louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05309928: Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy
Official title: A Rational Approach to the Identification of New Treatment Options to Prevent Congenital Syphilis: Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Pregnancy Related
Keywords: pharmacokinetics
amoxicillin
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 20
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study design is a prospective phase I pharmacokinetic study focused on dosing of 500 mg oral amoxicillin administration in pregnant women in the 2nd and 3rd trimester.
Primary purpose: BASIC_SCIENCE

Brief summary: The study design is a prospective phase I pharmacokinetic study focused on dosing of 500 mg oral amoxicillin administration in pregnant women in the 2nd and 3rd trimester.

Detailed description: Twenty adult pregnant women in good health who are admitted for preterm premature rupture of membranes (24-34 weeks gestational age) will be enrolled in this intensive pharmacokinetic study. Basic information will be collected from the medical record including age, weight, height, pregnancy dating, medications, and allergies.

Eligibility criteria: Inclusion Criteria:

1. Pregnant, engaged in prenatal care with a medical provider (at least one visit)
2. Estimated gestational age 24-34 weeks
3. Able to provide informed consent
4. English speaking

Exclusion Criteria:

1. Receipt of amoxicillin within the past 7 days. (Routine GBS prophylaxis with ampicillin or other antibiotic and routine surgical prophylaxis prior to cesarean with cephalexin and azithromycin 500 mg IV is allowed).
2. Known hypersensitivity or intolerance of amoxicillin, penicillin, other beta lactam or cephalosporin antibiotics.
3. Known renal impairment (serum creatinine ≥1.2 mg/dL).
4. Active concomitant medications known to interact with amoxicillin: allopurinol, methotrexate, mycophenolate, immune checkpoint inhibitors (ie. pembrolizumab), tetracyclines (ie. doxycycline), vitamin K antagonists (ie. warfarin), aminoglycosides (ie. gentamicin).

Primary outcomes:
measure: Change of Amoxicillin Level in Plasma during Pregnancy
timeFrame: 0, 1, 2, 3, 4, 6, 8 hours after medication administration
measure: Amoxicillin Level in Cord Blood
timeFrame: at delivery
measure: Change of Amoxicillin Level in Plasma in the Postpartum state
timeFrame: 0, 1, 2, 3, 4, 6, 8 hours after medication administration
Secondary outcomes:
measure: additional pharmacologic measures
timeFrame: 1-8 hours after administration
measure: Additional pharmacologic measure
timeFrame: 1-8 hours after administration
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jodie Dionne, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05078528: Low-cost Imaging Technology for Global Prevention of Cervical Cancer
Official title: Low-cost Mobile Colposcopy and Confocal Imaging for Global Prevention of Cervical Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Intraepithelial Neoplasia
Keywords: image analysis
cancer prevention
cervical intraepithelial neoplasia
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
Collaborators: name: William Marsh Rice University
name: M.D. Anderson Cancer Center
name: Irmandade Santa Casa de Misericórdia de Porto Alegre
First posted: 2021-10-14
Enrollment: 1060
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Cervical cancer remains the first or second leading cause of cancer death among women in many low-and middle-income countries. Cervical cancer prevention programs in low-resource settings are hampered by a lack of personnel with appropriate clinical expertise, lack of pathology services, and lack of associated infrastructure. There is an urgent need for appropriate diagnostic tools to enable accurate screening and diagnosis in low-resource settings. The purpose of this study is to develop and validate a low-cost Multimodal Mobile Colposcope (MMC) for global cervical cancer prevention programs. This new device will combine the imaging capabilities of a mobile colposcope with the microscopic imaging capabilities of a fiber-optic confocal imaging probe.


Eligibility criteria: Inclusion Criteria:

* Women \>25 years of age;
* Women undergoing colposcopy due to abnormal cervical screening or follow-up for a history of dysplasia;
* Women of childbearing potential must have a negative urine or blood pregnancy test;
* Ability to understand and willingness to provide informed consent by signing specific Informed Consent Document.

Exclusion Criteria:

* Women under 25 years of age;
* Women who have undergone hysterectomy with removal of the cervix;
* Women with known allergy to proflavine or acriflavine;
* Women who are pregnant or nursing at the time of enrollment;
* Incapacitated women or in vulnerable situations or who are not willing to give consent;

Primary outcomes:
measure: Develop and validate a Multimodal Mobile Colposcope (MMC)
timeFrame: Day 1 - at the colposcopy day
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericórdia de Porto Alegre
state: Rio Grande do Sul
city: Barretos
country: Brazil
facility: Barretos Cancer Hospital
state: São Paulo
Study officials:
References:
citation: Hunt B, Fregnani JHTG, Brenes D, Schwarz RA, Salcedo MP, Possati-Resende JC, Antoniazzi M, de Oliveira Fonseca B, Santana IVV, de Macedo Matsushita G, Castle PE, Schmeler KM, Richards-Kortum R. Cervical lesion assessment using real-time microendoscopy image analysis in Brazil: The CLARA study. Int J Cancer. 2021 Jul 15;149(2):431-441. doi: 10.1002/ijc.33543. Epub 2021 Apr 3.
Clinical trial NCT01582828: Serial Hybrid Atrial Fibrillation Ablation
Official title: Serial Hybrid Atrial Fibrillation Ablation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial
fibrillation
pvi
vats
ablation
hybrid
Lead sponsor: Medisch Spectrum Twente
Sponsor class: OTHER
First posted: 2012-04-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of (long-standing) persistent atrial fibrillation (AF) remains cumbersome and the surgical (epicardial) approach seems to be the most effective. Still, however a significant amount of failures exist which is mostly due to incompleteness of the surgical ablation lines. Checking, and if necessary additional ablation, of these lines afterwards endocardially by the cardiologist (the so-called serial hybrid approach) could overcome this problem.


Eligibility criteria: Inclusion Criteria:

* patients are screened and accepted for pulmonary vein isolation according to the current guidelines
* long standing persistent or persistent AF as defined in the guidelines
* left atrial size needs to be more than \>46 mm on long axis or \>35 cc/m2
* CHADSVASC score should be more than 0 as an indicator of a substantial substrate for atrial fibrillation.

Exclusion Criteria:

* Significant coronary artery disease has to be excluded as a trigger for AF by means of cardiac CT, if necessary a coronary angiogram will be performed.
* Previous PVI ablation (epicardial or endocardial) or cardiac surgery.
* Significant valvular disease present on echo.
* Concomitant cardiac surgery needed.

Primary outcomes:
measure: Atrial fibrillation Freedom
timeFrame: 12 months
Secondary outcomes:
measure: re-isolation
timeFrame: 8-10 weeks
measure: Percentage of cross-over
timeFrame: 1 year
measure: Complications
timeFrame: 1 year
measure: Atrial fibrillation Burden
timeFrame: 1 year
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
state: OV
Study officials:
affiliation: Medisch Spectrum Twente
name: Jurren van Opstal, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01370928: Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial
Official title: Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Adenomas
Keywords: Colonoscopy performance
Pain
Discomfort
Screening
Colorectal cancer
Colorectal cancer screening, diagnostics of adenomas
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2011-06-10
Enrollment: 190
Sex: ALL
Minimum age (years): 54
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare the performance of a new prototype colonoscope with a standard colonoscope used world-wide today. The prototype colonoscope is more flaccid with a smaller diameter than the standard colonoscope. The hypothesis to be tested is that the prototype will improve negotiation of sharp bends and inflict less discomfort or pain to the patient. Both colonoscopes are manufactured by the same company.


Eligibility criteria: Inclusion Criteria:

* Persons included in the NordICC trial are eligible for inclusion
* For information about the NordICC trial see clinicaltrials.gov NCT00883792

Exclusion Criteria:

* Pregnancy
* Persons younger than 18 years
* Persons unable to comprehend the information given
* not possible to start the examination without prior administration of sedation/analgesics

Primary outcomes:
measure: Patients´ evaluation of pain and discomfort
timeFrame: 24 hours
Secondary outcomes:
measure: Time used to reach the caecum
timeFrame: 1 hour
measure: Need for sedation/analgesics during the colonoscopy procedure
timeFrame: 1 hour
measure: Need to change to a different colonoscope to complete the procedure
timeFrame: 10 minutes
measure: Caecum intubation rate
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Sørlandet Sykehus HF
Study officials:
affiliation: Oslo University Hospital
name: Michael Bretthauer, MD, Ph.d.
role: STUDY_CHAIR
References:
citation: Garborg KK, Loberg M, Matre J, Holme O, Kalager M, Hoff G, Bretthauer M. Reduced pain during screening colonoscopy with an ultrathin colonoscope: a randomized controlled trial. Endoscopy. 2012 Aug;44(8):740-6. doi: 10.1055/s-0032-1309755. Epub 2012 May 23.
Clinical trial NCT00746928: Cardiovascular Consequences of Intermittent Hypoxia in Healthy Subjects
Official title: Cardiovascular Consequences of Intermittent Hypoxia in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea Syndrome
Keywords: Blood pressure
Hypertension
sympathetic control
chemosensitivity
baroreflex
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2008-09-04
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study is a prospective field evaluation to assess the effects of the chronic Intermittent Hypoxia exposure in 12 healthy humans.

Precisely, the study was designed to :

Set up a new model of Chronic Intermittent Hypoxia (CIH) applied to healthy human. This CIH is mimicking the CIH undergone by patients suffering from Sleep Apnea Syndrome.

Evaluate the cardiovascular effect of CIH. Neuronal and humoral sympathetic control, blood pressure control, vascular resistance.

Evaluate the Sleep quality, the ventilation under exposure and the long terms effect on ventilation control of CIH (central and peripheral chemoreflex).

Investigates the biological aspects of CIH exposure.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Any history or significant medical condition

Primary outcomes:
measure: Blood Pressure
timeFrame: Two Weeks
Secondary outcomes:
measure: Neuronal and humoral sympathetic control and vascular resistance.
timeFrame: Two weeks
measure: Sleep quality
timeFrame: Two Weeks
measure: The ventilation under exposure and the long terms effect on ventilation control of CIH (central and peripheral chemoreflex)
timeFrame: two weeks
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Pulmonary Function and sleep Lab, CHU Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Renaud Tamisier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01113528: Omega-3 and Aspirin in Periodontal Regeneration
Official title: The Effect of Host Response Modulation Therapy (Omega 3 Plus Low-dose Aspirin) as an Adjunctive Treatment of Chronic Periodontitis (Clinical and Biochemical Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Periodontal Disease
Keywords: Bone allograft
IL-1
IL-10
periodontal regeneration
omega-3
aspirin
Lead sponsor: October 6 University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2010-04-30
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of systemic administration of omega 3 PUFA plus low dose aspirin as an adjunctive therapy to regenerative modality of grade II furcation defects in periodontitis patients.

Detailed description: In this study, we tested the hypothesis that the administration of omega 3 PUFA plus low dose aspirin would augment the results following regenerative therapy of furcation defects in chronic periodontitis patients.

Eligibility criteria: Inclusion Criteria:

* suffering moderate to sever chronic periodontitis and displaying at least a single grade II furcation defect according to Glickman's classification 1953, determined by both clinical and radiographic examinations;
* free from systemic diseases known to influence the periodontal condition and not receiving any medication known to affect the periodontal status;
* have not receive any periodontal therapy for a minimum of 6 months prior to the study.

Exclusion Criteria:

* Known hypersensitivity or allergy to one of the used medications
* Pregnancy or lactation
* Heavy smoking (more than 10cigarretes/day)
* History of alcohol abuse
* Participation in other clinical trials

Primary outcomes:
measure: Cytokine levels
timeFrame: six months
Secondary outcomes:
measure: Gingival inflammation
timeFrame: six months
measure: Healing after regenerative therapy
timeFrame: six months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: October 6 University
state: Overnorate of 6 October
Study officials:
affiliation: October 6 University
name: Amr M. Elkhouli, ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06118528: EAT: A Reliable Eating Assessment Technology for Free-living Individuals
Official title: EAT: A Reliable Eating Assessment Technology for Free-living Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wearable Electronic Device
Keywords: Wearable
Electronic
Device
Behavior
Eat
Privacy
Camera
Obesity
Obfuscation
Filter
Cartoon
Blur
Raw
Edge
Burden
Wearer
Bystander
Monitor
BMI
Calories
Tool
Algorithm
RGB
Thermal
Data
Health
Chest
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-11-07
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study utilizes a small, privacy-conscious wearable device intended to monitor human behaviors. The device is worn around the neck, capturing the wearer's head and upper torso within its field of view, and records color images without audio. Participants visit the lab for consent, device training and recording of several activities using the device. Participants will then take the device home and wear it during their normal schedules for four "active" weeks. During each active week, participants will wear the device, keep a log of all food and drink items consumed throughout the day and participate in unscheduled phone calls with a dietitian. A "washout" week occurs in between each active week in which participants do not need to complete any study tasks. Alongside the device, we have included three privacy filters (blur, edge, and avatar) capable of obscuring faces and objects seen in the device-captured images. All participants will be subject to unfiltered recording during their first week followed by a different filter each following active week in a random order. At the start of each active week, participants view an example of what their recorded images will look like that week (given the privacy filter). At the end of the seven weeks, participants will return the device and provide the lab with feedback on the design of the device and its privacy-preserving features.


Eligibility criteria: Inclusion Criteria:

* BMI greater than or equal to 18.5
* Chicago metropolitan area resident
* Able to speak, read and write in English
* Has a valid phone number
* Owns a smartphone
* Has access to a computer

Exclusion Criteria:

* Pregnant or breastfeeding individuals
* Experienced significant weight loss/gain in the last three months (25 lbs or more)
* Diagnosed with or has a family history of genetic obesity syndromes (e.g., Prader-Willi, Bardet-Biedl, Cohen Syndrome)
* Member of household enrolled in the study

Primary outcomes:
measure: Daily wear time
timeFrame: 7 days
Secondary outcomes:
measure: Self-report acceptability
timeFrame: 7 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
Clinical trial NCT06855628: Assessment of Novel Metabolic Imaging Modalities as A Predictor Of Therapeutic EfficacyiIn Glioblastoma (GBM)
Official title: Assessment Of A Novel Metabolic Imaging Modalities As A Predictor Of Therapeutic Efficacy In Glioblastoma (GBM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Glioma
GBM
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2025-03-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to evaluate the prognostic capacity of DMI in a trial assessing the efficacy of adding BPM31510, a lipid nano dispersion of CoQ10 to standard treatment of Glioblastoma (GBM).


Eligibility criteria: Inclusion Criteria:

* Any participant that consents to entry into the Phase II BPM31510 parent study (BPM31510IV-11)
* Women of childbearing potential must have a negative pregnancy test
* Ability to understand and the willingness to provide written informed consent.

Exclusion Criteria:

* Refuse to have an IV
* Allergy to MRI contrasts
* Diabetic patients who are taking insulin

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: up to 36 months
measure: Overall Survival (OS)
timeFrame: up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Lawarence Recht
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01949428: House Dust Mite Observational Study
Official title: A Field Study to Observe Symptom Scores and Allergy Medication Usage in Subjects With a History of House Dust Mite-Induced Rhinoconjunctivitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinoconjunctivitis
Keywords: HDM Allergy
Rhinoconjunctivitis
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
Collaborators: name: Pharm-Olam International
First posted: 2013-09-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a History of House Dust Mite-Induced Rhinoconjunctivitis

Brief summary: A Field Study to Observe Symptom Scores and Allergy Medication Usage in Subjects with a History of House Dust Mite-Induced Rhinoconjunctivitis

Detailed description: House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in HDM-sensitised patients.

The proposed observational study is designed to gather information on subjects with HDM-related rhinoconjunctivitis.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18-65 years
* A history of moderate to severe rhinoconjunctivitis (sneezing, rhinorrhoea, itchy nose, nasal blockage, and/or itchy/watery/red/sore eyes) consistent with allergy to HDM for at least 1 year.
* Non-asthmatic, or asthma controlled by Step 1 or 2 treatment as defined by GINA for at least one month.
* Subjects must have a 7-day reflective TRSS (i.e., reflective over the previous 7 days) of ≥12 and must have a score of ≥2 in at least two of the individual symptom components.
* Subjects must have Der p or Der f specific IgE ≥0.35 kU/L as measured by ImmunoCAP®. A blood draw for HDM-specific IgE must be performed during the Screening period.
* Subjects must have Der p or Der f specific IgE ≥0.35 kU/L as measured by ImmunoCAP®. A blood draw for HDM-specific IgE must be performed during the Screening period.

Exclusion Criteria:

* Clinically significant confounding symptoms of allergy to relevant local seasonal allergens (e.g., ragweed, mugwort, tree, grass, mountain cedar, mould) and cannot complete the Screening and Observation period outside the respective allergy seasons.
* Previous immunotherapy treatment with any HDMA for more than 1 month within 5 years prior to screening

Primary outcomes:
measure: To Document the combined Total Rhinocnjunctivitis Systom Scores (TRSS) and Total allergy medication score
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Pharm-Olam
state: Ontario
Study officials:
References: