louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03629821: Effect of Classic Ballet Practice on School Children's Postural Balance
Official title: Effect of Classic Ballet Practice on School Children's Postural Balance: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Child, Only
Keywords: Postural Balance
Dance Therapy
Exercise Therapy
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 50
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups design where one group receives treatment and the other not in the same period of time.
Primary purpose: TREATMENT

Brief summary: Is a parallel longitudinal protocol where half patients receive a experimental protocol and the other half receive orientation to maintain your daily live routine as usually. The experimental protocol include Ballet sessions. The hypothesis is interventional group will improve the balance control more than control group.


Eligibility criteria: Inclusion Criteria:

* Female sex
* 9 to 12 years of age

Exclusion Criteria:

* Musculoskeletal pain at last 3 months
* Perform other physical activity besides scholar's physical activity
* Has been participated Ballet class.

Primary outcomes:
measure: Change from baseline in total score of Star Excursion Balance Test at 8 weeks.
timeFrame: Before, immediate after intervention protocol
measure: Change from baseline in anteriorposterior and mediolateral displacements of Pressure Center at 8 weeks.
timeFrame: Before, immediate after intervention protocol
measure: Change from baseline in average speed of Pressure Center at 8 weeks.
timeFrame: Before, immediate after intervention protocol
measure: Change from baseline in 95% ellipse area of Pressure Center at 8 weeks.
timeFrame: Before, immediate after intervention protocol
measure: Maintenance at 30 and 60 days from baseline in total score of Star Excursion Balance Test.
timeFrame: Immediate after, 30 and 60 days after intervention protocol.
measure: Maintenance at 30 and 60 days from baseline in anteroposterior and mediolateral displacements of pressure center
timeFrame: Immediate after, 30 and 60 days after intervention protocol.
measure: Maintenance at 30 and 60 days from baseline in average speed of pressure center
timeFrame: Immediate after, 30 and 60 days after intervention protocol.
measure: Maintenance at 30 and 60 days from baseline in 95% ellipse area of pressure center
timeFrame: Immediate after, 30 and 60 days after intervention protocol.
Secondary outcomes:
measure: Vertical stiffness
timeFrame: Before, immediate after, 30 and 60 days after intervention protocol
measure: Peak and absortion rate of ground reaction force
timeFrame: Before, immediate after, 30 and 60 days after intervention protocol
Other outcomes:
measure: Physical activity level
timeFrame: Before intervention
Locations:
city: Santa Maria
country: Brazil
facility: Kelen Munhos Pinto
state: RS
Study officials:
References:
Clinical trial NCT00624221: Study of Eye Bank Pre-cut Donor Grafts for Endothelial Keratoplasty
Official title: A Prospective, Randomized, Single Center Study Evaluating Use of Surgeon- and Eye Bank-prepared Donor Tissue for Descemet's Stripping and Endothelial Keratoplasty, a Type of Cornea Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fuchs Endothelial Dystrophy
Corneal Edema
Lead sponsor: Cornea Research Foundation of America
Sponsor class: OTHER
Collaborators: name: North Carolina Lion's Eye Bank
name: Price Vision Group
First posted: 2008-02-27
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Descemet's stripping with endothelial keratoplasty (DSEK) is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. The DSEK technique requires lamellar dissection of the donor tissue prior to implantation in the patient's eye. The surgeon usually dissects the donor cornea with a microkeratome at the time of surgery. Recently some eye banks have begun to pre-cut the donor graft as an added service. The purpose of this study was to compare outcomes with eye bank pre-cut and surgeon-dissected donor grafts for DSEK.


Eligibility criteria: Inclusion Criteria:

* candidate for Descemet's stripping with endothelial keratoplasty
* at least 21 years old
* willing and able to return for scheduled follow-up visits
* reads and signs Informed Consent document

Exclusion Criteria:

* visual acuity of less than 20/400 in fellow eye
* known sensitivity to planned study concomitant medications

Primary outcomes:
measure: Endothelial Cell Loss
timeFrame: 6 months after grafting
Secondary outcomes:
measure: Best Corrected Vision
timeFrame: 6 months and 1 year after grafting
measure: Graft Dislocation
timeFrame: 1 day to 1 month after grafting
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Cornea Research Foundation of America
state: Indiana
Study officials:
affiliation: Cornea Research Foundation of America
name: Francis W Price, Jr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04697121: Artichoke and Bergamot Phytosome
Official title: Artichoke and Bergamot Phytosome: a Randomized Double Blind Clinical Trial in Bergamot Poor-responders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: bergamot
Cynara cardunculus
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: According to WHO data, about 50% of deaths each year are caused by cardiovascular disease. One of the strategies for prevention of cardiovascular diseases, in addition to a correct lifestyle, is to implement therapies that reduce the level of cholesterol in the blood and at the same time control the glycemic levels, which are closely related in the maintenance of metabolic homeostasis. The aim of this clinical study is to confirm the potential broader activity as hypocholesterolemic agent in bergamot poor-responders subjects with mild hypercholesterolemia. The study was a 8-week randomized double-blind placebo-controlled trial. Participants were randomized to either the supplement based on dry extract from artichoke leaf and bergamot phospholipid (31) or placebo arm (29).


Eligibility criteria: Inclusion Criteria:

* mild hypercholesterolemia (220 - 280 mg/dl)
* subjects were not taking any medication likely to affect lipid metabolism (such as statins)
* subjects were bergamot poor-responders

Exclusion Criteria:

* liver, renal and thyroid diseases
* history of cardiovascular disease (CVD)

Primary outcomes:
measure: Changes of lipid parameters
timeFrame: Baseline / 30 days / 60 days
Secondary outcomes:
measure: Changes of lipid parameters
timeFrame: Baseline / 30 days / 60 days
measure: Changes of metabolic parameters
timeFrame: Baseline / 30 days / 60 days
measure: Changes of metabolic parameters
timeFrame: Baseline / 30 days / 60 days
measure: Changes of anthropometric measurements
timeFrame: Baseline / 30 days / 60 days
measure: Changes of anthropometric measurements
timeFrame: Baseline / 30 days / 60 days
measure: Changes of body composition
timeFrame: Baseline / 30 days / 60 days
measure: Changes of safety parameters
timeFrame: Baseline / 30 days / 60 days
measure: Changes of safety parameters
timeFrame: Baseline / 30 days / 60 days
measure: Changes of safety parameters
timeFrame: Baseline / 30 days / 60 days
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Azienda di Servizi alla Persona
Study officials:
References:
Clinical trial NCT05919121: Effect Of Hydrocortisone Phonophoresis Versus Iontophoresis In Patients With Subacromial Impingement Syndrome
Official title: Effect Of Hydrocortisone Phonophoresis Versus Iontophoresis In Patients With Subacromial Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Impingement Syndrome
Subacromial Impingement Syndrome
Lead sponsor: Horus University
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study will be to compare the efficacy of adding hydrocortisone phonophoresis or iontophoresis on pain, function, range of motion and shoulder external rotation isometric strength in patients with subacromial impingement syndrome.

Detailed description: Routine physiotherapy has been advocated was an effective treatment for SIS. However, there is lack of best exercise treatment and lots of studies are under consideration. According to published data focused on management of shoulder pain, it looks like that therapeutic exercise is not sufficient to treat SIS and it is compulsory to combine with other remedies to get the best results

Eligibility criteria: Inclusion Criteria:

1. All patients were diagnosed as unilateral SIS with stage II Neer classification \> 3 months.
2. Positive impingement sign (Neer's test or Hawkins-Kennedy test), / painful arc during active arm elevation, pain or weakness with resisted isometric external rotation or resisted scapular plane abduction with the humeral internal rotation (empty can test)
3. The age of patients ranged from 18 - 60 years old.
4. Both genders will be involved.
5. Shoulder pain scores more than 5 on a numeric rate scale for pain of 0- 10.
6. Failure to respond to conservative NSAID.

Exclusion Criteria:

1. Frozen shoulders.
2. Arthritis of the shoulder.
3. Shoulder instability.
4. Pregnant women.
5. A pacemaker.
6. Previous shoulder surgery.
7. History of dislocation of the shoulder.
8. Internal metallic fixation.
9. Malignancy.
10. Previous corticosteroid injection.
11. Rheumatoid arthritis
12. Partial or Full thickness tear of the rotator cuff.
13. Cervical radiculopathy.
14. Physiotherapeutic shoulder treatment within the last 3 months.
15. The patients will randomly be assigned into 3 equal groups, 20 patients for each group.

Primary outcomes:
measure: Assessing the change in isometric shoulder strength
timeFrame: at baseline and after 6 weeks of intervention
measure: Assessing the change in Shoulder Pain and Disability
timeFrame: at baseline and after 6 weeks of intervention
measure: Assessing the change in shoulder Range Of Motion
timeFrame: at baseline and after 6 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Damieta
country: Egypt
facility: Outpatient clinic faculty of physical therapy, horus university, egypt
Study officials:
affiliation: Horus University in Egypt
name: Mohsen Ibrahim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01991821: European Phase III Study of APD421 in PONV
Official title: Randomised, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Prophylaxis Against Post-operative Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: PONV
Lead sponsor: Acacia Pharma Ltd
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.


Eligibility criteria: Inclusion Criteria:

* Male or female patients ≥ 18 years of age
* Patients undergoing elective surgery (open or laparoscopic technique) under general anaesthesia, expected to last at least one hour from induction of anaesthesia to wound closure and expected to require at least one overnight stay in hospital

Exclusion Criteria:

* Patients scheduled for outpatient/day case surgery
* Patients scheduled to undergo intra-thoracic, transplant or central nervous system surgery
* Patients scheduled to receive only a local anaesthetic/regional neuraxial (intrathecal or epidural) block
* Patients who are expected to remain ventilated for a period after surgery
* Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed

Primary outcomes:
measure: Complete Response (no Emesis, Significant Nausea or Rescue Medication)
timeFrame: 24 hours after end of surgery
Secondary outcomes:
measure: Complete Response (no Emesis or Rescue Medication)
timeFrame: 24 hrs after end of surgery
measure: Total Response (no Emesis, Nausea or Rescue Medication)
timeFrame: 24 hrs after end of surgery
measure: Incidence of Emesis (Vomiting/Retching)
timeFrame: 24 hours after end of surgeryry
measure: Incidence of Nausea
timeFrame: 24 hours after end of surgery
measure: Incidence of Significant Nausea
timeFrame: 24 hours after end of surgery
measure: Use of Rescue Medication
timeFrame: 24 hours after end of surgery
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: CHU de Hautepierre
city: Würzburg
country: Germany
facility: University Hospitals of Würzburg
Study officials:
affiliation: Hôpital de Hautepierre
name: Pierre Diemunsch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00360321: Descriptive Study of a French Sample of "at Risk" and Pathological Gamblers Followed in a French Structure Specialised in Addictive Disorders.
Official title: Descriptive Study of a French Sample of "at Risk" and Pathological Gamblers Followed in a French Structure Specialised in Addictive Disorders.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pathological Gambling
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2006-08-04
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: International surveys about pathological gambling estimate that there are about 1 to 3 per cent of gamblers who develop a pathological behavior about gamble.In France, pathological gambling is not a priority of public health, in contrast with other addictive disorders, like alcoholism or nicotine addiction. The aim of our study is to describe accurately for the first time in France, a sample of "at risk" and pathological French gamblers. We want to collect socio-demographical and clinical data from this subjects (story of the addictive behaviour, co morbidities, and more specifically, detailed study of pathological gamblers' personality), in order to compare our data with those of international literature.Secondarily, we want to test the feasibility of this kind of detailed evaluations for another study planned for 2007-2008 and which purpose will be to compare pathological gamblers' personality characteristics according to the kind of game that they mainly practice.The participation at the study will be proposed to every patient consulting in the "service d'addictologie du CHU de Nantes". The study consists in a single evaluation (about 8 hours) with standardized tools used all other the world.


Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 70
* Consulting or ex-consulting since 2000 in the "service d'addictologie du CHU de Nantes"
* Who meet sufficient criteria of pathological or "at risk" gambling in the DSM-IV section about pathological gambling
* Who accept to participate
* Who give their consent
* Who don't have any exclusion criteria

Exclusion Criteria:

* Gambling behaviour directly and chronologically explain by an acute maniac fit
* Superior function trouble
* Who don't agree to participate
* Difficulties in reading or writing in French

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Nantes University Hospital
name: Venisse Jean Luc, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00817921: Effect of Prematurity on Renal Function in 5 Years Old Children
Official title: Effect of Prematurity on Renal Function in 5 Years Old Children Comparison of Former Premature Children Treated by Ibuprofen in the Neonatal Period to Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prematurity of Fetus
Keywords: premature renal function
ibuprofen
blood pressure
Renal function
Lead sponsor: Maternite Regionale Universitaire
Sponsor class: OTHER
First posted: 2009-01-07
Enrollment: 168
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children from a previous trial followed at 3, 4 and 5 years of age

Brief summary: Purpose of the study:

1. To evaluate the effect of prematurity on renal function in 5 years old children
2. To compare former premature children treated by ibuprofen in the neonatal period to controls


Eligibility criteria: Inclusion Criteria:

* Former premature children included at birth in a trial about ibuprofen and renal function in premature infants (ClinicalTrial.gov identifier:NCT00217191)

Exclusion Criteria:

* lack of parental consent

Primary outcomes:
measure: Creatinine clearance
timeFrame: 5 years of age
Secondary outcomes:
measure: Growth
timeFrame: at 3 years of age
measure: Blood Pressure
timeFrame: 5 years of age
measure: Hemodynamic tolerance to mild exercise
timeFrame: 3 years of age
measure: Growth
timeFrame: 4 years of age
measure: Growth
timeFrame: 5 years of age
measure: Hemodynamic tolerance to mild exercise
timeFrame: 4 years of age
measure: Hemodynamic tolerance to mild exercise
timeFrame: 5 years of age
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU
city: Marseille
country: France
facility: AP-HM (Néonatologie)
city: Nancy
country: France
facility: Maternite Regionale Universitaire
Study officials:
affiliation: Maternite Regionale Universitaire
name: Jean-Michel HASCOET, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vieux R, Hascoet JM, Franck P, Guillemin F. Increased albuminuria in 4-year-old preterm-born children with normal height. J Pediatr. 2012 Jun;160(6):923-8.e1. doi: 10.1016/j.jpeds.2011.12.005. Epub 2012 Jan 18.
Clinical trial NCT01834521: Web-based Screening and Tailored Support
Official title: Web-based Screening and Tailored Support for Breast Cancer Patients at the Onset of the Survivorship Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
psychosocial
website
empowerment
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2013-04-18
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The ever expanding breast cancer survivor population urges the health care system to develop (cost-)effective screening and management of convalescent care needs that can be easily implemented in conventional follow-up care. Internet-delivered systems may be well-equipped to meet these demands. The aim of the current study is to assess the effectiveness of a web-based support system. Key features of this system are patient self-screening of physical and psychosocial problems, tailored patient education on reported problems and self-referral to professional care. In this era of high internet usage, we expect that internet is a highly suitable medium to provide tailored support for breast cancer patients and will empower the patient to take control over their convalescence.


Eligibility criteria: Inclusion Criteria:

* Adult female breast cancer patients (aged ≥ 18 years of age).
* Recent completion (≤6 months) of (neo)adjuvant chemotherapy for primary breast cancer
* Ability to comprehend Dutch (both reading and writing).
* Access to internet (e.g. at home, via family or friends)
* Informed consent provided

Exclusion Criteria:

• Chemotherapy treatment with palliative intent or recurrent breast cancer

Primary outcomes:
measure: Change from 6 to 12 weeks follow-up in optimism and control over the future
timeFrame: 6 and 12 weeks
Secondary outcomes:
measure: Change from 6 to 12 weeks follow-up in knowledge level
timeFrame: 6 and 12 weeks
measure: Change from 6 weeks to 12 weeks follow-up in acceptance of problems
timeFrame: 6 and 12 weeks
measure: Change from baseline to 12 weeks follow-up in quality of life
timeFrame: Baseline and 12 weeks follow-up
measure: Change from baseline to 12 weeks follow-up in psychological distress
timeFrame: Baseline and 12 weeks follow-up
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: A.K.L. Reyners, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03351621: The Reality of Nutritional Therapy in Brazil: Quality Assessment
Official title: The Reality of Nutritional Therapy in Brazil: Quality Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutritional Therapy Quality
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do estado de Minas Gerais
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2017-11-24
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitals with nutritional therapy (Public, private and teaching hospitals)

Brief summary: Nutritional status depletion is associated with complications such as increased morbidity and mortality, worsening of patients' quality of life and increased length of hospital stay. Thus, nutritional therapy defined as the set of therapeutic procedures for maintenance or recovery of the nutritional status of the patient, becomes a procedure of extreme importance in the hospital setting. It should be carried out by an interprofessional team, in order to ensure adequate patient care. Aim: This study intends to evaluate the reality of Nutritional Therapy in Brazil, 18 and 14 years after the introduction of the resolution n ° 272 and the RDC n ° 63, respectively, regarding the practice of this important therapy and the existence of interdisciplinary teams. Method: Descriptive, observational and national study. In each Brazilian state was selected the capital, and drawn a city of average and other one of small size. Next, a public, private and university hospital in each municipality was randomly selected. Data collection will be done by means of a questionnaire, based on the Secretary of Sanitary Surveillance of the Ministry of Health resolution n ° 272 and the RDC n ° 63. The questionnaire will be applied by the researchers, and directed to the health professionals involved in the Nutritional Therapy practice in each of the selected hospitals.


Eligibility criteria: Inclusion Criteria:

* Hospitals with nutritional therapy

Exclusion Criteria:

* Hospitals with no nutritional therapy

Primary outcomes:
measure: The Reality of Nutritional Therapy in Brazil
timeFrame: December, 2017.
Secondary outcomes:
measure: Performance of interdisciplinary teams of nutritional therapy
timeFrame: December, 2017.
measure: Number of patients in nutritional therapy in hospitals
timeFrame: December, 2017.
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Hospital of Clinics of the University Federal of Minas Gerais
state: Minas Gerais
Study officials:
References: