louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06870123: Randomized MINIMA Stem with DELTA TT or DELTA ST-C
Official title: A Prospective Randomized Clinical Study Evaluating the Outcomes of MINIMA Stem with DELTA TT or DELTA ST-C Cup After Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis, Hip
Lead sponsor: Limacorporate S.p.a
Sponsor class: INDUSTRY
First posted: 2025-03-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is aimed to provide a clinical and radiographic evaluation of 120 suitable subjects who underwent a total hip arthroplasty with MINIMA stem coupled with Delta TT or Delta ST-C cup.

Detailed description: This is a post-market, interventional, prospective, randomized, not comparative, open label study designed to reflect real life clinical practice as closely as possible.

Eligibility criteria: Inclusion Criteria:

* Both genders
* Any race
* A diagnosis in the target hip of one or more of the following: a) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis; b) rheumatoid arthritis; c) post-traumatic arthritis; d) fractures of femoral neck;
* patien willingness to partecipate and signature of informed consent form

Exclusion Criteria:

* local or systemic infection
* septicaemia
* persistent acute or chronic osteomyelitis
* confirmed nerve or muscle lesion compromising hip joint function
* vascular or nerve disease affecting the concerned limb
* poor bone stock (for example due to osteoporosis) compromising the stability of the implant
* metabolic disorders which may impair fixation and stability of the implant
* any concomitant disease and dependence that might affect the implanted prosthsis
* metal hypersensitivity to implant materials
* required revision of previous standard femoral stem
* women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remail on an acceptable method of birth control throughout the entire study period
* life expectancy less than 5 years

Primary outcomes:
measure: Harris Hip Score (HHS)
timeFrame: 3 years
Secondary outcomes:
measure: Harris Hip Score (HHS)
timeFrame: 5 years
measure: Implant stability
timeFrame: 6 months, 1 year, 3 years, 5 years after surgery
measure: Oxford Hip Score (OHS)
timeFrame: 5 years
measure: Forgotten Joint Score (FJS)
timeFrame: 3 months (baseline) to 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery
measure: Survival Rate
timeFrame: 5 years
measure: Safety assessment
timeFrame: Intra operative, 3 months, 6 months, 1 year, 3 years, 5 years
Other outcomes:
Locations:
city: Martin
country: Slovakia
facility: The Orthopedic Clinic University Hospital Martin
Study officials:
References:
Clinical trial NCT06941623: Ultrasound Assessment for Comparison of Gastric Residual Volume After Ingestion of Carbohydrate Drink and Water in Obesity Class II and III Volunteers at Risk of Aspiration
Official title: Ultrasound Assessment for Comparison of Gastric Residual Volume After Ingestion of Carbohydrate Drink and Water in Obesity Class II and III Volunteers at Risk of Aspiration: A Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Gastroesophageal Reflux
Keywords: Carbohydrate drink
Gastric residual volume
Gastric ultrasound
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to compare gastric residual volume between drinking a carbohydrate drink and water in obesity class II and III volunteers at risk of aspiration.


Eligibility criteria: Inclusion Criteria:

* BMI ≥ 35 kg/m2 (obesity class II and III)
* Gastroesophageal reflux disease and/or active gastroesophageal reflux symptoms in 6 months (heartburn and/or acid regurgitation)
* ASA status I-III
* NPO for 8 hours before the study

Exclusion Criteria:

* Chronic kidney disease or End-stage renal disease
* Diabetes Mellitus
* Use of any medication that affects gastric secretion or emptying within the past 24-hour
* Pregnancy
* History of major upper gastrointestinal surgery
* Allergy to ultrasound gel

Primary outcomes:
measure: Gastric Residual Volume
timeFrame: before the study and 0, 10, 20, 30, 60, 90, 120 minutes after drinking the prepared drink each arm.If time to empty gastric antrum is extended, ultrasound will be serial performed at 150 and 180 minutes.
Secondary outcomes:
measure: Time to empty gastric antrum
timeFrame: 0, 10, 20, 30, 60, 90, 120 minutes after drinking the prepared drink each arm. If participants doesn't be empty stomach, time will extended to 120 and 180 minutes.
measure: Point-of-care testing(POCT) glucose
timeFrame: Point-of-care testing(POCT) glucose is measured before the study, 60 and 120 after drinking the prepared drink each arm.
measure: Hunger Numeric Rating Scale(NRS)
timeFrame: before the study, 60, and 120 minutes after drinking the prepared drink each arm
measure: Thirst Numeric Rating Scale(NRS)
timeFrame: before the study, 60, and 120 minutes after drinking the prepared drink each arm
measure: Nausea Numeric Rating Scale(NRS)
timeFrame: before the study, 60, and 120 minutes after drinking the prepared drink each arm
Other outcomes:
Locations:
city: Hatyai
country: Thailand
facility: Faculty of medicine, Songklanagarind Hospital
state: Songkhla
Study officials:
affiliation: Prince of Songkla University
name: Chanya Deekiatphaiboon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03404323: "Cataract Surgery in Eyes With Epiretinal Membrane"
Official title: "Retinal Thickness Change Following Cataract Surgery in Eyes With Epiretinal Membrane"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epiretinal Membrane
Pseudophakic Cystoid Macular Edema
Irvine-Gass Syndrome
Cataract
Keywords: central retinal thickness
epiretinal membrane
cataract surgery
pseudophakic cystoid macular edema
Lead sponsor: St John of God Hospital, Vienna
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thirty patients with visually compromising cataract and asymptomatic epiretinal membrane (ERM group) and 15 consecutive eyes with senile cataract with a healthy macula (control group) were included.

Brief summary: The purpose of the study is to evaluate retinal thickness change and the occurrence of central structural retinal changes after uneventful small-incision cataract surgery in eyes with asymptomatic early stages of epiretinal membrane.

Detailed description: Optical coherence tomography (OCT) is nowadays used in daily clinical practice and has become a helpful tool for detection of macular changes also in presence of opacification of the lens before cataract surgery. Using recent high-resolution OCT technology, early stages of epiretinal membranes can easily be detected and analysed. Since cataract surgery is one of the most frequently performed operations worldwide, this study was aimed to investigate the influence of uncomplicated cataract surgery on central retinal thickness and the incidence of structural and morphological macular changes after surgery in eyes with asymptomatic epiretinal membrane.

Eligibility criteria: Inclusion Criteria:

* visually compromising cataract and asymptomatic early stages of epiretinal membrane with no structural changes such as cysts or photoreceptor distribution in optical coherence tomography.

Exclusion Criteria:

* visual impairment or metamorphopsia due to epiretinal membrane
* history of branch retinal vein occlusion
* central retinal vein occlusion
* wet or dry macular degeneration
* diabetic retinopathy
* uveitis or other inflammatory eye disease.

Primary outcomes:
measure: central macular thickness
timeFrame: Change from Baseline central macular thickness at 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: St John of God Hospital, Vienna
name: Barbara Wetzel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St John of God Hospital, Vienna
name: Georgios Mylonas, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06407323: Pediatric Rehabilitation for Children With Cerebral Palsy Through PVT Using AI to Reduce Spasticity
Official title: Pediatric Rehabilitation for Children With Cerebral Palsy Through Personalized Vibration Therapy Powered By Artificial Intelligence: An Innovative Approach to Reduce Spasticity and Improved Motor Function and Quality Of Life
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 32
Sex: ALL
Minimum age (years): 2
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study foucs on pediatric rehabilitation for children with cerebral palsy through personalized vibration therapy powered by artificial intelligence.

Detailed description: Innovative approach to reduce spasticity, improved motor function, quality of life. Vibration therapy reduces spasticity by activating the body's natural stretch reflex, which in turn triggers muscular contractions. Furthermore, it has been proposed that the primary ends of the muscle spindle Ia afferent are stimulated by muscular vibration. This leads to the excitation of alpha motor neurons, subsequent contractions of motor units, ultimately producing a tonic muscle contraction. This study will modify vibration therapy by introducing Artificial intelligence to rehabilitate the patients suffering from spastic CP.

Eligibility criteria: Inclusion Criteria:

* Diagnosed spastic CP as per neurologist report, GMFCS level I-III
* Ability to safely withstand intensity of vibrating device.
* have no planned surgery within 5 months before/after entering the study

Exclusion Criteria:

* A bone fracture within 12 weeks of enrollment.
* History of using anabolic agents, glucocorticoids (excluding inhaled), or growth hormone (regardless of dose) for at least 1 month, within the 3 months prior to enrollment.
* History of botulinum toxin injection into the lower limb(s) within the 3 months before enrollment.
* History of an illness or findings on physical examination that might prevent the child from completing the study (e.g., acute thrombosis, tendinitis).

Primary outcomes:
measure: Modified Ashworth Scale
timeFrame: 12 Months
measure: Quality of life-child Questionnaire
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Johar pain relief center
state: Punjab
city: Lahore
country: Pakistan
facility: Ali Fatima hospital
state: Punjab
Study officials:
References:
Clinical trial NCT00839423: Randomised Placebo-controlled Venlafaxine-referenced Study of Efficacy and Safety of 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults
Official title: Double-blind, Randomised, Placebo-controlled Study Comparing the Efficacy and Safety of Two Fixed Dosages of a Novel Antidepressant Compound to That of Placebo in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder
Placebo-controlled
Active reference
Multicenter study
Randomised study
Acute treatment
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2009-02-09
Enrollment: 426
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this Venlafaxine-referenced study is to evaluate the efficacy, safety and tolerability of two fixed doses of Vortioxetine in the acute treatment of Major Depressive Disorder (MDD).


Eligibility criteria: Inclusion Criteria:

* MDE as primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx)
* Current MDE duration of at least 3 months and less than 12 months
* The patient has a MADRS total score \>=30

Exclusion Criteria:

* Any current psychiatric disorder other than MDD as defined in the DSM-IV TR
* Any substance disorder within the previous 6 months
* Female patients of childbearing potential who are not using effective contraception
* Use of any psychoactive medication 2 weeks prior to screening and during the study

Other protocol-defined inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in MADRS Total Score After 6 Weeks of Treatment
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Change From Baseline in MADRS Total Score After 1 Week of Treatment
timeFrame: Baseline and Week 1
measure: Change From Baseline in HAM-D 24 Total Score After 6 Weeks of Treatment
timeFrame: Baseline and Week 6
measure: Change From Baseline in HAM-A Total Score After 6 Weeks of Treatment
timeFrame: Baseline and Week 6
measure: Change From Baseline in CGI-S Score After 6 Weeks of Treatment
timeFrame: Baseline and Week 6
measure: Change in Clinical Status Using CGI-I Score at Week 6
timeFrame: Week 6
measure: Proportion of Responders at Week 6 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)
timeFrame: Week 6
measure: Proportion of Remitters at Week 6 (Remission is Defined as a MADRS Total Score <=10)
timeFrame: Week 6
Other outcomes:
Locations:
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: Alvarez E, Perez V, Dragheim M, Loft H, Artigas F. A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder. Int J Neuropsychopharmacol. 2012 Jun;15(5):589-600. doi: 10.1017/S1461145711001027. Epub 2011 Jul 18.
Clinical trial NCT03145623: Retrospective Efficacy and Safety Study With Elbasvir/Grazoprevir in HCV-infected Patients With Chronic Kidney Disease
Official title: Retrospective Efficacy and Safety Study With Elbasvir 50 mg/Grazoprevir 100 mg in HCV-infected Patients With Chronic Kidney Disease Stage 4-5 During the French Temporary Authorization for Use (ATU) Program: Data From Real-life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Chronic Kidney Diseases
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: MSD France
First posted: 2017-05-09
Enrollment: 100
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: CKD subjects with GT1 and GT4 HCV, compensated cirrhotic or non-cirrhotic (i.e all subjects with EBR 50 mg/GZR 100 mg based therapy in ATU allocation) will be included in this retrospective analysis

Brief summary: Retrospective Efficacy and Safety Study With Elbasvir (EBR) 50 mg/Grazoprevir (GZR) 100 mg in Hepatitis C Virus (HCV)-infected Patients With Chronic Kidney Disease (CKD) Stage 4-5 During the French Temporary Authorization for Use (ATU) Program: Data From Real-life

Detailed description: Primary objective : Retrospectively collect and describe the real life efficacy (SVR 12)\* and safety data of EBR 50 mg/GZR 100 mg based therapy, 12 or 16 weeks dosed in HCV-infected patients with chronic kidney disease. These data are collected following French ATU allocation.

Eligibility criteria: Inclusion Criteria:

* documented chronic (at least 6 months) HCV Genotype1 (GT1) and Genotype 4 (GT4) infection
* Mono infected by HCV or co-infected by HCV and HIV
* Have an HCV treatment status corresponding to one of the following:

  1. Treatment-naïve: Naïve to all anti-HCV treatment
  2. Prior interferon or pegylated interferon + ribavirin treatment failure (null responders, partial responders, relapsers)
  3. Prior Interferon (IFN) or pegylated (PEG)-IFN + ribavirin + telaprevir or boceprevir or simeprevir treatment failures
  4. Prior sofosbuvir based therapy failures
  5. Pegylated interferon ribavirin intolerant
* Have CKD defined as:

Subjects with glomerular filtration rate (GFR) ≤30 ml/min who are non-dialysis dependent (NDD) or have been on hemodialysis (HD) for at least 3 months (including subjects awaiting kidney transplant and subjects with failed kidney transplants no longer on immunosuppressant therapy).

Exclusion Criteria:

* none

Primary outcomes:
measure: Efficacy of Elbasvir (EBR)/Grazoprevir (GZR)
timeFrame: 12 weeks after the end of all study therapy
Secondary outcomes:
measure: Safety during treatment
timeFrame: during treatment
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Laurent ALRIC, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02478723: A Study Evaluating the Sonendo GentleWave™ System
Official title: An Observational Study Evaluating the Sonendo GentleWave™ System and the EndoTechnologies CPoint™ Obturation for Treatment of Molar Teeth Requiring Root Canal Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Root Canal
Keywords: requiring therapy
Teeth
Lead sponsor: Sonendo, Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-23
Enrollment: 20
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: Patients 18 years of age or older, who have a 1st or 2nd molar tooth that received root canal therapy with the Sonendo GentleWave System and obturation with CPoint and BC Sealer in at least one canal.

Brief summary: A post market, observational study evaluating the treatment of 1st and 2nd molars indicated for root canal therapy and treated with the Sonendo GentleWave System and obturated with CPoint and BC Sealer in at least one canal.


Eligibility criteria: Inclusion Criteria:

* The patient is 18 years of age or older
* The subject tooth has been treated for root canal therapy with the Sonendo GentleWave System and obturated with CPoint and BC Sealer in at least one canal
* The subject tooth is a 1st or 2nd molar

Exclusion Criteria:

* Vertical fracture, horizontal fracture, or perforation extending below the Cemento-Enamel Junction (CEJ) of the subject tooth
* Subject tooth having previous or attempted pulpectomy or root canal therapy

Primary outcomes:
measure: Subject teeth that are healed or are healing at the twenty-four month follow-up visit.
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Sonendo
state: California
Study officials:
affiliation: Sonendo, Inc.
name: Dan Miller
role: STUDY_DIRECTOR
References:
Clinical trial NCT00087750: Interaction Between Cocaine and Quetiapine - 1
Official title: Interaction Between IV Cocaine and Quetiapine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2004-07-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety of intravenous (IV) cocaine in subjects taking quetiapine at 3 dosage levels.

Detailed description: A placebo-controlled, double-blind, inpatient assessment of interaction between intravenous cocaine and quetiapine (seroquel) in cocaine-experienced subjects. To assess the safety of IV cocaine in subjects taking quetiapine at 3 dosage levels.

Eligibility criteria: Inclusion Criteria:

Includes but is not limited to: non-treatment seeking individuals. Must meet DSM-IV criteria for cocaine abuse or dependence. Must be able to verbalize understanding of consent and provide written informed consent and verbalize willingness to complete study procedures. Site will provide further details.

Exclusion Criteria:

Please contact site for further information

Primary outcomes:
measure: Adverse events
measure: pharmacokinetic assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Domenic Ciraulo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06462950: Experiment Among Smokers in Which Two Variables Are Manipulated: Ostracism and Concealability
Official title: Study 3: The Experimental Examination of Ostracism and Concealability on Gendered Stigma Smoking Outcomes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ostracism
Keywords: stigmatization
Lead sponsor: Dickinson College
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this experimental study is to learn about the effects of ostracism and concealment among adult smokers. The main aims are:

1. Determine the causal consequences of gendered stigmatization. Specifically, do women react more strongly than men to exclusion (as opposed to inclusion) especially when their gender is revealed (as opposed to concealed) for outcomes such as smoking stigma, stress, cognitive depletion, smoking attitudes, and smoking cessation intentions (Study 3)?
2. Examine the moderating roles of cultural context. Specifically, contrasting the cultural context in the US and Denmark (where gender norms are more egalitarian) do Danish smokers show fewer gender differences than US smokers in how they describe and react to their smoking stigmatization experiences (Study 1, 2, and 3)?

Detailed description: The proposed studies examine cross-culturally the reasons why among smokers, women feel more stigmatized than men do. An experiment with US and Danish smokers will examine how men and women differ in their reactions to being stigmatized (using a standard exclusion manipulation) when their gender is revealed instead of concealed. The outcome measures will include stress, smoking stigma, cognitive depletion, smoking attitudes, and smoking cessation intentions.

Eligibility criteria: Inclusion Criteria:

* daily smoker who smoker more than 5 cigarettes daily and have smoked for at least 1 year
* speak English reside in the United States

Primary outcomes:
measure: Cognitive depletion
timeFrame: 10 min
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: