louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02220868: Sofosbuvir, Ribavirin, for the Treatment of Chronic Hepatitis C Virus Genotype 1 in HIV-Coinfected Patients Receiving Fixed Dose Co-formulation Emtricitabine/ Tenofovir/Cobicistat/Elvitegravir: A Pilot Study
Official title: Sofosbuvir, Ribavirin, for the Treatment of Chronic Hepatitis C Virus Genotype 1 in HIV-Coinfected Patients Receiving Fixed Dose Co-formulation Emtricitabine/ Tenofovir/Cobicistat/Elvitegravir: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C Infection
HIV Infection
Keywords: HIV
HCV
DAA
Lead sponsor: Saint Michael's Medical Center
Sponsor class: OTHER
First posted: 2014-08-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The protocol will study the safety and efficacy of using sofosbuvir and ribavirin for the treatment of hepatitis c in patients taking stribild.

Detailed description: The objective of this study is to evaluate the safety, efficacy and pharmacokinetics of sofosbuvir 400mg once daily plus ribavirin 1000-1200 mg daily in HIV-infected patients on fixed dose co-formulation emtricitabine/tenofovir/cobicistat/elvitegravir (Stribild).

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Chronic HCV genotype 1 infection
* Receiving emtricitabine/tenofovir/cobicistat/elvitegravir for at least 8 weeks.
* CD4 count \>200 cells/mm3 at screening and no CD4 count \<200 in previous 12 weeks
* HIV RNA PCR \<50 copies/ml at screening and no HIV RNA PCR \> 200 copies/ml in previous 12 weeks

Exclusion Criteria:

* History of integrase inhibitor resistance
* History of integrase inhibitor failure
* Absolute neutrophil counts under 1500/mm3 ( Black/ African Americans \<1200/mm3
* Patients with cirrhosis
* Platelet count under 90,000 per cubic millimeter
* Hemoglobin levels \<11 gm/dl in women or \<12 gm/dl in men
* Previous treatment with a DAA
* Hepatocellular carcinoma
* AFP\>100 ng/mL
* hepatitis B virus (HBsAg positive)
* Evidence of decompensated liver disease including, but not limited to, a history of presence of clinical ascites, bleeding varices, or hepatic encephalopathy

Primary outcomes:
measure: • SVR,12 defined as undetectable HCV RNA levels for 12 weeks after the completion of therapy
timeFrame: 12 weeks post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Saint Michael's Medical Center
state: New Jersey
Study officials:
affiliation: Saint Michael's Medical Center
name: Jihad Slim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01747668: Lactation Fortification Study
Official title: Impact of Nutrient Supplementation on Breast Milk Levels of Lactating Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lactation
Keywords: Mother and Infant Pairs
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2012-12-12
Enrollment: 89
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the impact of nutrient supplementation during lactation on levels in breast milk.


Eligibility criteria: Inclusion Criteria:

Subjects will be eligible for the study if they meet all of the following inclusion criteria:

1. Mother with singleton birth, 37-42 weeks gestation and ≥ 2490g
2. Pre-pregnancy BMI \</= 30
3. Mother is ≥ 18 years of age
4. Mother is 4-6 weeks postpartum and has been successfully continuously lactating
5. Mother agrees to abstain from the use of any Docosahexaenoic acid (DHA), lutein and/or vitamin E containing supplements for at least 10 days prior to providing a baseline breast milk sample
6. Mother agrees to abstain from the use of non-study supplements throughout the study
7. Mother plans to continue breastfeeding for at least 6 weeks from the start of the study
8. No significant ongoing medical problems in the infant as determined from infant's medical history as related by the parent(s) to the enrolling center personnel

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the following criteria:

1. Subject had adverse maternal and/or fetal medical history
2. Subject is participating in a non-Abbott approved concomitant trial
3. Mother is taking cholesterol medication and/or medication affecting lipid absorption and/or transport

Primary outcomes:
measure: Breast milk concentration of carotenoids
timeFrame: 1 - 43 days
Secondary outcomes:
measure: Breast milk concentration of fatty acids
timeFrame: 1 - 43 days
Other outcomes:
measure: Blood levels of nutrients and fatty acids
timeFrame: 1 and 43 days
Locations:
city: Indianapolis
country: United States
facility: Northpoint Pediatrics, LLC
state: Indiana
city: Dayton
country: United States
facility: Ohio Pediatric Research Association, Inc
state: Ohio
city: Kettering
country: United States
facility: Ohio Pediatric Research Association, Inc
state: Ohio
city: Mayfield Heights
country: United States
facility: Institute of Clinical Research
state: Ohio
city: Parma
country: United States
facility: The Cleveland Pediatric Research Center, LLC
state: Ohio
city: Westlake
country: United States
facility: The Cleveland Pediatric Research Center, LLC
state: Ohio
Study officials:
affiliation: Abbott Nutrition
name: Christina Sherry, PhD, RD
role: STUDY_CHAIR
References:
citation: Sherry CL, Oliver JS, Renzi LM, Marriage BJ. Lutein supplementation increases breast milk and plasma lutein concentrations in lactating women and infant plasma concentrations but does not affect other carotenoids. J Nutr. 2014 Aug;144(8):1256-63. doi: 10.3945/jn.114.192914. Epub 2014 Jun 4.
Clinical trial NCT02873468: Efficacy and Safety of Three Doses of Florence Oral Suspension in Adults With Eosinophilic Esophagitis
Official title: Randomized, Double-blind, Multicentric, Parallel, National, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Three Doses of Florence Oral Suspension in Adults With Eosinophilic Esophagitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Eosinophilic Esophagitis
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2016-08-19
Enrollment: 116
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 purpose of this study is to evaluate the efficacy of three doses of Florence oral suspension on changes of eosinophilic infiltration in esophageal biopsies.


Eligibility criteria: Inclusion Criteria:

* Signed consent;
* Participants aged 18 years or more;
* Participants diagnosed with eosinophilic esophagitis, defined as:

  1. Presence of symptoms of esophageal dysfunction intermittently or continuously during previous week to the screening visit;
  2. Eosinophilic esophageal inflammation with ≥ 15 eosinophils/high-power field, in the screening endoscopy;
  3. Exclusion of other causes of esophageal eosinophilia.

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* Participants with a stricture on endoscopy that prevents passage of the endoscope;
* History of alcohol abuse or drug use;
* Use of concomitant therapies for any reason that may affect the assessment;
* History of gastroesophageal surgery;
* History of the abnormal gastrointestinal disorder;
* Another disorder that causes esophageal eosinophilia;
* Pregnancy or risk of pregnancy and lactating patients;
* Participants with known allergy, contraindication or hypersensitivity to the components of the medicine used in the clinical trial;
* Participation in clinical trial in the year prior to this study.

Primary outcomes:
measure: Proportion of participants presenting a histological response, defined as the presence of ≤ 6 eosinophils/high-power field, at the end of treatment.
timeFrame: 100 days
Secondary outcomes:
measure: Incidence and severity of adverse events recorded during the study.
timeFrame: 170 days
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Allergisa
state: São Paulo
Study officials:
References:
Clinical trial NCT06874868: Salivary Cortisol As a Biomarker in Patients with Temporomandibular Disorder
Official title: Assessment of Salivary Cortisol As a Biomarker in Patients with Temporomandibular Disorder
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Temporomandibular Joint Disorder
Keywords: Temporomandibular disorders
TMD
Cortisol
Lead sponsor: University of Coimbra
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals diagnosed with any form of temporomandibular disorder (TMD) based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).

Brief summary: t is recognized that cortisol, a hormone produced by the adrenal glands, is a marker that is elevated in patients with psychological disorders, particularly anxiety. On the other hand, Temporomandibular Disorders (TMD) are a condition with a multifactorial etiology, in which emotional disturbances play a crucial role.

Therefore, the aim of this study is to evaluate whether patients with TMD have higher levels of salivary cortisol compared to the general population.

Initially, an assessment will be conducted using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) protocol to determine whether the patient suffer of any kind of Temporomandibular Disorder. Based on the results, individuals will be classified into two groups: the study group, consisting of patients with TMD, and the control group, composed of individuals without the disorder.

Those who agree to participate will be required to sign an informed consent form. Subsequently, a saliva sample will be collected for analysis.


Eligibility criteria: Inclusion Criteria:

* Patients who attend the dental clinic of the Faculty of Medicine of University of Coimbra

Exclusion Criteria:

* Pregnant women, minors and non-autonomous individuals

Primary outcomes:
measure: Salivary cortisol concentration
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Faculty of Medicine of University of Coimbra
Study officials:
References:
Clinical trial NCT03026868: Novel Quadrilateral Surface Plate for Acetabular Fracture
Official title: Randomized Trails of Different Fixations for Acetabular Fracture Involving Quadrilateral Surface
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture Dislocation
Keywords: acetabular
quadrilateral surface plate
Lead sponsor: Hebei Medical University Third Hospital
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The novel plate could be used to manage acetabular fractures involving quadrilateral surface and posterior column, which may lower the intraoperative blood loss and reduce complication rate.

Detailed description: Stoppa approach was more minimally invasive than ilioinguinal approach for pelvic and acetabular fractures. Then, Stoppa approach was widely used clinically. For the fragments involving quadrilateral surface, the Kocher-Langenbeck approach was added because the fixation of posterior fragments could not be obtained with reconstruction plate through single Stoppa approach. Novel quadrilateral surface plate was used in this study to examine its fixed role for posterior fragments. Functional outcome and complication were recorded to compare with the results treated with reconstruction plate. If good results were obtained for the patients fixed with quadrilateral surface plate, it was meaningful to popularize the fixed method.

Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Fracture involving quadrilateral surface
* Operation was conducted within 14 days
* Fixed with quadrilateral surface plate through Stoppa approach

Exclusion Criteria:

* Presented with a pathologic acetabular fracture
* Neuropathic arthropathy,dementia and other disease processes which made postoperative compliance unreliable
* Refused to participate
* Follow-up insufficient 12 months

Primary outcomes:
measure: fracture healing time
timeFrame: 4 months
Secondary outcomes:
measure: complication
timeFrame: 1 month
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Zhiyong Hou
state: Hebei
Study officials:
affiliation: Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
name: Ruipeng Zhang, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02375568: Large-scale Expansion and Characterization of Mesenchymal Stem Cells for Clinical Application
Official title: Large-scale ex Vivo Expansion and Characterization of Synovial Membrane Mesenchymal Stem Cells (SM-MSC) and Infrapatellar Fat Pad Mesenchymal Stem Cells (IF-MSC) for Clinical Application
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Injuries
Keywords: mesenchymal stem cells
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
Collaborators: name: EMO Biomedicine Corporation
First posted: 2015-03-02
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient who have an total knee replacement surgery

Brief summary: According to many recent research, mesenchymal stem cells (MSC) isolated from synovial membrane and infrapatellar fat pad have higher ex vivo proliferation capacity, multipotency and ability to undergo chondrogenesis.

Based on this concept, the investigators plan to get two removed tissues (synovial membrane and infrapatellar fat pad) from patients who have an operation of total knee replacement. The investigators are going to isolate and expand MSC from these two tissues respectively, and then compare the chondrogenesis ability for clinical application. In the other hand, the investigators plan to build techniques and procedures which comply with "Good Tissue Practices (GTP)"


Eligibility criteria: Inclusion Criteria:

Patient who have an total knee replacement surgery

Exclusion Criteria:

Patient who don't sign the agreement

Primary outcomes:
measure: Cell viability ratio of synovial membrane MSC and infrapatellar fat pad MSC from the first to the tenth cell passage
timeFrame: 6 months
measure: Doubling time of synovial membrane MSC and infrapatellar fat pad MSC from the first to the tenth cell passage
timeFrame: 6 months
measure: Percentage expression of cluster differentiation 90,105, 34, 45 surface markers of synovial membrane MSC and infrapatellar fat pad MSC from the first to the tenth cell passage
timeFrame: 6 months
Secondary outcomes:
measure: Alcian blue staining of synovial membrane MSC and infrapatellar fat pad MSC
timeFrame: 6 months
measure: Tyep II collagen and aggrecan gene expression of synovial membrane MSC and infrapatellar fat pad MSC
timeFrame: 6 months
Other outcomes:
Locations:
city: Pan-Ciao
country: Taiwan
facility: Far Eastern Memorial Hospital
state: Taipei
Study officials:
References:
Clinical trial NCT06531668: A Clinical Trial to Examine the Efficacy of a Supplement to Support Hormone Regulation in Women
Official title: A Clinical Trial to Examine the Efficacy of a Supplement to Support Hormone Regulation in Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hormone Regulation
Keywords: Women's Health
Menstrual Cycle
Estrogen
Lead sponsor: Scale Media Inc
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2024-08-01
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, triple-blind, placebo-controlled trial will evaluate the efficacy of Live Conscious's Beyond Hormone supplement in regulating hormone production in women. The study involves 50 generally healthy female participants aged 25-45 who are not menopausal. The trial spans three menstrual cycles and assesses both objective hormone levels and subjective well-being through blood tests and questionnaires, respectively.


Eligibility criteria: Inclusion Criteria:

* Female at-birth, aged 25-45.
* Not menopausal or perimenopausal.
* Regularly menstruating.
* Not taking any medication, supplement, or vitamin affecting hormone levels.
* Generally healthy and not living with any uncontrolled chronic disease.

Exclusion Criteria:

* Medical conditions or treatments affecting hormonal regulation.
* Endocrine disorders, gynecological or reproductive health conditions.
* Use of hormonal contraceptives or hormone therapy.
* Recent major illness or surgery.
* Severe allergies or hypersensitivities.

Primary outcomes:
measure: Hormone Levels Blood Panel (estradiol, testosterone, DHEA, insulin, and progesterone)
timeFrame: Baseline (Day 0), Midline (Day 45), and Endline (Day 90)
Secondary outcomes:
measure: Participants' Perceptions of Quality of Life
timeFrame: Baseline (Day 0), Midline (Day 45), and Endline (Day 90)
measure: Participants' Mood and Energy Levels using the Visual Analog Scale (VAS)
timeFrame: Baseline (Day 0), Midline (Day 45), and Endline (Day 90)
measure: Participants' Monthly Cycle Symptoms using the Menstrual Cycle Symptom Diary (MCSD)
timeFrame: Baseline (Day 0), Midline (Day 45), and Endline (Day 90)
measure: Participants' Libido using a Libido Questionnaire
timeFrame: Baseline (Day 0), Midline (Day 45), and Endline (Day 90)
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT06324968: Ro60 Expression in Macrophages in Sjogren's Disease
Official title: Ro60 Expression in Macrophages in Patients with Primary Sjogren's Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sjogren's Syndrome
Keywords: Sjogren's Syndrome
cardiovascular risk
Ro60
protein
connective tissue disorder
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Context: The Ro60 protein associates with YRNAs (or RNYs) to form the RoRNP complex, which regulates RNA surveillance and maturation. It is hypothesized that its impairment by nuclear penetration of the anti-Ro60 autoantibodies, would deregulate the anti-inflammatory response in monocytes/macrophages (Mo/Mp) in patients with Sjögren's disease (SD).


Eligibility criteria: Inclusion Criteria:

* Patients with SSp Subjects aged between 18 and 75, without chronic disease; Subject meeting the classification criteria for SSp; Subject with positive anti-SSA serology; French-speaking subject able to give written consent; Subject affiliated to the Sécurité Sociale or an equivalent scheme; Subject willing to have blood samples taken;
* Control subjects Subjects aged between 18 and 75, without chronic disease and not meeting SSp classification criteria; Subject who understands and speaks French and is able to give written consent; Subject affiliated to the French Social Security system or an equivalent scheme; Subject willing to have blood taken;

Exclusion Criteria:

* Subject receiving current anti-inflammatory treatment (e.g. corticosteroid therapy, non-steroidal anti-inflammatory drugs) or a regimen of more than 1 month within the last 3 months;
* Subject undergoing biotherapy or cytoreductive treatment;
* Subjects with positive serologies for human immunodeficiency virus (HIV), viral hepatitis B virus (HBV) and viral hepatitis C virus (HCV) in the 3 months preceding the inclusion visit;
* Protected persons as defined in articles of the French Public Health Code.

Primary outcomes:
measure: SSA/Ro60 interactions
timeFrame: 1 year
Secondary outcomes:
measure: The molecular and functional impact : inflammatory cytokine and chemokine profiles
timeFrame: 1 year
measure: The molecular and functional impact : cell apoptosis/survival and cellular polarization
timeFrame: 1 year
measure: The molecular and functional impact : clinical and biochemical phenotypes of CD14+ monocytes/macrophages
timeFrame: 1 year
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU Nice
state: Alpes-Mritimes
Study officials:
affiliation: CHU NICE
name: Nihal MARTIS, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03086668: Fingers Hook Technique to Facilitate Nasotracheal Intubation
Official title: Tube-Videostylet Assembly for Nasotracheal Intubation Assisted by a Fingers-Hook Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasotracheal Intubation
Keywords: Nasotracheal Intubation
jaw thrust
hook-finger
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: to compare either using conventional jaw thrust technique or with a novel fingers-hook technique to facilitate video-stylet assisted nasotracheal intubation

Detailed description: It is necessary to adequately exposure of glottis during naso-tracheal intubation using video-stylet. However, inadequate upward epiglottis or over-elevation of arytenoids all inhibit the tube tip smoothly into trachea. Therefore, the study is to investigate either jaw thrust or fingers-hook technique is advantages of nasotracheal intubation.

Eligibility criteria: Criteria:

Inclusion Criteria:

1. patients with American Society of Anesthesiologists physical status I-III
2. aged 20-65 years
3. Requiring general anesthesia undergoing oxo-maxillofacial surgery
4. unlimited mouth open
5. unlimited neck motion

Exclusion Criteria:

1. mouth open \< 3 cm
2. Ankylosing arthritis patients.
3. BMI≧35 kg/m2

Primary outcomes:
measure: grade of glottic field exposure and nasotracheal difficulty intubation score
timeFrame: half an hour
Secondary outcomes:
measure: the tube-videostylet assembly range of motion
timeFrame: half an hour
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Medical University
Study officials:
affiliation: Department of Anesthesiology, Kaohsiung Medical University Hospital, Kaohsiung Medical University,Taiwan
name: Kuang I Cheng, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Cheng KI, Yun MK, Chang MC, Lee KW, Huang SC, Tang CS, Chen CH. Fiberoptic bronchoscopic view change of laryngopharyngeal tissues by different airway supporting techniques: comparison of patients with and without open mouth limitation. J Clin Anesth. 2008 Dec;20(8):573-9. doi: 10.1016/j.jclinane.2008.01.013.