louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06025045: Dynamic Monitoring of ctDNA Predicts Recurrence of Advanced Ovarian Cancer After Primary Treatments
Official title: Dynamic Monitoring of ctDNA Predicts Recurrence of Advanced Ovarian Cancer After Primary Treatments
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer Stage IV
Ovarian Cancer Stage III
Keywords: ctDNA
Ovarian cancer
PDS
IDS
adjuvant chemotherapy
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Nanjing Shihejiyin Technology, Inc.
First posted: 2023-09-06
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced ovarian cancer patients

Brief summary: Patients who receive satisfactory PDS, currently the change in CA125 during chemotherapy can only be used to evaluate the effectiveness of chemotherapy. This study plans to use ctDNA dynamic monitoring to detect minimal residual lesions during treatment, to demonstrate the application value of ctDNA dynamic monitoring in predicting the recurrence of ovarian cancer after PDS/IDS surgery.

Detailed description: This study plans to include ovarian cancer patients who have undergone PDS/IDS surgery. By analyzing the surgical tissue samples of ovarian cancer patients, we aim to identify risk factors related to the prognosis and recurrence of ovarian cancer. By monitoring the ctDNA status after PDS surgery, we analyze the role of ctDNA-MRD in predicting postoperative recurrence of ovarian cancer. By monitoring the MRD status at the end of the 3rd cycle of adjuvant chemotherapy and at the end of adjuvant treatment, we analyze the predictive role of serial cDNA-MRD for the efficacy of adjuvant treatment, providing a basis for determining the number of cycles of adjuvant treatment after PDS.

Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years old.
2. Patients diagnosed with stage IIIC-IVA ovarian cancer through pathological examination.
3. The participant has read and fully understands the patient information, and has signed the informed consent form.
4. The patient is willing to undergo primary debulking surgery (PDS) or interval debulking surgery（IDS）. -

Exclusion Criteria:

1. Other tumors have been detected within the last 5 years.
2. Organ transplant recipients or those who previously had non-autologous (allogeneic) bone marrow or stem cell transplants.
3. Patients was deemed unsuitable to participate in this study by other researchers.
4. Patients who have previously received neoadjuvant chemotherapy or targeted therapy.

Primary outcomes:
measure: 2 years DFS rate
timeFrame: 2 years
Secondary outcomes:
measure: DFS
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT02037945: 18F-Fluorocholine (18F-FCho) to Distinguish Necrosis From Recurrence in Brain Metastases
Official title: 18F-Fluorocholine (18F-FCho) to Distinguish Necrosis From Recurrence in Brain Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Metastases
Keywords: 18F-Fluorocholine (18F-FCho)
Pet Scan
MRI
13-199
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2014-01-16
Enrollment: 19
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main purpose of this study is to determine the distribution of 18F Fluorocholine (18F-FCH) in the brain which can help distinguishing radiation-induced scarring from tumor regrowth. In addition, the study will measure levels of 18F-FCH in the blood and (if applicable) in the brain lesion tissue that is removed as part of the planned brain surgery.


Eligibility criteria: Inclusion Criteria:

* Patient and/or guardian is able to provide written informed consent prior to study registration
* Age ≥ 21 years old
* Evolving brain lesions post SRS requiring neurosurgical resection (whether for symptomatic control or to establish pathology)

Exclusion Criteria:

* Inability to undergo a MRI or PET scan (e.g., claustrophobia or metal implant)
* Pregnant or nursing female
* Unable to cooperate for PET/CT

Primary outcomes:
measure: to distinguish radiation necrosis from progressive tumor
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kathryn Beal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05064345: A Study to Evaluate HB0034 in Healthy Adult Participants
Official title: A Phase Ia, Randomized, Double-blind, Placebo-controlled, Single Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HB0034 in Adult Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-10-01
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single dose.

Detailed description: This is a first-in-human (FIH) study of HB0034 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects age ≥ 18 and ≤ 55 years.
* Body Mass Index (BMI) ≥ 17.5 and ≤ 32 kg/m².
* Normal ECG, blood pressure, respiratory rate, temperature, and heart rate, unless the investigator considers any abnormality to be not clinically significant.
* Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.

Exclusion Criteria:

* History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease.
* Current or history of malignancy.
* Family history of premature Coronary Heart Disease (CHD)
* History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).
* Pregnant or Breasting feeding subject. Women with a positive pregnancy test (HCG).
* Further exclusions criteria apply.

Primary outcomes:
measure: Percentage of subjects with drug related adverse events (AEs)
timeFrame: up to 2000 hours
Secondary outcomes:
measure: Cmax
timeFrame: up to 2000 hours
Other outcomes:
measure: AUC0-infinity
timeFrame: up to 2000 hours
Locations:
city: Auckland
country: New Zealand
facility: New zealand Clinical Research
Study officials:
affiliation: NZCR OpCo limited AKL
name: Christian Schwabe
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03761745: Rotational Stability of Different Intraocular Lenses in The Capsular Bag
Official title: Rotational Stability of Different Intraocular Lenses in The Capsular Bag
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraocular Lens Complication
Phacoemulsification
Keywords: Rotation
Postoperative Care
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received Femtosecond laser-assisted phacoemulsification surgery in The Eye Hospital of Wenzhou Medical University

Brief summary: To evaluate the rotational stability difference among different intraocular lens. The rotational stability is evaluated by measurement of rotation of the IOL after surgery.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patients who had received Femtosecond laser-assisted phacoemulsification surgery with IntelliAxis-L capsular mark.
* The operation was smooth and there were no surgical complications.

Exclusion Criteria:

* Corneal and other ocular diseases (such as corneal opacity, keratitis, glaucoma, uveitis, lens dislocation or subluxation, lens capsule relaxation, retinopathy, etc.);
* History of ocular trauma or surgery before this cataract surgery;
* intraoperative and postoperative complications, such as posterior capsule rupture, corneal endothelium decompensation;
* Patients with severe or unstable heart, liver, kidney, lung, endocrine (including thyroid dysfunction), blood, mental dysfunction and other diseases affect the results of this study;

Primary outcomes:
measure: Alignment of intraocular lens
timeFrame: 1 day postoperatively
measure: Alignment of intraocular lens
timeFrame: 1 week postoperatively
measure: Alignment of intraocular lens
timeFrame: 1 month, postoperatively
Secondary outcomes:
measure: Intraocular Pressure
timeFrame: 1 day, 1 week, 1 month, postoperatively
measure: Corrected Visual Acuity (UCVA) at Distance
timeFrame: 1 day, 1 week, 1 month, postoperatively
measure: Uncorrected Visual Acuity (UCVA) at Distance
timeFrame: 1 day, 1 week, 1 month, postoperatively
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye Hispital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Wenzhou Medical University
name: AYong Yu, MD.PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00454545: Atorvastatin in Moderate Active Crohns Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohns Disease
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
First posted: 2007-03-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open pilot study to collect information regarding the effect of atorvastatin on patients with active Crohns disease.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Crohns disease
* C-reactive protein level \> 2 mg/L in absence of an infection
* Fecal calprotectin \> 250 mg/kg or CDAI \> 150

Exclusion Criteria:

* CDAI \> 450
* Prednisolone dosage above 15 mg/day

Primary outcomes:
measure: Inflammatory markers in plasma before and after treatment.
Secondary outcomes:
measure: Change in clinical activity index and mucosal inflammation after treatment.
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Department of Medicine, Division of Gastroenterology and Hepatology
Study officials:
affiliation: Malmo University Hospital, Region Skåne
name: Olof Grip, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Malmo University Hospital, Region Skåne
name: Anders Bredberg, MD, PhD
role: STUDY_CHAIR
affiliation: Malmo University Hospital, Region Skåne
name: Gunnel Bredberg, MD, PhD
role: STUDY_CHAIR
References:
citation: Grip O, Janciauskiene S. Atorvastatin reduces plasma levels of chemokine (CXCL10) in patients with Crohn's disease. PLoS One. 2009;4(5):e5263. doi: 10.1371/journal.pone.0005263. Epub 2009 May 6.
Clinical trial NCT01865045: Pharmacogenetics Of Vinorelbine In Malignant Pleural Mesothelioma Patients
Official title: Pharmacogenetics of Vinorelbine in Malignant Pleural Mesothelioma Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Pleural Mesothelioma
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2013-05-30
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Malignant pleural mesothelioma patients treated with vinorelbine as a second or later line chemotherapy with at least an objective response evaluation.

Brief summary: This is a multicenter retrospective analysis .The aim of the present study is to investigate the molecular predictors of vinorelbine response in tumor samples of a series of MPM patients and evaluate the possible impact on clinical outcome.

Sample size: around 150 patients based on the availability of tumor size

Detailed description: Vinorelbine has recently become an alternative option for palliation in selected pemetrexed-pretreated patients with malignant pleural mesothelioma (MPM). However, nowadays there are no definitive data about vinorelbine predictors of response in MPM patients. The identification of molecular predictors of effective therapy is important for maximizing therapeutic efficacy and minimizing useless treatment in cancer patients.

In oncology a pharmacogenetic approach to customize the chemotherapy treatment according to individual as well as tumour genetic characteristics represents a modern and intriguing challenge. Recent studies have suggested that the expression levels of class III β-tubulin (TUBB3) or BRCA1, are related to a survival benefit from vinorelbine chemotherapy among patients with advanced solid malignancies, especially non-small cell lung cancer. There are no data about the predictive factors to vinorelbine in MPM patients. The identification of molecular predictors of effective therapy may allow in the future the development of better therapies.

Eligibility criteria: Inclusion Criteria:

* MPM patients treated with vinorelbine in the ≥ second line setting will be retrospectively analyzed
* Patients will be selected based on the availability of tumor tissue

Exclusion Criteria:

* NA

Primary outcomes:
measure: Expression of TUBB3 and BRCA1 in MPM tumor tissue by immunohistochemistry and RT-PCR.
timeFrame: 2 months
Secondary outcomes:
measure: Association of expression of TUBB3 and BRCA1 with clinical outcome (response, survival) .
timeFrame: 2 months
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milan
Study officials:
affiliation: Istituto Clinico Humanitas
name: armando santoro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01549145: Sub-chronic Neurostimulation Delivered in the Middle Ear for Tinnitus Suppression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Keywords: Severe
Ongoing
Unilateral
present for more than 6 months
Lead sponsor: EstimME Ltd.
Sponsor class: INDUSTRY
First posted: 2012-03-09
Enrollment: 14
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: The objectives of this study are to evaluate the safety and efficacy of applying electrical stimulation on the promontorium (EPS) for the suppression of tinnitus in a sub-chronic stimulation regimen.


Eligibility criteria: Inclusion Criteria:

1. Total score on the Handicap Inventory (THI) of at least 40.
2. Visual scale over 5.
3. Tinnitus origin is peripheral (related to long term noise exposure, or to a sudden exposure to a very loud noise etc.)
4. Tinnitus is on-going; present for more than 50% of the time over the past 12 months.
5. Unilateral tinnitus
6. Tinnitus prevalent at least 12 months.
7. Willingness to abstain from part taking in other, non-study procedures indicated to lessen tinnitus and/or its perception.
8. Willing and able to refrain from engaging in activities or work involving loud noise exposure.
9. Male or females 18-60 years of age

Exclusion Criteria:

1. Prior history of sudden hearing loss and/or fluctuating hearing levels.
2. Tinnitus prevalent more than 3 years.
3. History of frequent middle ear infections
4. Patient under immunosuppressant therapy
5. Auditory nerve damage.
6. Vestibular Schwannoma
7. Cochlear implant.
8. Pregnant or lactating.
9. Developmental disability or cognitive impairment that would make it difficult for the subject to partake in the clinical study, including adequate comprehension of the informed consent form and ability to record the necessary measurements.
10. Involvement in litigation and/or a worker's compensation claim and/or receiving disability benefits related to tinnitus and/or hearing loss.
11. Not being physically or geographically capable of returning for scheduled follow-up visits.
12. Any physical, psychological, or emotional disorder that would interfere with the planned surgical operations
13. Mentally retarded, developmentally delayed or suffering from organic brain dysfunction.

Primary outcomes:
measure: Efficacy
timeFrame: 2 months
Secondary outcomes:
measure: Safety
timeFrame: 2 months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
References:
Clinical trial NCT01225445: Treatment of Early Immunoglobulin A Nephropathy by Angiotensin Converting Enzyme Inhibitor - A Randomized Controlled Trial
Official title: Treatment of Early Immunoglobulin A Nephropathy by Angiotensin Converting Enzyme Inhibitor - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Biopsy-confirmed IgA Nephropathy
Proteinuria Less Than 0.5 g Per Day
Normal Blood Pressure
Serum Creatinine Below 120 Umol/l
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2010-10-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Immunoglobulin A (IgA) nephropathy is the most common type of primary glomerulonephritis in the world. The treatment of IgA nephropathy with normal renal function and minimal proteinuria is unknown. Since angiotensin-converting enzyme (ACE) inhibitors reduce proteinuria and retard the rate of decline of renal function in chronic proteinuric nephropathies, including IgA nephropathy. The investigators conduct a randomized control study to evaluate the efficacy of ACE inhibitor in the treatment of early IgA nephropathy. Sixty patients with biopsy-proven IgA nephropathy and minimal proteinuria are recruited. They will be randomized to ramipril for 5 years or no treatment. Blood pressure, proteinuria and renal function will be monitored. This study will explore the effects of ACE inhibitor in the treatment of early IgA nephropathy, which is a major cause of dialysis-dependent renal failure.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 65
* biopsy-confirmed IgA nephropathy
* proteinuria less than 0.5 g per day, normal blood pressure, and serum creatinine below 120 umol/l
* willingness to give written informed consent and willingness to participate in and comply with the study protocol

Exclusion Criteria:

* expected survival less than 2 years
* pregnant or nursing mother, or women of childbearing potential without an effective method of birth control
* history of myocardial infarction, congestive heart failure, or any other medical indication that necessitate the use of ACE inhibitor
* evidence of clinically significant hepatic, gastrointestinal, autoimmune disease
* history of malignancy, drug or alcohol abuse
* participation in any previous trial on ACE inhibitor
* taking other investigational drugs within the past 30 days
* history of non-compliance to medical regimens and patients who are considered potentially unreliable
* known history of sensitivity / allergy to ACE inhibitor

Primary outcomes:
measure: blood pressure
timeFrame: 5 years
measure: proteinuria
timeFrame: 5 years
measure: serum creatinine
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Department of Medicine & Therapeutics, Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Cheuk Chun Szeto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05650645: The Efficacy of Incobotulinum Toxin A Injections for Treatment of Tinnitus: a Randomized Controlled Trial
Official title: The Efficacy of Incobotulinum Toxin A Injections for Treatment of Tinnitus: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Tinnitus
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 33
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: Tinnitus is a persistent non-physiologic, non-psychiatric, ringing in the ear that affects up to 20% of the general US population. The purpose of this study is to assess the patient reported effectiveness of Xeomin (incobotulinumtoxinA) injections into the auricular muscles for relief of tinnitus with use of the Tinnitus Handicap Inventory questionnaire.


Eligibility criteria: Inclusion Criteria:

* Adults age 18 or older
* Unilateral or bilateral tinnitus present for ≥ 2 months
* A score \>16 on the Tinnitus Handicap Inventory
* Participants must be willing and able to provide informed consent.

Exclusion Criteria:

* Patients with known hypersensitivity to any botulinum toxin product or to any of the components in the formulation.
* Patients who have received botulinum toxin injections for any medical reason within 4 months prior to screening.
* Patients with infection at proposed injection sites.
* Patients scheduled for neurological or otological surgery for chronic ear disease, vestibular schwannoma, meningioma, or skull base tumors.
* Significant psychiatric history or associated diagnosis of major depression.
* Women who are pregnant or breastfeeding.

Primary outcomes:
measure: Change in the Tinnitus Handicap Inventory score
timeFrame: pre-injection baseline to 4-6 weeks post injection
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Stephanie Standal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00414245: Metformin for the Treatment of Diabetes in Pregnancy
Official title: Metformin for the Treatment of Diabetes in Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gestational Diabetes
Diabetes Mellitus Type 2
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
Collaborators: name: Ben-Gurion University of the Negev
First posted: 2006-12-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether metformin is effective and safe in the treatment of diabetes in pregnancy.


Eligibility criteria: Inclusion Criteria:

* pregnant women
* GDM A2
* diabetes mellitus type 2
* singleton pregnancy

Exclusion Criteria:

* diabetic nephropathy or proliferative retinopathy
* cannot swallow tablets

Primary outcomes:
measure: glycemic control
measure: pregnancy complications
Secondary outcomes:
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Division of Obstetrics and Gynecology, Soroka University Medical Center
Study officials:
affiliation: division of obstetrics and gynecology, soroka university medical center
name: Boaz Sheizaf, MD
role: PRINCIPAL_INVESTIGATOR
References: