louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01249157: Histologic Assessment of the Difference Between 18F-2-fluoro-2-deoxy_D-glucose Positron Emission Mammography(PEM) and Magnetic Resonance Imaging (MRI) of the Breast
Official title: Histologic Assessment of the Difference Between 18F-2-fluoro-2-deoxy_D-glucose Positron Emission Mammography(PEM) and Magnetic Resonance Imaging (MRI) of the Breast
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Keywords: MRI
PEM
10-189
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2010-11-29
Enrollment: 6
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Positron Emission Mammography (PEM) is a newly developed imaging examination of the breast that uses a radioactive glucose based tracer, which is a form of sugar attached to a low radiation agent, to detect cancer cells. The radioactive glucose based tracer is called fluorodeoxyglucose (FDG), and it is FDA approved. A PEM scanner is able to better detect cancer cells within the breast, more than a regular PET scanner. The PEM scanner is also FDA approved. This type of imaging may be able to see the breast cancer before it could be seen with mammograms and may be as good as or better than breast MRI.

The purpose of this study is to compare the value of FDG Positron Emission Mammography (PEM) with contrast enhanced Magnetic Resonance Imaging (MRI) of the breast for patients with breast cancer. This study will also perform special pathology test to compare the FDG PEM and contrast enhanced breast MRI images with the results from the standard of care breast surgery. This may teach us more about the biology of each breast tumor.


Eligibility criteria: Inclusion Criteria:

* Female patients with recently diagnosed invasive or in situ breast cancer by core needle biopsy or FNA (confirmed at MSKCC) prior to enrollment.
* Patients planning treatment with mastectomy at MSKCC.
* Patients 21 years old or older.
* Patients who had or are having a breast MRI within 30 days or less of PEM.
* Patients who had or are having a digital mammogram.

Exclusion Criteria:

* Patients who are pregnant or breast feeding.
* Patients with prior radiation therapy or endocrine therapy.
* Patients who had a prior lumpectomy.
* Patients who are diabetic.
* Patients with moderate to end stage kidney disease.
* Patients who have a contraindication to MRI (i.e. pacemaker, metallic implants, etc).

Primary outcomes:
measure: To Evaluate the Accuracy of Preoperative 18FDG PEM
timeFrame: 2 years
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: Maxine Jochelson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01658657: A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension
Official title: A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Plasma Renin Activity
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Cornell University
name: Wake Forest University Health Sciences
First posted: 2012-08-07
Enrollment: 17
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: The purpose of this study is to investigate the effect of plasma renin activity-guided therapy for determining hypertension treatment. Plasma renin is an enzyme in your blood that can be measured to determine your hypertension subtype. Once the subtype is known, doctors can prescribe specific medications to target your specific hypertension subtype. This study will investigate whether targeting the specific hypertension subtype helps to achieve blood pressure control sooner and with fewer medications compared to a standard fixed dose combination therapy.


Eligibility criteria: Inclusion Criteria:

* Systolic BP average during at least one recent (within 1 month) clinic or emergency room visit ≥ 150 mmHg, or diastolic BP average during at least one recent (within 1 month) clinic or emergency room visit ≥ 95 mmHg
* Not currently taking BP-lowering medication
* Clinician recommends pharmacologic treatment
* Willing to make necessary study visits
* Able to be contacted by phone
* Has a primary care clinician
* At least 18 years old

Exclusion Criteria:

* Known secondary cause of hypertension
* Pregnancy
* Known diabetes, coronary artery disease or renal disease
* Known sulfonamide allergy or history of gout
* Participant's clinician recommends he/she not enroll
* Hyponatremia, hypokalemia, hypernatremia, or hyperglycemia at baseline visit
* Baseline visit systolic visit BP average \< 140 mmHg and diastolic BP average \< 90 mm Hg
* Resting heart rate \< 55 beats per minute

Primary outcomes:
measure: Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
Study officials:
affiliation: Distinguished Associate Professor, Family Medicine
name: Anthony Viera, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06355557: Human vs Machine: a RCT Comparing Traditional In-person Instruction, AI Versus VR for Learning Basic CCE
Official title: Human vs Machine: a Randomised Controlled Trial Comparing Traditional In-person Instruction, Artificial Intelligence Versus Virtual Reality for Learning Basic Critical Care Echocardiography
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ultrasound
Keywords: artificial intelligence, echocardiography, POCUS
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 66
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3-arm prospective randomised controlled trial.
Primary purpose: OTHER

Brief summary: The aim of the study is to investigate if hands-on training for basic CCE with virtual reality simulators or guided by artificial intelligence is non-inferior to training by an experienced instructor.

Detailed description: Basic (Level 1) Critical care echocardiography (CCE) involves using an ultrasound device to qualitatively assess the heart at the bedside. It is increasingly being used at the bedside for diagnostics and screening of key differential diagnoses. Increasingly, CCE is being taught to more medical staff from many fields in medicine, including emergency medicine, anaesthesiology, intensive care medicine and even family medicine. There is a wealth of learning resources online but access to direct supervision by trainers and in-person courses is can be limited and costly. At the time of the study, one local medical school incorporated a lecture there is no credentialling pathway within local medical schools or institution. There has been increasing use of machine learning in medical imaging and deep learning algorithms are now able to guide image acquisition and allow novices with minimal training in echocardiography to obtain diagnostic-quality images. Artificial intelligence (AI) in echocardiography may improve image by novices. Ultrasound hardware that implement machine learning software in real-time can help with structure detection and identification, but more studies are needed to determine the extent that AI impacts learning.

Eligibility criteria: Inclusion Criteria:

* Medical students will have limited clinical exposure to critical care echocardiography
* above the age of 21 years

Exclusion Criteria:

* prior attendance of a critical care echocardiography courses or
* refusal to participate in the study or complete both hands on sessions

Primary outcomes:
measure: Improvement in image acquisition and structure identification at the end of 3 months.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
References:
Clinical trial NCT02766257: Anesthesia for Ambulatory Pediatric Surgery in Sub-Saharan Africa (SSA)
Official title: Anesthesia for Ambulatory Pediatric Surgery in Sub-Saharan Africa (SSA): a Pilot Study in Burkina Faso
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications
Lead sponsor: Centre Hospitalier Universitaire Pédiatrique Charles de Gaulle
Sponsor class: OTHER
First posted: 2016-05-09
Enrollment: 103
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Long surgical wait-times and limited hospital capacity are common obstacles to surgical care in many countries in sub-Saharan Africa (SSA). Ambulatory surgery might offer a solution to these problems. The aim is to study the introduction of ambulatory surgery in a pediatric hospital in SSA.

This is a cross-sectional descriptive study which took place over 6 months. It includes all the patients assigned to ambulatory surgery in the Pediatric University Hospital in Ouagadougou, Burkina Faso.


Eligibility criteria: Inclusion Criteria:

* ASA 1 status
* elective surgery with low potential for blood loss or severe pain, lasting less than 90 minutes
* whose parents could be contacted by telephone and who could return to the hospital in less than 1 hour
* Parents gave consent for the surgical procedure

Exclusion Criteria:

* non operative patients

Primary outcomes:
measure: Failure of ambulatory surgery
timeFrame: 1day
Secondary outcomes:
measure: Morbidity
timeFrame: 3 days
measure: Complication after discharge from hospital
timeFrame: 3 days
Other outcomes:
Locations:
Study officials:
References:
citation: Kabre YB, Traore IS, Kabore FA, Ki B, Traore AI, Ouedraogo I, Bandre E, Wandaogo A, Ouedraogo N. Anesthesia for Ambulatory Pediatric Surgery in Sub-Saharan Africa: A Pilot Study in Burkina Faso. Anesth Analg. 2017 Feb;124(2):623-626. doi: 10.1213/ANE.0000000000001780.
Clinical trial NCT05944757: Compare of PRP Autologous Serum and Autologous Serum by Intrastromal Injection in Different Eye Disease Conditions
Official title: Compare of PRP Autologous Serum and Autologous Serum by Intrastromal Injection in Different Eye Disease Conditions
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: PRP
Keywords: PRP
Dry Eye
Keratoconus
Dystrophy
Regenerative therapy
Lead sponsor: Eye Hospital Pristina Kosovo
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Both models participated in this study.Models aged were from 20 up to 70
Primary purpose: TREATMENT

Brief summary: Platelet-rich plasma (PRP) is an autologous blood product rich in proteins and growth factors. Its application has been the subject of many studies in the field of ophthalmology to stimulate tissue healing and regeneration. Due to its anatomical features (lack of blood vessels), the cornea is among the most susceptible to damage structures of the eye. Therefore, the study of the impact of various regenerative therapies (autologous blood products, serums, ) on corneal lesions is important not only scientifically, but also practically for ophthalmologist. Numerous reports described the healing effect of PRP on corneal lesions.

Detailed description: Purpose The objective of the study is to compare the efficacy of 100% prp autolog serum eye drops with 100 % of intrastromal injection-rich plateles plasma autolog serum eye drops in patients with moderate to severe dry eye in keratoconus disease,corneal dystrophy,chemical burns.

Methods A total of 40 eyes were included in this prospective study. Clinical records of 20 consecutive patients with dry eye disease who had been treated with conventional autolog eye drops via intrastromal injection(conventional treatment group) and 20 consecutive patients treated with intrastromal autologous PRP eye drops i(PRP eye drops treated group) from September 2021.

Eligibility criteria: Inclusion Criteria:

* Dry eye diseases from other conditions( diabetes,allergy,keratoconus and others)
* Corneal dystrophy
* Chemical burns
* Keratoconus

Exclusion Criteria:

* Hemoglobin saturation (less than 11 mg/dl);
* hepatopathies;
* nephropathies;
* coagulopathies;
* hemoglobinopathies;
* decompensated heart diseases;
* infectious diseases such as Chagas, syphilis, HIV, HTLV, hepatitis B and C, and others transmissible by blood considered.

Primary outcomes:
measure: Improving dry eye symptoms
timeFrame: 12 months
Secondary outcomes:
measure: Improving corneal transparency
timeFrame: 12 months
Other outcomes:
Locations:
city: Prishtina
country: Kosovo
facility: Eye Hospital,University Center Clinic of Kosova
Study officials:
affiliation: Eye Hospital,Univeristy Center Clinic of Kosova
name: Anita Syla Lokaj
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05190757: Supraglottic Airway Needed To Achieve Ventilation
Official title: Supraglottic Airway Needed To Achieve Ventilation (SANTA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Complication of Anesthesia
Difficult or Failed Intubation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo elective surgery

Brief summary: The purpose of this research is to compare if insertion of laryngeal mask airway (LMA) vs. use of face mask, will reduce the time needed to achieve adequate ventilation prior to insertion of the breathing tube.


Eligibility criteria: Inclusion Criteria:

* BMI ≥ 35.
* Patients willing to participate and provide an informed consent.
* Patients scheduled to undergo an elective surgical procedure including laparoscopic or robotic that requires GETA.

Exclusion Criteria:

* Patients who require administration of succinylcholine for induction/intubation
* Patients with history of uncontrolled GERD.

Primary outcomes:
measure: Successful ventilation
timeFrame: Up to 15 minutes during the initial period of intubation.
Secondary outcomes:
measure: Subjective criteria of difficult ventilation and intubation
timeFrame: Up to 30 minutes during the initial period of intubation
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Klaus Torp, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05478057: Supplementary Motor Area is a Potential Target for Speech Disturbance in Parkinson Disease
Official title: Supplementary Motor Area is a Potential Target for Speech Disturbance in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: speech disturbance
transcranial magnetic stimulation
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Speech disturbance is common in patients with Parkinson disease. Pharmacotherapy improves motor symptoms but has inconsistent effects on speech disturbance in PD patients. Transcranial magnetic stimulation (TMS) is a safe and non-invasive tool used for brain stimulation. Repetitive transcranial magnetic stimulation (rTMS) has positive effects on motor function of PD. Yet, its effect on speech disturbance seems to be inconclusive. Previous rTMS studies mainly focused on the primary motor cortex for PD speech disturbance. Nevertheless, we think supplementary motor area (SMA) may be a better target. Speech disturbance in PD may be associated with basal ganglia-thalamocortical motor circuits and SMA involves in the cortex part. In addition, neuroimaging studies showed that SMA were under-activation in PD patients. Therefore, we conduct this 3-year study including two experiments. The aim of the study is to determine if rTMS over SMA can improve the speech function of PD patients and change the functional connectivity of speech pathway in the brain. This will be the first study to investigate the effect of rTMS over SMA on speech.


Eligibility criteria: Experiment 1

Inclusion Criteria:

* right-handed healthy adult volunteers who understand and agree on the informed consent of the study

Exclusion Criteria:

* pregnancy or possibility of pregnancy
* history of seizure
* family history of epilepsy
* metals in any part of the body.

Experiment 2

Inclusion Criteria:

* PD patients with speech disturbance who understand and agree on the informed consent of the study. The speech item scored 2 or 3 in the unified Parkinson's disease rating scale (UPDRS) part III.

Exclusion Criteria:

* dementia
* the history of stroke, brain lesion, other central nervous system diseases
* the contraindication of TMS which described above
* any contraindication of MRI

Primary outcomes:
measure: Change of speech performance from baseline in experiment 1
timeFrame: Baseline ((1) before rTMS), (2) immediately after rTMS
measure: Change of speech performance from baseline in experiment 2
timeFrame: Baseline ((1) before rTMS), (2) within 24 hours after 10 times of rTMS (3) 8 weeks later after 10 times of rTMS
measure: Change of functional connectivity from baseline in experiment 2
timeFrame: Baseline ((1) before rTMS), (2) within 24 hours after 10 times of rTMS
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04647357: A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer
Official title: A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer Without Progression After First Line Concurrent Chemoradiotherapy Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Limited-stage Small Cell Lung Cancer, LS-SCLC
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2020-11-30
Enrollment: 60
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: SHR-1316 as Maintenance therapy for limited stage small cell lung cancer without progression after first line platinum based concurrent chemoradiotherapy


Eligibility criteria: Inclusion Criteria:

1. The age is 18-75 years old (including both ends), regardless of gender;
2. Histologically confirmed limited stage small cell lung cancer ;
3. ECOG PS 0 \~ 1;
4. Patients received at least 2 cycles of platinum based chemotherapy and radiotherapy, and completed within 1 to 42 days before the first medication.
5. The last chemotherapy must be finished before or at the same time of radiotherapy.
6. The disease did not progress after concurrent chemoradiotherapy;
7. The expected survival time was more than 3 months;
8. Pulmonary function: FEV1 \> 70%;

Exclusion Criteria:

1. The subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
2. Mixed SCLC or NSCLC confirmed by histology;
3. Locally advanced small cell lung cancer receiving sequential chemoradiotherapy;
4. Have received anti-tumor therapy of systemic immune checkpoint inhibitors for SCLC;
5. Extensive SCLC;
6. Operable SCLC (clinical stage T1-2N0, except for those who are contraindicated or refuse surgery);
7. Interstitial pneumonia
8. History of active, known or suspected autoimmune diseases and autoimmune diseases, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.
9. HIV, active Hepatitis B or Hepatitis C infection

Primary outcomes:
measure: PFS
timeFrame: Up to approximately 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00089557: An Open-Label Extension Study of NGX-4010 for the Treatment of Neuropathic Pain
Official title: An Open-Label Extension Study of NGX-4010 for the Treatment of Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Herpes Zoster
Neuralgia
Pain
HIV Infections
Peripheral Nervous System Diseases
Diabetic Neuropathies
Diabetes Mellitus
Polyneuropathies
Keywords: Dermal assessment
Pain assessment
Diary
Analgesics
Capsaicin
Herpes zoster
Neuralgia
Pain
HIV Infections
Peripheral Nervous System Diseases
Diabetic Neuropathies
Diabetes Mellitus
Polyneuropathies
Complementary Therapies
Lead sponsor: NeurogesX
Sponsor class: INDUSTRY
First posted: 2004-08-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: This study is an open-label, multicenter, extension study for subjects who completed NeurogesX Study C111 and received treatment with NGX-4010 (Capsaicin Patch) within 12 weeks (up to +7days) before entry into Study C114


Eligibility criteria: Key Eligibility Criteria:

* Must have completed NeurogesX Study C111 and received treatment with NGX-4010 (Capsaicin Patch) within 12 weeks (up to +7 days) before entry into Study C114.
* Demonstrated adherence to protocol requirements during Study C111, and willing and able to comply with protocol requirements for the duration of the study participation.
* Must not have had any serious adverse experience since enrollment in Study C111, whether or not considered to be study drug-related.
* Must have intact skin at the treatment area.
* Must be prepared to remain on the same pain medications at the same doses as before the study for the entire duration of the study (36 weeks).
* Must not use topical pain medications on painful areas.
* Must be at least 18 years old, not pregnant, and able to take care of self independently, with only occasional assistance if needed.
* No history or current problem with substance abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: