linjc16/ctgov huggingface dataset:
Applications Site Reactions After Injection of Insulin Detemir and Saline in Subjects With Diabetes

Study Overview
=================
Brief Summary
-----------------
To compare application site reactions after superficial and deep subcutaneous and intradermal injections of insulin detemir and saline in patients with diabetes - The patient serves as his own control, n=100 patients with diabetes

Official Title
-----------------
Doubleblind, Randomised, Single Centre Investigator Sponsored Study of Applications Site Reactions After Deep and Superficial Subcutaneous and Intradermal Injection of Insulin Detemir and Saline in Subjects With Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: insulin detemir
* Drug: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus HbA1c<11 % BMI: 20-35 kg/m2 Insulin detemir naive Basal insulin dose>20E Exclusion Criteria: Known allergy to study drug Current steroid or antiallergic treatment Lipodystrophy Change in insulin and antihypertensive treatment < 30 days Smokers or alcoholics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>insulin detemir | Drug: insulin detemir<br>* 3 cutaneous injections<br>|
| Placebo Comparator: 2<br>saline | Drug: saline<br>* 3 cutaneous injections<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| laser doppler blood flow |  | 10 minutes - 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical signs |  | 10 min - 7 days | 
| insulin detemir specific antibodies |  | 3 months |
Chloroquine for Glioblastoma.

Study Overview
=================
Brief Summary
-----------------
Adjuvant chloroquine to the conventional treatment for glioblastoma; A randomized, single-blind, placebo-controlled, phase I/II trial.

Official Title
-----------------
Adjuvant Chloroquine to the Conventional Treatment for Glioblastoma.

Conditions
-----------------
Glioblastoma

Intervention / Treatment
-----------------
* Drug: Oral tablet
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed glioblastoma Adequate hematologic, hepatic, and renal function Karnofsky performance status score ≥ 70% Life expectancy ≥ six weeks Exclusion Criteria: Abnormal severe un-controlled medical conditions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chloroquine group<br> | Drug: Oral tablet<br>* Oral 250mg chloroquine tablets<br>|
| Placebo Comparator: Placebo drug group<br> | Drug: Placebo<br>* Oral placebo tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival duration after surgery |  | Three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End-point evaluation, survival at three years |  | Three years |
Study of Liatermin (r-metHuGDNF) Administered by Bilateral Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
This randomized study was designed to evaluate the efficacy and safety of IPu-infused liatermin (15mg/putamen/day) compared with placebo in subjects with symptomatic, levodopa-response Parkinson's disease. This study consisted of a 90-day evaluation period followed by implantation of the IPu delivery system and then a 6-month double-blind treatment period.

Official Title
-----------------
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Liatermin (r-metHuGDNF) Administered by Bilateral Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease

Conditions
-----------------
Idiopathic Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Liatermin (r-metHuGDNF)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Diagnosis of bilateral, idiopathic Parkinson's disease

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 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

| Intervention/Treatment |
| --- |
|Drug: Liatermin (r-metHuGDNF)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| United Parkinson's Disease Rating Scale |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Motor Tests |  |  | 
| Dyskinesia ratings |  |  | 
| Diary ratings |  |  | 
| Patient reported outcomes measures |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bilateral, Idiopathic Parkinson's Disease
Prevention With Oleanolic Acid of Insulin Resistance

Study Overview
=================
Brief Summary
-----------------
Oleanolic acid (OA), a triterpene that is highly present in olive leaves, has been proposed as component of functional foods in the prevention of metabolic syndrome due to its anti-inflammatory activity. In this research project we will study the presence of OA in postprandial TRL in healthy adolescents and in normal weight. Moreover, THP-1 macrophages will be incubated with LPS for 48h after pretreatment with OA at different concentrations. Also, TRL will be isolated from healthy adolescents before and 2 and 5h postprandially after the intake of a meal containing the functional olive oil or common olive oil and incubated with THP-1 macrophages.

Official Title
-----------------
Prevention With Oleanolic Acid of Insulin Resistance and Metabolic Syndrome in Adolescents

Conditions
-----------------
Insulin Resistance, Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: Functional olive oil
* Other: Olive oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Participants without digestive, metabolic or oncologic disorders or any other pathology Exclusion Criteria: -Not having the informed consent signed by the parents

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OA-enriched functional olive oil<br> | Other: Functional olive oil<br>* Eleven adolescents will consume OA-enriched functional olive oil. After eating the olive oil, aliquots of cubital blood will be drawn at 2 and 5 hours of the postprandial period. During that time, free access to water intake will be allowed.<br>|
| Active Comparator: Olive oil not enriched in OA<br> | Other: Olive oil<br>* Eleven adolescents will consume olive oil. After eating the olive oil, aliquots of cubital blood will be drawn at 2 and 5 hours of the postprandial period. During that time, free access to water intake will be allowed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pro-inflammatory cytokines | The pro-inflammatory cytokines were studied in THP-1 macrophages stimulated with postprandial triglyceride-rich lipoproteins | One year |
Emergency/Compassionate Use - Membranous VSD Occluder

Study Overview
=================
Brief Summary
-----------------
Emergency/Compassionate use of the AMPLATZER Membranous VSD Occluder

Conditions
-----------------
Membranous, Ventricular, Septal, Defects, VSD

Intervention / Treatment
-----------------
* Device: Device closure with the AMPLATZER Membranous VSD Occluder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Emergency/compassionate use for patients not meeting the inclusion critera for the AMPLATZER Membranous VSD clinical trial
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Device closure with the AMPLATZER Membranous VSD Occluder|Device closure with the AMPLATZER Membranous VSD Occluder|

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
-----------------
membranous, ventricular, septal, defects, VSD
Clinical Evaluation of the QuantiFERON CMV Assay

Study Overview
=================
Brief Summary
-----------------
Validate the use of the device in the clinical setting for assessing the risk of CMV Infection in SOT recipients after the completion of antiviral prophylaxis.

Official Title
-----------------
Clinical Evaluation of the QuantiFERON CMV Assay

Conditions
-----------------
CMV

Intervention / Treatment
-----------------
* Device: QuantiFERON CMV Assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult CMV D+/R- liver, kidney, heart, pancreas, lung, intestinal, or combined transplant recipients that are 18 years of age or older. Scheduled to receive between 3 to 6 months of antiviral prophylaxis Provide Informed Consent Exclusion Criteria: Subjects less than 18 years old Scheduled to receive longer than 6 months or shorter than 3 months of prophylaxis Unable to provide Informed Consent

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 |
| --- | --- |
| All subjects<br>Those receiving a SOT and coming off either 3 months or 6 months of antiviral prophylaxis. | Device: QuantiFERON CMV Assay<br>* Assay to measure cell-mediated immune function using QuantiFERON CMV assay.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in time to CMV Infection between sub-groups of QF-CMV assay classifications. | Measurement of QF-CMV result | At time of prophylaxis termination, +1 month from termination, +2 months from termination |
Neuropathic Pain Study With Botulinum Toxin A in Spinal Cord Injury Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether botulinum toxin A is effective in the treatment of neuropathic pain in spinal cord injury patients.

Detailed Description
-----------------
Neuropathic pain remains a significant cause of life quality deterioration. This study includes spinal cord injury patients with refractory chronic neuropathic pain and investigates whether injection with botulinum toxin A improves pain scores.

Official Title
-----------------
The Effect of Botulinum Toxin A in Post Spinal Cord Injury Neuropathic Pain

Conditions
-----------------
Spinal Cord Injury, Neuropathic Pain

Intervention / Treatment
-----------------
* Drug: Botulinum toxin type A
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more than twenty years of age paraplegic or tetraplegic due to cervical and thoracic spinal cord injury more than 12 months since spinal cord injury and ASIA impairment scale unchanged for more than 6 months persistence of neuropathic pain for more than three months or remission and recurrence of neuropathic pain for more than six months a pain score of 40mm or more on the visual analogue scale Exclusion Criteria: neuropathic pain caused by confounding factors other than spinal cord injury contraindicated for botulinum toxin type A a change in pain medication one month prior to study enrollment a condition involving neuromuscular junction (Ex. Eaton Lambert disease, myasthenia gravis) person who received botulinum toxin type A within three months prior to study enrollment

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Active Comparator: botulinum toxin A<br> | Drug: Botulinum toxin type A<br>* Subcutaneous injection of botulinum toxin type A<br>|
| Placebo Comparator: normal saline<br> | Drug: normal saline<br>* Subcutaneous injection of normal saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale |  | 4 weeks after intervention |
Incidental Cancer in Gallbladder Surgical Specimens Focus on Elderly Patients

Study Overview
=================
Brief Summary
-----------------
Causes such as long-term stones and polyp are thought to play a role in the etiology of gallbladder cancer. The routine histopathological examination provides the detection of incidental gallbladder cancers. It should be remembered that acute or chronic cholecystitis accompanied by the thicked wall and a prolonged history of gallstones may be the cause of malignancy, especially in elderly patients.

Detailed Description
-----------------
The investigators aimed to incidental gallbladder cancer and compare other pathology results with elderly patients.

Official Title
-----------------
Incidental Cancer in Gallbladder Surgical Specimens Focus on Elderly Patients, Retrospective Analysis of 2389 Patients

Conditions
-----------------
Pathology

Intervention / Treatment
-----------------
* Diagnostic Test: Histopathological result


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute cholecystectomy elective cholecystectomy Exclusion Criteria: lack of data incidental cholecystectomy, cholecystectomy secondary to trauma cholecystectomy secondary to malignancy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elder<br>elderly (≥60 years old). | Diagnostic Test: Histopathological result<br>* Incidental gallbladder cancer and other pathology<br>|
| Young<br>young (<60 years old) | Diagnostic Test: Histopathological result<br>* Incidental gallbladder cancer and other pathology<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Incidental Cancer | Number of Participants with adenocarcinom | 2 or 3 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cholecystectomy, cholecystitis, cholelithiasis, gallbladder neoplasms, histopathology, surgical procedures
Phase II Study of TRK-820 Soft Capsules - Intractable Pruritus in Patients With Chronic Liver Disease -

Study Overview
=================
Brief Summary
-----------------
The efficacy and safety of TRK-820 are to be evaluated in the treatment of intractable pruritus in patients with Chronic Liver Disease by administering 2.5, 5 and 10 microg of this drug or placebo for 28 days in four groups with a design of randomized, double-blind, parallel-group comparison. In addition, the plasma concentrations of TRK-820 and its primary metabolites are to be determined.

Official Title
-----------------
Phase II Study of TRK-820 Soft Capsules - Intractable Pruritus in Patients With Chronic Liver Disease -

Conditions
-----------------
Pruritus With Chronic Liver Disease

Intervention / Treatment
-----------------
* Drug: Nalfurafine Hydrochloride (TRK-820)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic Liver Disease is present; and the patient's general condition is judged by the physician to be stable with no prospect of an abrupt change in pathophysiology. It can be confirmed by either of the following that treatment of pruritus with antihistamines or antiallergics has not been adequately effective in such patients: Exclusion Criteria: Malignant tumors Depression, integration dysfunction syndrome (schizophrenia), or dementia Hepatic encephalopathy, or hepatic cirrhosis in which ascites or esophageal or gastric aneurysm cannot be controlled Alcoholic liver disease Atopic dermatitis, chronic urticaria, or other skin disease producing generalized pruritus that is judged by the physician to affect the assessment of pruritus associated with Chronic Liver Disease in this study Allergy to opioid drugs Drug dependence or alcohol dependence Chronic renal failure

Ages Eligible for Study
-----------------
Minimum Age: 20 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> | Drug: Nalfurafine Hydrochloride (TRK-820)<br>* TRK-820 2.5, 5 and 10 microg is to be administered orally once daily, after supper in principle, for 28 days.<br>* Other names: REMITCH;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Placebo is to be administered orally once daily, after supper in principle, for 28 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in VAS value (based on morning or evening scores, whichever larger, during the treatment period [4th week]) |  | 4 weeks |
Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The trial will compare the overall survival of perifosine plus capecitabine to placebo plus capecitabine in patients with refractory advanced colorectal cancer.

Official Title
-----------------
A Phase III Randomized Study to Assess the Efficacy and Safety of Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Capecitabine
* Drug: Perifosine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have failed available therapy for the treatment of advanced colorectal cancer, including fluoropyrimidine, irinotecan, oxaliplatin, bevacizumab and for K-ras wild-type (WT) patients, anti-EGFR antibody (cetuximab or panitumumab) containing therapies. For oxaliplatin-based therapy, failure of therapy will also include patients who had oxaliplatin discontinued secondary to toxicity. No prior exposure to capecitabine in the metastatic colorectal cancer setting, except limited-course radiosensitizing capecitabine Patients must have at least one measurable lesion by RECIST criteria Exclusion Criteria: Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction to 5-FU

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 |
| --- | --- |
| Active Comparator: Perifosine + Capecitabine<br>Perifosine 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days | Drug: Capecitabine<br>* 1000 mg/m2 BID/ Days 1-14<br>Drug: Perifosine<br>* 50 mg daily x 21 days<br>|
| Placebo Comparator: Placebo + Capecitabine<br>Placebo 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days | Drug: Capecitabine<br>* 1000 mg/m2 BID/ Days 1-14<br>Drug: Placebo<br>* 1 pill daily x 21 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | Monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival |  | Every 6 weeks |