louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01725711: Osseointegrated Prostheses for the Rehabilitation of Amputees
Official title: Osseointegrated Prostheses for the Rehabilitation of Amputees.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Transfemoral Amputation
Lead sponsor: Integrum
Sponsor class: INDUSTRY
Collaborators: name: Sahlgrenska University Hospital
name: Göteborg University
First posted: 2012-11-14
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with transfemoral amputations (TFA) frequently experience problems related to the use of socket-suspended prostheses 1-3. These problems increase with short or deformed stumps 4. The potential for improvement is substantial. Based on the very good long-term results with osseointegrated titanium implants for edentulous patients 5, osseointegrated hearing aids 6, cranio-facial prostheses 7 and prostheses for thumb-amputated patients 8, the clinical development of osseointegrated prostheses for TFA started in 1990, in Gothenburg, Sweden. The concept has gradually been modified and improved. In 1999, a prospective clinical trial began.

The hypothesis is that the treatment will improve quality of life.


Eligibility criteria: Inclusion Criteria:

* Transfemoral amputation

Exclusion Criteria:

* Transfemoral amputation due to vascular disease

Primary outcomes:
measure: Q-TFA Prosthetic Use Score
timeFrame: 0,1,2,3,5,7,10,15,20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
state: VG
Study officials:
References:
Clinical trial NCT01179711: Under-correction in Refractive Accommodative Esotropia
Official title: The Maximal Tolerable Reduction in Hyperopic Correction in Patients With Refractive Accommodative Esotropia: A 6-month Follow-up Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accommodative Esotropia
Keywords: accommodative esotropia
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-08-11
Enrollment: 41
Sex: ALL
Minimum age (years): 24
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In most clinics, physicians reduce diopter of hyperopic glasses in older patients with accommodative esotropia. However, there are risks of decompensation in that practice. The authors are going to try measure the change of stability of eye alignment after reducing diopter of hyperopic glasses.

Detailed description: Inclusion criteria :

patients with accommodative esotropia

At initial visit(of study), the physician will reduce the diopter of hyperopic glasses as much as the patient can maintain their eye alignment (maximum amount 1.5D).

Outcome measure :

Follow-up examinations are scheduled at 1 week, 1 month, 3 months, and 6 months after the patients begin wearing under-corrected spectacles. At every visit, symptoms such as asthenopia, diplopia, or blurred vision will be documented and ocular examinations, including visual acuity and ocular alignment status for distance and near will be performed. Tests of fusion and stereoacuity will be performed at the 1-month, 3-month, and 6-month follow-up visits.

Eligibility criteria: Inclusion Criteria:

* patients with accommodative esotropia
* older than 24 months

Exclusion Criteria:

* unstable eye alignment
* older than 18 years

Primary outcomes:
measure: eye alignment
timeFrame: 6 months
Secondary outcomes:
measure: stereopsis
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Sei Yeul Oh, MD
role: STUDY_CHAIR
References:
citation: Park KA, Kim SM, Oh SY. The maximal tolerable reduction in hyperopic correction in patients with refractive accommodative esotropia: a 6-month follow-up study. Am J Ophthalmol. 2011 Mar;151(3):535-41.e2. doi: 10.1016/j.ajo.2010.09.023. Epub 2011 Jan 13.
Clinical trial NCT03723811: Clinical Study to Investigate the Efficacy and Safety of SJP002 Ophthalmic Solution in Patients With Dry Eye Syndrome.
Official title: A Multicenter, Placebo Controlled, Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of SJP002 Eye Drops in Patients With Dry Eye Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndromes
Lead sponsor: Samjin Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-10-30
Enrollment: 152
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the efficacy and safety of SJP002 ophthalmic solution compared to placebo in patients with Dry Eye Syndrome.


Eligibility criteria: Inclusion Criteria:

* Age over 19.
* Must meet all criteria listed below at least in one eye.

  1. Fluorescein corneal staining score ≥ 2
  2. Schirmer test ≤ 10mm in 5 mins
  3. Tear break-up time ≤ 10 secs

Exclusion Criteria:

* Ocular disorder that may confound interpretation of study results.
* Wearing contact lenses 72 hrs prior to screening visit and unwilling to avoid wearing contact lenses for the duration of the study period.
* History of laser-assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to screening visit, and/or any other intraocular surgery within 90 days prior to screening visit.
* Female currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test.
* Participation in other studies within 30 days of screening visit.

Primary outcomes:
measure: Change from baseline of Fluorescein Corneal Staining(FCS) score
timeFrame: 4 weeks
Secondary outcomes:
measure: Change from baseline of Fluorescein Corneal Staining(FCS) score
timeFrame: 2 weeks
measure: Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score
timeFrame: 2, 4 weeks
measure: Change from baseline of Schirmer Test score
timeFrame: 2, 4 weeks
measure: Change from baseline of Tear Break-Up Time(TBUT)
timeFrame: 2, 4 weeks
measure: Change from baseline of Standard Patient Evaluation of Eye Dryness questionnaire(SPEED)
timeFrame: 4 weeks
measure: Numbers of used artificial tears during the study period
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Choun-Ki Joo, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01600911: Establish a Vegetable Signature Database From Human Metabolomics Responses
Official title: Establish a Vegetable Signature Database From Human Metabolomics Responses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Human Metabolomic Responses to Plant Foods
Blood Pressure
Keywords: metabolomics
nutri-metabolomics
plant food
blood pressure
Lead sponsor: National Health Research Institutes, Taiwan
Sponsor class: OTHER
Collaborators: name: Tri-Service General Hospital
First posted: 2012-05-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Vegetable is well known to prevent chronic disease,however, the mechanism of its nutrients and non-nutrients still remains to be discovered.We design a feeding study which provides plant foods to subjects one by another and monitoring metabolomic changes up to 7 hours.The goal of this study is to establish a protocol for documenting metabolomics response to plant foods and try to characterize plant foods in terms of their anti-hypertension potentials with metabolomic profiling information.


Eligibility criteria: Inclusion Criteria:

* Age :18-60 years
* Body Mass Index :18.5-30(kg/m2)
* Non-smoking,alcohol abusing,and other bad hobbies

Exclusion Criteria:

* With regular drug intake e.g. anti-hypertensive or antidiabetes drug or history of immune, hepatic and metabolic disease or other unsuitable disorders e.g. cancer.
* unwilling to stop regular food supplement e.g. vitamins, herb
* cannot cooperate with designed diet
* History of urinary tract infection or antibiotic use within the previous 3 month

Primary outcomes:
measure: blood pressure
timeFrame: one day
Secondary outcomes:
measure: metabolomic profile of serum and urine
timeFrame: one day
Other outcomes:
Locations:
city: Miaoli County
country: Taiwan
facility: National Health Research institues, Taiwan
Study officials:
affiliation: National Health Research Institutes, Taiwan
name: Wen-Harn Pan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02873611: Estimation of the Localization Accuracy of the Genicular Ablation Procedure Applied for Chronic Pain Suppression
Official title: Estimation of the Localization Accuracy of the Genicular Ablation Procedure Applied for Chronic Pain Suppression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: TPM Medical Systems Ltd.
Sponsor class: INDUSTRY
First posted: 2016-08-19
Enrollment: 30
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: BASIC_SCIENCE

Brief summary: Estimation of the localization accuracy of the genicular ablation procedure applied for chronic pain suppression


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years and older.
* Diagnosed with primary degenerative osteoarthritis.
* Complaining of knee pains
* Patients clinically eligible for genicular nerve ablation procedure non-electively based on physical examination
* Patient signed ICF

Exclusion Criteria:

* Co-morbidities: patient suffers from neuropathy, bony tumors, traumatic fractures and DM.
* Claustrophobic or failing cooperativity assessment of laying still during long MRI scans
* Pregnancy or pregnancy suspicion
* Enrolled in concurrent studies that may confound the results of this study
* Clinical condition that in the investigator's opinion would not allow the subject to complete the study, e.g., tremor, extreme obesity, mental disorders.

Primary outcomes:
measure: Location and orientation of the relevant genicular nerves based on eye-balling inspection of MRI images by a radiologist
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assuta MC
name: Yehuda Fridman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01326611: Efficacy of Clarithromycin Treatment in Prevention of Chronic Lung Disease in Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Lung Disease
Keywords: Chronic lung disease
Clarithromycin
Ureaplasma urealyticum
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2011-03-31
Enrollment: 273
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy of clarithromycin in eradication of ureaplasma urealyticum and prevention of chronic lung disease in premature infants with birthweight \< 1250 g and have ureaplasma urealyticum colonization.


Eligibility criteria: Inclusion Criteria:

* The babies under 1250 gram
* The babies must be appropriate for gestational age

Exclusion Criteria:

* Multiple congenital anomalies or known syndromes
* Intrauterine growth retardation with birthweight less than 10 percentile for gestational age

Primary outcomes:
measure: To evaluate the efficacy of clarithromycin in eradication of Ureaplasma urealyticum from premature nasopharynges
timeFrame: 12 days after treatment by clarithromycin
Secondary outcomes:
measure: To evaluate the efficacy of clarithromycin in prevention of Chronic lung disease in premature infants with birthweight <1250 g and have Ureaplasma urealyticum colonization.
timeFrame: From first day of inclusion of study to at postpartum 36th week of day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching Hospital Neonatology department
Study officials:
affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
name: Omer Erdeve, Ass Prof
role: STUDY_DIRECTOR
affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
name: Evrim Alyamac Dizdar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01359111: Performance and Safety Evaluation of an Intradermal Delivery Device
Official title: Phase I Performance and Safety Evaluation of an Intradermal Delivery Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Injections, Intradermal
Keywords: Intradermal injections
Vaccination
Lead sponsor: PATH
Sponsor class: OTHER
First posted: 2011-05-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate whether an investigational vaccine delivery device (the ID adapter) can safely and precisely inject liquid into the intradermal layer of the skin.


Eligibility criteria: Inclusion Criteria:

* Female and male participants ages 18 to 55 years.
* Healthy enough to participate in the clinical trial per site investigator assessment.
* Healthy skin on the upper deltoid region of both arms.
* Able to provide signed informed consent and understand study procedures per ICH/GCP guidelines.
* Literate in English.
* Available by telephone 48 hours after the study visit.

Exclusion Criteria:

* Skin abnormalities on upper deltoid region of either arm (scars, rash, infection) or other skin conditions that would interfere with the ability to visualize an intradermal injection in the opinion of the investigator.
* Unable to understand the study purpose or procedures.

Primary outcomes:
measure: Proportion of Injections Delivered to the Intradermal Layer of the Skin
timeFrame: 1 day
Secondary outcomes:
measure: Proportion of Participants With Safety Events
timeFrame: 2 days
measure: Proportion of Injections Administered With Needle Bevel up and Needle Bevel Down Delivered to the Intradermal Layer of the Skin.
timeFrame: 1 day
Other outcomes:
Locations:
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
Study officials:
affiliation: Rainier Clinical Research Center
name: Leslie Klaff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00170911: Efficacy and Safety of AAE581 in Postmenopausal Women With Osteopenia/Osteoporosis.
Official title: Efficacy and Safety of AAE581 in Postmenopausal Women With Osteopenia/Osteoporosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis
Keywords: Osteoporosis
Postmenopausal women
Cathepsin K inhibitor
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 160
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: AAE581 is a specific inhibitor of the cysteine protease cathepsin K. This trial is designed to provide detailed information about the effects( efficacy and safety) of AAE581 on Bone Mineral Density.


Eligibility criteria: Inclusion Criteria:

* Low spine Bone Mineral Density
* 0 to 1 prevalent fracture in non lumber spine

Exclusion Criteria:

* History or presence of any bone disease other than osteopenia /osteoporosis
* Previous treatment with other anti-osteoporosis agent(Wash out required)
* Evidence of vitamin D deficiency

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change of lumbar spine(L1-L4)BMD at 12 months
measure: Safety of 12 month treatment
Secondary outcomes:
measure: Change of BMD of lumbar spine(L1-L4,L2-L4)、total hip, femoral neck, forearm and total body at 3, 6, 9 and 12 months
measure: Change of Bone markers(Serum CTX,P1NP, OC, BSAP and urinary NTX, DPyr at 1,3,6,9 and 12 months
measure: Plasma concentration of AAE581 and AEE325 at 1,3,6,9 and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Sponsor GmbH
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT05217511: Effects of Neuromuscular Electrical Stimulation on Critically Ill Patients With Mechanical Ventilation
Official title: Effects of Neuromuscular Electrical Stimulation on Critically Ill Patients With Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Insufficiency Requiring Mechanical Ventilation
Keywords: Diaphragm ultrasound
Intercostal muscle ultrasound
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Up to 25% of patients who require mechanical ventilation (MV) more than seven days in the intensive care unit (ICU) develop muscle weakness, which comprises deep muscle weakness , including the respiratory muscles.Early active mobilization in ICU patients is a safe and viable strategy to prevent the physical problems caused by immobility. Neuromuscular electrical stimulation (NMES) is an alternative to mobilize and exercise because it does not require active patient participation and can be used on bedridden patients.No previous studies have shown whether training-specific respiratory muscles using an electrical stimulation can have overall benefits for ICU patients on MV.For this reason, the aim of this study was to evaluate, the effectiveness of the NMES therapy combined with early rehabilitation in the respiratory muscles of patients on MV.


Eligibility criteria: Inclusion Criteria:

* Prolonged MV(\>72 h);
* Written informed consent was obtained from the patients or their relatives

Exclusion Criteria:

* Previous neuromuscular disease;
* Unrelieved pneumothorax, restricted diaphragmatic dyskinesia including abdominal high pressure, a large number of ascites
* Thoracic or diaphragmatic malformation;
* Local skin damage and infection;
* Indwelling a temporary or permanent pacemaker;
* Severe obesity(BMI\>35 kg/m2)
* Various reasons (severe intestinal gas accumulation, structural abnormalities) lead to the failure of ultrasonic detection of diaphragm movement;
* Patients with an expected survival time of less than 7 days or with palliative care

Primary outcomes:
measure: diaphragmatic thickening fraction(DTF)
timeFrame: baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation
Secondary outcomes:
measure: Parasternal Intercostal Muscle Ultrasound
timeFrame: baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation
Other outcomes:
measure: ventilator-free days at 28 days
timeFrame: 28 days
Locations:
city: Qingdao
country: China
facility: Neuromuscular electrical stimulation
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: Jinyan Xing, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01812811: Twentyfour Ambulatory Pulse Wave Velocity and Central Augmentation Index in Type 2 Diabetes
Official title: Twentyfour Ambulatory Pulse Wave Velocity and Central Augmentation Index in Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: pulse wave analysis
pulse wave velocity
Arteriograph24
Ambulatory
diabetes
reproducibility
diurnal variation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Regionshospitalet Silkeborg
First posted: 2013-03-18
Enrollment: 22
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetes patients recruited from out patient clinic

Brief summary: The functionality and reproducibility of pulse wave analysis is investigated in 20 type 2 diabetic patients who had two 24 hour measurements performed within one week with the Arteriograph24 equipment.

Detailed description: Arteriograph24 is a new monitor for measuring ambulatory blood pressure and additional performing brachial cuff based on analysis of a suprasystolic pulse wave.

The study aim to test the feasibility of ambulatory pulse wave analysis every twenty minute (the fraction of missed measurements)and the reprodicility of pulse wave velocity and central augmentation index in type 2 diabetic patients. In addition we will explore the relation between diurnal variation of brachial blood pressure, central blood pressure and pulse wave velocity.

20 type 2 diabetic patients will have 24h ambulatory blood pressure performed twice with an interval of one week.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes

Exclusion Criteria:

* Atrial fibrillation

Primary outcomes:
measure: Fraction of missed pulse wave analysis
timeFrame: Meaured two times with an interval of one week
Secondary outcomes:
measure: Reproducibility of pulse wave analysis parameters
timeFrame: Measured two times with an interval of one week
Other outcomes:
measure: Diurnal variation of brachial blood pressure, central blood pressure and pulse wave velocity
timeFrame: Measured two times with an interval of one week
Locations:
city: Silkeborg
country: Denmark
facility: Medical department, Diagnostic Center, Regional Hospital Silkeborg
Study officials:
affiliation: Medical department, Diagnostic Center, Regional Hospital Silkeborg, Denmark
name: Klavs W Hansen, MD, dr.med.
role: PRINCIPAL_INVESTIGATOR
References: