linjc16/ctgov huggingface dataset:
Artificial Intelligence for Automated Diagnosis of Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Mammography is a two-dimensional imaging technique which involves the tissues overlapping under the projective image; dense glandular tissue above or below the lesion can reduce the visibility of the lesion. The trouble could be the interpretation of the image obtained which may lead to the inability to visualize a fist stage cancer and the probability that to a healthy person will be diagnosed a pathology that is not present (false positive). The introduction of an almost three-dimensional technique imaging called breast digital tomosynthesis (DBT) can overcome most limitations. In the last 5 years image analysis methods based on Artificial Intelligence (, AI) have also been massively introduced in breast cancer detection. The study is a prospective observational study based on Artificial intelligence whose the mail goal is to develop a method to identify a lesion.

Official Title
-----------------
Study of an Artificial Intelligence Algorithm for the Classification of Digital Tomosynthesis Breast Images for Automated Breast Cancer Diagnosis

Conditions
-----------------
Breast Cancer Diagnosis

Intervention / Treatment
-----------------
* Diagnostic Test: Breast digital tomosynthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who refer to the Regina Elena for diagnostic mammography tests Informed consent Exclusion Criteria: presence of prostheses, artifacts, outcomes of a study in the breast intervention under the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Breast digital tomosynthesis|Introduction of an almost three-dimensional imaging technique called breast digital tomosynthesis|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Artificial Intelligence system to detect a lesion | Lesion detction is based on breast density, case type, BIRADS assessment categories, mammographic appearance, size and pathological profile of malignant lesions | 12 months |
Physical Therapy on Phrenic Nerve Function

Study Overview
=================
Brief Summary
-----------------
This study was conducted to investigate the effects of a designed physical therapy program on respiratory function and phrenic nerve activity in cervical disc compression.

Detailed Description
-----------------
Twenty patients from the Spinal Unite represented the sample of the study. Their mean ages were 43 years and they suffering from acute cervical disc compression at the level of cervical 3, 4, 5. Methods: Evaluation was carried out before and after three months of treatment. It included measuring of pulmonary functions (VC, FVC, FEV1, PEF and MVV) by using spirometer, diaphragmatic excursion and thoracic volume via x-ray and conduction velocity and amplitude of phrenic nerve using electromyography. Treatment program included heat application, ultrasound, cervical traction and diaphragmatic breathing exercises.

Official Title
-----------------
Outcomes of Physical Therapy Program on Respiratory and Phrenic Nerve Functions in Cervical Disc Compression

Conditions
-----------------
Pulmonary Function Test, Phrenic Nerve Irritation, Cervical Disc Lesion

Intervention / Treatment
-----------------
* Device: Ultrasound (Phyaction 190 I); with a frequency of 3 MHz was used


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suffered from cervical disc compression for 6-8 months. patients examined and referred by physician. Exclusion Criteria: Any cardio pulmonary disorders which may alter pulmonary function. They did not receive any physical therapy program prior to their participation in the study.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| intervention group<br>Patients underwent physical therapy program 3days/week for three months in the form of Heat therapy by using infrared on the cervical region for relaxation of spasmed neck muscles, while the patient in sitting position. While the patient is sitting, the ultrasound was applied on the para spinal muscles of cervical region for controlling pain. Intermittent cervical traction (traction force equal 8% of body weight) was applied with the patient lying supine and the head in neutral position. | Device: Ultrasound (Phyaction 190 I); with a frequency of 3 MHz was used<br>* Intermittent cervical traction (traction force equal 8% of body weight) was applied with the patient lying supine and the head in neutral position.<br>* Other names: Cervical traction (Eltrac 471); for widening of cervical disc space.;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary function test | to measure vital capacity | 4 months | 
| phrenic nerve amplitude | objective method to detect phrenic nerve function | 4 months |
Stimulant Use and Methylation in HIV

Study Overview
=================
Brief Summary
-----------------
This study will leverage extracted leukocyte DNA specimens from a completed NIH-funded project to examine the efficacy of a behavioral intervention model that reduced stimulant use on DNA methylation over 6 months.

Official Title
-----------------
Stimulant Use and Methylation in HIV

Conditions
-----------------
HIV Infections, Methamphetamine-dependence, Methamphetamine Abuse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years old Documentation of HIV-positive serostatus Speak English Biological verification of recent methamphetamine use Completion of at least three contingency management (CM) visits Self reported anal sex with a man in the past 12 months Exclusion Criteria: Inability to provide informed consent, evidenced by cognitive impairment HIV negative serostatus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Leukocyte DNA Samples<br>Leukocyte DNA specimens extracted from participants enrolled in a completed NIH funded trial will be examined to determine if prior exposure to different behavioral interventions modifies DNA methylation patterns over 6 months. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuroimmune Signaling | Decreased methylation of genes for genes relevant to neuroimmune signaling such as beta-2 (β2) adrenergic (i.e., ADRB2), glucocorticoid (i.e., NR3C1 and FKBP5), and oxytocin (i.e., OXTR) receptors as well as brain-derived neurotrophic factor (BDNF) promoters. | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA Methylation Pathways | Pathway Analyses examining alterations in methylation patterns relevant to immune and neural function. | 6 Months | 
| Immune Dysfunction | Soluble makers of monocyte activation such as soluble CD14 (sCD14) and inflammation such as soluble Tumor Necrosis Factor - Alpha Receptors I and II (sTNF-aRI and sTNF-aRII) | 6 Month | 
| Dysregulated Metabolism of Amino Acid Precursors for Neurotransmitters measured via high-performance liquid chromatography (HPLC) | Using HPLC, higher kynurenine/tryptophan (K/T) ratio indexes catabolism of tryptophan into kynurenine and other downstream catabolites versus serotonin over 6 months. Using HPLC, the phenylalanine/tyrosine ratio reflects decreased metabolism of tyrosine into catecholamines such as dopamine over 6 months. | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Methamphetamine, Methylation
Special Investigation for Booster Dose of Comirnaty in Children Ages 6 Months Though 4 Years

Study Overview
=================
Brief Summary
-----------------
The purpose of this post-marketing study is to assess the safety of Comirnaty monovalent XBB.1.5. for booster vaccination children ages 6 months though 4 years under actual use medical practice.

Official Title
-----------------
Special Investigation for Booster Dose of Comirnaty (ｍonovalent: Omicron XBB.1.5.) Intramuscular Injection in Children of the 6 Months Though 4 Years of Age.

Conditions
-----------------
SARS-CoV-2, COVID-19

Intervention / Treatment
-----------------
* Biological: COMIRNATY intramuscular injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 6 months to 4 years at the time of the booster vaccination (4th dose) who (or whose representative) gave written consent to take part in the study. Exclusion Criteria: -There are no exclusion criteria for this study.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 4 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COMIRNATY intramuscular injection for 6 months to 4 years old (monovalent, omicron XBB.1.5.)<br> | Biological: COMIRNATY intramuscular injection<br>* Booster injection in the muscle, 1 dose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with adverse reaction |  | For 28 days after the booster dose | 
| Percentage of participants with serious adverse reaction |  | For 28 days after the booster dose | 
| Percentage of participants with reactogenicity events. |  | For 7 days following the booster dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, SARS-CoV-2, Children (6 months though 4 years old), RNA Vaccine, Post-Marketing Study, Pediatric
Evaluation of ClearLLab LS Screening Panel

Study Overview
=================
Brief Summary
-----------------
This is a multi-center study to evaluate the clinical performance of ClearLLab LS screening panel with specimens from subjects for the diagnosis of hematologic malignancies.

Detailed Description
-----------------
This study aims to evaluate the clinical accuracy of ClearLLab LS screening panel in the diagnosis of hematologic malignancies. The residual specimens, which from Subjects presenting to the flow cytometry laboratory as part of their standard of care for hematologic diseases work-up, will be tested by ClearLLab LS screening panel.

Official Title
-----------------
Evaluation of ClearLLab LS Screening Panel for the Diagnosis of Hematological Malignancies

Conditions
-----------------
Hematologic Malignancy, Hematologic Neoplasms, Hematologic Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: Flow Cytometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Residual whole blood, bone marrow, or lymph node tissue samples from subjects with hematologic tumor-related symptoms and/or signs that are clinically recommended for Flow Cytometry Immunophenotyping Exclusion Criteria: Specimens and/or spent samples that are visibly hemolyzed Specimens and/or spent samples that are visibly clotted Specimens and/or spent samples collected in Ethylene Diamine Tetraacetic Acid (EDTA) anticoagulant older than 24 hours from time of collection Specimens and/or spent samples collected in Heparin or Acid Citrate-Dextrose (ACD) anticoagulant older than 48 hours from time of collection Samples with insufficient volume to complete the protocol tests Samples from subjects with known myeloid malignancies or multiple myeloma
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Flow Cytometry|Immunophenotyping of residual clinical samples tested with ClearLLab LS screening panel on a specified Flow Cytometry|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy: sensitivity and specificity | Diagnostic accuracy measured as sensitivity and specificity of ClearLLab LS screening panel in identifying hematological malignancies and non-malignancies compared with the clinical criteria (WHO guidelines) | Baseline |
Evaluation of 3D Ultrasound in Brain Tumor Surgery

Study Overview
=================
Brief Summary
-----------------
Evaluation of impact of use of 3D ultrasound in brain tumor surgery on extend of resection. Benefit for surgery, neurological outcome, accuracy and image quality are secondary outcome parameters. Control group is a retrospective matched pair cohort.

Official Title
-----------------
Evaluation of 3D Ultrasound in Brain Tumor Surgery

Conditions
-----------------
Residual Tumor

Intervention / Treatment
-----------------
* Device: resection with help of 3D ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age above 18 suspected intra-axial lesion (metastasis or Glioma) potential gross total resection of lesion Exclusion Criteria: no ability for informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: retrospective matched pair control
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prospective arm<br>Use of 3D ultrasound intraoperative before intraoperative MRI | Device: resection with help of 3D ultrasound<br>* see above<br>|
| No Intervention: retrospective matched pair arm<br>no use of intraoperative ultrasound before intraoperative MRI | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of resection | Volumetric assessment of residual T1 contrast enhancement or FLAIR signal changes in enhancing and non-enhancing glioma, respectively. | 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| image quality | ultrasound image quality, both for 2D and 3D as rated by surgeon and scored from 1(best) to 6 (worst). | during surgery | 
| neurological outcome | both at discharge and at 3 months follow up using NIHSS Score | both after surgery and at 3 months | 
| Accuracy of device | ultrasound image acuracy compared to preoperative MRI, both for 2D and 3D as rated by surgeon and scored from 1(best) to 6 (worst), including rating of brainshift and navigation inaccuracy. | during surgery |
Effects of Therapeutic Intervention Through Selective Functional Movement Assessment on Pain, Function, Balance and Gait in Patients With Chronic Nonspecific Neck Pain

Study Overview
=================
Brief Summary
-----------------
According to the order of the physical examination, the scope of the problem is narrowed down by excluding the parts of the body that do not have problems and adjusting the load related to stability. A list of problems can be created through an algorithmic approach that guesses which structures will have problems through active or passive movement. This provides an optional therapeutic intervention.

Official Title
-----------------
Effects of Therapeutic Intervention Through Selective Functional Movement Assessment on Pain, Function, Balance and Gait in Patients With Chronic Nonspecific Neck Pain

Conditions
-----------------
Chronic Nonspecific Neck Pain

Intervention / Treatment
-----------------
* Behavioral: Personalized exercise
* Behavioral: Stabilization exercise
* Behavioral: General exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults between the ages of 18 and 65 who have experienced chronic neck pain for more than 12 weeks (Blanpied et al., 2017). Those with more than moderate pain (4/10 cm) on the visual analogue scale (VAS) (Paksaichol et al., 2012). Those with a neck disability index (NDI) of mild disability (5/50 score) or higher (Lluch et al., 2014). Those who consented to participate in this study. Exclusion Criteria: Patients with severe pathology such as radiation pain due to intervertebral disc herniation or neurological signs consistent with tumor, whiplash injury, cervical vertebra fracture, or nerve root compression.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized exercise<br> | Behavioral: Personalized exercise<br>* After selective functional movement evaluation, customized interventions for each patient<br>|
| Active Comparator: Stabilization exercise<br> | Behavioral: Stabilization exercise<br>* Neck stabilization exercise and sensorimotor program<br>|
| Active Comparator: General exercise<br> | Behavioral: General exercise<br>* General mobility exercise and strength exercise program<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neck disability index | The questionnaire was composed of 10 questions to provide information on how neck pain affects daily life. | change from baseline neck disability index at 8weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise, neck pain, chronic pain
Efficacy of Adding Low Dose Ketamine or Fentanyl to Propofol-dexmedetomidine as Total Intravenous Anesthesia

Study Overview
=================
Brief Summary
-----------------
Efficacy of adding low dose ketamine or fentanyl to propofol-dexmedetomidine as total intravenous anesthesia for patients undergoing craniotomy in supra tentorial brain tumor

Detailed Description
-----------------
Efficacy of adding low dose ketamine or fentanyl to propofol-dexmedetomidine as total intravenous anesthesia for patients undergoing craniotomy in supra tentorial brain tumor surgery on brain relaxation score, hemodynamics, surgeon satisfaction score , total requirement of intra operative propofol and post operative analgesia

Official Title
-----------------
Efficacy of Adding Low Dose Ketamine or Fentanyl to Propofol-dexmedetomidine as Total Intravenous Anesthesia for Patients Undergoing Craniotomy

Conditions
-----------------
Randomised Triple Blinded Study

Intervention / Treatment
-----------------
* Drug: Ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients aged 18-70 years old ASA I - III with GCS 14-15 and BMI<35 scheduled for elective craniotomy for resection of supratentorial masses Exclusion Criteria: Patients will be excluded if they will refuse to give a written consent. Also patients with GCS < 14 or having endocrine or blood diseases or sever cardiac disease or sever liver disease or renal failure and patients with uncontrolled hypertension or uncontrolled diabetes mellitus and patients have allergy to any of the study drugs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Ketamine group recieve induction and maintenance doses of ketamine by target controlled infusion | Drug: Ketamine<br>* Total intravenous anesthesia in craniotomy<br>* Other names: Fentanyl;|
| Experimental: 2<br>Fentanyl group recieve induction and maintenance doses of fentanyl by target controlled infusion | Drug: Ketamine<br>* Total intravenous anesthesia in craniotomy<br>* Other names: Fentanyl;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of brain relaxation score | 1:perfectly relaxed , 2:satisfactory relaxed , 3:firm brain and 4:bulging brain | 2 hours |