louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00942760: Protocol to Distinguish Tumor Recurrence From Treatment-Related Necrosis in Patients With High Grade Gliomas
Official title: DMS-0901: Multimodal Magnetic Resonance Protocol to Distinguish Tumor Recurrence From Treatment-Related Necrosis in Patients With High Grade Gliomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent High Grade Gliomas
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2009-07-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recurrent GBM patients

Brief summary: Brain imaging tests are routinely used to detect the presence of a brain tumor or to evaluate the response to treatment. Sometimes the images obtained are not specific and the only way to establish a diagnosis is by obtaining a tissue sample. The hypotheses of the study is to determine if multimodal MR technique will provide tissue signatures that differentiate between tumor progression and treatment related necrosis in high grade glioma patients.


Eligibility criteria: Inclusion Criteria:

* Histologically proven high grae glioma with central pathology review at DHMC
* Age 18 equal to or greater than 18 years
* Karnofsky performance greater or equal to 60%
* Patients must have received radiation therapy and chemotherapy but should not have received any anti-angiogenesis therapy.

Exclusion Criteria:

* Any patient who requires urgent surgical resection of MRI abnormality would not be eligible
* Pregnant women are not eligible

Primary outcomes:
measure: To prospectively acquire multiparameter MR variables at 1.5T and 3T MRI from treated high grade glioma patients to assign tissue signatures for tumor recurrence and radiation necrosis as established by pathologic examination.
timeFrame: 24 months
Secondary outcomes:
measure: To compare the predictive values of the multiparameter MR tissue signatures acquired at 1.5T and 3T
timeFrame: 24 months
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
References:
Clinical trial NCT00372060: MK0431 (Sitagliptin) Pioglitazone Add-on Study for Patients With Type 2 Diabetes Mellitus (0431-055)(COMPLETED)
Official title: MK0431 (Sitagliptin) Phase III Clinical Study -Pioglitazone add-on Study for Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-09-06
Enrollment: 134
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical study determines the safety and efficacy of MK0431 in patients with type 2 diabetes mellitus who have inadequate glycemic control on pioglitazone as monotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients Have Type 2 Diabetes Mellitus
* On Diet/Exercise Therapy And Pioglitazone As Monotherapy

Exclusion Criteria:

* Patients Have Type 1 Diabetes Mellitus

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 12
timeFrame: 12 Weeks
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose at Week 12
timeFrame: 12 Weeks
Other outcomes:
measure: Change From Baseline in 2 Hour Postprandial Glucose at Week 12
timeFrame: 12 weeks
measure: Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 52
timeFrame: Week 52 (reflecting change from Week 0) for Sitagliptin/Sitagliptin group; Weeks 52 (reflecting change from Week 12) for Placebo/Sitagliptin group.
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Kashiwagi A, Kadowaki T, Tajima N, Nonaka K, Taniguchi T, Nishii M, Ferreira JC, Amatruda JM. Sitagliptin added to treatment with ongoing pioglitazone for up to 52 weeks improves glycemic control in Japanese patients with type 2 diabetes. J Diabetes Investig. 2011 Oct 7;2(5):381-90. doi: 10.1111/j.2040-1124.2011.00120.x.
Clinical trial NCT02465476: Rationalization of the Treatment Pathway of Patient Suffering From Rare Skin Disease With Telemedicine
Official title: Rationalization of the Treatment Pathway of Patient Suffering From Rare Skin Disease With Telemedicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Disease
Keywords: skin disease
telemedicine
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 212
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators want to demonstrate that a new organization with telemedicine could rationalize the treatment pathway of patient suffering from rare skin disease. A diagnosis and a personalised treatment pathway could be performed before the consultation in the hospital.


Eligibility criteria: Inclusion Criteria:

* New patients suffering from a rare skin disease whatever pathology or age, which needs a take-over by this centre
* Or patients already take-over by the centre but lost to follow-up for more than one year
* Patients (and/or parents) who give their consents
* Patients (and/or parents) able to fill in questionnaires

Exclusion Criteria:

* Pregnant or breast-feeding women.
* Patients subject to a judicial safeguard order
* Patients who need an emergency take-over
* Patients followed by a doctor who does not have a computerized system or refuse to send data via the secured messaging

Primary outcomes:
measure: Number of hospital visits
timeFrame: 6 months
Secondary outcomes:
measure: Improvement of the treatment pathway and its organization
timeFrame: 6 months
measure: Satisfaction of the patient
timeFrame: 6 months
measure: Change of the cost related to the patient care (direct and indirect).
timeFrame: 6 months
measure: management of time by the medical personal.
timeFrame: 6 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: UHToulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Juliette Mazereeuw-Hautier, MD . PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05079776: Assessing a Length Artificial Intelligence Algorithm to Estimate Length of Children
Official title: Assessing the Use of a Growth Artificial Intelligence Algorithm for Estimating the leNgth of Children in Real-world Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth; Stunting, Nutritional
Keywords: growth
length
artificial intelligence
algorithm
Lead sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: KK Women's and Children's Hospital
First posted: 2021-10-15
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children between 0-18 months of age with no physical deformities.

Brief summary: An exploratory study to explore the possibility of using computer vision algorithms to estimate a child's length using images taken by a healthcare professional or parents.

Detailed description: This is an exploratory, observational, pilot study that aims to evaluate the performance of a Length Artificial Intelligence (LAI) algorithm in a real world setting. Images will be collected by parents or healthcare professionals, together with physical length measurements. This data will be used to evaluate the accuracy of the algorithm and to explore potential improvements. Data on the acceptance and experience of the using the algorithm will be collected for improvements.

Eligibility criteria: Inclusion Criteria:

1. Children aged 0 to 18 months old.
2. Parent(s) should have access to the internet and a smartphone or tablet to complete study questionnaires, take images and upload images.
3. Parent(s) should be able to comprehend the content of the study and to complete the study questionnaires in English.
4. Written consent from parent.

Exclusion Criteria:

1. Parent(s) incapable of completing the study questionnaires and uploading of the images using smart phone or tablet with internet.
2. Children unable to undergo length measurement (e.g. children with structural abnormalities of the lower limbs or orthopedic conditions such as club foot, hip dysplasia, etc).

Primary outcomes:
measure: Accuracy of the length AI
timeFrame: 2 days
Secondary outcomes:
measure: Investigator's assessment on collection of images
timeFrame: 2 days
measure: Parental acceptability of the length AI
timeFrame: 2 days
measure: Investigators' (or delegates) acceptability of length AI
timeFrame: 2 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
References:
Clinical trial NCT01307176: Exercise Training Program for Cerebellar Ataxia
Official title: Exercise Training Program for Cerebellar Ataxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebellar Ataxia
Keywords: ataxia
exercise
training
cerebellar
rehabilitation
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2011-03-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a person's ability to adapt (i.e. short term motor learning) predicts their ability to benefit from physical therapy exercises.

Detailed description: The cerebellum is important for coordination of movement and for motor learning. No medications systematically improve cerebellar ataxia, and little is known about the effectiveness of rehabilitation exercises, which are often the only treatment option. Here, we ask whether a person's ability to adapt (i.e. short term motor learning) predicts their ability to benefit from physical therapy exercises. This pilot-clinical trial will test a subject's ability to adaptively learn a new walking pattern in a single session, and then any improvement of walking and balance over a 13 week time period during which they participate in a specialized home exercise training program. Our prediction is that those individuals with some preserved adaptive learning ability will be the best rehabilitation candidates.

Eligibility criteria: Inclusion Criteria:

* Cerebellar damage from stroke, tumor, or degeneration
* Able to stand and take steps with or without assistance
* Age 18-95

Exclusion Criteria:

* Extrapyramidal symptoms
* Peripheral vestibular loss (e.g. absence of VOR)
* Congestive heart failure
* Peripheral artery disease with claudication
* Pulmonary or Renal Failure
* Unstable angina
* Uncontrolled hypertension ( \> 190/100 mmHg)
* Dementia (Mini-Mental State exam \> 22)
* Severe aphasia
* Orthopedic or pain conditions
* Pregnancy
* Prisoner
* Evidence of chronic white matter disease on MRI

Primary outcomes:
measure: Change in walking speed from baseline to mid-training and to post-training
timeFrame: Participants are assessed at baseline (week 1 and week 3), mid-training (week 6), and post-training (week 9 and week 13). There are a total of 13 weeks for this study with 5 visits during that time period
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Motion Analysis Lab in the Kennedy Krieger Institute
state: Maryland
Study officials:
affiliation: Kennedy Krieger Institute and Johns Hopkins School of Medicine
name: Amy J Bastian, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05355376: Colorectal Surgical Site Infection
Official title: Colorectal Surgical Site Infection: a Cohort Study About How Can we Decrease it
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Site Infection
Lead sponsor: Centro Hospitalar Universitário Lisboa Norte
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 1139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients submitted to eletive colorectal surgery, by laparotomy, during a period of 5 years, in our colorectal department

Brief summary: Surgical site infection (SSI) is one of the most common postoperative complications in surgery, with high morbidity. In the tertiary-center that the investigators evaluated they had a significant rate of surgical site infection. Because of that the investigators created a care bundle of measures in order to improve the outcomes.

Detailed description: Prospectively the investigators implemented a care bundle of measures with retrospective analysis, to decrease SSI . The superficial, deep and organ/space infections were evaluated and compared before and after care bundle implementation.

Between january 1, 2016 and December 31, 2020, 1139 patient records relating to surgical incisions were submitted for analysis.

Eligibility criteria: Inclusion Criteria:

* Patients submitted to elective colorectal surgery between 2016, january 1 and 2020, december 31
* Age \> 18 years
* At least 30 days of follow-up

Exclusion Criteria:

* Patients submitted to urgent colorectal surgery

Primary outcomes:
measure: The rate of surgical site infections
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02080676: Effects of Marihuana Use on Optic Nerve Parameters and Ocular Blood Flow
Official title: Effects of Marihuana Use on Optic Nerve Parameters and Ocular Blood Flow
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intra Ocular Pressure
Keywords: Cannabis
Intra ocular pressure
Ocular perfusion
Blood pressure
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2014-03-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients over the age of 18, with no ocular pathology that are being treated in the neurology or pain clinics with medical cannabis for different indications.

Brief summary: Purpose of study: to check the effect of medical cannabis given for approved medical indications on ocular parameters including intra ocular pressure, optic nerve fibers thickness and choroidal thickness.

Detailed description: Purpose of study: to check the effect of medical cannabis given for approved medical indications on ocular parameters including intra ocular pressure, Retinal Nerve Fiber Layer (RNFL) thickness, optic nerve fibers thickness and choroidal thickness.

Adult patients with no ocular pathology that are being treated in the neurology or pain clinics with medical cannabis for different indications, were examined in the eye clinic.

First examination took place after the patient was not smoking for 5 hours. Three more examinations took place 1 hour 3 hours and 5 hours after smoking cannabis.

The following parameters were checked: blood pressure, pulse, visual acuity, intra ocular pressure, corneal thickness, axial length, slit lamp examination of anterior segment, fundoscopy and Optical Coherence Tomography (OCT) of the retina, and optic nerve.

Eligibility criteria: Inclusion Criteria:

* Age over 18
* Treated with medical cannabis for approved medical indications

Exclusion Criteria:

* Known ocular pathology
* Topical or systemic treatment for intra ocular pressure
* Previous topical, intra ocular or systemic steroid treatment

Primary outcomes:
measure: Intra ocular pressure
timeFrame: 5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: Carmel Medical Center
name: Orna Geyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01733576: High-definition Transcranial Direct Current Stimulation (HD-tDCS) Verbal Learning
Official title: Enhancing Verbal Learning and Memory Using High-Definition Transcranial Direct Current Stimulation (HD-tDCS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Verbal Learning and Memory
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This project will use a new form of non-invasive brain stimulation called high-definition transcranial direct current stimulation (HD-tDCS) to facilitate verbal learning. This form of stimulation is similar to transcranial direct current stimulation (tDCS) but allows for more spatially focused stimulation. We hypothesise that HD-tDCS when applied to regions of the brain important for learning and memory will improve verbal learning and memory compared to sham HD-tDCS.


Eligibility criteria: Inclusion Criteria:

* Ages 18 - 40 years
* Right-handed

Exclusion Criteria:

* concurrent medication likely to affect mental performance
* current history of drug or alcohol abuse or dependence
* any psychiatric or neurological disorder, recent head injury, or history of seizure or stroke.

Primary outcomes:
measure: Ray Auditory Verbal Learning Test (RAVLT)
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Black Dog Institute
state: New South Wales
Study officials:
References:
Clinical trial NCT03383276: Phase 1 Study for Safety and Tolerability of IL-1-Ra Topically Administered to Eyes of Healthy Adult Subjects
Official title: A Phase 1, Dose Escalating Study of the Safety, Tolerability, and Pharmacokinetics of IL-1-Ra Topically Administered to Eyes of Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Blepharokeratoconjunctivitis
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
Collaborators: name: Chengdu Rhodiola Bio-Pharmaceutical Co Ltd
First posted: 2017-12-26
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of ocular administration of Topical Interleukin-1-Receptor Antagonist in healthy volunteers. Additionally, the PK of Interleukin-1-Receptor Antagonist will be assessed.


Eligibility criteria: Inclusion Criteria:

* Healthy adult males and/or females between the ages of 18 and 45 years
* Medically healthy
* Best correction vision of greater than or equal to 20/20 in each eye
* BMI ≥ 19 and \< 24 kg/m2
* Ability to understand and provide informed consent to participate in this study
* Willingness to follow study instructions and likely to complete all required visits

Exclusion Criteria:

* Any ocular or systemic diseases
* History of skin or ocular allergy symptoms
* Use contact lenses during the trails.
* Taking inhaled or oral steroids (for example Advair, Orapred)
* Have an active infection
* Have serologic evidence of HIV, Hepatitis C, Hepatitis C, or tuberculosis
* Receipt of any blood or blood products within 2 months prior to the first dosing day.
* Use any drugs within 2 weeks prior to the first dosing day.
* Use of cyclosporine, steroid eye drops, serum eye drops, or any other eye medication or experimental drug within the past 4 weeks.
* Have been exposed to an investigational drug/device within the preceding 3 months
* Pregnant or lactating females
* History of substance abuse, drug addiction or alcoholism
* Males and females unwilling to use an acceptable method of contraception for the duration of the study

Primary outcomes:
measure: Corneal fluorescein staining
timeFrame: 3 days
measure: Best corrected visual acuity
timeFrame: 3 days
measure: Ocular symptomatology
timeFrame: 3 days
measure: Slit lamp examination
timeFrame: 3 days
measure: Measurement of intraocularpressure
timeFrame: 3 days
Secondary outcomes:
measure: ELISA based assay to determine Pharmacokinetics for the evaluation of systemic exposure of IL-1Ra in healthy volunteers.
timeFrame: 3 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing TongRen Hospital
Study officials:
References:
Clinical trial NCT06305676: Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)
Official title: Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oropharyngeal Cancer
HPV-Related Carcinoma
Keywords: Oropharyngeal Cancer
Early Detection
Screening
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2024-03-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of 100 early and 100 late disease pre-treatment Oropharyngeal Cancer cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh).

Brief summary: Investigators seek to determine the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early Oropharyngeal Cancer (OPC) cases from controls among 100 early and 100 late disease pre-treatment OPC cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh).


Eligibility criteria: Inclusion Criteria:

Cases:

* Aged at least 18 years
* Newly diagnosed primary tumor, histologically confirmed squamous cell carcinoma of the oropharynx (stages I-IV)
* Has not received treatment (surgery, chemotherapy, radiation, or immunotherapy) within the previous four weeks
* Provided written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker/biobanking study or is identified and enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center
* Aged at least 35 years
* Have no previous diagnosis of HNC or HPV-related cancer
* Fully understands study procedures
* Voluntarily agrees to participate by giving written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker/biobanking study or is enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center

Exclusion Criteria:

* Not meeting all of the above inclusion criteria for either the case or control group

Primary outcomes:
measure: Diagnostic Sensitivity
timeFrame: Up to 60 months
measure: Diagnostic Specificity
timeFrame: Up to 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
state: Pennsylvania
Study officials:
affiliation: Moffitt Cancer Center
name: Anna Giuliano, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Moffitt Cancer Center
name: Antonio Amelio, PhD
role: PRINCIPAL_INVESTIGATOR
References: