linjc16/ctgov huggingface dataset:
NPC Staged N2-3M0:Adjuvant Chemotherapy or Just Observation After Concurrent Chemoradiation

Study Overview
=================
Brief Summary
-----------------
By this clinical trial, the investigators are trying to give an answer to such a question. Whether NPC patients staged N2-3M0 need adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation?

Detailed Description
-----------------
Recent research (Lancet Oncology 2012)shows that no survival benefits were achieved by adding adjuvant chemotherapy after concurrent chemoradiation in patients with locoregionally advanced NPC. But in patients with even high risk of distant metastasis(staged N2-3M0),is adjuvant chemotherapy necessary?

Official Title
-----------------
Adjuvant Chemotherapy or Not for NPC Patients Staged N2-3M0 After Concurrent Chemotherapy :a Phase Ⅱ Study

Conditions
-----------------
Nasopharyngeal Carcinoma

Intervention / Treatment
-----------------
* Drug: Adjuvant chemotherapy with paclitaxel and nedaplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathologically confirmed untreated NPC patients staged N2-3M0 age: 18y - 65y with MRI examinations ECOG≤2 with written consent Exclusion Criteria: without a second cancer pregnancy with other severe diseases(blood,liver ,kidney or heart diseases) could not staged properly without written consent

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adjuvant chemotherapy with paclitaxel and nedaplatin<br>Patients will receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation | Drug: Adjuvant chemotherapy with paclitaxel and nedaplatin<br>* Patients receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation<br>* Other names: Adjuvant chemotherapy;|
| No Intervention: Observation<br>Patients will be followed up without adjuvant chemotherapy after concurrent chemoradiation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment toxicity based on a CTCAE3.0 grading system |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progress free survival |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasopharyngeal carcinoma staged N2-3M0, Adjuvant chemotherapy
Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis

Study Overview
=================
Brief Summary
-----------------
Background: Pulmonary involvement in leptospirosis has been reported to be on the increase and is emerging as the main cause of death due to leptospirosis in many countries, including Thailand. Methods: A prospective randomized controlled trial of desmopressin or high dose dexamethasone as adjunctive therapy in patients with suspected pulmonary hemorrhage associated with leptospirosis was conducted between July 2003 and October 2006 at 5 hospitals in Thailand.

Official Title
-----------------
An Open Randomized Controlled Trial of Desmopressin, and Dexamethasone as Adjunctive Therapy in Patients With Pulmonary Hemorrhage Associated With Leptospirosis

Conditions
-----------------
Leptospirosis

Intervention / Treatment
-----------------
* Drug: Dexamethasone, desmopressin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients (> 14 years) with suspected severe leptospirosis patients who presented with acute fever (oral temperature more than 38.00 C for <15 days) in the absence of an obvious focus of infection In the opinion of the attending physician might have pulmonary hemorrhage (i.e. history of hemoptysis, and/ or bilateral nodular or air space infiltration). Exclusion Criteria: pregnant or breastfeeding those with history of bleeding disorder those who had underlying diseases such as chronic liver disease, diabetes mellitus those who received diuretic or glucocorticoid

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 90 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Standard supportive care | |
| Experimental: 2<br>Dexamethasone treatment | Drug: Dexamethasone, desmopressin<br>* 200 mg of dexamethasone IV infusion OD for 3 days or 0.3 microgram/ kg of desmopressin in 50 ml of saline, as a 30- minute infusion<br>* Other names: Minirin;|
| Experimental: 3<br>Desmopressin treatment | Drug: Dexamethasone, desmopressin<br>* 200 mg of dexamethasone IV infusion OD for 3 days or 0.3 microgram/ kg of desmopressin in 50 ml of saline, as a 30- minute infusion<br>* Other names: Minirin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | during in hospital admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of mechanical ventilation |  | during hospital admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Severe leptospirosis, Pulmonary hemorrhage
Effect of Oxygen Breathing on Flicker Induced Blood Flow Changes in the Optic Nerve Head

Study Overview
=================
Brief Summary
-----------------
Background It has recently been shown that diffuse luminance flicker increases retinal and optic nerve head blood flow. This indicates that a neuro-vascular coupling between neural activity and blood flow exists as described previously for the brain. Although a lot of mediators such as NO, pO2, pCO2, H+ and K+ have been proposed, the mechanism of this coupling is still a matter of controversy. However, it has been shown in an animal experiment, that an increase in blood flow, evoked by diffuse luminance flicker stimulation is paralleled by an decrease in pO2 in the tissue. Thus, in this study we set out to investigate the flicker light induced increase in blood flow under elevated blood pO2. Study rationale The motive for the investigation of retinal blood flow regulation is to enhance our understanding of the coupling mechanism between increased neural activity and blood flow in the retina in order to gain new insight in the pathophysiology of several eye diseases associated with ocular vascular disorders Study objectives To test the hypothesis whether oxygen breathing influences flicker light induced changes in optic nerve head blood flow

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: breathing 100% oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers Exclusion Criteria: Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study Treatment in the previous 3 weeks with any drug Symptoms of a clinically relevant illness in the 3 weeks before the first study day Blood donation during the previous 3 weeks

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: breathing 100% oxygen|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal vessel diameters |  |  |
Copeptin Serum Level in Liver Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The study aim is to measure perioperative copeptin concentration in blood of liver transplant recipients and to assess whether there is a correlation between its level and hemodynamic derangement.

Official Title
-----------------
Copeptin Serum Level in Liver Transplant Recipients

Conditions
-----------------
Liver Cirrhosis, Copeptin, Liver Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patient undergoing liver transplantation Exclusion Criteria: Serum creatinine > 1,5 mg/dl Retransplantation Patient refusal CRRT or dialysis preoperatively

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 |
| --- | --- | --- |
| Serum Copeptin concentration |  | Baseline, intraoperatively, 1,3,7,21 day postoperatively |
Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV to Treat Diabetic Tractional Retinal Detachment (IBETRA)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the amount of intraoperative intraocular bleeding during 23-gauge pars plana vitrectomy (PPV) for diabetic traction retinal detachment (TRD) with and without preoperative intravitreal bevacizumab treatment.

Official Title
-----------------
Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV for Diabetic Tractional Retinal Detachment (IBETRA Study)

Conditions
-----------------
Diabetic Retinopathy, Retinal Detachment

Intervention / Treatment
-----------------
* Drug: Bevacizumab
* Procedure: pars plana vitrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Macular traction retinal detachment lasting three months or less secondary to diabetic retinopathy. Exclusion Criteria: Massive vitreous hemorrhage preventing from detailed posterior pole examination; Previous intra-ocular surgery other than cataract surgery Hemodialysis, known bleeding disorders or use of anticoagulants drugs other than aspirin Prothrombin time, partial thromboplastin time or platelet count without normal limits History of previous thromboembolic events

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Preoperative Intravitreal bevacizumab and pars plana vitrectomy | Drug: Bevacizumab<br>* Intravitreal bevacizumab (1.5 mg; 0,06 ml) 1 week after baseline; pars plana vitrectomy 3 weeks after baseline<br>* Other names: Avastin;Procedure: pars plana vitrectomy<br>* pars plana vitrectomy 3 weeks after baseline<br>|
| Active Comparator: B<br>Pars plana vitrectomy only | Procedure: pars plana vitrectomy<br>* pars plana vitrectomy 3 weeks after baseline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of intraoperative intra-ocular bleeding |  | three weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic Retinopathy, Retinal detachment, Vitreous Hemorrhage, Bevacizumab, preoperative, pars plana vitrectomy
Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation SI-SI-LOK

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to gather clinical data on SI-LOK® for the treatment of sacroiliac joint dysfunction. The purpose of this prospective study is to evaluate clinical and radiographic outcomes, intra-operative parameters, patient satisfaction and work status following a procedure using SI-LOK® for treatment of sacroiliac joint dysfunction with a minimum of three screws.

Detailed Description
-----------------
Clinical Research Forms will be completed at all pre-op, intra-op and post-op visits by either the surgeon, clinical coordinator or patient. Forms completed by patients will be checked, initialed and dated by the site coordinator. Data collected will be presented as mean +/- standard deviation. Statistical significance will be evaluated at the P < 0.05 significance level.

Official Title
-----------------
Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation System

Conditions
-----------------
Joint Dysfunction

Intervention / Treatment
-----------------
* Device: SI-LOK


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A maximum age of 70 years Diagnosis of SIJ dysfunction Ability to provide Informed Consent for study participation and to return for all follow-up visits Exclusion Criteria: Previous documentation of osteopenia or osteomalacia History of metabolic bone disease (e.g. diabetes requiring daily insulin) Diagnosis of a condition or requires postoperative medication(s), which may interfere with bony/soft tissue healing Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.) History of substance abuse (drugs or alcohol) Condition that would preclude completing patient self assessment questionnaires Mentally incompetent or prisoner Currently a participant in another study

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 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 |
| --- | --- |
| SI-Joint Dysfunction<br>Device- SI-LOK | Device: SI-LOK<br>* Sacro-iliac joint fusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Evaluation | Fusion Assessment Radiolucency | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization Data | Operative Time Blood Loss Blood Transfusion Hospitalization Time | Intra-Operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sacro-iliac Joint
Thoracic Combined Spinal Epidural Anesthesia for Breast Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the efficacy of the thoracic combined spinal epidural anesthesia in breast surgery.

Detailed Description
-----------------
Previous studies of the regional anesthetic techniques such as erector spinae plane block and pectoralis nerve blocks (PECs blocks) additional to general anesthesia have described their use for postoperative analgesia in breast surgery. It has been also reported that these blocks can be used to provide surgical anesthesia in breast surgery . Segmental thoracic epidural anesthesia can be used as an alternative anesthetic technique in patients with severe chronic obstructive pulmonary disease and asthma undergoing breast surgery. It has been also reported that thoracic spinal anesthesia was effective and successful in patients undergoing laparoscopic surgery. In this study, efficacy of high thoracic spinal epidural anesthesia in patients undergoing breast surgery will be evaluated.

Official Title
-----------------
Segmental High Thoracic Combined Spinal Epidural Anesthesia for Breast Surgery

Conditions
-----------------
Pain, Breast Diseases

Intervention / Treatment
-----------------
* Other: thoracic combined spinal epidural anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who will be to undergo elective surgery for breast surgery American Society of Anesthesiologists (ASA) physical status classification groups I or II Exclusion Criteria: body mass index>35 kg/m2, presence of any condition complicating and contraindicating spinal epidural anesthesia.

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 70 Months

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: thoracic combined spinal epidural anesthesia|A combined spinal-epidural anesthesia set will be used for the block. Using the loss of resistance to saline technique, an 18 G Tuohy needle will be advanced to the T2-3 vertebral interspace with the mid-line approach. After confirming the epidural space, a 26 G pencil point spinal needle will be inserted slowly through the Tuohy needle to puncture the dura. After free flow of cerebrospinal fluid will be observed, local anesthetic wil be injected into the subarachnoid space over 15 secs. Then, an epidural catheter will be inserted into the epidural space.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Block success | the number of patients whose surgery was completed without general anesthesia | through study completion, an average of 3 months |
The Impact of Legally Enforced Embryo Transfer Policy (Belgian Law 2003) on Cumulative Delivery Rate.

Study Overview
=================
Brief Summary
-----------------
Multiple pregnancy (MP) is associated with significant fetomaternal complications and a high cost. The multiple pregnancy rate per cycle (MPR) of treatment with Assisted Reproductive Technology (ART) is 25 % or higher even in countries where ART is reimbursed, much higher than the 1% after natural conception, related to the number of embryos transferred, and preventable by single embryo transfer (SET). In Belgium, the laboratory costs for 6 fresh ART cycles are reimbursed for female patients younger than 43 with a Belgian insurance number since July 2003, but only if a limited number of embryos is transferred depending on female age and cycle rank. Although this policy has resulted in a significant reduction in the MPR after ART in Belgium from 24 % to 13 %, available data are cycle based and it is unknown if the cumulative delivery rate per patient is affected by this legislation. The aim of this study was to test the hypothesis that Belgian ART legislation since 2003, coupling lab reimbursement to restriced embryo transfer policy, has resulted in a reduced CDR when compared to the situation before 2003.

Conditions
-----------------
Impact of Legislation on Cumulative Delivery Rate

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with their first IVF/ICSI cycle Exclusion Criteria: cycles without oocytes or sperm, oocyte reception cycles, embryo reception cycles, cycles with preimplantation genetic diagnosis/screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 43 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 |
| --- | --- |
| after legislation 1st july 2003<br>2003-2006 | |
| before legislation 1st july 2003<br>1999-2003 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative delivery rate |  | 1999-2006 |
Evaluation of Neopterin Levels in Pre and Post-menopausal Women With Periodontitis Following Non Surgical Therapy

Study Overview
=================
Brief Summary
-----------------
Neopterin has been identified as a marker of cellular immune system activation. It is synthesized by macrophages upon stimulation with the cytokine interferon-gamma and is indicative of a pro-inflammatory immune status. Neopterin concentration increases with increasing severity of periodontal disease in diverse body fluids like Urine, Saliva and Plasma. Hence Neopterin can be considered as an important inflammatory marker in periodontal disease as well as other systemic diseases.

Detailed Description
-----------------
At baseline - plasma, urine and saliva samples were collected and analysed for neopterin levels from the pre and post-menopausal women with periodontitis . Followed by scaling and root planing done in both the groups. After 3 months again these 3 samples were collected and analysed for post treatment neopterin levels

Official Title
-----------------
Biochemical Evaluation of Plasma,Urine and Salivary Neopterin Levels in Pre and Post-menopausal Women With Periodontitis Following Non-surgical Therapy

Conditions
-----------------
Periodontitis

Intervention / Treatment
-----------------
* Procedure: Non surgical periodontal therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: moderate to chronic periodontitis non-smokers minimum 15 natural teeth present Exclusion Criteria: patients on long term steroid medication with gross oral pathology or tumors undergoing hormone replacement therapy not undergone periodontal therapy in past 6 months under medication in past 6 months systemic disorders and drugs which influence the periodontium

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-menopausal with periodontitis<br>non surgical periodontal therapy ( scaling and root planing) | Procedure: Non surgical periodontal therapy<br>* scaling and root planing<br>|
| Post-menopausal with periodontitis<br>non surgical periodontal therapy ( scaling and root planing) | Procedure: Non surgical periodontal therapy<br>* scaling and root planing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Co-relating neopterin and periodontitis levels in pre and post menopausal women |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
periodontitis, neopterin, plasma, urine, saliva, menopause