louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05686096: A Study to Evaluate the Absorption, Metabolism, and Excretion (ADME) of BMS-986435
Official title: A Phase 1, Open-label, Single Dose Study to Assess the Absorption, Metabolism, and Excretion of [14C]BMS-986435 in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Absorption, Metabolism, and Excretion (ADME)
MYK-224
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-01-17
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the absorption, metabolism, excretion; and to evaluate the safety and tolerability of BMS-986435 in healthy male participants

Participants will be admitted to the study site for 3 weeks.


Eligibility criteria: Key Inclusion Criteria:

* Body mass index between 18 and 32 kg/m\^2, inclusive, at screening. - Healthy male participants as determined by the investigator and sponsor.
* Adequate acoustic windows to enable accurate transthoracic echocardiogram (TTE) assessment of parameters of left ventricular (LV) systolic function by TTE.
* Documented left ventricular ejection fraction (LVEF) ≥ 60% at screening.

Key Exclusion Criteria:

* Any acute or chronic medical illness.
* History of dizziness and/or recurrent headaches (ie, daily headaches lasting for a 1-week duration in the last month prior to study intervention administration).

Head injury in the last 2 years, intracranial tumor, or aneurysm. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: Up to 45 days
measure: Time to maximum observed concentration (Tmax)
timeFrame: Up to 45 days
measure: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
timeFrame: Up to 45 days
Secondary outcomes:
measure: Metabolite profiling of BMS-986435 in plasma, urine, and feces
timeFrame: Up to 45 days
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 45 days
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 45 days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 45 days
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 45 days
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 45 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Local Institution - 0001
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04063696: AntibaCterial presCribing & OraL Health Practice
Official title: AntibaCterial presCribing & OraL Health Practice: The Leeds Dental Extraction Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dental Anxiety
Tooth Loss
Keywords: tooth extraction
dental anxiety
antibiotic
oral health
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: Oral and Dental Research Trust
First posted: 2019-08-21
Enrollment: 300
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending Leeds Dental Institute for tooth extraction.

Brief summary: A study by Allied Health Professionals to explore the experience of patients undergoing tooth extraction at Leeds Dental Institute in relation to antibiotic medication, dental anxiety and oral health practices

Detailed description: Consented patients attending the Leeds Dental Institute for tooth extraction will be asked to complete 3 questionnaires in order for the researchers to understand more about the background of patients who have teeth extracted at the centre. The study will focus on the patient's previous experience of dentistry such as whether they have had antibiotics prescribed for toothache, whether they suffer from dental anxiety and how they regularly look after their oral health.

Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing extraction of one or more teet
* Parents/Guardians of children aged 5-12 years old undergoing extraction of one or more teeth
* Patients aged 13-15 undergoing extraction of one or more teeth
* Patients and Parents/Guardians who are willing to give informed consent or assent to complete questionnaires

Exclusion Criteria:

* Patients, parents/guardians unable or unwilling to provide informed consent
* Parents/Guardians of patients aged less than 5 years old
* Patients or parents who are unable to communicate directly with the health person carrying out the treatment

Primary outcomes:
measure: Main endpoint: WHO Oral Health Questionnaire for Adults (Annexe 7) or WHO Oral Health Questionnaire for Children (Annexe 8)
timeFrame: Up to 2 hours before tooth extraction procedure
measure: Main endpoint: Antimicrobial survey
timeFrame: Up to 2 hours before tooth extraction procedure
measure: Main endpoint: Modified Child Dental Anxiety Scale (MCDAS) v1.0 dated 17/10/2016 (Wong et al 1998)
timeFrame: Up to 2 hours before tooth extraction procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Dental Institute
state: West Yorkshire
Study officials:
affiliation: University of Leeds
name: Sue Pavitt, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00765596: Ghrelin Changes After Roux-en-Y Gastric Bypass
Official title: Ghrelin Changes After Roux-en-Y Gastric Bypass: Does Gastric Pouch vs. Gastric Remnant Feeding Affect Secretion?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Insulin Resistance
Keywords: Obesity
Insulin resistance
Gastric tube
Ghrelin
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2008-10-03
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects were morbidly obese, scheduled for RYGB with gastric tube placement. Controls were matched to subjects by BMI, age, gender.

Brief summary: The purpose of this study is to determine whether gastric division (via Roux-en-Y gastric bypass) with resultant fundic isolation will alter the pattern(s) of Ghrelin secretion in the early post-operative period following feeding in morbidly obese subjects.


Eligibility criteria: Inclusion Criteria:

* Serum creatinine and liver function tests \< upper limits of normal
* Stable body weights for the past three months
* Women will have a negative pregnancy test
* patients who are already scheduled for RYGB with gastrostomy tube placement

Exclusion Criteria:

* Significant hepatic enzyme elevations (more than 100% of upper limits of normal)
* Serum creatinine \> 1.5 mg/dl
* history of ketoacidosis or current metabolic acidosis
* current use of oral anticoagulants
* Positive pregnancy test (beta-human chorionic gonadotrophin) for females
* intercurrent infections
* patients with prior gastric operations

Primary outcomes:
measure: Ghrelin
timeFrame: pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op
Secondary outcomes:
measure: HOMA
timeFrame: pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op
measure: metabolic hormones
timeFrame: pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Department of Surgery, Vanderbilt University Medical Center
name: Naji N Abumrad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Departement of Surgery, Vanderbilt University Medical Center
name: Erik N Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hansen EN, Tamboli RA, Isbell JM, Saliba J, Dunn JP, Marks-Shulman PA, Abumrad NN. Role of the foregut in the early improvement in glucose tolerance and insulin sensitivity following Roux-en-Y gastric bypass surgery. Am J Physiol Gastrointest Liver Physiol. 2011 May;300(5):G795-802. doi: 10.1152/ajpgi.00019.2011. Epub 2011 Mar 3.
citation: Isbell JM, Tamboli RA, Hansen EN, Saliba J, Dunn JP, Phillips SE, Marks-Shulman PA, Abumrad NN. The importance of caloric restriction in the early improvements in insulin sensitivity after Roux-en-Y gastric bypass surgery. Diabetes Care. 2010 Jul;33(7):1438-42. doi: 10.2337/dc09-2107. Epub 2010 Apr 5.
Clinical trial NCT02789696: Prevalence of Acromegaly in a Diagnostic Consultation for Sleep Apnea Syndrome
Official title: Prevalence of Acromegaly in a Diagnostic Consultation for Sleep Apnea Syndrome: A Prospective, National and Multicentric Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndrome
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Ipsen
First posted: 2016-06-03
Enrollment: 880
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Prevalence of sleep apnea syndrome in patients with acromegaly is about 70%. It seems that comorbidities of arterial hypertension or type 2 diabetes are more severe in patients with acromegaly and sleep apnea syndrome. Besides sleep apnea syndrome associated to acromegaly gives rise to few symptoms, that explains it is under diagnosed. The mechanisms of the association are based on maxillofacial modifications linked to acromegaly, a thickening of soft tissues with deposits of glyco-aminoglycanes but probably also because of the associated obesity, of the potential existence of a goiter and a muscular dystrophy of the dilatative muscles of the pharynx.

At present, no study clearly documented prevalence of acromegaly in a diagnostic consultation for sleep apnea syndrome.

Detailed description: 60 investigators will participate to this study. They will be chosen among those participating to the sleep observatory of the federation of pneumology (www.osfp.fr).

All participating pneumologists would have to fill in the questionnaire (co-morbidities, concomitant treatments, biological analysis) directly online and also clinical signs and symptoms of acromegaly. A blood test for the insulin-like growth factor (IGF-1) dosage will be systematically prescribed to the patient. Pneumologists will have to include all consecutive patients presenting with sleep apnea syndrome suspicion.

According to first IGF-1 results, patients may have to do a second blood test in a referenced laboratory to confirm the dosage.

Eligibility criteria: Inclusion Criteria:

* Body mass index \< 40 kg/m2
* Patient consulting for sleep breathing disorder
* Informed consent signed
* patient covered by french health insurance

Exclusion Criteria:

* Other sleep disorder already diagnosed
* Pregnant women
* Patients participating in an other study

Primary outcomes:
measure: determination of acromegaly prevalence
timeFrame: 1 year
Secondary outcomes:
measure: description of clinical signs of acromegaly associated to sleep apnea syndrome (Epworth scale)
timeFrame: 1 year
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
state: Isère
Study officials:
affiliation: University Hospital, Grenoble
name: Jean-Louis PEPIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01345396: Influence of an Asthma Education Programme on Asthma Control During Pregnancy
Official title: Assessment of an Educational Programme for Pregnant Asthmatic Women on the Level of Asthma Control and Unscheduled Doctor Visits During the Pregnancy
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Health education
Pregnancy
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2011-05-02
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Asthma is the most frequent respiratory disease during pregnancy. In a third of cases, the level of asthma control can decrease during the pregnancy, especially between the 29th and the 36th week. The occurrence of such complications are linked with a high asthma severity level just before the conception and an history of respiratory complications in a previous pregnancy. Many reviews and recommendations claim that pregnant women with asthma should be included in an educational progamme. However, this is poorly studied. The purpose of this study is to observe if an educational programme given before the 20th weeks of gestation has an effect on asthma control until the end of gestation.


Eligibility criteria: Inclusion Criteria:

* Pregnant woman (less than 20 weeks of gestation at the inclusion time)
* Diagnosis of asthma before the pregnancy (clinical history and specific medications used)
* Agreement to enter into the study

Exclusion Criteria:

* Pregnant woman (more than 20 weeks of gestation at the inclusion time)
* History of major respiratory problems during previous pregnancy(ies)
* Refusal to enter into the study

Primary outcomes:
measure: The level of asthma control
timeFrame: Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
Secondary outcomes:
measure: Number of unscheduled visits to the doctor for asthma
timeFrame: Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
measure: Quality of life
timeFrame: Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
measure: Knowledge about asthma
timeFrame: Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU St Pierre; pulmonology department
Study officials:
affiliation: CHU St Pierre Brussels
name: Vincent Ninane, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05825196: Study of Serum Tumor Markers of HBV Associated HCC
Official title: Study of Serum Tumor Markers of HBV Associated HCC
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HCC
Keywords: HBV related HCC
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: the patients admitted to the First Affiliated Hospital of Shandong First Medical University

Brief summary: In this study, the investigators will detect the expression of four potential HBV-related HCC biomarkers: PGIR,FAM3C,LAMB1 and SDC4 in tumor tissues and peripheral blood, to explore the specific molecular markers for the early diagnosis of HBV-related HCC.

Detailed description: Paired hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) and adjacent liver tissues were selected, and the mRNA and protein expressions of the PGIR,FAM3C,LAMB1 and SDC4 biomarkers in tissues were detected by RT-PCR, western Blot and immunohistochemical analysis. At the same time, healthy subjects were selected as the control group, and mRNA and protein expression levels of the above molecules in blood were detected by RT-PCR and ELISA. At the same time, the correlation between the above biomarkers and the clinical data of patients, such as diagnosis, pathological grading, recurrence, metastasis and survival time was statistically analyzed.

Eligibility criteria: Inclusion Criteria:

* No local or systemic treatment was performed before surgery. The patients were finally diagnosed with HBV-related HCC by examination and imaging examination, and the clinicopathologic data were complete.

Exclusion Criteria:

* Patients with benign liver diseases, such as hepatic cysts and hepatic hemangiomas, or have tumors other than HBV-related HCC.

Primary outcomes:
measure: Detection of RNA and protein for diagnosis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02040896: Who Contributes to the Ordering of CT Scans in Emergency Department Patients?
Official title: Who Contributes to the Ordering of Computed Tomography in Emergency Department Patients? A Prospective Survey Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergency
Keywords: computed tomography
emergency
CT scan
ordering behavior
diagnosis
radiation
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-01-20
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from age 0 to \<17 years, and patients age 18 years and older with traumatic and non-traumatic presentations, who visit Adult and Pediatric EDs and receive a CT scan during their ED visit

Brief summary: The primary objectives are:

1. To investigate which healthcare workers and other individuals contribute to the decision to order computed tomography (CT) scans for emergency department (ED) patients.
2. To investigate the specific reasons healthcare workers and other individuals order or request CT scans for ED patients.
3. To determine the frequency of clinically important actions following CT scan results.

Once the drivers of ED CT utilization are identified, interventions including education, incentives for compliance with evidence-based best practices, and interventions for noncompliance could be targeted appropriately.


Eligibility criteria: Inclusion Criteria:

- Patients from age 0 to \<17 years, and patients age 18 years and older with traumatic and non-traumatic presentations, who visit Adult and Pediatric EDs and receive a CT scan during their ED visit

Exclusion Criteria:

* Patients older than 17, yet younger then 18.
* Patients who are unable to consent and who do not have a legally authorized representative.

Primary outcomes:
measure: CT scans utilization
timeFrame: January 2014 - January 2015
Secondary outcomes:
measure: Abnormal vs. normal CT scans
timeFrame: January 2014 - January 2015
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke University
name: Joshua S Broder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06027996: Melodi Matrix™ in Breast Reconstruction
Official title: Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction With Infection Outcomes Assessment (ARIA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Reconstruction
Lead sponsor: Melodi Health, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-07
Enrollment: 702
Sex: FEMALE
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.


Eligibility criteria: Inclusion Criteria:

* Female.
* Age 22 or older at the time of enrollment.
* Is scheduled to undergo unilateral or bilateral mastectomy (including prophylactic) with immediate two-stage post-mastectomy alloplastic prepectoral breast reconstruction.
* Is able to and willing to comply with the study requirements and providing informed consent.

Exclusion Criteria:

* Has prior history of neoadjuvant radiotherapy.
* Has had prior history of failed tissue expansion or breast implantation at the intended reconstruction site.
* Has an active abscess or infection requiring antibiotics anywhere in their body within 30 days.
* Has a Body Mass Index (BMI) \< 14 or \> 40.
* Is pregnant or is nursing; or plans to become pregnant during the course of the study.
* Has any connective tissue/autoimmune disorder or rheumatoid disease.
* Has known allergies to study device materials.
* Is participating in another interventional research study that may interfere with study endpoints.
* Has limited life expectancy or co-morbid conditions, social/psychological problems, or cognitive impairments that precludes participation.
* Has a medical condition or is taking medications that would result in elevated risk and/or affect the validity of the study.
* Intraoperative assessment demonstrates unfavorable conditions (i.e., poor mastectomy skin flap thickness or viability) for immediate, two-stage post-mastectomy alloplastic prepectoral reconstruction in any breast.

Primary outcomes:
measure: Complications of Breast Reconstruction
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: