louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04459949: Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling
Official title: Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epiretinal Membrane
Macular Holes
Lead sponsor: Wills Eye
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the performance and anatomic outcomes of the Sharkskin internal limiting membrane (ILM) forceps and the Grieshaber ILM forceps in macular surgery.

Peeling of the ILM is a difficult aspect of vitreoretinal surgery and often daunting task from a vitreoretinal fellow's perspective. The hypothesis is that the newer Sharkskin forceps have a larger platform and micro-abrasions along the forcep surface to increase grasping ability and potentially limit trauma to the retina surface compared to the Grieshaber forceps. This project may also serve as an education tool for fellows learning the basics of ILM peeling.


Eligibility criteria: Inclusion Criteria:

* Macular pathology

Exclusion Criteria:

* No prior vitreoretinal surgery

Primary outcomes:
measure: Surgical time
timeFrame: During surgery
Secondary outcomes:
measure: Ease of peeling - surgeon
timeFrame: During surgery
measure: Ease of peeling - masked grader
timeFrame: Through study completion, up to one year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04404049: The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients
Official title: The HIV Functional Cure Potential of UB-421: A Phase II, Randomized, Open-label, Controlled, 48 Week, Proof of Concept Study, to Evaluate the Safety of UB-421 in Combination With Standard Antiretroviral Therapy (ART) and the Efficacy of HIV Reservoir Reduction as Compared With ART Alone in ART Stabilized HIV-1 Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: HIV-1-infection
Lead sponsor: UBP Greater China (Shanghai) Co., Ltd
Sponsor class: INDUSTRY
First posted: 2020-05-27
Enrollment: 39
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase II, randomized, open-label, multi-center, active-controlled study to assess the safety, tolerability, and efficacy of UB-421 administered as an add-on to the standard ART in ART-treated HIV-1 subjects with stably suppressed HIV-1 plasma VL. The study will be conducted at multiple study centers, designated AIDS hospitals in China.


Eligibility criteria: Inclusion Criteria:

1. HIV-1 sero-positive
2. Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.
3. HIV-1 plasma RNA level below 50 RNA copies/mL.

Exclusion Criteria:

1. Subjects with active systemic infections, except for HIV-1, that the Investigator feels the infections may confound evaluation and treatment for HIV-1.
2. Current active hepatitis B carriers, ie, hepatitis B surface antigen positive.
3. Current active hepatitis C carriers, ie, hepatitis C virus (HCV) antibody positive.
4. History of anaphylaxis to other mAbs.
5. Any vaccination within 8 weeks prior to the first dose of assigned drug.
6. Use of immunomodulators, HIV vaccine, or systemic chemotherapy within 180 days prior to the first dose of assigned drug.
7. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.

Primary outcomes:
measure: treatment related TEAEs
timeFrame: 48Weeks
Secondary outcomes:
measure: the change of immune profiles
timeFrame: 16Weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01796249: Prediction of Immediate Postoperative Pain Using Analgesia/Nociception Index (ANI)
Official title: Prediction of Immediate Postoperative Pain Using Analgesia/Nociception Index (ANI): an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Keywords: Analgesia Nociception Index
ANI
Lead sponsor: Hôpital Edouard Herriot
Sponsor class: OTHER
First posted: 2013-02-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients underoing surgical procedures performed on general anesthesia

Brief summary: The aim of this study is to evaluate the performance of Analgesia/Nociception Index (ANI) measured at the end of surgery for the prediction of immediate postoperative pain in postoperative care unit in adult patients undergoing general anesthesia.

Detailed description: Assessment of the performance of ANI to predict immediate postoperative pain on a 0-10 numerical rating scale (NRS) \>3 by building a receiver operating characteristic curve.

Eligibility criteria: Inclusion Criteria:

* adult
* ear-nose-throat or orthopedic surgical procedures
* halogenated and remifentanil-based general anesthesia

Exclusion Criteria:

* age \<18 yrs or \>75 yrs
* arrythmia
* administration of anticholinergic drugs or neuromuscular blockade reversal in the 20 previous minutes
* psychiatric diseases
* autonomic nervous system disorders (epilepsy)
* inability to understand the verbal rating pain scale

Primary outcomes:
measure: Analgesia/Nociception Index (ANI) receiver operating characteristic (ROC) curve area under the curve (AUC) for the prediction of immediate postoperative pain
timeFrame: At day 0 at the end of surgery immediately before extubation for ANI and at arrival in postoperative care unit within 10 minutes after arrival
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Édouard Herriot hospital, HCL
state: Rhône
Study officials:
affiliation: Hôpital Edourd Herriot
name: Emmanuel Boselli, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hôpital Edouard Herriot
name: Bernard Allaouchiche, Md, PhD
role: STUDY_CHAIR
References:
citation: Boselli E, Daniela-Ionescu M, Begou G, Bouvet L, Dabouz R, Magnin C, Allaouchiche B. Prospective observational study of the non-invasive assessment of immediate postoperative pain using the analgesia/nociception index (ANI). Br J Anaesth. 2013 Sep;111(3):453-9. doi: 10.1093/bja/aet110. Epub 2013 Apr 16.
citation: Boselli E, Bouvet L, Begou G, Dabouz R, Davidson J, Deloste JY, Rahali N, Zadam A, Allaouchiche B. Prediction of immediate postoperative pain using the analgesia/nociception index: a prospective observational study. Br J Anaesth. 2014 Apr;112(4):715-21. doi: 10.1093/bja/aet407. Epub 2013 Dec 8.
Clinical trial NCT03851549: A User Performance and System Use Evaluation of a New Blood Glucose Monitoring System ( BGMS)
Official title: US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a New Blood Glucose Monitoring System.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: LifeScan Scotland Ltd
Sponsor class: INDUSTRY
Collaborators: name: Institut für Diabetes-Technologie ( IfDT)
First posted: 2019-02-22
Enrollment: 360
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is the US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a new Blood Glucose Monitoring System (BGMS).

Detailed description: User Performance - Assess Lay User fingertip test results obtained on the new BGMS compared to a validated method (YSI 2300 STAT PLUS glucose analyzer results) according to FDA Guidance 2016 section VI.C.

Assess System Use of the new BGMS, as relevant to self-testing technique, with reference to the Owner's Booklet.

Eligibility criteria: Summary of inclusion criteria:

Subject is at least 12 years old. Informed Consent. Subject has a current diagnosis of type 1 or type 2 diabetes mellitus. Subject reads and understands English. Subject is currently performing unassisted self-monitoring of blood glucose (SMBG) OR naive to SMBG for a 10% sub-group.

Summary of exclusion criteria:

Conflict of interest. Technical expertise.

Primary outcomes:
measure: User Performance ( UP)
timeFrame: < 30 minutes
measure: System Use Evaluation
timeFrame: < 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Institut für Diabetes-Technologie
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
state: Lothian
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Inverness
country: United Kingdom
facility: Centre for Health Science
Study officials:
affiliation: LifeScan Scotland
name: Kirsty Macleod
role: STUDY_DIRECTOR
References:
citation: Katz LB, Stewart L, King D, Cameron H. Meeting the New FDA Standard for Accuracy of Self-Monitoring Blood Glucose Test Systems Intended for Home Use by Lay Users. J Diabetes Sci Technol. 2020 Sep;14(5):912-916. doi: 10.1177/1932296820906184. Epub 2020 Feb 14.
Clinical trial NCT04641949: Methoxyflurane and Fentanyl in LBNP
Official title: Methoxyflurane and Fentanyl in the Lower Body Negative Pressure Model of Hypovolemia in Healthy Volunteers; a Randomized, Placebo-controlled Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypovolemia
Cardiac Output, Low
Analgesia
Keywords: Methoxyflurane
Fentanyl
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, placebo controlled, crossover study.
Primary purpose: BASIC_SCIENCE

Brief summary: The study is a single-centre, placebo-controlled, crossover study on healthy volunteers aiming to explore non-inferiority of methoxyflurane and fentanyl compared to placebo on the tolerance to hypovolemia.

Detailed description: The study will explore the effects of fentanyl and methoxyflurane versus placebo (NaCl; saline) on the hemodynamic response to hypovolemia in healty volunteers. Hypovolemia will be induced in the "lower body negative pressure" model. XX healthy volunteers will be exposed to inhaled methoxyflurane, 3 ml or intravenous fentanyl, XX mg or placebo in a randomized order (cross-over) at least 3 days apart.

Eligibility criteria: Inclusion Criteria:

* Must be at least 18 years of age.
* Must be below 65 years of age.
* Signed informed consent and expected cooperation for the study and follow up must be obtained and documented according to ICH GCP, and national/local regulations.

Exclusion Criteria:

* Any medical condition limiting physical excertional capacity or requiring regular medication (allergy and oral contraceptives excepted)
* Pregnancy
* History of syncope (syncope of presumed vasovagal nature with known precipitating factor excepted)
* Any known cardiac arrhythmia
* History of renal disease
* History of liver disease
* Previous substance abuse
* Allery or known serious side-effects to opioids or methoxyflurane

Primary outcomes:
measure: Cardiac output
timeFrame: Measured continuously during LBNP-exposure.
Secondary outcomes:
measure: Time to hemodynamic decompensation
timeFrame: 15 minutes
measure: Mean arterial pressure
timeFrame: Measured continuously during LBNP-exposure.
measure: Stroke volume
timeFrame: Measured continuously during LBNP-exposure.
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
Clinical trial NCT03438149: Microparticles in Obstructive Sleep Apnea
Official title: Microparticles as a Biomarker of Incident Cardiovascular Risk in Patients With Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Apnea, Obstructive
Keywords: microparticles
cardiovascular outcomes
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2018-02-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with prevalent cardiovascular diseases referred to a sleep clinic for suspected OSA.

Brief summary: Obstructive sleep apnea (OSA) is independently associated with cardiovascular diseases, including myocardial infarction and stroke. OSA may promote atherosclerosis risk factors such as hypertension, diabetes and dyslipidemia and may have direct proatherogenic effects on the vascular wall. A growing number of studies have recently focused on the role of microparticles (MPs) in the atherogenic process. Case-control studies have shown that platelet-, endothelial- and leukocyte-derived MP levels are increased in OSA and that leukocyte-derived MP are released during the night in OSA. Furthermore, experimental evidence shows that MPs from OSA patients induce endothelial dysfunction.

The objective of this prospective study is to evaluate the impact of increased levels of leukocyte derived MPs on the cardiovascular outcomes in patients with prevalent cardiovascular diseases investigated for OSA.

Detailed description: MPs are small plasma membrane vesicles that can be released by a variety of vascular or blood cells and that contain membrane and cytosolic elements. Case-control studies have shown that platelet-, endothelial- and leukocyte-derived MP levels are increased in OSA. Experimental evidence shows that MPs from OSA patients induce endothelial dysfunction, inflammation, and vascular hyperreactivity when injected to mice.

The impact of increased levels of MPs on the cardiovascular prognosis in OSA patient with prevalent cardiovascular diseases in unknown.

Eligibility criteria: Inclusion Criteria:

* diagnosis of coronary artery disease or cerebrovascular disease
* diagnosis of moderate-to-severe OSA

Exclusion Criteria:

* pregnancy
* previously treated OSA

Primary outcomes:
measure: death from any cardiovascular cause
timeFrame: first event within 5 years after inclusion
measure: myocardial infarction (acute infarct or silent myocardial infarction or unstable angina)
timeFrame: first event within 5 years after inclusion
measure: cerebrovascular infarction (stroke or transient ischemic attack)
timeFrame: first event within 5 years after inclusion
measure: hospitalization for heart failure
timeFrame: first event within 5 years after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Laboratoire du Sommeil, Département de Pneumologie, CHU d'Angers
Study officials:
References:
Clinical trial NCT01085149: The Effect Of Simvastatin On Bone Remodeling In Socket Of Mandibular Teeth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypercholesterolemia
Keywords: simvastatin
alveolar bone
tooth extraction
remodeling
alveolar bone remodeling
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2010-03-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: Simvastatin has been reported to promote osteoblastic activity and inhibit osteoclastic activity by enhancing the expression of BMP2. There have been many studies demonstrating the bone-promoting effect of local application various animal models including after application into socket of teeth in a rat. the purpose of the study is to investigate the effect of slow release topical simvastatin in socket of mandibular teeth on bone remodeling in the socket

Detailed description: after extraction of mandibular single root teeth 10 mg of slow release simvastatin would be inserted to the socket. observation will be at 1 week, 4 weeks and 3 months.after 3 months the patients will have dental CT as done routinely in our clinic before placing dental implants and the bone density and height will be measured on this data. during the procedure of inserting a dental implant a trephine will be taken for histology.

Eligibility criteria: Inclusion Criteria:

* need extraction of single root tooth
* intend to have prosthetic implant in place of extraction

Exclusion Criteria:

* treated with simvastatin P.O for hypercholesterolemia

Primary outcomes:
measure: bone height and density in former socket
timeFrame: 3 months
Secondary outcomes:
measure: bone mineralization
timeFrame: 3 months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Oral and Maxillofacial Clinic, Hadassah
Study officials:
affiliation: Hadassah Medical Organization
name: casap nardi, MD, DMD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu Z, Liu C, Zang G, Sun H. The effect of simvastatin on remodelling of the alveolar bone following tooth extraction. Int J Oral Maxillofac Surg. 2008 Feb;37(2):170-6. doi: 10.1016/j.ijom.2007.06.018. Epub 2007 Sep 4.
Clinical trial NCT05356949: Effectiveness of Enhanced Mental Health Support for Young People
Official title: Effectiveness of Enhanced Mental Health Support for Young People
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Anxiety
Emotional Stress
Keywords: Depression
Anxiety
Intervention
Adolescents
School
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Turku
name: City of Turku
First posted: 2022-05-02
Enrollment: 124
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the research project is to measure the effectiveness of an early and rapid psychiatric nurse intervention at schools in improving the emotional well-being and functioning of adolescents.

Detailed description: In this study, the impact of a short psychological intervention on adolescent emotional well-being, symptoms, and functioning is assessed. The intervention is a short intervention based on the methods of cognitive-behavioral therapy comprising 6 weekly sessions. It is delivered by psychiatric nurses working in the schools in the City of Turku. The participants are adolescents aged 12-18 who seek student health care due to mental health problems. The goal is to recruit 150 participants. The intervention is not tied to some particular disorder and thus, the main response variable is emotional well-being. Emotional well-being is measured at both the beginning and the end of the intervention, and at 6-month follow-up using the Young Person's Clinical Outcomes for Routine Evaluation (YP-CORE) questionnaire. Effectiveness is measured as a change in the YP-CORE scores.

Eligibility criteria: Inclusion Criteria:

* Young Person's Clinical Outcomes for Routine Evaluation (YP-CORE) score ≥14
* Willing and able to commit to the intervention and study protocol
* Sufficient proficiency in Finnish

Exclusion Criteria:

* Other ongoing mental health treatment
* Substance use as the main problem

Primary outcomes:
measure: Emotional well-being, short-term
timeFrame: 6 weeks
Secondary outcomes:
measure: Emotional well-being, long-term
timeFrame: 6 months
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
state: Southwest Finland
Study officials:
affiliation: Turku University Hospital
name: Max Karukivi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04843449: Study to Evaluate the Effects of Itraconazole and Rifampin on the Pharmacokinetics of ASC40 in Healthy Subjects
Official title: A Phase I, Open Label, Drug-drug Interaction Study to Evaluate the Effects of Itraconazole and Rifampin on the Pharmacokinetics of ASC40 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
DDI (Drug-Drug Interaction)
Itraconazole
Rifampicin
ASC40
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2021-04-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the effects of itraconazole (a strong inhibitor of cytochrome P450 3A (CYP3A)) and rifampicin (a strong inducer of CYP3A) on the pharmacokinetics of ASC40 in healthy volunteers.


Eligibility criteria: Key Inclusion Criteria:

-19kg/m2 ≤ BMI \<40kg/m2.

Key Exclusion Criteria:

* History of, or current digestive system, nervous system disease, etc..
* Taking drugs or foods that inhibit or induce the liver's metabolism.

Primary outcomes:
measure: AUC of ASC40
timeFrame: Up to 24 days
measure: Cmax of ASC40
timeFrame: Up to 24 days
Secondary outcomes:
measure: t1/2 of ASC40
timeFrame: Up to 24 days
measure: CL/F of ASC40
timeFrame: Up to 24 days
measure: Vd/F of ASC40
timeFrame: Up to 24 days
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to 24 days
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan provincial people's hospital
state: Hunan
Study officials:
References:
Clinical trial NCT05936749: Pre-implantation Genetic Testing for Monogenic Disease: Single Center Experience
Official title: Pre-implantation Genetic Testing for Monogenic Disease: Single Center Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genetic Disease
Aneuploidy
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 76
Sex: FEMALE
Minimum age (years): 34
Maximum age (years): 42
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All 76 participants that underwent PGTM testing in the Fertility Center starting from the beginning of 2016 all through the end of 2022, will be included in the study.

Brief summary: This monocentric retrospective observational study aims to evaluate the efficacy of pre-implantation genetic testing for monogenic diseases (PGT-M). The effectiveness will be assessed in terms of live birth rate (LBR), cumulative live birth rate (CLBR) per couple, and abortion rate (AR). Considering how many cycles the participants have undergone to achieve a viable blastocyst. The secondary objective is to evaluate the incidence of aneuploidy in unaffected embryos, in order to understand the need for pre-implantation genetic testing for aneuploidy (PGT-A)in addition to PGT-M.


Eligibility criteria: Inclusion Criteria:

* Patients fertile or infertile that have undergone preimplantation genetic testing for monogenic diseases (PGTM).

Exclusion Criteria:

* No exclusion criteria will be taken into consideration.

Primary outcomes:
measure: Live birth rate (LBR)
timeFrame: 7 years of inclusion
measure: Cumulative live birth rate (CLBR) per couple
timeFrame: 7 years of inclusion
measure: Abortion rate (AR)
timeFrame: 7 years of inclusion
Secondary outcomes:
measure: Aneuploidy
timeFrame: 7 years of inclusion
Other outcomes:
Locations:
Study officials:
References: