linjc16/ctgov huggingface dataset:
Assertive Community Treatment in Copenhagen

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the effect of assertive community treatment in Copenhagen in two regions compared with two regions where this treatment was not implemented. The effect on user satisfaction, use of bed days, social network, global assessment of functioning, substance misuse will be evaluated.

Detailed Description
-----------------
In area where assertive community treatment was implemented 100 patients had filled in a form regarding their social situation. They were interviewed after one year and asked about user satisfaction and followed up in Danish registers. Register information was extracted concerning vital status, cause of death, use of psychiatric services and criminal record. The same procedure was carried out for a comparison group, carefully matched, from other regions in Copenhagen, where assertive community treatment was not implemented.

Official Title
-----------------
Quasi-Experimental Trial of the Effect of Assertive Community Treatment Among Those With Severe Mental Disorder

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

Intervention / Treatment
-----------------
* Behavioral: Assertive Community Treatment
* Behavioral: Treatment in Community Mental Health Center


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: User of bed days exceeded 40 days last two years; or 4+ admissions during last two years; or A second diagnosis of substance misuse; or Non compliance with medication or outpatient visits in usual settings; or Being unable to use other existing services Exclusion Criteria: Forensic patient with a sentence to stay in hospital

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Assertive Community Treatment|nan|
|Behavioral: Treatment in Community Mental Health Center|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experience of violation of personal integrity and privacy in relation to treatment |  |  | 
| User satisfaction |  |  | 
| Quality of Life |  |  | 
| Substance misuse |  |  | 
| Social network |  |  | 
| Affiliation to labor market |  |  | 
| Independent living |  |  | 
| Crime |  |  | 
| Suicidal behaviour |  |  | 
| Use of psychiatric services |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Assertive community treatment
Treatment of Stable Both-Bone Midshaft Forearm Fractures in Children

Study Overview
=================
Brief Summary
-----------------
We create a randomized clinical trial between the treatment with above elbow armcast alone and the treatment of above elbow in combination with a short arm cast for stable midshaft both-bone forearm fractures.

Detailed Description
-----------------
children who arrive at the emergency unit with a stable both-bone midshaft forearm fracture will be asked to join the trial. If the fracture will be stable during reposition in the operating room, a randomization between 2 kinds of plaster treatment will be done. Outpatient clinic visits till a follow-up of 6 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complains in daily living and complications.

Official Title
-----------------
Treatment of Stable Both-Bone Midshaft Forearm Fractures in Children: A Randomized Trial Between Treatment With Above Elbow Cast and a Combination of Above- and Below Elbow Armcast.

Conditions
-----------------
Fracture, Forearm, Midshaft, Child, Treatment

Intervention / Treatment
-----------------
* Device: above or below elbow cast for the last 3 weeks of treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: both-bone forearm fracture age < 16 years dislocation stable Exclusion Criteria: fracture older than 1 week no informed consent refracture open fracture (Gustillo 2 and 3)

Ages Eligible for Study
-----------------
Maximum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: above or below elbow cast for the last 3 weeks of treatment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pronation and supination |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications, function, esthetics, complains in daily living, X-rays |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fracture, forearm, midshaft, child, treatment
Validation of the Gated Blood Pool SPECT: ERNA vs 3D Echo

Study Overview
=================
Brief Summary
-----------------
This research study is designed to evaluate the accuracy of the techniques that are used to analyze heart function. The main purpose of this study is to analyze and compare three different methods of assessment of regional and overall heart function.

Detailed Description
-----------------
The purpose of the present study is to establish the reproducibility and to validate gated blood pool SPECT imaging with application of attenuation correction (ACGBS) in evaluation of left ventricular regional and global function and volumes, by direct comparison with Equilibrium Radionuclide Angiocardiography (ERNA) and 3-dimensional ECHO (3DE).

Official Title
-----------------
Validation of the Gated Blood Pool SPECT: Comparison to ERNA and 3-dimensional Echocardiography.

Conditions
-----------------
Congestive Heart Failure, Ventricular Function, Left

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients scheduled for routine clinically requested ERNA study for ejection fraction measurement at the Yale University Cardiovascular Nuclear Imaging Laboratory are eligible to be enrolled in the study. Exclusion Criteria: Unstable medical condition preventing additional imaging. Weight greater than 300lbs, prohibiting imaging on the SPECT/CT imaging system. Patients with intracardiac shunts, emphysema or previously demonstrated allergies to octafluoropropane (the gas in the microbubbles), will not receive intravenous contrast during 3 DE image acquisition.

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 |
| --- | --- |
| 1<br>Patients being referred for the routine Equilibrium Radionuclide Angiocardiography (ERNA) for assessment of their left ventricular function will be asked to participate in the study. All patients will be asked to sign the consent form. Patients will be given a choice to participate in either or both studies (i.e. ERNA plus ACGBS or ERNA plus ACGBS and 3 DE). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2D echo provides a good estimate of regional LV function but if done with 3D analysis can provide a good estimate of global LV function and volumes. The quality of 3DE can be further improved by use of IV contrast which is FDA approved. |  | 1 day |
A Clinical Research on the Relation of Blood Drug Concentration and Calcium Folinate Rescued in High-dose MTX Therapy

Study Overview
=================
Brief Summary
-----------------
At present, the most effective drugs to osteosarcoma include ADM,DDP,,HD-MTX,IFO and so on.The effective rate of single drug was about 30%, and if the chemotherapy contains HD-MTX, the survival rate can reach about 60%, so the HD-MTX is the most important component in patients of osteosarcoma. Studies have shown that, MTX efficacy and adverse reactions were associated with blood concentration level and duration, selecting the right time and dose to give CF is the critical point.

Conditions
-----------------
Osteosarcoma

Intervention / Treatment
-----------------
* Drug: Methotrexate,Calcium folinate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Proved by pathology in 60 cases of osteosarcoma patients PS ≤ 2, survival period is more than 6 months Normal function of liver and kidney No chemotherapy contraindication, patients treat with high dose methotrexate Get signed written informed consent form Have a good compliance with take blood and follow-up Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 60 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: Methotrexate and Calcium folinate<br> | Drug: Methotrexate,Calcium folinate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood concentration of MTX |  | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| other adverse reaction |  | up to 3 years |
Allied Health in Rheumatology Triage Project

Study Overview
=================
Brief Summary
-----------------
There is accumulating evidence that early treatment leads to better outcomes for patients with inflammatory arthritis (IA). Triage, which is the process of identifying the urgency of a patient's disease state efficiently and correctly, may facilitate early referral to a rheumatologist. Several studies have suggested that placing allied health professionals (occupational therapists, physical therapists, nurses, etc.) in a triage roll may reduce wait time for patients with suspected IA. The goal of this investigation will be to demonstrate the system-level impact of an Arthritis Society extended role occupational therapist (OT) or physical therapist (PT) working in a triage role in improving access to rheumatologists for people with IA. In this study two groups will be observed: intervention and usual care as determined by historical chart review. Wait times will be compared between both groups.

Official Title
-----------------
Allied Health in Rheumatology Triage Project

Conditions
-----------------
Inflammatory Arthritis

Intervention / Treatment
-----------------
* Other: Therapist Triage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New referrals from a GP Adults with possible IA (determined by rheumatologist through paper triage) Exclusion Criteria: Currently on a disease-modifying antirheumatic drug (DMARD) Previously seen by a rheumatologist. FM, non-IA OA; soft tissue rheumatism; mechanical LBP

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapist Triage<br>All subjects in this group will be triaged by an extended role occupational or physical therapist prior to their visit with the rheumatologist. | Other: Therapist Triage<br>* An extended role occupational or physical therapist will triage each subject in the study to determine the urgency of their case and how soon they need to see the rheumatologist.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first visit with the rheumatologist (wait time) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to diagnosis |  | 3 months | 
| Time to treatment (disease-modifying antirheumatic drug) |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriatic arthritis, Ankylosing spondylitis, Rheumatoid arthritis, Seronegative
High Risk Adult T-cell Leukemia/Lymphoma (ATLL-HR) and Allogeneic Transplant

Study Overview
=================
Brief Summary
-----------------
Patients are recruited at diagnosis or at relapse of ATLL-HR in French Caribbean islands and Guyana. They all receive Zidovudine and Pegylated Interferon (ZPI). For patients younger than 65 years old, an allogeneic donor is searching out. Patients included at relapse and with lymphoma clinico-biological subtype also receive chemotherapy (CT). Responses are assessed during ZPI+/-CT and eligible patients (depending on age, comorbidities and response criteria) receive allogeneic transplant. Patient follow-up is planned for 3 years old

Official Title
-----------------
Observational Prospective Study, Evaluating the Standard of Care as Recommend by International Consensus With Zidovudine-Pegylated Interferon +/-Polychemotherapy in High Risk Adult-T-cell Lymphoma/Leukaemia (T-cell Lymphoma/Leukaemia) Followed by Allogeneic Transplant Among Eligible Patients Younger Than 65 Years Old

Conditions
-----------------
T-cell Lymphoma, Leukaemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient >18 years old and ≤ 75 years old, with ATLL-HR who signed informed consent. Exclusion Criteria: Pregnant or nursing women are not eligible; neither are women of childbearing potential unless using effective contraception as determined by the patient's physician.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| ZPI<br>Zidovudine 1000mg/day : Retrovir® 250mg/day) PegINF (Pegasys®) 180μg x1 injection/week | |
| ZPI+CHOP-21<br>Zidovudine 1000mg/day : Retrovir® 250mg/day) PegINF (Pegasys®) 180μg x1 injection/week CHOP-21 Day1 = day 21 (3 cycles) Day 1 Cyclophosphamide : 750 mg/m2, Doxorubicine : 50 mg/m2, Vincristine : 1,4mg/m2, Prednisone : 100mg/day PO. day 2-Day 5 Prednisone 1mg/kg/day PO. | |
| ZPI +DHAP-21<br>Zidovudine 1000mg/day : Retrovir® 250mg/day) PegINF (Pegasys®) 180μg x1 injection/week DHAP Day 1= day 21 (3 cycles) Day 1 : Cisplatina 100 mg/m2 Day 2 and day 3 : Aracytine 2000mg/m2/day Day 1-day 4 : Dexamethasone 40mg | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with relapse |  | Up to 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of presence of gene expression of Tax and HBZ confirmed by Rt-PCR | The titrations of genes are performed at month 12, month 24 and month 36 | 1 year |
Novel Treatment Delivery of ECAP-controlled Closed-loop SCS for Chronic Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test and evaluate novel treatment delivery of ECAP-controlled closed loop SCS through the incorporation of new software and/or hardware features for patients with the Evoke System.

Official Title
-----------------
A Prospective, Multicentre, Single-arm Feasibility Study Examining Novel Treatment Delivery of the Evoke Spinal Cord Stimulator (SCS) System to Treat Patients With Chronic Pain of the Trunk and/or Limbs

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Device: Evoke Spinal Cord Stimulation (SCS) System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Subject has undergone trial implant or is planning to be implanted with the Evoke System within its approved indication. 2. Subject is willing and capable of giving informed consent and able to comply with study-related requirements. Exclusion Criteria: N/A

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ECAP-controlled, closed-loop SCS<br>Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude | Device: Evoke Spinal Cord Stimulation (SCS) System<br>* ECAP-controlled, closed-loop SCS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Evoke Compound Action Potentials (ECAPs) as measured by the Evoke SCS System |  | Through study completion, up to 2 years |
Cefiderocol in the Treatment of Multidrug-resistant Gram-negative Bacilli Infections, a Retrospective Study

Study Overview
=================
Brief Summary
-----------------
Cefiderocol is a new antibiotic from the siderophore cephalosporin family for which there are few real-life data on its use in the treatment of infections with multidrug-resistant Gram-negative bacilli. The circulation of bacterial strains multi-resistant to antibiotics is important at the Strasbourg University Hospital, so the investigators wish to report their local experience of the 1st uses of Cefiderocol in the treatment of infections with multi-resistant Gram-negative bacilli to antibiotics in order to better clarify the use of this antibiotic (therapeutic indication, method of administration)

Official Title
-----------------
Cefiderocol in the Treatment of Multidrug-resistant Gram-negative Bacilli Infections, a Retrospective Study

Conditions
-----------------
Multidrug Resistant Bacterial Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult patient (≥18 years old) taken care of in the HUS and treated as part of routine care with Cefiderocol between 04/01/2020 and 08/31/2022. Subjects who have not expressed their opposition to the reuse of their data for scientific research purposes. Exclusion criteria: - Patient who has expressed his opposition to the retrospective reuse of his data for scientific research purposes.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective evaluation of the therapeutic management of patients treated as part of routine care with Cefiderocol | Survival, significant clinical improvement, absence of microbiological failure or infectious recurrence on day 30 after treatment with Céfiderocol | 30 days post treatment with Céfiderocol | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multidrug Resistant Bacterial Infections, Gram-negative bacilli infections, Cefiderocol, Antibiotics
Adjunctive Study of AL-37807 Ophthalmic Suspension

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the safety and intraocular pressure-lowering efficacy of AL-37807 ophthalmic suspension vs. Timolol gel forming solution vs. AL-37807 vehicle, all dosed concomitantly with Xalatan, in patients with open-angle glaucoma or ocular hypertension.

Official Title
-----------------
Comparison of Safety and Efficacy of Al-37807 Ophthalmic Suspension vs. Timolol Gel Forming Solution and Vehicle, All Dosed Concomitantly With Xalatan in Patients With Open-Angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: AL-37807 ophthalmic suspension, 0.1%
* Drug: Timolol gel forming solution, 0.5%
* Other: AL-37807 ophthalmic solution vehicle
* Drug: Latanoprost ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Open-angle glaucoma Ocular hypertension Must have been on Xalatan for at least 3 months VA not worse than 0.60 Other protocol-defined inclusion criteria may apply Exclusion Criteria: Age related Other protocol-defined exclusion criteria may apply

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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AL-37807<br>AL-37807 ophthalmic suspension, 0.1%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks | Drug: AL-37807 ophthalmic suspension, 0.1%<br> <br> Drug: Latanoprost ophthalmic solution<br> <br> * Other names: XALATAN;|
| Active Comparator: Timolol<br>Timolol gel forming solution, 0.5%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks | Drug: Timolol gel forming solution, 0.5%<br> <br> Drug: Latanoprost ophthalmic solution<br> <br> * Other names: XALATAN;|
| Placebo Comparator: AL-37807 vehicle<br>AL-37807 ophthalmic solution vehicle, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks | Drug: AL-37807 ophthalmic suspension, 0.1%<br> <br> Other: AL-37807 ophthalmic solution vehicle<br> <br> Drug: Latanoprost ophthalmic solution<br> <br> * Other names: XALATAN;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in intraocular pressure |  | Baseline, up to 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Hypertension