linjc16/ctgov huggingface dataset:
Measurement of Lung Water by Transpulmonary Thermodilution in Lung Transplanted Patients

Study Overview
=================
Brief Summary
-----------------
Repeated measurements of lung water by single transpulmonary thermodilution during the first postoperative days following lung transplantation

Official Title
-----------------
Interest of Repeated Extravascular Lung Water Measurements With the PICCO Device in Lung Transplanted Patients

Conditions
-----------------
Mucoviscidosis, Pulmonary Insufficiency

Intervention / Treatment
-----------------
* Procedure: Double-lung transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: double-lung transplanted patients Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Double-lung transplanted patients<br> | Procedure: Double-lung transplantation<br>* Double-lung transplanted patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| extra-vascular lung water |  | first postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary permeability index |  | first postoperative days |
Post Marketing Surveillance Study of Actimmune in Patients With Severe, Malignant Osteopetrosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish a registry of all children with severe, malignant osteopetrosis who are treated with Actimmune (IFN-g 1b or Interferon gamma-1b) to monitor the effects of IFN-g 1b on preventing progression of this disease and to follow the safety of patients receiving it on a long-term basis. In addition, evaluation of the possible effect of Actimmune therapy on the humoral response to normal childhood vaccinations in this same patient population will be examined.Interferon gamma is a substance that the body makes naturally.

Detailed Description
-----------------
It is made by white blood cells and appears to be involved in regulating the body's ability to fight off infection. Actimmune is a synthetic form of Interferon gamma which is similar to that normally made by white blood cells. IFN-g 1b (Actimmune®) is currently approved by the United States Food and Drug Administration (FDA) for the treatment of patients with chronic granulomatous disease (CGD) to reduce the frequency and severity of serious infections. It is also approved in patients with severe, malignant osteopetrosis to delay the time to disease progression. In research trials, IFN-g 1b has been given to over 2,000 patients in diseases such as CGD, osteopetrosis, atopic dermatitis, pulmonary fibrosis, atypical mycobacteria and various cancers.

Official Title
-----------------
Post-Marketing Surveillance Study of Actimmune (Interferon Gamma-1b) in Patients With Severe Malignant Osteopetrosis

Conditions
-----------------
Osteopetrosis

Intervention / Treatment
-----------------
* Drug: Actimmune Registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Male or female Diagnosis of severe, malignant osteopetrosis Currently receiving or planning to initiate therapy with Actimmune (Interferon gamma-1b) Willing to attend follow-up appointments every 6 months following enrollment into the study, if clinically indicated
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Actimmune Registry|as administered by physician|

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
-----------------
Registry, Actimmune, osteopetrosis
Multimodal Monitoring in Patients With Spontaneous Intracerebral Hemorrhage

Study Overview
=================
Brief Summary
-----------------
Spontaneous intracerebral bleeding also known as spontaneous intracerebral hemorrhage (sICH) constitute 10-15 % of all apoplexies. The Prognosis is considerably worse than it is for the larger population of patients suffering from cerebral thrombosis. Development of brain edema seemingly contributes to the disadvantageous prognosis. However, the mechanisms behind is only understood fragmentarily. By using multimodal neuro monitoring, the investigators seek to investigate electrophysiological and metabolic processes, which seem to accompany the formation of edema and clinical deterioration in patients suffering from sICH.

Official Title
-----------------
Multimodal Monitoring in Patients With Spontaneous Intracerebral Hemorrhage

Conditions
-----------------
Cerebral Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis: spontaneous intracerebral hemorrhage verified by CT Clinical indication for craniotomy or craniectomy Admitted to the hospital within 24 hours from assumed ictus Age over 18 years Exclusion Criteria: Pregnancy

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 |
| --- | --- |
| spontaneous intracerebral hemorrhage<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary brain injury | Assessed by GCS, CAM-ICU, mRS, Imaging, EEG background activity. | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
miRNA, Cortical Spreading Depression, Cerebral Hemorrhage, Reactivity in EEG, Multimodal monitoring, EEG
An Extension Study to Demonstrate the Equivalence of Long-Term Efficacy and Safety of CT-P13 in Patients With Ankylosing Spondylitis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 1.1

Study Overview
=================
Brief Summary
-----------------
This open-label, single-arm, multicenter, multiple single-dose intravenous (IV) infusion, efficacy, and safety extension study of the Phase 1 Study CT-P13 1.1 is designed to assess the long-term efficacy and safety of multiple doses of CT-P13.

Official Title
-----------------
An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 in Patients With Ankylosing Spondylitis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 1.1

Conditions
-----------------
Ankylosing Spondylitis

Intervention / Treatment
-----------------
* Biological: Infliximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who has completed the scheduled visits, including the End-of-Study Visit, in Study CT-P13 1.1 Patient who has not had any major protocol violation in Study CT-P13 1.1 Exclusion Criteria: Patient who has been withdrawn from Study CT-P13 1.1 for any reason Patient who, at the time of providing informed consent, has any ongoing medical issues such as serious adverse events(SAEs) or intolerance issues that mean continuation in this extension study could be detrimental to their health, in the option of the investigator Patient who plans to participate in a study with an investigational drug during the period of this extension study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CT-P13<br>infliximab | Biological: Infliximab<br>* CT-P13 (5mg/kg) administered as a 2-hour IV infusion per dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term efficacy evaluated by Assessment of Spondylo Arthritis International Society(ASAS) criteria and Long term safety evaluated by immunogenicity and clinical laboratory test |  | Up to Week 40 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AS, Biosimilar
RELIEF: Randomized Episodic Versus Long-Term Suppression Experience With Famciclovir

Study Overview
=================
Brief Summary
-----------------
This trial will assess whether RGH patients who have two recurrent episodes within a three month period would benefit from suppressive treatment and whether patients prefer episodic therapy or suppressive therapy for the treatment of their RGH.

Official Title
-----------------
A Study to Determine the Safety and Efficacy of Famciclovir in the Episodic and Suppressive Treatment of Recurrent Genital Herpes (RGH). The Study Will Also Evaluate Quality of Life and Patient Satisfaction

Conditions
-----------------
Recurrent Genital Herpes (RGH)

Intervention / Treatment
-----------------
* Drug: Famciclovir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Patients who are immunocompetent and who have had 4 or more episodes of Recurrent Genital Herpes (RGH) in the last 12 months. Patients with active HSV-2 or HSV-1 infection as confirmed by Polymerase Chain Reaction (PCR). Patients with active symptoms (i.e., itching, burning, tingling, aching, tenderness, rash or pain) associated with a recurrent episode of genital herpes Exclusion Criteria: • Female patients who are pregnant or breast-feeding. Current, history or suspicion of liver disease or kidney disease. HIV infected (as confirmed by positive HIV serology). Other protocol-defined inclusion/exclusion criteria may apply.

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (days from randomizations) to first recurrence of symptoms of recurrent genital herpes confirmed by PCR. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total score of the Recurrent Genital Herpes Quality of Life. |  |  | 
| Safety assessed by adverse events. |  |  | 
| Time to first recurrence of genital herpes. |  |  | 
| Number of genital herpes recurrences confirmed by PCR. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Recurrent Genital Herpes (RGH), famciclovir, episodic treatment, suppressive treatment, Polymerase Chain Reaction (PCR).
Infrastructure for Developing Gastrointestinal Cancer Prognostic and Predictive Markers

Study Overview
=================
Brief Summary
-----------------
The proposal seeks to establish: A comprehensive compilation (database) of clinical information comprising clinical, histopathological, treatment and follow-up characteristics of past and future gastrointestinal cancer (GIC) cases in Singapore that can be shared by investigators. The characteristics will include clinical (eg age, sex, stage), histopathological (eg. grade, type), treatment (eg. treatment status, regimens) and outcome data (eg. survival, toxicity) from medical records. A collection (bank) of corresponding frozen and fixed tissue, blood and processed samples (enriched blood mononuclear cells, protein, RNA, DNA, tissue arrays) in Singapore that can be shared by the investigators. A gastrointestinal cancer co-operative group (GCCG) of clinicians and scientists researching prognostic and predictive markers in GIC, which will benefit from the multi-disciplinary knowledge, information and samples of its members. To characterise genetic polymorphisms related to Gastrointestinal cancer chemotherapy treatment in controls (healthy volunteers)

Official Title
-----------------
Infrastructure for Developing Gastrointestinal Cancer Prognostic and Predictive Markers

Conditions
-----------------
Gastrointestinal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cancers of the gastrointestinal tract (eg. colorectal, gastric, pancreatic, esophageal) Exclusion Criteria: None

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with cancers of the gastrointestinal tract (eg. colorectal, gastric, pancreatic, esophageal) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Twenty-five-year Experience With the Medtronic-Hall Valve Prosthesis

Study Overview
=================
Brief Summary
-----------------
Background-:. The Medtronic-Hall (MH) valve was developed and for the first time implanted in Oslo in 1977. A total of 1,104 patients received this valve at Rikshospitalet-Radiumhospitalet HF in the period 1977-87. In the present study we followed all 816 patients undergoing aortic valve replacement (AVR) over a 25-year period.

Detailed Description
-----------------
The Medtronic-Hall (MH) tilting valve disk was first implanted in Oslo in June 1977. From 1977 through 1987, the valve was used as the only valve of choice and inserted in a total of 1,104 consecutive patients at our department. The MH valve is made of a single piece of titanium with no welds. The disk is made of tungsten impregnated graphite with a carbon pyrolytic coating. The tungsten renders the disk radiopaque. In the aortic position the maximal opening is 75˚. A central aperture in the disk allows free rotation. The valve is rotatable in the sewing ring. The sewing ring is made of Teflon. Aortic sizes are 20-31 mm (outer diameter). The initial clinical results were published in 1979 (1). The cohort of patients has been followed-up and analysed at 5, 10 and 15 years (2-5). In the present study we report our 25-year follow-up data for the 816 patients undergoing aortic valve replacement (AVR) with special reference to survival, functional status, valve-related complications and the impact of concomitant surgery.

Official Title
-----------------
Twenty-five-year Experience With the Medtronic-Hall Valve Prosthesis

Conditions
-----------------
Aortic Valve Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with aortic valve replacement 1977-87
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AVR<br>All consecutive patients in the study period | |

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
-----------------
Valves, heart disease, prosthesis.
Monitoring Alectinib Treatment by Detection of ALK Translocations in Serial Blood Samples From Non-Small Cell Lung Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Circulating tumor DNA can be used to monitor the treatment effect and identify developing resistance mutations during ALK directed TKI treatment.

Detailed Description
-----------------
The purpose and objectives of the non-interventional study with primary data collection is To determine if monitoring the amount of translocated DNA in the blood reflects alectinib treatment effect. To assess the presence and type of resistance mutations using ctDNA at the time patients experience clinical progression on alectinib. To investigate if the resistance mutations identified at clinical progression could have been identified in blood samples taken before clinically evident progression.

Official Title
-----------------
Monitoring Alectinib Treatment by Detection of ALK Translocations in Serial Blood Samples From Non-Small Cell Lung Cancer Patients

Conditions
-----------------
ALK Gene Mutation, Lung Cancer, Resistance, Disease, Mutation

Intervention / Treatment
-----------------
* Drug: Alectinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ALK translocated metastatic NSCLC, treated with alectinib as 1st line therapy in routine clinical practice Written (personally dated and signed) informed consent Exclusion Criteria:

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Alectinib|Use of ctDNA to establish response and resistance to alectinib.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS on alectinib | time from initiation of treatment to progression | 46 month | 
| mechanism of resistance | ctDNA to establish resistance mechanisms to alectinib treatment | 15.2 month |
Phase II Study , Association of Cisplatine Topotecan and Cetuximab in Patients Whith Late or in Progress Epithelial Cancer of the Cervix

Study Overview
=================
Brief Summary
-----------------
The efficacy of chimiotherapy in cervix epithelial cancer is low even with the association cisplatine - topotecan . News thérapeutics are needed in the goal of increase the survival and quality of life in patients with cervix cancer. Cetuximab has shown the potentialisation on the efficacy of cisplatine and irinotecan. Cisplatine and topotecan have shown an efficacy in cervix cancer. Cetuximab is well tolerate. Many clinical trials shown the faisability of the association of cetuximab and cisplatine in cancer. Many clinical trials have shown the faisability of association of cetuximab and irinotecan in colorectals metastatiques cancers .

Conditions
-----------------
Cervix Cancer

Intervention / Treatment
-----------------
* Drug: ERBITUX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: More than 18 years old. Epidermoïde carcinoma or adenocarcinoma of the cervix, hystologic proved Patientes in a late stage or with progresive desease. One mesurable lesion in irradiated zone. Patient who have already treated radio-chimiothérapy with platine should have a 6 month free interval. Index status of ECOG ( Eastern Cooperative Oncology Group )less than 2. Good biologicals and hematologicals fonctions: Neutrophiles noless than 1,5.109/L. Platelets nolss than 100.109/L. Total bilirubin no more than 1,5 time the normal superior range. Transaminases no mote than 3 x Time NSR Creatinine clairance Cockroft) more than 50 mL/min . Inform consent signed. Exclusion Criteria: Previous cytotoxic traitement exept radio-chaemiotherapy of the pelvis cerebrals metastasis. Other cancer in the last 5 years exept treated BCC. Dermatologic desease. Crohn desease or Hemorragic rectal-Colitis. Neuropathy. Psychologic disorder. Social troubles. Pregnant women.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ERBITUX|400 mg/m² 2h injection at week 1, then 250 mg/m² in one hour injection the following weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| responses rate regarding the RECIST criteria. |  | up to progression | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life, free interval, safety. |  | up to progression |