louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05643378: Role and Outcome of Endovascular Revascularization of Chronic Limb Ischaemia
Official title: Role and Outcome of Endovascular Revacularization of Chronic Limb Threatening Ischaemia in Patients With Chronic Kidney Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Limb Ischemia, Critical
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients fulfilled these criteria will be included in this study as an availability sample for year duration sample size : 100 patients

Brief summary: identify the safety and efficacy of percutaneous transluminal angioplasty in critical limb ischaemia patients with chronic kidney dieases

Detailed description: patients with chronic kidney diseases are at higher risk of developing peripheral artery diseases needing revascularization of diseased arteries via endovascular transluminal angioplasty

Eligibility criteria: Inclusion Criteria:

* all patients with chronic kidney diseases on medical treatment or on dialysis and have critical limb ischaemia

Exclusion Criteria:

* patients with acute renal failure and lower limb ischaemia.
* chronic kidney diseased patients underwent previous intervention or surgery for lower limb ischaemia.
* patients presented with acute limb ischaemia

Primary outcomes:
measure: one year evaluation for maintaining vessel patency without restenosis or need for re intervention in 100 participants
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Dayama A, Tsilimparis N, Kolakowski S, Matolo NM, Humphries MD. Clinical outcomes of bypass-first versus endovascular-first strategy in patients with chronic limb-threatening ischemia due to infrageniculate arterial disease. J Vasc Surg. 2019 Jan;69(1):156-163.e1. doi: 10.1016/j.jvs.2018.05.244.
citation: Imamura T. Optimal therapeutic strategy for those with chronic kidney disease and peripheral artery disease receiving peripheral vascular intervention. Clin Cardiol. 2020 Dec;43(12):1348. doi: 10.1002/clc.23483. Epub 2020 Oct 19. No abstract available.
citation: Moussa Pacha H, Al-Khadra Y, Darmoch F, Soud M, Mamas MA, Moussa Pacha A, Zaitoun A, Kaki A, AlJaroudi WA, Alraies MC. In-hospital outcome of peripheral vascular intervention in dialysis-dependent end-stage renal disease patients. Catheter Cardiovasc Interv. 2020 Feb 15;95(3):E84-E95. doi: 10.1002/ccd.28522. Epub 2019 Oct 21.
Clinical trial NCT02740478: Reassure Device: Measurement Accuracy of Continuous Respiration Rate
Official title: A Comparison of the Non-contact Reassure Device Measurement Accuracy of Respiration Rate With SOMNOScreen, When Measured on a Continuous Basis Whilst the Subjects Are Asleep
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Accuracy of Respiration Rate Measurement
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2016-04-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Quantity 20 volunteer subjects willing to undergo the trial: lying still for 2 hours, following a pre-scripted set on lying positions.

Brief summary: The aim of the trial is to prove that the Reassure10.5 GHz sensor is equivalent in performance to the SomnoScreen Plus RC in indicating the breathing rate of adult subjects over a number of hours when the subjects are lying still or in bed asleep

Detailed description: Each recording comprised at least 2 hours duration. The subject was lying on a bed, wearing the SomnoScreen and with the Reassure on a bed-side table in the recommended position: at arm's length, pointing at the subject's upper torso.

The subject was asked to lie in set positions on the bed for 20 minutes at a time. The data was recorded continuously for the duration of the trial and so encompassed the acts of turning from one position to another and any minor movement made by the subject. If the subject fell asleep during the trial, they were only woken when it came time for the next position change.

Key Duration Remarks Supine \>=20minutes Subject Lying on back Prone \>=20minutes Subject Lying face down Facing Left \>=20minutes Subject's Chest facing Reassure device Facing Right \>=20minutes Subject's Back facing Reassure device Foetal Left \>=20minutes Subject's Chest facing Reassure device Foetal Right \>=20minutes Subject's Back facing Reassure device

Eligibility criteria: Inclusion Criteria:

* Willing Volunteer

Exclusion Criteria:

* Restless leg syndrome

Primary outcomes:
measure: Respiration Rate Comparability
timeFrame: 2 hour recording
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: ResMed Sensor Technologies Ltd
name: Paul Phillips, MA, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lim WS, Carty SM, Macfarlane JT, Anthony RE, Christian J, Dakin KS, Dennis PM. Respiratory rate measurement in adults--how reliable is it? Respir Med. 2002 Jan;96(1):31-3. doi: 10.1053/rmed.2001.1203.
Clinical trial NCT01184378: Tolerance and Digestibility of a New Formula in Healthy Infants
Official title: Study of Tolerance and Lipid Digestibility of a Formula in Healthy 3 Months Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Steatorrhea
Growth
Keywords: infant formula
dairy fat
soluble milk protein
Lead sponsor: Lactalis
Sponsor class: INDUSTRY
First posted: 2010-08-18
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The great majority of infants formula contain fats exclusively from vegetable oil. Nevertheless, the use of both vegetable and dairy lipids is on a real interest to obtain an infant formula closer to the nutritional composition of maternal milk.


Eligibility criteria: Inclusion Criteria:

* normal growth;
* considered as healthy by the investigator according to the medical interrogation and the clinical examination;
* receiving exclusively infant formula for at least 15 days.
* without any solid food during the month of the study

Exclusion Criteria:

* Premature born children or small born weights;
* Children breast-fed or weaned for less than 15 days;
* Children with solid food
* Food allergy, particularly in milk proteins allergy , and lactose intolerance ;
* Tumoral, inflammatory, cardiac, lung, renal, digestive diseases(syndrome of malabsorption);
* Digestive pathology previous to the inclusion, in particular infectious (rotavirus, gastroenteritis) or functional symptoms (important stomach pains, colicky) having required a lot of change in formula quality;
* Children under medical treatment (ex: paracetamol).

Primary outcomes:
measure: digestibility of lipids in formula
timeFrame: during the 30d consumption period
Secondary outcomes:
measure: tolerance and growth
timeFrame: during the 30d of formula intake
Other outcomes:
Locations:
city: Dijon
country: France
facility: Faculté de Médecine
city: Rennes
country: France
facility: Hopital Mère-Enfants
Study officials:
References:
Clinical trial NCT06129578: Plant Protein Supplementation Within a Healthy Lifestyle Modulates Plasma Circulating Amino Acids and Improves the Health Status of Overweight Individuals
Official title: Plant Protein Supplementation Within a Healthy Lifestyle Modulates Plasma Circulating Amino Acids and Improves the Health Status of Overweight Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Metabolic Syndrome
Metabolic Disorder
Inflammation
Immune System and Related Disorders
Lead sponsor: University of Seville
Sponsor class: OTHER
Collaborators: name: Spanish National Research Council
First posted: 2023-11-13
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: A dietary pattern based on Mediterranean diet has been reported as healthy for humans, as well as doing aerobic exercise regularly, diminishing the development of potential inflammation in subjects. Protein intake has been proposed as nutritional strategy to further improve these positives outcomes in terms of preventing inflammation diseases. In this work, overweight patients followed a Mediterranean diet together with aerobic exercise according to WHO-guidelines and were supplemented with 20 g of hemp protein/day, for twelve weeks.

Anthropometric and biochemical measures (including analysis of oligoelements), as well as plasma circulating amino acids were evaluated in each patient at the end of the intervention, to assess whether biologically relevant changes could be observed.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 65 years old
* waist circumference ≥94cm in men and ≥88cm in women
* MET\<4

Exclusion Criteria:

* prediabetic patients on pharmacotherapy
* subjects suffering from medical issues (e.g., diabetes or another chronic disease)
* smokers
* pregnant or lactating women.

Primary outcomes:
measure: Evolution of cytokines in intervention
timeFrame: [Time Frame: Up to 6 hours]
measure: Effect of the intervention on subjects' biochemical measures
timeFrame: [Time Frame: Up to 6 hours]
measure: Effect of the intervention on the serum amino acid levels of the subjects.
timeFrame: [Time Frame: Up to 6 hours]
measure: Effect of the intervention on the serum mineral levels of the subjects.
timeFrame: [Time Frame: Up to 6 hours]
Secondary outcomes:
Other outcomes:
Locations:
city: Seville
country: Spain
facility: University of Seville
Study officials:
References:
Clinical trial NCT02592278: Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars
Official title: Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Caries
Keywords: Dental Caries
Fluoride Varnish
Preschool child
Prevention
Lead sponsor: Universidad Iberoamericana
Sponsor class: OTHER
Collaborators: name: Colgate Palmolive
First posted: 2015-10-30
Enrollment: 180
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine the effectiveness of fluoride varnishes in the prevention of dental caries lesions in erupting permanent first molars, in high-risk patients. Using as reference ICDAS criteria, when the success means that the surface maintain an ICDAS value 0 and failure that has change in ICDAS value 0 to 1.

Sample: The sample comprise 180 patients between 6-7 years old with high-risk of dental caries.

Study design: It proposed an experimental design randomized into 3 groups according to the frequency of topical fluoride application.(Group A: every 6 month; Group B: every 3 month; Group C: positive control).


Eligibility criteria: Inclusion Criteria:

* Informed Consent from parents.
* Child assent
* High risk of dental caries
* At least one sound first permanent molar (ICDAS=0)

Exclusion Criteria:

* Bad behaviour
* Any systemic condition, disability

Primary outcomes:
measure: Number of first permanent molars with caries Lesion (taking into account ICDAS criteria)
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Iberoamericana
name: Ninoska Abreu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01102478: Bioequivalency Study of Losartan Potassium/Hydrochlorothiazide 100 mg/25 mg Tablet Under Fasted Conditions
Official title: A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Losartan Potassium/Hydrochlorothiazide Tablets 100 mg/25 mg Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-04-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Losartan Potassium/Hydrochlorothiazide 100/25 mg tablet under fasted conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to losartan potassium hydrochlorothiazide or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence determined by statistical comparison Cmax
timeFrame: 25 days
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: CEDRA Clinical Research, LLC
state: Texas
Study officials:
affiliation: CEDRA Clinical Research, LLC
name: Daniel V Freeland, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01834378: Diabetes Prevention in Clinical Practice.
Official title: Diabetes Prevention in Primary Health Care With Special Emphasis on Physical Activity.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: diabetes
insulin resistance
exercise
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We randomize individuals with impaired glucose tolerance to one of three arms for degree of physical activity: 1. Continue with your current life style; 2. Ordinary life activities for increased physical activity; 3. Scheduled group activities for changed behavior. The overall aim is to focus on change of physical activity and to keep other life style activities more or less unchanged (diet, smoking, etc) and the effect on metabolic variables.


Eligibility criteria: Inclusion Criteria:

1. Impaired glucose tolerance
2. Age: 20-85yrs

Exclusion Criteria:

1. Type2 diabetes
2. Significant disease making life style changes unlikely to happen
3. Unable to communicate in Swedish

Primary outcomes:
measure: HOMA IR
timeFrame: 12 months after inclusion (baseline)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00712478: Observational Study Describing Conditions for Intensification of Insulin Therapy in Type 2 Diabetes
Official title: Observational Study on Efficacy of Intensification of Insulin Therapy to at Least 3 Daily Injections in Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-07-10
Enrollment: 114
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women aged 40 years old and more with type 2 diabetes

Brief summary: This study is conducted in Europe. The aim of this observational study is to determine diabetes control improvement, during the third month of follow-up after insulin intensification to at least 3 daily insulin injections, in assessing the proportion of uncontrolled fasting and postprandial glycaemia values recorded on a diary.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes patients
* Treatment with two insulin daily injections and needing insulin intensification regimen to at least three daily injections
* HbA1c greater than or equal to 8.0%

Exclusion Criteria:

* Patients not performing glycaemia self-measurements
* Secondary diabetes
* Requirement of or use of an insulin pump
* Treatment with corticoids

Primary outcomes:
measure: Evaluate improvement of diabetes control with fasting glycemia and after diner glycemia measurements
timeFrame: After 3 months
Secondary outcomes:
measure: Evaluate improvement of diabetes control with fasting glycemia and after diner glycemia measurements
timeFrame: After first 2 months
Other outcomes:
Locations:
city: Paris La Défense
country: France
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06996678: Effect of Virtual Reality on Cognitive Skills
Official title: Investigation of the Effect of Virtual Reality on Cognitive Skills in Children With Attention Deficit Hyperactivity Disorders
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Virtual Reality
Keywords: Attention deficit and hyperactivity disorder
cognitive functions
motor skills
Virtual Reality
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups with an intervention group and a control group
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to investigate the effects of virtual reality (VR) intervention on cognitive skills in children with attention deficit hyperactivity disorder (ADHD).

Detailed description: The study was designed as a randomized controlled trial. A simple randomization method will be used to randomly assign individuals to two groups (intervention and control groups). A simple randomization method will be used where the intervention and control group papers are selected from a sealed envelope. Following the initial assessment of each participant, one of the papers labeled "intervention" or "control" will be randomly selected. This decision will determine whether the individual will be assigned to the intervention or control group. The study will be conducted at Hacettepe University. The intervention group will receive occupational therapy (OT) for 30 minutes once a week for 8 weeks and will play a virtual reality (VR) game with the Sony PlayStation 2 Eye Toy system for 20 minutes. Both the intervention and control groups will receive occupational therapy for only 30 minutes once a week for 8 weeks. The Dynamic Occupational Therapy Cognitive Assessment (DOTCA-Ch) will be administered before and after the intervention to assess children's cognitive functions.

Eligibility criteria: Inclusion Criteria:

* being between the ages of 7-12, having diagnosed with ADHD by a child psychiatrist in accordance with the DSM-5 diagnostic criteria, having stabilized medications used for ADHD, being open to communication, and being able to understand and follow instructions at a basic level

Exclusion Criteria:

* having any neurological, orthopedic or psychiatric diagnosis in addition to ADHD diagnosis, having undergone any surgical intervention in the last 3 months, being inadequate in understanding visual and auditory commands, and having a visual or hearing impairment.

Primary outcomes:
measure: Dynamic Occupational Therapy Cognitive Assessment (DOTCA-Ch)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT00395278: Development of Serologic Assays for Human Herpes Virus-8
Official title: Development of Serologic Assays for Human Herpes Virus-8
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kaposi Sarcoma
HIV Infection
Keywords: Antibody
Kaposi's Sarcoma
HIV
Kaposi Sarcoma
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2006-11-02
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stored samples from individuals who had previously participated in studies conducted by the NIAID CCMD HIV/AIDS program

Brief summary: Dr. Burbelo and colleagues have developed a technique for rapidly and quantitatively detecting antibody responses in sera to a variety of pathogens using recombinant proteins. We would like to apply this technique to develop an assay for detecting antibodies to HHV-8 (KSHV, the etiologic agents of Kaposi's sarcoma, an AIDS-defining condition). We initially plan to examine samples from patients with Kaposi's sarcoma, since all those patients are almost certainly infected with HHV-8. We are thus using samples from patients with previously diagnosed Kaposi's sarcoma. The samples in question are stored at the NCI FCRF repository operated by SAIC Frederick or in Rockville, MD.

Detailed description: Our colleagues have developed a technique for rapidly and quantitatively detecting antibody responses in sera to a variety of antigens using recombinant proteins. We would like to apply this technique to develop an assay for detecting antibodies to HHV- 8 (KSHV, the etiologic agent of Kaposi s sarcoma, an AIDS-defining condition). In addition we would like to potentially measure antibody responses to HIV, other infectious agents, and human antigens, to see if antibodies (or high antibody titers) to these antigens are associated with Kaposi s sarcoma or HIV infection. We initially plan to examine samples from patients with Kaposi s sarcoma, since all those patients are almost certainly infected with HHV-8. We would subsequently plan to examine samples from HIV positive and HIV negative patients without known Kaposi s sarcoma. We are thus requesting permission to use samples from patients with and without previously diagnosed Kaposi's Sarcoma. In addition to antibody testing, we would also like to examine these samples for evidence of infection with other infectious agents, such as newly identified or unknown viruses, using techniques such as PCR or deep

sequencing.

Eligibility criteria: * Data analysis only

Primary outcomes:
measure: HHV8 serology
timeFrame: At sample collection
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Institutes of Health Clinical Center (CC)
name: Joseph A Kovacs, M.D.
role: PRINCIPAL_INVESTIGATOR
References: