louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00208598: Measures of Obesity and Co-Morbid Conditions in Maori
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Composition
Keywords: Maori
Body Composition
DEXA
Cardiovascular disease
Diabetes
Lead sponsor: Edgar National Centre for Diabetes Research
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: It has been proposed that a higher cut off for BMI (body mass index) is to be used in Maori to define overweight and obesity. However, no one has assessed the prevalence of co-morbid conditions associated with BMI. It is well known that Maori are at greater risk of diabetes and cardiovascular disease compared to non-Maori and a delay in the identification of those who are overweight and obese may be detrimental for Maori. We will assess BMI, other measures of adiposity and prevalence of co-morbid conditions with a comparison with a similar matched non-Maori population.

Detailed description: This is a body composition analysis study of people self-identifying Maori and non-Maori participants from both Dunedin and Invercargill. The study consists of a clinical visit for anthropometry and oral glucose tolerance test (OGTT), followed by a single Dexa Scan visit. Participants meeting all the inclusion criteria were invited to participate in the study.

Outcome will be determined by examining Dexa Scan data and surrogate clinical endpoints. The clinical endpoints include: anthropometric measurements, Dexa analysis, bioelectric impedance, and BP measurements, and the biochemical measures of: lipid profile, fasting insulin and glucose, liver functions and uric acid levels.

Eligibility criteria: Inclusion Criteria:

* Self identify as Maori and non-Maori aged between 18-68 years
* Male and female
* Non-diabetic
* Resident of Dunedin and Invercargill

Exclusion Criteria:

* The presence of diabetes, renal or liver failure, or any other medical condition which is unstable and for which they are currently having active treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dunedin
country: New Zealand
facility: Edgar National Centre for Diabetes Research
state: Otago
Study officials:
affiliation: Edgar National Centre for Diabetes Research
name: Jim I Mann, FRACP, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06156098: Bedside Renal Ultrasound Assessment in Patients With Acute Kidney Injury
Official title: Bedside Renal Ultrasound Assessment in Critically Ill Patients With Acute Kidney Injury: an Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Illness
Keywords: Critical Illness
Ultrasound Therapy
Kidney injury
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Criteria for sepsis patients: Clear infection focus, Sequential Organ Failure Assessment (SOFA) score ≥ 2. Criteria for septic shock patients: Despite active fluid resuscitation, patients still require vasoactive drugs to maintain blood pressure, with arterial blood lactate level ≥ 2mmol/L. Other critically ill patients include those with shock of various causes,

Brief summary: Exploring the predictive and evaluative value of various indicators of bedside critical renal ultrasound in critically ill patients with acute kidney injury (AKI)

Detailed description: This study aims to perform bedside renal ultrasound examinations on critically ill patients admitted to the ICU (including sepsis, respiratory failure, shock, multiple trauma, etc.) and prospectively observe the relationship between ultrasound parameters and the occurrence and progression of AKI, in conjunction with traditional renal function indicators. This will provide clinicians with a rapid, non-invasive, and visual examination tool at the bedside for early diagnosis and treatment of AKI.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years and ≤ 70 years
* Criteria for sepsis patients

Exclusion Criteria:

* Pregnant women.
* Patients with malignant tumors, severe heart failure, chronic renal insufficiency, end stage renal disease, kidney transplantation.

Primary outcomes:
measure: Survival
timeFrame: 28 days
Secondary outcomes:
measure: AKI
timeFrame: 28 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Qin Zhang, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01322698: Staging Candidiasis in ICU Patients
Official title: Staging Candidiasis in ICU Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Candidiasis
Keywords: ICU
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2011-03-25
Enrollment: 422
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: The target population includes patients in ICUs at the Nîmes and Montpellier University hospitals. This is a population of non-neutropenic patients (polynuclear neutrophils \> 500/mm3) at risk of developing invasive candidiasis.

Brief summary: Our primary objective is to evaluate the relevance of the early determination of Candida infection status among non-neutropenic patients hospitalized over 48 hours in ICUs.


Eligibility criteria: Inclusion Criteria:

* Polynuclear neutrophils \> 500/mm\^3
* Hospitalized for \> 48 hours in participating ICUs

Exclusion Criteria:

* Patients discharged from ICU in \< 48h
* Patient diagnosed with invasive candidosis before entry to ICU
* Patient is taking an anti-fungal treatment
* polynuclear neutrophils \< 500/mm\^3
* patient transferred to another ICU
* patient included in the Abmidex protocole

Primary outcomes:
measure: Number of positive Candidiasis tests
timeFrame: 7 days
Secondary outcomes:
measure: Number of positive Candidiasis tests
timeFrame: 2 days
measure: Patient leaves ICU unit, yes/no
timeFrame: 1 month
measure: Patient passes away in ICU unit, yes/no
timeFrame: 1 month
measure: Patient has been prescribed an antifungal treatment in the past month, yes/no
timeFrame: 1 month
Other outcomes:
Locations:
city: Nimes
country: France
facility: CHU de Nîmes
state: Gard
city: Montpellier Cedex 05
country: France
facility: CHU de Montpellier
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Laurence Lachaud, MD
role: STUDY_DIRECTOR
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Nathalie Bourgeois, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02634398: A Post Market Study on DRG Stimulation in FBSS (SYMPATHY)
Official title: A Post Market ObServational StudY on the Effect of DRG StiMulation in PATients witH Chronic Pain Following Surgical Lumbar DiscectomY (Failed Back Surgery Syndrome): SYMPATHY
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Failed Back Surgery Syndrome
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-12-18
Enrollment: 0
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 suffering from chronic pain post discectomy surgery

Brief summary: The purpose of this Post Market Observational Study is to monitor the effect of the Axium® SCS System in the management of chronic pain following surgical lumbar discectomy in subjects whom are routinely scheduled for treatment with the Axium® SCS System.


Eligibility criteria: Inclusion Criteria:

1. Subject is at least 18 years old
2. Subject is able and willing to comply with the follow-up schedule and protocol
3. Chronic pain following surgical lumbar discectomy for at least 6 months
4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
5. Minimum baseline pain rating of 60 mm on the VAS in the subjects' primary area of pain
6. Subject is able to provide written informed consent

Exclusion Criteria:

1. Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
2. Escalating or changing pain condition within the past month as evidenced by investigator examination
3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
4. Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
5. Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
6. Subject is unable to operate the device
7. Subjects with indwelling devices that may pose an increased risk of infection
8. Subjects currently has an active infection
9. Subject has participated in another clinical investigation within 30 days
10. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
11. Subject has been diagnosed with cancer in the past 2 years.
12. Subject has an anatomical spinal abnormality which is anticipated to require further surgery

Primary outcomes:
measure: Pain Relief
timeFrame: Post implantation at; 1 week and 1, 3, 6 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Morges
country: Switzerland
facility: Centre d'Antalgie de l'EHC-Hôpital de Morges
state: Vaud
Study officials:
References:
Clinical trial NCT00238498: A Clinical Study to Assess the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes
Official title: A Clinical Study to Assess the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
vildagliptin
HbA1c
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-13
Enrollment: 291
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of a number of doses of vildagliptin, an unapproved drug, in the treatment of people with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 2 diabetes
* Patients who have been placed on diet and exercise therapy without achievement of glycemic control
* Outpatients

Exclusion Criteria:

* Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
* Significant cardiovascular diseases
* Significant diabetic complications
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in HbA1c at 12 weeks
Secondary outcomes:
measure: Change from baseline for postprandial glucose at 12 weeks
measure: Change from baseline on fasting plasma glucose at 12 weeks
measure: Change from baseline on postprandial glucose AUC at 12 weeks
measure: Change from baseline in HOMA B at 12 weeks
measure: Change from baseline in HOMA IR at 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06834698: Steroid Treatment for Meatal Stenosis
Official title: Topical Steroid Treatment for Meatal Stenosis: Clinical Outcomes and Uroflowmetry Assessment of Treatment Success
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meatal Stenosis
Lead sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 32
Sex: MALE
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included patients who were treated for meatal stenosis.

Brief summary: The goal of this observational study is to learn about the efficacy of topical steroid treatment for meatal stenosis.

The main question it aims to answer is:

Is steroid therapy effective for treatment of meatal stenosis? Participants already treated for meatal stenosis will be included.


Eligibility criteria: Inclusion Criteria:

* Presence of meatal stenosis

Exclusion Criteria:

* Presence of any anatomical problem or history of surgery

Primary outcomes:
measure: The number of patients who showed significant clinical improvement over the course of the study
timeFrame: 2 months
Secondary outcomes:
measure: The number of participants who exhibited treatment-related improvements in voiding curve pattern and maximal urine flow rate, as assessed by uroflowmetry, which measures the free flow of urine during micturition
timeFrame: 2 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sancaktepe Ilhan Varank Training and Research Hospital
state: Sancaktepe
Study officials:
References:
Clinical trial NCT01398098: Measurement of Gastric Emptying During and After COLOKIT® Intake
Official title: Gastric Emptying Time Assessment During Bowel Preparation With COLOKIT®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colonoscopy
Lead sponsor: Laboratoires Mayoly Spindler
Sponsor class: INDUSTRY
First posted: 2011-07-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Ultra-sound study to assess changes in intragastric volume after bowel preparation.


Eligibility criteria: Inclusion Criteria:

* Subject who signed an informed consent to participate in the trial.
* Subject affiliated with Social Security
* Men and women aged 18 to 75 years.
* Subject with an indication of scheduled outpatient colonoscopy.
* colonoscopy performed within six hours after the second sequence COLOKIT®.
* Subject able to swallow tablets.

Exclusion Criteria:

1. Women pregnant or likely to be (without contraception) or nursing.
2. Subject having any of the following diseases or conditions:

   * allergy or hypersensitivity to the product tested or any of its excipients,
   * nausea, vomiting or abdominal pain,
   * clinically significant renal failure,
   * primary hyperparathyroidism associated with hypercalcemia,
   * congestive heart failure,
   * ascites,
   * a known or suspected bowel obstruction,
   * megacolon (congenital or acquired)
   * intestinal perforation,
   * ileus,
   * an inflammatory disease or suspected inflammatory bowel disease,
   * swallowing disorders,
   * known digestive motor disorders (gastroparesis, scleroderma, mega-esophagus),
   * diabetes mellitus (insulin or non insulin-dependent)
   * a history of gastric surgery (partial or total)
   * a contraindication to the anesthesia required for the completion of the colonoscopy,
   * Any clinical condition which, in the opinion of the investigator, would not allow the subject to perform the test in good conditions.

Primary outcomes:
measure: Percentage of patients with a residual antral volume lower than 20 mL
timeFrame: after 2nd treatment regimen intake
Secondary outcomes:
measure: Adverse events
timeFrame: After drug intake
measure: Acceptability of COLOKIT®.
timeFrame: After drug intake
measure: Colonoscopy results
timeFrame: After colonoscopy.
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Hospital
Study officials:
affiliation: Cochin Hospital
name: Stanislas CHAUSSADE, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coriat R, Polin V, Oudjit A, Henri F, Dhooge M, Leblanc S, Delchambre C, Esch A, Tabouret T, Barret M, Prat F, Chaussade S. Gastric emptying evaluation by ultrasound prior colonoscopy: an easy tool following bowel preparation. World J Gastroenterol. 2014 Oct 7;20(37):13591-8. doi: 10.3748/wjg.v20.i37.13591.
Clinical trial NCT01502098: Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair
Official title: Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair With Double Row Technique in Small or Medium Ruptures. Prospective, Comparative and Randomized.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rotator Cuff Tear
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2011-12-30
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to establish whether one month postoperative immobilization compared early passive motion after rotator cuff arthroscopic repair in small or medium ruptures with double row technique has any healing significance.


Eligibility criteria: Inclusion Criteria:

* Patients skeletally mature (older 18 years old)
* Small or medium rupture of rotator cuff
* Repaired with arthroscopic double row technique

Exclusion Criteria:

* Impossibility to perform MRI (claustrophobic, pacemaker, heart or brain metallic implants)
* AC arthritis with mumford procedure
* Smokers
* Diabetes
* Postoperative complication (severe pain, thrombosis, infection)
* Psychiatric disorder

Primary outcomes:
measure: MRI
timeFrame: 6 months
Secondary outcomes:
measure: ASES (American Shoulder and Elbow Surgeons Subjective Shoulder Scale)
timeFrame: 1, 3, 6 months
measure: Range of Motion
timeFrame: 1, 3, 6 months
measure: VAS of pain
timeFrame: 1, 3, 6 months
measure: WORC
timeFrame: 1, 3, 6 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
References:
Clinical trial NCT00774098: Improving Glycogen Liver Content Will Improve Post-operative Liver Function in Patients Undergoing Major Liver Resections
Official title: Improving Glycogen Liver Content Will Improve Post-operative Liver Function in Patients Undergoing Major Liver Resections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Function
Keywords: all adult patients (>18 years) planned to undergo a major liver resection
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2008-10-17
Enrollment: 60
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: We would like to study the effect of preserving liver glycogen storage by using intravenous dextrose infusion on postoperative liver function and complications after major liver resections.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* planned to undergo a major liver resection at McGill University Health Center (MUHC)

Exclusion Criteria:

* patients known with chronic viral liver disease
* uncontrolled or type one diabetes mellitus (DM)
* patients on oral beta-blocker agents
* patients with unresectable disease determined intra-operatively
* patients unable to give consent for the study.

Primary outcomes:
measure: Postoperative liver function test
timeFrame: Postoperative
Secondary outcomes:
measure: Liver and muscle glycogen, TG, and protein content at beginning and end of the procedure.
timeFrame: Begining + end of the procedure
measure: Incidence of complications
timeFrame: Postoperative
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
References:
citation: Hassanain M, Metrakos P, Fisette A, Doi SA, Schricker T, Lattermann R, Carvalho G, Wykes L, Molla H, Cianflone K. Randomized clinical trial of the impact of insulin therapy on liver function in patients undergoing major liver resection. Br J Surg. 2013 Apr;100(5):610-8. doi: 10.1002/bjs.9034. Epub 2013 Jan 21.
citation: Fisette A, Hassanain M, Metrakos P, Doi SA, Salman A, Schricker T, Lattermann R, Wykes L, Nitschmann E, Smith J, Cianflone K. High-dose insulin therapy reduces postoperative liver dysfunction and complications in liver resection patients through reduced apoptosis and altered inflammation. J Clin Endocrinol Metab. 2012 Jan;97(1):217-26. doi: 10.1210/jc.2011-1598. Epub 2011 Oct 26.
citation: Sato H, Lattermann R, Carvalho G, Sato T, Metrakos P, Hassanain M, Matsukawa T, Schricker T. Perioperative glucose and insulin administration while maintaining normoglycemia (GIN therapy) in patients undergoing major liver resection. Anesth Analg. 2010 Jun 1;110(6):1711-8. doi: 10.1213/ANE.0b013e3181d90087. Epub 2010 Apr 7.