linjc16/ctgov huggingface dataset:
French Register Of Patients With Hemopathy Eligible For CAR-T Cell Treatment (DESCAR-T)

Study Overview
=================
Brief Summary
-----------------
This study is a registry including prospective and retrospective data on all patients who have been presented in a Multidisciplinary tumor board or RCP to be eligible for CAR-T cell treatment.

Official Title
-----------------
French Register Of Patients With Hemopathy Eligible For CAR-T Cell Treatment (DESCAR-T)

Conditions
-----------------
Hematopathology Eligible or CAR-t Cell Treatment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Retrospective inclusion : Patient treated with CAR-T from 1 July 2018 under temporary authorization (ATU) or covered by French health insurance system (under post-ATU or MA) in a qualified center before activation of this register in this center If the patient is alive, the patient has been informed of the collection and use of their data, and the patient has not opposed this use. If the patient has died, the patient did not opposed the use of their data while alive Prospective inclusion : Patient eligible for a treatment with CAR-T for an hematological malignancy which is covered by French health insurance (for ATUs / post-ATUs or MA), or as part of a clinical trial with the same indication, after the activation of this register in this center. Patient whose CAR-T indication has been validated during a multidisciplinary tumor board (RCP) of a qualified center, according to the ministerial order of 8 August 2019 Patient deemed eligible for a treatment with CAR-T after a medical exam performed in a qualified center according to the ministerial order of 8 August 2019 If the patient is alive, the patient has been informed of the collection and use of their data, and the patient has not opposed this use. If the patient has died, the patient did not opposed the use of their data while alive. Exclusion Criteria Patient not registered with the social security in France

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival from eligibility |  | 15 years | 
| Overall survival from administration |  | 15 years | 
| complete response rate |  | 15 years | 
| Progression free survival |  | 15 years | 
| Duration of response |  | 15 years | 
| Delays between patient eligibility and CAR-T treatment |  | 15 years |
Descriptive Study of the Incidence of Malignancy in Severe Asthma Patients Receiving Benralizumab and Other Biologic Therapy, a Post Authorization Safety Study

Study Overview
=================
Brief Summary
-----------------
This is a real-world, observational, prospective cohort study in patients with severe asthma recruited into the International Severe Asthma Registry (ISAR) and the US severe asthma registry (CHRONICLE) and followed-up for occurrence of new malignancies. The primary objective is to measure the incidence of malignancy in the overall severe asthma population as well as its relevant subgroups, including patients receiving benralizumab, patients receiving non-benralizumab biologics, and patients not receiving biologics. The secondary objective is to describe the clinical characteristics of new malignancy cases that develop in severe asthma patients and relevant subgroups.

Official Title
-----------------
Descriptive Study of the Incidence of Malignancy in Severe Asthma Patients Receiving Benralizumab and Other Biologic Therapy, a Post Authorization Safety Study

Conditions
-----------------
Asthma, Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study population includes patients with severe asthma recruited into ISAR and CHRONICLE. Severe asthma patients are defined as those receiving treatment consistent with Global Initiative for Asthma (GINA) Step 5 or who are uncontrolled on GINA Step 4 treatment regimens. Exclusion Criteria: - Patients who are not willing and able to sign written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 130 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 |
| --- | --- |
| Benralizumab<br>Patients who have received Benralizumab. | |
| Other biologics<br>Patients who have received non benralizumab biologics. | |
| Non-biologic<br>Patients who have received non biologic drug. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neoplasm | Incidence of neoplasm each year, starting from index date. | Annually, up to 5 years |
Health Economic Assessment of Tygacil® in the Treatment of Secondary Peritonitis in Intensive Care Units (ICUs)

Study Overview
=================
Brief Summary
-----------------
The main goals of the study are: Assessment of Tygacil's cost-effectiveness; Process cost analysis from a hospital perspective (including length of stay, treatment costs, side effect management costs, costs of monitoring, costs of diagnostic procedures, cost of care (TISS 10 score etc.); Efficacy of Tygacil under usual care conditions (cure rate).

Official Title
-----------------
Health Economic Assessment of Tygacil® in the Treatment of Secondary Peritonitis in Intensive Care Units

Conditions
-----------------
Peritonitis

Intervention / Treatment
-----------------
* Drug: Tygacil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of secondary peritonitis Treatment in an ICU Patient age >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 |
| --- |
|Drug: Tygacil|Initial dose of 100mg followed by 50mg every 12 hours for 5 to 14 days|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Oxidative Stress in Standard Laparoscopic vs Single Port Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
Study of Oxidative Stress Markers in order to assess whether there are differences between standard laparoscopic cholecystectomy vs single port cholecystectomy for uncomplicated cholelithiasis

Official Title
-----------------
Study of Oxidative Stress in Standard Laparoscopic vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis (Lap vs SILS)

Conditions
-----------------
Uncomplicated Cholelithiasis, Cholecystectomy, Laparoscopy, Standard Technique, Single Port Laparoscopy

Intervention / Treatment
-----------------
* Other: Laparoscopic cholecystectomy
* Other: Single incision laparoscopic cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Uncomplicated cholelithiasis American Society of Anesthesiologists (ASA) I or II No previous operations in upper abdomen Body mass index (BMI) - Exclusion Criteria:Cholecystitis ASA > II BMI>30 Previous operations in upper abdomen Previous operations in intestine Smokers Alcohol Drugs -

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lap Group<br>Patients in this group are operated for uncomplicated cholelithiasis with standard 4 port laparoscopic cholecystectomy | Other: Laparoscopic cholecystectomy<br>* Standard 4 port laparoscopic cholecystectomy<br>Other: Single incision laparoscopic cholecystectomy<br>* One port placed through the umbilicus<br>|
| Active Comparator: SILS group<br>Patients in this group are operated for uncomplicated cholelithiasis with Single Incision Laparoscopic Cholecystectomy | Other: Single incision laparoscopic cholecystectomy<br>* One port placed through the umbilicus<br>|

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
-----------------
SILS, Oxidative Stress, 8-epiPGF2a, SILS vs standard laparoscopic cholecystectomy
the Potential Immunomodulatory Effects of Spirulina on Thalassemic Children

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the possible immunologic effects of spirulina in children with beta thalassemia.

Official Title
-----------------
the Potential Immunomodulatory Effects of Spirulina on Thalassemic Children

Conditions
-----------------
Beta Thalassemia Major

Intervention / Treatment
-----------------
* Dietary Supplement: Spirulina


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with thalassemia major Exclusion Criteria: children with other chronic hemolytic anemias

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients<br>thirty children with beta thalassemia major will receive oral spirulina (tablets=500 mg) for 3 months with a dose of 250 mg/kg/day (maximum dose 4 gm) | Dietary Supplement: Spirulina<br> <br> |
| No Intervention: controls<br>thirty healthy children of matched age and sex | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cluster of differentiation (CD4/CD25) ratio |  | 3 months | 
| cluster of differentiation (CD33/CD11b/Lin) ratio |  | 3 months | 
| serum immunoglobulins levels |  | 3 months | 
| serum levels of interferon gamma |  | 3 months |
Results of the Application of the Clinical Pathway of Intensified Recovery Surgery for Adults in the Processes of Total Knee and Hip Replacement at the Maz Hospital

Study Overview
=================
Brief Summary
-----------------
The investigators are going to study all the patients who have undergone surgery at the MAZ hospital from 2019 to the present for knee replacement and hip replacement. The investigators want to analyze the results to see if applying the RICA clinical pathway results are better.

Official Title
-----------------
Evaluation of the Clinical Pathway of Intensified Recovery Surgery for Adults in the Processes of Total Knee and Hip Replacement at the Maz Hospital

Conditions
-----------------
Arthropathy of Knee, Arthropathy of Hip

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults, over 18 years old. Diagnosis of moderate-severe gonarthrosis or moderate-severe coxarthrosis. Patients who are operated by orthopedic surgeons at MAZ Hospital with knee or hip arthroplasty. Between January 2019 and June 2022. ASA I-II-III. Exclusion Criteria: ASA IV. Minors.

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 |
| --- | --- |
| Patients who have undergone surgery at the MAZ hospital for knee/hip replacement.<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of compliance with the criteria for performing surgery according to the clinical pathway |  | One month postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthroplasty, Fast-track surgery
Fluoroscopic Analysis of PFC CR 150 Versus Standard PFC CR Total Knee Arthroplasty Implants in Deep Flexion

Study Overview
=================
Brief Summary
-----------------
The investigators are comparing the range of movements the knees of patients who had total knee replacement surgery for knee osteoarthritis. In the study arm, the implant used was a Sigma Cruciate Retaining (CR) Press Fit Condylar (PFC) 150, which is a high flexion knee system designed to combine function with wear resistance. It can accommodate up to 150 degrees of knee flexion. In the cohort arm, the implant used was the standard Sigma CR which can accommodate up to 120 degrees of flexion.

Detailed Description
-----------------
Both sets of patients will undergo routine post-operative follow up in clinic. The study involves patients who had their surgery more than 2 years ago. We assess their range of movement using fluoroscopy. They are asked to perform lunges, squats and climbing up and down 3 steps. The fluoroscopic images are then analysed to assess their individual range of movements.

Official Title
-----------------
Fluoroscopic Analysis Comparing the Dynamic Flexion of 2 Different Knee Arthroplasty Implants

Conditions
-----------------
Knee Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who underwent total knee replacement surgery who received either the PFC CR 150 knee implants or the PFC CR standard knee implant Surgery more than 2 years Able to walk, climb stairs Exclusion Criteria: Knee stiffness with less than 100 degrees of knee range of movement Patients who required revision surgery Patients who received an all polyethylene tibial insert Patients who received rotating platform tibial tray

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 95 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 |
| --- | --- |
| PFC CR 150 total knee implant<br>Study group implant: PFC CR 150 Control group implant: PFC CR standard | |
| PFC CR Standard<br>study group implant: PFC CR 150 control group implant: PFC CR Standard | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flexion-extension range of movement of operated knee | Fluoroscopic studies are done as patient perform lunges, squats and climb up and down stairs. | 2 years after their total knee replacement surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
knee osteoarthritis
Importance of Patient´s Satisfaction With Telemedicine Based on Monitoring Systems

Study Overview
=================
Brief Summary
-----------------
Valiosa is a national, multicenter and prospective post market study. The objectives of the study are to generate and validate an instrument to evaluate patient and clinician's satisfaction with remote monitoring and to create awareness of the importance of remote monitoring among patients, physicians and decision makers.

Conditions
-----------------
Arrythmia

Intervention / Treatment
-----------------
* Device: CareLinK


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients- naïve in CareLink®: First implant patients, who initiate in CareLink® Replacements patients who initiate in CareLink. Long term users in CareLink®: patients in CareLink for more than a year. Both male and female More than 18 years old. Be at the disposal of using CareLink monitoring system. Complete informed consent and accept the conditions of CareLink system. Exclusion Criteria: Less than 18 years old Suffer from any menthal pathology who prevents the patient to collaborate in the study. Be unable to understand or answer questionnaires in Spanish. Deny to continue in the study.

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 |
| --- | --- |
| naïve with CareLink<br>patients with a first implant of an implanted cardiac device naïve in CareLink or patients with a refill who have not used CareLink until the implant | Device: CareLinK<br> <br> |
| users of CareLink<br>patients with an implanted cardiac device who have used CareLink for more than one year | Device: CareLinK<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with telemedicine measured by the questionnaire in evaluation |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with medical treatment measured by visual analog scale |  | 12 months | 
| Quality of Life measured by SF-36 |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
remote monitoring, satisfaction, telemonitoring, quality of life
Safety and Efficacy of Brimonidine in Patients With Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
This Study will evaluate the safety and efficacy of brimonidine in patients with glaucoma or ocular hypertension

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: brimonidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ocular hypertension or glaucoma in both eyes currently treated with brimonidine requires IOP-lowering therapy in both eyes Exclusion Criteria: uncontrolled systemic disease known allergy or sensitivity to brimonidine

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: brimonidine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lowering of intraocular pressure |  |  |
Control of Head Lice Infestations in Children and Adults

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to see if heated air will kill head lice and their eggs. The treatment visit is approximately 1 hour long with a follow up phone call.

Detailed Description
-----------------
Head lice strikes fear into the hearts of parents of school age children. Ridding a child of head lice is one of the most frustrating experiences a parent can face. The objective of this project is to test whether louse desiccation using our prototype is an effective means of controlling head louse infestations in children. Children age 6 and over are included in this study.

Official Title
-----------------
Control of Head Lice in Children and Adults

Conditions
-----------------
Pediculosis

Intervention / Treatment
-----------------
* Device: lousebuster


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be at least 6 years old, male or female Parent to attend treatment Able to comb the hair with no problems Exclusion Criteria: Chemical shampoos used within 14 days Open sores or wounds on the scalp Recent head radiation

Ages Eligible for Study
-----------------
Minimum Age: 6 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

| Intervention/Treatment |
| --- |
|Device: lousebuster|Subject serves as own control the length of treatment is approximately 30 minutes for full head treatment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of using heated air to kill head lice and their eggs |  | Through out | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of device |  | Through out | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Head Lice