louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02935868: Periodontal and Salivary Evaluation of Type 1 Diabetes Mellitus Patients
Official title: Periodontal and Salivary Evaluation of a Sample of Type 1 Diabetes Mellitus Patients in Brazil
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Periodontal Diseases
Keywords: Saliva
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Test Group: Patients diagnosed with Type 1 diabetes mellitus

Brief summary: Diabetes Mellitus is a risk factor for periodontal disease increasing its prevalence, extension and severity. Periodontal disease is considered the sixth complication of diabetes. There is a global epidemic of diabetes, including an increase of incidence of type 1 diabetes in younger patients. Thus, the aim of this observational study was to evaluate the periodontal and salivary condition of a sample of patients with type 1 diabetes of a brazillian city.


Eligibility criteria: Inclusion Criteria:

* Diagnose of Type 1 diabetes mellitus
* Age between 18 and 35 years old
* Presenting on tooth per quadrant

Exclusion Criteria:

* Diagnose of Type 2 diabetes mellitus
* Edentulous patients
* Other systemic diseases

Primary outcomes:
measure: Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity
timeFrame: one day
measure: Salivary pH and buffering Capacity - collection of stimulated saliva in 10 minutes and measurement of acidity with a pHmeter
timeFrame: one day
measure: Salivary glucose - collection of stimulated saliva in 10 minutes and measurement with a colorimetric kit
timeFrame: one day
measure: Salivary peroxidase - collection of stimulated saliva in 10 minutes, measurement by a spectrophotometer.
timeFrame: one day
Secondary outcomes:
measure: Plaque index - measured by visual observation and classification in scores (1 for presence, 0 for absence)
timeFrame: One day
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: Bauru School of Dentistry
state: Sao Paulo
Study officials:
References:
citation: Aren G, Sepet E, Ozdemir D, Dinccag N, Guvener B, Firatli E. Periodontal health, salivary status, and metabolic control in children with type 1 diabetes mellitus. J Periodontol. 2003 Dec;74(12):1789-95. doi: 10.1902/jop.2003.74.12.1789.
Clinical trial NCT03964168: An Outcomes Study to Determine the Reasons Patients on Biologic Therapy Discontinue Treatment and Fail to Follow-up With Their Providers
Official title: An Outcomes Study to Determine the Reasons Patients on Biologic Therapy Discontinue Treatment and Fail to Follow-up With Their Providers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Lead sponsor: Psoriasis Treatment Center of Central New Jersey
Sponsor class: OTHER
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2019-05-28
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female adults ≥ 18 years of age.

Brief summary: Patient interviews to evaluate the reason patients discontinue biologic therapy and/or fail to follow up with provider.

Detailed description: Retrospective chart review and patient interviews to evaluate the reason patients discontinue biologic therapy and/or fail to follow up with provider. This research intends to improve the continuity of care by determining why patients stop therapy and what can be done to improve their experience with the provider, pharmaceutical companies and specialty pharmacies.

Eligibility criteria: Inclusion Criteria:

* Male or female adults ≥ 18 years of age.
* Was receiving first or second biologic therapy
* Has not had a follow up with treating physician in ≥ 9 months

Exclusion Criteria:

* Actively receiving biologic therapy

  * Was not receiving first or second biologic therapy

Primary outcomes:
measure: Determine the most common reason for discontinuation
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
Study officials:
References:
Clinical trial NCT04075968: The Effect of Cognitive Group Exercise Combined With Physical Exercise in MS
Official title: The Effect of Cognitive Group Exercise Combined With Physical Exercise in Multiple Sclerosis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-09-03
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with definitive Multiple Sclerosis between 20-65 years, with an Mini Mental State Test score less than 24, with an Extended Disability Status Scale score less than 4, trained for at least 5 years, have not received steroid therapy in the last 1 month

Brief summary: The aim of this study is to investigate the effect of cognitive rehabilitation in group with physical exercise in patients with Multiple Sclerosis. We assume that cognitive therapy is an effective treatment for multiple sclerosis.

Detailed description: The aim of this study is to investigate the effect of cognitive rehabilitation in group with physical exercise in patients with Multiple Sclerosis.

Eligibility criteria: Inclusion Criteria:

* Patients with an Mini Mental State Test score less than 24
* Patients with an Extended Disability Status Scale score less than 4
* Patients trained for at least 5 years
* Patients who have not received steroid therapy in the last 1 month

Exclusion Criteria:

* Patients who have not passed at least 3 months from the last Multiple Sclerosis attack
* Patients with hearing and vision problems that may interfere with communication
* The patients who Have other neurological and psychiatric disorder that will cause cognitive impairment
* Patients receiving medical treatment for spasticity, tremor, bladder disorder and fatigue

Primary outcomes:
measure: Neuro-psychometric Test (NPT)
timeFrame: 1 hour
measure: Berg Balance Scale
timeFrame: 15 minutes
measure: Mini Mental State Test (MMST)
timeFrame: 10-15 minutes
Secondary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Health Sciences University Istanbul Physical Therapy and Rehabilitation Training and Research Hospital
Study officials:
affiliation: IstanbulPMHTRH
name: Arzu Esmeray
role: STUDY_CHAIR
References:
Clinical trial NCT01431768: Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B
Official title: Clinical Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B in the Primary Health Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: Influenza
Human
Orthomyxoviridae infections
RNA Virus Infections
Virus Diseases
Respiratory Tract infections
Respiratory Tract Diseases
Lead sponsor: Respirio Pty Ltd
Sponsor class: INDUSTRY
First posted: 2011-09-12
Enrollment: 250
Sex: ALL
Minimum age (years): 7
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a open label, prospective, pair comparison, randomised, multi-centre trial. The primary aim of this study to is to clinically validate the sensitivity and specificity of the Respirio Flu Test (RFT) in detecting Influenza A as compared with (a) the best available rapid Influenza A test in the market Quidel QuickVue (QQV) and (b) the gold standard for identifying Influenza A infection Polymerase Chain Reaction (PCR).

The secondary aim is to clinically validate the sensitivity and specificity of the Respirio Flu Test (RFT) in detecting Influenza B as compared to QQV and PCR.


Eligibility criteria: Inclusion Criteria:

1. Male and female subjects aged between 7 and 80 years (inclusive);
2. Fever \> 37.5 or a self-reported history of fever or feeling feverish (includes fever controlled by medication) in the absence of documented fever;
3. Cough or sore throat;
4. Rhinorrhea or nasal congestion;
5. ≤ 5 days from onset of clinical Influenza - Like Illness (ILI) symptoms;
6. Subject (or parent/guardian) capable and willing to give informed consent;
7. Subject provides written assent according to his/her age, if applicable.

Exclusion Criteria:

1. Recent craniofacial abnormality or injury (last 3 months);
2. Nasal or sinus surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months;
3. Craniofacial abnormality, such as severe deviation of the nasal septum;
4. Onset of clinical Influenza - Like Illness (ILI) symptoms \> 5 days;
5. Know history of allergic reaction to plastics or adhesives;
6. Subject (or parent/guardian) unwilling or unable to give informed consent.

Primary outcomes:
measure: Sensitivity and specificity of Influenza A
timeFrame: Day 1
Secondary outcomes:
measure: Sensitivity and specificity of Influenza B
timeFrame: Day 1
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Taringa 7 Day Medical Practice
state: Queensland
city: Brisbane
country: Australia
facility: Capalaba Medical Centre
state: Queensland
Study officials:
affiliation: Unaffliated
name: Julie Todhunter, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04788368: TRECA - TREatment of Colorectal Adenomas and Early Colorectal CAncer in Region Västra Götaland
Official title: TRECA - TREatment of Colorectal Adenomas and Early Colorectal CAncer in Region Västra Götaland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Neoplasms
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with rectal cancer treated with a local resection

Brief summary: All early colorectal cancers (T1-T2) treated in the Region Västra Götaland from 2007-2020 will be evaluated. To establish the extent to which early colorectal cancers have been treated with local excision? How have treatment strategies changed over time? The study will provide information on where these patients have been treated in the Region Västra Götaland. During the study period, ESD was introduced as a treatment modality, and it will investigated how this may have influenced treatment strategies for complex adenomas. Clinical outcome measures will include recurrence rates and re-intervention rates for the respective treatments. Possible areas of improvement will be identified and determine if evidence based and best practice guidelines are met with the current treatment strategies in Region Västra Götaland.


Eligibility criteria: Inclusion Criteria:

* Rectal cancer resected by local resection

Exclusion Criteria:

* All other types of resection or treatment for rectal cancer

Primary outcomes:
measure: Pathological clear margins
timeFrame: 1-2 months after surgery
measure: Complications after surgery
timeFrame: 90 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
References:
Clinical trial NCT02580968: Study of Key Electro-acupuncture Technique on Migraine
Official title: Study of Key Electro-acupuncture Technique on Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: Electroacupuncture therapy
Migraine
Acupuncture Therapy
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 2
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: A random controlled trail to evaluate the efficacy of migraine standard electroacupuncture formula, and to analysis the regulation of the intensity-effects and to observe the peripheral NO, CGRP and NF-кB expression level of migraine patients after electroacupuncture treatment.

Detailed description: acupuncture group(group A): treated by acupuncture for 20 days, 1 time per day control group(group B): treated by FlunarizineHydrochloride for 20 days, 1 table per day.

Eligibility criteria: Inclusion Criteria:

* met the diagnostic criteria for migraine; suffering from migraine attacks; migraine attacks for more than 5 days per month, and lasts for 3 months; voluntarily join this study with informed consents.

Exclusion Criteria:

* other systemic, neurological and psychiatric disorders; headache caused by other diseases; not treatment compliance during the study.

Primary outcomes:
measure: Migraine Disability Assessment Questionnaire (MIDAS)
timeFrame: 20 days
Secondary outcomes:
measure: The medical outcomes study 36-item short-form health survey(SF-36)
timeFrame: 20 days
measure: peripheral Nitrogen Monoxide(NO) protein expression
timeFrame: 20 days
measure: peripheral Calcitonin gene related peptide(CGRP) protein expression
timeFrame: 20 days
measure: peripheral Nuclear factor-kappa B(NF-кB) protein expression
timeFrame: 20 days
measure: Visual Analogue Scale (VAS) to assess pain
timeFrame: 20 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital,Shanghai University of Traditional Chinese Medicine
Study officials:
affiliation: Longhua Hospital
name: Jian Pei, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT05290168: Normal Vascular Doppler Pattern of Abdominal Organ in Children
Official title: Normal Vascular Doppler Pattern of Abdominal Organ in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Normal Children
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 100
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The following ultrasonic findings are obtained at both time points before and after induction of anesthesia (T1) and after induction (T2) in normal children . Positive pressure ventilation (Tidal volume of 6-8 ml/kg and a positive exhalation pressure of 5 cmH2O) is applied after anesthetic induction.

1. Inferior vena cava diameter and distensibility
2. Hepatic vein Doppler
3. Portal vein Doppler
4. Splenic artery and vein Doppler
5. Renal artery and vein Doppler Based on this, the reference values for Doppler findings before and after anesthesia in normal children are obtained.


Eligibility criteria: Inclusion Criteria:

* Children undergoing simple surgery

Exclusion Criteria:

* thoracic/abdominal surgery
* surgery for congenital heart disease
* disease involving liver, kidney, spleen
* vascular disease

Primary outcomes:
measure: portal vein flow velocity (cm/s) during self respiration
timeFrame: just before anesthesia induction (about 5 minutes before anesthetic induction)
measure: portal vein flow velocity (cm/s) during general anesthesia
timeFrame: during positive pressure ventilation (within 5 - 60 minutes after anesthetic induction)
measure: splenic vein flow velocity (cm/s) during self respiration
timeFrame: just before anesthesia induction (about 5 minutes before anesthetic induction)
measure: inferior vena cava diameter (mm) during self respiration
timeFrame: just before anesthesia induction (about 5 minutes before anesthetic induction)
measure: inferior vena cava diameter (mm) during general anesthesia
timeFrame: during positive pressure ventilation (within 5 - 60 minutes after anesthetic induction)
measure: hepatic vein flow velocity (cm/s) during self respiration
timeFrame: just before anesthesia induction (about 5 minutes before anesthetic induction)
measure: hepatic vein flow velocity (cm/s) during general anesthesia
timeFrame: during positive pressure ventilation (within 5 - 60 minutes after anesthetic induction)
measure: renal artery/vein flow velocities (cm/s) during self respiration
timeFrame: just before anesthesia induction (about 5 minutes before anesthetic induction)
measure: renal artery/vein flow velocities (cm/s) during general anesthesia
timeFrame: during positive pressure ventilation (within 5 - 60 minutes after anesthetic induction)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin-Tae Kim
Study officials:
References:
Clinical trial NCT05859568: Baseline Performance and Fitting Parameters for Sonova Products
Official title: Baseline Performance and Fitting Parameters for Sonova Products
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hearing Loss
Ear Diseases
Hearing Disorders
Otolaryngological Disease
Lead sponsor: Advanced Bionics
Sponsor class: INDUSTRY
First posted: 2023-05-16
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effectiveness and optimization of various FDA approved products.

Detailed description: This study uses a prospective within-subjects repeated-measures design in which each subject serves as her/his own control. The purpose of this study is to assess the effectiveness and optimization of various FDA approved hardware, signal preprocessing and processing software, fitting characteristics, and service delivery methods, such as remote support and/or tele-audiology on an expanded subject demographic. The insights gained from this study will be used to optimize listening configuration recommendations, refine audiological practice, and inform future innovations.

Eligibility criteria: Inclusion Criteria:

* Ability to provide Informed Consent/Assent
* Adults (age +18 years) and children (8-17 years) can be enrolled in this study

  * If child is aged 8-17 years, an assent will be completed, and the subject must be accompanied by a parent or legal guardian for all study activities
* Have the functional capability to operate the controls for the device and to comply with all directions during the study as determined by the investigator conducting the consent/baseline visit
* English language proficiency as determined by the investigator

Exclusion Criteria:

• Have any significant medical condition that, in the opinion of any of the investigators, is likely to interfere with study procedures or likely to confound evaluation of study endpoints

Primary outcomes:
measure: Speech performance in noise
timeFrame: 1 day
Secondary outcomes:
measure: Localization performance
timeFrame: 1 day
measure: Analysis of usability and preference questionnaire
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Valencia
country: United States
facility: Advanced Bionics
state: California
Study officials:
References:
Clinical trial NCT00485368: Angiotensin Converting Enzyme Inhibitors in Marfan Syndrome
Official title: The Effect of an Angiotensin Converting Enzyme Inhibitor on Aortic Wall Properties in Patients With Marfan Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Marfan Syndrome
Keywords: marfan syndrome
aortic root diameter
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
Collaborators: name: Baker Heart Research Institute
name: The Alfred
First posted: 2007-06-13
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research is to assess the effects of a drug called perindopril on the aorta in people known to have Marfan Syndrome. The aorta is the major artery of the body that comes out of the heart and supplies blood to the body. We know that in people with Marfan Syndrome, the aorta is stiff and this stiffness results in its enlargement over many years. This enlargement of the aorta can be very serious. We know from treatment of other heart conditions that drugs of the same type as perindopril reduce stiffness of the arteries. This type of drug has never been tried in people with Marfan Syndrome.


Eligibility criteria: Inclusion Criteria:

* Age 18-40
* Diagnosis of Marfan Syndrome, on the basis of the Ghent Criteria

Exclusion Criteria:

* Age \<18, \>40
* Women of child-bearing potential not on adequate contraception
* Serum creatinine of \>0.11
* A history of intolerance to ACEI
* Patients on angiotensin receptor blockers
* Blood pressure \>140/90mmHg
* History of previous aortic surgery

Primary outcomes:
measure: aortic root diameter
timeFrame: 24 weeks
Secondary outcomes:
measure: arterial stiffness
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Baker Heart Research Institute
name: Bronwyn A Kingwell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahimastos AA, Aggarwal A, D'Orsa KM, Formosa MF, White AJ, Savarirayan R, Dart AM, Kingwell BA. Effect of perindopril on large artery stiffness and aortic root diameter in patients with Marfan syndrome: a randomized controlled trial. JAMA. 2007 Oct 3;298(13):1539-47. doi: 10.1001/jama.298.13.1539.