linjc16/ctgov huggingface dataset:
Effect of Arista Powder on Bleeding in Reductive Mammary Surgery

Study Overview
=================
Brief Summary
-----------------
To evaluate whether Arista AH which contains microporous polysaccharides used as a powder applied to the wound area during mammary surgery reduces the amount of bleeding and the duration of surgery. Both mammae are operated on in the same procedure, and one side without Arista serves as control side

Detailed Description
-----------------
During the operation,before the first incision a randomization envelope is opened. Always starts on the same side, with or without Arista according to the envelope. After surgery, vacuum drains are placed and the amount of drained material and hgb content is measured 24 hours later by nursing staff blinded to what side had Arista.Patients scores postoperative pain with VAS score bilaterally. Three months postoperatively the patients are checked by a physician blinded for what side had Arista

Official Title
-----------------
Effect of Arista AH-Haemostatic Powder in Plastic Surgery. A Prospective, Consecutive Randomized Study in 30 Women Undergoing Reduction of Both Mamma

Conditions
-----------------
Mammaplasty

Intervention / Treatment
-----------------
* Drug: Arista AH hemostasis powder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women for mammary hypertrophy day surgery. No exclusions in this group.
Sexes Eligible for Study
-----------------
Female

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: Arista AH hemostasis powder|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of surgery |  |  | 
| amount of bleeding on drain |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mammary glands, hemostasis, Mammaplasty
The Effect of Periodontal Treatment on the Level of Free Radicals in the Saliva

Study Overview
=================
Brief Summary
-----------------
This study will examine the relationship between free radicals in the saliva and periodontitis. 30 adults, 15 with periodontitis and 15 as a control group will give a sample of saliva before treatment and after treatment. The investigators will examine the free radicals in both groups.

Detailed Description
-----------------
Periodontal disease is a chronic adult condition. Bacteria implicated in the etiology of this disease causes destruction of connective tissue and bone. As a result of stimulation by bacterial antigen PMN produces free radicals via respiratory burst as a part of host response to infection. Free radicals can be defined as molecules or molecular fragments with an unpaired electron which imparts certain characteristics to the free radicals such as reactivity . Reactive free radicals are able to produce chemical modifications and to damage proteins, lipids, carbohydrates and nucleotides in the tissues.

Official Title
-----------------
The Effect of Periodontal Treatment on the Level of Free Radicals in the Saliva

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18 no medical problems Exclusion Criteria: medical problems

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
saliva, free-radicals, periodontitis
Assessment of Risk Factors for Depression Treatment at a Safety Net Clinic

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to identify the barriers for effective treatment of depression, specifically whether modified CHIS Scale is a valid tool for identifying the high risk patients for depression.

Detailed Description
-----------------
Depression is a major illness that affects 10% of the population in a medical setting. It is often under diagnosed and under treated. It is an illness that can challenge a persons ability to perform even routine daily activities. Review of the charts of patients diagnosed with depression showed 80% of the patients do not have follow up appointments. We wondered if modified CHIS scale could identify the risk factors for medication non-adherence. We hypothesised that modified CHIS Scale an effective tool ,for identifying the compliance of patients with the antidepressant medication. We are conducting a retrospective cohort study at two of our residency based clinics by interviewing approximately 100 patients with CHIS Scale and PHQ9 Questionnaire on their office visits

Official Title
-----------------
Assessment of Risk Factors for Depression Treatment at a Safety Net Clinic

Conditions
-----------------
Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of depression before April 15, 2009 At least one visit since April 15, 2008 Age 18+ 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 |
| --- | --- |
| depression<br>Patients diagnosed with depression before April 15, 2009 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of anti-depressant prescriptions filled |  | August 1, 2008 through July 31, 2009 |
A Study of Two Different Doses of ABT-378/Ritonavir in HIV-Infected Patients Who Have Taken Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and effectiveness of a high dose of ABT-378/ritonavir

Official Title
-----------------
A Study of Two Different Doses of ABT-378/Ritonavir in HIV-Infected Patients Who Have Taken Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Lopinavir/ritonavir
* Drug: Ritonavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: HIV positive Are at least 18 years old Subject has not been treated for an active AIDS-defining opportunistic infection within 15 days of screening HIV RNA level > 1000 copies/mL Previous therapy with at least one protease inhibitor, at least one non-nucleoside reverse transcriptase inhibitor and at least one nucleoside reverse transcriptase inhibitor Exclusion: Subject is pregnant or breast-feeding Subject has received an investigational drug within 30 days prior to screening Have a history of pancreatitis History of intolerance to ritonavir Abnormal laboratory tests at screening

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lopinavir/ritonavir|nan|
|Drug: Ritonavir|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virologic and immunologic activity evaluations include plasma HIV RNA, CD4 and CD8 cell counts |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV
Pharmacokinetic Interaction Between AZD3480 and Donepezil

Study Overview
=================
Brief Summary
-----------------
The aims of this study are to 1) examine the effects of AZD3480 and donepezil on the blood concentrations of each other and 2) assess the safety and tolerability of the combined administration of AZD3480 with donepezil.

Official Title
-----------------
A Double-blind, Randomised, Cross-over, Placebo-controlled Study of Repeated Oral Doses of AZD3480 and a Single Dose of Donepezil to Evaluate the Pharmacokinetic Interaction Between AZD3480 and Donepezil in Healthy Extensive and Poor Metabolisers of CYP2D6

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: AZD3480
* Drug: Donepezil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent prior to any study-specific procedures BMI between 18 and 30 kg/m2 Medical and surgical history and physical examination without any clinically significant findings Genotyped as an EM, defined in this study as having ≥ 1.5 functional CYP2D6 alleles, or a PM, defined as having zero functional CYP2D6 alleles Exclusion Criteria: History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator Clinically significant illness as judged by the Investigator, within two weeks before the first administration of investigational product Female subjects who have a positive pregnancy test or who are pregnant or breast-feeding

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>AZD3480 + Donepezil | Drug: AZD3480<br>* 18 total doses of 40 mg, on days 1-18<br>Drug: Donepezil<br>* One single dose of mg on day 5<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK variables |  | Frequent sampling occasions during | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, blood pressure, pulse, safety lab) |  | During the whole treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy volunteers
Economic Evaluation of Systemic Treatments for Moderate-to-severe Psoriasis

Study Overview
=================
Brief Summary
-----------------
This study is health economic analysis of medicinal treatment options for moderate-to-severe psoriasis vulgaris from the societal perspective. Efficacy data and other clinical outcomes will be derived from an up-to-date meta-analysis of randomized clinical trials (RCTs) for moderate-to-severe psoriasis. Direct and indirect costs will be extracted from various different sources, including summary of product characteristics (SPCs) and the German S3 guideline on psoriasis care, health care utilization data and official statistics. The study aims to investigate the comparative cost-effectiveness of biologic and conventional systemic treatments currently (as of June 1st, 2012) approved for moderate-to-severe plaque-type psoriasis in Germany. Effectiveness will be measured by means of the pooled (Psoriasis Area and Severity Index) PASI-75 response rates as reported in RCTs Direct cost as well as indirect cost will be considered.

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Methotrexate
* Drug: Cyclosporins
* Drug: fumaric acid
* Drug: Acitretin
* Drug: Infliximab
* Drug: etanercept
* Drug: Adalimumab
* Drug: Ustekinumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -diagnosis of moderate-to-severe psoriasis Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Methotrexate|nan|
|Drug: Cyclosporins|nan|
|Drug: fumaric acid|nan|
|Drug: Acitretin|nan|
|Drug: Infliximab|nan|
|Drug: etanercept|nan|
|Drug: Adalimumab|nan|
|Drug: Ustekinumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost per quality-adjusted life year (QALY) gained through treatment with each individual agent compared to supportive care as well as compared to placebo |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
moderate-to-severe psoriasis, cost utility analysis, cost effectiveness analysis, systemic treatment
The Effect of Ketogenic Diet on Malignant Tumors- Recurrence and Progress

Study Overview
=================
Brief Summary
-----------------
The aim of the study is, to study the efficacy of the ketogenic diet in delaying or preventing recurrence and tumor growth progression of patients who have been previously treated by concomitant chemoradiotherapy (6 months) for high-grade glial tumors. It will be an open-label trial of nutritional intervention for up to 1 year. An interim analysis of the data will be carried out to assess safety, compliance and efficacy of the diet. This will be reviewed by both SHS and the Clinical trial team.

Conditions
-----------------
Malignant Tumors

Intervention / Treatment
-----------------
* Other: Nutritional support with Standard diet
* Other: Nutritional intervention with the Ketogenic diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Consenting adults aged ≥ 18 years. Recurrent or progressive high grade glioma after failure of at least one line of standard oncological treatment. Gliomatosis cerebri, including patients declining radiation treatment. Exclusion criteria: Patients with malignant tumors who are receiving treatment at the time of the recruitment. Early termination - patients who will wish to stop their participation in the trial will discontinue the ketogenic diet and return to their usual diet.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard diet: Nutritional support<br> | Other: Nutritional support with Standard diet<br>* Nutritional support with Standard diet<br>|
| Experimental: Nutritional intervention: Ketogenic diet.<br> | Other: Nutritional intervention with the Ketogenic diet<br>* Nutritional intervention with ketogenic diet. The Diet plan will be based on each patient individually according to his nutritional needs. Age, weight, activity levels, culture and food preferences are taken in consideration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the effect of the ketogenic diet on tumor growth progression and longevity in patients with Malignant glioblastoma. | This will be done by comparing tumor size by repeated MRI studies (every 2 months) |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Performance scale and quality of life evaluation (Karnofsky and EQ5D scale) |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with malignant tumors
Study Comparing the Pharmacokinetics, Pharmacodynamics, and Safety of K-312 in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
This study will test single doses of the study drug in increasing amounts to see if it is safe.

Conditions
-----------------
Safety and Tolerability

Intervention / Treatment
-----------------
* Drug: K-312
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject provides written informed consent before any study-specific evaluation is performed. Subject is a healthy adult male or a female of non-childbearing potential between the ages of 18 and 45 years, inclusive. Subject has a body mass index of 18.5 to 32 kg/m2, inclusive. Exclusion Criteria: Subject is a woman who is of childbearing potential or is breastfeeding. Subject has the presence of an active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1 Active<br> | Drug: K-312<br> <br> |
| Experimental: Dose 2 Active<br> | Drug: K-312<br> <br> |
| Experimental: Dose 3 Active<br> | Drug: K-312<br> <br> |
| Experimental: Dose 4 Active<br> | Drug: K-312<br> <br> |
| Experimental: Dose 5 Active<br> | Drug: K-312<br> <br> |
| Experimental: Dose 6 Active<br> | Drug: K-312<br> <br> |
| Experimental: Dose 7 Active<br> | Drug: K-312<br> <br> |
| Placebo Comparator: Dose 1 Placebo<br> | Drug: Placebo<br> <br> |
| Placebo Comparator: Dose 2 Placebo<br> | Drug: Placebo<br> <br> |
| Placebo Comparator: Dose 3 Placebo<br> | Drug: Placebo<br> <br> |
| Placebo Comparator: Dose 4 Placebo<br> | Drug: Placebo<br> <br> |
| Placebo Comparator: Dose 5 Placebo<br> | Drug: Placebo<br> <br> |
| Placebo Comparator: Dose 6 Placebo<br> | Drug: Placebo<br> <br> |
| Placebo Comparator: Dose 7 Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | 10 Days |
Evaluation of the Circulatory Status of Stomach Tube and Gastrooesophageal Anastomosis

Study Overview
=================
Brief Summary
-----------------
The incidence of anastomotic leaks after gastroesophageal anastomosis after thoracolaparoscopic cancer esophagus surgery is high at the Oslo University Hospital. The patients selected for operation shall be investigated for microcirculatory changes at the thoracic anastomosis site and followed up for any post operative anastomotic leaks.

Detailed Description
-----------------
- Microcirculation shall be evaluated during the operation with trans serosal laser doppler flowmetry and visible light spectroscopy (LDFVLS). Different anatomical areas of the stomach and gastric tube shall be examined With LDFVLS to find any changes in SO2, rHb, flow, and velocity. Repeat measurements shall be taken to compare them with the baseline measurements.

Official Title
-----------------
Impact of Circulatory Changes on Thoracic Anastomosis in Patients Undergoing Thoracolaparoscopic Surgery for Oesophageal Carcinoma

Conditions
-----------------
Circulatory; Change, Microcirculation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with oesophageal carcinoma planned to have thoracolaparoscopic operation and thoracic gastroesophageal anastomosis shall be included. Exclusion Criteria: Patients who do not give written consent will not be included.
Sexes Eligible for Study
-----------------
All

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of local microcirculatory changes on the thoracooesophegial anastomosis after cancer oesophagus surgery | Repeated measurements of microcirculation With laser dopper flometer and visible light spectrometry shall be performed trans serosally of the stoach and gastric tube to register changes in microcirculation. Patients shall be followed up for anastomotic leaks. Besides CT angiography shall be performed before surgery. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer oesophagus