louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01173991: Carbohydrate Counting in Adults With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion
Official title: Clinical Assessment of Carbohydrate Counting in Adult Patients With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion: a Randomized Controlled Study (GIOCAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 1
Insulin Pump, Programmable
Keywords: carbohydrate counting
continuous subcutaneous insulin infusion
type 1 diabetes mellitus
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2010-08-03
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators postulate that carbohydrate (CHO) counting in adult patients with type 1 diabetes mellitus (T1DM) treated with continuous subcutaneous insulin infusion (CSII) may improve glycemic control, glycemic variability and quality of life.

Detailed description: This study was designed as a randomized, controlled (versus standard education), open, one-center trial. Patients in group 1 were taught carbohydrate counting to estimate insulin preprandial bolus, while the patients in group 2 followed standard education. Primary outcome (glycosylated hemoglobin, HbA1c) and secondary outcomes (fasting glucose, glycemic variability, insulin requirement, body mass index (BMI), waist circumference, quality of life) were measured at baseline, 3, and 6 months.

Eligibility criteria: Inclusion Criteria:

* type 1 diabetes mellitus
* age 18-65
* continuous subcutaneous insulin infusion for at least 3 months

Exclusion Criteria:

* patients who have already been trained in carbohydrate counting
* known hypothyroidism not on replacement therapy
* renal disease (serum creatinine \>1.4 mg/dl in females and \>1.7 mg/dl in males)
* patients with celiac disease
* pregnancy
* serious diseases or disabilities which may interfere with study assessments

Primary outcomes:
measure: Glycated haemoglobin (HbA1c)
timeFrame: 6 months
Secondary outcomes:
measure: Fasting glucose
timeFrame: 6 months
measure: Glycemic variability (mean, sd, min, max, variability range, BG in target range, LBGI, HBGI) based on capillary glucose data
timeFrame: 6 months
measure: Daily insulin requirement (basal daily requirement, bolus daily requirement, total daily requirement)
timeFrame: 6 months
measure: Body Mass Index (BMI)
timeFrame: 6 months
measure: Waist circumference
timeFrame: 6 months
measure: Quality of life by Diabetes Specific Quality of Life Scale (DSQOLS) questionnaire
timeFrame: 6 months
measure: Hypoglycemia (capillary glucose<50 mg/dl)
timeFrame: 6 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: San Raffaele Scientific Institute
Study officials:
affiliation: San Raffaele Scientific Institute, Milano Italy
name: Emanuele Bosi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03957291: Chlorohexidine Versus Povidone Iodine as Apreoperative Ophthalmic Disinfectant
Official title: Chlorohexidine Versus Povidone Iodine as Apreoperative Ophthalmic Disinfectant
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Disinfectant Causing Toxic Effect
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized prospective trial
Primary purpose: PREVENTION

Brief summary: 1. Is to assess the efficacy of preoperative disinfection with chlorohexidine and povidone iodine in different concentrations separately .
2. Is to compare the efficacy of chlorohexidine to povidone iodine.
3. Compare patient comfort after instillation of each disinfectant .
4. To find which disinfectant is more effective tolerated and more safe for use .

Detailed description: Methods: This is a single center prospective study comparing antiseptic efficacy and ocular surface irritation with PI (povidine iodine) and AC (aqueous chlorhexidine). . Prior to sugery patients who meet inclusion criteria will be identified and informed consent will be obtained. Study personnel will obtain two samples one from conjunctival sac and th other from skin around the eye. Topical antisepsis will then be applied, the first eye will be randomized to one drop of either PI 5% - 2.5% or AC 0.1%- 0.05% and the second eye will receive the other agent. One minute after instillation of the eye drop to each eye, patients will rate their pain in each eye using the Wong-Baker (smiley face) rating scale. After 15 minutes the second swabs will be taken in the same manner as the first swabs. . On post-operative day three, study personnel will meet the patient and ask to rate the pain in each eye using the same verbal numerical rating scale and to perform slit lamb examination for any complication.

Eligibility criteria: Inclusion Criteria:

* Current patient of the Assiute University Hospital arranged for ophthamic surgery
* Age greater than 12.

Exclusion Criteria:

* Documented allergy to PI or AC
* Current diagnosis of infectious keratitis
* History of unilateral contact lens wear in the past 30 days
* Current unilateral use of prescription eye drops.

Primary outcomes:
measure: Patient Comfort
timeFrame: day three post operative
Secondary outcomes:
measure: Culture of conjunctiva for bacteria
timeFrame: 7 days
measure: Patient Comfort
timeFrame: I minute after disinfectant drop instilled
Other outcomes:
Locations:
Study officials:
References:
citation: Grzybowski A, Kanclerz P, Myers WG. The use of povidone-iodine in ophthalmology. Curr Opin Ophthalmol. 2018 Jan;29(1):19-32. doi: 10.1097/ICU.0000000000000437.
Clinical trial NCT03620591: Lidocaine and Analgesia After Laparoscopic Cholecystectomy
Official title: Intraoperative Use of Lidocaine and Postoperative Analgesia After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Opioid Consumption
Keywords: Lidocaine
Postoperative Pain
Opioid consumption
Laparoscopic cholecystectomy
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate how effective is the intraoperative use of lidocaine to attenuate postoperative pain and opioids consumption after laparoscopic cholecystectomy

Detailed description: Acute postoperative pain may predict the development of chronic pain.Recently, the analgesic effect of lidocaine, as a part of a multimodal analgesia, has been evaluated in many studies. They have shown that lidocaine may have a role in the postoperative pain management, as an adjunct.

Acute postoperative pain after laparoscopic cholecystectomy is complex in nature. Postoperative pain is the main complaint and the primary reason for delay discharge after laparoscopic cholecystectomy.The study includes patients undergoing laparoscopic cholecystectomy.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I-II
* Age ≥ 18 years old
* BMI ≤ 35

Exclusion Criteria:

* Allergy in local anesthetics
* History of liver, kidney or heart failure
* Existence of chronic pain history or daily analgesics
* Psychiatric disorders
* Inability to understand pain assessment

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: 24 hours after the procedure
Secondary outcomes:
measure: Postoperative pain
timeFrame: Departure of the patient from the recovery room (0hrs)
measure: Postoperative pain
timeFrame: 6 hrs after the procedure
measure: Postoperative pain
timeFrame: 12 hrs after the procedure
measure: Postoperative pain
timeFrame: 24 hrs after the procedure
measure: Incidence of Nausea and Vomiting
timeFrame: 24 hours
measure: Incidence of sedation and respiratory depression
timeFrame: 24 hours
measure: Incidence of shoulder pain
timeFrame: 24 hours
measure: Incidence of headache and dizziness
timeFrame: 24 hours
measure: Change from baseline Mean Blood Pressure
timeFrame: Intraoperative
measure: Change from Baseline Heart Rate
timeFrame: Intraoperative
measure: Change in depth of anesthesia
timeFrame: Intraoperative
measure: Side effect related to administration of lidocaine
timeFrame: 24 hours
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University Hospital of Larissa
Study officials:
affiliation: University Hospital of Larissa
name: Ioannis Baloyiannis
role: STUDY_DIRECTOR
affiliation: University Hospital of Larissa
name: Chamaidi Sarakatsianou
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Larissa
name: Stavroula Georgopoulou
role: STUDY_CHAIR
References:
Clinical trial NCT01470391: Adductor-Canal-Blockade Versus the Femoral Nerve Block Effect on Muscle Strength, Pain and Mobilization After Total Knee Replacement
Official title: "A Comparison of the Efficacy of the Adductor-Canal-Blockade Versus the Femoral Nerve Block on Muscle Strength, Pain and Mobilization After Total Knee Arthroplasty: a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: Adductor-Canal-Blockade
Femoral Nerve Block
Postoperative Pain
Total Knee Arthroplasty
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2011-11-11
Enrollment: 54
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the efficacy of the Adductor-Canal-Blockade versus the Femoral Nerve Block on muscle strength, pain and mobilization after total knee arthroplasty. We hypothesize that the Adductor-Canal-Blockade has the same effect on pain and morphine consumption as the Femoral Nerve Block, but without the same reduction in quadriceps muscle strength.


Eligibility criteria: Inclusion Criteria:

* ASA 1-3
* BMI \> 18 og \< 40
* total knee arthroplasty in spinal anesthesia

Exclusion Criteria:

* Can not cooperate to the exam
* Do not speak or understand Danish
* Drug allergy
* Alcohol or drug abuse
* Daily consumption of strong opioids
* Rheumatoid arthritis
* Intake of glucocorticoids
* Effect of spinal anesthesia stopped prior to performing the regional block

Primary outcomes:
measure: The difference in quadriceps muscle strength between the Adductor-Canal-Blockade and the femoral nerve block
timeFrame: 24 h postoperatively
Secondary outcomes:
measure: The difference in adductor muscle strength between the Adductor-Canal-Blockade and the Femoral Nerve Block
timeFrame: 24 h postoperatively
measure: Pain during flexion of the knee
timeFrame: 2-24 hours
measure: Pain at rest
timeFrame: 2-24 hours
measure: Total morphine consumption
timeFrame: 0-24 hours
measure: Postoperative nausea
timeFrame: 2-24 hours
measure: Postoperative vomiting
timeFrame: 0-24 hours
measure: Sedation
timeFrame: 2-24 hours
measure: Zofran consumption
timeFrame: 0-24 hours
measure: The difference in mobilization between the groups
timeFrame: 24 hours
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Anaesthesia, Copenhagen University Hospital, Frederiksberg
Study officials:
affiliation: Rigshospitalet, Denmark
name: Pia Jæger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jaeger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015.
Clinical trial NCT00139191: Study Evaluating the Correlation Between C-11 Acetate Uptake and Retention as Measured by PET and FAS in Prostate Cancer
Official title: A Pilot Study Evaluating the Correlation Between Carbon 11 Acetate (C-11 Acetate) Uptake and Retention as Measured by Positron Emission Tomography (PET) and Fatty Acid Synthase (FAS) Expression in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
positron emission tomography
carbon 11 acetate
PET
fatty acid synthase
FAS
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: Massachusetts General Hospital
First posted: 2005-08-31
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to understand if a new type of radiology test called positron emission tomography (PET) with carbon 11 acetate will help us to understand which cancers produce more of a protein called fatty acid synthase (FAS).

Detailed description: * Within 4 weeks of the patient's scheduled surgery they will undergo a C11 acetate PET scan. This scan will be performed at the Massachusetts General Hospital's Nuclear Medicine Department and involves an intravenous injection of acetate with a radioactive tracer followed by a PET scan. The scan will determine how well the tumor is taking up the acetate.
* Patients will also undergo a CT scan of the pelvis at the same time as the PET scan.
* After surgery, the removed tumor will have additional testing that will look at different factors that may tell us how aggressive the tumor is and how much FAS is within the tumor. FAS seems to be produced in higher amounts by prostate cancer cells than normal cells. We will then try to determine if the results of the C11 acetate PET scan can tell us how much FAS is produced by prostate cancer cells.

Eligibility criteria: Inclusion Criteria:

* Histologically documented prostate cancer
* Planned radical prostatectomy
* \> 50% cores positive for prostate cancer from prostate biopsy or a palpable prostate nodule
* Older than 18 years of age

Exclusion Criteria:

* Inability to lay on a scanner for 60 minutes

Primary outcomes:
measure: To explore the associations between measures of C-11 acetate uptake and retention into prostate tumors and levels of FAS expression in tissue.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Robert Ross, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03906994: Treating Amblyopia in Adults With Interactive Video Games
Official title: Treating Amblyopia in Adults With Interactive Video Games
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Amblyopia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Researchers are trying to determine whether interactive video game play, while wearing a patch over better-seeing eye, will improve subject reduced vision (amblyopia).

Detailed description: The purpose of this research is to determine whether amblyopia (reduced vision in one eye) in adults can be improved using interactive video game play.

Study participation involves playing the video game Mario KartTM (provided by the study), while wearing a patch over their better-seeing eye. Participants are asked to play the game for a total of 40 hours over a one-month period.

The primary outcome measure will be LogMAR visual acuity measured 1 month after initiating game play.

Eligibility criteria: Inclusion Criteria:

* Aged \>17 years old
* Refraction within past year and wearing updated glasses or contact lenses
* Diagnosis of strabismic, anisometropic or combined amblyopia (\> 2 lines inter-ocular difference)
* Stable visual acuity as defined as \<1 LogMAR change over 2 visits 8 weeks apart, or wearing glasses for at least 16 weeks

Exclusion Criteria:

* Monovision and unwilling to wear corrective glasses
* Allergy to adhesive bandages
* Women who are currently pregnant

Primary outcomes:
measure: Change in visual acuity
timeFrame: Baseline, one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Erick Bothun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04975594: Statin-Intolerance Registry
Official title: Statin-Intolerance Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dyslipidemias
Keywords: Statins
Muscle symptoms
Cardiovascular
Lipid Metabolism Disorders
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: University of Jena
name: University Hospital Dresden
name: Charite University, Berlin, Germany
First posted: 2021-07-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with statin-intolerance

Brief summary: The Statin-Intolerance Registry will characterize the patient population suffering from statin-intolerance which is a frequent but incompletely understood patient condition with important clinical implications for atherosclerotic cardiovascular disease (ASCVD) prevention.

Patients will be systematically and prospectively included and followed by the registry.

Detailed description: This non-interventional registry based on routine clinical practice will collect data under real-life conditions. The treatment of patients will not be changed by this study.

Data on patient characteristics and the treatment history will be collected via questionnaires at study entree. Yearly follow up visits will re-assess the baseline parameters and document cardiovascular events.

The data will be analyzed using descriptive statistics.

Eligibility criteria: Inclusion Criteria:

1. Patients with dyslipidemia and statin intolerance, defined as:

   Use of 2 or more statins and intolerance of these drugs in any dose or inability to tolerate dosage increasement beyond a maximum weekly dose of 70 mg atorvastatin, 140 mg Simvastatin, pravastatin, or lovastatin, 35 mg rosuvastatin, 280 mg of Fluvastatin and symptoms improve or disappear when statin is reduced in dosage or discontinued
2. Participants are ≧ 18 years old
3. Written declaration of consent is available
4. The patient is cognitively, linguistically and organizationally capable to meet the study requirements. The possibility of 1 year follow-up is very likely.

Exclusion Criteria:

1. Use of any experimental or investigational drugs within 30 days prior to screening.
2. An employee or contractor of the facility conducting the study, or a family member of the principal investigator, co-Investigator, or sponsor.

Primary outcomes:
measure: Number of treatment adjustments
timeFrame: 3 years
measure: Change in LDL cholesterol level
timeFrame: 3 years
Secondary outcomes:
measure: Change in quality of life
timeFrame: 3 years
measure: Development of muscle symptoms over time that initially lead to discontinuation of statin therapy
timeFrame: 3 years
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Uniklinik Leipzig
state: Saxony
Study officials:
affiliation: University of Leipzig
name: Ulrich Laufs
role: STUDY_DIRECTOR
References:
Clinical trial NCT03115294: Digital Image Correlation in Right Ventricular Evaluation
Official title: Digital Image Correlation in Right Ventricular Evaluation in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Ventricles
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University of Technology
First posted: 2017-04-14
Enrollment: 20
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients undergo medication intervention (w/intravenous theophylline) and ventilator volume adjustements, and serial ventricular function parameters are compared (pre-and post-intervention measurements).
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Observational study of patients undergoing open heart surgery. During the procedure video clips of right heart are stored and compared to trans-oesophageal ultrasound recordings and ECG recordings.

Detailed description: Observational study of patients undergoing open heart surgery. During the procedure video clips of right heart are stored and compared to trans-oesophageal ultrasound recordings and ECG recordings. Right heart volume status and function is controlled and induced with theophylline and ventilator regulated positive end-expiratory pressure recordings.

Eligibility criteria: Inclusion Criteria:

* open heart surgery, patient acceptance and informed consent, age 75 or more

Exclusion Criteria:

* patient refusal, psychiatric disorder or intoxication, irrepairable coronary artery disease, epilepsy or active neurological condition, active tbc or other contagious infection.

Primary outcomes:
measure: Heart ventricle function
timeFrame: Within the operation
Secondary outcomes:
Other outcomes:
measure: ECG
timeFrame: Within the operation
measure: Transesophageal ultrasound
timeFrame: Within the operation
measure: Cardiac output
timeFrame: Within the operation
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital, Heart Center
Study officials:
affiliation: Professor, Cardio-thoracic Surgery
name: Jari Laurikka, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soltani A, Lahti J, Jarvela K, Laurikka J, Kuokkala VT, Hokka M. Characterization of the anisotropic deformation of the right ventricle during open heart surgery. Comput Methods Biomech Biomed Engin. 2020 Feb;23(3):103-113. doi: 10.1080/10255842.2019.1703133. Epub 2019 Dec 17.
citation: Soltani A, Lahti J, Jarvela K, Curtze S, Laurikka J, Hokka M, Kuokkala VT. An Optical Method for the In-Vivo Characterization of the Biomechanical Response of the Right Ventricle. Sci Rep. 2018 May 1;8(1):6831. doi: 10.1038/s41598-018-25223-z.