test) and dyspnea were measured.

Eligibility criteria: Inclusion Criteria:

* Subjects with a clinical and spirometric diagnosis of moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD)
* In a stable condition (without exacerbations or infections for at least a month)
* Had to be former smokers (\> 6 months without smoking)
* subjects referred by a physician to the Pulmonary Rehabilitation Program

Exclusion Criteria:

* Subjects with a known history of asthma, or severe and/or unstable heart disease or any other pathological condition that could impair their physical activities

Primary outcomes:
measure: Inspiratory muscle strength
timeFrame: 8 weeks
Secondary outcomes:
measure: Exercise capacity
timeFrame: 8 weeks
measure: Dyspnea
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Evangelical Faculty of Paraná
name: Silvia R Valderramas, PhD
role: STUDY_CHAIR
References: