louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02461212: Validation of HepaFat-Scan for Noninvasive Measurement of Steatosis in Youth
Official title: Validation of HepaFat-Scan for Noninvasive Measurement of Steatosis in Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-alcoholic Fatty Liver Disease
Keywords: HepaFat-Scan
Liver Disease
Pediatrics
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Resonance Health
First posted: 2015-06-03
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to see if the HepaFat-Scan (a special sequence of images done in a MRI) can accurately detect the amount of fat in the liver.

Detailed description: The leading cause of liver disease for both adults and children in the US is nonalcoholic fatty liver disease (NAFLD), an obesity-related liver disease closely associated with the metabolic syndrome. NAFLD increases the risk of liver disease but also increases risk of type II diabetes, cardiovascular disease (CVD) and the metabolic syndrome. Invasive liver biopsy has been considered the best diagnostic tool for confirming NAFLD. This study will establish magnetic resonance imaging (MRI) / magnetic resonance spectroscopy (MRS) as a quantitative noninvasive "virtual biopsy" and benefit the health of children with liver diseases by decreasing risk and improving diagnosis. Specifically, in NAFLD, this fat quantification protocol will be broadly useful in future research studies, including therapies for NAFLD as well as for patient diagnosis and follow-up.

Eligibility criteria: Inclusion Criteria:

* Boys and girls age 7-18 years
* Scheduled for a clinically indicated liver biopsy
* Able to undergo MRI without sedation
* Written informed consent from parent or legal guardian
* Written informed assent from the child when indicated by age

Exclusion Criteria:

* Renal disease with a creatinine \> 2 or requiring dialysis
* Metal, braces or other implanted devices not compatible with MRI
* Not willing to try to hold still for an un-sedated MRI
* Pregnancy
* Failure to give consent or assent

Primary outcomes:
measure: Correlation between HepaFat-Scan and pathology based assessment of steatosis
timeFrame: 12 months
measure: Correlation of HepaFat-Scan measurement with magnetic resonance spectroscopy (MRS) and computerized steatosis
timeFrame: 12 months
measure: Correlation of HepaFat-Scan measurement with magnetic resonance spectroscopy (MRS) and grade of pathology of assessment
timeFrame: 12 months
measure: Repeatability of HepaFat-Scan
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta at Egleston
state: Georgia
Study officials:
affiliation: Emory University
name: Miriam B Vos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06727812: Multicenter Phase I Study of HRS-6208 in Patients With Solid Tumors
Official title: A Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HRS-6208 Monotherapy in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumors
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-11
Enrollment: 206
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: TREATMENT

Brief summary: This is an open, multicenter Phase I study to evaluate the safety and tolerability of HRS-6208 in patients with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

1. Patients with unresectable locally advanced or metastatic solid tumors confirmed by histology or cytology who have relapsed or progressed after standard treatment, or have no standard treatment options, or do not apply standard treatment at this stage;
2. Age 18\~75 years old;
3. At least one measurable lesion per RECIST v1.1 criteria;
4. ECOG PS score: 0-1.

Exclusion Criteria:

1. History of other malignancies within the past 5 years, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
2. The adverse reactions of previous anti-tumor therapy have not recovered to NCI-CTCAE v5.0 grade evaluation ≤ 1;
3. He has severe cardiovascular and cerebrovascular diseases;
4. Severe infection within 4 weeks prior to the first dose.

Primary outcomes:
measure: Incidence and severity of adverse events (AEs)
timeFrame: From Day 1 to 30 days after the last dose.
measure: Maximum tolerated dose (MTD)
timeFrame: From Day 1 to 21 days after the first dose.
measure: Dose limiting toxicitie (DLT)
timeFrame: From Day 1 to 21 days after the first dose.
measure: Recommended phase 2 dose (RP2D)
timeFrame: From Day 1 to 30 days after the last dose.
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).
measure: Duration of Response (DoR)
timeFrame: From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).
measure: Disease Control Rate (DCR)
timeFrame: From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).
measure: Progression free Survival (PFS)
timeFrame: From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).
measure: Overall Survival (OS)
timeFrame: From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT02457312: The Effect of 7 Days of Letrozole Pretreatment Combined With Misoprostol on the Placental and Decidual Tissues
Official title: The Effect of 7 Days of Letrozole Pretreatment Combined With Misoprostol on the Placental and Decidual Tissues
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pregnancy
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2015-05-29
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study aims at studying the effect of letrozole in early pregnancy in placenta and decidua including the progesterone receptor and the apoptotic factors.

Detailed description: Twenty healthy subjects requesting legal surgical abortion up to 63 days gestation will be recruited for this study. They will be randomized to receive either placebo tablets or letrozole 10 mg daily for 7 days before suction evacuation. Suction evacuates which include the placenta and some decidua collected by the procedure in these 20 subjects will be used for the laboratory studies.

Eligibility criteria: Inclusion Criteria:

* The gestational age should be up to 63 days. An ultrasound assessment would be performed to confirm the gestation.
* The woman is willing and able to participate after the study has been explained
* Age \>18 years old

Exclusion Criteria:

* Criteria for prospective exclusion

Any indication of past or present ill health will be considered a contraindication for recruitment to the study. In particular, subjects should not be recruited if any of the following conditions is present:

1. multiple pregnancies
2. uterine fibroids
3. any significant medical disorder
4. intrauterine contraceptive device in situ
5. contra-indications to the use of letrozole or misoprostol

   * Criteria for exclusion from a secondary analysis

Situation in which subjects who have been formally admitted to the study could be excluded from a secondary analysis include:

1. the use of drugs other than those prescribed by the investigator for the treatment of possible therapy-related side-effects especially drugs with prostaglandin synthetase inhibitory activity such as salicylates, indomethacin or mefenamic acid
2. any violation of the study protocol
3. essential data missing from the subject's records making it impossible to judge the treatment outcome

Primary outcomes:
measure: The expression of progesterone receptors and apoptotic factors in the placental and decidual cells by immunostaining.
timeFrame: 8 days
Secondary outcomes:
measure: Apoptosis in the placental and decidual cells as demonstrated by TUNEL assay.
timeFrame: 8 days
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Vivian CY Lee, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02010112: Bag Mode BreathID Hp Validation Versus Endoscopy in Detection of Helicobacter Pylori
Official title: Clinical Validation Study to Evaluate Presence of H. Pylori With 13C-Urea Breath Test Using the Dual Mode BreathID® Hp System Compared to Congruent Biopsy Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Helicobacter Pylori Infection
Keywords: H.Pylori
Lead sponsor: Meridian Bioscience, Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-12
Enrollment: 193
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: A new method of breath collection for testing for Helicobacter Pylori infection has been developed by Exalenz. In this study, it will be compared to the gold standard- endoscopy results to prove its accuracy.

Detailed description: This study will validate a breath collection method by comparing a newly developed breath test kit, IDkit:Hp™ TWO using breath collection bags, to congruent biopsy results (a composite reference standard by analyzing specimens with microbial culture, histological examination and rapid urease test- RUT) in detecting H.Pylori

Eligibility criteria: Inclusion Criteria:

* Present with clinical indication of H. pylori and candidate for upper endoscopy
* Have the ability and willingness to sign the Informed Consent Form for initial diagnosis cohort
* Naive to treatment in the past 18 months
* No known H.pylori status (no conclusive test results within last 6 months)

Exclusion Criteria:

* Participation in other interventional trials
* Antibiotics and/or Bismuth preparations within four (4) weeks prior to breath test
* PPI (proton pump inhibitors) or H2 blockers within two (2) weeks prior to breath test
* Pregnant or breastfeeding women
* Allergy to test substrates

Primary outcomes:
measure: overall percent agreement
timeFrame: 21 days
Secondary outcomes:
measure: overall percent agreement
timeFrame: 21 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Digestive Disease Associates, PA
state: Maryland
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterology Group
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Ocean Springs
country: United States
facility: Digestive Health Care
state: Mississippi
city: Bronx
country: United States
facility: Montefiore Hospital
state: New York
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Jackson
country: United States
facility: Clinical Research Solutions
state: Tennessee
city: Houston
country: United States
facility: JM Research
state: Texas
city: Richmond
country: United States
facility: Bon Secours Health System
state: Virginia
Study officials:
affiliation: VP of clinical affairs, Exalenz
name: Melina Arazy, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01781312: Probiotics in IgA Nephropathy
Official title: Proof-of-concept Study of Efficacy and Safety of Dietary Supplementation With Probiotics in IgAN Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: IgA Nephropathy
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Linkoeping
name: Karolinska Institutet
First posted: 2013-01-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Recent studies have shown an increased gastrointestinal reactivity and increased intestinal permeability in IgA nephropathy (IgAN). Probiotic supplementation is known to impact the gastrointestinal immune system possibly by improvement of both the immunologic and the non-immunologic intestinal barrier. Probiotic supplementation should thus theoretically have an effect on IgAN. In this study the investigators will study the efficacy and safety of Lactobacillus reuteri.


Eligibility criteria: Inclusion Criteria:

* Above 18 years
* Primary IgAN, verified by biopsy
* Albuminuria \> 0.75 g/24 h (verified by at least four sample results within a two years period prior to inclusion)
* Serum creatinine less than 200 umol/L (verified by at least four sample results within a two years period prior to inclusion)
* Having signed informed consent form

Exclusion Criteria:

* Participation in another clinical intervention trial
* Patients with celiac disease
* Patients with secondary IgAN
* Creatinine clearance below 30 ml/min (mean of 3 measurements)
* Introduction of an ACE inhibitor or angiotensin II receptor blocker during the last three months prior to inclusion
* Patients treated with immunosuppressive or systemic corticosteroid drugs within the last twelve months
* Patients using probiotic products within the last three months (includes probiotic milk products)
* Known allergy or intolerance to any of the ingredients in the probiotic product

Primary outcomes:
measure: Change in albuminuria
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change in renal function
timeFrame: Baseline and 3 months
measure: Change in IgA/IgG immune complexes
timeFrame: Baseline and 3 months
measure: Change in hematuria
timeFrame: Baseline and 3 months
measure: Change in immunological markers in blood
timeFrame: Baseline and 3 months
measure: Change in IBS (irritable bowel syndrome) symptoms
timeFrame: Baseline and 3 months
Other outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 3 months and 5 months
Locations:
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hosptial
Study officials:
References:
Clinical trial NCT01843712: Eating in the Absence of Hunger and Caloric Compensation in Preschool Children, Link With Parental Feeding Practices
Official title: Study of Eating in the Absence of Hunger and of Caloric Compensation in French Children, and of Their Relationships With Parental Feeding Practices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Intake Regulation in Healthy Children
Keywords: Caloric compensation
Eating in the absence of hunger
Children
Parental feeding practices
Lead sponsor: Centre des Sciences du Goût et de l'Alimentation
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2013-05-01
Enrollment: 236
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population was composed of 236 children aged 2 to 7 years-old

Brief summary: Objectives: The aims were to measure caloric compensation (CC) and eating in the absence of hunger (EAH) in 2 to 7 year-old French children in their regular eating context and to link these measurements with individual characteristics (adiposity, age, gender) and parental feeding practices.

Design: Three consecutive weeks an identical lunch was served in four preschool canteens reaching 236 children. The first lunch was a control session. For the CC situation (week 2), thirty minutes before the lunch children were offered a preload (137 kcal). For the EAH situation (week 3), ten minutes after lunch children were exposed to palatable foods (430 kcal). Food intake was measured at the individual level. Parental eating behaviour and feeding practices were measured by questionnaires. Child's height and weight were measured by a medical doctor.


Eligibility criteria: Inclusion Criteria:

* To be registered to the school canteen, to provide parental approval

Exclusion Criteria:

* Chronic disease or food allergies.

Primary outcomes:
measure: Caloric compensation measurement
timeFrame: 1 week
measure: Control measurement of energy intake
timeFrame: 1 week
measure: Eating in the absence of hunger measurement
timeFrame: 1 week
Secondary outcomes:
measure: Parental feeding practices
timeFrame: One month after inclusion
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre des sciences du goût et de l'alimentation
Study officials:
affiliation: Centre des Sciences du Goût et de l'Alimentation
name: Nicklaus Sophie, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Remy E, Issanchou S, Chabanet C, Boggio V, Nicklaus S. Impact of adiposity, age, sex and maternal feeding practices on eating in the absence of hunger and caloric compensation in preschool children. Int J Obes (Lond). 2015 Jun;39(6):925-30. doi: 10.1038/ijo.2015.30. Epub 2015 Mar 17.
Clinical trial NCT01903512: Arthrocentesis and Temporomandibular Joint Disorders a Conservative Alternative to Surgical Treatments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: TMJ Internal Derangement
Keywords: TMJ arthrocentesis
internal derangement
conservative treatment
Lead sponsor: Università degli Studi di Sassari
Sponsor class: OTHER
First posted: 2013-07-19
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 30 patients with TMJ internal derangement and pain with history of failed conservative management were selected. 70% had anteriorly displaced discs (AD), and 30 complained of other disorders (osteophytes, signs of soft tissues inflammmation, TMJ structure alterations).

Brief summary: This study aims to evaluate the efficacy of arthrocentesis in the treatment of internal derangement of the temporomandibular joint (TMJ).

Detailed description: This work was designed as a prospective case series clinical study. Patients imaging was evaluated with Cone-Beam Computed Tomography and Nuclear Magnetic Resonance at the beginning of the treatment and after the last arthrocentesis.

Eligibility criteria: Inclusion Criteria:

* TMJ pain
* TMJ noises and click
* history of unsuccessful conservative management (NSAID and occlusal bite)
* occlusal bite still present

Exclusion Criteria:

* degenerative joint disease (such as osteoarthritis, rheumatoid arthritis etc.)
* history of condylar fractures or previous TMJ trauma
* TMJ surgery

Primary outcomes:
measure: Pain decrease
timeFrame: baseline (preop), 1 week, 1 month, 2 months, 6 months, 12 months (postop)
measure: increase in the mouth opening
timeFrame: Baseline (preop), 1 week, 1 month, 2 months, 6 months, 12 months (postop)
measure: TMJ click and noises reduction
timeFrame: Baseline (preop), 12 months (postop)
Secondary outcomes:
measure: number of subjects showing signs of TMJ inflammation or structural alterations at Magnetic Resonance Imaging and Cone Beam Computerized Tomography pre- and postop.
timeFrame: Baseline (preop)- 60 days postop
Other outcomes:
Locations:
city: Sassari
country: Italy
facility: Maxillofacial Unit, University of Sassari
state: SS,
Study officials:
affiliation: Università degli Studi di Sassari
name: Silvio M Meloni, assist prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Riu G, Stimolo M, Meloni SM, Soma D, Pisano M, Sembronio S, Tullio A. Arthrocentesis and temporomandibular joint disorders: clinical and radiological results of a prospective study. Int J Dent. 2013;2013:790648. doi: 10.1155/2013/790648. Epub 2013 Nov 11.
Clinical trial NCT02133612: Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma
Official title: Phase 2 Study of Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Patients With Advanced Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Cancer
Keywords: esophageal cancer
adjuvant chemotherapy
esophageal surgery
paclitaxel
cisplatin
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2014-05-08
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.

* Five year survival rate after radical esophagectomy is modest at about 40%.The patients with regional lymph node metastases have worse outcome than those without lymph node metastases.
* No standard postoperative adjuvant chemotherapy has ever been established.


Eligibility criteria: Inclusion Criteria:

* ability to give informed consent
* histological proof of thoracic esophageal squamous cell carcinoma with negative proximal and distal margins
* node-positive and pathologic stage M0 .
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Patients were enrolled 4 to 10 weeks after surgery.
* Adequate organ function was required in 2 weeks of registration and was defined as: serum creatinine within normal institutional limit, and creatinine clearance (CrCl) ≥60ml/minute. Aspartate aminotransferase and bilirubin\<2 times of upper normal institutional limits.

Exclusion Criteria:

* prior chemotherapy or concurrent radiation therapy before esophagectomy
* R1 or R2 resection
* clinically significant hearing loss or symptomatic peripheral neuropathy during initial examination

Primary outcomes:
measure: 3 year overall survival
timeFrame: 5 year
Secondary outcomes:
measure: 3 year disease-free survival
timeFrame: 5 year
Other outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 5 year
Locations:
city: Beijing
country: China
facility: Xiao Lv
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Jing Huang, M.D
role: PRINCIPAL_INVESTIGATOR
References: