linjc16/ctgov huggingface dataset:
TICAP - Titanium Clips for Appendiceal Stump Closure

Study Overview
=================
Brief Summary
-----------------
Laparoscopic appendectomy is progressively accepted as the treatment of choice for acute appendicitis. Although the surgical technique of laparoscopic appendectomy has been well established, some controversy exists regarding the closure of the appendiceal stump. The available methods for stump closure are currently: pre-knotted loops (Roeder Loops or Endoloop, linear stapler and polymeric clips. A new device is a the DS Titanium Ligation Clip. The design of the DS-Clip is characterized by two parallel shanks. The aim of this study is to collect data of a large number of patients treated with the product in real-life clinical routine.

Official Title
-----------------
Prospective Multicenter Observational Study (Registry) on the Aesculap DS Titanium Ligation Clips for Appendiceal Stump Closure.

Conditions
-----------------
Appendicitis

Intervention / Treatment
-----------------
* Device: DS-Ligature Clip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: indication for a laparoscopic appendectomy informed consent Inclusion criteria to be checked intraoperatively: conventional laparoscopic approach (no SILS, NOTES, SPA) Aesculap DS Titanium Ligation Clips were used Exclusion: patient age under 16 years appendix is severely inflamed with involvement of the caecum

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: DS-Ligature Clip|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Applicability/feasibility of the DS Clips | Documentation of the number of successful (= completed stump closure) versus non-successful (= clip could not be applied) applications of the DS-Clip | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra- and post-operative complications related to surgery |  | 30 days after surgery | 
| Duration of operation |  | intra-operative | 
| Conversion rate to open surgery |  | 30 days | 
| Length of hospitalization |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic appendectomy, appendical stump closure
Dosing of Ketorolac in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
The optimal dose of ketorolac in the Emergency Department setting is no clear. We will compare 3 doses to determine the optimal dose.

Detailed Description
-----------------
Patients from 4 groups will be treated with 3 different doses of ketorolac. The groups are 1. headache 2. abdominal pain 3. musculo-skeletal pain 4. viral syndrome. The doses will be 0, 10, 30mgs of ketorolac to clarify the placebo effect and the optimal dosage as a function of condition.

Official Title
-----------------
Dosing of Ketorolac for Four Classes of Complaints in the Emergency Department

Conditions
-----------------
Acute Pain

Intervention / Treatment
-----------------
* Drug: Ketorolac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 y/o Exclusion Criteria: pregnant allergic other contraindication

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
Interventional Model Description: 4 groups with 3 different treatments
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 0 mg<br>0 mg ketorolac - placebo | Drug: Ketorolac<br>* IV drug<br>* Other names: Use of placebo, low, usual dose ketorolac;|
| Active Comparator: 10 mg<br>10 mg ketorolac - low dose ketorolac | Drug: Ketorolac<br>* IV drug<br>* Other names: Use of placebo, low, usual dose ketorolac;|
| Active Comparator: 30 mg<br>30 mg ketorolac - usual dose ketorolac | Drug: Ketorolac<br>* IV drug<br>* Other names: Use of placebo, low, usual dose ketorolac;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of pain | pain score on 0-10 scale | 30 minutes |
Generation of Standard Laboratory Values for Pneumococci Antibodies

Study Overview
=================
Brief Summary
-----------------
The determination of reference values is a necessary basis for research and clinical routine testing for pneumococci antibodies

Detailed Description
-----------------
This study is meant to determine specific pneumococcal antibodies stratified for age. The investigators also correlate our assay with the results from a commercially available pneumococcal screening ELISA (iGG1 and IgG2) in order to facilitate a screening for immunodeficiency, and to monitor the success of a performed immunization

Official Title
-----------------
Generation of Standard Laboratory Values for Pneumococci Antibodies

Conditions
-----------------
Reference Values

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects undergoing elective surgery Exclusion Criteria: Chronic illness condition, Immunodeficiency
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sufficient samples to calculate reference values |  | 10(2006-10/2007) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sufficient samples to correlate with screening assay |  | 10/2006-10/2007 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumococci, Antibody, Standard laboratory values
Radiofrequency Denervation for Reducing Chronic Pain: a Meta-analysis

Study Overview
=================
Brief Summary
-----------------
The meta-analysis of data obtained from randomized controlled trial on effectiveness of radiofrequency denervation on reducing chronic neck and low back pain.

Official Title
-----------------
Radiofrequency Denervation for Reducing Chronic Pain: a Meta-analysis

Conditions
-----------------
Chronic Neck Pain, Chronic Low Back Pain

Intervention / Treatment
-----------------
* Other: Radiofrequncy Denervation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: RCTs with pain VAS as outcome Exclusion Criteria: None

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 |
| --- | --- |
| Placebo<br> | |
| Intervention<br>Radiofrequncy Denervation | Other: Radiofrequncy Denervation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Visual Analogue Scale |  | 4 months |
Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis

Study Overview
=================
Brief Summary
-----------------
Chronic pain due to calcific tendonitis of shoulder is a prevalent condition usually treated with recurrent courses of NSAIDs, physical therapy or surgical interventions. Colchicine has been reported to be effective in the acute attack of shoulder tendonitis, however, has never been examined in controlled study in patients with chronic shoulder pain secondary to calcific tendonitis. Eighty patients with chronic shoulder pain (at least 3 months duration) due to calcific tendonitis will be randomized to receive colchicine 0.5 mg twice daily or placebo (lactose capsules) for 4 months. At the end of this blinded part of the study, patients who received placebo and did not improve, will be eligible to continue study in the open mode for additional 4 months with study drug. Efficacy (VAS for shoulder pain, shoulder range of motion and shoulder pain and disability index) and safety (blood tests) follow-ups will be scheduled bi-monthly for all patients.

Official Title
-----------------
Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis: Double Blind Placebo-controlled Study

Conditions
-----------------
Calcific Tendonitis

Intervention / Treatment
-----------------
* Drug: Colchicine
* Drug: lactose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic, more than 3 months duration, shoulder pain tendinous calcifications on shoulder X-rays Exclusion Criteria: renal insufficiency liver insufficiency lactose intolerance hypersensitivity to colchicine

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: colchicine<br> | Drug: Colchicine<br>* 0.5 mg twice daily for 4 months<br>|
| Placebo Comparator: Lactose capsule<br> | Drug: lactose<br>* lactose capsules twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS for shoulder pain |  | 4-8 months | 
| shoulder range of motion |  | 4-8 months | 
| shoulder pain and disability index |  | 4-8 months |
Evaluate the Safety and Anti-Hypertensive Efficacy of Hyzaar(R) In Patients With Mild To Moderate Essential Hypertension (0954A-323)

Study Overview
=================
Brief Summary
-----------------
Evaluate the safety and anti-hypertensive efficacy of hyzaar(R) in patients with mild to moderate essential hypertension.

Official Title
-----------------
Evaluate the Safety and Tolerability of Hyzaar(R) (Losartan 50 Mg/ Hydrochlorothiazide 12.5 Mg) In the Treatment of Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: MK0954A, hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 12 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is either receiving high blood pressure monotherapy or no treatment Patient will have reached the legal age by the time enter the study Patients diagnosed with mild to moderate essential high blood pressure or high blood pressure with other conditions such as diabetes or cardiovascular diseases and are taking high blood pressure medication (exclude diuretic), but did not meet treatment goal Exclusion Criteria: Patient with high levels of uric acid in the blood who has received medications for uric acid in the urine within 3 months prior to enrollment Patients who are hypersensitive to any component of the study medication Patients who are hypersensitive to other sulfonamide-derived drugs Patients with anuria (hyzaar(R) is not recommended for patients with hepatic impairment or severe renal impairment, creatinine clearance </= 30 ml/min) Unstable diabetes (hba1c > 8%), or a change in diabetes medication during study treatment. patients with stable diabetes may enter the study.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0954A, hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 12 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure over 12 weeks |  |  | 
| Safety and Tolerability. |  |  |
Prognostic Factors in Malignant GI Bleeding Treated With Hemostatic Powder

Study Overview
=================
Brief Summary
-----------------
This is a retrospective study to identify the prognostic factors of the good outcomes in patients who presented with upper GI bleeding from tumor and received Hemospray via endoscopy for hemostatic control. The good outcomes were assessed by immediate hemostasis, rebleeding at 72 hours as well as 7, 14 and 30 days following presentation at initial bleeding episode and also 6-month survival rate.

Detailed Description
-----------------
Tumor-related gastrointestinal (GI) bleeding is increasing due to the advancement of treatment in oncology. However, conventional endoscopic hemostatic methods are not reliable to control bleeding. Surgery, embolization, and radiotherapy can served as the salvage hemostasis; though, a bridging endoscopic therapy is required during resuscitation and stabilization of the patients. Hemospray is a recent novel endoscopic hemostatis powder which has a trend to be an effective instrument for controlling the active upper GI tumor bleeding from a match-pair, case-control study by the author's recent publication. Consequently, the authors hypothesized that there are some prognostic factors related to the outcome of Hemospray treatment in tumor bleeding.

Official Title
-----------------
Prognostic Factors of Outcome in Patient With Malignant Gastrointestinal Bleeding Treated With a Novel Hemostatic Power

Conditions
-----------------
Death

Intervention / Treatment
-----------------
* Device: Hemostatic powder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients seen in the emergency room and/or hospitalized for malignant gastrointestinal haemorrhage from 2011 to 2017 Exclusion Criteria: Age < 18 years

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 |
| --- | --- |
| Hemospray application<br>The patients with GI bleeding from tumor and received Hemospray as a hemostasis method. | Device: Hemostatic powder<br>* HemosprayTM (Tc-325) is an endoscopic hemostatis powder that came onto market recently. It is made of an inorganic, non-absorbable powder which acts locally at the mucosa. When spraying the powder on to the bleeding site, it creates an adherent stable barrier sheath that allows for at least temporary hemostasis. Neither luminal nor systemic side effects have been reported to date.<br>* Other names: HemosprayTM;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate | Death rate after applying HemosprayTM | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rebleeding rate | Bleeding from tumor after applying HemosprayTM | 30 days |
Correlation Between Vitamin D Status and Bone Mineral Density in Patients With Hemophilia

Study Overview
=================
Brief Summary
-----------------
Study will look at baseline Vitamin D levels, calcium, albumin, liver enzymes, testosterone, osteocalcin, urine N telopeptides, bone mineral density, nutritional assessment and physical activity assessment of boys with hemophilia A or B (ages 2-20 yrs). Patients with low vitamin D levels will receive therapeutic doses of Vitamin D. At end of one year follow up studies will be repeated.

Official Title
-----------------
Correlation Between Vitamin D Status and Bone Mineral Density in Patients With Hemophilia

Conditions
-----------------
Hemophilia A, Hemophilia B, Vitamin D Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D and calcium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of Hemophilia A or B ages 2-21 years Exclusion Criteria: therapeutic vitamin D or calcium supplementation within 3 months of study entry

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hemophilia, Vitamin D deficiency<br>Hemophilia, Rickets - Vitamin D per endocrine consult Hemophilia, Vitamin D deficient - Vitamin D 2000 units daily plus calcium Hemophilia, Normal Vitamin D - no intervention - observation only | Dietary Supplement: Vitamin D and calcium<br>* Doses will be based on Vitamin D levels<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate between Vitamin D deficiency, low bone mass and lack of weight bearing physical activity |  | 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine bone mass (density) in hemophilia patients |  | 1 yr | 
| establish dose and duration of treatment with vitamin D |  | 1 yr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemophilia, Vitamin D
Mechanistic Study of ISIS ISIS-APOCIIIRX in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of ISIS ISIS-APOCIIIRX on Triglyceride Levels and Insulin Sensitivity in Subjects with Type 2 Diabetes on stable treatment with metformin.

Official Title
-----------------
A Randomized, Double Blind, Placebo-Controlled, Phase 2 Study to Investigate the Effects of ISIS 304801 Lowering of ISIS-APOCIIIRX on Triglyceride Levels and Insulin Sensitivity in Subjects With Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: ISIS-APOCIIIRX
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI >/= 25 to </= 40 kg/m2 Type 2 Diabetes Mellitus and on a stable dose of metformin Hypertriglyceridemia Exclusion Criteria: Significant abnormalities in medical history, clinical examination or clinical testing Use of oral anti-diabetic medication other than metformin within 3 months prior to dosing History of outpatient insulin use for more than 2 weeks in the last year

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ISIS-APOCIIIRX<br> | Drug: ISIS-APOCIIIRX<br>* 3 doses of ISIS ISIS-APOCIIIRX on alternate days during the first week and then once-weekly doses for 12 weeks.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 3 doses of placebo on alternate days during the first week and then once-weekly doses for 12 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total apoC-III | The effect of treatment with ISIS ISIS-APOCIIIRX or Placebo on fasting total apoC-III levels. | 91 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Sensitivity | Change from baseline in insulin sensitivity | Day 92 |
An Open-Label Study To Assess The Pharmacokinetics, Safety And Toleration Of Vfend®; Following Multiple Dosing With Vfend

Study Overview
=================
Brief Summary
-----------------
This is a study to investigate the pharmacokinetics, safety and tolerability of intravenous voriconazole and SBECD in patients with moderate renal insufficiency

Detailed Description
-----------------
The study was put on hold after the first subject was enrolled and experienced a serious adverse event (SAE) of renal failure chronic after receiving his I.V. dose on Day 1. The study was taken off hold after the subject recovered and an independent consultant had deemed the SAE as not treatment related; however, the site was unwilling to enroll additional subjects. Another site, based in New Orleans, was damaged by hurricane Katrina and was unable to enroll any subjects. A decision was made by the sponsor to terminate the study on 11 Apr 2006 due to poor study enrollment. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

Official Title
-----------------
An Open-Label Study To Assess The Pharmacokinetics, Safety And Toleration Of Vfend®; Iv Containing Sbecd As An Excipient Following Multiple Dosing With Vfend®; I.V. In Subjects With Moderately Impaired Renal Function

Conditions
-----------------
Kidney Failure

Intervention / Treatment
-----------------
* Drug: Vfend®; I.V.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with moderate renal insufficiency Exclusion Criteria: Active infection

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vfend®; I.V.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to tolerate up to seven days of intravenous voriconazole without worsening of pre-existing renal insufficiency |  |  |