linjc16/ctgov huggingface dataset:
Comparison Study of MDX-010 (CTLA-4) Alone and Combined With Docetaxel in the Treatment of Patients With Hormone Refractory Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The primary objectives of the study are to determine the safety and activity of multiple doses of MDX-010 in patients with hormone-refractory prostate cancer (HRPC), and to determine the safety and activity profile of a single dose of cytotoxic chemotherapy (docetaxel) in combination with MDX-010

Official Title
-----------------
A Randomized Study Comparing 4 Monthly Doses of MDX-010 (CTLA-4) as a Single Agent or Used in Combination With a Single Dose of Docetaxel in Patients With Hormone-Refractory Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: MDX-010 / MDX-010 + Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of adenocarcinoma of the prostate. Metastatic prostate cancer (positive bone scan or measurable disease). Progressive disease after androgen deprivation. No prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control prostate cancer). Exclusion Criteria: Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or superficial bladder cancer, or any other cancer from which the patient has been disease-free for greater than or equal to 5 years. Previous occurrence of autoimmune disease. Active infection requiring therapy including HIV or chronic hepatitis.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MDX-010 / MDX-010 + Docetaxel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Impact of Anesthesia Type on Outcome in Patients With Acute Ischemic Stroke (AIS) Undergoing Endovascular Treatment

Study Overview
=================
Brief Summary
-----------------
Recent observational studies have found an association between general anaesthesia and increased post-operative mortality in acute ischemic stroke patients undergoing endovascular treatment. It is unknown whether there is a causal relationship in this observation. The investigators are performing a large randomised trial of general versus local anaesthesia to definitively answer the question of whether anaesthetic type alters perioperative outcome.

Official Title
-----------------
Impact of General vs Local Anesthesia on Neurological Function in Patients With Acute Ischemic Stroke Undergoing Endovascular Treatment

Conditions
-----------------
Acute Stroke

Intervention / Treatment
-----------------
* Other: Intravenous anesthetics
* Other: local anesthesia
* Other: Controlled ventilation
* Other: Spontaneous breathing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with AIS scheduled to receive emergency endovascular treatment, older than 18; the onset time is within 12 hours. Exclusion Criteria: Radiological ambiguity concerning infarction and vessel occlusion. Additional intracerebral hemorrhage. Posterior circulation infraction. Coma on admission (Glasgow coma score less than 8). NIHSS less than 10 or more than 35. Severe agitation or seizures on admission. Obvious loss of airway protective reflexes and/or vomiting on admission. Being intubated before treatment on admission. Known allergy to anesthetic or analgesic.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Local anesthesia<br>local anesthesia and spontaneous breathing will be maintained. | Other: local anesthesia<br> <br> Other: Spontaneous breathing<br> <br> |
| Other: General anesthesia<br>Intravenous anesthetics and controlled ventilation will be used . | Other: Intravenous anesthetics<br> <br> Other: Controlled ventilation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin score |  | post-procedural 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ischemic Stroke, Anesthesia, Endovascular Procedures
Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2006-2007

Study Overview
=================
Brief Summary
-----------------
This study aims to collect data and assess the number of rotavirus related hospitalizations in 11 hospitals in Belgium - season 2006-2007 in order to develop proper age-cohort analysis over time.

Detailed Description
-----------------
This retrospective study will use anonymised data, extracted from hospital databases during the period of the 1st of June 2006 until the 31st of May 2007. IMS Health sales data will be used to provide rotavirus vaccine coverage estimates (Rotarix and Rotateq) for the Belgian population during the study period. Any additional source of vaccine coverage status describing rotavirus vaccine uptake in the study population will also be reported.

Official Title
-----------------
Assessing the Number of Rotavirus Related Hospitalizations in 11 Hospitals in Belgium - Season 2006-2007

Conditions
-----------------
Infections, Rotavirus

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child aged ≤5 years; A stool sample has been provided for a rotavirus detection test during the study period; Laboratory test result of rotavirus is available. Exclusion Criteria: Not applicable.

Ages Eligible for Study
-----------------
Maximum Age: 5 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 |
| --- | --- |
| Group A<br>All children ≤ 5 years old with a rotavirus detection test (inpatient and ambulatory tests) performed during the period of June the 1st 2006 and May the 31st 2007. | Other: Data collection<br>* Each participating centre will be requested to generate a coded list of all stool samples taken during the study period (June 1st 2006- May 31st 2007) and analysed for rotavirus, in children aged ≤5 years.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the absolute number of rotavirus related hospitalisations in children up to five years old. |  | From June 1st 2006 up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Classification of patients with rotavirus hospitalisation by birth cohorts, gender, time of the event, vaccine coverage status. |  | From June 1st 2006 up to 1 year | 
| Determination of the duration of rota-related hospitalisation for community acquired and nosocomial infection per birth cohort. |  | From June 1st 2006 up to 1 year | 
| Evaluation of the herd effect. |  | From June 1st 2006 up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rotavirus, hospitals, Belgium
Prevention of Recurrent Preterm Delivery by a Natural Progesterone Agent

Study Overview
=================
Brief Summary
-----------------
To examine the preterm delivery rate of a preterm delivery high risk group of pregnant women, using once daily natural progesterone agent.

