louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06379906: Upper Extremity Muscle Strength, Balance and Functional Skills in DMD
Official title: The Association Between Upper Extremity Muscle Strength, Balance and Functional Skills in Children With Duchenne Muscular Dystrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duchenne Muscular Dystrophy
Keywords: duchenne muscular dystrophy
upper extremity
balance
functional skills
Lead sponsor: Halic University
Sponsor class: OTHER
Collaborators: name: Biruni University
name: Istanbul University
First posted: 2024-04-23
Enrollment: 32
Sex: MALE
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Participants who applied to the Child Neurology outpatient clinic of Istanbul University, Istanbul Faculty of Medicine, Department of Child Health and Diseases

Brief summary: This study aims to examine the relationship between upper extremity muscle strength, balance and functional skills of children with DMD.


Eligibility criteria: Inclusion Criteria:

* diagnosed with DMD by a child neurologist and confirmed by genetic test results,
* were at Level 1-4 according to Brooke Lower Extremity Functional Classification (able to ambulate independently and get up from a chair)
* had cooperation with the researchers

Exclusion Criteria:

* had undergone a surgical operation in the last 6 months
* had contractures that would affect functional activities

Primary outcomes:
measure: Upper Extremity Muscle Strength Measurements
timeFrame: one time (baseline)
measure: Trunk Control Measurement Scale
timeFrame: one time (baseline)
measure: Functional Reach Test
timeFrame: one time (baseline)
measure: Timed Up & Go Test
timeFrame: one time (baseline)
Secondary outcomes:
measure: Pediatric Evaluation of Disability Inventory
timeFrame: one time (baseline)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haliç University
state: Eyüpsultan
Study officials:
affiliation: HALİÇ UNİVERSİTY
name: GÜLSENA UTKU UMUT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02710799: Evaluation of the Effects of Teleconsultations on a Endocrinology Referral List
Official title: Evaluation of the Effectivity of Teleconsultations for Improving the Referrals From Primary Care to Specialized Care of Patients With Chronic Endocrinological Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Hypothyroidism
Hyperthyroidism
Goiter
Thyroid Nodule
Obesity
Keywords: Endocrinology
Referral list
Teleconsultation
Telemedicine
Cluster randomized clinical trial
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Secretaria Estadual da Saúde do Estado do Rio Grande do Sul
name: Programa de Pesquisa e Pós-Graduação em Epidemiologia da UFRGS
name: TelessaúdeRS / UFRGS
First posted: 2016-03-17
Enrollment: 3470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is evaluate the effects of telephone teleconsultations to primary care physicians (compared to the state's referral protocol) in the referrals waiting list for endocrinological appointments.

Detailed description: Rio Grande do Sul state's referral list for endocrinology evaluation in specialized care is highly overloaded. There is currently a referral protocol to select patients how should be referred. It will be evaluated if a intervention of telephone-based teleconsultations provided by the TelessaúdeRS to the primary care physicians can provide additional benefits. TelessaúdeRS is a telehealth program from the University of Rio Grande do Sul. This will be evaluated in a cluster randomized clinical trial.

Eligibility criteria: Inclusion Criteria:

* Patients from counties with at least 5 endocrinology referrals waiting appointment.
* Patients referred from primary care physicians
* Patients referred because one of the protocol conditions (Diabetes Mellitus, Hypothyroidism, Hyperthyroidism, Goiter, Thyroid nodule, Obesity).

Exclusion Criteria:

* Patients from counties with more than one hundred endocrinology referrals waiting appointment.

Primary outcomes:
measure: Number of consultations authorized
timeFrame: 1 year
Secondary outcomes:
measure: Number of new referrals for endocrinology
timeFrame: 1 year
measure: Adherence to the state's protocols
timeFrame: 1 year
measure: Usage of TelessaúdeRS teleconsultations
timeFrame: 1 year
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Secretaria Estadual da Saúde
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Erno Harzheim, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03988699: Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus
Official title: Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus: An Early Feasibility Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tinnitus
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Researchers are gathering information on the safety and effectiveness of a novel device called the Tinnitus Implant System for the treatment of tinnitus.

Detailed description: This study requires one year of participation with at least 21 visits to Mayo Clinic in Rochester MN for device programming and audiometric testing. The device is implanted during an outpatient surgery. Participants may keep the study device after participation is complete.

Eligibility criteria: Inclusion Criteria

* Age: ≥18 years of age
* Normal to moderate SNHL (≤70 dB HL; based on PTA of 0.5, 1 and 2 kHz) and WRS ≥ 75%.
* Unilateral or asymmetrical subjective tonal tinnitus
* Tinnitus present for at least 6 months, but not longer than 3 years
* Tinnitus that is disruptive

  * THI score in the severe range (≥56/100)
  * TFI score in the severe range (≥52/100)
  * Tinnitus VAS ≥50/100
* Tinnitus that is intractable, and has not been ameliorated by conventional measures such as a hearing aid or masking

Exclusion Criteria

* Age: \<18 years of age
* Tinnitus present less than 6 months or longer than 3 years
* Current pregnancy
* History of brain or major ear surgery
* Prior major head trauma

  * Presence of clinically significant depressive or anxiety symptoms determined by screening using the GAD-7, PHQ-8, and SHAI

    * GAD-7 \>9 (indicates clinically significant anxiety)
    * PHQ-8 \>9 (indicates clinically significant depression)
    * SHAI \>25 (hypochondriacal level illness anxiety)
  * Inability to assess, continue or complete trial
* Currently on antidepressants, anxiolytics or antipsychotics
* Active use of other tinnitus treatments (not including non-masking hearing aid use)
* Normal contrast-enhanced MRI of the head
* Normal temporal bone CT

Primary outcomes:
measure: Number of subjects with treatment-related adverse events
timeFrame: One year
measure: Number of subjects to experience significant improvement from implantation of the device
timeFrame: Baseline, 3 weeks, 5 weeks, 7 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks, 14 weeks, 15 weeks, 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew L Carlson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01085799: Education Intervention to Reduce Helminth Infections and Absenteeism in Grade 5 School-children
Official title: Effectiveness of a Post-deworming Education Intervention to Reduce Soil-transmitted Helminth Infections and Absenteeism in Grade 5 School-children in a Community of Extreme Poverty, Peruvian Amazon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infections
Keywords: Educational activities
Cluster-randomized controlled trial
Albendazole
Deworming
School-age children
Peru
Ascaris lumbricoides
Trichuris trichiura
Hookworm
STH infections
Intestinal helminth infections
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2010-03-12
Enrollment: 1101
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To efficiently control soil-transmitted helminths (Ascaris, Trichuris, and hookworm), WHO, PAHO, and others recommend the inclusion of an education strategy in school-based deworming programs. However, the effectiveness of such a strategy on the rate of STH re-infection and on education indicators, such as absenteeism, remains to be fully understood. The proposed research aims to evaluate the effectiveness of a post-deworming education intervention targeted to Grade 5 school children enrolled in Belén's schools using a cluster-randomized trial design. Results will be used to inform school-based deworming programs in Peru and other similar endemic areas in Latin America and, indeed, around the world.


Eligibility criteria: Inclusion Criteria:

* Girls and boys enrolled in Grade 5 in eligible schools located in the Belén district of Iquitos, Peru. Eligible schools have a minimum of 10 boys and 10 girls enrolled in grade 5.
* Informed written consent obtained from the parents or legal guardian of the child.
* Verbal assent from child.

Exclusion Criteria:

* Parents (or guardians) refusing participation of their child.
* Child who refuses to participate.

Primary outcomes:
measure: Soil-transmitted helminth re-infection (Ascaris, Trichuris, or Hookworm).
timeFrame: 4 months post-deworming
Secondary outcomes:
measure: Absenteeism rate.
timeFrame: During the first 4 months following deworming
measure: Eggs per grams reduction rate.
timeFrame: 4 months post-deworming
measure: Weight gain (kg)
timeFrame: 4 months post-deworming
measure: Height gain (cm)
timeFrame: 4 months post-deworming
Other outcomes:
Locations:
city: Iquitos
country: Peru
facility: Asociación Civil Selva Amazónica
state: Loreto
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Theresa W. Gyorkos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asociación Civil Selva Amazónica
name: Martín Casapía, MD, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT01868399: Pilot Survey of Dengue Fever in Solomon Islands
Official title: Pilot Survey of Dengue Fever in Solomon Islands
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arbovirus Infections
Keywords: dengue virus
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Foreign Affairs, Republic of China, TAIWAN
name: Ministry of Health and Medical Services, Solomon Islands
name: National Referral Hospital
First posted: 2013-06-04
Enrollment: 2200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Residents of Solomon Islands
* people who understand the purpose of the study
* people who agree to sign the informed consent

Brief summary: Since 2009, Kaohsiung Medical University Hospital organized a medical team to provide the medical service for people in Solomon Islands thru Taiwan Health Center at the local. In addition to Malaria and pulmonary tuberculosis, the investigators also found dengue virus, Japanese Encephalitis virus, Chikungunya virus infections and intestinal parasitic infections might be the existing but overlooked and neglected medical issues in Solomon Islands. These infections show similarity in clinical manifestations and usually difficulty in clinical diagnosis, instead these infections rely on the laboratory identification with good laboratory quality and facility.

Detailed description: In this study, the investigators plan to investigate the local people, either from the community or the hospitals, to identify the prevalence and incidence of dengue fever, including laboratory identification of related infections for differential diagnosis, including Japanese Encephalitis virus, Chikungunya virus and intestinal parasitic infections. Intestinal parasite survey has been the routine long-term service offered by the Kaohsiung Medical University Hospital in Solomon Islands. At the same time, the subjects enrolled in this study will also be asked the common medical illness in Solomon Islands (i.e. malaria, pulmonary tuberculosis and metabolic syndrome etc.) in order to delineate the association of dengue fever and these acute and chronic illness.

Eligibility criteria: Inclusion Criteria:

* healthy volunteer
* reported dengue virus infection volunteer
* people who understand the purpose of the study and agree the to sign the informed consent

Exclusion Criteria:

* people who refuse to join the study

Primary outcomes:
measure: Dengue fever
timeFrame: at the time of sampling (blood)
Secondary outcomes:
measure: Co-infection and interplay of dengue-like pathogens
timeFrame: within the first 3 months after blood sampling
Other outcomes:
Locations:
city: Kaohsiung city
country: Taiwan
facility: Tropical Medicine center
Study officials:
affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Wen-Ter Lai, MD
role: STUDY_CHAIR
affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Jih-Jin Tsai, MD, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03614299: Eye Dryness Evaluation in Primary Sjögren's Syndrome
Official title: Pateint-reported Outcomes and Objective Eye Dryness Evaluation in Primary Sjögren's Syndrome.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Sjögren Syndrome
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive pSS patients seen in Rheumatology

Brief summary: The objective of this observational study is to develop new tools to assess primary Sjögren's syndrome (pSS) symptoms and to measure the severity of eye involvement in these patients.

Detailed description: All clinical trials evaluating the efficacy of immunomodulatory drugs in pSS are negative. This could be due to a lack of sensitivity of the outcome measures used so far to define the response. In this study, investigator will evaluate the feasability, tolerability, and performance of new tools to assess disease evolution:

* investigator will develop a webapp to measure the intensity of the symptoms at home on a daily basis (ecological assessment)
* investigator will evaluate new ophthalmologic procedures, already used in other conditions but never in pSS, which assess the severity of eye involvement in the disease
* investigator will develop an automated method to score the severity of ocular surface lesions in the disease.

Patients with a diagnosis of pSS will be included in the study, will undergo detailed ophtalmologic examination, and will then use a webapp, installed on their smartphone, to score their symptoms everyday during 3 months.

Eligibility criteria: Inclusion Criteria:

* diagnosis of pSS according to ACR/EULAR classification criteria

Exclusion Criteria:

* patient does not possess a smartphone with web connection
* patient unable to sign an informed consent

Primary outcomes:
measure: Variability in the intensity of patient-reported symptoms
timeFrame: 3 months
Secondary outcomes:
measure: Tolerability of the daily use of a webapp to measure the symptoms
timeFrame: Month 3
measure: Interferometry
timeFrame: 3 months
measure: Automated eye surface coloration measurement
timeFrame: 3 months
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de BREST
Study officials:
References:
Clinical trial NCT04321499: SHOX2_PTGER4 DNA Methlyation in Lung Cancer
Official title: Establishing a Non-invasive Diagnostic Biomarker Test for Early Diagnosis of Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lungcancer
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: lung cancer, benign nodule

Brief summary: Data on SHOX2 and PTGER4 DNA Methylation suggest possible use as a biomarker for early lung cancer diagnosis.

In this study a control group consisting of COPD patients with a CT-scan of the chest no older than 6 weeks and a control group of patients with a nodule and ruled out diagnosis of lung cancer will be included.

SHOX2 and PTGER4 will be analyzed via PCR.

Detailed description: Data on SHOX2 and PTGER4 DNA Methylation suggest possible use as a biomarker for early lung cancer diagnosis.

In this study a control group consisting of COPD patients with a CT-scan of the chest no older than 6 weeks and a control group of patients with a nodule and ruled out diagnosis of lung cancer will be included.

A total of 150 patients will be enrolled in this study. SHOX2 and PTGER4 will be analyzed via PCR of blood plasma samples.

Eligibility criteria: Inclusion Criteria:

suspicious finding for lung cancer on CT-scan

Exclusion Criteria:

* history significant for former malignant diseases

Primary outcomes:
measure: DNA Methylation at early stages of lung cancer
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Ruhrlandklinik, Department of Interventional Pneumology
state: NRW
Study officials:
affiliation: head of deparment of interventional pneumology, Ruhrlandklinik, UHEssen
name: Kaid Darwiche, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weiss G, Schlegel A, Kottwitz D, Konig T, Tetzner R. Validation of the SHOX2/PTGER4 DNA Methylation Marker Panel for Plasma-Based Discrimination between Patients with Malignant and Nonmalignant Lung Disease. J Thorac Oncol. 2017 Jan;12(1):77-84. doi: 10.1016/j.jtho.2016.08.123. Epub 2016 Aug 18.
Clinical trial NCT00996099: Continuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients
Official title: Feasibility Study of the Use of Continuous Glucose Monitoring Combined With Computer-based eMPC Algorithm for Tight Glucose Control in Cardiosurgical ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Cardiac Surgery
Keywords: continuous glucose monitoring
intensive insulin therapy
critically ill
cardiac surgery
hyperglycemia of critically ill
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2009-10-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of a system combining continuous glucose measurement with a computer-based algorithm for insulin delivery in patients undergoing elective cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* elective cardiac surgery

Exclusion Criteria:

* insulin allergy
* mental incapacity
* language barrier

Primary outcomes:
measure: Percentage of glycemic values in the A and B zone of Clarke Error Grid Analysis (a tool for assessing the accuracy of glucose meters)
timeFrame: first 24 hours after cardiac surgery
Secondary outcomes:
measure: Entire study average glycemia level; time within, above and below the target range throughout the whole study period and after reaching the target range
timeFrame: first 24 hours after cardiac surgery
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: General University Hospital
Study officials:
affiliation: 3rd Department of Medicine, General University Hospital, Prague
name: Martin Haluzik, Prof, D.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04875299: Optimal Adalimumab Plasma Concentrations in Ankylosing Spondylitis Patients
Official title: Evaluation of the Optimal Concentration Range of Adalimumab for Ankylosing Spondylitis in a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing Spondylitis
adalimumab
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
Collaborators: name: Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
name: Central South University
name: First Affiliated Hospital of Chongqing Medical University
name: Tianjin First Central Hospital
name: Wuxi No. 2 People's Hospital
name: The First People's Hospital of Changzhou
name: Affiliated Hospital of Nantong University
name: Shandong Provincial Hospital
name: Qingdao Municipal Hospital
name: Liaocheng People's Hospital
name: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
First posted: 2021-05-06
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This prospective observational study will include Chinese adult patients with active ankylosing spondylitis receiving adalimumab treatment.

Brief summary: The optimal plasma concentration range of adalimumab in Chinese patients with active ankylosing spondylitis remains unknown, the aims of this study is to determine the concentration-effect relationship, and explore the effect of anti-drug antibody or biomarkers on clinical outcomes in a real-world setting.

Detailed description: This prospective observational study will include Chinese adult patients with active ankylosing spondylitis receiving adalimumab treatment. The primary outcome is the mean change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS).

Eligibility criteria: Inclusion Criteria:

1. Consent of the patient.
2. Patient who meets the definition of Ankylosing Spondylitis based on the 1984 Modified New York Criteria, has a diagnosis of active Ankylosing Spondylitis (BASDAI ≥ 4, Back pain ≥ 4).
3. Patients who have indication of adalimumab.
4. Patients on NSAIDs treatment need to be on a stable dose for at least 4 weeks.

Exclusion Criteria:

(1) Hepatitis B or tuberculosis patients

Primary outcomes:
measure: Mean Change From Baseline in ASDAS
timeFrame: Week 24
Secondary outcomes:
measure: ASAS20 response
timeFrame: Week 2, 4, 8, 12, 24
measure: ASAS40 response
timeFrame: Week 2, 4, 8, 12, 24
measure: BASDAI50 response
timeFrame: Week 2, 4, 8, 12, 24
measure: ASDAS response
timeFrame: Week 2, 4, 8, 12, 24
measure: ASDAS remission
timeFrame: Week 2, 4, 8, 12, 24
measure: Safety analysis - Occurence of adverse event
timeFrame: Week 24
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The Affiliated Hospital of Soochow University
name: Liyan Miao, Ph.D
role: STUDY_CHAIR
References: