louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00517491: Study to Evaluate Patients With Acromegaly Treated With Lanreotide Autogel (Somatuline ATG)
Official title: A Pilot Study to Evaluate the Correlation Between Plasma Lanreotide Levels and GH/IGF-1 Dynamics and Clinical Improvement in Patients With Acromegaly Treated With Lanreotide Autogel (Somatuline ATG)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Acromegaly
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2007-08-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the protocol is to evaluate the correlation between plasma lanreotide levels and Growth Hormone (GH)/Insulin Like Growth Factor 1 (IGF-1) dynamics and clinical improvement in patients with acromegaly treated with lanreotide Autogel (Somatuline ATG)


Eligibility criteria: Inclusion Criteria:

* Patient on treatment with octreotide LAR 20 mg administered every 28 days for at least 3 months prior to visit 1.
* Patient must have serum GH level ≤ 2.5 ng/mL and serum IGF-1 ≤ 1.3 ULN, 28 days after their last injection of octreotide LAR 20 mg at visit 1.
* Patients must have serum GH level \> 2.5 ng/mL AND serum IGF-1 level \> 1.3 ULN, 6 or 8 weeks after their last injection of octreotide LAR 20 mg.

Exclusion Criteria:

* The patient has received pituitary radiation therapy of any kind at any time prior to visit 1.
* The patient has received pituitary surgery within 3 months prior to visit 1.
* The patient's serum creatinine is higher than 150 µmol/l.

Primary outcomes:
measure: GH (basal and during Oral Glucose Tolerance Test (OGTT)) and IGF-1 levels, in acromegalic patients previously treated with octreotide long acting release (LAR) 20 mg.
timeFrame: Weeks 16, 18 & 20
measure: Acromegaly symptoms.
timeFrame: Weeks 16, 18 & 20
measure: Indices of insulin secretion & sensitivity
timeFrame: Weeks 16, 18 & 20
measure: Adverse events
timeFrame: Throughout study
Secondary outcomes:
measure: Number of patients with GH levels ≤ 2.5 ng/mL and the number of patients with IGF-1 level < upper limit of normal (ULN).
timeFrame: Weeks 16, 18 & 20.
measure: Serum lanreotide Autogel 120 mg concentrations.
timeFrame: Weeks 16, 18 & 20.
measure: ECG and gallbladder ultrasound
timeFrame: Week 20
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Centro Médico Nacional Siglo XXI, IMSS
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02904291: Bariatric Surgery and Pharmacokinetics of Amlodipine
Official title: Bariatric Surgery and Pharmacokinetics Amlodipine: BAR-MEDS Amlodipine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Gastrointestinal tract
Biological availability
Pharmacokinetics
Amlodipine
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Volvat Medisinsk Senter Stokkan
name: Namsos Hospital
name: Alesund Hospital
First posted: 2016-09-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

Brief summary: Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study we investigate the pharmacokinetic effects of bariatric surgery on amlodipine.


Eligibility criteria: Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract

Primary outcomes:
measure: Amlodipine concentration in blood serum (area under curve (AUC))
timeFrame: From baseline to 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: St. Olavs University Hospital
name: Magnus Strømmen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03595891: The Study of How Long Participants Stay in the Hospital After Receiving Apixaban for a Blood Clot in the Lung
Official title: Apixaban Length-Of-Stay Pulmonary Embolism Study - Hospital Admissions (ALPHA-PE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism (PE)
Pulmonary Thromboembolism
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-07-23
Enrollment: 660
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 patients (≥ 18 years of age) at index date presenting with acute Pulmonary Embolism (PE), which was then objectively confirmed, and received anticoagulation upon diagnosis of PE and in receipt of anticoagulation at discharge.

Brief summary: A study based on a chart review of participants that presented with a sudden blood clot in the lung


Eligibility criteria: Inclusion Criteria:

* Adults participants at date of admission
* Primary presentation consistent with PE followed by objectively-confirmed acute PE
* Received anti-coagulation upon diagnosis of PE during study period and in receipt of anti-coagulation at discharge

Exclusion Criteria:

* PE diagnosed during a hospital admission for a reason other than PE during the study period
* Patients receiving anticoagulation at the time of presentation
* Patients presenting outside the defined study period

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Compare the average length of stay in secondary care
timeFrame: 60 days
Secondary outcomes:
measure: Total length of stay, including repeat admissions
timeFrame: During the first 30 days after presentation of PE
measure: Distribution of clinical characteristics of patients admitted with a PE
timeFrame: Baseline
measure: Distribution of demographic data of patients admitted with a PE
timeFrame: Baseline
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01827891: Remote Ischemic Preconditioning and Risk of Contrast-Induced Acute Kidney Injury in Patients Undergoing Coronary Stent Implantation
Official title: Remote Ischemic Preconditioning and Risk of Contrast-Induced Acute Kidney Injury in Patients Undergoing Coronary Stent Implantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Kidney Injury
Keywords: acute kidney injury
percutaneous coronary intervention
remote ischemic preconditioning
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2013-04-10
Enrollment: 310
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: PREVENTION

Brief summary: This single-center, randomized controlled trial is to investigate the impact of remote ischemic preconditioning (RIPC) on the risk contrast-induced acute kidney injury and its long-term impact on renal function for patients with diabetes undergoing percutaneous coronary intervention.

Detailed description: Patients with diabetes undergoing elective percutaneous coronary intervention in Beijing Anzhen Hospital were enrolled, and all the eligible participants were randomized to either remote ischemic preconditioning (RIPC) group or control group. Those randomized to RIPC group had a pneumatic medical tourniquet cuff (width , 5 cm ; length , 40 cm) placed around their upper arm at \< 2 hours before the PCI procedure. The pneumatic medical cuff was inflated to a pressure of 200 mm Hg for 5 minutes , followed by 5 minutes of deflation to allow reperfusion. This procedure was repeated for 3 times. Control participants did not experience this procedure of transient upper-limb ischemia.

Eligibility criteria: Inclusion Criteria:

* Patients with diabetes undergoing percutaneous coronary intervention were included.

Exclusion Criteria:

1. emergency PCI,
2. baseline troponin value \> 0.04 ng/mL,
3. nicorandil or glibenclamide use (preconditioning-mimetic and preconditioning-blocking medication, respectively),
4. patient on dialysis,
5. patients who had some inability to cooperate with the trial,
6. those who could not give informed consent, and (7) second procedure of staged elective PCI in this hospitalization.

Primary outcomes:
measure: acute kidney injury
timeFrame: 72 hours after procedure
Secondary outcomes:
measure: relative reduction in estimated glomerular filtration rate
timeFrame: 180 days after procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
Study officials:
References:
Clinical trial NCT05931094: Augmented Reality Game-based Training on Social Communication of Children With Autism Spectrum Disorder
Official title: Effects of Augmented Reality Game-based Training on Social Communication of Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism
Augmented Reality
Social communication
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 18
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to determine the effects augmented reality game-based training on social communication of children with autism spectrum disorder.

Detailed description: Augmented Reality allows children to see a representation of imaginary content and pretend play overlaid on the real-world environment. Today, technology can be a safe and motivating way of engaging children with autism in social interaction activities. Current research in therapeutic technology for autism is aimed toward improving behavior and psychomotor activities that impact social communication. The aim of this research project is to help teachers, parents, practitioners, and researchers to understand the unique strengths of their children with autism along with technology based educational and therapeutic activities for home and classroom.

Eligibility criteria: Inclusion Criteria:

* Participants diagnosed with autism spectrum disorder in the age range of 5-12 years at verbal imitation and 1-step command following.

Exclusion Criteria:

* Sensory issues and patients on medication.

Primary outcomes:
measure: Social Responsiveness Scale
timeFrame: After 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Child Development Center
state: AL
Study officials:
affiliation: Riphah International University
name: Suman Sheraz, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berenguer C, Baixauli I, Gomez S, Andres MEP, De Stasio S. Exploring the Impact of Augmented Reality in Children and Adolescents with Autism Spectrum Disorder: A Systematic Review. Int J Environ Res Public Health. 2020 Aug 24;17(17):6143. doi: 10.3390/ijerph17176143.
citation: Liu R, Salisbury JP, Vahabzadeh A, Sahin NT. Feasibility of an Autism-Focused Augmented Reality Smartglasses System for Social Communication and Behavioral Coaching. Front Pediatr. 2017 Jun 26;5:145. doi: 10.3389/fped.2017.00145. eCollection 2017.
Clinical trial NCT02974894: The Effects of Lactobacillus Plantarum on Cortisol, IgA and Alpha-amylase Levels in Human Saliva During Stress
Official title: The Effects of Lactobacillus Plantarum on Cortisol, IgA and Alpha-amylase Levels in Human Saliva During Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Reaction
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In the present study the main goal has been to clarify the effect of the probiotic bacteria Lactobacillus plantarum 299v on the salivary cortisol level in young adults under examination stress. Salivary IgA from minor glands and in whole human saliva was measured as alternative marker of stress. The hypothesis was that the levels of cortisol would be reduced or stabilized in the test group in comparison to the placebo group where the cortisol levels were expected to increase due to the examination-induced stress. By contrast, the salivary IgA levels were expected to increase in the test group in comparison to the placebo group.


Eligibility criteria: Inclusion Criteria:

* adults
* studying at the University in Lund
* participation in ongoing examination period

Exclusion Criteria:

* pregnancy
* intake of antibiotics
* medication with cortisone during the study period

Primary outcomes:
measure: The impact of Lactobacillus plantarum on the levels of stress-induced cortisol in saliva.
timeFrame: Change from baseline in cortisol levels at 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Andersson H, Tullberg C, Ahrne S, Hamberg K, Lazou Ahren I, Molin G, Sonesson M, Hakansson A. Oral Administration of Lactobacillus plantarum 299v Reduces Cortisol Levels in Human Saliva during Examination Induced Stress: A Randomized, Double-Blind Controlled Trial. Int J Microbiol. 2016;2016:8469018. doi: 10.1155/2016/8469018. Epub 2016 Dec 22.
Clinical trial NCT00755794: The Singulair® add-on Study Effectiveness of Adding Montelukast to Inhaled Corticosteroids in Adult Subjects With Uncontrolled Asthma (0476-384)
Official title: An 8 Week Multicenter, Open-label, Observational Study to Evaluate the Effectiveness of Adding Montelukast Sodium 10 mg Per Day to Inhaled Corticosteroids in Adult Subjects With Uncontrolled Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-09-19
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of adding Montelukast Sodium (singulair®) 10 mg per day to inhaled corticosteroids in adult subjects with uncontrolled asthma.


Eligibility criteria: Inclusion Criteria:

* Patients Is 18 Years Old

Note 1: Regulatory Requirements Necessitate The Following Criterion. It May Not Be Appropriate For Your Patients. Female Patients Of Childbearing Potential Should Be Informed Not To Become Pregnant During The Study By Using The Appropriate Contraceptive Methods (Oral Or Long-Acting Contraceptive Injections (Depo Provera), Intrauterine Device (Iud), Or Barrier Methods (E.G. Condom Or Diaphragm Plus Spermicide) Or To Be Abstinent (No Sexual Intercourse)) Beginning At Least 7 Days Before Visit 1 And Continuing At Least 14 Days After Visit 4 Or A Discontinuation Visit

Note 2: For Alberta: Investigators Who Will Recruit In Private Office, No Patients Can Be Recruited In The Study Until Approval From The College Of Physicians And Surgeons Of Alberta Ethics Committee Is Obtained

Exclusion Criteria:

* Patient Is Well Controlled, Adherent And Satisfied With Current Controller Therapy

Primary outcomes:
measure: To describe the percentage of patients with asthma who will be controlled after 8 weeks of treatment with montelukast used in combination with inhaled corticosteroids
timeFrame: 8 weeks
Secondary outcomes:
measure: To evaluate the safety and tolerability of montelukast
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: FitzGerald JM, Foucart S, Coyle S, Sampalis J, Haine D, Psaradellis E, McIvor RA. Montelukast as add-on therapy to inhaled corticosteroids in the management of asthma (the SAS trial). Can Respir J. 2009 May-Jun;16 Suppl A(Suppl A):5A-14A. doi: 10.1155/2009/593753.
Clinical trial NCT01574794: Exercise Intervention and Running Biomechanics in Older Adults
Official title: Changes in Running Gait Biomechanics Following an Intervention Program in Older Runners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Physical Activity
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Running Injury Clinic
name: Alberta Heritage Foundation for Medical Research
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2012-04-10
Enrollment: 105
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this study is to understand the effects of muscle strengthening and stretching exercise intervention on isometric muscle strength, joint flexibility and running biomechanical patterns in older recreational runners. To do so, the subjects will be assessed before and after they engage in a 8-week exercise intervention program.


Eligibility criteria: Inclusion Criteria:

* no injuries of the lower extremity within 3 months prior to participation
* running recreationally 2-3 times/week
* familiar and comfortable with treadmill running
* in good health upon entry into the study
* no use of orthotics in the shoe

Exclusion Criteria:

* lower extremity injury within the last 3 months
* surgery to the lower extremity within the last 8 months
* head injury/vestibular disorder within the last 6 months
* inability to speak or read English.

Primary outcomes:
measure: Changes from baseline of biomechanical movement patterns
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes in isometric muscle strength and joint flexibility
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Running Injury Clinic
state: Alberta
Study officials:
affiliation: Running Injury Clinic, Faculty of Kinesiology, University of Calgary
name: Reed Ferber, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03141294: Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy
Official title: Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Respiratory Depression
Keywords: tracheostomy，fascia，force gauge
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 46
Sex: ALL
Minimum age (years): 44
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Percutaneous dilatational tracheostomy (PDT), especially single-step dilatational tracheostomy (sd-PDT), is now frequently preferred to surgical tracheostomy. Occasionally, it needs a second dilation maneuver .Dissection of the deep cervical fascia during PDT, known as reformative PDT (re-PDT), may facilitate the procedure. This study was designed to compare re-PDT with sd-PDT in ICU patients

Detailed description: Percutaneous dilatational tracheostomy (PDT) is a popular airway management technique in the intensive care unit (ICU).Occasionally the first dilation may be challenging when using Ciaglia and colleagues' method, and a second dilation may be needed to insert the tracheostomy tube. In these circumstances, potentially life-threatening complications, such as hemorrhage and hypoxia, may arise. The investigators found the reasons for difficulty in achieving smooth dilation of the stoma.The investigators compared the traditional method with the improved method.

Eligibility criteria: Inclusion Criteria:

* age ≥18 years;
* requirement for long-term mechanical ventilation;
* failure of weaning from mechanical ventilation.

Exclusion Criteria:

* age \<18 years;
* pre-existing infection at the tracheostomy site;
* pre-existing malignancy at the tracheostomy site;
* difficulty in identifying the anatomic landmarks;
* unstable cervical spine fracture;
* international normalized ratio (INR) \>2;
* platelet count \<50 000 mm3.

Primary outcomes:
measure: Force(newton)
timeFrame: Intraoperative (Force was measured the exact moment when investigators insert the'J' guidewire)
Secondary outcomes:
measure: Time(seconds)
timeFrame: Time was measured from tracheal puncture to tracheal tube placement, 180 seconds maxime
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affliated Hospital wiht Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The first Affliated Hospital with Nanjing Medical University
name: Jinhai Li
role: STUDY_CHAIR
References:
citation: Natale G, Condino S, Stecco A, Soldani P, Belmonte MM, Gesi M. Is the cervical fascia an anatomical proteus? Surg Radiol Anat. 2015 Nov;37(9):1119-27. doi: 10.1007/s00276-015-1480-1. Epub 2015 May 7.
Clinical trial NCT00846794: AcuGraph and Digestive Symptoms
Official title: Can AcuGraph Differentiate Between Participants With and Without Digestive Symptoms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Digestive Disorders
Irritable Bowel Syndrome
Constipation
Diarrhea
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2009-02-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Logan students currently enrolled

Brief summary: This research is designed to study the reliability of the results of an AcuGraph in college students and faculty members with reported digestive symptoms

Detailed description: The specific aim of the study is to test the reliability of the AcuGraph in subjects with irritable bowel syndrome (IBS). The hypothesis is that the AcuGraph will be a reliable method to identify disorders in subjects.

Eligibility criteria: Inclusion Criteria:

* Subjects will be required to answer a questionnaire evaluating for a percentage of digestive disorders "disability" based on the subject's answers. If a participant's answers do not qualify as a disability, they will be assigned to the asymptomatic group and will still be examined with an AcuGraph to provide normative data.

Exclusion Criteria:

* heart condition
* kidney disorder
* thyroid disorders
* diabetes
* chronic disease or illness
* neurological diseases
* skin or bleeding disorders
* pregnant
* currently taking drugs or nutritional supplements
* pacemaker and/or

Primary outcomes:
measure: AcuGraph: computerized device to analyze & document the energetic status of the acupuncture meridians
timeFrame: At examination
Secondary outcomes:
measure: IBS Questionnaire
timeFrame: At examination
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan University, College of Chiropractic
state: Missouri
Study officials:
References: