louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03948126: Prevalence of Geophagy and Knowledge About Its Health Effects Among Native Sub-Saharan Africa, Caribbean and South America Healthy Adults Living in France
Official title: Prevalence of Geophagy and Knowledge About Its Health Effects Among Native Sub-Saharan Africa, Caribbean and South America Healthy Adults Living in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Geophagia
Keywords: geophagia
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults originating from Sub-Saharan Africa, South America and the Caribbean and attending a travel medicine and international vaccination consultation in France.

Brief summary: Since geophagy is widespread among women from Sub-Saharan Africa, South America and the Caribbean, we aimed to determine the frequency of geophagy and the level of knowledge about its health effects among healthy adults originating from these countries and attending a travel medicine and international vaccination consultation in France.

Detailed description: Since geophagy is widespread among women from Sub-Saharan Africa, South America and the Caribbean, we aimed to determine the frequency of geophagy and the level of knowledge about its health effects among healthy adults originating from these countries and attending a travel medicine and international vaccination consultation in France.

A cross-sectional study was performed in the consultation for travel medicine and international vaccination in Reims University Hospital, France. All adult travellers who were natives of Sub Saharan Africa, South America and the Caribbean or born in France of parents from these countries were eligible to complete a confidential questionnaire about geophagy, which was defined as eating soil or clay. Descriptive analysis was performed.

Eligibility criteria: inclusion criteria : All adult travellers who were natives of Sub Saharan Africa, South America and the Caribbean or born in France of parents from these countries

Primary outcomes:
measure: Prevalence of geophagia
timeFrame: Day 0
Secondary outcomes:
measure: Awareness about iron-deficient anaemia
timeFrame: Day 0
measure: Awareness about soil-transmitted intestinal parasitic infections
timeFrame: Day 0
measure: Awareness about constipation
timeFrame: Day 0
measure: Awareness about intestinal occlusion
timeFrame: Day 0
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
citation: Decaudin P, Kanagaratnam L, Kmiec I, Nguyen Y, Migault C, Lebrun D, Hentzien M, Bertin E, Drame M, Bani-Sadr F. Prevalence of geophagy and knowledge about its health effects among native Sub-Saharan Africa, Caribbean and South America healthy adults living in France. Eat Weight Disord. 2020 Apr;25(2):465-469. doi: 10.1007/s40519-018-0624-9. Epub 2018 Dec 13.
Clinical trial NCT03170726: Impact of Preemptive Intravenous Ibuprofen on Intraoperative Analgesia in Third Molar Teeth
Official title: Impact of Preemptive Intravenous Ibuprofen on Intraoperative Analgesia in Third Molar Teeth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preemptive Intravenous Ibuprofen
Intraoperative Analgesia
Keywords: Preemptive intravenous ibuprofen
Intraoperative analgesia
Third molar tooth surgery
Lead sponsor: Erzincan University
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was planned to evaluate the analgesic efficacy of preemptive intravenous (iv) ibuprofen on pain occurring during and after the mandibular third molar surgeon


Eligibility criteria: Inclusion Criteria:

* Patients who are to be elected third molar tooth extraction
* Patients between the ages of 20-35
* Patients who are symptomatic
* Third molar tooth angular or horizontal settled patients

Exclusion Criteria:

* Patients who refuse to participate in the study
* Patients under 20 years old, over 35 years old
* Patients who are allergic to known non-steroidal anti-inflammatory drugs
* Pregnant patients
* Patients with severe liver failure,
* patients with severe renal insufficiency

Primary outcomes:
measure: intraoperative pain as assessed by visual analogue scale
timeFrame: 5 month
Secondary outcomes:
measure: postoperative pain as assessed by visual analogue scale
timeFrame: 5 month
Other outcomes:
Locations:
city: Erzincan
country: Turkey
facility: Erzincan University
Study officials:
affiliation: Erzincan University
name: ilke kupeli
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jerjes W, El-Maaytah M, Swinson B, Banu B, Upile T, D'Sa S, Al-Khawalde M, Chaib B, Hopper C. Experience versus complication rate in third molar surgery. Head Face Med. 2006 May 25;2:14. doi: 10.1186/1746-160X-2-14.
citation: Oscier CD, Milner QJ. Peri-operative use of paracetamol. Anaesthesia. 2009 Jan;64(1):65-72. doi: 10.1111/j.1365-2044.2008.05674.x.
citation: Hariharan S, Moseley H, Kumar A, Raju S. The effect of preemptive analgesia in postoperative pain relief--a prospective double-blind randomized study. Pain Med. 2009 Jan;10(1):49-53. doi: 10.1111/j.1526-4637.2008.00547.x.
citation: Trampitsch E, Pipam W, Moertl M, Sadjak A, Dorn C, Sittl R, Likar R. [Preemptive randomized, double-blind study with lornoxicam in gynecological surgery]. Schmerz. 2003 Jan;17(1):4-10. doi: 10.1007/s00482-001-0129-7. German.
citation: Buvanendran A, Kroin JS. Multimodal analgesia for controlling acute postoperative pain. Curr Opin Anaesthesiol. 2009 Oct;22(5):588-93. doi: 10.1097/ACO.0b013e328330373a.
Clinical trial NCT01755026: Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery
Official title: Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery Receiving Two Differing Doses of Pre-operative Cefazolin.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cesarean Delivery
Wound Infection
Obesity
Keywords: Cesarean Delivery
Wound infection
Obesity
Prophylactic antibiotics
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2012-12-21
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Patients undergoing Cesarean delivery (C-Section) with a body mass index of 35 or greater (this BMI number is in the obese range) will be given either 2 grams or 4 grams of an antibiotic before surgery. The antibiotic is intended to prevent infection from the surgery.It is unknown what the best dose for large women is for the usual medicine used for this purpose (an antibiotic medicine called cefazolin).Samples of the tissue just under the skin will be biopsied at the time the incision is made and at the time the cut is stitched or stapled closed. A sample of the muscle of the womb will be taken as the womb is stitched closed after the delivery. Blood tests will be done at the start and end of surgery to test the antibiotic level. A blood sample will be taken from the umbilical cord after the baby has been delivered and the umbilical cord has been cut. The umbilical cord blood sample will be tested for the antibiotic level.These tests will be used to find out if the usual dose of medicine is enough or if more medicine is needed to prevent infection in large women undergoing c-sections.


Eligibility criteria: Inclusion Criteria:

1. Age 18 years or above
2. Body mass index (BMI) of 35 or greater at the time of the first obstetric clinic visit
3. Undergoing cesarean delivery

Exclusion Criteria:

1. BMI less than 35.
2. Not undergoing Cesarean delivery.
3. Age less than 18 years.
4. Pre-existing infection.
5. Allergy to cephalosporin medications or a history of an anaphylactic reaction to penicillin.
6. Cesarean delivery being performed under emergent circumstances.

Primary outcomes:
measure: Cefazolin Levels
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
Study officials:
affiliation: West Virginia University
name: William H Holls, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: West Virginia University
name: Michael L Stitely, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00564226: SSR240600C Treatment in Women With Overactive Bladder
Official title: A Placebo Controlled Randomized, 12-week, Dose-ranging, Double-blind Study Versus Placebo Using Tolterodine as a Study Calibrator, to Evaluate Efficacy and Safety of SSR240600C in Women With Overactive Bladder Including Urge Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder
Keywords: urge urinary incontinence
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-11-27
Enrollment: 345
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the efficacy of SSR240600C in women with overactive bladder compared to placebo using tolterodine as a study calibrator.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of overactive bladder

Exclusion Criteria:

* Stress incontinence or mixed incontinence where stress incontinence is the predominant component based on prior history
* Urinary incontinence due to cause other than detrusor overactivity (eg, overflow incontinence)
* Current Urinary Tract Infection (UTI) or frequent UTIs
* Urinary retention or other evidence of poor detrusor function
* Pain during voiding or bladder pain without voiding
* History of radiation cystitis or history of pelvic irradiation
* History of interstitial cystitis or bladder related pain syndrome

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Primary outcomes:
measure: Change from baseline in the number of micturitions per 24 hours
timeFrame: at week 12
Secondary outcomes:
measure: Changes from baseline in number of urge urinary incontinence episodes, in number of urgency episodes, in number of nocturia episodes, in volume of urine per void
timeFrame: at week 12
measure: Safety of SSR240600C
timeFrame: at week 12
measure: Quality of life
timeFrame: at week 12
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Aministrative Office
state: New Jersey
city: Laval
country: Canada
facility: Sanofi-Aventis Administrative Office
state: Quebec
city: Praha
country: Czech Republic
facility: Sanofi-Aventis Administrative Office
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Berlin
country: Germany
facility: Sanofi-Aventis Administrative Office
city: Gouda
country: Netherlands
facility: Sanofi-Aventis Administrative Office
city: Porto Salvo
country: Portugal
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01749826: Inflammatory Responses to Acute and Chronic Opioid Exposure in Humans
Official title: Inflammatory Responses to Acute and Chronic Opioid Exposure in Humans
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Inflammation
Keywords: Inflammation, opioids, immune system
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We aim to examine the extent to which inflammation is affected by acute and chronic opioid exposure.

Detailed description: We are interested in learning how the immune system and the inflammation process is effected by acute and chronic opioid exposure. Preliminary evidence in animal models show that acute opioid exposure leads to decreased inflammatory responses, while chronic opioid exposure causes increased inflammatory responses, as measured by local cytokine release at the site of injury. Translating these findings to humans will lead to important new mechanistic knowledge that may ultimately improve our ability to treat pain.

Eligibility criteria: Inclusion Criteria:

* 18-60 years old
* Healthy volunteer
* Not allergic to remifentanil

Exclusion Criteria:

* Patients younger than 18 or older than 70
* Patients unwilling or unable to follow study instructions
* Patients who don't speak English
* Patients who are taking prescription opioid medications (e.g. vicodin, percocet) or are unwilling to refrain from taking anti-inflammatory medications such as Advil or Naproxen during 2 weeks prior to and during the 1 month study

Primary outcomes:
measure: Changes in Cytokine Release
timeFrame: Changes in cytokine release are compared between blood samples drawn on Day 1 and Day 30
Secondary outcomes:
measure: Laser Doppler Images
timeFrame: Changes in laser doppler images are measured between images taken on Day 1 and Day 30
measure: Peltier Device-Heat Pain
timeFrame: Differences in heat pain are assessed between measurements taken on Day 1 and Day 30
measure: Mechanical Pain Stimuli
timeFrame: Changes in mechanical pain stimuli will be assessed between measurements taken on Day 1 and Day 30
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Dr Larry Fu-nien Chu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06965426: Effect of Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation on Skin Carotenoid Concentration: A Six-Month, Placebo-Controlled Crossover Study
Official title: Effect of Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation on Skin Carotenoid Concentration: A Six-Month, Placebo-Controlled Crossover Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Macular Degenerative Disease
Keywords: Carotenoids
Macular degeneration
MacuHealth
Lead sponsor: Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,
Sponsor class: OTHER
Collaborators: name: MacuHealth
First posted: 2025-05-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: To compare skin carotenoid scores over 12 weeks of individuals randomized to placebo or MacuHealth and comparing that to a 12 week crossover evaluation.


Eligibility criteria: Inclusion Criteria:

* Adult patients 18-50 years old of any sex and any race.
* Willing to comply with the protocol instructions.
* Has read (or has had read to), understood, and signed an Informed Consent.

Exclusion Criteria:

* Current Smoker
* Pregnant, plan to become pregnant or breastfeeding
* History of any non-controlled disease states including diabetes, cancer, heart diseases ETC (we need to confirm this with previous protocols) BMI greater than 30
* Currently taking MacuHealth or similar supplements or previous use

Primary outcomes:
measure: Carotenoid concentration
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00271726: Operative Treatment of Extraarticular Colles' Fractures of the Distal Radius (OTEC)
Official title: Prospective, Randomized, Multi-Center Pilot Study on the Treatment of Unstable, Extraarticular Colles Fractures of the Distal Radius by Palmar Locking Plate, External Fixator or Kirschner Wires
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colles' Fracture
Radius Fractures
Keywords: distal radius fracture
extraarticular Colles fracture
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: Philipps University Marburg
First posted: 2006-01-04
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, multi-center pilot study of unstable extraarticular fractures of the distal radius with dorsal displacement of the distal fragment in elderly patients. The patients are randomly assigned to osteosynthesis with palmar locking plate, external fixator, or Kirschner wires.

