linjc16/ctgov huggingface dataset:
Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma in Argentina

Study Overview
=================
Brief Summary
-----------------
Prospective, observational study to collect and analyze data on patients with advanced hormone dependent prostate cancer treated with Firmagon® according to routine medical practice in Argentina

Official Title
-----------------
Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma in Argentina

Conditions
-----------------
Advanced Hormone Dependent Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Firmagon® (degarelix)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced Prostate Cancer patients to be treated with Firmagon in the context of usual clinical practice Written informed consent Exclusion Criteria: Contraindications to Firmagon Patients already on Firmagon therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Advanced Prostate Cancer<br>Advanced Prostate Cancer that receive Firmagon therapy in the context of usual clinical practice | Drug: Firmagon® (degarelix)<br>* Monthly subcutaneous injections<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) failure rate (with failure defined as either prostate-specific antigen (PSA) failure, introduction of additional therapy related to prostate cancer, or death) | The PFS failure rate will be estimated with time to PFS failure as dependent and adjusting for disease stage at baseline, baseline PSA, baseline testosterone (if available) and baseline serum Alkaline Phosphatase (s-ALP, if available) | During 3 years treatment |
Efficiency of Bumetanide in Autistic Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a treatment by bumetanide presents an efficiency at the level of the neuronal maturation in the autism

Official Title
-----------------
Study of the Efficiency of a Treatment by Bumetanide in a Population of Autistic Children

Conditions
-----------------
Autistics Children

Intervention / Treatment
-----------------
* Drug: bumetanide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children from 3 to 10 years old, answering the diagnosis of typical autism according to the diagnostic criteria of autism of the classification of the WHO ( CIM-10) and the parents of which gave a free, enlightened and written consent. Exclusion Criteria: Patients epileptic autistics treated by anticomitiaux or having hurts of the central nervous system Patients autistics receiving a psychotropic treatment Patients presenting disorders electrolytes Patients presenting a hypersensibility known about sulpha drugs Presenting patients against indications relative to the treatment by bumetanide Patients already treated by diuretics Patients presenting a hepatic or renal incapacity Patients presenting an elongation of the QT to the electrocardiogram. Patients autistics of CARS sore is lower than 30.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 10 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bumetanide<br> | Drug: bumetanide<br>* Administration by oral route in 2 times (in the morning and evening) of 0.5 mg by taking (= 1 mg by 24 hours)<br>|
| Placebo Comparator: Control<br> | Drug: bumetanide<br>* Administration by oral route in 2 times (in the morning and evening) of 0.5 mg by taking (= 1 mg by 24 hours)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Autism Rating Scale score |  | day 0 to day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical global impressions score |  | day 0 to day 90 | 
| Repetitive end restricted behavior score |  | day 0 to day 90 | 
| GRAM score |  | day 0 to day 90 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autism, Bumetanide, GABA, NKCC1
Multihance Versus Magnevist in Breast MRI

Study Overview
=================
Brief Summary
-----------------
To show if one MRI contrast agent is better than another one in the diagnosis of malignant breast lesions compared to histopathology

Official Title
-----------------
Phase III Multicenter Double-Blind, Randomized, Crossover Study to Compare MultiHance With Magnevist in Contrast-enhanced Magnetic Resonance Imaging (MRI) of the Breast

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Multihance
* Drug: Magnevist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provides written informed consent Female Age 18 years or older Suspicious or known breast lesion based on results from mammography or ultrasound Planned to undergo histological diagnosis of breast lesion by having a non surgical biopsy or breast surgery within 30 days after the MRI exam Exclusion Criteria: Body weight > 100 kg Pregnant or lactating Server or end-stage organ failure Moderate to severe renal impairment Undergoing radiotherapy or completed radiotherapy in the last 18 months Chemotherapy within 6 months of the 1st MRI exam

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: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Multihance|0.5 Molar at a single dose injection|
|Drug: Magnevist|0.5M at a single dose injection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity in diagnosing breast lesions compared to histopathology results |  | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, specificity, accuracy, PPV and NPV at region, breast and patient levels |  | up to 6 months |
Influence of Stress on Non Surgical Periodontal Treatment

Study Overview
=================
Brief Summary
-----------------
Treatment of periodontal diseases is influenced by several risk factors. Psychological stress is considered as one of them. Aim of this study is to assess if stress influences results of non surgical periodontal treatment in severe chronic forms of periodontitis.

Official Title
-----------------
Influence of Stress on Non Surgical Periodontal Treatment

Conditions
-----------------
Chronic Periodontitis

Intervention / Treatment
-----------------
* Other: Non surgical periodontal treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe generalized chronic periodontitis Minimum 15 teeth Attachment loss > 5mm 30% of sites affected- 5% of pockets>5mm Bone loss- Bleeding on probing Exclusion Criteria: Patient at risk of endocarditis Pregnant women Patient under therapy for depression Patient treated for periodontal diseases previously

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: questionary<br> | Other: Non surgical periodontal treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changing depths of periodontal pockets |  | 6 months |
Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to continue to assess safety and tolerability, and to allow continued access to study treatment for subjects already receiving spartalizumab as single agent or in combination with other study treatments.

Official Title
-----------------
An Open-label, Multi-center Rollover Protocol for Continued Characterization of Safety and Tolerability for Subjects Who Have Participated in a Novartis-sponsored Spartalizumab Study as Single Agent or in Combination With Other Study Treatments

Conditions
-----------------
Advanced Solid Tumors

Intervention / Treatment
-----------------
* Drug: PDR001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is currently enrolled in a pre-defined Novartis-sponsored study and is receiving spartalizumab as single agent or in combination with other study treatment, Subject is currently deriving clinical benefit from the study treatment, as determined by the investigator. Other protocol defined inclusion criteria may apply Exclusion Criteria: Subject has been permanently discontinued from spartalizumab in the parent protocol for any reason other than enrollment in the Roll over Study Subject does not meet the criteria specified in the parent protocol criteria for continued study treatment.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PDR001<br>All subjects in all combination will be entered in one arm | Drug: PDR001<br>* PDR001<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and nature of AE and SAE by subject | Safety data. | 5 years | 
| Number of subjects with PDR001 dose interruption and/or reduction |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects receiving PDR001 |  | 5 years | 
| Subject's exposure duration |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase Ib, PDR001, PD-1, continued access
Long-term Follow-up of Patients With Alcoholic Liver Cirrhosis Who Had Administered Cellgram-LC in PMC-P-07 Study

Study Overview
=================
Brief Summary
-----------------
This Long-term follow-up is designed to evaluate the safety of patient with Alcoholic Liver Cirrhosis who had administered Cellgram-LC in PMC-P-07 study.

Detailed Description
-----------------
To evaluate the safety for 60 months after a single dose of Cellgram-LC in patients with alcoholic liver cirrhosis.

Official Title
-----------------
Long-term Follow-up of Patients With Alcoholic Liver Cirrhosis Who Had Administered Cellgram-LC in PMC-P-07 Study

Conditions
-----------------
Alcoholic Cirrhosis

Intervention / Treatment
-----------------
* Biological: Cellgram-LC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those who participated in PMC-P-07 clinical trials and received Cellgram-LC Those who voluntarily agreed in writing to participate in this investigation Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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: Cellgram-LC<br>Patients with Alcoholic Liver Cirrhosis who had administered Cellgram-LC in PMC-P-07 study. | Biological: Cellgram-LC<br>* Patients who had administered Cellgram-LC in PMC-P-07 study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of AESI | death, neoplasms or malignancies in tissues or organs, Immune response including exacerbation or new outbreaks of previous autoimmune diseases, Other delayed AE related to Cellgram LC) | For 5 years | 
| Rate of Liver transplant | Liver transplant | For 5 years |
A Taste and Acceptance Study of FruitiVits in Children Aged 4-8 Years Following a Ketogenic Diet.

Study Overview
=================
Brief Summary
-----------------
Subjects will be asked to substitute their usual vitamin and mineral supplement/s with FruitiVits for seven consecutive days.

Detailed Description
-----------------
The study will involve 12 subjects between 4 and 8 years of age, who routinely use comprehensive micronutrient supplementation as part of their dietary management. Primary Hypothesis: FruitiVits is an acceptable source of vitamin, mineral and trace elements for patients on a Ketogenic diet. Secondary Hypothesis: FruitiVits will be well accepted and tolerated when given orally to children on a Ketogenic diet.

Official Title
-----------------
A Taste and Acceptance Study of FruitiVits, for Use in the Dietary Management of Young Children Requiring Very Restrictive Diets Such as the Ketogenic Diet.

Conditions
-----------------
Seizure Disorders

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of condition requiring a Ketogenic diet Currently on a Ketogenic diet Aged 4 - 8 years Routinely taking a complete micronutrient supplement Oral feeding Exclusion Criteria: 1) Children aged less than 4 years or older than 9 years of age

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 9 Years

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

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

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: FruitiVits<br>Daily administration of FruitiVits dietary supplement | Dietary Supplement: FruitiVits<br>* Daily administration of FruitiVits dietary supplement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of FruitiVits | The study product was rated on a scale of 1-5: (liked very much) (liked moderately) (neither liked nor disliked) (disliked moderately) (disliked very much). | Day 8 of trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of Preparation of FruitiVits | Ease of preparation of FruitiVits was rated on a scale of 1-5: (very easy) (moderately easy) (neither easy nor difficult) (moderately difficult) (very difficult). Those who considered it not difficult to prepare and scored 1-3 on the scale: 11/11 patients | Day 8 of trial |
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of GLPG0634 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses of GLPG0634 given to healthy subjects for 10 days compared to placebo. During the course of the study, the amount of GLPG0634 present in the blood (pharmacokinetics) as well as the effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized.

Official Title
-----------------
Double-blind Placebo Controlled Dose-ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Oral Dosing of GLPG0634 in Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: GLPG0634
* Drug: GLPG0634
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male, age 40-60 years BMI between 18-30 kg/m2 Exclusion Criteria: Any condition that might interfere with the procedures or tests in this study Drug or alcohol abuse Smoking

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLPG0634 capsules<br> | Drug: GLPG0634<br>* GLPG0634 300 mg oral capsules, qd, 10 days<br>Drug: GLPG0634<br>* GLPG0634 450 mg oral capsules, qd, 10 days<br>|
| Placebo Comparator: Placebo capsules<br> | Drug: Placebo<br>* Placebo oral capsules, qd, 10 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | To evaluate the safety and tolerability of GLPG0634 in comparison with placebo after multiple oral doses in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments | From screening up to 10 days after the last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) and pharmacodynamics (PD) | To determine the plasma levels of GLPG0634 as a measure of PK and the levels of immune- and inflammation-related parameters as a measure of PD | From first dose up to 10 days after the last dose |
Study on the Ability of Virtual Reality Glasses in Anxiety and Pain Reduction in 50 Women Undergoing Amniocentesis or Feticide

Study Overview
=================
Brief Summary
-----------------
Both amniocenteses and especially feticide are procedures that incorporate both anxiety and pain. As anxiety and pain can be reduced when using a distraction, The investigators speculate that the use of virtual reality glasses during these procedures will elevate both anxiety and pain. The investigators will examine this hypothesis by comparing two groups of participants who undergo amniocentesis or feticide, one group will undergo the procedure while using virtual reality glasses and the other without the use of the glasses.

Official Title
-----------------
The Ability of Virtual Reality in Anxiety and Pain Reduction in Women Undergoing Amniocentesis or Feticide

Conditions
-----------------
Anxiety Acute, Amniocentesis, Foeticide

Intervention / Treatment
-----------------
* Device: virtual reality glasses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women undergoing amniocentesis/foeticide who will sign an informed consent form - Exclusion Criteria: Women younger than 18 years Twin pregnancies Women with vertigo

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: women using virtual glass during amniocentesis/foeticide<br> | Device: virtual reality glasses<br>* In the intervention arm, women undergoing amniocentesis/foeticide will use virtual reality glasses during the procedure.<br>|
| No Intervention: women undergoing amniocentesis/foeticide<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety level | Spielberger's State-Trait Anxiety Inventory | Up to one hour before the procedure | 
| Anxiety level | Spielberger's State-Trait Anxiety Inventory | Up to one hour after the procedure |
Preoperative Assessment of Colon Tumor

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a colonic tumor can be classified as malignant or benign with magnetic resonance (MR) colonography. Patients with a verified colon carcinoma or benign tumor based on diverticulitis are offered a MR colonography with intravenous (I.V.) contrast. The tumor is classified as malignant or benign by assessing the dynamic contrast uptake and morphology. The Investigator is blinded from the verified diagnosis and the MR classification is compared to the histological diagnosis.

Official Title
-----------------
Preoperative Assessment of Colon Tumor: A Prospective, Blinded Study.

Conditions
-----------------
Colorectal Cancer, Colorectal Tumor

Intervention / Treatment
-----------------
* Procedure: MR colonography with dynamic contrast uptake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Colorectal cancer Colorectal tumor Exclusion Criteria: Active diverticulitis Pacemaker Metal in the body Claustrophobia

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: MR colonography with dynamic contrast uptake|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity in determining malignant or benign diagnose |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity/specificity of MR colonography |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal cancer, Colorectal tumor, Dynamic contrast uptake, MR colonography