louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05003414: The Medacta International GMK Sphere Cementless Post-Marketing Surveillance Study
Official title: A Prospective, Multicentre, International, Post-marketing, Longitudinal, Observational Cohort Study to Monitor the Performances of GMK Sphere Cementless Knee Prosthesis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthritis
Traumatic Arthritis
Rheumatoid Arthritis
Poly-arthritis
Avascular Necrosis
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2021-08-12
Enrollment: 200
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: NON_PROBABILITY_SAMPLE
Study population: Patients requiring Total Knee Arthroplasty and who are suitable to receive Medacta GMK Sphere cementless Knee Replacement will be proposed to take part to the current post-market surveillance study during their pre-operative visit.

Brief summary: This is a Post-Marketing Surveillance study of GMK Sphere cementless knee prosthesis.


Eligibility criteria: Inclusion Criteria:

* A disabled or severely disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis, poly-arthritis or avascular necrosis
* Patients between the age of 18 and 80 at the time of consent
* Listed for total knee replacement surgery.
* Patients who are willing and able to give informed written consent

Exclusion Criteria:

* Progressive local or systemic infection
* Muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable
* Severe instability secondary to advance destruction of condralar structures or loss of integrity of the medial or lateral ligament
* Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
* Patient whose BMI exceeds 40
* Any case not described in the inclusion criteria

Primary outcomes:
measure: Survival rate
timeFrame: 10 years
Secondary outcomes:
measure: Clinical outcome: Knee Society score
timeFrame: Preop and 1, 2, 5, 10 years postop
measure: Patient-reported outcome: Forgotten Joint Score
timeFrame: 1, 2, 5, 10 years postop
measure: Radiographic performance of the implants looking for radiolucencies, migration, loosening, subsidence
timeFrame: Immediately postop + 1, 2, 5, 10 years postop
measure: Intraoperative and postoperative Adverse events
timeFrame: Intraop + Immediately postop + 1, 2, 5, 10 years postop
Other outcomes:
Locations:
city: Bourgoin-Jallieu
country: France
facility: Clinique Saint Vincent de Paul
city: Caen
country: France
facility: Clinique du Parc
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar
city: Cucq
country: France
facility: Clinique des Acacias
city: Meyrin
country: Switzerland
facility: Hôpital de la Tour
Study officials:
affiliation: Clinique Saint Vincent de Paul
name: Emmanuel Marchetti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03204214: Binge Drinking And Addiction : Case-Control Study in Hospital
Official title: Binge Drinking And Addiction : Case-Control Study in Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alcohol Dependence
Keywords: binge drinking
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 252
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases recruited in Addiction Unit in Rouen University Hospital Controls recruited by the Clinical investigation center in Rouen University Hospital

Brief summary: Case Control Study :

Objective:

Frequent Binge drinking during 18-25 years is a risk factor of alcohol addiction in adulthood (25-40 years) Hypothesis: 25% of frequent binge drinking, OR = 2, power 80%, alpha risk : 5% 126 Cases aged 25 to 40 years: alcohol addict patients recruited in Addiction Unit in Rouen University Hospital 126 controls aged 25 to 40 years: non alcohol addict recruited by the Clinical investigation center in Rouen University Hospital An anonymous self-questionnaire was completed Binge Drinking during 18-25 years was retrospectively evaluated Confusion biais was also recorded


Eligibility criteria: Inclusion Criteria

* 25 to 40 years:
* alcohol addiction for the cases

Exclusion criteria

* age \<20 and \>40
* alcohol addiction for the controls

Primary outcomes:
measure: Frequent binge drinking
timeFrame: 18-25 years old
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Marie-Pierre TAVOLACCI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tavolacci MP, Berthon Q, Cerasuolo D, Dechelotte P, Ladner J, Baguet A. Does binge drinking between the age of 18 and 25 years predict alcohol dependence in adulthood? A retrospective case-control study in France. BMJ Open. 2019 May 5;9(5):e026375. doi: 10.1136/bmjopen-2018-026375.
Clinical trial NCT05141214: Virtual Reality as a Dietary Education Adjunct for Pediatric Patients With Obesity
Official title: Virtual Reality as a Dietary Education Adjunct for Pediatric Patients With Obesity: A Pragmatic, Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Virtual Reality
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Childhood obesity is a national crisis, effecting up to 1 in 5 of children in the US. In the Lucile Packard Children's Hospital Pediatric Weight Management Clinic, the investigators educate parents and caregivers about the importance of dietary modification. In addition to physician guidance, the investigators partner with registered dieticians to counsel families during an hour-long interview. However, traditional methods of education are limited by long-term recall. A typical person only recalls 2- 3% of didactic content after a period of 30 days. In order to improve recall and increase involvement of our pediatric patients in their own dietary modifications, the investigators propose a pragmatic, randomized pilot study investigating the effectiveness of Virtual Reality (VR) in changing dietary choices and improving recall.


Eligibility criteria: Inclusion Criteria:

* Ages 6-18 years of age
* Able to consent or have parental consent
* Diagnosis of Obesity Grade 1, 2 and 3 at LPCH/SHC facilities

Exclusion Criteria:

* People who do not consent
* Significant Cognitive Impairment
* History of Severe Motion Sickness
* Visual Problems

Primary outcomes:
measure: Immediate behavior modification
timeFrame: Duration of appointment, typically 2-3 hours
Secondary outcomes:
measure: Pediatric Adapted Liking Survey
timeFrame: Duration of appointment, typically 2-3 hours
measure: Nutritional knowledge survey
timeFrame: Duration of appointment, typically 2-3 hours
measure: Satisfaction Survey
timeFrame: Duration of appointment, typically 2-3 hours
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
Study officials:
References:
Clinical trial NCT04200014: Bradycardia Risk Stratification With Loop Recorder After Syncope
Official title: Bradycardia High Risk Patient Identification After Syncope With Loop Recorder an Observational Study in Nancy University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Implantable Loop Recorder
Keywords: Syncope
Arrhythmia
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who have benefited from an Implantable Loop recorder in the Nancy's Teaching Hospital between 1 January 2010 and 31 decembre 2019

Brief summary: Syncope is a common symptom that may be related to a conductive disorder. If no bradycardia is authenticated, it is often necessary to implant an implantable loop recorder.

In somes cases, implantable loop recorder records cardiac conductive disorders. In this study, we want to try to identify a group of patients for whom we could immediately implant a pacemaker without prior implantation of an implantable loop recorder given the high probability of implantation of a pacemaker after interrogation of the implantable loop recorder. It would be interesting for the reduction of interventions for the patients and for the economic aspect of the healthcare system


Eligibility criteria: Inclusion Criteria:

* All patients who have benefited from an Implantable Loop recorder in the Nancy's Teaching Hospital

Exclusion Criteria:

* No Exclusion Criteria

Primary outcomes:
measure: significant bradycardia whitch result with an Indication of pacemaker implantation
timeFrame: At the moment of enregistrement of a significative arrhythmia or at the end of the 3 years of follow up
Secondary outcomes:
measure: Patient group without benefit of implantation of the Implantable Loop Recorder
timeFrame: At the end of the 3 years of follow-up
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: De Ciancio
Study officials:
References:
citation: Brignole M, Moya A, de Lange FJ, Deharo JC, Elliott PM, Fanciulli A, Fedorowski A, Furlan R, Kenny RA, Martin A, Probst V, Reed MJ, Rice CP, Sutton R, Ungar A, van Dijk JG; ESC Scientific Document Group. 2018 ESC Guidelines for the diagnosis and management of syncope. Eur Heart J. 2018 Jun 1;39(21):1883-1948. doi: 10.1093/eurheartj/ehy037. No abstract available.
citation: Edvardsson N, Wolff C, Tsintzos S, Rieger G, Linker NJ. Costs of unstructured investigation of unexplained syncope: insights from a micro-costing analysis of the observational PICTURE registry. Europace. 2015 Jul;17(7):1141-8. doi: 10.1093/europace/euu412. Epub 2015 Mar 10.
citation: Padmanabhan D, Kancharla K, El-Harasis MA, Isath A, Makkar N, Noseworthy PA, Friedman PA, Cha YM, Kapa S. Diagnostic and therapeutic value of implantable loop recorder: A tertiary care center experience. Pacing Clin Electrophysiol. 2019 Jan;42(1):38-45. doi: 10.1111/pace.13533. Epub 2018 Dec 4.
Clinical trial NCT05055414: Arformoterol/Budesonide for COVID-19
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 2 Study to Evaluate the Efficacy and Safety of UI030 in COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Coronavirus Infection
Lead sponsor: Korea United Pharm. Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-24
Enrollment: 140
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, randomized, double-blind, placebo-controlled, parallel, phase 2 study to evaluate the efficacy and safety of UI030 in COVID-19 patients

Detailed description: Patients with moderate and severe COVID-19 were randomly assigned (1:1) to receive either UI030 (Budesonide/Arformoterol dry powder inhaler, 2 inhalations b.i.d) or placebo for 2 weeks.

Eligibility criteria: Inclusion Criteria:

* Adult, aged 19 years or above
* New onset of symptoms suggestive of COVID-19 (fever, cough, soar throat, etc) or diagnosed with COVID-19 within 7 days of participant being seen at visit 1
* In the Investigator's opinion, is able and willing to comply with all trial requirements

Exclusion Criteria:

* A condition requiring invasive oxygen support;
* History of hypersensitivity to budesonide and arformoterol
* Pregnancy, Breast-feeding
* Participation in other clinical studies within 4 weeks prior to enrollment in this study.
* Refusal of the patient to continue participating in the study/withdrawal of informed consent by the patient.

Primary outcomes:
measure: Time to Clinical Improvement on World Health Organization (WHO) Ordinal Scale
timeFrame: 28 days
Secondary outcomes:
measure: World Health Organization (WHO) Ordinal Scale for Clinical Improvement
timeFrame: 28 days
measure: World Health Organization (WHO) Ordinal Scale change
timeFrame: 28 days
measure: Clinical cure rate
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01840514: Cardiac Functions in Living Donor Liver Transplant Recipients. An Echocardiographic Study.
Official title: Cardiac Functions in Living Donor Liver Transplant Recipients. An Echocardiographic Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Transplant
Keywords: recipient
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: recipient of living donor liver

Brief summary: The stress of orthotopic living donor liver transplantation in patients with cirrhosis could induce worsening of an already recorded myocardial dysfunction or may be associated with a new myocardial dysfunction in patients previously having normal myocardial functions, therefore this study will be designed for intra-operative detection of new onset ventricular dysfunction or worsening of already diagnosed ventricular dysfunction in living donor liver transplant recipient and the possible contribution of several hemodynamic and oxygenation parameters in the generation of any cardiovascular function impairment will be also investigated and to determine the impact of ventricular dysfunction on early (7 PO days) graft function, 28 days survival and patient outcomes.


Eligibility criteria: Inclusion Criteria:

* all adult recipient

Exclusion Criteria:

* massive blood transfusion
* grade III esophageal varices

Primary outcomes:
measure: hemodynamic monitoring
timeFrame: intraoperative
Secondary outcomes:
measure: graft function
timeFrame: 7 days
Other outcomes:
measure: survival
timeFrame: 28 days
Locations:
city: Mansoura
country: Egypt
facility: Liver transplantation program - Gastroenterology surgical center
state: Dakahlia
city: Mansoura
country: Egypt
facility: Liver transplantation project - Gastroenterology surgical center - Mansoura university
state: Dakahlia
Study officials:
affiliation: Liver transplant program, mansoura faculty of medicine
name: amr yassen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01952314: Medical Expulsive Therapy for Ureter Stone Using Naftopidil
Official title: Medical Expulsive Therapy for Ureter Stone Using Naftopidil: Multicenter, Randomized, Double-blind, Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ureter Stones
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Dong-A ST Co., Ltd.
First posted: 2013-09-27
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to investigate whether naftopidil is effective or not for the spontaneous passage of ureteral stones with sizes of 3 to 10 mm.

Detailed description: 1. Enrollment

   1. patients with ureteral stones of sizes from 3 to 10 mm
   2. patients aged more than 18 years
2. Randomization

   1. naftopidil 75 mg qd for 14 days or placebo
   2. Standard treatment with pain-killers were also applied.(aceclofenac)
3. Follow-up for 28 days

   1. We confirm the stone free status by CT or X-ray films at 14th and 28th days.
   2. Rates of active treatment will be also evaluated.

Eligibility criteria: Inclusion Criteria:

* \>= 20 years
* single 3 to 10 mm ureter stone (longest diameter)

Exclusion Criteria:

* Presence of multiple ureter stones
* Renal insufficiency (serum Cr \> 1.4 mg/dL)
* Febrile urinary tract infections(fever \> 38°C, evidence of urinary infection)
* pregnancy or breast feeding
* solitary kidney
* hypersensitivity to naftopidil
* current use of any alpha-blocker, calcium-channel blocker, corticosteroid (within 4 weeks)
* moderate or severe cardiovascular or cerebrovascular disease
* hepatic dysfunction (\>2 x normal upper limit)
* significant active medical illness which in the opinion of the investigator would preclude protocol treatment
* Genetic disorder such as Galactose intolerance, Lapp Lactase deficiency, Glucose-Galactose malabsorption

Primary outcomes:
measure: Stone-free rate at 14th day of study
timeFrame: 14th day
Secondary outcomes:
measure: Stone-free rate at 28th day of study
timeFrame: 28th day
measure: Duration to stone passage within 28days of study
timeFrame: for 28 days
measure: amount of analgesics used for 28 days of study
timeFrame: for 28 days
measure: Rate of active treatment
timeFrame: for 28 days
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Donguk University Ilsan Hospital
state: Kyunggi
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyunggi
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: National Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
Study officials:
affiliation: Seoul National University Hospital
name: Chang Wook Jeong, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04475614: Therapeutic Options for Treatment of Burning Mouth Syndrome
Official title: Different Therapeutic Options for Burning Mouth Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burning Mouth Syndrome
Keywords: burning mouth syndrome
treatment
Lead sponsor: University of Zagreb
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 62
Sex: ALL
Minimum age (years): 39
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Burning mouth syndrome is a painful condition of unknown etiology that impairs the quality of life and does not have an adequate therapeutic option. The purpose of this study is to determine the most effective treatment option for burning mouth syndrome, among oral probiotics, low-level laser, B-vitamin injections and informative treatment only.


Eligibility criteria: Inclusion Criteria:

* newly diagnosed with burning mouth syndrome and excluded local and systemic causes

Exclusion Criteria:

* patients who have received treatment for burning mouth earlier
* patients with local or systemic causes of burning mouth

Primary outcomes:
measure: Change in the patient's quality of life using Oral Health Impact Profile 14 questionnaire (OHIP-14)
timeFrame: up to two months (follow up was one month after the end of treatment, in each patient)
Secondary outcomes:
measure: Change in subjective burning symptoms
timeFrame: up to two months (follow up was one month after the end of treatment, in each patient)
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: School of Dental Medicine, University of Zagreb
Study officials:
References:
Clinical trial NCT01347814: Effect of 10mg Domperidone on Gastric Emptying of a High-fat Meal and Appetite Sensations in Healthy Adults
Official title: Does Domperidone, a D2-antagonist Alter Gastric Emptying Rates and Appetite Sensations in Healthy Adults?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Domperidone
gastric emptying
obesity
diabetes mellitus
Domperidone/pharmacology
Pharmacologic Actions
Physiological Effects of Drugs
Gastrointestinal Agents
Humans
Lead sponsor: University of Limerick
Sponsor class: OTHER
Collaborators: name: Irish Research Council
First posted: 2011-05-04
Enrollment: 13
Sex: ALL
Minimum age (years): 10
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether domperidone was sufficient to accelerate gastric emptying of a high-fat solid meal and reduce satiety responses in a healthy adult population.

Detailed description: This study aims to investigate the effect of domperidone on gastric emptying and appetite sensations in healthy subjects. Domperidone is a dopamine 2 (D2) receptor antagonist with claims of gastrointestinal tract pro-kinetic activity. Accelerated gastric emptying (GE) may lead to reduced satiation, increased food intake and is associated with obesity and diabetes mellitus. It is hypothesized that domperidone will increase gastric emptying rate and reduce satiety responses to a high-fat meal.

The effect of acute oral administration of 10 mg domperidone on gastric emptying of a high-fat pancake test meal, and subjective appetite sensations by visual analogue scale will be measured for six hours postprandially in a randomized, placebo-controlled, single-blinded manner in 13 healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 18-40 years

Exclusion Criteria:

* History of gastrointestinal-related conditions, diabetes mellitus or cardiovascular disease

Primary outcomes:
measure: Gastric emptying half time
timeFrame: 6.5 Hours post ingestion
Secondary outcomes:
measure: Appetite sensations
timeFrame: 6.5 hours post ingestion
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: Department of Physical Education & Sport Sciences, University of Limerick
Study officials:
affiliation: University of Limerick
name: Amir Shafat
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reddymasu SC, Soykan I, McCallum RW. Domperidone: review of pharmacology and clinical applications in gastroenterology. Am J Gastroenterol. 2007 Sep;102(9):2036-45. doi: 10.1111/j.1572-0241.2007.01255.x. Epub 2007 May 3.
citation: Markey O, Shafat A. Does domperidone, a D2-antagonist alter gastric emptying rates and appetite sensations in healthy adults with high-fat meal? A block-randomised, single-blind placebo-controlled study. Ir J Med Sci. 2012 Jun;181(2):215-9. doi: 10.1007/s11845-011-0785-2. Epub 2011 Nov 29.