linjc16/ctgov huggingface dataset:
Pathological Comparisons of Surgical Open Lung Biopsies and Cryobiopsies in Non-IPF ILD

Study Overview
=================
Brief Summary
-----------------
Pathological comparisons of surgical open lung biopsies and cryobiopsies in non-IPF ILD. Patients with non-IPF ILD eligible for an open lung biopsy will undergo cryobiopsy in the same time. Between observers agreement will be assessed for each pairs of samples.

Official Title
-----------------
Le rôle de la Cryobiopsie Transbronchique Dans le Diagnostic Des Maladies Pulmoniares Interstitielles

Conditions
-----------------
Non Definite IPF, Interstitial Lung Diseases

Intervention / Treatment
-----------------
* Procedure: Lung cryobiopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non IPF ILD eligible for surgical lung biopsy reviewed during multidisciplinary approach Exclusion Criteria: Ineligible for lung biopsy: pulmonary hypertension, coagulation deficiency, FEV<11, giant emphysematous bullae, hemodynamic instability severe hypoxia, general anesthetic ineligibility

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lung cryobiopsy<br> | Procedure: Lung cryobiopsy<br>* Transbronchial cryobiopsy<br>* Other names: Per endoscopy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of concordant diagnoses between cryobiopsy and surgical lung biopsy. | The gold standard is the consensual diagnosis between the two readers established from surgical biopsy | for statistical analysis, 12 months after the first inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage homology between diagnosis obtained by surgical biopsy and cryobiopsy with the multidisciplinary approach |  | one day after inclusion | 
| The percentage homology intra and inter observer for histopathological analysis of each type of sample by Mac Nemar test |  | for statistical analysis, 12 months after the first inclusion | 
| The number of elementary lesions actually present in the two samples for the same patient |  | One day after inclusion | 
| The time of the gesture and the respective anesthetic complexities of each procedure |  | One day after inclusion | 
| The rate of adverse events |  | for statistical analysis, 12 months after the first inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ILD, Pathology, diagnosis, lung biopsy
Drug Use Investigation for REVOLADE (ITP)

Study Overview
=================
Brief Summary
-----------------
To investigate safety and efficacy in the actual use of REVOLADE collected from all subjects receiving the drug until data from a specified number of subjects are accumulated to identify factors considered to influence its safety and efficacy. <Priority investigation item> Thromboembolism

Official Title
-----------------
Drug Use Investigation for REVOLADE (Chronic Idiopathic Thrombocytopenic Purpura)

Conditions
-----------------
Purpura, Thrombocytopaenic, Idiopathic

Intervention / Treatment
-----------------
* Drug: Eltrombopag


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with chronic idiopathic thrombocytopenic purpura Exclusion Criteria: Not applicable
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects prescribed REVOLADE<br>Subjects with chronic idiopathic thrombocytopenic purpura prescribed REVOLADE during study period | Drug: Eltrombopag<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects with any adverse events treated with REVOLADE |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appearance of thromboembolism | If thromboembolism is appeared or not in subjects who received REVOLADE will be investigated throughout the study period | 1 year |
Lapatinib/Carboplatin/Paclitaxel in Previously Treated Ovarian or Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness, safety, tolerability and best dose of Lapatinib (GW572016) in combination with carboplatin and paclitaxel.

Detailed Description
-----------------
The MTD was found in the phase I portion of this study to be oral lapatinib 1000 mg per day for each 4 week cycle and paclitaxel 60 mg/m2 weekly x 3 of a 4 week cycle and carboplatin AUC 2 weekly x 3 of a 4 week cycle.

Official Title
-----------------
Phase I/II Lapatinib Plus Carboplatin and Paclitaxel in Stage III or IV Relapsed Ovarian or Stage IV Breast Cancer Patients

Conditions
-----------------
Ovarian Epithelial Cancer Stage III, Stage IV Ovarian Cancer, Stage IV Breast Cancer

Intervention / Treatment
-----------------
* Drug: lapatinib (GW572016)
* Drug: Carboplatin
* Drug: Paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsed (Stage III or IV) ovarian, primary peritoneal, fallopian tube carcinoma patients. Stage IV metastatic breast cancer patients who have failed no more than four previous chemotherapies for Stage IV disease. Ability to swallow and retain oral medications. Measurable disease Exclusion Criteria: Treatment with previous weekly carboplatin and paclitaxel. No prior treatment with erbB targeting therapies such as erlotinib, gefitinib and cetuximab. No concomitant requirement for medication classification as CYP3A4 inducers or inhibitors.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lapatinib (GW572016)|1000 mg po qd|
|Drug: Carboplatin|AUC 2 weekly x 3 of 4 week cycle|
|Drug: Paclitaxel|60 mg/m2 weekly x 3 of 4 week cycle|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response (PR or CR) |  | 1 year |
Endoscopic-assisted Microsurgical Removal of Cerebellopontine Angle Lesions

Study Overview
=================
Brief Summary
-----------------
It is a Prospective descriptive hospital based clinical study to determine the value of introduction of endoscope after microscopic excision of cerebello-pontine angle lesions to estimate the following : Intraoperative judgement of lesions excision, residual parts, visualization and operative corridor pre and after endoscope introduction. Post-operative tumor control confirmed comparison between pre and postoperative MRI. Postoperative complications, advantages and disadvantages compared with these when use pure microscopic excision from the literature

Official Title
-----------------
Evaluation of Endoscopic-assisted Microsurgical Removal of Cerebellopontine Angle Lesions

Conditions
-----------------
Cerebellopontine Angle Tumor

Intervention / Treatment
-----------------
* Device: endoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cerebellopontine angle lesions meningeoma. vestibular schwannoma. arachnoid cyst. petroclival meningeoma. Exclusion Criteria: trigeminal neuralgia. facial neuralgia.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formerly Arm Label<br> | Device: endoscope<br>* It is a Prospective descriptive hospital based clinical study to determine the value of introduction of endoscope after microscopic excision of cerebello-pontine angle lesions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative residual tumor | post operative MRI will be done and will be compared with the preoperative one to determine if complete excision was done or if there is residual parts | 1 week |
Telemedicine for Sleep Apnea Patients

Study Overview
=================
Brief Summary
-----------------
Objective: Set up an interoperable telemedicine system for the follow-up of patients with sleep apnea syndrome.

Detailed Description
-----------------
The medico-economics protocol will use the MAST (Methodology for Assessment of Telemedicine) criteria. 200 patients will be randomized into 2 arms (telemedicine with GPRS transmission of CPAP data from patients' home and classical follow-up) during the 3 first months of the follow-up. The main end-point is CPAP compliance with the aim of detecting a mean increase of at least 1hr in the use of CPAP.

Official Title
-----------------
A Telemedicine System for the Follow-up of Patients With SAS

Conditions
-----------------
Sleep Apnea

Intervention / Treatment
-----------------
* Device: With teletransmission


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AHI > 30/hr hypersomnolence agreement for the use of CPAP internet and GSM connection Exclusion Criteria: central apnea >20%, pneumothorax, severe nasal obstruction, previous pharyngeal surgery, severe COPD, heart failure, previous use of CPAP, no social security coverage, unavailability, no GSM and internet network

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Without telemonitoring<br>Without teletransmission of alerts | |
| Experimental: With telemonitoring<br>With teletransmission of alerts | Device: With teletransmission<br>* Teletransmission of alerts<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPAP adherence measured by the number of hours of nightly use |  | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| economics: cost estimation: investment and running costs |  | 3 months | 
| Quality of life | SF36 (french version) and FOSQ (Functional Outcomes of Sleep Questionnaire) | 3 months | 
| Organizational changes of home care providers and medical structures |  | 9 months after the first patient inclusion | 
| Perception of healthcare professionals (autoquestionnaire RENEWING HEALTH) |  | 3 months | 
| Patients satisfaction |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CPAP, adherence, SAOS, telemedicine
Prolonged Laryngeal Mask Airway ProSealTM Use

Study Overview
=================
Brief Summary
-----------------
The investigators conclude that use of the LMA ProSealTM for prolonged procedures is feasible. In principle, it should be safer and more effective than the LMA ClassicTM provided basic guidelines are followed.

Detailed Description
-----------------
There is controversy concerning use of the classic laryngeal mask airway (LMA ClassicTM) for prolonged procedures, particularly over 2 hours, as some clinicians consider it unsuitable for positive pressure ventilation (needed to counter the alleged progressive respiratory fatigue with time) and/or unsuitable for airway protection (needed to counter the alleged progressive increase in aspiration risk with time). The LMA ProSealTM is a laryngeal mask device with a modified cuff to facilitate ventilation and a drain tube to provide airway protection. In principle, the LMA ProSealTM should be more suitable than the LMA ClassicTM for prolonged procedures; however, there are only four reports and one case series.

Official Title
-----------------
Prolonged Use of the Laryngeal Mask Airway ProSealTM: a Report of Seven Cases Lasting 5-11 Hours

Conditions
-----------------
Airway Management

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA 1 - 3 Age 19-85 yr Written informed consent Exclusion Criteria: Difficult airway Non fasted BMI > 35

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Feasibility of the LMA ProSealTM for prolonged use | Oropharyngeal leak pressure | 30 Minutes |
Substitution of First Phase Insulin Response in Patient With Type 2 Diabetes.

Study Overview
=================
Brief Summary
-----------------
The purpose of the project is to shown whether a little dose of a short acting insulin analogue given 3 time daily before the meals compared with placebo could normalise the increase in blood glucose after teh meals in diet treated Type 2 diabetic patients.

Detailed Description
-----------------
Patients with Type 2 diabtes has a defect in the insulinsecretion combined with an increased insulin resistance. At an intravenously glucosestimulation, patients with Type 2 diabtes has a decresed first phase insulin response compared to healty peoples. Because the hyperglycemia after meal, observed i Type 2 diabetics patients, is related to the defect in the first phase insulin response it is our hypothesis that substitution of the first phase insulin response with a little dose of insulin could normalise the blood glucose after the meal. 20 patients with Type 2 diabetes will in a randomised, placebocontrolled, dobble-dummy study be included for three days treatment with Insulin aspart vs placebo. Primary endpoint is bloodglucose fluctuations monitored by a continously glucose monitor.

Official Title
-----------------
Multiple Substitution of First Phase Insulin Response With a Rapid Action Insuli Analogue in Patient With Newly Diagnosed Type 2 Diabtes.

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Insulin Aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabtes according to the WHO criteria Fasting blood glucose >7 HbA1c between 6-9 Normal liver function Normal renal function - Exclusion Criteria: Ongoing treatment with antidiabetic medicine Pregnancy and lactation -

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Insulin Aspart|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose fluctuations |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of hypoglycemia |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabtes, Postprandial hyperglycemia, Insulin treatment
Phase I Study of Cisplatin Plus OSI-7904L in Patients With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This is a Phase I, open-label, dose escalation, study of the combination of cisplatin and OSI-7904L given on Day 1 every 21 days in patient who have advanced solid tumors.

Official Title
-----------------
Phase I Study of OSI-7904L in Combination With Cisplatin in Patients With Advanced Solid Tumors

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

Intervention / Treatment
-----------------
* Drug: OSI-7904L
* Drug: Cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Advanced and/or metastatic solid tumor for which no effective therapy is available ECOG performance status 0-2 Adequate bone marrow, hepatic and renal function Exclusion Criteria: Patients with active or uncontrolled infections Neurotoxicity >= Grade 2 Symptomatic brain metastases which are not stable

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: OSI-7904L|nan|
|Drug: Cisplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Molecular Effects of Vitamin B3 (Niacinamide) in Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
This is a single center, randomized, single-blind, placebo-controlled study to evaluate the safety and biochemical effects of niacinamide on metabolic parameters of the kidney in patients undergoing cardiac surgery.

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Drug: Oral niacinamide, 1 gram daily
* Drug: Oral niacinamide, 3 gram daily
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria All patients undergoing cardiac surgery with the use of cardiopulmonary bypass at high risk for acute kidney injury. A Cleveland score of 6 or more is used to define patients at high risk for acute kidney injury Age ≥ 18 Signed informed consent Exclusion criteria Pre-existing acute kidney injury Kidney transplantation Off-pump heart surgery Pregnancy End stage renal disease Pregnancy (female subjects of childbearing potential must have a negative serum pregnancy test) Subjects with any kind of dependency on the investigator (e.g. any subject who is under direct supervision of the investigator/co-investigators or employed by the investigator/co-investigators) 8 Subjects held in an institution by legal or official order (e.g. subjects in jail, prison, juvenile offender facility, or treatment facility including those who are in hospitals, alcohol, and drug treatment facilities under court order, and individuals with psychiatric illnesses who have been committed involuntarily to an institution)

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Niacinamide 1 gram<br>Oral niacinamide, 1 gram daily | Drug: Oral niacinamide, 1 gram daily<br> <br> |
| Active Comparator: Niacinamide 3 grams<br>Oral niacinamide, 3 grams daily | Drug: Oral niacinamide, 3 gram daily<br> <br> |
| Placebo Comparator: Placebo<br>Oral placebo pill | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in serum metabolite profile of niacinamide |  | Baseline and days 1 through 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in urine metabolite profile of niacinamide |  | Baseline and days 1 through 4 |