louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00646542: Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency
Official title: A Multi-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Tolerability of 24 Weeks Treatment With (50 mg qd) Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes, vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-03-28
Enrollment: 525
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal insufficiency.


Eligibility criteria: Inclusion Criteria:

* History T2DM
* Moderate or Severe Renal Impairment

Exclusion Criteria:

* Glucose \> 270 mg/dL (\>15 mmol/L)

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 24 weeks of treatment
timeFrame: 24 weeks
Secondary outcomes:
measure: To assess concentration levels of vildagliptin and its metabolites in patients with T2DM and moderate or severe renal insufficiency.
timeFrame: 24 weeks
measure: To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Heidelberg Heights
country: Australia
city: Winnipeg
country: Canada
city: Cartago
country: Costa Rica
city: Tampere
country: Finland
city: Angers
country: France
city: Dormagen
country: Germany
city: Chennai
country: India
city: Oslo
country: Norway
city: Saint Petersburg
country: Russian Federation
city: Alicante
country: Spain
city: Lund
country: Sweden
Study officials:
References:
Clinical trial NCT05980442: Comparative Study of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty
Official title: Randomized, Controlled, Single Center Observational Study to Compare the Safety and Performance of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis, Knee
Joint Diseases
Rheumatoid Arthritis of Knee
Posttraumatic Arthropathy
Keywords: computer assisted orthopedic surgery
robotic assisted orthopedic surgery
orthopedic navigation
total knee arthroplasty
total knee replacement
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2023-08-08
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients between 18 and 90 years of age having indication for a fixed-bearing total knee endoprosthesis, without retropatellar arthrosis requiring patella resurfacing

Brief summary: Randomized, controlled, single center observational study to compare the safety and performance of navigation-assisted OrthoPilot Elite and robotic-assisted MAKO total knee arthroplasty (TKA). The aim of the study is the comparison of the clinical outcome between navigated and robotic-assisted TKA. The hypothesis of the study is that both treatments achieve similar results regarding functional and clinical aspects.


Eligibility criteria: Inclusion Criteria:

* Indication for a TKA with a fixed-bearing total knee endoprosthesis
* Written informed consent for participating in the clinical study

Exclusion Criteria:

* Patient age \<18 years and \>90 years
* Patient not willing to participate at the follow-up
* Pregnancy
* retropatellar arthrosis requiring patella resurfacing
* American Society of Anaesthesiologists (ASA) Classification \>3

Primary outcomes:
measure: Functional outcome of the Knee Surgery measured by the Knee Society Score (KSS) (functional component)
timeFrame: one year postoperatively
Secondary outcomes:
measure: Survival of the implant components
timeFrame: one year postoperatively
measure: Clinical outcome of the Knee Surgery measured by the Knee Society Score (KSS) (clinical component)
timeFrame: one year postoperatively
measure: Quality of Life [EQ-5D-5L]
timeFrame: one year postoperatively
measure: Anterior knee pain
timeFrame: one year postoperatively
measure: Comparison of Radiographic alignment
timeFrame: one year postoperatively
measure: Comparison of Radiographic status
timeFrame: one year postoperatively
measure: (Serious) Adverse Events
timeFrame: During the course of the study up to one year postoperatively
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Bundeswehr Krankenhaus Ulm
state: Baden-Württemberg
Study officials:
affiliation: Bundeswehr Krankenhaus Ulm
name: Hans-Joachim Riesner, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00061542: Safety and Efficacy Study of BETOPTIC S 0.25% and Timolol Gel-forming Solution 0.25% and 0.5% in Pediatric Patients With Glaucoma or Ocular Hypertension
Official title: Safety and Efficacy Study of BETOPTIC S 0.25% and Timolol Gel-forming Solution 0.25% and 0.5% in Pediatric Patients With Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Ocular Hypertension
Keywords: Glaucoma
Ocular Hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2003-05-30
Enrollment: 105
Sex: MALE
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
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 BETOPTIC S and Timolol Gel-forming solution in pediatric patients. Patients will dose with study drug at 8 am and 8 pm daily for twelve weeks. Patients will have vision tested, slit lamp exam, blood pressure and pulse checks at each visit. Patients will have a dilated fundus exam and corneal measurements taken at first and last visit.


Eligibility criteria: INCLUSION:

* Children 5 years old and younger
* require treatment for glaucoma or ocular hypertension
* whose vision is 20/80 or better
* have a cup-to-disc ratio of 0.8 or less

EXCLUSION:

* do not have abnormal fixation
* IOP greater than 36 mm Hg
* significant retinal disease
* penetrating keratoplasty
* severe ocular pathology
* optic atrophy
* eye surgery in the past 30 days
* cardiovascular abnormalities
* hypersensitivity to beta blockers

Primary outcomes:
measure: Mean change from baseline in IOP
timeFrame: Up to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center
state: Texas
Study officials:
References:
citation: Plager DA, Whitson JT, Netland PA, Vijaya L, Sathyan P, Sood D, Krishnadas SR, Robin AL, Gross RD, Scheib SA, Scott H, Dickerson JE; BETOPTIC S Pediatric Study Group. Betaxolol hydrochloride ophthalmic suspension 0.25% and timolol gel-forming solution 0.25% and 0.5% in pediatric glaucoma: a randomized clinical trial. J AAPOS. 2009 Aug;13(4):384-90. doi: 10.1016/j.jaapos.2009.04.017.
Clinical trial NCT02254642: Effects of Ischemic Preconditioning After Aortic Clamping
Official title: Protective Effects of Ischemic Preconditioning on Cardiac, Renal, Pulmonary and Muscular Functions After Aortic Clamping
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vascular Surgery
Ischemia-reperfusion
Ischemia Preconditioning
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2014-10-02
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Open surgery for aneurysmal aortic disease can lead to cardiac, renal, pulmonary or muscular complications, essentially due to the aortic clamping. Ischemic preconditioning can be useful in order to decrease these complications. The investigators would like to use an ischemic preconditioning protocol during open surgery of aortic aneurysm in order to decrease these complications.


Eligibility criteria: Inclusion criteria:

* Patients with an aortic aneurysm requiring open surgery (with no possibility of endovascular surgery)
* Patients who received clear information, with signed consent
* Patients 18 to 85 years

Exclusion criteria:

* Patients under guardianship
* No possibility to give the patients clear information (comprehension difficulties, emergency surgery)
* Pregnancy, lactation
* Hemodialysis

Primary outcomes:
measure: Myocardial damage measured by troponin level > 0.4 microgr/L (day 1)
timeFrame: Day 1
Secondary outcomes:
measure: Renal damage
timeFrame: Day 0, day 1, day 3 or day 5.
measure: Muscle weakness
timeFrame: Day 0, day 1, day 3 or day 5
measure: Myocardial damage measured by troponin level > 0.4 microgr/L
timeFrame: Day 0, 3, or 5
Other outcomes:
Locations:
city: Besancon
country: France
facility: Service de Chirurgie Vasculaire, CH Jean Minjoz
city: Dijon
country: France
facility: Service de Chirurgie Vasculaire, CHU le Bocage
city: Strasbourg
country: France
facility: Service de Chirurgie vasculaire et transplantation rénale, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
city: Vantoux
country: France
facility: Service de Chirurgie Vasculaire, Hôpitaux Privés de Metz, Site de Mercy
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Anne Lejay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01423942: Maturation of the Autonomic Nervous System in Prematures
Official title: Maturation of the Autonomic Nervous System in Prematures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Analysis, Event History
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2011-08-26
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prematures

Brief summary: The purpose of this study is to try to evaluate the maturation of the autonomic nervous system in prematures.

Detailed description: To evaluate the maturation of the autonomic nervous system in prematures by using heart rate variability analyses.

Eligibility criteria: Inclusion Criteria:

* All prematures

Primary outcomes:
measure: Herat rate variability (HRV) characteristics
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: RMC
Study officials:
affiliation: RMC
name: Amir Weissman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04580342: Ivabradine Versus Propranolol for Induced Hypotension in Endoscopic Sinus Surgery
Official title: Comparative Study Between Oral Ivabradine Versus Oral Propranolol for Induced Hypotension in Functional Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hypotension
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: the study is designed to compare the effect of addition of oral Ivabradine, propranolol to general anesthesia aimed reduction in blood loss during functional endoscopic sinus surgery.


Eligibility criteria: Inclusion Criteria:

* Age of 18 - 60 years.
* Patients of both genders.
* ASA grade I - II .

Exclusion Criteria:

* Patient refusal.
* Any contraindication to medication included in the study .
* Patients with allergy to medication included in the study.

Primary outcomes:
measure: change in blood loss
timeFrame: immediately after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Talaat Ahmed
Study officials:
affiliation: Assiut University
name: Ahmed T Ahmed, A professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01891942: Influence of Trigger Threshold on Controlled Twitch Mouth Pressure
Official title: Influence of Trigger Threshold on Controlled Twitch Mouth Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Healthy
Keywords: Normal
subjects
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2013-07-03
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

Brief summary: The inspiratory pressure trigger is essential when assessing the twitch mouth pressure (Tw Pmo) for avoiding glottic closure. However, the difference in inspiratory pressure trigger threshold may influence the values of Tw Pmo. We sought to determine the trigger threshold for healthy subjects and COPD patients.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of COPD
2. Stable with no episodes of exacerbation within the previous 2 months
3. Do not currently being treated with oral corticosteroids

Exclusion Criteria:

1. Not stable within the previous 2 months.
2. Patients with COPD were currently being treated with oral corticosteroids

Primary outcomes:
measure: Twitch mouth pressure
timeFrame: 2 weeks
Secondary outcomes:
measure: Twitch oesophageal pressure
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Institute Respiratory Disease
state: Guangdong
Study officials:
affiliation: Guangzhou Instiute of Respiratory Disease
name: Rong-chang Chen, Master
role: STUDY_CHAIR
affiliation: Guangzhou Institue of Respiratory Disease
name: Dong-ming Hua, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangzhou Institue of Respiratory Disease
name: Nan-shan Zhong, Bachelor
role: STUDY_CHAIR
References:
citation: Walker DJ, Ertl T, Walterspacher S, Schlager D, Roecker K, Windisch W, Kabitz HJ. Respiratory muscle function during a six-week period of normocapnic hyperpnoea training. Respir Physiol Neurobiol. 2013 Aug 15;188(2):208-13. doi: 10.1016/j.resp.2013.05.005. Epub 2013 May 17.
citation: Hua DM, Liang YH, Xie YK, Liu Q, Zheng ZG, Chen RC, Zhong NS. Use of twitch mouth pressure to assess diaphragm strength in patients with chronic obstructive pulmonary disease. Respir Physiol Neurobiol. 2013 Jul 1;187(3):211-6. doi: 10.1016/j.resp.2013.04.012. Epub 2013 Apr 15.
Clinical trial NCT05877742: AA on Drug Abusers by Nursing Students
Official title: Around the Turn: A Feasibility Cluster Randomized Controlled Trial of Using Auricular Acupressure to Abstain From Drug Abuse Through Training Nursing Students
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Drug Abuse
Keywords: Auricular Acupressure
Nursing Students
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 80
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: Drug abuse is a serious public health issue. Despite the serious consequences of drug abuse, there are around 2000 new cases reported by drug abusers each year. There is growing evidence of the use of auricular acupressure (AA), a traditional Chinese medicine (TCM) treatment modality, in reducing withdrawal symptoms among drug abusers. This study aims to investigate the feasibility and effectiveness of training nursing students to deliver brief education on AA on drug abusers.

Detailed description: A 2-arm feasibility cluster RCT will be conducted in the 80 drug abusers from 7 substance abuse clinics in Hong Kong Hospital Authority following the CONSORT statement. The intervention group will receive AA intervention individually from trained nursing students. The control group will individually receive a 5-minute seminar delivered by a research assistant.

Eligibility criteria: Inclusion Criteria:

* Aged 18 or above
* Have reported to abuse drugs within the past 30 days
* Can communicate in Cantonese and read Chinese

Exclusion Criteria:

* Unstable mental conditions that are not suitable for the intervention
* Receiving acupuncture or acupressure treatment currently or in the previous 30 days

Primary outcomes:
measure: Screening rate
timeFrame: at the 6-month follow-up
measure: Eligibility rate
timeFrame: at the 6-month follow-up
measure: Consent rate
timeFrame: at the 6-month follow-up
measure: Randomization rate
timeFrame: at the 6-month follow-up
measure: Attendance rate
timeFrame: at the 6-month follow-up
measure: Retention rate
timeFrame: at the 6-month follow-up
measure: Adherence to intervention protocol
timeFrame: at the 6-month follow-up
measure: Complete rate
timeFrame: at the 6-month follow-up
measure: Missing data
timeFrame: at the 6-month follow-up
measure: Adverse events
timeFrame: at the 6-month follow-up
Secondary outcomes:
measure: Self-reported abstinence
timeFrame: at the 6-month follow-up
measure: Abstinence with urine testing
timeFrame: at the 6-month follow-up
measure: Self-reported levels of craving
timeFrame: at the 6-month follow-up
measure: Anxiety
timeFrame: at the 6-month follow-up
measure: Quality of life measures by short-Form Six-Dimension
timeFrame: at the 6-month follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Katherine Lam
Study officials:
affiliation: School of Nursing, Hong Kong Polytechnic University
name: Ka Wai Katherine Lam
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00975442: Effects of Eccentric Training for Patients With Lateral Epicondylalgia
Official title: Effects of Eccentric Training for Patients With Lateral Epicondylalgia - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tennis Elbow
Epicondylitis, Lateral Humeral
Keywords: Elbow
Tendinitis
Sports Medicine
Athletic injuries
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Rehband Sweden
First posted: 2009-09-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate eccentric training as an intervention for lateral epicondylalgia (tennis elbow) in a clinical setting.


Eligibility criteria: Inclusion Criteria:

* Positive diagnostic criteria according to Haker (1991): A history of pain around the lateral epicondyle for at least one month.
* Pain at palpation of the lateral epicondyle of humerus and positive results in two of the following three pain provocation tests: Middle finger test, resisted extension of the wrist, and Vigorimeter test. Each of these tests is described in detail by Haker (1991)

Exclusion Criteria:

* Subjects with rheumatoid arthritis
* Fibromyalgia
* Previous surgery in the elbow region
* Neck dysfunction suggesting possible cervical rhizopathy
* Entrapment of n.radialis
* Patients with ongoing treatment, or previous treatment less than three months before enrolled to the study.

Primary outcomes:
measure: Diagnostic criteria, whether or not the patient had recovered according to the diagnostic criteria for LE, Haker (1991) at follow up examinations
timeFrame: 3 wk and 6 wk follow up
Secondary outcomes:
measure: Measurements of pain free functional grip strength using the Martin Vigorimeter test, and maximum pain free isometric extensor strength by using Nicholas Myometer
timeFrame: 3 wk and 6 wk follow-up
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Huddinge, Sweden
name: Johan Söderberg, P.T.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05421442: A Post-marketing Study on the Safety of Abatacept Treatment in Denmark Using the Danish Database
Official title: A Nationwide Post-marketing Study on the Safety of Abatacept Treatment in Denmark Using the DANBIO Register
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rheumatoid Arthritis (RA)
Psoriatic Arthritis (PsA)
Keywords: Abatacept
Orencia
Malignancies
Long-term safety follow-up
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-06-16
Enrollment: 1450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with RA or PsA who are enrolled in the Danish Database for Biologic Therapies (DANBIO) register in Denmark and were receiving abatacept, non-targeted DMARDs, or targeted DMARDs between January 2007 and December 2021.

Brief summary: The purpose of this study is to expand on the ongoing post-marketing monitoring of abatacept to include all participants with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) treated with abatacept captured in Danish Database for Biologic Therapies (DANBIO).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of rheumatoid arthritis (RA) or psoriatic arthritis (PsA)
* Receiving treatment with abatacept
* Receiving treatment with non-targeted DMARD
* Receiving treatment with targeted DMARD

Exclusion Criteria:

-Not applicable

Primary outcomes:
measure: Incidence Rates of Overall Malignancies
timeFrame: Up to 5 years
measure: Incidence Rates of Melanoma
timeFrame: Up to 5 years
measure: Incidence Rates of Non-melanoma Skin Cancer
timeFrame: Up to 5 years
measure: Incidence Rates of Basal Cell Carcinoma
timeFrame: Up to 5 years
measure: Incidence Rates of Squamous Cell Carcinoma
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Local Institution
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: