louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01034618: Protein Hydrolyzation and Glycemic Control
Official title: The Additional Effects of Protein Hydrolysate Supplementation on Glucose Homeostasis in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
protein
protein hydrolysate
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2009-12-17
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The insulinotropic effects of protein hydrolysate/amino acid ingestion have been shown to regulate blood glucose homeostasis in both type 2 diabetes patients and normoglycemic controls. The objective of the study is to investigate the optimal dose of such an insulinotropic mixture.


Eligibility criteria: Inclusion Criteria:

* Male
* Age between 40 and 70 years
* Oral blood glucose lowering medication
* BMI \< 35 kg/m2

Exclusion Criteria:

* Exogenous insulin use
* Cardiac disease (any cardiac event in the last 5 years)
* Diabetic complications (microvascular complications, microalbuminuria: albumin:creatinine ratio \>2,5)

Primary outcomes:
measure: Glucose and insulin homeostasis.
Secondary outcomes:
measure: Plasma amino acid profiles
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center+
state: Limburg
Study officials:
References:
Clinical trial NCT01071018: A Study of MK2206 in Locally Advanced or Metastatic Solid Tumors (2206-007)
Official title: A Phase I Study of MK2206 in Patients With Locally Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: locally advanced or metastatic solid tumors
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-02-18
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MK2206 when administered with Every Other Day (QOD) and Once Weekly (QW) dosing schedules.


Eligibility criteria: Inclusion Criteria:

* Patient must have confirmed locally advanced or metastatic solid tumors that have failed to respond to standard therapy, have gotten worse or have come back after existing therapy
* Has adequate organ function
* Is ECOG Performance Scale 0-1
* Has a negative urine pregnancy test if patient is female
* Is able to swallow capsules and has no surgical or bodily condition that will prevent the patient from swallowing and absorbing oral medications on an ongoing basis

Exclusion Criteria:

* Patient has had chemotherapy, radiotherapy, biological therapy or surgery within 4 weeks of starting the study and has not recovered from adverse events caused by the treatment
* Is currently participating or has participated in a study with an investigational compound or device within 28 days
* Has a primary central nervous system tumor
* Has a history or current evidence of heart disease, slow heart rate or untreated high blood pressure
* Is a known diabetic who is taking insulin or oral antidiabetic therapy
* Is pregnant or breastfeeding or planning to become pregnant during the study
* Is positive HIV antibody, HBs antigen or HCV antibody

Primary outcomes:
measure: Characterize safety and tolerability of MK2206 by monitoring incidence of protocol-defined dose limiting toxicities (DLTs)
timeFrame: Day 1 - Day 28 (Cycle 1)
Secondary outcomes:
measure: Assess pharmacokinetic (PK) profile of MK2206 by determining parameters: AUC, Cmax, and Tmax
timeFrame: Day 1 - Day 28 (Cycle 1)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Doi T, Tamura K, Tanabe Y, Yonemori K, Yoshino T, Fuse N, Kodaira M, Bando H, Noguchi K, Shimamoto T, Ohtsu A. Phase 1 pharmacokinetic study of the oral pan-AKT inhibitor MK-2206 in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Aug;76(2):409-16. doi: 10.1007/s00280-015-2810-z. Epub 2015 Jun 24.
Clinical trial NCT03200418: Evaluation of the Effect of Output on Newly Developed Adhesives
Official title: Evaluation of the Effect of Output on Newly Developed Adhesives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2017-06-27
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study investigates the impact real output has on the adhesion of the adhesives.


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had a stoma for more than one year
4. Have intact skin on the area used in the evaluation
5. Has a stoma with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tab-let/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
5. Actively participating in other interventional clinical investigations or have previously participated in this investigation.

Primary outcomes:
measure: Trans epidermal water loss
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebaek
country: Denmark
facility: Coloplast A/S
Study officials:
References:
Clinical trial NCT04538118: Relationship of Patient-Specific Functional Scale With Shoulder Functions: A Prospective Study
Official title: Relationship of Patient-Specific Functional Scale With Shoulder Functions in Physiotherapy and Rehabilitation Program Applied to Patients With Shoulder Problems
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Impingement
Frozen Shoulder
Humeral Fractures
Rotator Cuff Tears
Disability Physical
Pain, Shoulder
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with shoulder problems

Brief summary: The aim of the study is to examine the relationship between the Patient- Specific Functional Scale (PSFS) and shoulder functions in the physiotherapy and rehabilitation program applied to patients with shoulder problems.


Eligibility criteria: Inclusion Criteria:

* having a shoulder pathology
* being volunteer
* having shoulder pain at least 3 months
* being literate

Exclusion Criteria:

* having more than one upper extremity pathology
* having an upper extremity pathology involving the neck and trunk
* having a neurological finding

Primary outcomes:
measure: Disability
timeFrame: 6 weeks
measure: Activity Limitation
timeFrame: 6 weeks
measure: Functional Disorder
timeFrame: 6 weeks
Secondary outcomes:
measure: Pain Intensity
timeFrame: 6 weeks
measure: Range of Motion
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Hidayet Cuha, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT00313118: Mean Values of Oxidative Stress Parameters in Healthy Subjects
Official title: Determination of the Mean Values of Oxidative Stress Parameters in the Plasma of Healthy Subjects
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Healthy
Keywords: oxidative stress parameters
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Laboratory Dr. Bayer GmbH, Stuttgart, Germany
First posted: 2006-04-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy persons

Brief summary: Determination of the mean value of oxidative stress parameters in normals and of the plasma and serum levels, resp. of malondialdehyde, glutathion and superoxide dismutase in healthy subjects.

Detailed description: In certain situations, free radicals can be generated in an exaggerated manner and can injure tissues and organs by interacting with lipids, proteins, or DNA. So, oxidative stress has been implicated in a large number of human diseases. To survive, the human body has developed a complex, efficient, and highly adaptive antioxidant defense system. The eye is also protected against oxidative stress by several mechanisms involving antioxidant enzymes such as catalase (CAT) and superoxide dismutase (SOD), as well as by low-molecular-weight antioxidants such as glutathion (GSH) and ascorbate.

Primary open-angle glaucoma (POAG) is a chronic, slowly progressive optic neuropathy, characterized by excavation of the optic nerve head (ONH) and a distinctive pattern of visual field (VF) defects. The disease is multifactorial in origin, so that besides more extensively investigated factors oxidative stress has also been proposed as a contributing factor in the etiology of glaucomatous optic neuropathy. Oxidative stress represents a harmful state defined by the presence of pathologic levels of reactive oxygen species (ROS) relative to antioxidant defense.

Therefore, it would be also important to determine whether there is a relationship between circulating levels of the defense parameters to oxidative stress like malondialdehyde, GSH and SOD, and the occurrence of POAG.

Since there are only the limits of variation for these defense parameters available, mean values of the plasma levels of malondialdehyde, glutathion and superoxide dismutase will be determined in healthy subjects.

Eligibility criteria: Inclusion Criteria:

* German native speakers
* Age between 18-80 years
* Healthy without medication
* No ophthalmic disease

Exclusion Criteria:

* Any history of ocular or systemic diseases or of drug or alcohol abuse
* Any mentally impaired patient

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Eye Clinic Basel
state: BS
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Selim Orgül, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03452618: Predictive Factors for the Diagnosis of Early Noninvasive Ventilation Equipment
Official title: Predictive Factors for the Diagnosis of Early Noninvasive Ventilation Equipment in Patients With Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: diagnostic criteria
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study compare the diagnostic's variables in patients who received NIV one year after diagnosis and those who did not.
Primary purpose: DIAGNOSTIC

Brief summary: To compensate for insufficiency of diagnostic tools, the present study propose to look for the predictive factors of an early fitting by noninvasive ventilation.

Detailed description: Amyotrophic lateral sclerosis (ALS) is the most common motor neuron disease. The diagnosis of this diaphragmatic dysfunction in the ALS subject is done all too often on the occasion of a hospitalization for acute respiratory insufficiency, which aggravates then the prognosis of the patients.

The presence of these factors at diagnosis will allow more surveillance to detect early diaphragmatic insufficiency and establish a NIV (Non Invasive Ventilation), the only therapeutic measure definitely improving the quality of life and survival of patients. A clinical score will be established to determine the risk of early Non Invasive Ventilation (NIV) equipment.

Eligibility criteria: Inclusion Criteria:

* diagnosis of amyotrophic lateral sclerosis just performed,
* Patient who do not have the criteria for fitting by NIV and who have a Vital capacity ≥ 70% of theoretical values

Exclusion Criteria:

* Patient under court bail/ guardianship
* Lack of consent for participation in the study
* Presence of criteria for setting up the NIV for diagnosis according to the HAS (HealthCare Analytics Summit) 2006 recommendations
* Vital capacity \<70% of the theoretical values
* Patient under Continuous Positive Pressure (CPP) or NIV for a respiratory pathology other

Primary outcomes:
measure: Early Surgical Clinical Score
timeFrame: One year after diagnostic
Secondary outcomes:
measure: Sensitivity, specificity, negative and positive predictive values
timeFrame: One year after the diagnostic
measure: Percentage of decrease
timeFrame: One year after the diagnostic
measure: Slope of FVC decline
timeFrame: One year after the diagnostic
measure: Quality of life score
timeFrame: One year after the diagnostic
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Marion Dupuis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05384418: Cardiac Amyloidosis Prevalence and Outcome in Aortic Stenosis Patients Undergoing Transcatheter Aortic Valve Implantation
Official title: Cardiac AMyloidosis Prevalence and Outcome in Aortic Stenosis Patients Undergoing Transcatheter Aortic Valve Implantation (CAMPOS-TAVI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Stenosis
Keywords: Cardiac amyloïdosis
aortic stenosis
transthyretine amyloïdosis
CA-TTR
transcatheter aortic valve implantation
TAVI
prevalence
outcome
survival
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 103
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Aortic stenosis (AS) is the most frequent valvulopathy in the general population in France and more generally in developed countries, due to populations aging. Its standard treatment is historically surgical aortic valve replacement (SAVR). In the 2000s, the management of this valvulopathy was revolutionized by the development of the technique of per-cutaneous aortic valve replacement (TAVI). TAVI opens the possibility of curative treatment to patients at high operational risk not operable by conventional surgery, and for whom outcome was affected with high mortality under medical treatment alone.

Amyloidosis, a pathology with multiple etiologies, is a rare condition and its cardiac form (AC) even more (8 to 17 / 100,000 people / year). However, its prevalence is increasing. Some autopsies series have found prevalence up to 50% of cardiac amyloidosis with transthyretin (AC-TTR) after 60 years. In addition, recent data suggested that AC-TTR prevalence is higher in the population of patients with heart disease: 13% in heart failure with preserved ejection fraction and up to 16% in patients with AS. The outcome of patients with AC-TTR remains unknown after TAVI. Thus, the diagnosis of AC-TTR in patients undergoing TAVI represents an important issue. Indeed, a treatment stabilizing the process of accumulation of transthyretin deposits, effective on the survival of these patients, is now available. In addition, a non-invasive screening strategy for AC-TTR, alternative to biopsy, is now validated.

Detailed description: The aim of the study is to describe prevalence of cardiac amyloidosis with transthyretin in patients undergoing transcatheter aortic valve implantation.

Eligibility criteria: inclusion criteria :

* patients over 60 years old
* Patients admitted in Reims university cardiology department for per-cutaneous aortic valve replacement due to severe aortic stenosis
* Patients enrolled in the national healthcare insurance program
* Patients consenting to participate to the study

exclusion criteria :

- AL amyloïdosis patients

Primary outcomes:
measure: transthyretine cardiac amyloïdosis
timeFrame: Hour 3
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
Clinical trial NCT04865718: Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow
Official title: Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aneurysm, Brain
Arteriovenous Malformation of Brain
Neurovascular Disorder
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll adults planned for craniotomy procedures such as planned resections for brain tumor or neurovascular procedure such as aneurysm or arteriovenous malformation

Brief summary: The purpose of this research study is to evaluate the ability of laser speckle contrast imaging to visualize blood flow in real time during neurosurgery. Real-time blood flow visualization during surgery could help neurosurgeons better understand the consequences of vascular occlusion events during surgery, recognize potential adverse complications, and thus prompt timely intervention to reduce the risk of stroke. The current standard for visualizing cerebral blood flow during surgery is indocyanine green angiography (ICGA), which involves administering a bolus of fluorescent dye intravenously and imaging the wash-in of the dye to determine which vessels are perfused. Unfortunately, ICGA can only be used a few times during a surgery due to the need to inject a fluorescent dye, and provides only an instantaneous view of perfusion rather than a continuous view. Laser speckle contrast imaging does not require any dyes or tissue contact and has the potential to provide complementary information to ICGA. In this study we plant to collect blood flow images with laser speckle contrast imaging and to compare the images with ICGA that is performed as part of routine care during neurovascular surgical procedures such as aneurysm clipping.


Eligibility criteria: Inclusion Criteria:

* Adults (18 years or older).
* Size of craniotomy at least 2 cm.
* Possibility of intraoperative ICGA.
* Able to render written informed consent.

Exclusion Criteria:

* Patients unable to legally consent.
* Patients with impaired cognitive function.

Primary outcomes:
measure: blood flow visible in laser speckle contrast images
timeFrame: during surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Dell Seton Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT06758518: Study of the Carpal Tunnel Syndrome in Relation to Stress and Depression Among Medical Students
Official title: Are Anxiety and Depressive Disorders Related to Carpal Tunnel Syndrome in Medical Students?
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Carpal Tunnel Syndrome (CTS)
Keywords: carpal tunnel syndrome
anxiety
depression
medical students
Lead sponsor: University of Ioannina
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 180
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: medical students of the university of ioannina

Brief summary: Participants will undertake validation of the median nerve and their anxiety and depression levels. Possible correlation will be searched.

Detailed description: Medical students of the University of Ioannina will be submitted to ultrasound of the medial nerve as to assess its surface. Those with pathological findings will undertake a non-interventional electromyography test. Afterwards they will complete anonymously two validated tests regarding depression and anxiety (Yung ans STAI scales). Statistical analysis will be conducted with the question of correlation between median nerve dysfunction and psychiatric disorders.

Eligibility criteria: Inclusion Criteria:

* medical students

Exclusion Criteria:

* known pathology of the carpal joint

Primary outcomes:
measure: Correlation of median nerve disorder with anxiety and/or depression
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: Medical School, University of Ioannina
state: Epirus
Study officials:
References:
Clinical trial NCT06011018: Comparison of Effects of Mirror Therapy Combined With Neuromuscular Electrical Stimulation or Binaural Beats Stimulation on Cortical Excitability, Heart Rate Variability and Lower Limb Motor Function in Patients With Stroke
Official title: Comparison of Effects of Mirror Therapy Combined With Neuromuscular Electrical Stimulation or Binaural Beats Stimulation on Cortical Excitability, Heart Rate Variability and Lower Limb Motor Function in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Healthy Adults
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomly assigned treatment groups:

1. Mirror Therapy
2. Mirror Therapy + Electrical Stimulation
3. Mirror Therapy + Binaural Beat
Primary purpose: TREATMENT

Brief summary: This study aims to compare the effects of mirror therapy combined with either neuromuscular electrical stimulation or binaural beat stimulation on post-stroke lower limb motor function recovery. The study also explores the relationship between patients' cortical excitability and motor function improvement.


Eligibility criteria: Inclusion Criteria:

1. First occurrence of stroke≧ 6 months
2. Mini-mental state examination≧24
3. Modified Ashworth's scale of ankle muscle ≦3
4. Sit independently≧30 mins
5. Brunnstrom stage ≧3
6. Aged between 20 and 80 years

Exclusion Criteria:

1. Speech impairment
2. Hearing impairment
3. Visual impairment
4. Other orthopedic diseases or nerve damage
5. Complete sensory impairment
6. Pacemaker or metal implants

Primary outcomes:
measure: Fugl-Meyer assessment, lower extremity
timeFrame: 10minutes
Secondary outcomes:
measure: Modified ashworth scale
timeFrame: 5minutes
measure: Timed up and go test
timeFrame: 5minutes
measure: The postural assessment scale for stroke patients
timeFrame: 10 minutes
measure: Barthel index
timeFrame: 5minutes
Other outcomes:
measure: Electroencephalography
timeFrame: 20minutes
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University, Department of Physical Therapy
Study officials:
affiliation: Kaohsiung Medical University,department of Physical Therapy
name: LIN JAU HONG, Ph.D.
role: STUDY_CHAIR
References: