louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04153474: Exit Strategy After Percutaneous Nephrolithotomy: Large or Small Bore Tube?
Official title: Exit Strategy After Percutaneous Nephrolithotomy: Large or Small Bore Tube? Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urolithiasis
Nephrolithotomy
Percutaneous Nephrolithotomy (PNL)
Nephrostomy Tube (NT)
Pain
Keywords: Percutaneous nephrolithotomy (PNL)
Nephrostomy tube (NT)
Pain
Patient satisfaction
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 220
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: Regarding to the distribution of nephrostomy tube (NT) size usage by country. There was a clear distinction between countries that used solely the small bore (SB) NT (Chile and Australia) and those that used solely the large bore (LB) NT (Czech Republic and Japan). There is also a trend toward SB NT in North America (\~75% in USA and Canada) and toward LB NT in South America (\~80% in Argentina and Mexico). In Europe the trend is equal (\~50% in Germany, France, Greece and UK). Based on previous data and in view of conflicting data about postoperative complication including extravasation, bleeding and hemoglobin change and pain between previous studies, we will conduct this randomised trial comparing SB and LB NT following PNL.

Our aim to evaluate the safety of small versus large bore NT reporting complications using the Clavien-Dindo system with categorisation of PNL-specific complications


Eligibility criteria: Inclusion Criteria:

1. Staghorn calculi
2. Renal pelvis stones =\>2 cm
3. Lower pole stones= \>1.5 cm
4. upper ureteral calculi =\>1.5 cm
5. SWL-resistant stones

Exclusion Criteria:

1. Age \<18 years or Pregnancy
2. Tubeless PNL
3. Need for 3 percutaneous tracts intraoperative
4. Morbid obesity (BMI \>40)
5. Refuse to complete study requirements
6. Tumour in the presumptive access tract area or Potential malignant kidney tumour

Primary outcomes:
measure: Rate of hemoglobin reduction difference between groups
timeFrame: 8 months
Secondary outcomes:
measure: postoperative pain score
timeFrame: 8 months
measure: postoperative patient satisfaction
timeFrame: 8 months
measure: overall postoperative complication
timeFrame: 8 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center
state: Aldakahlia
Study officials:
References:
Clinical trial NCT05648474: Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure
Official title: Advanced Techniques in Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure: a Utility Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intervertebral Disc Degeneration
Stenosis, Spinal
Spondylolisthesis
Spinal Deformity
Spinal Instability
Keywords: Spine
Surgery
Adult
Neuromonitoring
Electromyography
Somatosensory evoked potentials
Lead sponsor: Alphatec Spine, Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-13
Enrollment: 400
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 of both sexes undergoing LLIF surgery atone or two levels inclusive of the L4-5 level.

Brief summary: This study is designed to evaluate the clinical utility of a known intraoperative neuromonitoring modality (SSEP) using saphenous nerve as the site of stimulation to identify changes to the lumbar nerves which may be at risk during the lateral lumbar interbody fusion (LLIF) procedure.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age at the time of planned surgery.
* Indicated for 1- or 2-level instrumented LLIF surgery (in either prone or lateral decubitus positions), inclusive of the L4-5 disc space.
* Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Patients requiring surgical treatment at more than 2 lumbar levels.
* Patients with peripheral neuropathy such as from diabetes or other conditions that might affect the reliability of intraoperative neuromonitoring.
* Patients with prior history of partial/full hip or knee joint replacement surgery (i.e., arthroplasty or resurfacing) on the leg targeted for saphenous monitoring and electrode placement.
* Patients with presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
* Female patients who are pregnant or wanting to become pregnant during the timeframe of study participation.
* Patients participating in another clinical study which may compromise this study's results or compliance with this study's procedures.

Primary outcomes:
measure: Sensitivity and specificity of SSEP neuromonitoring in post-operative clinical diagnosis of motor/sensory deficits
timeFrame: 6 weeks or until new or worsened neural deficits are resolved, but not exceeding 12 months.
Secondary outcomes:
measure: Determination of the positive predictive value (PPV) and negative predictive value (NPV) of free run and SSEP monitoring modalities.
timeFrame: 6 weeks or until new or worsened neural deficits are resolved, but not exceeding 12 months.
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: Alphatec Spine Inc.
state: California
Study officials:
References:
Clinical trial NCT01333774: Influence of Different Approaches to Dietary Advising on the Effects of Acarbose Treatment in Obese Diabetic Patients Under Real-life Setting
Official title: Compliance With Dietary Recommendations in Obese Diabetic Patients Undergoing Acarbose Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Diabetes
Acarbose
Diet
Compliance
Advising
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-04-12
Enrollment: 423
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic diabetic patients not treated with acarbose for approx. 3 mths.

Brief summary: It has been recently suggested, that not the diet by itself, but also patient's adherence to dietary recommendations and all actions performed to improve dietary compliance, may be a significant factor influencing blood glucose control. There are no clinical data on the influence of different approaches to dietary advising on the effects of acarbose treatment in obese diabetic patients under real-life setting in Poland. Thus, the aim of this study was to assess the influence of different approaches to dietary advisory on the effects of acarbose treatment (reflected by changes in HbA1c) in obese DM patients. We also intended to assess the influence of different approaches to dietary advising on the appearance of potential adverse events in acarbose treated obese DM patients.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes
* age\>18 years

Exclusion Criteria:

* Hypersensitivity to acarbose or any of the excipients
* age\<18
* pregnancy and in nursing
* inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction
* chronic intestinal diseases associated with marked disorders of digestion or absorption
* states which may deteriorate as a result of increased gas formation in the intestine, (e.g. Roemheld's syndrome \[an angina pectoris-like syndrome or aggravation of an angina pectoris due to the post-prandial filling of the stomach\] and larger hernias)
* hepatic and severe renal impairment (creatinine clearance \<25 mL/min/ 1,73m2)

Primary outcomes:
measure: Change in HbA1c value between initial and final visit
timeFrame: approx. 3 mths after acarbose treatment initiation
Secondary outcomes:
measure: Number of participants with adverse events in both study groups. The influence of different approaches to dietary advising on the appearance of adverse events.
timeFrame: approx 3 mths after acarbose treatment initiation
Other outcomes:
Locations:
city: Many Locations
country: Poland
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06013774: Interventional X-ray and Scintigraphy Imaging of 99mTc-MAA During the Radioembolisation Pretreatment Procedure
Official title: Interventional X-ray and Scintigraphy Imaging of 99mTc-MAA During the Radioembolisation Pretreatment Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: To establish the safety and feasibility of interventional x-ray and scintigraphy imaging during the pre-treatment procedure of hepatic radioembolization


Eligibility criteria: Inclusion Criteria:

1. Participants must have given written informed consent and comply with the requirements of the study protocol.
2. Must be aged 18 years or over.
3. Must be selected to undergo a 99mTc-MAA procedure as part of their radioembolisation treatment.
4. Sufficiently fit to undergo an additional examination time of 30-90 minutes.
5. Have a CT acquired less than 6 weeks before the pre-treatment radioembolisation procedure.

Exclusion Criteria:

1. Patients expected to require more than two injection positions for radioembolisation treatment.
2. Pregnancy or nursing.
3. Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
4. Patients who are declared incompetent.
5. Previous enrollment in the present study
6. Claustrophobia
7. The last dose of prior chemotherapy has been received less than weeks prior to the planned 99mTc-MAA pre-treatment procedure.
8. Radiation therapy within the last 4 weeks before the planned 99mTc-MAA pre-treatment procedure
9. Major surgery within the last 4 weeks prior to the planned 99mTc-MAA pre-treatment procedure
10. Any unresolved toxicity greater than Common Terminology Criteria for Adverse Events (CTCAE version 5) grade 2 from previous anti-cancer treatment
11. Body weight over 250 kg (because of maximum table load)
12. Patient length over 1.90 m (to fit IXSI geometry)
13. Patient bust line over 135 cm (to fit IXSI geometry)

Primary outcomes:
measure: Device Feasibility
timeFrame: Immediately after surgery
Secondary outcomes:
measure: Radioactivity distribution over time
timeFrame: Immediately after surgery
measure: Radioactivity distribution in 3D
timeFrame: Immediately after surgery
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
References:
Clinical trial NCT04631874: A Clinical Trial to Compare Pharmacokinetics of the "CDFF0318" and "Champix Tab. 1mg"
Official title: A Phase 1 Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of the "CDFF0318" and "Champix Tab. 1mg (Varenicline Tartrate)" in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking Cessation
Pharmacokinetics
Lead sponsor: CTC Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-17
Enrollment: 32
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Phase 1 Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics after Administration of the "CDFF0318" and "Champix Tab. 1mg (Varenicline tartrate)" in Healthy Male Volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects aged 19 to 45 years
* a body mass index of 18.0-30.0 kg/m2

Exclusion Criteria:

* Subjects with disease history or current disease of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood/tumor, urinary system, cardiovascular system, etc.
* Subjects with a history of gastrointestinal diseases or gastrointestinal surgery that may affect the absorption of investigational drugs
* Subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs containing varenicline and other drugs (ketoprofen, aspirin, antibiotics, etc.)
* Subjects who have an abnormal diet that may affect the absorption, distribution, metabolism, and excretion of the drug, or who eat food that may affect drug metabolism

Primary outcomes:
measure: Pharmacokinetics (AUC0-t)
timeFrame: 72 hours
measure: Pharmacokinetics (Cmax)
timeFrame: 72 hours
Secondary outcomes:
measure: Safety and tolerability (Vital sign)
timeFrame: 72 hours
measure: Safety and tolerability (Vital sign)
timeFrame: 72 hours
measure: Safety and tolerability (12-lead ECG)
timeFrame: 72 hours
measure: Safety and tolerability (12-lead ECG)
timeFrame: 72 hours
measure: Safety and tolerability (Laboratory tests)
timeFrame: 72 hours
measure: Safety and tolerability (Laboratory tests)
timeFrame: 72 hours
measure: Safety and tolerability (Laboratory tests)
timeFrame: 72 hours
measure: Safety and tolerability (Adverse events)
timeFrame: 72 hours
Other outcomes:
Locations:
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
Study officials:
affiliation: Chungbuk National University Hospital
name: Min-Kyu Park
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02079974: Statins: A New Therapeutic Option for Treatment of Patients With Endometriosis
Official title: Statins: A New Therapeutic Option for Treatment of Patients With Endometriosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Endometriosis
Keywords: endometriosis
pain
fertility
Lead sponsor: Toronto Centre for Advanced Reproductive Technology
Sponsor class: OTHER
First posted: 2014-03-06
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Endometriosis is a chronic inflammatory disorder leading to painful periods, pain with intercourse and infertility. The available treatment options to alleviate pain involve mainly hormonal treatments and surgery. All current hormonal treatments are effective but disrupt the normal variations in reproductive hormones which prevent ovulation, and thus pregnancy. Statins, a group of cholesterol lowering drugs, have anti-inflammatory properties which may be helpful also for the pain related to endometriosis. The investigators plan to undertake a pilot study of 10 patients with endometriosis who will take pravastatin sodium together with coQ10, which is inhibited by statins, for a period of 3 months. If this pilot study shows that the statin treatment may decrease pain symptoms in endometriosis, then the investigators plan to undertake a larger study to further investigate this matter.

Detailed description: * Initial grading of pain by a Linear Analogue Scale (LAS) from 1-10
* Initial blood biochemistry including liver function test, lipid profile, creatine/BUN, creatine kinase
* 3 months of treatment with statins (Pravastatin) in a dose of 40mg daily
* Supplementation with CoQ10 (200mg) daily for 3 months

Eligibility criteria: Inclusion Criteria:

* female patients of reproductive age group (18-38 years) with a clinical or surgical diagnosis of endometriosis with pain symptoms

Exclusion Criteria:

* use of hormonal suppression for pain control (OCP, GnRHa) within 6-months
* history of surgery for endometriosis within 6- months
* current renal or hepatic active disease
* current or history of myopathic disease
* medication that may interact with statins (erythromycin, gemfibrosil, antifungals, antiretrovirals, other cholesterol lowering drugs)

Primary outcomes:
measure: subjective assessment of pain
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital, University of Toronto
state: Ontario
Study officials:
affiliation: Dept of Obstetrics and Gynecology, University of Toronto
name: Robert Casper, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00833274: Evaluation of Apathy Using Attentional Reaction Test in Neurodegenerative Diseases
Official title: Evaluation of Apathy Using Attentional Reaction Test in Neurodegenerative Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2009-02-02
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Apathy, defined as a lack of motivation in behaviour, cognition and affect, is common in neurodegenerative diseases. Specific scales are available for the evaluation of apathy but it lacks objective evaluation methods.

The aim of this study is to evaluate the changes in reaction time task according to the presence or absence of reward stimulation and to assess the relation between these performances and apathy scales.

Detailed description: MATERIAL: 13 patients with Mild Cognitive Impairment (MCI), 15 patients with Alzheimer's disease (AD) and 91 elderly healthy subjects were enrolled. A computerized test using the experiment software E-prime® was designed to assess reaction times (in ms) in different experimental conditions after a training trial (neutral, stimulation, stress, stimulation after stress, extinction) and relation between the performances to the test and the Apathy Inventory (AI) scores (lack of initiative, lack of interest, emotional blunting) were observed.

METHOD: Using a computerized test, each patient is asked to press a button (mouse of the computer) each time the screen of the computer becomes completely white. After pressing the button, a randomized colorized geometric figure appears on the screen, and disappears automatically after a few seconds, replaced by a new white screen. Reaction time (in ms) between a white screen and a press of the button is analysed. After a training trial, reaction times are analysed in different experimental conditions: neutral - stimulation1 (patient gets points when pressing the button) - stress (alarm) - stimulation2 (patient gets points when pressing, after the stress trial) - extinction (similar to neutral condition).

Eligibility criteria: Inclusion Criteria:

* Elderly patients with diagnosis of Alzheimer's Disease according to DSM-IV criteria
* MMSE \>20

Exclusion Criteria:

* None
* Motor or psychiatric disorders

Primary outcomes:
measure: Reaction times (ms), using a computerized test
timeFrame: one time point, at day 0 (day of inclusion) during the computerized test
Secondary outcomes:
measure: Apathy severity, using a specific apathy scale (Apathy Inventory)
timeFrame: one time point, at day 0 (day of inclusion), during the visit
Other outcomes:
Locations:
city: Nice
country: France
facility: CM2R, Nice University Hospital
Study officials:
References:
Clinical trial NCT04638374: Adaptation of Lumbar Spine to a Mattress: a MRI Evaluation.
Official title: Adaptation of Lumbar Spine to a Mattress: a MRI Evaluation.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lumbar Spine Adaptation
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy people between 18 and 45 years of age.

Brief summary: People spend almost a third of their life sleeping and understanding how the spine can adapt to a mattress is essential for promoting people's health. The general objective of this study is to study and evaluate the adaptation of the spine to a mattress. The primary objective is the assessment of the variation in the lumbar lordosis angle (sagittal plane) in the supine position, on a mattress, compared to the value measured in the supine position on a rigid surface.


Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 45 years old
* Female or Male sex
* Cognitive integrity
* Absence of usual contraindications to MRI

Exclusion Criteria:

* Clinical condition diagnosed by a doctor
* Spinal pathologies
* Pregnant woman
* Claustrophobia

Primary outcomes:
measure: Evaluation of lumbar section of spine in a supine position on a mattress
timeFrame: 10 minutes
measure: Evaluation of lumbar section of spine in a supine position without mattress
timeFrame: 10 minutes
Secondary outcomes:
measure: Evaluation of lumbar section of spine in a standing position
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
References:
Clinical trial NCT03075774: Observational Study About the Use of Fibrinogen in Adult Cardiac Surgery
Official title: FibCard Study: Observational Study About the Use of Fibrinogen in Adult Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Surgery
Extracorporeal Circulation
Fibrinogen
Lead sponsor: Société Française d'Anesthésie et de Réanimation
Sponsor class: OTHER
Collaborators: name: Keyrus Biopharma
First posted: 2017-03-09
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient that underwent a cardiac surgery with extracorporeal circulation.

Brief summary: Multicenter prospective observational study, involving all adult patients who underwent cardiac surgery with extracorporeal circulation


Eligibility criteria: Inclusion Criteria:

* Patient over the age of 18 that underwent a cardiac surgery with extracorporeal circulation.
* Patient who agreed to participate in the study.

Exclusion Criteria:

* Patient under the age of 18.

Primary outcomes:
measure: The international recommendations published by ESA in 2016
timeFrame: 13 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: