linjc16/ctgov huggingface dataset:
Assessement of the Peal Force Needed to Peel New Adhesives From the Skin

Study Overview
=================
Brief Summary
-----------------
This study investigates the adhesion of new adhesives to the skin.

Official Title
-----------------
A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Handle Moisture From Abdominal and Peristomal Skin

Conditions
-----------------
Ileostomy - Stoma

Intervention / Treatment
-----------------
* Other: Standard adhesive 1
* Other: Standard adhesive 2
* Other: LT-2
* Other: LT-21
* Other: LT-25
* Other: 33-20


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have given written informed consent Be at least 18 years of age and have full legal capacity Have intact skin on the area used in the investigation Exclusion Criteria: Currently receiving or have within the past 2 months received radio- and/or chemotherapy Currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment. Are pregnant or breastfeeding Have dermatological problems in the abdominal area (assessed by investigator)

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testing of new adhesive strips<br>Each subject will test six adhesive strips on pre-stripped skin. Standard adhesive 1 Standard adhesive 2 LT-2 LT-21 LT-25 33-20 The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits. | Other: Standard adhesive 1<br>* This strip consists of a standard hydrocolloid adhesive found in ostomy devices<br>Other: Standard adhesive 2<br>* This strip consists of a standard hydrocolloid adhesive found in ostomy devices<br>Other: LT-2<br>* Newly developed adhesive<br>Other: LT-21<br>* Newly developed adhesive<br>Other: LT-25<br>* Newly developed adhesive<br>Other: 33-20<br>* Newly developed adhesive<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Swelling of the adhesive | 1. Swelling of adhesive strips measured by weight (Difference between weight of strip before and after test) | 21 days |
Perceived Impact of Art Therapy in Patients With Cystic Fibrosis and in Professional Interdisciplinary Teams Taking Care of Them.

Study Overview
=================
Brief Summary
-----------------
Cystic fibrosis is so far a disease whose treatment remains essentially symptomatic care teams perceive the boundaries of a support mainly focused on drug treatments. The patient had no other choice but to learn to live with their disease, the goal is to make every effort so that tames the disease while maintaining high self-esteem that gives meaning to his life, allowing, among other things, a good grip of treatment. Through this research we hope to encourage the integration of art therapy in the course of care of cystic fibrosis patients, from children to adults before and after transplantation, in connection with the patient education and counseling

Official Title
-----------------
Perceived Impact of Art Therapy in Patients With Cystic Fibrosis (Adolescents, Adults and Transplanted Not Transplanted) and in Professional Interdisciplinary Teams Taking Care of Them.

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Other: Non interventional study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cystic fibrosis aged adolescents 13 to 18 years, as part of their monitoring at cystic fibrosis center of Nantes Adults over 18 years nontransplanted in their follow at cystic fibrosis center/transplantation center of Foch More than 18 adult transplant as part of their monitoring at cystic fibrosis center/transplantation center Foch Professional interdisciplinary teams taking care of the cystic fibrosis children center of Nantes, cystic fibrosis center/transplantation center of Foch Agreeing to participate in research Non Inclusion Criteria: Patient refusal of adolescent parents to participate in the study Professional refusal of teams to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Non interventional study|First individual interviews will be set up with teenagers of Nantes University Hospital . Then, focus group will be conduct with patients and professionals in Nantes and Foch University Hospital.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient responses to the effects of art therapy and music therapy | The depth interviews with patients will achieve a thematic and structural analysis of the speech. This will capture the effects of art therapy and music therapy on patients, their point of view. | 1 day |
Effect of Caldine® on Renal Function in Balanced Hypertension

Study Overview
=================
Brief Summary
-----------------
The study aimed at comparing the evolution of renal function in patients showing a hypertension treated by various therapeutic strategies. Due to the contract research organisation (CRO) decision in September 2000, the database was locked and not accessible for Boehringer Ingelheim France. Consequently it was decided to stop the study and not proceed to the analysis. Thus, only safety data were processed in the safety database.

Official Title
-----------------
Study on Protective Effect of Caldine® on Renal Function in Patients With a Balanced Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Lacidipine
* Drug: Diuretics
* Drug: antihypertensive drugs
* Drug: alpha blockers
* Drug: Angiotensin-Converting Enzyme Inhibitors
* Drug: beta blockers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with hypertension requiring treatment Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hypertension treatment strategies<br> | Drug: Lacidipine<br> <br> * Other names: Caldine;Drug: Diuretics<br> <br> Drug: antihypertensive drugs<br> <br> Drug: alpha blockers<br> <br> Drug: Angiotensin-Converting Enzyme Inhibitors<br> <br> Drug: beta blockers<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events |  | up to two years |
European Study of Cerebral Aspergillosis Treated With Isavuconazole

Study Overview
=================
Brief Summary
-----------------
Study clinical context Cerebral aspergillosis (CA) is a rare location of invasive aspergillosis (IA), associated with a high morbidity and mortality. Since 2002, voriconazole is the recommended first line treatment of invasive aspergillosis. More recently, isavuconazole appeared to be not less effective than voriconazole in the treatment of filamentous IFI, with a better tolerance profile. The investigators aim to evaluate better the efficacy and the safety of isavuconazole in the treatment of cerebral aspergillosis by a descriptive, multicentric, international retrospective cohort study.

Official Title
-----------------
European Study of Cerebral Aspergillosis Treated With Isavuconazole

Conditions
-----------------
Cerebral Aspergillosis, Invasive Aspergillosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Proven or probable cerebral aspergillosis according to the EORTC criteria modified by adding diabetes in the host criteria In child or adult Treated by isavuconazole at least 7 days Diagnosed between March 2017 and June 2020 Exclusion Criteria: Possible cerebral aspergillosis isavuconazole treatment for less than 7 days
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 |
| --- | --- | --- |
| Outcome of the patients : alive without CA treatment/alive under CA treatment/ deceased. | Number of patients alive without CA treatment/alive under CA treatment/ deceased. | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitoring of isavuconazole : dosage in the serum and in the cerebro-spinal-fluid | dosage of isavuconazole in the serum and in the cerebro-spinal-fluid | At baseline | 
| -Adverse events under isavuconazole and drug interactions | Adverse events under isavuconazole and drug interactions | At baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebral aspergillosis, isavuconazole
Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Knees

Study Overview
=================
Brief Summary
-----------------
Enrolled subjects will receive one bilateral Ulthera® treatment on the knees. Up to 30 subjects will be enrolled. Study photos will be obtained prior to study treatment, immediately following study treatment, and at each post-treatment follow-up visit. Follow-up visits will occur at 90 and 180 days post-treatment.

Detailed Description
-----------------
This pilot study is a prospective, single-center clinical trial of the Ulthera® System for treating skin laxity on the knees. Global Aesthetic Improvement Scale scores and Patient Satisfaction questionnaires will be obtained at each follow-up visit.

Official Title
-----------------
Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Knees

Conditions
-----------------
Skin Laxity

Intervention / Treatment
-----------------
* Device: Ulthera® System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, aged 30 to 65 years. Subject in good health. Mild to moderate skin laxity around the knees. Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period. Exclusion Criteria: Presence of an active systemic or local skin disease that may affect wound healing. Excessive subcutaneous fat around the knees. Excessive skin laxity around the knees.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

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

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

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: Ulthera® treatment of the knees<br>Bilateral treatment of the knees using the Ulthera® System | Device: Ulthera® System<br>* Focused ultrasound energy delivered below the surface of the skin<br>* Other names: Ultherapy™ treatment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in overall lifting and tightening of knee skin laxity. | Assessed based on Principal Investigator assessment using the Global Aesthetic Improvement Scale. | 90 and 180 days post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall improvement in skin laxity. | Determined based on a qualitative masked assessment comparing pre-treatment and post-treatment photographs; subjects' assessment based on the Subject Global Aesthetic Improvement Scale; completion of the Patient Satisfaction Questionnaire. | 90 and 180 days post-treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skin laxity, Knees
Nerve Injury in the Hand, an Interview Study

Study Overview
=================
Brief Summary
-----------------
This qualitative study sought to explore the exerience of change in physical activity due to nerve injury in the arm and hand.

Detailed Description
-----------------
Aim: Has the physical activity level changed in connection with the nerve injury. Experiences of factors influensing this change. Population: Patients surgically treated for digital,median,ulnar-or plexus nerveinjuries at Södersjukhuset or Universitets sjukhuset in Linköping. 1-3 years ago. Age 18-75. Method: Interviews are carried out over the phone, digitally recorded and trascribed. The analysis is inductive approach.

Official Title
-----------------
Patients´ Experiences of Changed Physical Activity Level Following Nerve Injury in the Upper Limb- a Qualitative Study

Conditions
-----------------
Nerve Injury

Intervention / Treatment
-----------------
* Other: Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Injury to the median, ulnar or digital nerve or injury to the brachial plexus. 1-5 years post injury. Exclusion Criteria: Severe psychiatric disease. Drug or alcohol abuse. Insufficient language understanding. Severe diabetes mellitus with nerve complications.

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 |
| --- | --- |
| Nerve injury<br>This is an interview study of patients with injury to the median, ulnar or digital nerve or brachial plexus injury. | Other: Surgery<br>* Treatment according to clinical practise<br>* Other names: Rehabilitation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interview | A semi structured interview will be conducted, utilizing semi structured interview. Themes regarding changes in physical activity related to the nerve injury will be presented. | 1-5 years post injury |
Collection of Blood Specimens From Patients in AL-3789 Studies for Elevated Intraocular Pressure (IOP)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to obtain blood samples from patients who are or were participants in any Alcon AL-3789 clinical trial. Association will be conducted to search for genetic markers in patients with glaucoma or ocular hypertension.

Official Title
-----------------
Collection of Blood Specimens From Patients in AL-3789 Studies for Elevated Intraocular Pressure (IOP)

Conditions
-----------------
Open-Angle Glaucoma

Intervention / Treatment
-----------------
* Other: Blood Collection Only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must be currently or previously enrolled in Alcon clinical study and received AL-3789 Exclusion Criteria: Age related

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 who are or were participants in any Alcon AL-3789 study. | Other: Blood Collection Only<br>* Blood Collection Only<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
-----------------
Open-angle glaucoma, IOP
Symbicort in Chronic Obstruktive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
Under daily routine conditions and without any intervention by the sponsor regarding the selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non- medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians (i.e.general practitioners and internists) are asked to document relevant data related to the budesonide/formoterole therapy in patients with COPD.

Official Title
-----------------
Symbicort in Chronic Obstruktive Pulmonary Disease

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with COPD treated with budesonide/formoterol Exclusion Criteria: limitiations; possible risks; warnings; contraindications mentioned in the SPC.
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 with COPD treated with budesonide/formoterol | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy and tolerability of budesonide /formoterole in subjects with COPD who are treated by general practitioners and internists. |  | change of a quality of life score compared to baseline by using CRQ, stratified by present therapy and severity of COPD; incidence of the occurrence of unknown, unexpected and/or rarely occurring adverse events AE under outpatient medical care conditions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to get further insight into the details of the use , dosage scheme and duration of treatment with budesonide /formoterol in this population |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
treatment of COPD, documentation of relevant data, related to the budesonide/formoterole therapy in patients with COPD.
Study on the Diagnosis and Management of CLL in Italy by GIMEMA

Study Overview
=================
Brief Summary
-----------------
retrospective and prospective multicenter observational clinical and biological data collection from all patients with newly diagnosed CLL, SLL or MBL. retrospective cohort: all cases with a diagnosis between January 1st 2010 and August 31th 2021. prospective cohort: all patients with a diagnosis between September 1st 2021 and September 1st 2025.

Detailed Description
-----------------
This is a retrospective and prospective multicenter observational study designed by the Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA). The study consists of clinical and biological data collection from all patients with newly diagnosed CLL, SLL or MBL (according to the WHO 2007 and 2018 diagnostic criteria). The retrospective part aims at including all cases followed at participating centers with a diagnosis between January 1st 2010 and August 31th 2021 (planned study initiation), while the prospective part will include all patients with a documented diagnosis of CLL, SLL or MBL between September 1st 2021 and September 1st 2025 by the first immunophenotypic/histological evaluation. The data is collected through electronic case report form accessible by the participating centers on a dedicated platform.

Official Title
-----------------
Observational Study on the Diagnosis and Management of Chronic Lymphocytic Leukemia (CLL) in Italy by Gruppo Italiano Malattie EMatologiche Dell'Adulto (GIMEMA)

Conditions
-----------------
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, MBL-CLL - Monoclonal B-Cell Lymphocytosis Chronic Lymphocytic Leukaemia-Type

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years at diagnosis One of the following diagnoses that meet the international diagnostic criteria (iwCLL2018 and WHO2017) Chronic lymphocytic leukemia (CLL) Small lymphocytic lymphoma (SLL) CLL-like monoclonal B-cell lymphocytosis (MBL) Retrospective cohort: CLL/SLL/MBL diagnosis between January 1st 2010 and August 31th 2021. Prospective cohort: CLL/SLL/MBL diagnosis between September 1st 2021 and September 1st, 2025. Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable) Exclusion Criteria: - -

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Describe the diagnosis and management of CLL patients | evaluation of CLL management in terms of time to first treatment | at 1 year for the prospective cohort and at 4 years for the retrospective cohort |