louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03747003: Gonadal Function in Young to Middle Aged HIV-infected Men
Official title: Gonadal Function in Young to Middle Aged HIV-infected Men Assessed by Isotopic Dilution-liquid Chromatography-mass Spectrometry (ID-LC-MS/MS) and Chemiluminescent Immunoassay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus
Hypogonadism, Male
Erectile Dysfunction
Lead sponsor: Azienda Ospedaliero-Universitaria di Modena
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 315
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort of Young-to-Middle Aged HIV-infected Patients

Brief summary: HIV infection is associated to premature decline of serum testosterone. However, prevalence and biochemical characterization of hypogonadism in HIV-infected men are still to be well defined. HIV-infection is strongly associated to erectile dysfunction in men, but preliminary data suggest that it is poorly associated with serum testosterone in this context.

Detailed description: The aim of this study is to evaluate the gonadal function of young to middle aged HIV-infected men in order to characterize hypogonadism by assessing circulating total testosterone with either Liquid Chromatography tandem Mass Spectrometry (LC-MS/MS) or chemiluminescent immunoassay. Furthermore, secondary aim is to assess the erectile function through the use of validated questionnaires (International Index of Erectile Function (IIEF) 15 and 5).

Eligibility criteria: Inclusion Criteria:

* Male gender
* Age 18-50 years
* HIV-infection
* Ongoing Highly Active Antiretroviral Therapy

Exclusion Criteria:

* Previous treatment with androgens, anti-androgens
* Severe liver insufficiency
* Severe renal insufficiency

Primary outcomes:
measure: Serum total testosterone
timeFrame: Assessed only once at the moment of enrollment with liquid chromatography tandem mass spectrometry
measure: Serum total testosterone
timeFrame: Assessed only once at the moment of enrollment with chemiluminiscent immunoassay
Secondary outcomes:
measure: Serum free testosterone
timeFrame: Calculated only once at the moment of enrollment
measure: Score at IIEF questionnaire
timeFrame: Assessed only once at the moment of enrollment
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Azienda Ospedaliero - Universitaria di Modena
Study officials:
References:
Clinical trial NCT05411003: Urdu Version Of Nottingham Extended Activities Of Daily Living Scale: Reliability And Validity Study
Official title: Is Nottingham Extended Activities Of Daily Living Scale in Urdu Language a Reliable and Valid Tool to Assess the Level of Independence While Performing Activities of Daily Livings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Nottingham Extended Activities Of Daily Living Scale
Urdu Version
Reliability
Validity
Stroke
Neurological Disorders
Activities of Daily Living
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 80
Sex: ALL
Minimum age (years): 67
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke population of Pakistan over 67 years of age

Brief summary: The aim of the study is to know the validity and reliability as well as to translate and culturally adapt the Nottingham Extended Activities Of Daily Living Scale into Urdu language in Pakistani population of Stroke. This study also aims to correlate the scale with the Modified Barthel Index and Frenchay Activities Index.

Detailed description: As per previous recommendation the English version of Nottingham Extended Activities Of Daily Living Scale will be translated into Urdu and it will be culturally adapted. Nottingham Extended Activities Of Daily Living Scale will be given to eighty individuals of stroke population which were selected on the basis of convenience sampling and the criteria of inclusion and exclusion. Study will investigate both inter-observer and intra-observer reliability of Nottingham Extended Activities Of Daily Living Scale, Modified Barthel Index and Frenchay Activities Index; the 2 set of questionnaire designed will be given to the participants on the same day to be filled, by two observers. And with a gap of half an hour between distributions of first two forms questionnaires will be given for inter-observer assessment. And after a time period of one week a third assessment will be collected by the first observer (intra-observer assessment). Statistical Package of Social Sciences Version 24 will be used for data entry and analysis. Cronbach alpha value will be used for checking internal consistency and intra-class correlation coefficient will be used to analyze test retest reliability.

Eligibility criteria: Inclusion Criteria:

1. Having age of 67 years or more
2. Having stroke
3. Both males and females

Exclusion Criteria:

1. Neurological condition other than stroke
2. Any fracture of lower extremity
3. Any amputation of lower extremity

Primary outcomes:
measure: Nottingham Extended Activities Of Daily Living Scale
timeFrame: 1st day
measure: Frenchay Activities Index
timeFrame: 1st day
measure: Modified Barthel Index
timeFrame: 1st day
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT00616603: The Effects of Dexamethasone on the Duration of Sciatic Nerve Blocks
Official title: The Effects of Dexamethasone on the Duration of Sciatic Nerve Blocks
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: Total Knee Arthroplasty.
Sciatic nerve Blocks.
Dexamethasone.
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2008-02-15
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Dexamethasone is a commonly used steroid. This medication has been used for many years by physicians for many different indications. Recent articles, multiple case reports, and experience at this institution have indicated that dexamethasone successfully prolongs the effective duration of local anesthetics for regional blocks. This can cause a significant reduction in postoperative pain and the decreased need for postoperative narcotics. Although other adjuncts can be used for prolonging nerve blocks, epinephrine causes local vasoconstriction which can cause ischemia and nerve damage in a large nerve such as the sciatic nerve.Dexamethasone will not cause this problem and yet could prolong the duration of a sciatic nerve block. Therefore, the goal of this study is to prospectively evaluate the effectiveness of dexamethasone, both locally through the nerve block and systemically via IV administration, in prolonging the effective duration of local anesthetics when used in sciatic nerve blocks.


Eligibility criteria: Inclusion Criteria:

* Age 18-80 yrs, male or female subjects.
* Subjects must be scheduled to undergo total knee arthroplasty under general anesthesia with consent for a femoral and sciatic nerve block post operatively for pain control.
* American Society of Anesthesiology Class 1,2,3,or 4.
* Capable of speaking and understanding English sufficiently to provide written informed consent and able to respond when asked.
* Weight \> or equal to 60kg.

Exclusion Criteria:

* Any allergies or hypersensitivity to ropivacaine or dexamethasone.
* Subject is on chronic steroids preoperatively for any reason.
* History of chronic pain syndrome (i.e. CPRS, Lumbar radiculopathy).
* History of documented or stated nerve damage or neuropathy to the surgical lower extremity.
* Contraindication to placement of sciatic nerve block.
* Sciatic block placement failure.
* Subject mistakenly receives steroids intraoperatively.

Primary outcomes:
measure: Duration of Sciatic Nerve Block
timeFrame: from the time the block was placed up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
affiliation: Loma Linda University
name: Charles Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05538403: AI Performance for the Detection of Bone Fractures in Children
Official title: Assessment of AI Performance for the Detection of Bone Fractures in Children Aged Less Than 2 Years Old in Suspected Child Abuse Setting.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fracture
Keywords: Aged
Radiography
Paediatric imaging
Artificial intelligence
child abuse
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 210
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged less than 2 years old in suspected child abuse setting

Brief summary: The artificial intelligence (AI) software BoneView (GLEAMER Company, Paris, France) has been designed, tested and validated to detect and locate recent or semi-recent fractures on standard radiographs.

The objective will be to assess the AI performance for the detection of bone fractures in children aged less than 2 years old in suspected child abuse setting.

These patients benefit from a whole body radiography with a double blind reading by a "generalist" radiologist and a radiologist with expertise in child abuse. This readings will be compared with the AI results.

Hypothesis is that AI is effective for child fractures detection and could be of help especially for radiologists who are not experts in child abuse.


Eligibility criteria: Inclusion criteria:

* aged less than 2 years old
* whole body radiography performed for suspected child abuse setting
* report available with a double blind reading (generalist radiologist and radiologist with expertise in child abuse)

Exclusion criteria:

* Radiograph not interpretable ( poor quality)
* AI not applicable

Primary outcomes:
measure: Percentage of fracture detected by AI on radiographs
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital
Study officials:
affiliation: University Hospital, Montpellier
name: Ingrid Millet, PUPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT01121003: Effects of Fructose and Exercise on Hepatic Lipid Metabolism
Official title: Effects of a Weight Maintenance, High Fructose Diet and of Exercise on Hepatic Lipid Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolism
Keywords: Fructose
VLDL-triglycerides
de novo lipogenesis
Human metabolism
Lead sponsor: University of Lausanne
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Vaudois
First posted: 2010-05-11
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 8 healthy male volunteers will be studied each on 3 occasions, ie

* after 4 days on a weight maintenance diet containing 5% simple sugars + low physical activity
* after 4 days on a weight maintenance diet containing 30% fructose + low physical activity
* after 4 days on a weight maintenance diet containing 30% fructose + high physical activity At the end of each of these 3 periods, fructose induced hepatic de novo lipogenesis (13C palmitate synthesis in response to ingestion of a 13C fructose load) and plasma VLDL-triglyceride kinetics (measured with a bolus of 2H-labeled glycerol) will be measured


Eligibility criteria: Inclusion Criteria:

* age between 18 and 30 years
* males
* BMI between 19 and 25
* low to moderate physical activity (\< 3 sessions/week)

Exclusion Criteria:

* smoking
* consumption of alcohol\>50g/week
* consumption of drugs or illicit substances
* food allergies

Primary outcomes:
measure: Hepatic de novo lipogenesis
timeFrame: after 4 days on controlled diet+exercise
Secondary outcomes:
measure: Plasma VLDL-triglyceride kinetics
timeFrame: after 4 days on controlled diet+exercise
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: VD
Study officials:
affiliation: University of Lausanne
name: Luc Tappy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00079703: Diet, Genetics, and CVD Risk Factor Response in Blacks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2004-03-15
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To test the hypothesis that the responsiveness of major and emerging cardiovascular disease risk factors to changes in diet composition clusters within families depending on genetic susceptibility factors.

Detailed description: BACKGROUND:

Reduction in risk of cardiovascular disease (CVD) through dietary change has considerable potential for a beneficial impact on public health. On a population basis, moderation of both lipid profiles and blood pressure can be accomplished readily with a prudent diet. Nevertheless, individual response to dietary impact on CVD risk factors varies widely, presumably as a result of genetic differences. In particular, Blacks who constitute a subpopulation with documented increased risk of morbidity and mortality from CVD would disproportionately benefit from interventions designed to maximize the impact of dietary change tailored to individual genetic makeup. Therefore, study of the influence of diet on CVD risk factors, along with enhanced understanding of the genetic components involved, would greatly potentiate chronic disease interventions.

The study is conducted in response to a Request for Applications issued in October, 2001 on the Interaction of Genes and the Environment in Shaping Risk Factors for Heart, Lung, Blood, and Sleep Disorders.

DESIGN NARRATIVE:

Two-generational family lines will be identified in Blacks with elevated low density lipoprotein-C (LDLC) in probands. The population will be fed a controlled diet contrasting an established heart healthy regimen with a typical American one. Concomitant rigorous genetic, anthropometric, and behavioral evaluation will provide data with which to analyze individual differences in response to consistent dietary intake. In Specific Aim 1, Black, two-generational, families will be recruited and provided interventional diets designed to reduce (or not) LDL-C and blood pressure. In Specific Aim 2, non-genetic predictors of CVD risk factor response will be identified through extensive assessments of baseline behavioral characteristics, anthropometric features, and metabolic factors. In Specific Aim 3, the underlying genetic factors that predispose to response (or the lack of) to dietary interventions will be identified through the examination of polymorphisms in candidate genes and the identification of susceptibility loci by linkage analyses. In Specific Aim 4, interactions between diet, CVD risk factor response and genetic factors will be dissected through measures of potential mediating metabolic pathways.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: LSU Pennington Biomedical Research Center
name: Michael LeFevre
References:
Clinical trial NCT02649543: Comparison of Surgical Site Infection Rate Between Primary, Delayed Primary and Vacuum Assisted Closures.
Official title: Comparison of Surgical Site Infection Rate Between Primary, Delayed Primary and Vacuum Assisted Closures. A Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound Infection
Keywords: Surgical Wound Infection
Negative-Pressure Wound Therapy
Wound Closure Techniques
Laparotomy.
Abdominal Wound Closure Techniques
Lead sponsor: Tecnologico de Monterrey
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of the study is to compare infection rates between primary, delayed primary and vacuum assisted closures in contaminated and dirty/infected laparotomy wounds.

Detailed description: The objective of this study is to compare infection rates between primary, delayed primary and vacuum assisted closures in contaminated and dirty/infected laparotomy wounds.

Social, demographic, surgical, postsurgical and medical variables were registered. A descriptive analysis expressed as total and percentages, medians and interquartile ranges. Comparison between groups was made using the Kruskal-Wallis, U-Mann Whitney or Chi-squared as appropriate. A p value of less than 0.05 was considered significant.

Eligibility criteria: Inclusion Criteria:

* Laparotomy wound classified as class III or IV according to CDC's Criteria for Defining a Surgical Site Infection.

Exclusion Criteria:

* Patient refusal to participate in the trial

Primary outcomes:
measure: Incidence of Surgical Wound Infection with each Wound Closure Technique
timeFrame: Two months
Secondary outcomes:
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Escuela Nacional de Medicina, Tecnologico de Monterrey
state: Nuevo Leon
Study officials:
affiliation: Escuela Nacional de Medicina, Tecnologico de Monterrey
name: Gerardo Lozano Balderas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04561843: 3D Transperineal Ultrasound of the Pelvic Floor Muscles in Women With Pelvic Floor Disorders: A Cross-sectional Study.
Official title: 3D Transperineal Ultrasound of the Pelvic Floor Muscles in Women With Pelvic Floor Disorders: A Cross-sectional Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Floor Disorders
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 91
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Women complaining of any of the pelvic floor disorder symptoms such as: Pelvic organ prolapse (POP), Stress urinary incontinence (SUI), urgency symptoms of obstructed defecation, fecal incontinence (FI), pelvic pain, and/or sexual problems.

Brief summary: The present study aimed to evaluate the levator ani muscle in both morphology (rest), and function (contraction and valsalva) in symptomatic women using 2D, 3D trans-perineum ultrasound (TPUS), to compare these features to clinical digital palpation and symptoms, and helping in diagnosis of muscle dysfunction.

Detailed description: The prevalence of Pelvic floor dysfunction is high, affecting millions of women worldwide in different conditions (social, sexual, physical, psychological, domestic relationships, financial, etc.), many people still have no, limited knowledge, or awareness of pelvic floor health and so do not have, or seek how to prevent or correct these disorders . This dysfunction may be presented as pelvic organ prolapse, stress urinary incontinence, fecal incontinence , chronic pelvic pain, sexual problems, and/or chronic constipation . Assessment of pelvic floor muscle activity plays a major role in Urogynecology and physiotherapy as a part of the conservative treatment of pelvic floor disorders (PFD) . Presence of Levator avulsion is a major risk factor for female pelvic organ prolapse (POP) and recurrence after surgical correction . This dysfunction can be diagnosed clinically using vaginal palpation . Palpation is subjective, less reproducible, and difficult to teach than imaging methods \[6\]. Studies that used ultrasound for assessment of pelvic floor muscle activity and strength are still few . The present study aimed to evaluate the levator ani muscle in both morphology (rest), and function (contraction and valsalva) in symptomatic women using 2D, 3D trans-perineum ultrasound (TPUS), to compare these features to clinical digital palpation and symptoms, and helping in diagnosis of muscle dysfunction.

Eligibility criteria: Inclusion Criteria:

* Women complaining of any of the pelvic floor disorder symptoms.

Exclusion Criteria:

* women with a history of chronic intestinal disease (Crohn's disease, ulcerative colitis), acute gastroenteritis within the week preceding consultation women who underwent any surgical or diagnostic procedure involving the anal canal

Primary outcomes:
measure: pelvic floor muscle function.
timeFrame: 15 miutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01716143: Left Atrium Substrate Based Ablation Plus Circumferential Pulmonary Vein Isolation to Treat Chronic Atrial Fibrillation
Official title: Left Atrium Substrate Based Ablation Plus Circumferential Pulmonary Vein Isolation in the Treatment of Persistent and Long-standing Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
catheter ablation
Mapping
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2012-10-29
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether left atrium substrate based ablation plus circumferential is effective in the treatment of persistent and long-standing atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

All persistent or permanent AF patients with refractory or intolerant to at least one Class 1 or Class 3 antiarrhythmic medication.

Exclusion Criteria:

1. Patients with paroxysmal AF (self-terminating episodes lasting \< 7 day)
2. Patients who have had a previous AF ablation procedure
3. Pregnancy

Primary outcomes:
measure: The primary study end point was freedom from atrial arrhythmias off antiarrhythmic drugs at 3,6,12,18 and 24 months after a single-ablation. procedure.
timeFrame: 3 years
Secondary outcomes:
measure: The percentage of macro-reentrant atrial tachycardia in recurrent arrhythmias after atrial fibrillation ablation
timeFrame: December 31, 2012
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Division of Cardiology, the First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References:
citation: Yang G, Yang B, Wei Y, Zhang F, Ju W, Chen H, Li M, Gu K, Lin Y, Wang B, Cao K, Kojodjojo P, Chen M. Catheter Ablation of Nonparoxysmal Atrial Fibrillation Using Electrophysiologically Guided Substrate Modification During Sinus Rhythm After Pulmonary Vein Isolation. Circ Arrhythm Electrophysiol. 2016 Feb;9(2):e003382. doi: 10.1161/CIRCEP.115.003382.