louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06462924: Feasibility of Gadolinium Contrast Reduced Brain MRI: the Potential of Deep Learning
Official title: Feasibility of Gadolinium Contrast Reduced Brain MRI: the Potential of Deep Learning
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Artificial Intelligence
Deep Learning
Lead sponsor: DeepMeds
Sponsor class: INDUSTRY
First posted: 2024-06-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: MRI scans were performed using 3 different 1.5T scanners with an eight-channel head coils. Following a 3D pre-contrast T1w scan, a low-dose contrast-enhanced 3D T1w scan was obtained using 20% (0.02 mmol/kg) of the standard dosage of gadoterate meglumine.

The subjects were immediately administered the remaining 80% (0.08 mmol/kg) of the contrast agent to reach the standard dose of 0.1 mmol/kg, which served as a training ground truth for further quantitative assessment. All three acquisitions were performed during a single imaging session, with no additional gadolinium dose administered above the standard protocol.


Eligibility criteria: Inclusion Criteria:

1. Clinical indications for imaging with a contrast-enhanced 3D-T1w MRI sequence including tumor suspicion, postoperative tumor follow-up, multiple sclerosis, routine brain imaging, etc.,
2. no plan for dynamic contrast administration or deviation from the standard dose of 0.1 mmol/kg body weight (e.g., sella imaging, magnetic resonance angiography),
3. no clinical contraindications to imaging prolongation (i.e., emergency, poor patient condition).

Exclusion Criteria:

1. prominent image artifacts,
2. incomplete study sequences (e.g., early termination)
3. errors related to contrast agent administration.

Primary outcomes:
measure: Image quality
timeFrame: 1 Day After MRI session
measure: Vessel conspicuity
timeFrame: 1 Day After MRI session
Secondary outcomes:
measure: Enhancement pattern
timeFrame: 1 Day After MRI session
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05580224: Anatomical Radiofrequency Ablation for Small Hepatocellular Carcinoma
Official title: Anatomical Radiofrequency Ablation for Peripherally Located Small Hepatocellular Carcinoma Using Combined Energy Delivery Mode and Triple Cooled-Wet Electrodes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 87
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate therapeutic outcomes of anatomical radiofrequency ablation for peripherally located small hepatocellular carcinoma using combined energy delivery mode and triple cooled-wet electrodes.


Eligibility criteria: Inclusion Criteria:

* Child-Pugh class A or B7.
* Presence of chronic hepatitis B or liver cirrhosis.
* Patients with hepatocellular carcinomas diagnosed by histopathology or noninvasive imaging-based diagnosis according to the Korean Liver Cancer Association-National Cancer Center Korea guidelines.
* Patients with viable hepatocellular carcinoma after locoregional treatment diagnosed by the Liver Imaging Reporting and Data System.
* Tumor location is less than 5 cm from liver capsule.

Exclusion Criteria:

* The number of tumor is three or more.
* Tumor size is over 3 cm.
* Tumor location is over 5 cm from liver capsule.
* Child-Pugh class B8-9 or C.
* Presence of macrovascular invasion and/or distant metastasis.
* Platelet count \< 50,000 mm3, or international normalized ratio \> 1.5 (prothrombin time \>1.5 × normal).

Primary outcomes:
measure: Technical success
timeFrame: Immediately after radiofrequency ablation
measure: Local tumor progression rate
timeFrame: 12 months after radiofrequency ablation
Secondary outcomes:
measure: Complication after radiofrequency ablation
timeFrame: Immediately, 1 month, 3 months, 6 months, 9 months, and 12 months after radiofrequency ablation
measure: Recurrence-free survival
timeFrame: 12 months after radiofrequency ablation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04346524: SweMaMi DMI, Microbiome
Official title: SweMaMi DM1, Diabetic Women's Microbiome During Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
Microbioma
maternal and fetal pregnacy outcomes
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women with type 1 diabetes

Brief summary: Dysbiosis is associated with an increased risk of preeclampsia during pregnancy. The microbiome differs between those with and without type 1 diabetes and the cause of type 1 diabetes has been associated with dysbiosis. Increased knowledge of the microbiome and its variation, depending on the state of health during pregnancies complicated with type 1 diabetes, could in the future lead to preventive care and treatments during these pregnancies.

Detailed description: Prospective cohort. All women with type 1 diabetes that are planning a pregnancy and being cared for at the diabetic ward at Södersjukhuset will be asked to participate, n= 55.

All pregnancies complicated with type 1 diabetes that are being cared for at the special maternity ward at Södersjukhuset, n=45.

The expected to include is 100. Expected viable pregnancies: 50.

The maternal vaginal, fecal and oral microbiome will be sampled by "self-sampling" at home before, during and after the pregnancy, by this schedule:

1. Inclusion, before pregnancy after an appointment with the diabetic doctor or nurse. Or at the first visit at the special maternity care ward during pregnancy (around gestational week 8).
2. When the pregnancy is first discovered if the inclusion were before pregnancy.
3. Week 28.
4. When attending delivery ward in labor
5. 6-10 weeks postpartum from both the mother and the new-born. The tests will be sent to the obstetric research center at Södersjukhuset, where the tests will be saved in freezes. The analysis will be performed at CTMR at the Karolinska Institute.

Background, pregnancy and delivery data will then be associated with the woman microbiome in the vagina, in feces and in saliva.

Eligibility criteria: Inclusion Criteria:

* Pregnant Women with type 1 diabetes
* Included as a patient at women's clinic Soderhospital in Stockholm
* Acceptant to sample her microbiome during pregnancy

Exclusion Criteria:

* Women without type 1 diabetes

Primary outcomes:
measure: Maternal complications during pregnancy
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Fetal complications during pregnancy
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Danderyd
country: Sweden
facility: Eva Wiberg-Itzel
state: Sverige
city: Stockholm
country: Sweden
facility: Eva Wiberg-Itzel
Study officials:
affiliation: Karolinska Institute Sodersjukhuset Sweden
name: Eva Wiberg-Itzel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02230124: Magnetic Resonance Elastography in Hydrocephalus
Official title: Magnetic Resonance Elastography in Hydrocephalus
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hydrocephalus
Keywords: Hydrocephalus
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2014-09-03
Enrollment: 35
Sex: ALL
Minimum age (years): 45
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this project is to assess the utility of a new magnetic resonance technique called magnetic resonance elastography (MRE) in the non-invasive diagnosis of normal pressure hydrocephalus. The investigators hypothesize that MRE produces a unique imaging signature for hydrocephalus that distinguishes the disease from the normal (non-hydrocephalic) but atrophied brain, a distinction not possible with conventional MR imaging studies that are presently available.


Eligibility criteria: Inclusion Criteria:

* Age \>21;
* One or more of the following complaints: memory loss/dementia, urinary incontinence, or progressive gait disturbance
* Ventriculomegaly defined as temporal horn width \>2 mm or a FH:ID ratio\>30% on computed tomography or MRI, where FH is the maximal distance between the frontal horns and ID is the internal diameter from inner table to inner table of the skull at this level (Greenberg)
* A diagnosis of any adult onset hydrocephalus (NPH, post-traumatic, post-hemorrhagic, obstructive, or idiopathic) will be considered for enrollment in this study

Exclusion Criteria:

* Implanted neuro-stimulator or cardiac pacemaker
* Known coagulopathy; major organ dysfunction
* End-stage congestive heart failure
* Oxygen-dependent pulmonary disease, hepatic cirrhosis, or dialysis- dependent renal failure; or other condition which, according to the assessment of the treating surgeon or anesthesia team
* Precludes consideration of elective surgery
* Patients who may be pregnant will be excluded from this study as well

Primary outcomes:
measure: Mean shear modulus
timeFrame: 15 Years
Secondary outcomes:
measure: Pre-operative (and pre-drain placement) shear modulus in the experimental group will be compared with various assessments of clinical improvement after VP shunting.
timeFrame: 15 Years
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth College
name: Keith D Paulsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01519024: Postural Control in Breast Hypertrophy
Official title: Poorer Postural Control in Women With Breast Hypertrophy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertrophy
Sensation Disorders
Keywords: hypertrophy
breast
postural balance
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2012-01-26
Enrollment: 28
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The fourteen women for breast hypertropy group were recruited from the Department of Plastic Surgery and Department of Gynecology of Clinical Hospital, Faculty of Medicine, University of São Paulo, and the fourteen women of control group (without breast hypertrophy)was compound by women dwelling community.

Brief summary: Principles of motor control suggest that breast hypertrophy can lead to sensoriomotor alterations and impairment in body balance due to postural misalignment. The investigators conducted this study to evaluate the postural control with different sensorial information condition in women with breast hypertrophy.

Detailed description: Up to the moment, changes caused by breast hypertrophy are described based on the alteration of body mass distribution leading to an impact of psychological and physical aspects. However, the investigators hypothesize that due to alterations in postural alignment, sensoriomotor inputs are also impaired and postural or motor control are ultimately compromised.

Eligibility criteria: Inclusion Criteria:

* For the breast hypertrophy group, the women had to be in attendance in the Department of Plastic Surgery and Department of Gynecology of Clinical Hospital.

Exclusion Criteria:

* For both groups:

  * rheumatic, neurological, respiratory and vestibular conditions due to possible balance alterations

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Physical Therapy, Speech and Occupational Therapy Department, School of Medicine: University of São Paulo
Study officials:
affiliation: Full Professor - Department of Physical Therapy, Communication Science & Disorders, Occupational Therapy, Faculty of Medicine - USP
name: Clarice Tanaka, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00797524: Function and Structure Imaging in Different Retinal Diseases: Retinal Leakage Analyzer Versus Optical Coherence Tomography
Official title: Function and Structure Imaging in Different Retinal Diseases. Retinal Leakage Analyzer vs. Optical Coherence Tomography.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Age-Related Macular Degeneration
Macular Edema
Lead sponsor: Association for Innovation and Biomedical Research on Light and Image
Sponsor class: OTHER
First posted: 2008-11-25
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects followed regularly by their ophthalmologist at the AIBILI Clinical Trial Center (Azinhaga de Santa Comba - Celas, Coimbra, Portugal), performing, as part of their follow-up, fluorescein angiography with the Heidelberg Retina Angiograph (HRA) and optical coherence tomography with OCT, and fulfilling the inclusion/exclusion criteria will be included.

Brief summary: The main objective of this observational study is to characterize and correlate functional and structural changes at the retinal level using the Retinal Leakage Analyzer (RLA) and the Optical Coherence Tomograph (OCT).

To show if it is possible to use OCT as an indirect measurement of leakage, this study will check, in a primary analysis, for OCT changes between fluorescein leaking and non-leaking areas (identified by Retinal Leakage Analyzer).

As a secondary objective, changes in RLA and OCT over time (between two consecutive visits) will be analyzed and characterized.

The results of this study will be used exclusively for scientific purposes.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of DR, ARMD or ME
* Females or Males
* Age over 18 years
* Signed Informed Consent Form

Exclusion Criteria:

* Cataract or other eye disease that may interfere with fundus examinations
* Vitreous syneresis or posterior vitreous detachment
* Dilatation of the pupil \< 5 mm

Primary outcomes:
measure: Retinal leakage and retinal thickness.
timeFrame: After the visit
Secondary outcomes:
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: AIBILI
Study officials:
affiliation: Association for Innovation and Biomedical Research on Light and Image
name: José Cunha-Vaz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bernardes R, Maduro C, Serranho P, Araujo A, Barbeiro S, Cunha-Vaz J. Improved adaptive complex diffusion despeckling filter. Opt Express. 2010 Nov 8;18(23):24048-59. doi: 10.1364/OE.18.024048.
Clinical trial NCT01136824: Chemotherapy-induced Symptoms in Sarcoma Patients and the Impact of Tumor Burden
Official title: Chemotherapy-induced Symptoms in Sarcoma Patients and the Impact of Tumor Burden
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Soft Tissue Sarcoma
Keywords: Sarcoma
questionnaire
doxorubicin plus ifosfamide (AI)
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Soft tissue sarcoma patients treated with the adjuvant and neoadjuvant chemotherapy protocol of doxorubicin plus ifosfamide (AI)

Brief summary: Assessments (survey data) in this study are designed to sample the symptom burden of patients undergoing adjuvant and neoadjuvant chemotherapy in the hospital. There will be no change in the treatment plan for these patients.


Eligibility criteria: Inclusion Criteria:

* Patients who are receiving doxorubicin plus ifosfamide (AI)

Exclusion Criteria:

* There is no exclusion criteria

Primary outcomes:
measure: To determine the extent of symptom burden and quality of life in sarcoma patients receiving AI chemotherapy.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh, Hillman Cancer Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Hussein Tawbi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Charles Horn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04861324: Effects of a Lifestyle Intervention on Gestational Diabetes Management
Official title: Effects of a Lifestyle Intervention on Gestational Diabetes Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Type 2 Diabetes
Nutritional and Metabolic Disease
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of nutrition education focusing on colorful fruit and vegetable intake with after-meal physical activity guidance on glycemic control and complications in women with gestational diabetes and pre-gestational diabetes.

Detailed description: Diabetes (high blood sugar) developed during pregnancy can be harmful to the mother as it can lead to delivery complications because of a large baby and increases risks of type 2 diabetes and heart disease in the mother and baby in later life. Thus, pregnancy is a critical time during the human lifespan to make effective dietary changes that are safe for both mother and the fetus and reduce risks of developing diabetes and pregnancy complications. Women at risk for gestational diabetes will be randomly assigned to the standard care or the nutrition education group. Blood draws and other biomedical measures will be collected at baseline and at end of the study before delivery.

Eligibility criteria: Inclusion Criteria:

* high risk for gestational diabetes
* willing to make lifestyle changes
* history of diabetes

Exclusion Criteria:

* carrying more than one fetus
* history of chronic conditions except diabetes and hypertension

Primary outcomes:
measure: Maternal glycemic control
timeFrame: 12 weeks
measure: Maternal gestational weight gain
timeFrame: 12 weeks
measure: Maternal medication usage
timeFrame: 12 weeks
measure: Maternal Lipids
timeFrame: 12 weeks
Secondary outcomes:
measure: Maternal inflammation
timeFrame: 12 weeks
measure: Maternal serum carotenoids
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: UNLV School of Medicine MFM clinic
state: Nevada
Study officials:
affiliation: University of Nevada at Las Vegas
name: Arpita Basu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01799824: Clinical Trial to Evaluate ANT-1403 in the Treatment of Primary Axillary Hyperhidrosis
Official title: Clinical Trial to Evaluate ANT-1403 in the Treatment of Primary Axillary Hyperhidrosis in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Axillary Hyperhidrosis
Lead sponsor: Anterios Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-27
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 confirm the effect of ANT-1403 in the treatment of primary axillary hyperhidrosis.


Eligibility criteria: Inclusion Criteria:

* ages 18 - 70 years of age
* diagnosis of moderate to severe primary axillary hyperhidrosis
* ≥50 mg of sweat production/axilla in 5 minutes as measured gravimetrically
* HDSS score of ≥3

Exclusion Criteria:

* diagnosis of secondary hyperhidrosis
* skin affliction in the axilla requiring medical treatment
* 20% aluminum hydrochloride, e.g. Drysol®, in 2 weeks prior of Baseline
* oral anticholinergic treatment
* botulinum toxin treatment in the prior 9 months
* history of surgery for axillary hyperhidrosis
* present or history of neuromuscular disease
* female subjects who are pregnant or are nursing a child

Primary outcomes:
measure: HDSS
timeFrame: Week 8
Secondary outcomes:
measure: GSP
timeFrame: Week 8
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
city: Pinellas Park
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Louisville
country: United States
state: Kentucky
city: East Windsor
country: United States
state: New Jersey
city: Rochester
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Yardley
country: United States
state: Pennsylvania
city: Norfolk
country: United States
state: Virginia
Study officials:
References: