louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05224492: Sulforaphane Use to Effect Inflammatory and Metabolic Changes in Virally Suppressed HIV Patients
Official title: Sulforaphane Use to Effect Inflammatory and Metabolic Changes in Virally Suppressed HIV Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: Sunshine Specialty Health Care
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assess the effects of Sulforaphane supplementation in HIV patients that have achieved viral suppression.


Eligibility criteria: Inclusion Criteria:

* HIV patients on active treatment who have a suppressed viral load and have been virally suppressed for 6 months or more.
* BMI increase of 10% or more since initiation of HIV treatment over a year period.
* BMI equal to or greater than 30.
* 18-85 years of age.

Exclusion Criteria:

* Cancer
* Pregnancy or breastfeeding
* Intolerance to cruciferous vegetables
* Intolerance to sulforaphane
* Gluten Intolerance
* Creatinine \> 1.3 mg/dL
* GFR \< 60
* AST or ALT \> 1.5 times upper limit of normal.
* White cell count \< 2000 cells per ml.
* Hemoglobin \< 10.5 g/dL.
* Platelet count \< 140,000 per ml.

Primary outcomes:
measure: Lipids
timeFrame: 4 months
measure: Inflammatory Markers
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sunshine Specialty Health Care
name: Jose A. Giron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03636789: Evaluation of the Prevalence of Oculomotor Disorders in Patients With Radiologically Isolated Syndrome
Official title: Evaluation of the Prevalence of Oculomotor Disorders in Patients With Radiologically Isolated Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiologically Isolated Syndrome (RIS)
Multiple Sclerosis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims to investigate the prevalence of subclinical oculomotor disorders in a population of patients with radiologically isolated syndrome.


Eligibility criteria: Inclusion Criteria:

* The patient must have given his informed consent and signed the consent form.
* The patient must be affiliated or beneficiary of a health insurance plan.
* The patient is at least 18 years old (≥) and under 50 years old (≤).
* Patients with radiologically isolated syndrome according to the criteria of Okuda et al. (2009)
* Diagnosis of a radiologically isolated syndrome confirmed by the national expert center of Nice for less than 3 years.

Exclusion Criteria:

* The subject participates in another study.
* The subject is in an exclusion period determined by a previous study.
* The subject is under guardianship, curatorship or safeguard of justice.
* The patient is pregnant or breastfeeding
* The subject refuses to sign the consent.
* It is not possible to give the subject informed information.
* Patient presenting a pathological neurological examination.
* Patient with visual acuity less than 5/10 or with ocular instability

Primary outcomes:
measure: Evaluation of the occurrence of oculomotor disorders
timeFrame: Day 0
Secondary outcomes:
measure: To establish the prevalence of each of the different types of oculomotor abnormalities that constitute the oculomotor disorder
timeFrame: Day 0
measure: To identify a correlation between oculomotor disorders and MRI abnormalities.
timeFrame: Day 0
measure: To identify a correlation between oculomotor disorders and the cognitive impairment test (Symbol Digit Modalities Test)
timeFrame: Day 0
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Neurologique Pierre Wertheimer
city: Montpellier
country: France
facility: Hôpital Guy de Chauliac
city: Nice
country: France
facility: Nice University Hospital
city: Nîmes
country: France
facility: Nimes University Hospital
city: Paris
country: France
facility: Pitié Salpêtrière University Hospital (APHP)
city: Toulouse
country: France
facility: Toulouse University Hospital
Study officials:
affiliation: Nîmes University Hospital
name: Giovanni Castelnovo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01621789: Efficacy of Lutein, Zeaxanthine and Trypan Blue to Stain the Anterior Lens Capsule
Official title: A Descriptive Study to Evaluate the Efficacy of the Dye Compound of the Combination of Lutein, Zeaxanthin and Trypan Blue to Stain the Anterior Lens Capsule During Cataract Phacoemulsification.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Keywords: lutein
zeaxanthin
trypan blue
dye
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-06-18
Enrollment: 25
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Effectiveness of lutein, zeaxanthin and trypan blue to stain the anterior lens capsule during cataract phacoemulsification.

Detailed description: Twenty patients with cataract (nuclear, entumecente, total) and indication for cataract surgery will be selected to participate in this study.

Eligibility criteria: Inclusion Criteria

* Patients over 50 years
* Diagnosis of cataract (nuclear, entumecente, total)
* Absence of red reflex
* Indication of cataract surgery

Exclusion Criteria

* Posterior subcapsular cataract
* Any history of eye disease
* Glaucoma
* Eye infection affecting any structure prior ocular
* Any previous ocular surgery

Primary outcomes:
measure: Visibility of the anterior lens capsule after the injection of dye
timeFrame: during the cataract surgery
Secondary outcomes:
measure: Degree of impregnation of the dye
timeFrame: during the surgery
measure: usefulness of the dye
timeFrame: at the end of the cataract surgery
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Dept. of Ophthalmology - UNIFESP/Hospital São Paulo
state: SP
Study officials:
affiliation: Fderal University of São Paulo
name: Rubens Belfort Jr, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vianna LM, Cohen MJ, Muccioli C, Lima A, Sousa-Martins D, Maia M, Belfort R Jr. Efficacy of a lutein-based dye (Phacodyne) for visualizing anterior capsulorhexis during cataract surgery by phacoemulsification. Arq Bras Oftalmol. 2014 May-Jun;77(3):173-7. doi: 10.5935/0004-2749.20140044.
Clinical trial NCT00000189: Gepirone vs Placebo in Treatment of Cocaine Dependence - 3
Official title: Gepirone vs Placebo in Treatment of Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: Cocaine Dependence
Gepirone
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 41
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test antidepressant medication, gepirone, as a pharmacotherapy for cocaine dependent subjects.


Eligibility criteria: Please contact site for information.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: James Cornish, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jenkins SW, Warfield NA, Blaine JD, Cornish J, Ling W, Rosen MI, Urschel H 3rd, Wesson D, Ziedonis D. A pilot trial of gepirone vs. placebo in the treatment of cocaine dependency. Psychopharmacol Bull. 1992;28(1):21-6.
Clinical trial NCT05636189: Effect of Prewarming During Induction of General Anesthesia Combined With Warmed Intravenous Fluid on Core Temperature.
Official title: Effect of Prewarming During Induction of General Anesthesia Combined With Warmed Intravenous Fluid on Core Temperature in Patients Undergoing Urologic Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urologic Diseases
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hypothermia occurs frequently during general anesthesia. This study is to evaluate the efficacy of 10 minutes of prewarming during induction of general anesthesia during urologic surgery.

Detailed description: Hypothermia is of continuous issue in patients undergoing general anesthesia. During urologic operation (transurethral resection of bladder and prostate), bladder irrigation worsens hypothermia. Hence, various methods including prewarming of the patient are used to maintain core temperature during operation.

Prewarming is found to be effective in maintaining core temperature perioperatively by increasing peripheral tissue heat content. However, applying more than 30 minutes of prewarming may be impractical as a clinical routine practice. Hence, developing simple and effective method to prevent hypothermia is expected.

Here, the investigators planned to examine the effect of active warming (10 minutes of warming during induction of general anesthesia and prewarmed intravenous fluid intraoperatively) on hypothermia in patients undergoing urologic operation under general anesthesia.

Eligibility criteria: Inclusion Criteria:

* patients undergoing urologic surgery(transurethral resection of bladder, prostate)

Exclusion Criteria:

* moderate to severe cardiopulmonary, renal impairment
* previous thyroid disease
* any infection sign
* abnormal temperature prior to induction of general anesthesia (\<36'C or \>37.5'C)
* refusal to participate in the study
* unable to understand the study

Primary outcomes:
measure: incidence of hypothermia at the end of the operation
timeFrame: approximately 1-2hours after induction (at the end of operation)
Secondary outcomes:
measure: change in temperature drop before and end of operation
timeFrame: on arrival at the OR upto 1-2hours after induction (at the end of the operation)
measure: thermal comfort
timeFrame: upto 1hour after end of the operation (at discharge of postanesthesia care unit)
measure: incidence of shivering
timeFrame: upto 1 hour after end of the operation (on arrival at the postanesthesia care unit)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sanggye paik hospital
Study officials:
affiliation: assistant professor
name: In-Jung Jun, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04766489: Evaluation of the Treatment Response in Breast Cancer Related Lymphedema
Official title: Evaluation of the Treatment Response in Breast Cancer Related Lymphedema After Mastectomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema of Upper Limb
Breast Cancer
Breast Cancer Lymphedema
Keywords: Lymphedema
Mastectomy
Breast Cancer
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 30
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: This study aims to evaluate the effects of the treatment for breast cancer lymphedema. After taking a detailed history and giving a physical examination, breast cancer related lymphedema patients(n:30) will be informed and will be given Complete Decongestive Therapy, which includes decongestive exercises, manual lymphatic drainage, compression therapy(either through short stretch bandaging and/or pneumatic device) and exercise. Patients will be evaluated with limb volume, lymphedema index acquired through bioimpedance device, QuickDASH for upper extremity function, hand dynamometer for upper extremity grip strength and CLUE(Breast Cancer-Related Lymphedema of the Upper Extremity standardized clinical evaluation tool) scoring for lymphedema before and after the intervention. The values will be compared in order to show whether there are significant differences between before and after scores, and whether CLUE score is correlated with the other indicators of breast cancer related lymphedema.


Eligibility criteria: Inclusion Criteria:

* Unilateral lymphedema of the arm after mastectomy for breast cancer

Exclusion Criteria:

* Bilateral lymphedema
* Primary bone tumor and/or metastasis
* Patients with ongoing radiotherapy
* Circulation disorders of the upper extremity(eg; peripheral vascular disease, thrombosis)
* Patients with infectious lymphedema/elephantiasis
* Presence of local infection in upper extremities(cellulitis) and/or presence of severe systemic infection
* Carcinomatous lymphangitis
* Congestive heart failure(NYHA class 3 or 4)
* History of prosthesis on upper extremities
* Use of drugs which may alter the fluid or electrolyte balance

Primary outcomes:
measure: CLUE score
timeFrame: 1 month
Secondary outcomes:
measure: Hand Grip Strength
timeFrame: 1 Month
measure: Extremity volume
timeFrame: 1 Month
measure: Lymphedema index
timeFrame: 1 Month
measure: QuickDASH
timeFrame: 1 Month
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Faculty of Medicine
state: Bornova
Study officials:
References:
citation: Spinelli B, Kallan MJ, Zhang X, Cheville A, Troxel A, Cohn J, Dean L, Sturgeon K, Evangelista M, Zhang Z, Ebaugh D, Schmitz KH. Intra- and Interrater Reliability and Concurrent Validity of a New Tool for Assessment of Breast Cancer-Related Lymphedema of the Upper Extremity. Arch Phys Med Rehabil. 2019 Feb;100(2):315-326. doi: 10.1016/j.apmr.2018.08.185. Epub 2018 Oct 4.
Clinical trial NCT01169389: Analgesic Control Following Knee Arthroscopy
Official title: Analgesic Control Following Knee Arthroscopy: Results of a Randomised , Double-blinded Trial Comparing a Hyaluronic Acid Supplement to Bupivacaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee
Arthroscopy
Analgesia
Lead sponsor: Orthopaedic Research and Innovation Foundation, Ireland
Sponsor class: OTHER
First posted: 2010-07-26
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to investigate the analgesic effects offered by bupivacaine and Durolane (a hyaluronic acid supplement) administered immediately following the completion of knee arthroscopy.

Detailed description: There is increasing evidence of the toxic effects of intraarticular administration of local anaesthetic. Hyaluronic acid supplementation given at the time of knee arthroscopy has not been fully evaluated as a possible alternative. We have studied the efficacy of a hyaluronic acid (HA) supplement (Durolane®) and a local anaesthetic (Bupivacaine) at providing early and short-term post-operative analgesic control following knee arthroscopy.Patients will be randomised to receive either 10mls of 0.5% Bupivacaine or 10mls of Durolane® into the joint immediately after completion of surgery. WOMAC and Tegner-Lysholm scores were obtained at baseline then at 1, 2, and 6-weeks post surgery. VAS pain scores were obtained at baseline; 1 and 24-hours; and 1, 2 and 6 weeks following surgery.

Eligibility criteria: Inclusion Criteria:

* those undergoing knee arthroscopy for: diagnostic purposes, removal of loose bodies, articular cartilage debridement or, meniscectomy
* age over 18 years

Exclusion Criteria:

* American Society of Anaesthesiologists (ASA) grade ≥3;
* arthroscopic assisted osteotomies;
* a history of two or more prior procedures on the ipsilateral knee;
* post-operative morbidities indirectly linked to the procedure (e.g. anaesthetic complications, DVT or PE);
* systemic steroid requirements;
* previous intra-articular anaesthetic or steroid injection within the last three months;
* intra-articular HA injection within the last nine months;
* intra-articular sepsis within the previous three months;
* prior history of knee arthroplasty, peri-articular fracture, ligamentous instability, inflammatory arthritis or a previous diagnosis of Complex Regional Pain Syndrome.

Primary outcomes:
measure: Visual Analogue Scale pain score
timeFrame: 1 day
measure: Visual Analogue Scale pain score
timeFrame: 1 week
measure: Visual Analogue Scale pain score
timeFrame: 2 weeks
measure: Visual Analogue Scale pain score
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Sports Surgery Clinic
Study officials:
affiliation: Orthopaedic Research and Innovation Foundation, Ireland
name: Kevin J Mulhall, FRCSI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02891889: Description of the Appearance of Brown Fat in Scanner
Official title: Description of the Appearance of Brown Fat in Scanner
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Description of Brown Fat
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients had a thoraco-abdominopelvic PET-CT examination with18F-FDG in a clinical setting which warranted.

Brief summary: The aim of this study is to investigate aspects of brown fat in scanner with injection via the PET-CT study.

Detailed description: Brown fat is metabolically active adipose tissue. It can be responsible in PET-CT of a fixation of 18-FDG and a look of pseudo-infiltration of fat. These aspects can be sources of false positives. The objective here is to gain a better knowledge of the scanner in areas of brown fat.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients since June 2014, who underwent a thoraco-abdominopelvic PET-CT examination with 18F-FDG in the University Hospital of Brest, in a clinical setting which warranted.
* Major Patients
* No opposition formalized

Exclusion Criteria:

* Refusal of participation

Primary outcomes:
measure: Density value
timeFrame: 1 year
Secondary outcomes:
measure: Standard Uptake Values (SUV) adipose tissue "white" and "brown".
timeFrame: 1 year
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: CHRU de Brest
name: Douraied Ben Salem, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00624689: Effects of Milk Fat Globule Membrane (MFGM) - Enriched Formula With Reduced Energy and Protein Content on Growth and Development
Official title: Double-blinded Interventional Study on the Effects of MFGM-enriched Formula With Reduced Energy and Protein Content on Growth and Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant
Keywords: Body composition
Glucose tolerance
Intima-media thickness
Visual acuity
Neurological development
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2008-02-27
Enrollment: 240
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Formula-fed infants differ from breast-fed infants in the growth pattern, risk for obesity and cardiovascular diseases, neurological development and morbidity in infections.

The investigators' hypothesis is that a modified formula with reduced energy and protein content and enrichment with Milk Fat Globule Membrane (MFGM) containing bioactive proteins and phospholipids will reduce the difference between formula-fed and breast-fed infants.


Eligibility criteria: Inclusion Criteria:

* Term infants with birth weight 2500-4500 gr
* Fed with breastmilk only or formula only before 2 months of age

Exclusion Criteria:

* Chronic illness

Primary outcomes:
measure: Body composition
timeFrame: 4 months
Secondary outcomes:
measure: Neurological development
timeFrame: 1 year
Other outcomes:
measure: Neurological development
timeFrame: 6.5 years
Locations:
city: Umeå
country: Sweden
facility: Dept of clinical sciences, pediatrics, Umeå University
Study officials:
References:
citation: Timby N, Hernell O, Vaarala O, Melin M, Lonnerdal B, Domellof M. Infections in infants fed formula supplemented with bovine milk fat globule membranes. J Pediatr Gastroenterol Nutr. 2015 Mar;60(3):384-9. doi: 10.1097/MPG.0000000000000624.
citation: Timby N, Domellof E, Hernell O, Lonnerdal B, Domellof M. Neurodevelopment, nutrition, and growth until 12 mo of age in infants fed a low-energy, low-protein formula supplemented with bovine milk fat globule membranes: a randomized controlled trial. Am J Clin Nutr. 2014 Apr;99(4):860-8. doi: 10.3945/ajcn.113.064295. Epub 2014 Feb 5.
Clinical trial NCT00385489: Study Evaluating LXR-623 in Healthy Japanese Adults
Official title: Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of LXR-623 Administered Orally to Healthy Japanese Male Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-10-09
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety of LXR-623 in healthy Japanese subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy, Japanese Males aged 20-45 years

Exclusion Criteria:

* A history or active presence of clinically important medical disease

Primary outcomes:
measure: Safety
Secondary outcomes:
Other outcomes:
Locations:
city: Toshima-ku
country: Japan
state: Tokyo
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: