louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05518422: Role of Endothelin-1 Modulating Insulin-stimulated Blood Flow and Sympathetic Nervous System Activity in Obesity
Official title: Role of Endothelin-1 Modulating Insulin-stimulated Blood Flow and Sympathetic Nervous System Activity in Obesity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Insulin Resistance
Autonomic Dysfunction
Obesity
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this project is to determine role for ET-1 in individuals with obesity.


Eligibility criteria: Inclusion Criteria:

* 18-55 years of age
* Male sex
* Obese (BMI ≥30 kg/m2)

Exclusion Criteria:

* Female sex
* Current smoking/Nicotine use
* Nerve/neurologic disease
* Cardiovascular, hepatic, renal, respiratory disease
* Blood pressure ≥140/90 mmHg
* Diabetes
* Vigorous exercise \>3 times/week
* Communication barriers
* taking any medications known to affect metabolic, respiratory, cardiovascular, and/or autonomic

Primary outcomes:
measure: Amount of muscle sympathetic nerve activity (MSNA)
timeFrame: Change from baseline at minute 60
measure: Amount of leg blood flow
timeFrame: Change from baseline at minute 60
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Missouri-Columbia
name: Jacqueline K Limberg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05017922: Efficacy of TACE With Endoscopic Therapy for Unresectable Hepatocellular Carcinoma
Official title: Efficacy of TACE Combined With Endoscopic Therapy for Unresectable Hepatocellular Carcinoma With Esophagogastric Varices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Esophagogastric Varices
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is aimed to explore the efficacy of transarterial chemoembolization (TACE) combined with endoscopic therapy for unresectable hepatocellular carcinoma (HCC) complicated with esophagogastric varices (EGV) and seek out predictors associated with survival.


Eligibility criteria: Inclusion Criteria:

* 1. HCC was diagnosed in accordance with the 2017 edition of diagnosis guidelines, all patients were in CNLC stage Ib to IIIa, and treated with TACE; 2. EGV was demonstrated through endoscopic examination; 3. Child-Pugh grade A or B, or grade C patients improved liver function to grade A or B through aggressive treatment; 4. age between 18 and 75 years.

Exclusion Criteria:

* 1. HCC with diffuse or distant metastasis, or with other systemic malignancies; 2. severe jaundice, hepatic encephalopathy, refractory ascites or hepatorenal syndrome; 3. severe cardiac, cerebrovascular, lung and renal diseases and cannot tolerate endoscopic treatment; 4. severe coagulation dysfunction; 5. severe infection, bleeding with unstable vital signs; 6. history of liver surgery; 7. cannot or refuse to sign the informed consent.

Primary outcomes:
measure: Time of overall survival
timeFrame: In July 2020 or the day of death or the day of lost to follow-up or follow-up for 3 years
measure: Number of bleeding episodes
timeFrame: In July 2020 or the day of death or the day of lost to follow-up or follow-up for 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital , Shandong University
state: Shandong
Study officials:
References:
citation: Tao Z, Ruan Y, Peng Z, Zhang K, Gao Y. Transarterial Chemoembolization Combined With Endoscopic Therapy Is Beneficial for Unresectable Hepatocellular Carcinoma With Esophagogastric Varices. Front Oncol. 2021 Dec 2;11:783574. doi: 10.3389/fonc.2021.783574. eCollection 2021.
Clinical trial NCT04451122: Treatment of Ocular Demodicosis by Cleansing the Eyelid Margins Combined With Tea Tree Oil Ointment
Official title: Treatment of Ocular Demodicosis by Cleansing the Eyelid Margins Combined With Tea Tree Oil Ointment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mite-Borne
Keywords: eyelid margins
ocular demodicosis
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate whether the cleaning of eyelid margins increases the effectiveness of traditional tea tree oil eyelid margins in treating mites. The investigators randomly divided 60 participants into two groups: Group A was treated with traditional tea tree oil eyelid margin, Group B was treated with traditional tea tree oil eyelid margin + eyelid cleansing, and participants were rechecked after 3 months of regular medication.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosisof ocular surface mite parasitism

Exclusion Criteria:

* any acute keratoconjunctivitis;c dacryocystitis

Primary outcomes:
measure: The severity of dry eyes
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
References:
Clinical trial NCT00171522: Preference of Tegaserod vs. PEG 3350 in Patients With Constipation
Official title: A Randomized, Open-label, Pilot Crossover Study to Assess the Patient Preference of Tegaserod Versus Polyethylene Glycol 3350 in Patients With Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Constipation
Keywords: Constipation
Tegaserod
Polyethylene Glycol 3350
PEG
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine whether female patients have a preference for tegaserod of PEG 3350 relative to dosage form, convenience, ease of administration and taste


Eligibility criteria: Inclusion Criteria:

* Females aged 18 to 64 years of age
* Patients with constipation as defined by the Rome II criteria

Exclusion Criteria:

* Patients who have been previously been treated with tegaserod and/or PEG 3350
* Evidence of cathartic colon or a history of laxative abuse or laxative dependence
* History of fecal impaction which necessitated surgical intervention
* Patients with clinically significant abnormal TSH levels at screening
* Women who are pregnant or breast feeding

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: To determine after 14 / 35 days of treatment if women with constipation have a preference for tegaserod compared to PEG 3350, based on the assessment of the Constipation Treatment questionnaire (satisfaction with treatment, willingness to re-use)
Secondary outcomes:
Other outcomes:
Locations:
city: Oro Valley
country: United States
facility: Harmony Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Central Phoenix Medical Clinic, LLC
state: Arizona
city: Tucson
country: United States
facility: Adobe Gastroenterology, PC
state: Arizona
city: Buena Park
country: United States
facility: Associated Pharmaceutical Research Center, Inc
state: California
city: Boca Raton
country: United States
facility: Clinical Trial Management of Boca Raton, Inc.
state: Florida
city: Pratt
country: United States
facility: Health Science Center
state: Kansas
city: Boston
country: United States
facility: Beth Israel Deacon Medical Center
state: Massachusetts
city: Omaha
country: United States
facility: Heartland Clinical Research, Inc
state: Nebraska
city: Margate
country: United States
facility: MBS Clinical Research, LLC
state: New Jersey
city: Bellbrook
country: United States
facility: Midwest Clinical Research
state: Ohio
city: Hermitage
country: United States
facility: Associates in Gastroenterology
state: Tennessee
city: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc.
state: Texas
city: Richmond
country: United States
facility: National Clinical Research, Inc
state: Virginia
city: Virginia Beach
country: United States
facility: East Coast Clinical Research
state: Virginia
Study officials:
References:
Clinical trial NCT01552122: Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Alendronate (MK-0822-050)
Official title: A Phase III Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Effects of Odanacatib (MK-0822) on Bone Mineral Density, Tolerability, and Safety in the Treatment of Postmenopausal Women With Osteoporosis Previously Treated With Alendronate
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Osteoporosis
Postmenopausal Osteoporosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-03-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the therapeutic effects and safety of odanacatib on bone mineral density in osteoporotic postmenopausal women who were previously treated with alendronate.


Eligibility criteria: Inclusion Criteria:

* In good general health, and postmenopausal for at least 5 years or more
* Diagnosed with postmenopausal osteoporosis
* Currently taking alendronate for at least 3 years or more for the treatment of osteoporosis
* One hip free of orthopedic hardware (ie, total hip device, hip pin); anatomy is suitable to undergo a dual-emission X-ray absorptiometry (DXA) scan (ie, bone mineral density scan)
* Agrees to not to use any other medications for the treatment of osteoporosis except those provided to the participant during the study

Exclusion Criteria:

* Evidence of metabolic bone disorder
* History of malignancy (cancer) for 5 years or less
* Active thyroid disease that cannot be managed with medication
* Severe renal insufficiency (kidney disease), myocardial infarction, unstable angina, stroke or revascularization, untreated malabsorption syndrome, and/or osteonecrosis of the jaw, or anticipates undergoing a major dental procedure (e.g. dental extraction or implantation)
* Use, misuse, abuse, and/or addiction of illicit drugs and/or recent history

(within the last year) of drug or alcohol abuse or dependence

* Use of estrogen with or without progestin and/or raloxifene (ie, Evista®) or tamoxifen (ie, Nolvadex®, Tamofen®)
* Use of any oral bisphosphonate therapy other than alendronate; intravenous bisphosphonates (zoledronate, ibandronate, pamidronate); any form of calcitonin other than intranasal; anabolic steroids; and/or Strontium-containing products (ie, Osteovalin™)

Primary outcomes:
measure: Percent Change from Baseline in Bone Mineral Density (BMD) of the Femoral Neck
timeFrame: Baseline and Month 24
Secondary outcomes:
measure: Percent Change from Baseline in BMD of the Lumbar Spine, Total Hip, and Trochanter
timeFrame: Baseline and Month 24
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00288522: Lanreotide (Somatuline Autogel) in Thyroid-associated Ophthalmopathy Treatment
Official title: A Phase II, Single Centre, Randomized, Double-blind, Parallel and Placebo Controlled, Pilot Study to Evaluate the Efficacy and Safety of Somatuline Autogel 60mg in Patients With Active Thyroid-associated Ophthalmopathy of Moderate Intensity.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Thyroid-Associated Ophthalmopathy
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2006-02-08
Enrollment: 5
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: The main purpose of this study is to evaluate the efficacy and safety of 3 doses of Somatuline Autogel 60mg to control the muscle infiltration and edema, eyelid retraction and extraocular muscular contraction in patients with active thyroid-associated ophthalmopathy of moderate intensity.


Eligibility criteria: Inclusion Criteria:

* Patients with autoimmune thyroid disease and whose centre's medical records confirm the presence of euthyroidism for at least two months before being included into the study
* Thyroid-associated ophthalmopathy diagnosed a minimum of six months before his/her participation in the study, well documented in the centre's medical records and based on the moderate intensity of thyroid-associated ophthalmopathy in the worst eye
* Patients whose ophthalmopathy activity has been demonstrated by a positive octreoscan

Exclusion Criteria:

* The patient presents compressive optical neuropathy signs which require immediate surgical treatment or suffers from serious intensity thyroid ophthalmopathy
* The patient has been treated with radio-iodine for his/her thyroid disturbance in the past 6 months
* The patient's thyroid-associated ophthalmopathy has been treated previously (except for drops and local measures) or is planned to be treated with radio-iodine or thyroidectomy for his/her autoimmune thyroid disease during the study or suffers from myopia, glaucoma or any other eye disease which could modify the ophthalmological progress
* The patient is a smoker of more than 5 cigarettes per day

Primary outcomes:
measure: Extraocular muscle infiltration and edema exam by evaluating (at Day 0 and Weeks 4, 8 and 12): extraocular muscle size, proptosis and intraocular pressure (tonometry)
measure: Eye inspection (at Day 0 and Weeks 4, 8 and 12): assessment of conjunctival injection presence, chemosis, cheratitis and eyelid edema; extrinsic muscle function evaluation and eyelid retraction
Secondary outcomes:
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Hospital General d'Alacant
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02895022: EpiConCES - Epidural Lidocaine for Conversion to CaEsarean Section
Official title: Determination of ED95 of 2% Lidocaine With Epinephrine for Converting Analgesia Epidural Anesthesia in Surgical Epidural in the Labor Current Cesarean
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnant Women>37SA
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The need to resort to a midwifery course work in cesarean is a common practice. Epidural analgesia for labor analgesia is practiced in 90% of women in obstetric work, as when the cesarean decision is taken course work in practice and the recommendations are to use the epidural catheter in place to convert the epidural analgesia in epidural anesthesia by re-injecting a local anesthetic on the catheter. General anesthesia is reserved only cases of extreme urgency and cons-indications for regional anesthesia as a purveyor of high maternal morbidity and mortality.

The initial assumption is that the 2% lidocaine with epinephrine is the optimal and recommended local anesthetic solution.

Detailed description: There is a real variability in the volume administered by practitioners repository fault.

The main objective is to determine the ED95 dose of 2% lidocaine with epinephrine injected into the epidural catheter for which it does not arise from failure to surgical anesthesia for cesarean during labor.

The secondary objectives are to determine the failure risk factors, the hemodynamic consequences related to the volume administered and evaluate maternal satisfaction.

Eligibility criteria: Inclusion Criteria:

* Pregnant \> 37SA
* Between 150 and 190cm
* IMC between 20 and 40
* Single pregnancy
* Elective cesarean indication during obstetric labor

Exclusion Criteria:

* Presentation of siege
* Extreme and semi emergency caesarean indication

Primary outcomes:
measure: Success or failure of lidocaine 2% with epinephrine dose administered
timeFrame: at day 1
Secondary outcomes:
measure: Study tolerance of epidural anesthesia for caesarean section
timeFrame: at day 1
measure: maternal pain (Visual Analog Scale)
timeFrame: at day 1
measure: maternal satisfaction
timeFrame: at day 1
measure: nausea and vomiting intraoperatively
timeFrame: at day 1
measure: blood pressure (PAM, PAS (mmHg))
timeFrame: at day 1
measure: fluid replacement (ml)
timeFrame: at day 1
measure: hypotension
timeFrame: at day 1
measure: necessary to use vasopressors
timeFrame: at day 1
measure: Apgar score
timeFrame: at day 1
measure: fetal arterial and venous cord pH
timeFrame: at day 1
measure: Intravenous sedation for inadequate anesthesia
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Martine BONNIN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06522022: PTSD Screening in Pregnant Black Women
Official title: Comparing Two Screening Approaches for PTSD to Improve Health Outcomes in Pregnant Black Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Early
PTSD
Keywords: Pregnancy
Black Women
Screening for Maternal PTSD
Obstetric Care
African-American Women
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: University of Missouri, Kansas City
First posted: 2024-07-26
Enrollment: 804
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will compare the effectiveness of two active screening interventions in improving post-traumatic stress disorder (PTSD) symptoms, maternal perinatal care utilization, satisfaction utilization of mental healthcare services, and maternal health and birth-related outcomes for Black pregnant women.

Detailed description: Researchers will examine whether Culturally Responsive Screening, Brief Intervention, and Referral to Treatment (SBIRT) for obstetrics (OB) is more effective in reducing PTSD symptoms compared to brief screening for PTSD. This study will help participating OB clinics to determine the best option for screening for PTSD in Black pregnant persons in their clinic during first-trimester prenatal visits.

The study population will include Black pregnant women receiving medical care in their first trimester of pregnancy. Surveys and chart abstraction will be used in this study to collect data. The approximate study duration for individuals is 4 visits over 12 months.

Eligibility criteria: Inclusion Criteria:

* 18+ years old,
* Ability to provide informed consent,
* English-speaking,
* Willingness to participate in the study,
* Self-identification as Black or African American,
* Pregnant and in the first trimester attending initial prenatal care visit,
* Endorsement of at least one traumatic event in their lifetime.

Exclusion Criteria:

* Active suicidality

Primary outcomes:
measure: PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) Score
timeFrame: Initial OB visit (weeks 1-13), second trimester (Weeks 14 to 27), third trimester (weeks 28-40), and 6-weeks postpartum
Secondary outcomes:
measure: Adequacy of prenatal care utilization (APNCU)
timeFrame: 6 weeks postpartum
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Kansas City
country: United States
facility: Truman Medical Center (TMC) system
state: Missouri
Study officials:
affiliation: Emory University
name: Abigail Lott, PhD, ABPP
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Briana Woods-Jaeger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03448822: Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour
Official title: Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Testicular Germ Cell Tumor
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 76
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suspected of testicular germ cell tumour

Brief summary: Assessment of accuracy of sentinel node biopsy, defined as the false negative rate.

Detailed description: Current practice in patients with Clinical Stage I (CS I) testicular germ cell tumour is active surveillance after orchiectomy, with relapses occurring in 15-20% of patients. The majority of relapses occur in the lymph nodes as lymphogenic spread is the dominant route of dissemination. A sentinel node procedure, in which the sentinel lymph node is resected and pathologically examined, could be more reliable to identify patients who are likely to relapse.

Early identification of patients with micro-metastases in the sentinel node makes it possible to treat these patients at the earliest possible moment. Absence of metastases could lead in the future to a less intensive follow up protocol than the present one.

Eligibility criteria: Inclusion Criteria:

* Patients suspected of testicular germ cell tumour, based on physical examination, ultrasound imaging, and tumour markers
* Patients 18 years and older
* No evidence of metastases on first staging (thoraco-abdominopelvic CT)
* Written and signed informed consent

Exclusion Criteria:

* Patients with evidence of metastases at first staging
* Patients with a second primary tumour
* Patients with recent (\< 6 months before diagnosis) surgical treatment to the external genitals or recent surgical intervention in the inguinal or retroperitoneal regions
* Patients with previous abdominal surgery, necessitating open surgical approach for the sentinel node biopsy

Primary outcomes:
measure: identify patients witha low risk of cancer recurrenceincluded in current active surveillance protocols.
timeFrame: surgery 1 day, follow up 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NKI-AvL
name: Simon Horenblas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: