louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01077661: Regulatory Nebilet PMS
Official title: An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Effectiveness of Nebilet Administered in Korean Patients According to the Prescribing Information
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Heart Failure
Keywords: Nebivolol
PMS (post-marketing surveillance)
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-03-01
Enrollment: 743
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients administrated Nebivolol at the site

Brief summary: An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and effectiveness of Nebivolol administered in Korean patients according to the prescribing information

Detailed description: An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and effectiveness of Nebivolol administered in Korean patients according to the prescribing information

Nebivolol will be administered to Hypertension or Chronic heart failure (CHF) patients as described the prescribing information of Nebivolol by physician's decision.

Eligibility criteria: All subjects must satisfy the following criteria at PMS entry according to KFDA PMS regulation:

* Subjects with indication in the prescribing information
* Subjects administrated Nebivolol by physician's decision
* Subjects with no contraindication according to the prescribing information

Primary outcomes:
measure: Occurrence of adverse events after Nebivolol administration
timeFrame: 3months, 6months
Secondary outcomes:
measure: Occurrence of unexpected or serious adverse event after Nebivolol administration and effectiveness of Occurrence of unexpected or serious adverse event after Nebivolol administration and effectiveness of Nebivolol
timeFrame: 3 months, 6months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04824261: Effectiveness of 4% Boric Acid in Distilled Water Versus Clotrimazole Solution in Otomycosis Patients.
Official title: Effectiveness of 4% Boric Acid in Distilled Water Versus Clotrimazole Solution in Otomycosis Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Otomycosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Otomycosis is a fungal infection that affects one, or occasionally both, of the ears. It mostly affects people who live in warm or tropical areas. It also often affects people who swim frequently, live with diabetes, or have other chronic medical and skin conditions. It is a pathologic entity, with candida and aspergillus the most common fungal species. \]Various predisposing factors include a humid climate, presence of cerumen, instrumentation of the ear, increased use of topical antibiotics / steroid preparations, immune-compromised host, patients who have undergone open cavity mastoidectomy and those who wear hearing aids with occlusive ear mold. The infection is usually unilateral and characterized by inflammatory pruritis, scaling and otalgia.Treatment recommendations have included local debridement, local and systemic antifungal agents and discontinuation of topical antibiotics. Sometimes otomycosis presents as a challenging disease for its long term treatment and follow up, yet its recurrence rate remains high.

According to Thai National List of essential medicines for topical antifugal agents are:

* acetic acid (2% in aqueous and 2% in 70% isopropyl alcohol)
* boric acid (4% in distilled water)
* gentian violet
* clotrimazole ear drop. Some fungal infections such as Aspergillus may be resistant to the usual ear drops. They may require oral medications.


Eligibility criteria: Inclusion Criteria:

* Symptomatic otomycosis.
* Microscopic direct examination and/or culture positive for fungus.

Exclusion Criteria:

* During usage of systemic antifungal drug
* Allergic to 4% boric acid in distilled water or clotrimazole solution

Primary outcomes:
measure: Curative rate of otomycosis
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ho T, Vrabec JT, Yoo D, Coker NJ. Otomycosis: clinical features and treatment implications. Otolaryngol Head Neck Surg. 2006 Nov;135(5):787-91. doi: 10.1016/j.otohns.2006.07.008.
citation: Mugliston T, O'Donoghue G. Otomycosis--a continuing problem. J Laryngol Otol. 1985 Apr;99(4):327-33. doi: 10.1017/s002221510009678x.
citation: Kaur R, Mittal N, Kakkar M, Aggarwal AK, Mathur MD. Otomycosis: a clinicomycologic study. Ear Nose Throat J. 2000 Aug;79(8):606-9.
Clinical trial NCT02628561: Transcranial Direct Current Stimulation Associate to Constraint Induced Movement Therapy Over Premotor Cortex in Severe Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stroke
Cerebrovascular Disorders
Cerebral Infarction
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 60
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 is to compare the effects of tDCS and constraint induced movement therapy (CIMT) in the premotor cortex vs. primary motor cortex in severely subacute stroke survivors.

Detailed description: Stroke survivors experience one or more movement-related impairments and activity limitations. In this sense, the premotor cortex (PMC) can be considered as an alternative locus for post-stroke rehabilitation. In relation to physical rehabilitation protocols, associate to neuromodulation, the investigators have chosen a standardized physical therapy protocol for this study, the Constraint Induced Movement Therapy (CIMT), which presents evidence of good therapeutic results. The investigators hypothesized that applying tDCS and CIMT over the PMC promotes motor restoration in stroke patients.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years
* Diagnosis of unilateral, non-recurring, subacute stroke
* Participants also had to be able, by using any method of pinch, to grasp a washcloth from a table top, lift it up a few inches, and release it.

Exclusion Criteria:

* Patients with difficulty to follow the procedures or understand the instructions; cognitive deficits
* tDCS criteria:

  * use of modulators of the Central Nervous System drugs
  * patients with implanted metallic or electronic devices
  * pacemaker
  * seizures
  * pregnancy
  * any other condition that might limit or interfere in the sensorimotor system

Primary outcomes:
measure: Functional Independence measured by Barthel Index
timeFrame: Change for functional independence at baseline and week 2
Secondary outcomes:
measure: Spasticity (Modified Ashworth Scale)
timeFrame: Baseline and Week 2
measure: Muscle strength (Medical Research Council Scale)
timeFrame: Baseline and Week 2
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Suellen Andrade
state: PB
Study officials:
References:
Clinical trial NCT01444261: Prevention of Iron Deficiency in Breastfed Infants
Official title: Prevention of Iron Deficiency in Breastfed Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Iron Deficiency
Anemia
Keywords: iron deficiency
anemia
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
Collaborators: name: University of Iowa
First posted: 2011-09-30
Enrollment: 219
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: With early screening and appropriate iron supplementation, iron deficiency in the first year of life can be prevented in breastfed infants.

Detailed description: Infants with low ferritin at 1 month are at high risk of iron deficiency. They will receive iron drops starting at 2 months. All other infants are at low risk of iron deficiency. All infants will receive iron-fortified cereal starting at 4 months of age.

Eligibility criteria: Inclusion Criteria:

* Term infants
* gestational age 37-42 weeks
* birth weight \> 2500 g
* exclusively breastfed at 28 d of age
* intend to breast feed until 9 mo of age

Exclusion Criteria:

* supplemental formula before 4 mo of age

Primary outcomes:
measure: Iron deficiency anemia will be prevented in all infants before 5.5 mo of age
timeFrame: 5.5 mo
Secondary outcomes:
measure: Determine the number of infants with iron deficiency between 5.5 and 9 mo of age
timeFrame: 9 mo
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Ekhard Ziegler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01117961: Promoting Healthy Weight Gain During Pregnancy
Official title: Promoting Healthy Weight Gain During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Weight Gain
Keywords: Excessive gestational weight gain
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: California Polytechnic State University-San Luis Obispo
name: Women and Infants Hospital of Rhode Island
name: University of California, Berkeley
First posted: 2010-05-06
Enrollment: 401
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Study goal is to determine whether behavioral lifestyle intervention during pregnancy can reduce the number of women who exceed the Institute of Medicine recommendations for weight gain during pregnancy.

It is hypothesized that the intervention will reduce the number of women who exceed weight gain guidelines relative to standard care. The investigators also expect the intervention to reduce the proportion of women exceeding weight gain guidelines in both normal weight and overweight groups.


Eligibility criteria: Inclusion Criteria:

* non-smoking, adults,
* \< 16 weeks gestation

Exclusion Criteria:

* medical comorbidities

Primary outcomes:
measure: Percentage of women above the Institute of Medicine Guidelines for gestational weight gain
timeFrame: 40 weeks
Secondary outcomes:
measure: Behavioral measures
timeFrame: 40 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Mercado A, Marquez B, Abrams B, Phipps MG, Wing RR, Phelan S. Where Do Women Get Advice About Weight, Eating, and Physical Activity During Pregnancy? J Womens Health (Larchmt). 2017 Sep;26(9):951-956. doi: 10.1089/jwh.2016.6078. Epub 2017 May 19.
citation: Phelan S, Phipps MG, Abrams B, Darroch F, Grantham K, Schaffner A, Wing RR. Does behavioral intervention in pregnancy reduce postpartum weight retention? Twelve-month outcomes of the Fit for Delivery randomized trial. Am J Clin Nutr. 2014 Feb;99(2):302-11. doi: 10.3945/ajcn.113.070151. Epub 2013 Nov 27.
citation: Phelan S, Phipps MG, Abrams B, Darroch F, Schaffner A, Wing RR. Randomized trial of a behavioral intervention to prevent excessive gestational weight gain: the Fit for Delivery Study. Am J Clin Nutr. 2011 Apr;93(4):772-9. doi: 10.3945/ajcn.110.005306. Epub 2011 Feb 10.
Clinical trial NCT00753961: Effect Of The Consumption Of Fermented Dairy Drink On Common Infections In Shift-Workers
Official title: EFFECT OF THE CONSUMPTION OF FERMENTED DAIRY DRINK ON COMMON INFECTIONS IN SHIFT-WORKERS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Shiftworkers
volunteers
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2008-09-17
Enrollment: 1340
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: PREVENTION

Brief summary: This clinical study plans to investigate the effect of the consumption of a fermented dairy drink on the occurrence of common infections. This study will be performed in a healthy adult population of shift workers.


Eligibility criteria: Inclusion Criteria:

* Male/female subjects aged 18 to 65 years (bounds included)
* Healthy subjects.
* Subjects working in two- or three-shift work including night work

Exclusion Criteria:

* Subject with any food allergy
* Subject in a situation that, in the investigator opinion, could interfere with optimal participation in the present study or could constitute a special risk for the subject.

Primary outcomes:
measure: Occurrence of common infectious diseases during the 16 weeks of study product consumption
timeFrame: 0-16 weeks
Secondary outcomes:
measure: Mean duration of common infectious diseases during the 16 weeks of study product consumption.
timeFrame: 0-16 weeks
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: SGS
city: Caen
country: France
facility: Therapharm
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu
city: Plymouth
country: United Kingdom
facility: VEEDA
Study officials:
References:
Clinical trial NCT02731261: Chronic Effects of Exercise on Motor Memory Consolidation in Elderly People
Official title: Chronic Effects of Exercise on Motor Memory Consolidation in Elderly People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Lead sponsor: Instituto Politécnico de Castelo Branco
Sponsor class: OTHER
First posted: 2016-04-07
Enrollment: 38
Sex: ALL
Minimum age (years): 65
Maximum age (years): 72
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study was to investigate if a six months period of physical exercise could improve motor memory consolidation in elderly people.

Detailed description: 38 subjects of both genders, with a mean age of 71 years old participated in the study. Subjects were divided in two groups: a control group and an experimental group. Before the intervention of a physical exercise program, subjects performed a Finger Tapping Sequence to measure baseline performance. After the intervention, the assessment of the impact of exercise on motor memory consolidation was held in three stages: Training; 1 hour after training and 24 hours after training.

Eligibility criteria: Inclusion Criteria:

* individuals not engaged in physical activity;
* persons aged from 65 years.

Exclusion Criteria:

* sensory abnormalities;
* mental abnormalities;
* motor abnormalities;
* other atypical health problems.

Primary outcomes:
measure: Subjects performed a Finger Tapping Sequence to measure a performance in Motor memory consolidation.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04744961: Effect of Surgical Site Infections on Patient Reported Cosmetic Outcomes in Dermatologic Surgery
Official title: Effect of Surgical Site Infections on Patient Reported Cosmetic Outcomes in Dermatologic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Site Infection
Patient Satisfaction
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All included patients had a surgical procedure performed at our department. One group had documented surgical site infections and the other didn't.

Brief summary: This study involves surveying two matched groups of patients that underwent dermatologic surgery at our department. One group had a documented surgical site infection and the other didn't. All patients will be asked to complete a questionnaire in which they assess the physical appearance of their scars and its psychosocial impact. Results will be compared between the groups.

Detailed description: 65 patients with a documented surgical site infection will be compared to 65 patients with normal wound healing in terms of patient reported outcome regarding scar physical appearance and psychosocial impact using SCAR-Q questionnaire.

Eligibility criteria: Inclusion Criteria:

* Patient above 18 years of age that underwent a dermatosurgical procedure at our department between march 2017 and march 2020.

Exclusion Criteria:

* Patients assessed as not suitable for telephone survey due to hearing disabilities or cognitive impairment

Primary outcomes:
measure: Comparing mean values of SCAR-Q scores in both groups
timeFrame: 3 months
Secondary outcomes:
measure: Association between patient characteristics and SCAR-Q scores
timeFrame: 3 months
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of dermatology, Skåne university hospital
Study officials:
References:
Clinical trial NCT01058161: High-Field MRI Characterization of Wrist and Hand Cartilage Abnormalities in Inflammatory and Chronic Rheumatisms
Official title: High-Field MRI Characterization of Wrist and Hand Cartilage Abnormalities in Inflammatory and Chronic Rheumatisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abnormality
Inflammation
Rheumatism
Keywords: wrist and hand cartilage abnormalities in inflammatory and chronic rheumatisms
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2010-01-28
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The present project aims at evaluating the diagnostic potential of high-field MRI (3 Teslas) for joint disease. At this field, given that isotropic image resolution of 400 microns can be obtained, one could expect an early detection of joint abnormalities. The additional aim of this project will be to develop a quantitative analyse of the corresponding high-resolution images.


Eligibility criteria: Inclusion Criteria:

* gp Suspects or affected by rheumatoid polyarthritis

  1. Morning articular Stiffness of at least 15 minutes.
  2. Arthalgias or Arthritises of at least three joints(articulations), among which those of the hand.
  3. Possible rheumatoid Presence of a factor(mailman) and\\or Antibody anti peptides positive citrullinés.
  4. Typical possible radiological Hurts on the standard clichés(pictures) of the reached(affected) joints(articulations).
* gp Affected by stiffening spondylitis with axial and peripheral infringement :

  . Lumbago and steepness lumbar vertebra inflammatory. 2. Arthralgias and\\or peripheral arthritises 3. Possible presence of an allèle HLA 4. Possible presence of a sacro-illite 5. Absence of the other rheumatic markers
* gp Affected by connectivity with anti-nuclear antibody positive and / or specific antibodies, suffering of polyarthralgias with or without arthritis
* gp Healthy control
* gp Presenting a degenerative osteoarthritis of the wrist traumatic comment, noticed radiologically, which will serve as not inflammatory control.

Exclusion Criteria:

* Claustrophobia,
* metallic foreign bodies,
* pacemakers The pregnant women,
* parturients or who breast-feed are excluded from the study

Primary outcomes:
measure: can be obtained, one could expect an early detection of joint abnormalities
timeFrame: 24 months
Secondary outcomes:
measure: will be to develop a quantitative analyse of the corresponding high-resolution images.
timeFrame: 24 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: sandrine guis, PU PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05995561: HERA FIb Registry for Patients With Atrial Fibrillation
Official title: Heidelberg Registry of Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 12297
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A cohort of approximately 13000 consecutive patients with atrial fibrillation presenting to the emergency department of the Heidelberg University Hospital.

Brief summary: The single-center HERA AFIb registry was created to assess real-world prevalence, demographic characteristics and management of patients with atrial fibrillation (AF) in the era of novel oral anticoagulant regimes (NOAC) presenting in the emergency department (ED) of University of Heidelberg

Detailed description: HERA AFIb is a single-center retrospective registry which enrolled consecutive cases presenting with atrial fibrillation at the emergency department of University Hospital of Heidelberg. Clinical parameters and characteristics for cases were assessed retrospectively. Follow-up was performed via review of medical reports, phone calls and postal queries. Outcome parameters included rates for all-cause mortality, non-hemorrhagic stroke, myocardial infarction and major bleeding.

Eligibility criteria: Inclusion Criteria:

* documented atrial fibrillation
* availability of at least one hsTnT measurement

Exclusion Criteria:

* lost to follow-up

Primary outcomes:
measure: all-cause mortality
timeFrame: 24 months
Secondary outcomes:
measure: ischaemic stroke
timeFrame: 24 months
measure: major bleeding
timeFrame: 24 months
measure: myocardial infarction
timeFrame: 24 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital of Heidelberg
state: Baden-Württemberg
Study officials:
References: