louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04389216: Radiofrequency Ablation (RFA) in Breast Tumors
Official title: Radiofrequency Ablation in Breast Tumors in Early Stages
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer Female
Keywords: radiofrequency
early stage
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 30
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Radiofrequency ablation
Primary purpose: TREATMENT

Brief summary: To validate the efficacy and safety of the cool-tip ablation method for breast tumors smaller than 2 cm.

Detailed description: A prospective, phase II-III study, which will include a series of cases of 30 patients. The hospitals involved will be Bellvitge University Hospital and Hospital del Mar.

Efficacy was evaluated according magnetic resonance image and biopsy of the breast 1 month after the procedure.

Patients will be followed up over a 2-year period to assess cosmetic results, short and long-term complications and possible recurrences.

Eligibility criteria: Inclusion Criteria:

* Infiltrating ductal carcinoma according the biopsy of the breast,
* Tumor visible by ultrasound, smaller than 2 cm,
* Located \> 1 cm from the chest wall and the skin.

Exclusion Criteria:

* Personal antecedents of breast cancer
* Multifocality or intraductal carcinoma
* Lobular infiltrating carcinoma
* Neoadjuvant therapy

Primary outcomes:
measure: MRI post-RFA
timeFrame: 1 month after procedure
measure: BAG post-RFA
timeFrame: 1 month after procedure
Secondary outcomes:
measure: Adverse Effects
timeFrame: Through study completion, an average of 1 year
measure: Quality
timeFrame: 1 month after procedure
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
affiliation: Hospital Universitari Bellvitge
name: Amparo Garcia-Tejedor, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02313116: Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)
Official title: Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Breast Cancer
Keywords: Lumpectomy
Breast cancer
Optical coherence tomography
Tumor margin
Imaging
Lead sponsor: Diagnostic Photonics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-09
Enrollment: 50
Sex: FEMALE
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: Women with breast cancer undergoing lumpectomy.

Brief summary: This intraoperative study is a prospective study analyzing specimens from fifty subjects. Patients scheduled to undergo breast-conserving surgery will be recruited in accordance with the inclusion and exclusion criteria. The study period per subject is the time it takes to assess the ex vivo breast tissue sample using the study device. Image review will be conducted during surgery and compared to the margin status findings in the post-operative pathology report.


Eligibility criteria: Inclusion Criteria:

1. Women 18 years of age or older
2. Signed informed consent form
3. Women who have been histologically diagnosed with carcinoma of the breast prior to surgery
4. Patients planning breast preservation and undergoing lumpectomy (partial mastectomy) procedure

Exclusion Criteria:

1. Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
2. Neoadjuvant systemic therapy
3. All T4 tumors
4. Previous radiation in the operated breast
5. Prior surgical procedure in the same quadrant
6. Implants in the operated breast
7. Pregnancy
8. Lactation
9. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study

Primary outcomes:
measure: Patients With All Positive/Close Margins Correctly Identified With the Device
timeFrame: 1 week after surgery
measure: Number of Margins With False Positive Device Readings
timeFrame: 1 week after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Lisa Jacobs
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02180516: Safety and Efficacy of Meloxicam Compared to Other Nonsteroidal Antiinflammatory Drugs (NSAIDs) in an Observational Cohort Study of Patients With Rheumatoid Arthritis, Osteoarthritis, Lumbago, Scapulohumeral Periarthritis, Neck, Shoulder and Arm Syndrome
Official title: Safety and Efficacy of Meloxicam (MOBIC) Compared to Other NSAIDs in Approved Therapeutic Dosages and Routes of Administration in an Observational Cohort Study of Patients With Rheumatoid Arthritis, Osteoarthritis, Lumbago, Scapulohumeral Periarthritis, Neck, Shoulder and Arm Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-02
Enrollment: 9984
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from hospitals or general practioners (Internal Medicine, Orthopedics)

Brief summary: Study to assess the safety profile of meloxicam by comparing incidence of gastrointestinal adverse events of meloxicam with that of NSAID in the routine daily therapeutic situation.


Eligibility criteria: Inclusion Criteria:

* Patients with Indications according to the package insert of the prescribed NSAID

Exclusion Criteria:

* There is no exclusion criterion, because this Post Marketing Study is an observational study

Primary outcomes:
measure: Incidence for adverse event of gastrointestinal disorder
timeFrame: up to 6 months
Secondary outcomes:
measure: Incidence for adverse drug reaction of gastrointestinal disorder
timeFrame: up to 6 months
measure: Incidence of adverse events
timeFrame: up to 6 months
measure: Incidence of adverse drug reactions
timeFrame: up to 6 months
measure: Incidence of serious adverse events
timeFrame: up to 6 months
measure: Incidence for adverse events Perforation, Ulcer and Bleeding (PUB) in the upper gastrointestinal tract
timeFrame: up to 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00000316: Human Dopamine Transported Imaging in Cocaine Abuse: 2 - 2
Official title: Human Dopamine Transported Imaging in Cocaine Abuse: 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Johns Hopkins University
First posted: 1999-09-21
Enrollment: 0
Sex: MALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the density of DA transporters during prolonged cocaine abuse and during withdrawal from cocaine use. This aim will test the hypothesis that DA transporters are altered by cocaine abuse and reestablished during withdrawal.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Psychological effects
measure: Effects of investigational drug
measure: Physiological changes in: heart rate and blood pre
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Dean Wong, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07026916: A Phase II Study to Evaluate GFH375 in Patients With KRAS G12D Mutant Metastatic Pancreatic Cancer
Official title: A Single-Arm, Multicenter, Open-Label, Phase II Clinical Study to Evaluate the Efficacy, Safety/Tolerability, and Pharmacokinetic Characteristics of GFH375 Monotherapy in Patients With Previously Treated KRAS G12D Mutant Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Metastatic Pancreatic Cancer
Lead sponsor: Genfleet Therapeutics (Shanghai) Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-18
Enrollment: 83
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 a multicenter, open-label, phase II study to explore the efficacy, safety/tolerability and pharmacokinetics (PK) of GFH375 in in Patients with Previously Treated KRAS G12D Mutant Metastatic Pancreatic Cancer.


Eligibility criteria: Inclusion Criteria:

1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
2. Male or female ≥ 18 years old and ≤75 years old.
3. With histologically or cytologically confirmed metastatic pancreatic cancer harboring KRAS G12D mutation
4. Be able to provide tumor tissue samples that meet the requirements
5. Have at least one measurable lesion according to RECIST1.1
6. ECOG performance status of 0-1.
7. With a life expectancy of ≥12 weeks.
8. Adequate laboratory parameters during the screening period.

Exclusion Criteria:

1. Active brain metastases.
2. Prior treatment with a KRAS G12D inhibitor or a pan-RAS/KRAS inhibitor.
3. With poorly controlled or severe cardiovascular disease.
4. Subjects with active hepatitis B or active hepatitis C.
5. Known allergy to the study drug or its components.
6. Pregnant or lactating women.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: 24 months
Secondary outcomes:
measure: ORR
timeFrame: 24 months
measure: DCR
timeFrame: 24 months
measure: DoR
timeFrame: 24 months
measure: TTR
timeFrame: 24 months
measure: PFS
timeFrame: 24 months
measure: The incidence and severity of AEs and SAEs
timeFrame: 24 months
measure: Plasma concentrations of GFH375
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04319016: Clinical Characteristics of Coronavirus Disease 2019 (COVID-19) in Pregnancy
Official title: Clinical Characteristics of Coronavirus Disease 2019 (COVID-19) in Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection Viral
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women with laboratory-confirmed 2019-n-CoV

Brief summary: The Novel Coronavirus (2019-nCoV), also known as Wuhan coronavirus, causes the 2019-nCoV acute respiratory disease.

Detailed description: Coronaviruses (CoVs) are the largest group of viruses belonging to the Nidovirales order. They are enveloped, non-segmented positive-sense RNA viruses.

Coronavirus are believed to cause a significant proportion of all common colds in adults and children. The Novel Coronavirus (2019-nCoV), also known as Wuhan coronavirus, causes the 2019-nCoV acute respiratory disease. The initial cases of 2019-nCoV occurred in Wuahn, China in December 2019.

A recent review evaluated the potential impact of 2019-nCoV in pregnancy. The authors reported published data on CoVs in pregnant women, including 2019-nCoV, severe acute respiratory syndrome (SARS-COV) and Middle East respiratory syndrome (MERS-COV). The review included 12 women with SARS-COV,4 11 women MERS-COV,5 and 9 women with 2019-n-CoV6 in pregnancy. No cases of vertical trasmission were reported, but the authors showed an high rate of preterm birth (45.8%), cesarean delivery (70.8%), maternal admission to intensive care unit (ICU) (63.3%), and maternal death (18.8%).

The aim of this study was to evaluate the pregnancy and perinatal outcomes of pregnant women with 2019-n-CoV.

This was a multicenter, retrospective, cohort study. Clinical records and compiled data of all consecutive hospitalized and outpatient pregnant women with laboratory-confirmed 2019-n-CoV Data on recent exposure history, clinical symptoms or signs, laboratory findings, and maternal and perinatal outcomes were collected. All medical recors were sent to the coordinator center. Data were entered into a computerized database and cross-checked. If the core data were missing, requests for clarification were sent to the coordinators.

Eligibility criteria: Inclusion Criteria:

* pregnant women with laboratory-confirmed 2019-n-CoV

Primary outcomes:
measure: Maternal and perinatal outcomes
timeFrame: at the time of delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Gabriele Saccone
Study officials:
References:
Clinical trial NCT06876116: Once-daily Fluorometholone vs Twice-daily Cyclosporine in Dry Eye Disease
Official title: Comparison of Therapeutic Effects of Once-daily Fluorometholone 0.1% Versus Twice-daily Cyclosporine 0.05% in Patients With Dry Eye Disease: A Randomized, Assessor-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Disease (DED)
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
Collaborators: name: Taejoon Pharmaceutical Co., Ltd.
First posted: 2025-03-14
Enrollment: 32
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: This study compares the therapeutic effects of once-daily fluorometholone 0.1% versus twice-daily cyclosporine 0.05% after short-term fluorometholone induction treatment in dry eye disease.


Eligibility criteria: Inclusion Criteria:

1. participants aged 18 years or older
2. complaint of dry eye symptoms for 6 months or longer at screening
3. ocular surface disease index (OSDI) score of 33 or higher
4. tear film breakup time of 7 seconds or less

Exclusion Criteria:

1. abnormal lid anatomy or active blepharitis
2. severe systemic autoimmune diseases
3. received permanent lacrimal plug within 3 months
4. DED secondary to alkali burns, cicatricial pemphigoid, or Stevens-Johnson syndrome
5. ocular/periocular malignancy
6. active ocular allergies or allergy to the study drug or its components
7. active infection
8. intraocular surgery or ocular laser surgery within 6 months
9. uncontrolled systemic disease or history of herpetic keratitis
10. contact lens user
11. intraocular pressure \>25mmHg
12. pregnancy or current breast-feeding.

Primary outcomes:
measure: Ocular Surface Disease Index (OSDI) score
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: tear breakup time (TBUT)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: corneal staining score (CSS)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Schirmer's test
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Meibomian gland dysfunction grade (0-4)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: tear matrix metalloproteinase-9 (MMP-9) grade
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: tear osmolarity
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: Tear IL-6 levels
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: tear 8-oxo-dG levels
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
References:
Clinical trial NCT03778424: An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303
Official title: An Extended Access Program (EAP) for Rufinamide in Pediatric Participants With Inadequately Controlled Lennox-Gastaut Syndrome
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Lennox Gastaut Syndrome
Keywords: Central Nervous System
E2080
Rufinamide
Epilepsy
Seizures
Brain Diseases
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-19
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is an extended access study for participants who have completed Rufinamide Study E2080-G000-303 to continue to have access to rufinamide until it becomes commercially available in Poland or until no participants remain in the EAP.


Eligibility criteria: Inclusion Criteria:

* Participants who were on rufinamide treatment and have completed Study E2080-G000-303 in Poland.

Exclusion Criteria:

* Participants were randomized to the other antiepileptic drug (AED) treatment group in study E2080-G000-303.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kielce
country: Poland
facility: Generała Tadeusza Kościuszki 52
city: Poznań
country: Poland
facility: Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Study officials:
References:
Clinical trial NCT00135824: Local Tolerability and Safety of Povidone K25 Eye Drops (Artificial Tears Containing Povidone) Versus Placebo in Healthy Volunteers
Official title: Local Tolerability and Safety of Povidone K25 (Artificial Tears Containing Povidone) vs. Placebo in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Artificial eye drops
tolerability
healthy volunteers
povidone
healthy subjects
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Instillation of artificial tears is standard treatment in dry eye syndrome and in patients experiencing dry eye symptoms when wearing contact lenses. Povidone K25 eye drops (povidone) is an isotonic solution containing povidone to simulate normal tears viscosity. Safety and local tolerability of Povidone K25 is evaluated in healthy volunteers in comparison to placebo eye drops.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Older than 18 years
* Ocular discomfort less than 20 mm on 100 mm visual analogue scale (VAS) prior to treatment

Exclusion Criteria:

* Known hypersensitivity to any of the constituents of the medications
* Known allergic disposition (e.g. hay fever)
* Wearing of contact lenses
* Any kind of current eye disease (e.g. dry eye)

Additional exclusion criteria are defined in the protocol

Primary outcomes:
measure: ocular discomfort by using a visual analogue scale (VAS)
Secondary outcomes:
measure: slit lamp assessment (conjunctival edema, palpebral hyperemia, lid edema)
measure: adverse events
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Novartis Investigational Site
Study officials:
affiliation: Universitäts-Augenklinik, Im Neuenheimer Feld 400,
name: PD. Dr. G. Auffarth
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03346824: Levosimendan Efficacy for Veno-arterial ECMO Weaning: a Retrospective Study
Official title: Levosimendan Efficacy for Veno-arterial ECMO Weaning: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiogenic Shock
Keywords: Levosimendan
Veno-arterial ECMO
Weaning
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who required the use of short-term assistance

Brief summary: Failure of Weaning from ECMO is a serious complication, reaching an incidence between 29 and 58%. Inotrops are frequently used to help separating patient from ECMO. Levosimendan is an ino-dilatatory medication and was used in different clinical settings. The aim of this study was to evaluate the benefit with levosimendan when used in weaning process.


Eligibility criteria: Inclusion Criteria:

* Age over 18
* Patient requiring the need for short-term assistance
* Patient who has agreed to use his medical data for research purposes

Exclusion Criteria:

* Refusal to participate in the study
* Non-weaning attempts due to a death under assistance or a relay by a long-term assistance or heart transplant
* Non-cardiac indications of assistance (indication of pulmonary replacement)
* Subject under guardianship or curatorship

Primary outcomes:
measure: Comparison of the incidence of weaning failure between patients with levosimendan and others
timeFrame: Data were recorded from admission until 48 hours after weaning from ECMO
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Réanimation chirurgicale cardiovasculaire-NHC
Study officials:
References:
Clinical trial NCT02178124: A Phase I Clinical Study, Randomized, Single-blind, Placebo-controlled, Multiple Doses, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Donepezil Patch in Healthy Male Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Icure Pharmaceutical Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-30
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study of the Safety, tolerability and pharmacokinetics with multiple doses of donepezil patch in healthy male subjects


Eligibility criteria: Inclusion Criteria:

* BMI : more than 19 ㎏/㎡, less than 27 ㎏/㎡
* Systolic blood pressure : more than 90, less than 140 (mmHg)
* Diastolic blood pressure : more than 60, less than 100 (mmHg)

Exclusion Criteria:

* Evidence of clinically significant, severe, active, or unstable gastrointestinal, renal,hepatic, respiratory, hematological, endocrine, or cardiovascular system disease.
* A history of skin disease or skin graft
* Hypersensitivity to donepezil or piperidine derivatives or any of the excipients.
* A known or suspected history of drug or alcohol dependency or abuse
* Patients who have participated in another clinical study within 60 days.
* Whole blood within 60 days, apheresis within 30 days, transfusion within 30 days
* Heavy alcohol intake(more than 21 units/week)
* Heavy smoker(more than 10 cigarette/day)
* Abnormal clinical laboratory values which are judged clinically significant by the investigator.
* Any condition that would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study.

Primary outcomes:
measure: safety and tolerability evaluation
timeFrame: patch : -1d~33d, oral : -1~11d
Secondary outcomes:
measure: pharmacokinetics characteristic evaluation
timeFrame: patch: -1~25d, oral -1~11d
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: ASAN Medical Center
Study officials:
References: