linjc16/ctgov huggingface dataset:
Same-session MR-only Simulation and Treatment With MRI-guided Adaptive Palliative RadioTherapy

Study Overview
=================
Brief Summary
-----------------
This proposed study is unique in that patients will not undergo computed tomography (CT) simulation at any point during their treatment course and will instead have same-session magnetic resonance (MR)-only simulation and treatment planning, on-table, using the adaptive radiotherapy (ART) workflow. In this manner, patients requiring urgent treatment could initiate treatment as early as the day of initial radiation oncology consultation.

Official Title
-----------------
Pilot Study of Same-session MR-only Simulation and Treatment With MRI-guided Adaptive Palliative RadioTherapy (MAP-RT)

Conditions
-----------------
Malignancy, Metastasis, Hemoptysis, Gastrointestinal Bleeding, Pelvic Bleeding, Superior Vena Cava Syndrome, Mediastinal Disease

Intervention / Treatment
-----------------
* Device: Volumetric MR imaging
* Radiation: Radiation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of malignancy (biopsy proven or high clinical suspicion with urgent/emergent clinical indications for palliative RT) Requires delivery of palliative radiation therapy for the treatment of painful metastasis, hemoptysis, gastrointestinal bleeding, pelvic bleeding, or superior vena cava syndrome/bulky mediastinal disease. At least 18 years of age. Able to understand and willing to sign an IRB-approved written informed consent document. Exclusion Criteria: Pregnant. Patients of childbearing potential must have a negative pregnancy test within 14 days of study entry. Medical contraindication to undergoing MR imaging.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Volumetric MR imaging planning<br>All patients will undergo volumetric MR imaging on treatment days in positioning appropriate for the specific treatment site. Patients will receive standard of care palliative radiation therapy | Device: Volumetric MR imaging<br>* This will most frequently be supine with arms positioned so not in the way of treatment beams.<br>Radiation: Radiation therapy<br>* -Standard of care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Same-session MRI-only Simulation as Defined as More Than 70% of Patients Receiving at Least 70% of Their Scheduled Treatment Fractions on the First On-table Attempt for Each Respective Fraction. |  | Completion of enrollment (approximately 29 months) |
Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
This is a study where there are no interventions planned. Investigators will only collect data already in the patient's history and analyze it. Particularly, we are interested in molecular data from AML patients. This means that patients will follow their regular diagnostic and clinical practice. The analyses will be conducted according to the routine diagnostic and clinical practice as well and no additional blood withdrawal will be performed.

Detailed Description
-----------------
The study will be conducted as follows: Retrospective phase clinical and molecular data of patients analyzed for IDH1/2 mutations will be retrospectively collected in the centers that have already introduced IDH1/2 mutational screening in their practice from cases collected according to standard procedure (Ficoll and lysis in RLT buffer). Prospective phase: each participating center already performing IDH1/2 mutational status on samples of their AML patients at diagnosis or relapse - on freshly isolate mononuclear cells from bone marrow and/or peripheral blood using Ficoll density gradient preparation - will prospectively collect the clinical and molecular data.

Official Title
-----------------
Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia

Conditions
-----------------
AML, Adult

Intervention / Treatment
-----------------
* Genetic: IDH mutation test performed at diagnosis or relapse until January 31st, 2019.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable); AML patients; Age ≥18; IDH mutation test performed at diagnosis or relapse until January 31st, 2019. Exclusion criteria: AML M3 subtype according to the FAB classification;

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AML patients<br>Adult AML patients with the IDH mutation test performed at diagnosis or relapse until January 31st, 2019. | Genetic: IDH mutation test performed at diagnosis or relapse until January 31st, 2019.<br>* Observation of the test result.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with the IDH mutations in AML at initial diagnosis. |  | At two years from study entry. | 
| Number of patients with the IDH mutations in AML at relapse. |  | At three years from study entry. |
Diagnostic and Prognostic Value of p16INK4a Expression in Low Grade Squamous Intraepithelial Lesions of the Cervix.

Study Overview
=================
Brief Summary
-----------------
P16INK4a has recently been described as a surrogate marker for HR-HPV associated squamous and glandular intraepithelial lesions of the cervix. The immunohistochemical staining pattern of p16INK4a in high grade intraepithelial neoplasia of the cervix (CIN 2 and 3) is diffuse, whereas in CIN 1 different staining patterns (diffuse, sporadic, focal or negative) can be seen. The aim of our study is to find out whether the p16INK4a staining pattern of CIN 1 is able to predict the outcome of the lesion. The retrospective part of the study includes cervical biopsies of 200 patients with CIN 1 and clinical follow-up for at least 5 years. p16INK4a staining and HPV detection by IHC will be correlated to clinical outcome.The prospective part of the study includes 300 patients with CIN 1 and LSIL on cytology. HPV detection by HCII and p16INK4a immunohistochemistry on liquid based cytology samples as well as p16INK4a staining and HPV detection by ISH on colposcopy guided biopsies will be correlated to clinical follow-up and colposcopy findings. Slides are analysed by 2 pathologists without knowledge of clinical data.

Official Title
-----------------
Diagnostic and Prognostic Value of p16INK4a Expression in Low Grade Squamous Intraepithelial Lesions of the Cervix. Immunohistochemical Study on Biopsies (Retrospective and Prospective Analysis) and on Liquid Based (SurePath) Cervical Cytology (Prospective Analysis). Correlation With HPV Typing and Clinical Outcome.

Conditions
-----------------
Cervical Intraepithelial Neoplasia Grade 1 (CIN 1)

Intervention / Treatment
-----------------
* Procedure: colposcopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Responsible women > 18 years with histologically proven CIN 1

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: colposcopy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| p16INK4a staining pattern and HPV status of the initial biopsy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| p16INK4a staining pattern and histologic diagnosis of follow-up biopsies correlated with colposcopic findings. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prognostic value of p16INK4a, CIN 1, LSIL, HPV
Interest of Saline MR Peritoneography for Pre-operative Assessment of Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
MR saline peritoneography could be useful to demonstrate the peritoneal outline of the pouch of Douglas. The investigators think that the localization of the rectal tumor in function of this anatomic mark could be decisive for pre-operative assessment.

Official Title
-----------------
Interest of Saline MR Peritoneography for Pre-operative Assessment of Rectal Cancer

Conditions
-----------------
Rectal Adenocarcinoma

Intervention / Treatment
-----------------
* Procedure: MR saline peritoneography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rectal adenocarcinoma Exclusion Criteria: Metastatic disease under 18y patient woman of childbearing age

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MR saline peritoneography<br>Patients that will undergo MR saline peritoneography | Procedure: MR saline peritoneography<br>* Ultrasound-guided Intraperitoneal injection of 250cc of steril saline solution with a 22G needle, followed by rectal MR imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the distance between a rectal tumor and the pouch of Douglas | Feasability of the determination of the distance between a rectal tumor and the pouch of Douglas by MR saline peritoneography: Visualisation of the Douglas Visualisation of the Tumor Determination of the distance between the tumor and the pouch of Douglas | Two years |
Frequency of Hepatobilliary Manifestations in Patients With Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
Hepatobilliary manifestations as extraintestinal manifestations of IBD are sometimes underdiagnosed which can impair patient prognosis

Detailed Description
-----------------
Non alcoholic fatty liver is aliver disease most commonly found in patient with IBD most commonly without intestinal activity. On the other hand primary according cholangitis is the most common specific with IBD commonly with ulcerative colitis. and is commonly overlap with autoimmune hepatitis IBD therapy can also be a cause it can lead to hepatic toxicity and some drugs like ant TNF can cause hepatitis b virus activation.

Official Title
-----------------
Frequency of Hepatobilliary Manifestations in Patients With Inflammatory Bowel Disease

Conditions
-----------------
Hepatobilliary Manifestations in Inflammatory Bowel Disease Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:all patients diagnosed IBD crohns and ulcerative on conventional treatment and biological treatment - Exclusion Criteria:no -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| The prevelance of hepatobilliary manifestations in IBD patients |  | 1 year |
Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.

Official Title
-----------------
Open-label Safety Study of a 1-year 8 to 24 mg/Day Dose Regimen of Iloperidone (FANAPT®) in Adolescent Patients With Schizophrenia or Bipolar I Disorder

Conditions
-----------------
Schizophrenia, Bipolar I Disorder

Intervention / Treatment
-----------------
* Drug: Iloperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is willing and able to provide assent and willing to complete all aspects of the study Patient's parent or legal guardian willing and able to provide consent Male or female patients 12 through 17 years of age (inclusive) Clinical diagnosis of either schizophrenia or bipolar I disorder Exclusion Criteria: Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer A positive test for drugs of abuse

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iloperidone<br>Open-label iloperidone | Drug: Iloperidone<br>* oral tablet<br>* Other names: FANAPT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period. |  | 1 year |
Combination Trial of Intravenous Paracetamol - Morphine for Treating Acute Renal Colic in Emergency Setting: An Optimum Treatment

Study Overview
=================
Brief Summary
-----------------
This randomized, placebo-controlled trial evaluated the analgesic efficacy and safety of intravenous morphine-paracetamol combination and morphine-dexketoprofen combination morphine for the optimum treatment of renal colic. Combination of IV morphine and paracetamol is as effective and rapid as combination of IV Morphine and IV dexketoprophen for optimum treating of renal colic.

Official Title
-----------------
Paracetamol Plus Morphine in ED

Conditions
-----------------
Renal Colic

Intervention / Treatment
-----------------
* Drug: Paracetamol+Morphine
* Drug: Dexketoprofen plus Morphine
* Drug: Placebo plus Morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Renal colic patients - Exclusion Criteria: Not renal colic patients -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Paracetamol+Morphine<br>* 1gr paracetamol plus 0.1 mg/kg morphine were performed simultanously<br>* Other names: Parol;Drug: Dexketoprofen plus Morphine<br>* Intravenous 75 mg Dexketoprofen plus 0,1 mg/kg morphine were performed simultanously<br>* Other names: Arveles;Drug: Placebo plus Morphine<br>* 100 cc NaCl plus 0.1 mg/kg morphine were performed simultanously<br>* Other names: SF;|
| Active Comparator: Paracetamol<br> | Drug: Paracetamol+Morphine<br>* 1gr paracetamol plus 0.1 mg/kg morphine were performed simultanously<br>* Other names: Parol;Drug: Dexketoprofen plus Morphine<br>* Intravenous 75 mg Dexketoprofen plus 0,1 mg/kg morphine were performed simultanously<br>* Other names: Arveles;Drug: Placebo plus Morphine<br>* 100 cc NaCl plus 0.1 mg/kg morphine were performed simultanously<br>* Other names: SF;|
| Active Comparator: Dexketoprofene<br> | Drug: Paracetamol+Morphine<br>* 1gr paracetamol plus 0.1 mg/kg morphine were performed simultanously<br>* Other names: Parol;Drug: Dexketoprofen plus Morphine<br>* Intravenous 75 mg Dexketoprofen plus 0,1 mg/kg morphine were performed simultanously<br>* Other names: Arveles;Drug: Placebo plus Morphine<br>* 100 cc NaCl plus 0.1 mg/kg morphine were performed simultanously<br>* Other names: SF;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain reductions in VAS scores during the 60th and 90th minutes |  | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for rescue analgesic |  | 30 minutes |
Functional Abilities in Rett Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate and determinate the functional abilities in Rett syndrome conforming to the established Pediatric Evaluation of Disability Inventory (PEDI).

Detailed Description
-----------------
Rett syndrome (RS) is a progressive neurological disturbance of genetic cause that affects females almost exclusively. It is caused by mutations, usually sporadic, of the MECP2 gene located in the X chromosome. In consequence to the serious cognitive and motor compromise, the RS patients have great difficulty in accomplishing day-to-day tasks. The objective of this work is to evaluate the functional abilities in RS to help therapists in theirs treatments programs.

Official Title
-----------------
Functional Abilities in Rett Syndrome

Conditions
-----------------
Rett Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Rett syndrome that matched the criteria for the classic form of the disease Exclusion Criteria: Any other disease; Rett syndrome associated with other disease Rett syndrome that not that matched the criteria for the classic form of the disease
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 64<br>All Patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rett Syndrome, Selfcare, Mobility limitation, Interpersonal relations, This study avaliated patients with Rett Syndrome
Genicular Nerve Block in Rheuamtoid Arthritis

Study Overview
=================
Brief Summary
-----------------
N=64 RA patients either early or established disease diagnosed after ACR/EULAR criteria 2010 with unilateral persistent knee arthritis. They were randomly assigned into two groups; group 1 received genicular nerve block, group 2 intra-articular triamcinolone. Both groups were examined by SOLAR scoring system, Visual analogue scale (VAS) and Lysholm score at 0, 2 and 12 weeks. A semi-quantitative score was used to assess tenderness and swelling at the same intervals.

Official Title
-----------------
Genicular Nerve Block in Rheumatoid Arthritis: a Prospective Randomized Clinical Trial

Conditions
-----------------
Pain, Joint Function Disorder, Inflammation

Intervention / Treatment
-----------------
* Drug: Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer)
* Drug: triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: RA patients Age > 18 unilateral persistent knee arthritis Exclusion Criteria: Participants with severe knee osteoarthritis peripheral neuropathy psoriatic arthritis skin infection or those who have allergy for Bupivacaine

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: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group received nerve block and another group received steroid
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nerve block group<br>3 point genicular nerve block under ultrasound guidance. half ml of Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer) was injected in each point. | Drug: Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer)<br>* 3 point genicular nerve block<br>Drug: triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)<br>* intra-articular injection of triamcinilone<br>|
| Other: intra-articular steroid injection<br>1 mL of triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) was injected intraarticular. | Drug: Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer)<br>* 3 point genicular nerve block<br>Drug: triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)<br>* intra-articular injection of triamcinilone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain changes by VAS | 0 means no pain and 10 means the most severe pain | at 0 time after 2 weeks and after 12 weeks | 
| SOLAR score for inflammation changes by ultrasound | 0 means normal and 27 means the worst possible inflammation | at 0 time after 2 weeks and after 12 weeks | 
| Lysholm score for change in knee function | 100 means the best performance and 0 means complete loss of function | at 0 time after 2 weeks and after 12 weeks |