linjc16/ctgov huggingface dataset:
Study to Investigate Adrenal Crisis (Six-year Follow-up)

Study Overview
=================
Brief Summary
-----------------
Patients with adrenal insufficiency are at risk to suffer from life threatening adrenal crisis. The aim of this trial was to reevaluate the frequency of adrenal crisis and risk factors for crisis within a prospective study (six-years follow-up of a former prospective study).

Detailed Description
-----------------
Despite established hormone replacement therapy, patients with chronic adrenal insufficiency are at risk of suffering from life threatening adrenal crisis with a considerable mortality. A former prospective study revealed a frequency of about 8 adrenal crisis/ 100 patient years and a crisis associated mortality of 0.5 per 100 patient years for patients; furthermore, patients with a previous adrenal crisis were at higher risk of crisis. The aim of the current trial was to reevaluate the frequency of adrenal crisis and risk factors by contacting the patients of the initial prospective study (see above) within a six-years follow-up. Patients are contacted by questionnaire and additionally by phone (in case of an adrenal crisis or implausible statements).

Official Title
-----------------
Prospective Study to Investigate Adrenal Crisis in Patients With Chronic Adrenal Insufficiency (Six-year Follow-up)

Conditions
-----------------
Adrenal Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic primary or secondary adrenal insufficiency; hormone replacement therapy with glucocorticoids (hydrocortisone, cortisone acetat, prednisone or prednisolone) Written informed consent Exclusion Criteria: Adrenal insufficiency due to adrenocortical carcinoma Adrenal insufficiency due to long-term pharmacological glucocorticoid treatment Glucocorticoid doses above 7.5 mg prednisolone equivalent for other reasons than adrenal insufficiency Age younger than 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of adrenal crisis | Evaluation of the frequency of adrenal crisis / number of adrenal crisis per patient years (adrenal crisis/100 patient years). Documentation of the number of adrenal crisis (within a follow-up-period of 6 years) of all participating patients. | six years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors | Identification of risk factors / confirmation of risk factors observed in former trials (previous adrenal crisis, female sex, diabetes insipidus) for adrenal crisis. Calculation of odds ratios. | six years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adrenal crisis, Risk factors
Observatory of Patients With Metastatic ProstAte Adenocarcinoma That is Resistant to Castration and Multi-LinE Strategies

Study Overview
=================
Brief Summary
-----------------
Evaluation the overall survival of patients with metastatic prostate adenocarcinoma resistant to castration

Official Title
-----------------
Observatory of Patients With Metastatic ProstAte Adenocarcinoma That is Resistant to Castration and Multi-LinE Strategies

Conditions
-----------------
Metastatic Prostate Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: Local chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient monitored for castration-resistant metastatic prostate Patients starting a first or second line treatment as part of castration resistance Patient not objecting to the study after reading the information letter Patient aged over 18 years Exclusion Criteria: Patient monitored for non-metastatic prostate cancer Patient monitored for castration-nonresistant prostate cancer Patient not able to understand the information letter

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| patient followed for metastatic prostate adenocarcinoma<br>patient wil be followed for metastatic prostate adenocarcinoma during 3 years | Drug: Local chemotherapy<br>* Local chemotherapy will be administrated according to local recommendation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of alive patient |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of alive patient disease free |  | 3 years |
Economic and Medical Evaluation of the Whole Mitochondrial DNA Screening by Surveyor and Mitochips Techniques

Study Overview
=================
Brief Summary
-----------------
Mitochondrial diseases are the most frequent metabolic diseases (2.5 persons among 10 000) and are clinically heterogeneous making diagnosis particularly challenging for clinicians. Molecular analysis of mitochondrial DNA (mtDNA) is a critical step in diagnosis and genetic counselling of respiratory chain defects. DNA sequencing remains the gold standard but it is time-consuming and fails to detect mutations that may be present at a low heteroplasmic level (20% or below); therefore the diagnosis is yet based on the detection of a few number of pathogenic mutations. The present study aims to evaluate the benefit and the cost of a diagnosis strategy based on the combined use of 2 techniques named Surveyor Nuclease and Mitochip. Surveyor nuclease is a mismatch-specific DNA endonuclease that will be used for screening the entire mtDNA in order to identify heteroplasmic mutations. In absence of any identified mutation, another technique based on the use an oligonucleotide sequencing microarray (MitoChip) will be performed for the identification of homoplasmic mutations. Mitochip is an array-based sequencing platform for rapid and high-throughput analysis of mitochondrial DNA. The economical study will compare the cost of these techniques to the standard diagnosis method in term of direct and indirect costs

Official Title
-----------------
Economic and Medical Evaluation of the Whole Mitochondrial DNA Screening by Surveyor and Mitochips Techniques.

Conditions
-----------------
Mitochondrial Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients without deletion of mitochondrial disease and/or 3243, 8344 and 8993 mutation patient with health insurance Exclusion Criteria: patients with deletion of mitochondrial disease and/or 3243, 8344 and 8993 mutation absence of patient consent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mitochondrial diseases diagnosis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the benefit and the cost of a mitochondrial disease diagnosis strategy based on the combined use of 2 techniques named Surveyor Nuclease and Mitochip |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the benefit of the studiad strategy in comparison with standard diagnosis method in term of indirect costs |  | 2 years |
Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of the treatment with Grindcare® on the muscles- and jaw symptoms and at the jaw muscle activity during sleep.

Official Title
-----------------
A Single Centre, Randomised, Clinical Placebo Controlled Study of the Optimal Treatment and Long-term Effect of FES on Sleep Bruxism

Conditions
-----------------
Bruxism

Intervention / Treatment
-----------------
* Device: Grindcare
* Device: Grindcare - inactive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed and dated ICF 18 years or older Fulfill the RDC-criteria for myofascial TMD diagnose (group 1a or 1b) Exclusion Criteria: Contraindication of concommitant diseases for the study judged by investigator Patients who are using occlusal splints in the treatment period.

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: Grindcare<br>24 patients receiving active treatment | Device: Grindcare<br>* Active treatment<br>|
| Placebo Comparator: Placebo treatment<br>24 patients receive a placebo treatment | Device: Grindcare - inactive<br>* Placebo treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the electromyography (EMG) activity per hour per night |  | 10 weeks after start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of long-term effect of FES on the EMG activity |  | a 4 weeks period after end og treatment with FES | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bruxism
Cataract Surgery in Eyes With Epiretinal Membrane

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate retinal thickness change and the occurrence of central structural retinal changes after uneventful small-incision cataract surgery in eyes with asymptomatic early stages of epiretinal membrane.

Detailed Description
-----------------
Optical coherence tomography (OCT) is nowadays used in daily clinical practice and has become a helpful tool for detection of macular changes also in presence of opacification of the lens before cataract surgery. Using recent high-resolution OCT technology, early stages of epiretinal membranes can easily be detected and analysed. Since cataract surgery is one of the most frequently performed operations worldwide, this study was aimed to investigate the influence of uncomplicated cataract surgery on central retinal thickness and the incidence of structural and morphological macular changes after surgery in eyes with asymptomatic epiretinal membrane.

Official Title
-----------------
Retinal Thickness Change Following Cataract Surgery in Eyes With Epiretinal Membrane

Conditions
-----------------
Epiretinal Membrane, Pseudophakic Cystoid Macular Edema, Irvine-Gass Syndrome, Cataract

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: visually compromising cataract and asymptomatic early stages of epiretinal membrane with no structural changes such as cysts or photoreceptor distribution in optical coherence tomography. Exclusion Criteria: visual impairment or metamorphopsia due to epiretinal membrane history of branch retinal vein occlusion central retinal vein occlusion wet or dry macular degeneration diabetic retinopathy uveitis or other inflammatory eye disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central macular thickness | Central 1-millimeter and 3-milimeter retinal thickness | Change from Baseline central macular thickness at 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
central retinal thickness, epiretinal membrane, cataract surgery, pseudophakic cystoid macular edema
Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children Ages 2-17

Study Overview
=================
Brief Summary
-----------------
Anidulafungin is a medicine being developed for treatment of adults with certain kinds of fungal infections. This study is evaluating anidulafungin in children and adolescents who have fever and a low white blood cell count (neutropenia).

Detailed Description
-----------------
Anidulafungin is an investigational drug being developed as an intravenous treatment for esophageal candidiasis, candidemia and other invasive fungal infections. Anidulafungin is an antifungal agent of the echinocandin class, which targets the fungal cell wall of yeast and other filamentous fungi.

Official Title
-----------------
Phase I/II Study of the Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children With Fever and Neutropenia

Conditions
-----------------
Neutropenia

Intervention / Treatment
-----------------
* Drug: Anidulafungin


Participation Criteria
=================
Eligibility Criteria
-----------------
Children ages 2-17 years with fever and neutropenia. The expected duration of neutropenia should be 10 days and due to cytotoxic chemotherapy or aplastic anemia.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 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

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

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
-----------------
neutropenia, fever, febrile neutropenia
Zosuquidar in Combination With Daunorubicin and Cytarabine in Patients Ages 55-75 With Newly Diagnosed Acute Myeloid Leukemia (AML)

Study Overview
=================
Brief Summary
-----------------
Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar may help daunorubicin and cytarabine kill more cancer cells by making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more effective with or without zosuquidar in treating acute myeloid leukemia.

Detailed Description
-----------------
Purpose: Phase I: To Evaluate the safety of different doses of zosuquidar. Phase II: This study is designed to study the safety and effectiveness of zosuquidar when given with daunorubicin and cytarabine in newly diagnosed AML patients.

Official Title
-----------------
An Open-Label, Phase I/II, Multicenter Dose Escalation Study of Zosuquidar, Daunorubicin, and Cytarabine in Patients Ages 55-75 With Newly Diagnosed Acute Myeloid Leukemia

Conditions
-----------------
Leukemia, Myeloid

Intervention / Treatment
-----------------
* Drug: Zosuquidar
* Drug: Daunorubicin
* Drug: Cytarabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed acute myeloid leukemia Ages 55-75 years Exclusion Criteria: Acute promyelocytic leukemia (FAB M3) Patients must not have received prior chemotherapy for AML. Prior exposure to anthracycline Use of any investigational agent within 4 weeks prior to enrollment into the study For Phase II: Patients must be P-glycoprotein positive

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 75 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

| Intervention/Treatment |
| --- |
|Drug: Zosuquidar|nan|
|Drug: Daunorubicin|nan|
|Drug: Cytarabine|nan|

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
-----------------
Leukemia, Myeloid, Relapse, Chemotherapy, Zosuquidar, Daunorubicin, Cytarabine, Acute, AML, Adult AML
Motivators and Barriers to Physical Activity in Knee Osteoarthritis Patients: a Qualitative Study

Study Overview
=================
Brief Summary
-----------------
This study sought to better identify the motivators and barriers to osteoarthritic patients practising regular physical activity. This is a crucial step towards enabling each health professional to adapt their therapy recommendations, while taking into account the patient's overall lifestyle.

Detailed Description
-----------------
The qualitative research design is well-suited to this type of issue. This choice was justified by need to investigate and understand the actions from the participants' point of view. This exploratory method, conducted in the form of individual interviews and focus groups, enabled us to document the personal experiences, practices, and personal history of each individual

Official Title
-----------------
Motivators and Barriers to Physical Activity in Knee Osteoarthritis Patients: a Qualitative Study

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

Intervention / Treatment
-----------------
* Other: Qualitative study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: symptomatic knee osteoarthritis Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| knee osteoarthritis<br> | Other: Qualitative study<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motivators and barriers to physical activity in knee osteoarthritis patients activity | Exploratory method, conducted in the form of individual interviews and focus groups enabled us to document the personal experiences, practices, and personal history of each individual (qualitative method) | During the spa treatment of 18 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Definition of physical activity with qualitative method |  | During the spa treatment of 18 days | 
| Differences between physical activity and sport with qualitative method |  | During the spa treatment of 18 days | 
| Functional status as assessed by WOMAC |  | During the spa treatment of 18 days | 
| Level of physical activity with IPAQ short form |  | During the spa treatment of 18 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical activity, Knee osteoarthritis, Non pharmacological treatment, Qualitative study
Study of a Phenylalanine Restricted Diet During Pregnancy to Prevent Symptoms in Offspring of Patients With Phenylketonuria

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Assess the impact of a phenylalanine restricted diet during pregnancy on symptoms in offspring of patients with phenylketonuria.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a multicenter study. Patients receive a phenylalanine restricted diet based on a medical food such as Phenyl-free, Lofenalac, PKU 3, or Maximum XP (may be supplemented with tyrosine as needed) to achieve a target blood phenylalanine level of 2-6 mg/dL. The diet begins approximately 3 months prior to conception and continues until delivery of the baby. Patients are evaluated once a month before conception and weekly during pregnancy. Patients also undergo sonographic examination at 8, 20, 28, and 34 weeks gestation. At birth, the cord blood is evaluated for plasma amino acids. If the baby is found to have an elevated phenylalanine level, blood and urine are obtained to determine the baby's genetic status. Phenylalanine and tyrosine levels are checked in the baby daily for three days after birth. The baby is followed for physical and mental development at 3 and 6 months and then annually thereafter.

Conditions
-----------------
Phenylketonuria

Intervention / Treatment
-----------------
* Behavioral: phenylalanine restricted diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Women with diagnosis of phenylketonuria who are planning on becoming pregnant Slightly elevated phenylalanine level (hyperphe variant) allowed

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Design Details

Primary Purpose: Prevention


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: phenylalanine restricted diet|nan|

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
-----------------
inborn errors of metabolism, phenylketonuria, rare disease
Investigation of Plasma Proteins in Patients With Hereditary Haemorrhagic Telangiectasia and PAVMs

Study Overview
=================
Brief Summary
-----------------
Hereditary Haemorrhagic Telangiectasia (HHT, also known as Osler-Weber-Rendu Syndrome) is an disease that leads to the development of dilated and fragile blood vessels, including arteriovenous malformations in the lungs (PAVMs). We hypothesize that the genetically-determined abnormality in the blood vessels of HHT patients leads to alteration in the concentrations or activity of several proteins in the blood stream. We propose to take blood samples from patients at defined times in order to study changes in blood protein levels and activity

Official Title
-----------------
Studies of Plasma Proteins Derived From Pulmonary Arteriovenous Malformation Patients

Conditions
-----------------
Telangiectasia, Hereditary Hemorrhagic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Patients with hereditary haemorrhagic telangiectasia and pulmonary arteriovenous malformations - Exclusion Criteria:Unable to provide informed consent -
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hereditary Hemorrhagic