louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03608111: Effects of Single-task Versus Dual-task Training on balancePERFORMANCE
Official title: Effects of Single-task Versus Dual-task Training on Balance Performance in Elderly Osteoarthritic Patients With Balance Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance Impairment
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Impairment in the control of balance is a common problem among elderly patients especially whom with osteoarthritis (OA).

Aim: The aim of this study was to compare the effects of single-task and dual-task training on balance performance in the elderly osteoarthritic patients with balance impairment.

Detailed description: Fifty elderly osteoarthritic patients with balance impairment were included into this study. Patients were randomly assigned to single task balance training (Group 1) or dual-task balance training (Group 2) groups. Balance activities were given to both groups for 3 times a week for 4 weeks. Patients in group 2 also performed cognitive tasks simultaneously with these exercises. Patients were evaluated with Berg balance scale (BBS), kinesthetic ability trainer (KAT 2000) static and dynamic scores, timed up and go test (TUTG) and walking speed for single and dual tasks, number of stopping and Activities Specific Balance Confidence (ABC) Scale at the baseline and at the end of 4 weeks.

Eligibility criteria: Inclusion Criteria:

* included age ≥65, able to walk 10 m, no neurological or musculoskeletal diagnosis, met the criteria of balance impairment, and scored \>19 on the mini mental state examination.

Exclusion Criteria:

* neurologic or musculoskeletal diagnosis such as stroke, orthopedic involvement, significant visual and auditory impairments, severe vitamin B12 deficiency and sedative drug use.

Primary outcomes:
measure: Berg balance scale
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02945111: Watching Live VIA/VILI Examinations on a Digital Screen May Reduce Patients' Anxiety
Official title: Watching Live VIA/VILI Examinations on a Digital Screen May Reduce Patients' Anxiety: a Randomized Trial of an Educational Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Anxiety
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 122
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to assess whether the degree of anxiety experienced by women undergoing visual inspection with acetic acid (VIA) and Lugol's iodine (VILI) can be reduced by watching the procedure in real-time on a digital screen.

Detailed description: The study took place in the District of Dschang, Cameroon. Women aged between 30 and 49 years, addressed to undergo a pelvic examination with VIA and VILI, were invited to participate. Throughout the examination, one part of the women underwent the routine VIA/VILI, with no visual support (control group), whereas the other part of patients were shown the pictures of the cervix in real-time on a digital screen (study group). At the end of the procedure, all women had the possibility to see the pictures retrospectively. Randomization determined the women's distribution between the two groups. Their anxiety level was measured by asking them to complete the Spielberg's State Anxiety Inventory (STAI) both prior to and immediately after the procedure.

Eligibility criteria: Inclusion Criteria:

* Women participating in a cervical cancer screening campaign organized by the District hospital of Dschang
* Women understanding the study procedure and accepting voluntarily to participate by signing an informed consent form (ICF).

Exclusion Criteria:

* Women not able to comply with the study protocol.

Primary outcomes:
measure: Anxiety level
timeFrame: Within thirty minutes of the VIA/VILI examination
Secondary outcomes:
Other outcomes:
Locations:
city: Dschang
country: Cameroon
facility: Dschang District Hospital
state: Yaoundé
Study officials:
affiliation: University Hospital, Geneva
name: Patrick Petignat, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Camail R, Kenfack B, Tran PL, Viviano M, Tebeu PM, Temogne L, Akaaboune M, Tincho E, Mbobda J, Catarino R, Vassilakos P, Petignat P. Benefit of Watching a Live Visual Inspection of the Cervix With Acetic Acid and Lugol Iodine on Women's Anxiety: Randomized Controlled Trial of an Educational Intervention Conducted in a Low-Resource Setting. JMIR Cancer. 2019 May 13;5(1):e9798. doi: 10.2196/cancer.9798.
Clinical trial NCT04806711: Eleven Years of Menicon Z Night Contact Lens Wear in Reducing Myopia Progression in Children
Official title: Eleven Years of Menicon Z Night Contact Lens Wear in Reducing Myopia Progression in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia, Progressive
Children, Only
Lead sponsor: Menicon Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Universidad Europea de Madrid
name: Clinica novovision
First posted: 2021-03-19
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, controlled, parallel, longitudinal
Primary purpose: TREATMENT

Brief summary: To compare axial length growth of white European myopic children wearing Menicon Z Night orthokeratology contact lenses to a control group of distance, single-vision glasses and contact lenses over an 11-year period.

Detailed description: This prospective, controlled, parallel, longitudinal study compared the axial length growth of white European myopic children wearing Menicon Z Night orthokeratology contact lenses to a control group of distance, single-vision glasses and or distance, single-vision soft contact lenses over an 11-year period.

Eligibility criteria: Inclusion Criteria:

* Be 6 to 12 years of age, both ages inclusive
* A low-to-moderate level of myopia (between 0.75 and 4.00 D) and of astigmatism (≤ 1.00 D)
* Neophyte contact lens wearer
* Be successfully fitted with spectacles or orthokeratology contact lenses
* Be able to achieve, through spherical refraction correction, a logMAR visual acuity of 0.8 or better in each eye
* Be willing and able to follow the subject instructions and to meet the protocol-specified schedule of follow-up visits
* White European ethnicity

Exclusion Criteria:

* Systemic or ocular disease affecting ocular health
* Use of any systemic or topical medications that could affect ocular physiology or contact lens performance
* Any lid or anterior segment abnormalities for which contact lens wear could be contraindicated
* CCLRU grade ≥ 2 for any given anterior segment ocular clinical signs
* Aphakic, amblyopic, and atopic individuals
* Refractive astigmatism ≥ ½ spherical refraction
* Previous contact lens wear

Primary outcomes:
measure: Axial length
timeFrame: 11 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutierrez-Ortega R. Myopia control with orthokeratology contact lenses in Spain: refractive and biometric changes. Invest Ophthalmol Vis Sci. 2012 Jul 31;53(8):5060-5. doi: 10.1167/iovs.11-8005.
citation: Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutierrez-Ortega R, Sugimoto K. Long-term Efficacy of Orthokeratology Contact Lens Wear in Controlling the Progression of Childhood Myopia. Curr Eye Res. 2017 May;42(5):713-720. doi: 10.1080/02713683.2016.1221979. Epub 2016 Oct 21.
Clinical trial NCT05552911: Drug-coated Balloon Therapy for In-stent Restenosis and de Novo Coronary Lesions
Official title: Clinical Prognosis and Influencing Factors of Drug-coated Balloon Therapy in Patients With Coronary In-stent Restenosis and de Novo Coronary Lesions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Heart Disease
Keywords: Drug-coated balloon
Percutaneous coronary intervention
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 400
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: Patients diagnosed with coronary heart disease by coronary angiography and treated with DCB alone in the Department of Cardiology of our hospital since January 2022 were included in this study.

Brief summary: This was a single-center, prospective, open-label, observational study. Patients with coronary artery disease confirmed by coronary angiography and treated with drug-coated balloon catheter alone for target vessels were enrolled in the Cardiology Department of our hospital in January 2022. The primary endpoint was late lumen loss within 12±3 months after surgery.


Eligibility criteria: Inclusion Criteria:

1. Patients aged ≥18 years with coronary heart disease;
2. If the target lesion stenosis ≥70% is complicated with angina pectoris or evidence of myocardial ischemia, DCB should be administered;
3. Residual lumen diameter stenosis ≤30% after lesion pretreatment and DCB, no vessel dissection, or type A or B dissection, and TIMI blood flow level 3;
4. Target lesions were treated with DCB for the first time.

Exclusion Criteria:

1. Intraoperative implantation of salvage stent in DCB;
2. Acute myocardial infarction occurred within 1 week after DCB operation;
3. Less than 3 months of dual antiplatelet therapy after DCB operation, or more than 1 month of discontinuation of antiplatelet therapy;
4. The position of the stent could not be determined by coronary angiography.
5. Desmovascular disease or left main artery disease;
6. Atrial fibrillation;
7. Patients with severe heart failure, valvular heart disease, renal insufficiency, severe infection and autoimmune disease.

Primary outcomes:
measure: LLL of 12±3 months after surgery
timeFrame: 12±3 months after surgery
Secondary outcomes:
measure: MACE event 12 months after surgery
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References:
Clinical trial NCT00675311: Remote Monitoring in Diabetes Disease Management
Official title: A Randomized Study of the Clinical and Economic Impact of Remote Monitoring Program With Disease Management Compared to Conventional Diabetes Disease Management Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Type 2 Diabetes
Keywords: Remote monitoring
Type 1 Diabetes
Type 2 diabetes
Lead sponsor: LifeScan
Sponsor class: INDUSTRY
First posted: 2008-05-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine whether remote monitoring in diabetes management is more effective at helping patients manage their disease than a standard disease management program.

Detailed description: To determine whether remote monitoring in diabetes management is more effective at helping patients manage their disease.

Eligibility criteria: Inclusion Criteria

* Between 18 and 64 years of age as of January 1, 2008
* Diagnosis of diabetes mellitus (listed ICD-9-CM diagnosis code on two or more outpatient claims, or on one or more inpatient admissions or emergency room claims in the most recent 12-month period)
* Continuously enrolled in a health plan with pharmacy and medical benefits for the most recent 12-month period or with one period of non-enrollment up to only 30 days
* Able to provide written informed consent for study participation

Exclusion Criteria

* Advanced renal disease (one or more claims in the most recent 12-month period) as defined by a claim for nephropathy or creatinine greater than 2.5 mg/dl
* Selected cancers (one or more claims in the most recent 12-month period)
* HIV/AIDS (one or more claims in the most recent 12-month period)
* Heart, liver, kidney, or multiple organ transplant (one or more claims in the most recent 12-month period)
* Cirrhosis of the liver (one or more claims in the most recent 12-month period)
* Current participation in another LifeScan study or other diabetes-related clinical trials
* Medicare is primary source of insurance coverage
* Unable to understand written and spoken English

Primary outcomes:
measure: The primary study measures for this study include glycemic control and LDL levels, satisfaction with diabetes care, and adherence to diabetes medications and self-monitoring recommendations
timeFrame: 1 Year
Secondary outcomes:
measure: Secondary measures include diabetes-related health-care utilization and physiologic data.
timeFrame: 1 Year
Other outcomes:
Locations:
city: Marietta
country: United States
state: Georgia
Study officials:
affiliation: Matria Healthcare
name: Donald Fetterolf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01448811: Auditory Evoked Potential Monitoring on Bronchoscopy
Official title: Impact of Auditory Evoked Potential Index Monitoring on Bronchoscopic Examination in the Mechanical Ventilated Patients - A Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedation Method
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2011-10-07
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To compare the difference of sedation monitoring for bronchoscopic examination monitoring by auditory evoked potentials (AEP) or Ramsay Sedation Scale (RSS) in mechanical ventilated patients.


Eligibility criteria: Inclusion Criteria:

* Mechanically ventilated patients with aged 18 or over and they needed bronchoscopic examination in the ICU were eligible for this study.

Exclusion Criteria:

* patients with pacemaker, neuromuscular blockades, propofol allergy or hearing impairment.

Primary outcomes:
measure: Change of mean arterial pressure, heart rate and AAI
timeFrame: 40 minutes
Secondary outcomes:
measure: mean propofol dose use during examination, times of propofol dose adjustment
timeFrame: 40 minutes
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Chien-Wei Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsu CW, Sun SF, Chu KA, Lee DL, Wong KF. Monitoring sedation for bronchoscopy in mechanically ventilated patients by using the Ramsay sedation scale versus auditory-evoked potentials. BMC Pulm Med. 2014 Feb 6;14:15. doi: 10.1186/1471-2466-14-15.
Clinical trial NCT03053011: Evaluation of the Awakening Capability by a Vibrating Bracelet (BRASSARD)
Official title: Alarm Relay Bracelet for Simplification and Security Respiratory Assistance at Home: Evaluation of the Nocturnal Awakening Capability in Ventilated Patients and Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Central Hypoventilation Syndrome
Patients With Nocturnal Ventilatory Assistance
Healthy Volunteers
Lead sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: As part of developing a relay alarm project, the aim of the study is to test a sleeper's capability to wake up via a vibrating alarm around the wrist (vibrating bracelet).


Eligibility criteria: Inclusion Criteria:

* speak french
* with social security For healthy volunteers : no sleep disorder, known neurological or respiratory pathology For patients : congenital central hypoventilation syndrome or ventilatory assistance whatever the indication, able to act on their ventilator, and in stable state on the respiratory level for at least 3 months.

Exclusion Criteria:

* subjects taking treatment that may interfere with sleep patterns
* intake of alcohol or any substance (alcohol, drugs) that may interfere with sleep patterns the day before the polysomnography

Primary outcomes:
measure: Total awakening capability
timeFrame: 1 night
Secondary outcomes:
measure: Awakening capability in each stage of sleep
timeFrame: 1 night
measure: Awakening without capability to do the cognitive task
timeFrame: 1 night
Other outcomes:
Locations:
city: Paris
country: France
facility: Service des pathologies du sommeil - GH Pitié-Salpêtrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Valérie ATTALI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04596111: Physiological Variables and Rowing Performance.
Official title: Can Aerobic and Anaerobic Fitness Tests be Used to Track Rowing Performance Changes in Collegiate Rowers?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Water Sports
Lead sponsor: Franklin Pierce University
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be current rowers of a college rowing team.

Brief summary: The purpose of this study is to investigate the association between the changes in physiological variables based on fitness testing and the changes in rowing performance.

Detailed description: The literature has shown that both aerobic capacity and anaerobic capacity are important for exercise performance in rowing. Simple fitness tests (e.g., the modified Wingate test and the graded exercise test) have been validated to examine aerobic and anaerobic capacities in rowers. However, it remains unclear whether these fitness tests can be used to track rowing performance changes. The purpose of this study is to investigate the association between the changes in fitness test outcomes and the changes in rowing performance. The investigators expect that improvements in rowing performance are closely related to improvements in fitness test outcomes.

Participants will attend two sessions of fitness testing, one in the fall 2020 and one in the spring 2021. Each session will include the modified Wingate test to examine anaerobic capacity, the graded exercise test to examine the aerobic capacity, and the 2,000-meter rowing test on rowing ergometers to assess rowing performance.

Modified Wingate test:

After 3 minutes of warm-up at 40-50% of heart rate reserve, the participants will perform 30 seconds of rowing at maximal effort on the rowing ergometer.

Graded exercise test:

Workload will start from 25 Watts and it will be increased by 25 Watts by each stage until exhaustion. Each stage includes 2 minutes of rowing and 1 minute of rest.

2,000-meter rowing test: A 2,000-meter race simulation will be performed using an indoor rowing ergometer.

Eligibility criteria: Inclusion Criteria:

• Collegiate rowers

Exclusion Criteria:

* Cardiovascular diseases
* Pulmonary diseases
* Metabolic diseases
* Other contraindications to exercise

Primary outcomes:
measure: Rowing performance
timeFrame: six months
Secondary outcomes:
measure: Maximal oxygen consumption
timeFrame: six months
measure: Maximal anaerobic power
timeFrame: six months
Other outcomes:
Locations:
city: Rindge
country: United States
facility: Franklin Pierce University
state: New Hampshire
Study officials:
affiliation: Franklin Pierce University
name: Tongyu Ma, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00541411: Phase II Pilot Study of Vincristine, Adriamycin, Actinomycin D, Ifosfamide Combination Chemotherapy in Ewing's Sarcoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ewing's Sarcoma
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2007-10-10
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase II Pilot Study of Vincristine, Adriamycin, Actinomycin D, Ifosfamide combination chemotherapy in Ewing's Sarcoma


Eligibility criteria: Inclusion Criteria:

* Patients with Ewing's Sarcoma

Primary outcomes:
measure: Efficacy
timeFrame: overall
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia
name: Muhammad Memon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01794611: Different Types Of Laryngoscopes During Routine Intubation in Adult Patients
Official title: Comparison Of C-MAC Videolaryngoscopy, Kingsvision Videolaryngoscopy and Macintosh Laryngoscopy During Routine Intubation in Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failed or Difficult Intubation
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2013-02-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: C-MAC videolaryngoscope (Karl Storz, Tuttlingen, GERMANY) with its Macintosh like blade is used with standard direct laryngoscopy technique. KingsVisionTM videolaryngoscopes (KingSystems, IN, USA) have also Macintosh like single use blades that are channeled, wider and shorter than conventional Macintosh blades.We aim to compare these two laryngoscopes and Macintosh laryngoscope during routine intubation in adult patients.


Eligibility criteria: Inclusion Criteria:

* 200 American Society of Anesthesiology I-III patients between 18-80 years old undergoing elective abdominal surgery and planned to be intubated orotracheally will be included in the study.

Exclusion Criteria:

* Patients with upper respiratory problems and predicted difficult airways will be excluded from the study.

Primary outcomes:
measure: Cormack-Lehane Score
timeFrame: 5 minutes
Secondary outcomes:
measure: time
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department
state: Fatih
Study officials:
affiliation: Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department
name: Guniz Koksal, Ass.Prof.
role: STUDY_DIRECTOR
References:
citation: Xue FS, Liao X, Cheng Y. Comparative performance of C-MAC video laryngoscope and macintosh direct laryngoscope for emergency intubation. Ann Emerg Med. 2012 Dec;60(6):817-8; author reply 818-9. doi: 10.1016/j.annemergmed.2012.05.044. No abstract available.