linjc16/ctgov huggingface dataset:
ATGAM General Investigation

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to confirm the safety of ATGAM in patients with moderate to severe aplastic anemia under the actual use in Japan. The registration criteria is patients with moderate to severe aplastic anemia who receive ATGAM. The observation period is 24 weeks (6 months) from the start of administration (Day 1). However, in cases where treatment has been completed or discontinued less than 24 weeks after the start of administration, observation is continued until completion (discontinuation) of treatment.

Official Title
-----------------
ATGAM Intravenous Infusion 250mg General Investigation

Conditions
-----------------
Aplastic Anemia

Intervention / Treatment
-----------------
* Drug: Anti-human thymocyte immunoglobulin, equine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with moderate to severe aplastic anemia who receive ATGAM Exclusion Criteria: No exclusion criteria is set out in this study.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 99 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 |
| --- | --- |
| Anti-human thymocyte immunoglobulin, equine<br>Patients with moderate to severe aplastic anemia who receive ATGAM (Anti-human thymocyte immunoglobulin, equine) | Drug: Anti-human thymocyte immunoglobulin, equine<br>* Usually, 40 mg of anti-human thymocyte immunoglobulin, equine per kilogram of body weight should be slowly administered by intravenous drip infusion once daily. The duration of treatment should be 4 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse drug reactions (ADRs) |  | 24 weeks (6 months) from the start of administration (Day 1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ATGAM;, Anti-human thymocyte immunoglobulin, equine;, Aplastic anemia;
Prognostic Values of PET Examination With 11 C-Fe_CIT With Voxel-based Analysis Method in Patients With Sporadic Parkonson's Disease and Parkinsonisms (Prot.PD-diagn).

Study Overview
=================
Brief Summary
-----------------
The role of PET for the in vivo study of the presynaptic dopaminergic system with 11C-Fe-CIT is universally recognized, and its use has also become routine in numerous nuclear medicine centers in Europe. The indication for the examination is provided exclusively by the clinic in the presence of extrapyramidal signs in the suspicion of Parkinson's disease (PD) or for the differential diagnosis of parkinsonisms. The existence of factors that influence the prognosis of patients with PD or parkinsonism associated with other degenerative diseases is known. Given these premises, the possibility of identifying the disease in the early stages appears fundamental. For this purpose the following should be considered: an automatic analysis method based on the measurement of radiotracer uptake at the level of individual voxels, following Statistical Parametric Mapping procedures. the analysis based on regions of interest (ROIs) positioned ad hoc by the operator which will give the value of the ROI to reference region ratio. In particular, ROIs on the basal ganglia (caudate, putamen) towards cerebellum. Both of these methods offer a quantitative measurement of the damage at the level of the structures involved that is absolutely better than the visual investigation of the distribution of radioactivity in the central nervous system. In this study the investigators want to compare results provided by methods 1 and 2 in the populations under examination to evaluate the data relating to the specificity and sensitivity of the test.

Official Title
-----------------
Prognostic Values of PET Examination With 11 C-Fe_CIT With Voxel-based Analysis Method in Patients With Sporadic Parkonson's Disease and Parkinsonisms (Prot.PD-diagn).

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Diagnostic Test: PET with 11C-Fe-CIT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with initial PD or parkinsonism; signature of informed consent. Exclusion Criteria: patients < 18 years

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: PET with 11C-Fe-CIT|Use of the PET11C-Fe_CIT method for the early diagnosis of Parkinson's and in the differential diagnosis between Parkinson's and parkinsonism.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PET11C-Fe_CIT method for the staging of patients with Parkinson. | All patients undergo to 11C Fe CIT PET examination and the data will be analyzed with ROI and SPM voxel based and correlated with neurological data. | 2 years |
Counseling Intervention in Hereditary Hemorrhagic Telangiectasia in the COVID Era.

Study Overview
=================
Brief Summary
-----------------
The goal of this interventional study is to determine the incidence of depression, anxiety, sleep disturbances and resilience in a sample of subjects affected by Hereditary Hemorrhagic Telangiectasia. The study is declined through the evaluation of some outcome parameters at the time of enrollment (T0), during the counseling intervention (T1 and T2) and at the end (T3) of the subjects who will have carried out an individual counseling intervention.

Official Title
-----------------
Counseling Intervention in Hereditary Hemorrhagic Telangiectasia in the COVID Era.

Conditions
-----------------
Hereditary Hemorrhagic Telangiectasia

Intervention / Treatment
-----------------
* Other: Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recruited subjects have a diagnosis of Hereditary Hemorrhagic Telangiectasia and are 18 years of age or older. Exclusion Criteria: Previous or current intellectual disability and a diagnosis of psychiatric disorders in accordance with the Diagnostic and Statistical Manual of Mental Disorders, DSM-5.

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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with Hereditary Hemorragic Teleangectasia<br>Patients with Hereditary Hemorragic Teleangectasia | Other: Counseling<br>* Counseling is a process which, through positive orientation and the enhancement of personal resources, is aimed at promoting the improvement of the quality of life in the other.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale (HADS) | Administration of psychometric scales | 12 months | 
| Connor-Davidson Resilience Scale (CD-RISC) | Administration of psychometric scales | 12 months | 
| Pittsburgh Sleep Quality Index (PSQI); | Administration of psychometric scales | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of counseling on clients affected by rare diseases | Administration of psychometric scales | 12 months |
Cognitive and Affective Processes Online

Study Overview
=================
Brief Summary
-----------------
This study will provide data for evaluating the psychometric characteristics of the tests assessing cognitive flexibility, including their (1) internal consistency, (2) feasibility and tolerability, their (3) convergent and discriminant validity of cognitive and affective constructs such as those introduced to understand mental disorders, and (4) sensitivity (and correspondence) to individual differences. For these tests to be useful in studying clinical conditions, they must show adequate reliability, validity, and sensitivity in large samples of convenience.

Official Title
-----------------
Computational Dissociation of the Causes of Cognitive Rigidity in Depression

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Diagnostic Test: Computational dissociation of the causes of cognitive rigidity in depression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 18 years or older English-speaking Live in the U.S. Have access to an internet connected computer Users of the mTurk and Prolific survey website Exclusion Criteria: NA

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Test Group<br>involves a single testing session with surveys and tasks relevant to the experiment involving behavioral tasks and self-report questions through an online crowd-sourcing platform | Diagnostic Test: Computational dissociation of the causes of cognitive rigidity in depression<br>* involves a single testing session with surveys and tasks relevant to the experiment involving behavioral tasks and self-report questions through an online crowd-sourcing platform<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship of cognitive rigidity to depressive symptoms | Relationship of model-based measures of learning from the past and anticipating the future to symptoms of depression, specifically anhedonia | 1 hour | 
| Relationship between environmental volatility and cognitive rigidity | Relationship between environmental volatility and model-based measures of cognitive rigidity. | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive rigidity, Foraging, Exploration-Exploitation
Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus

Study Overview
=================
Brief Summary
-----------------
comparison between standard cross-linking protocol and accelerated and transepithelial cross-linking

Detailed Description
-----------------
comparison between standard cross-linking protocol and accelerated and transepithelial cross-linking for treatment of documented pediatric keratoconus progression. The study patients are divided into 3 groups. Group A patient treated with standard cross-linking. Group B patients treated with accelerated cross-linking. Group C patients treated with transepithelial cross-linking.

Official Title
-----------------
Analysis of the Outcomes of Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus

Conditions
-----------------
Corneal Ectasia

Intervention / Treatment
-----------------
* Procedure: Standard CXL
* Procedure: Accelerated CXL
* Procedure: Transepithelial CXL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric patient less than 18 years old keratoconus stage I-III ABCD keratoconus grading system Exclusion Criteria: age more than 18 years previous eye surgery current eye infection or pathology

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard CXL<br>Patients treated according to Dresden Protocol with epithelium-off CXL. | Procedure: Standard CXL<br>* Epithelium-off CXL performed by removal of corneal epithelium, instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 30 minutes.<br>|
| Experimental: Accelerated CXL<br>Patients treated according to accelerated Protocol with epithelium-off CXL. | Procedure: Accelerated CXL<br>* Epithelium-off CXL performed by removal of corneal epithelium, instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 5 minutes.<br>|
| Experimental: Transepithelial CXL<br>Patients treated according to transepithelial Protocol with epithelium-on CXL. | Procedure: Transepithelial CXL<br>* Epithelium-on CXL performed by instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 5 minutes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected distance visual acuity | measured in logarithm of minimal angle of resolution (logMAR) | 36 months | 
| Corrected distance visual acuity | measured in logarithm of minimal angle of resolution (logMAR) | 36 months | 
| Sphere | measured in diopters (D) | 36 months | 
| Cylinder | measured in diopters (D) | 36 months | 
| Keratometry (Kmax) | measured in diopters (D) | 36 months |
Venetoclax in Combination With Standard Induction and Consolidation Chemotherapy in Newly Diagnosed Young AML Patients

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to to evaluate the efficacy and safety of Venetoclax in combination with DA60(daunorubicin 60 mg/m2/d for 3 days, and cytarabine 100 mg/m2 every 12 h for 7 days) induction and HD-AraC(cytarabine 3 g/m2 every 12 h for 3 days) consolidation, in young patients with newly diagnosed acute myeloid leukemia (AML).

Official Title
-----------------
The Efficacy and Safety of Venetoclax in Combination With Standard Induction and Consolidation Chemotherapy in Newly Diagnosed Young Acute Myeloid Leukemia

Conditions
-----------------
Acute Myeloid Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed, morphologically documented AML based on the World Health Organization (WHO) 2016 classification. Age ≥ 18 years and ≤ 59 years Have been treat with the venetoclax in combination with standard induction and consolidation chemotherapy therapy, and in follow-up. Be comprehensive of the research, and able to provide informed consent. Exclusion Criteria: Diagnosis of acute promyelocytic leukemia (APL). Prior treatment for AML, except for: leukapheresis, hydroxyurea, and growth factor/cytokine. Unable to understand or participate.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival (DFS) | DFS is calculated from the date of remission (inclusive of CR and CRi) to the date of relapse, death from any cause, or last follow-up. | Assess up to 24 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission (CR) rate | The rate of patient who get CR after induction therapy. | On Day 21 (window Day 21 to Day 35), a bone marrow aspirate specimen will be collected for morphology and pathology. | 
| Rate of minimal residual disease (MRD) negativity | Percentage of patients achieving CR with no evidence of MRD after induction therapy, 1 cycle of consolidation therapy, and 4 cycles of consolidation therapy. MRD negativity is defined as < 0.1% of CD45 expressing cells with the target immunophenotype, or as cycling threshold (Ct) ≥ 40 in ≥ 2 of 3 replicates by qPCR. | MRD will be tested after every cycle of therapy and during follow-up. | 
| Overall survival (OS) | OS is defined as the duration from initiation of induction treatment to the date of death from any cause or last follow-up. | Assess up to 24 months. |
Breast 3DUS ABUS System Comparison

Study Overview
=================
Brief Summary
-----------------
This comparative study will recruit 30 females who are scheduled for mammography and ultrasound assessment. The clinical 2D ultrasound is performed routinely, and the research portion of this study will add a few extra 3-D ultrasound images during the procedure. The ultrasound imaging laboratory under the direction of Dr. Aaron Fenster has developed a customized device designed to acquire 3D ultrasound of the breast using a commercial ultrasound machine. The purpose is to see how well 3-dimensional ultrasound acquire from that device is able to visualize tumours and other key features in comparison to the clinical system InveniaTM developed by GE Medical.

Official Title
-----------------
Comparing the Efficacy of 3D Ultrasound Imaging of Breast Pathology Between a Custom ITA Device and Invenia™ ABUS System by GE Medical

Conditions
-----------------
Breast Diseases

Intervention / Treatment
-----------------
* Device: 3D Ultrasound Image Acquisition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Patients who are scheduled for screening ABUS Adults Patients who are scheduled for short term follow-up with ABUS. Must be at least 18 years of age or older. Must be proficient in English (reading/writing). Exclusion Criteria: Patients with breast implants. Patients with contraindication for ABUS. Patients who cannot tolerate ABUS.

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients at Risk of Breast Cancer<br>These patients will be imagined with an experimental device designed to acquire ultrasound in three dimensional volumes | Device: 3D Ultrasound Image Acquisition<br>* A custom device will be used with a clinical ultrasound machine to acquire ultrasound images of the breast.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast Images | Images of the breast anatomy will be compared to standard of care imaging. | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
3D Ultrasound, Intervention
Pulmonary Hypertension Observational Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish the large PH cohort and biological database in China, aiming for precision medicine to optimize diagnosis and treatment choices.

Official Title
-----------------
A Observational Study in Chinese Patients With Pulmonary Hypertension (PH)

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Other: pulmonary hypertension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PH group: When the mean pulmonary artery pressure is greater than 25mmHg at rest or greater than 30mmHg during exercise. Signed informed consent obtained prior to participations with the ability to comply with protocol and be available for study visits over 5 years. Exclusion Criteria: Acute exacerbation in the past 3 months Having other respiratory diseases with massive lung tissue destruction such as severe bronchiectasis and tuberculosis, etc. Serious uncontrolled diseases thoracic or abdominal surgery in the last 3 months. Eye surgery in the last three months. Retinal detachment myocardial infarction in the last 3 months. Admission to hospital for any cardiac condition in the last month. Heart rate over 120 beats per minute. Antibacterial chemotherapy for tuberculosis pregnant or breast feeding.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| pulmonary hypertension<br> | Other: pulmonary hypertension<br>* The final outcome observed was a diagnosis of pulmonary hypertension.<br>|
| healthy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean pulmonary arterial pressure | For an adult at sea level, when the mean pulmonary arterial pressure is greater than 25 mmHg at rest or greater than 30mmHg during exercise. | 12 months |