Conditions
-----------------
Pregnancy, Premature Birth

Intervention / Treatment
-----------------
* Drug: Crinone Gel 8%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnancy 24 weeks' gestation Preterm labor in previous pregnancies - Exclusion Criteria: No medications for PTL or any kind of progesterone. Cervical suture Multiple pregnancy
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Crinone Gel 8%|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
-----------------
Pre-term labor, progesterone
Single Modality Trans Oral Robotic Surgery for Primary Oropharyngeal Cancer: Exploring the Impact of Surgical Margins on Local Disease Recurrence

Study Overview
=================
Brief Summary
-----------------
Retrospective observational cohort study investigating Single modality Trans Oral Robotic surgery for primary oropharyngeal cancer: exploring the impact of surgical Margins on local disease recurrence.

Detailed Description
-----------------
The STORM study will examine transoral surgery performed before 31st July 2019. STORM is a retrospective observational cohort study, involving international centres performing TORS for primary OPSCC. The main aim of this study is to explore the impact of surgical margins on local disease recurrence in primary oropharyngeal squamous cell carci-noma treated with transoral robotic surgery (TORS) without adjuvant therapy. The primary objective is to report local recurrence-free survival. The primary endpoint will be Local recurrence-free survival time. The secondary objectives are to report overall survival, disease-specific survival and disease-free survival, and to report post-operative haemor-rhage rates. The secondary endpoints include Overall survival time, Dis-ease-specific survival time, Disease-free survival time, Post-operative haemorrhage time. Exploratory objective to identify a clinically relevant cut-off for surgical margins as a predictor of local disease recurrence.

Official Title
-----------------
Single Modality Trans Oral Robotic Surgery for Primary Oropharyngeal Cancer: Exploring the Impact of Surgical Margins on Local Disease Recurrence

Conditions
-----------------
Head and Neck Squamous Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older. Primary OPSCC. Index cancer treated with TORS without adjuvant therapy. Any post-operative TNM classification. TORS performed on or before 31st July 2019. Exclusion Criteria: TORS preformed for diagnostic or palliative intentions. Known distant metastasis at time of TORS. Nasopharyngeal and thyroid cancers. Patients undergoing neoadjuvant or adjuvant chemotherapy, biotherapy, immunotherapy or radiotherapy to either the neck or primary site.

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 |
| --- | --- | --- |
| Local recurrence-free survival time |  | At 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival time |  | At 2 and 5 years | 
| Disease-specific survival time |  | At 2 and 5 years | 
| Disease-free survival time |  | At 2 and 5 years | 
| Post-operative haemorrhage time |  | Within 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary OPSCC
Intraocular Pressure, Blood Pressure, Ocular Perfusion and Blood Flow Fluctuations in Glaucoma Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate whether add-on to prostaglandin therapy with twice a day (bid) dorzolamide is statistically superior to twice a day (bid) timolol with regard to increasing ocular blood flow

Detailed Description
-----------------
Hypotensive treatments for glaucomatous optic neuropathy (GON), depending on their chemical composition can influence the ocular circulation independent of intraocular pressure (IOP) reduction. It is therefore important not only to identify ocular blood flow deficits in GON, but also document the influence of GON treatments on the ocular circulation

Official Title
-----------------
Comparison of Intraocular Pressure, Blood Pressure, Ocular Perfusion and Blood Flow Fluctuations During the Addition of Dorzolamid vs Timolol in Glaucoma Subjects Treated With Prostaglandin Analogue Monotherapy

Conditions
-----------------
Open Angle Glaucoma

Intervention / Treatment
-----------------
* Device: Color Doppler Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Open angle glaucoma subjects receiving prostaglandin monotherapy in both eyes Exclusion Criteria: younger than 18 years old women of child bearing potential

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 |
| --- | --- |
| combination topical glaucoma treatment<br>timolol or dorzolamide add on latanoprost monotherapy | Device: Color Doppler Imaging<br>* Color Doppler imaging (CDI) system for measurements of blood flow in the ophthalmic (OA), central retinal (CRA), and nasal (NPCA) and temporal (TPCA) posterior ciliary arteries. In each vessel, peak systolic velocity (PSV) and end diastolic velocity (EDV) were determined, and Pourcelot's resistive index will be calculated (RI = (PSV-EDV)/PSV).<br>* Other names: latanoprostum;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Color Doppler Imaging | Color Doppler Imaging Nasal post ciliary artery (NPCA) Temporal posterior ciliary artery (TPCA) Ophthalmic artery (OA) Central retinal artery (CRA) | 8 AM; 8 PM | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP, BP, OPP (mean, fluctuations, amplitude) | IOP, BP, OPP (mean, fluctuations, amplitude) Goldmann applanation tonometry Brachial artery pressure and radial pulse | 8 AM-12AM-4PM-8PM | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, ocular, blood flow, fluctuations
Diabetes Treatment With Glucobay in Combination With Metformin

Study Overview
=================
Brief Summary
-----------------
In this prospective, non interventional, observational Post Marketing Survelliance study data are obtained on the efficacy, safety and tolerability of Glucobay treatment on top of metformin under daily life treatment conditions.Specifically investigated is the influence of Glucobay on Post Prandial Blood Glucose and HbA1c as well as on pateint's weight when added to an already existing metformin therapy.The study is planned to carried out in 25000 - 30000 patients from 200 trial sites in India.The PMS study will be performed with commercially available medication prescribed within regular practice of the physician. No other examination will be performed than would be done without Post Marketing Survelliance study.

Official Title
-----------------
Prospecitve, Non Interventional, Non Controlled, Post Marketing Survelliance Study to Evaluate Efficacy, Safety, Tolerability of Glucobay on Top of Metformin Under Daily Life Treatment Conditions

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

Intervention / Treatment
-----------------
* Drug: Acarbose (Precose/Glucobay, BAYG5421)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patient with type 2 diabetes with one of the following treatment ongoing : 1) Metformin 2) Metformin + OHA. In such patients, if investigator feels that addition of acarbose would be benficial for the patients Exclusion Criteria: According to local product information

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 |
| --- | --- |
| Group 1<br> | Drug: Acarbose (Precose/Glucobay, BAYG5421)<br>* Oral Glucobay 25 titrated to Glucobay 50 three times a day with meals or as per investigators descretion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data collection on body weight |  | 16 weeks | 
| Data collection on blood glucose |  | 16 weeks | 
| Data collection on Hba1c |  | 16 weeks | 
| Data collection on pre treatment concomitant diseases |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables will be summarized using descriptive statistics based on adverse events collection |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Type-2, Acarbose, Drug Therapy, Combination
Trypan Blue Versus Brillant Blue for Epiretinal Membranes

Study Overview
=================
Brief Summary
-----------------
Membraneppeling alone versus Membranepeeling with Membrane Limitans Interna Pelling using two different Dyes for Epiretinal Membrane Surgery.

Official Title
-----------------
Membranepeeling With Trypan Blue Versus Membranpeeling With Brillant Blue for Patients With Idiopathic Epiretinal Membranes

Conditions
-----------------
Idiopathic Epiretinal Membranes

Intervention / Treatment
-----------------
* Procedure: Trypan Blue
* Procedure: Brillant Blue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic eperetinal membranes Phakic or pseudophakic eyes Age over 60 years Exclusion Criteria: Secondary epiretinal membranes Severe ocular pathologies

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| Active Comparator: Group 1<br>Trypan Blue | Procedure: Trypan Blue<br>* Membranepeeling with TB<br>|
| Active Comparator: Group 2<br>Brillant Blue | Procedure: Brillant Blue<br>* Membranepeeling and membrana limitans interna peeling with BB<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microperimetry optical coherence tomographie questionnaire (metamorphopsien) |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epiretinal membranes, vitreoretinal dyes, membranepeeling
Is Routine Cholecystectomy Reasonable in All Patients Receiving a Bypass Procedure: a Comparative Cohort Study

Study Overview
=================
Brief Summary
-----------------
Gallbladder management in bariatric surgery is controversially discussed. While some surgeons advocate routine prophylactic cholecystectomy (CCE) during Roux-en-Y gastric bypass (RYGB) others advocate CCE only in patients with pathological gallbladder findings. The aim of this study was to evaluate the necessity of prophylactic CCE in patients receiving a laparoscopic RYGB.

Conditions
-----------------
Given Indication for Gastric Bypass Procedure

Intervention / Treatment
-----------------
* Procedure: Laparoscopic Cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who received a laparoscopic Roux-en-Y-gastric bypass Exclusion Criteria: previous CCE open gastric bypass procedure previous bariatric procedure other than gastric banding patients lost to follow up

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 |
| --- | --- |
| laparoscopic Roux-en-Y-gastric-bypass without cholecystectomy<br> | |
| laparoscopic Roux-en-Y-gastric baypass with cholecystectomy<br> | Procedure: Laparoscopic Cholecystectomy<br>* Laparoscopic Cholecystectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biliary complications resulting from omitted prophylactic cholecystectomy |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of concurrent cholecystectomy |  | 30 days |