linjc16/ctgov huggingface dataset:
Assessment of Cardiac Fixation During PET Using a New Drug Within Amyloid Cardiac Injuries.

Study Overview
=================
Brief Summary
-----------------
To estimate distribution's parameters of 18F-Flutemetamol (Vizamyl®) fixation on myocardium for patients with amyloid cardiac injuries.

Detailed Description
-----------------
Hypothesis had been performed that PET with 18F-Flutemetamol (Vizamyl®) could lead an early diagnostic. Indeed, this tracer had been recently used to highlight inter-cerebral beta-amyloid plaques on patients with Alzheimer Disease. Because this labelling is performed on amyloid deposits, this tracer would lead to view and to quantify amyloid deposits within cardiac amyloid injuries. Results of this PET will be combined with scan examinations for a better anatomic tracking.

Official Title
-----------------
Assessment of Cardiac Fixation During Positron Emission Tomography (PET) Examination Using 18F-Flutemetamol (Vizamyl ®) Within Amyloid Cardiac Injuries.

Conditions
-----------------
Cardiac Amyloidosis

Intervention / Treatment
-----------------
* Drug: PET with 18 F-Flutemetamol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients followed for amyloidosis with proved cardiac injury or strongly suspected: cardiac echography with typical signs of amyloid injury, anatomical result confirming presence of amyloid deposits at cardiac or peripheral level Signature of Informed Consent Form, Affiliation to a social security system Exclusion Criteria: Patient who suffers from another pathology which could lead cardiac injury (coronary disease, valvular disease, other pathology of deposit), Pregnancy and lactating women, Absence of effective contraception, Irradiating examination performed within the last 12 months or scheduled within the next 12 months, Unable patient physically, mentally or legally to provide informed consent, Patient under a system of legal protection

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET with 18 F-Flutemetamol<br>PET with 18 F-Flutemetamol (Vizamyl®) = product under Alzheimer's disease indication | Drug: PET with 18 F-Flutemetamol<br>* PET with 18 F-Flutemetamol (Vizamyl ®)<br>* Other names: Vizamyl®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ratio Heart/ Upper Mediastinum | peak of 18F-Flutemetamol capture | average of last 15 minutes | 
| standardized uptake value (SUV) measures | standardized uptake value (SUV) measures | average of last 15 minutes |
Bone Density in Immediate Implant Placment and Loading(BDIIPL)

Study Overview
=================
Brief Summary
-----------------
Atrumatic extraction ,immediate implant placment , prf as plug,immediate loading , mesure bone density 0-3-6-9 month

Detailed Description
-----------------
Atrumatic extraction unrestorable tooth in esthetic zone and immediate implant placment and withdrow 10cc blood sample to gain prf plug as membrane and immediate provisional for one week and final restoration after 1 week , and mesure bone density from 0-3-6-9 month

Official Title
-----------------
Prf Controlled,Randamized Cinical Trial of EFFECTS OF THE PLATELET-RICH FIBRIN (PRF) ON BONE DENSITY IN IMMEDIATE IMPLANT PLACEMENT AND LOADING IN ESTHETIC ZONE

Conditions
-----------------
Bone Density Increased

Intervention / Treatment
-----------------
* Other: Prf


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: unrestorable anterior tooth. Good oral hygine Adequate bone hieght apical to the alveolus of failing tooth to ensure primary stability . Exclusion Criteria: systematic disease which affect osteointgration. Bad oral hygiene Broxism, clenching, deep bite, edge to edge and abnormal habits. Non-treated peeiodontal diseases. Pregnancy and smokers. Severe infection. Loss of labial crest after extraction of failing tooth.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: immediate placment and loading with prf<br>Immediat placment and loading with prf | Other: Prf<br>* Take 10cc blood from patient and gain prf blug<br>|
| No Intervention: immediate implant placment and loading<br>Immediate implant placment and loading without prf | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone density enhancement with prf in immediate implant placment and loding | Cbct | 9 month |
Double Trigger in Patients With Low Number of Oocytes Retrieved Per Number of Preovulatory Follicles

Study Overview
=================
Brief Summary
-----------------
The aim of this randomized controlled trial is to determine whether co-administration of GnRH agonist and hCG for final oocyte maturation ( 40 and 34 h prior to oocyte retrieval , respectively) can increase the oocytes yield in patients with history of poor oocytes yield, despite normal response to COH, due to low (<50%) number of oocytes retrieved per number of follicles > 14 mm in diameter on day of hCG administration

Official Title
-----------------
Double Trigger in Patients With Low Number of Oocytes Retrieved Per Number of Preovulatory Follicles. A Randomized Controlled Trial

Conditions
-----------------
Infertility, Female

Intervention / Treatment
-----------------
* Drug: Double trigger
* Drug: HCG trigger


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with history of poor oocytes yield in previous IVF attempt, despite normal response to COH, due to low (<50%) number of oocytes retrieved per number of follicles > 14 mm in diameter on day of hCG administration Patients with 6 to 15 mature follicles on the day oocyte trigger in the current IVF-ET attempt Exclusion Criteria: Endometriosis PCOS

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Double trigger<br>GnRH-agonist and HCG are used to trigger ovulation | Drug: Double trigger<br>* Final follicular maturation is triggered by the co-administration of GnRH-agonist (Triptorelin acetate, decapeptyl 0.2 mg, Slough, United Kingdom) and 10000 IU of HCG, 40 and 34 h prior to oocyte retrieval, respectively<br>|
| Active Comparator: HCG<br>HCG is used to trigger ovulation | Drug: HCG trigger<br>* Final follicular maturation is triggered by a dose of 10000 IU of HCG 36 h prior to oocyte retrieval<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes retrieved |  | First day after oocyte retrieval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate | The presence of gestational sac detected by ultrasound examination | First 5 weeks after oocyte retrieval | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IVF, HCG, GnRH agonist trigger
A Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Patients With Advanced Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of an investigational study drug DN-101 (calcitriol) when given in combination with gemcitabine ± erlotinib in the treatment of pancreatic cancer.

Official Title
-----------------
A Randomized Phase 2 Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Subjects With Advanced Pancreatic Adenocarcinoma

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: placebo + gemcitabine + erlotinib
* Drug: Placebo + gemcitabine
* Drug: calcitriol + gemcitabine
* Drug: calcitriol + gemcitabine + erlotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed diagnosis of locally advanced and unresectable, or metastatic pancreatic cancer Performance status 0, 1,or 2 Adequate bone marrow, renal and hepatic function Exclusion Criteria: Prior chemotherapy or radiation therapy for pancreatic cancer Prior treatment for other cancers in last 6 months Cancer of the brain or spine Active uncontrolled infection Hypercalcemia

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 |
| --- | --- |
| Placebo Comparator: A<br>Placebo + gemcitabine | Drug: Placebo + gemcitabine<br> <br> |
| Placebo Comparator: B<br>Placebo + gemcitabine + erlotinib | Drug: placebo + gemcitabine + erlotinib<br> <br> |
| Active Comparator: C<br>DN-101 + gemcitabine | Drug: calcitriol + gemcitabine<br> <br> |
| Active Comparator: D<br>DN-101 + gemcitabine + erlotinib | Drug: calcitriol + gemcitabine + erlotinib<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rate at 6 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  |  | 
| Duration of progression free survival |  |  | 
| Duration of overall survival |  |  |
Assessment in Patients After Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
Lung cancer is the leading cause of death in men and the second in women with a 5 year survival in Europe of less than 15%. One of the methods most used for its treatment is pulmonary resection. The objective of this study is to analyze the clinical profile presented to patients after pulmonary resection.

Detailed Description
-----------------
One of the most widely used methods for the treatment of lung cancer is pulmonary resection. The morbidity and mortality of pulmonary resection surgery is conditioned by both the type of intervention and the patient's condition. Functional deterioration is a risk associated with hospitalization in the elderly, with a high prevalence (35-70%) and serious consequences, since in the majority it can lead to the appearance of complications not related to the reason for admission or the specific treatment. It is very important to evaluate the clinical profile of patients after pulmonary resection in order to stablish a more specific repercussion.

Official Title
-----------------
Evaluation of Hospitalized Patients After Thoracic Pulmonary Resection Surgery

Conditions
-----------------
Thoracic Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient admitted for lung resection and who sign the informed consent Exclusion Criteria: Patients who did not agree to sign informed consent and those who presented other types of problems to be able to adequately carry out the assessment, such as not handling the language.

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 |
| --- | --- | --- |
| Strength in upper and lower limbs | Changes from baseline to postintervention during hospital stay in lower and upper limbs strength. The quadriceps and the hand-grip strength is assessed using a portable dynamometer with a standard protocol allowing three attempts on each side. | Baseline, up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity | Five times sit to stand test (5STS) will be used to assess exercise capacity. 5STS is a simple assessment tool that is feasible in all healthcare settings and involves asking the patient to stand up 5 times for the shortest possible time without arm support.. Saturation and heart rate will be monitored as well as levels of dyspnea and fatigue of the patient. | Baseline, up to 1 month |
Tocilizumab for Relapsing Polychondritis

Study Overview
=================
Brief Summary
-----------------
This is a study for one patient with severe relapsing polychondritis which has been unresponsive to other more conventional medications including prednisone, methotrexate, anakinra and TNF inhibitors. Tolerability, and efficacy of the drug, Tocilizumab will be monitored by clinical assessment and bloodwork.

Official Title
-----------------
Efficacy of Tocilizumab in a Patient With Relapsing Polychondritis

Conditions
-----------------
Relapsing Polychondritis

Intervention / Treatment
-----------------
* Drug: Tocilizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A single patient with unremitting inflammatory relapsing polychondritis Exclusion Criteria: As this is a study in a single patient, there are no exclusions

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tocilizumab|Tocilizumab 8mg/kg every 2 weeks given by IV infusion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Tocilizumab | Inhibition of inflammatory markers Improvement in symptoms and signs | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Tocilizumab | Monitoring of serum lipids and liver function tests | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relapsing Polychondritis, Unremitting, Inflammation, IL6
Optimizing the Effect of COPD Rehabilitation

Study Overview
=================
Brief Summary
-----------------
Patients with Chronic Obstructive Pulmonary Disease (COPD) may benefit from an 8-week pulmonary rehabilitation programme. However, the effect of the programme tends to attenuate with time. Patients who complete the programme are randomized to continued rehabilitation follow-up and control follow-up.

Detailed Description
-----------------
Patients with Chronic Obstructive Pulmonary Disease (COPD) may benefit from an 8-week pulmonary rehabilitation programme according to guidelines of the Danish Society of Pulmonary Medicine. However, the effect of programme tends to attenuate with time. Patients who complete the programme are randomized to continued rehabilitation follow-up and control follow-up.

Official Title
-----------------
Rehabilitation of COPD Patients: Can the Effect be Prolonged by Follow-up and Continued Rehabilitation

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

Intervention / Treatment
-----------------
* Behavioral: follow-up rehabilitation of participants with COPD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: FEV1 < 60% of expected Exclusion Criteria: Other severe chronic conditions
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: follow-up rehabilitation of participants with COPD|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease specific Quality of Life |  |  | 
| Work Capacity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days admitted to hospital |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, rehabilitation, quality of life
Left Atrial Remodelling in Hypertension: Effects of Ramipril or Irbesartan

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to compare in hypertensive patients the effect of one year therapy with ACE-inhibitor (RAMIPRIL) or angiotensin II receptor blocker (IRBESARTAN) on left atrial remodelling and diastolic function.

Official Title
-----------------
Left Atrial Remodelling in Hypertension: Effects of Ramipril or Irbesartan

Conditions
-----------------
Left Atrial Volume, Hypertensive Heart Disease, Antihypertensive Drugs, Diastolic Function, Renin Angiotensin System

Intervention / Treatment
-----------------
* Drug: ramipril
* Drug: irbesartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:· mild to moderate essential hypertension no antihypertensive treatment good quality echocardiogram Exclusion Criteria: cardiovascular diseases (AMI, stroke o TIA) heart failure, valvular heart disease diabetes secondary hypertension atrial fibrillation hepatic and renal severe failure pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>treatment with ramipril | Drug: ramipril<br>* ramipril 2.5- 5 mg once daily<br>|
| Experimental: 2<br>treatment with irbesartan | Drug: irbesartan<br>* irbesartan 150-300 mg once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left atrial volume |  | one year | 
| diastolic function |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic and diastolic blood pressure |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
left atrial volume, hypertension, ramipril, irbesartan, diastolic function
Pharmacokinetic Model of Fibrinogen Plasma Levels After Fibrinogen Administration

Study Overview
=================
Brief Summary
-----------------
characterize the fibrinogen PK in patients with acquired -chronic (cirrhotic patients) or acute- hypofibrinogenemia (severe trauma or critical haermorrhage), showing endogenous production.

Detailed Description
-----------------
Fibrinogen, a plasma-soluble protein synthesized by the liver, is the key substrate for the plasmatic blood coagulation, reaching a critically low plasma concentration earlier than other coagulation factors in case of bleeding. Fibrinogen Pharmacokinetics (PK) after single doses of fibrinogen concentrate (FC), using modeling approaches, has only been evaluated in congenital afibrinogenaemic patients. The aims of this study are to extend the modeling process to characterize the fibrinogen PK in patients with acquired -chronic (cirrhotic patients) or acute- hypofibrinogenemia (severe trauma or critical haermorrhage), showing endogenous production. Influencing factors of differences on the fibrinogen PK between sub-populations will be identified.

Official Title
-----------------
Population Pharmacokinetic Modeling of Fibrinogen in Patients With Congenital or Acquired -Chronic or Acute- Hypofibrinogenemia

Conditions
-----------------
Fibrinogen; Deficiency, Acquired, PHARMACOKINETICS

Intervention / Treatment
-----------------
* Other: DATA RECORDING


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AFIBRINOGENEMIC, TRAUMATIC AND CIRRHOTIC AFTER FIBRINOGEN ADMINISTRATION - Exclusion Criteria: NA -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AFIBRINOGENEMIA, CIRRHOSIS, TRAUMATICS<br>PATIENTS WITH CONGENIAL AFIBRINOGENEMIA:RECORD OF PLASMA FIBRINOGEN LEVEL PATIENTS WITH ADQUIRED CRONIC HIPOFIBRINOGENEMIA AND END STAGE OF THE LIVER DISEASE: RECORD OF PLASMA FIBRINOGEN LEVEL PATIENTS WITH ADQUIRED ACUTE HIPOFIBRINOGENEMIA AND ACUTE TRAUMA: RECORD OF PLASMA FIBRINOGEN LEVEL | Other: DATA RECORDING<br>* RECORD PLASMA FIBRI LEVELS AFTER FIBRINOGEN ADMINISTRATION<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma fibrinogen level | to develop a pharmacokinetic model to predict the plasma fibrinogen level after fibrinogen administration | JUNE 2021- AUGUST 2022 |