linjc16/ctgov huggingface dataset:
Documentation of the Efficacy of Desmopressin Within the Context of Surgical Procedures

Study Overview
=================
Brief Summary
-----------------
In this non-interventional multicentre, prospective, observational cohort study, the efficacy of desmopressin is evaluated in patients with platelet dysfunction due to acetylsalicylic acid or cox-1-inhibitors within the context of surgical procedures.

Official Title
-----------------
Documentation of the Efficacy of Desmopressin (MINIRIN Parenteral 4 Microgram/ml Solution for Injection) Within the Context of Surgical Procedures

Conditions
-----------------
Platelet Dysfunction

Intervention / Treatment
-----------------
* Drug: desmopressin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-, peri- or postoperative treatment with a standard dose of desmopressin as a result of platelet dysfunction (disturbance of blood platelet function) due to treatment with acetylsalicylic acid or cox-1-inhibitor. Decision on the therapy with MINIRIN parenteral 4 Microgram/ml solution for injection has already been made independently by the physician beforehand The patients (≥ 18 years) have been informed about the non-interventional study and have given their written consent for participation Exclusion Criteria: Participation in a clinical trial Treatment with acetylsalicylic acid for cardiovascular indications

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 |
| --- | --- |
| desmopressin<br>Treatment according to standard clinical practice. | Drug: desmopressin<br> <br> * Other names: Minirin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in platelet function pre- and post-administration of desmopressin | As measured by Platelet Function Analyzer (PFA) 100/200 | From baseline up to 7 days |
NOVOCART 3D Treatment Following Microfracture Failure

Study Overview
=================
Brief Summary
-----------------
This study is prospective single arm extension study of protocol AAG-G-H-1220. It is open only to participants of AAG-G-H-1220 randomized to the Microfracture treatment group.

Detailed Description
-----------------
This study is an extension of protocol AAG-G-H-1220 wherein patients were randomized to either NOVOCART 3D or Microfracture treatment groups. This prospective single arm extension study is only open to participants of AAG-G-H-1220 who were randomized to Microfracture treatment and who failed Microfracture treatment.

Official Title
-----------------
Safety and Efficacy of NOVOCART 3D in the Treatment of Articular Cartilage Defects Following Failure on Microfracture

Conditions
-----------------
Articular Cartilage Defect

Intervention / Treatment
-----------------
* Combination Product: NOVOCART 3D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participated in study AAG-G-H-1220 identified as a microfracture failure patient voluntary consent to participate in the study Exclusion Criteria: other cartilage repair procedures performed on target knee other conditions that would interfere with healing or evaluating outcomes lesions requiring implants larger than 9cm2 non-compliance with requirements in study AAG-G-H-1220

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 66 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: NOVOCART 3D<br>Matrix associated autologous chondrocyte implant | Combination Product: NOVOCART 3D<br>* Matrix associated autologous chondrocyte implant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS pain subdomain score | Comparison of pain scores from the KOOS questionnaire from baseline | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS function subdomain score | Comparison of function scores from the KOOS questionnaire from baseline | 24 months | 
| VAS pain scale | Comparison of pain from baseline | 24 months | 
| IKDC subjective scores | Comparison of IKDC subjective scores from baseline | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cartilage repair, cartilage regeneration, cartilage reconstruction, cartilage restoration, autologous chondrocyte implantation, matrix associated chondrocyte implantation
Chewing and Oral Processing of Solid Food

Study Overview
=================
Brief Summary
-----------------
Food texture modification is commonly used as an intervention for people with dysphagia (swallowing impairment). However, the field currently lacks a proper understanding of how this intervention works. The overall goal of this project was to collect measurements of food bolus transit through the oropharynx (i.e., mouth and throat) during chewing, oral processing and swallowing.

Detailed Description
-----------------
Aim: To explore chewing and oral processing behaviors across solid foods of different consistencies (minced and moist, soft & bite-sized, regular). Healthy adult participants will be asked to swallow foods representative of the minced and moist, soft and bite-sized and regular consistency levels of the International Dysphagia Diet Standardisation Initiative. We will measure the number of chews taken per bolus and the overall duration of chewing to understand differences across consistencies.

Official Title
-----------------
Chewing and Oral Processing of Solid Food in Healthy Swallowing

Conditions
-----------------
Dysphagia

Intervention / Treatment
-----------------
* Other: Food texture modification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults under age 60 Exclusion Criteria: prior history of swallowing, motor speech, gastro-esophageal or neurological difficulties, chronic sinusitis or taste disturbance. history of surgery to the speech or swallowing apparatus (other than routine tonsillectomy or adenoidectomy) Type 1 Diabetes Current use of dentures cognitive communication difficulties that may hinder comprehension of the study documents or instructions known allergies to medical adhesive known allergies to ingredients of the food products used in the experiment .

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Food texture modification|Food prepared in three different consistencies: minced and moist, soft and bite-sized and regular, as defined by the International Dysphagia Diet Standardisation Initiative|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Chewing Cycles Per Bolus | Using surface electromyography (sEMG) of the masseter muscle, we will count the number of muscle contraction spikes (i.e. chewing cycles) seen for chewing activity for a single comfortable bite of each bolus type. | Baseline (single timepoint only) | 
| Total Chewing Duration Per Bolus | Using surface electromyography (sEMG) of the masseter muscle, we will count the total duration of chewing activity for a single comfortable bite of each bolus type. | Baseline (single timepoint only) |
Expanded Access Protocol of Verdiperstat in Patients With Multiple System Atrophy (MSA)

Study Overview
=================
Brief Summary
-----------------
The purpose of this expanded access program is to provide access to the investigational drug verdiperstat in patients with Multiple System Atrophy (MSA). Expanded access allows patients with a serious or a life-threatening disease or condition access to an investigational drug when no satisfactory approved treatment options are available.

Official Title
-----------------
Intermediate-Size Patient Population Expanded Access Protocol of Verdiperstat in Patients With Multiple System Atrophy (MSA)

Conditions
-----------------
Multiple System Atrophy (MSA)

Intervention / Treatment
-----------------
* Drug: BHV3241, verdiperstat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: with a diagnosis of probable or possible MSA documented by a physician according to consensus clinical criteria,5 including patients with MSA of either subtype, MSA-P or MSA-C. able to swallow whole tablets without crushing or chewing. with established care with a physician at the specialized MSA center involved in the protocol and will maintain this clinical care throughout the duration of the EAP. not eligible for an ongoing clinical study with verdiperstat and/or an ongoing EAP for MSA Exclusion Criteria: Based on the Physician's judgement, any condition (including history of a clinically significant or unstable medical condition or lab abnormality) that would interfere with the patient's ability to comply with the EAP instructions, visit schedule, requirements and/or procedures, place the patient at unacceptable risk, or confound/interfere with the adequate assessment/interpretation of data; including difficulty swallowing verdiperstat tablets or any other sound medical, psychiatric and/or social reason. Presence of clinically significant thyroid disease despite treatment and/or TSH >10 mIU/ L at Screening/Baseline, confirmed by repeat. Patient is known to have acute or chronic liver disease that is clinically significant in the Prescriber's judgment First or second dose of COVID-19 vaccination within 7 days of first dose of verdiperstat.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: BHV3241, verdiperstat|BHV3241/Verdiperstat 600mg BID|

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
-----------------
Multiple System Atrophy, MSA, verdiperstat, BHV3241, MPO inhibitor, Myeloperoxidase inhibitor, MSA-P, MSA-C
Safety and Efficacy Study of EVO101 Topical Cream in Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
This is a Phase 2a safety and efficacy study of EVO101 for the treatment of adults with atopic dermatitis

Detailed Description
-----------------
This is a Phase 2a safety and efficacy study of EVO101 Topical Cream, 0.1%, applied twice daily for 8 weeks in adults with mild-to moderate atopic dermatitis.

Official Title
-----------------
A Randomized, Vehicle-controlled, Safety and Efficacy Study of EVO101 in Adult Subjects With Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis Eczema

Intervention / Treatment
-----------------
* Drug: EVO101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or non-pregnant, non-lactating females, age 18 years or older Chronic atopic dermatitis for at least 1 year IGA score of 2 or 3 BSA of AD involvement of 4-12% EASI of 5-20 Exclusion Criteria: Significant AD flare with 4 weeks Use of biologic therapy within 12 weeks Regular use of tanning booth within 4 weeks Skin condition that could interfere with study assessments

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EVO101 Cream<br>Active Treatment, BID, 8 weeks | Drug: EVO101<br>* Topical Cream<br>|
| Placebo Comparator: Vehicle Cream<br>Vehicle Treatment, BID, 8 weeks | Drug: EVO101<br>* Topical Cream<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eczema Area and Severity Index (EASI) | EASI assesses the extent and severity of atopic dermatitis. EASI is a composite index with scores ranging from 0 to 72. Higher values indicate more severe or extensive disease. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment (IGA) | The IGA assesses the overall appearance and severity of atopic dermatitis using a 5-point scale [0 (clear) to 4 (severe)]. | 8 weeks | 
| Body Surface Area (BSA) | BSA estimates the extent of atopic dermatitis involvement and is expressed as a percentage of total body surface area. | 8 weeks | 
| Pruritus-NRS | The pruritus-NRS is an 11-point scale used by subjects to rate their worst itch severity over the past 24 hours with 0 indicating no itch and 10 indicating worst itch imaginable. | 8 weeks |
Topical PDT Cream Without Irradiation Source in the Acne Treatment

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators are going to compare the clinical effect and safety of topical application of 1.5% Butenyl ALA cream formula without light source irradiation in the treatment of acne.

Official Title
-----------------
Topical Application of 1.5% Butenyl ALA Without Light Source Irradiation in the Treatment of Acne: a Double Blinded Randomized Controlled Trial.

Conditions
-----------------
Acne, Photodynamic Therapy

Intervention / Treatment
-----------------
* Drug: Topical application of 1.5% Butenyl ALA
* Drug: Topical application of sham control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild to moderate acne vulgaris (Leeds revised acne grading system score 2-7) at baseline. Exclusion Criteria: known pregnancy lactation any medical illness that might influence the results of the study a history of oral acne medication or surgical procedure, including laser treatment, within 6 months of study enrollment use of topical acne medication within 4 weeks of study enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1.5% Butenyl ALA<br>Topical application of 1.5% Butenyl ALA per every other day around acne lesions in the face | Drug: Topical application of 1.5% Butenyl ALA<br> <br> |
| Sham Comparator: Control<br>Topical application of sham control per every other day around acne lesions in the face | Drug: Topical application of sham control<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change of inflammatory acne lesions compared with baseline |  | 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change of non-inflammatory acne lesions compared with baseline |  | 12 week | 
| Percent change of overall severity of acne lesions compared with baseline |  | 12 week |
Study to Evaluate the Human Infection of the Lower Respiratory Tract in Children at High Risk

Study Overview
=================
Brief Summary
-----------------
- Estimate the incidence rate of hMPV infection detected by RT-PCR from frozen nasal wash aspirates in children at high risk for severe LRI disease (hospitalized at <2 years of age).

Detailed Description
-----------------
A prospective, epdemiological study to estimate the incidence rate of hMPV infection as determined by RT-PCR from frozen nasal wash aspirates taken from children hospitalized with LRI who are at high risk for severe disease. No study drug will be administered for this study.

Official Title
-----------------
A Study to Describe the Incidence Rate and Clinical Features of Human Meta Pneumovirus (hMPV) Infection of the Lower Respiratory Tract in Hospitalized Children at High Risk for Severe Disease

Conditions
-----------------
Severe Respiratory Disease

Intervention / Treatment
-----------------
* Behavioral: High Risk Respiratory Disease


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be premature (less than 36 weeks gestation) and less than or equal to 12 months of age, and/or Be less than or equal to 24 months of age with CHD (other than uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus) that is judged to be hemodynamically significant, and/or Be less than or equal to 24 months of age with CLD of prematurity (BPD) requiring medical intervention/management (i.e., supplemental oxygen, steroids, bronchodilators, or diuretics within the previous 6 months). Hospital admission diagnosis referable to an acute lower respiratory tract infection or cardio/respiratory illness with a presumed respiratory infection (e.g., bronchiolitis, bronchitis, or pneumonia or cardiac decompensation associated with respiratory infection); admission must occur between October 1 and June 30 for northern hemisphere sites, and between March 1 and November 30 for southern hemisphere sites. Study enrollment within 2 days after hospitalization. Admission from the community to the Pediatric ward, Neonatal Intensive Care Unit, or the Intensive Care Unit. Have written informed consent obtained from the parent or legal guardian prior to study entry. Exclusion Criteria: Known HIV infection or a mother with known HIV infection.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 24 Months

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: High Risk Respiratory Disease|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Sphenoorbital Meningioma Management.

Study Overview
=================
Brief Summary
-----------------
Investigators will discuss the different surgical techniques for removal of spheno_orbital meningiomas with proptosis.investigators also will follow up the patient to know the outcome of removal of these tumours.

Official Title
-----------------
Spheno_orbital Meningioma Enplaque With Proptosis; Surgical Techniques and Outcomes

Conditions
-----------------
Brain Meningioma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients who have spheno_orbital meningioma with proptosis and candidate for surgery. Exclusion Criteria: all patients have proptosis caused by other lesions than spheno_orbital meningioma.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Clinical assessment for vision. | With visual acuity examination | For 6 months | 
| Clinical assessment for proptosis | With proptosis index | For 6 months |
SWE Liver Stiffness as a Predictor of Progression of Chronic Liver Diseases

Study Overview
=================
Brief Summary
-----------------
This study is a multicenter individual patient-based meta-analysis that will assess the performances of liver stiffness measurements performed with supersonic shear imaging shearwave elastography (SSI-SWE) in patients with liver fibrosis to predict progression of chronic liver disease.

Official Title
-----------------
Evaluation of SWE as a Predictive Tool for Progression of Chronic Liver Diseases

Conditions
-----------------
Liver Fibroses

Intervention / Treatment
-----------------
* Device: Elastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had received a liver ultrasound exam at baseline for a suspected chronic fibrotic liver disease of viral and/or steatotic origin, Patients who had reached the age of majority in their countries, at baseline, Patients with a baseline liver biopsy for histological evaluation of liver fibrosis with a length ≥ 15 mm paraffin sections (except if cirrhosis), Patients for whom a minimum length of clinical follow-up from baseline of 1 year had been recorded Exclusion Criteria: Cause of chronic liver disease other than viral, ALD or NAFLD ( hemochromatosis, autoimmune hepatitis, biliary tract disease intrahepatic...) Any systemic, viral hepatitis and HIV co-infection

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 |
| --- |
|Device: Elastography|liver stiffness measurements by shear wave-based elastography|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver disease progression rate | Clinical signs of liver decompensation | Minimum of 28 days follow-up | 
| Mortality rate | Patient's death | Minimum of 28 days follow-up |