The aim of this pilot study is to allow a sample size calculation for a main randomized controlled trial (RCT). The primary outcome criterion is the functional status measured by the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Secondary outcome criteria are pain, range of motion (ROM), grip strength, and radiological parameters. Since this is a pilot study it is intended to generate a study hypothesis for the main RCT.


Eligibility criteria: Inclusion Criteria:

* Isolated, extraarticular, unstable Colles' fracture of the metaphysis of the distal radius (AO type A3)
* Age 65 years or older
* Patient agreed with and signed the "informed consent" form

Exclusion Criteria:

* Fractures older than 7 days (more than 1 week between injury and treatment)
* Other injuries of the hand
* Other relevant injuries of the upper extremities
* Open fracture
* Patients with one hand missing
* Clinical or radiological signs of any rheumatoid disease, osteoarthritis, or polyarthritis
* Previous skeletal injury or severe soft tissue injury of the arm
* History of drug or alcohol abuse
* Patients unlikely to cooperate or attend all scheduled visits
* Patients who have participated in any other device or drug clinical trial within the previous month
* Patients with legal incompetence

Primary outcomes:
measure: Functional status measured by DASH questionnaire
Secondary outcomes:
measure: Pain
measure: Range of motion (ROM)
measure: Grip strength
measure: Radiological parameters
measure: Feasibility
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Department of Trauma and Hand Surgery, University Hospital
Study officials:
affiliation: Department of Trauma and Hand Surgery, University Hospital, Moorenstrasse 5, D - 40225 Düsseldorf
name: Michael Schädel-Höpfner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02557126: Study of URC102 to Assess the Safety and Efficacy in Gout Patients
Official title: A Placebo-controlled, Randomized, Double-blind, Multicenter Phase 2 Study to Assess the Efficacy and Safety of URC102 in Gout Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gout
Hyperuricemia
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2015-09-23
Enrollment: 76
Sex: MALE
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess safety, Pharmacokinetics/Pharmacodynamics and Urate Lowering Effect of URC102 in gout patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with gout

Exclusion Criteria:

* Participated in other clinical study within 12 weeks prior to enrollment, and received an investigational product (including placebo)

Primary outcomes:
measure: Trend of serum uric acid reduction rate (%)
timeFrame: 2 weeks
measure: Trend of serum uric acid levels (mg/dL)
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: JW Pharmaceutical
state: Seocho-dong
Study officials:
References:
Clinical trial NCT00291226: Glycine vs Placebo for the Schizophrenia Prodrome
Official title: Glycine vs Placebo for the Schizophrenia Prodrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Schizophrenia Prodrome
Keywords: schizophrenia prodrome
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Glytech, Inc
name: National Alliance for Research on Schizophrenia and Depression
First posted: 2006-02-13
Enrollment: 8
Sex: ALL
Minimum age (years): 13
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Glycine is a natural amino acid neurotransmitter that acts as a co-agonist at NMDA receptors in brain. We hypothesize that symptoms of the schizophrenia prodrome will improve with glycine to a greater degree than with placebo.

Detailed description: A pilot clinical trial comparing glycine to placebo in patients with the schizophrenia prodrome.

Eligibility criteria: Inclusion Criteria:

* meet SIPS criteria for schizophrenia prodrome

Exclusion Criteria:

* history of psychosis

Primary outcomes:
measure: Scale of Prodromal Symptoms Total Score
timeFrame: Baseline
measure: Change in Scale of Prodromal Symptoms Total Score
timeFrame: Change from Baseline at 8 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: PRIME Clinic
state: Connecticut
Study officials:
affiliation: Yale University
name: Scott W Woods, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woods SW, Walsh BC, Hawkins KA, Miller TJ, Saksa JR, D'Souza DC, Pearlson GD, Javitt DC, McGlashan TH, Krystal JH. Glycine treatment of the risk syndrome for psychosis: report of two pilot studies. Eur Neuropsychopharmacol. 2013 Aug;23(8):931-40. doi: 10.1016/j.euroneuro.2012.09.008. Epub 2012 Oct 22.