linjc16/ctgov huggingface dataset:
MDT to Evaluate the Survival Benefit of Patients With Advanced Gastric / Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
This is a prospective, multicenter, non-interventional, controlled clinical study. Evaluate MDT performance and benefit analysis in patients with advanced gastric or colorectal cancer after MDT discussion under real medical practice.

Official Title
-----------------
A Prospective, Multicenter, Prospective, Non-intervention, Controlled Trial of MDT to Evaluate the Survival Benefit of Patients With Advanced Gastric / Colorectal Cancer in Realistic Medical Practice

Conditions
-----------------
Multi-disciplinary Treatment

Intervention / Treatment
-----------------
* Procedure: Multi-disciplinary Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histopathological diagnosis of recurrent / metastatic gastric or colorectal cancer. Participate in formal MDT discussions at the Research Center. MDT decision-making at least two subjects involved in treatment. Patient informed consent and signed written consent. Exclusion Criteria: Early or locally advanced gastric cancer or colorectal cancer. Accept informal MDT discussions. MDT decisions recommend only a single subject for treatment of patients. MDT decisions recommend only palliative patients.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| fully implemented to the MDT decision<br>group of patients fully implemented to the MDT decision | Procedure: Multi-disciplinary Treatment<br>* due to suggestion of Multi-disciplinary Treatment ,the patients would be suggested to chemotherapy or surgery.<br>|
| not completly implemented to the MDT-decision<br>group of patients not completly implemented to the MDT decision | Procedure: Multi-disciplinary Treatment<br>* due to suggestion of Multi-disciplinary Treatment ,the patients would be suggested to chemotherapy or surgery.<br>|
| not implemented to the MDT decision<br>group of patients not implemented to the MDT decision | Procedure: Multi-disciplinary Treatment<br>* due to suggestion of Multi-disciplinary Treatment ,the patients would be suggested to chemotherapy or surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in overall survival after performing MDT at center | Differences in overall survival after performing MDT at center | 1 years |
Evaluation of Efficacy and Safety of Specific Immunotherapy With Modified Allergen Extracts of House Dust Mites

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the efficacy and safety of specific subcutaneous immunotherapy with modified allergen extracts.

Official Title
-----------------
A Double-blind Placebo-controlled Trial to Evaluate Efficacy and Safety of Specific Subcutaneous Immunotherapy in Patients With Perennial Allergic Rhinitis Due to House Dust Mites

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Biological: modified allergen extract of house dust mites
* Biological: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive history of perennial allergic rhinitis due to house dust mites Positive screening skin prick test (wheal diameter > 3 mm) Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication Signed and dated patient´s Informed Consent, Exclusion Criteria: Previous immunotherapy with mite extracts within the last 3 years, Simultaneous participation in other clinical trials, Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance), Auto-immune disorders, Severe chronic inflammatory diseases, Malignancy, Alcohol abuse, Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection, Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: modified allergen extract of house dust mites<br> | Biological: modified allergen extract of house dust mites<br>* subcutaneous injections<br>|
| Placebo Comparator: Placebo<br> | Biological: placebo<br>* subcutaneous injections<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom and medication score |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the treatment |  | 1 year | 
| Documentation of adverse events |  | 1 year | 
| Clinical global improvement |  | 1 year | 
| Quality of Life Questionnaire |  | 1 year |
Emergency Use of OCR-002 in Acute Liver Failure (ALF)

Study Overview
=================
Brief Summary
-----------------
This study provides emergency use of the unapproved study medication in ALF patients with acute liver failure who are not responding to standard of care.

Detailed Description
-----------------
This is an open-label study in patients diagnosed with ALF who are not responding to the institution's standards of care. Standard of care may include, but is not limited to, administration of N-acetylcysteine, lactulose, hypothermia therapy, and consideration for orthotopic liver transplant.

Official Title
-----------------
Emergency Use of OCR-002 (Ornithine Phenylacetate) in the Treatment of Patients With Acute Liver Failure

Conditions
-----------------
Acute Liver Failure

Intervention / Treatment
-----------------
* Drug: OCR-002


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: International Normalized Ratio (INR) ≥1.5 with encephalopathy in patient with no prior history of liver disease Venous ammonia level of ≥ 100 μmol/L Exclusion Criteria: Patients who are pregnant
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: OCR-002|daily dose: 10 g infused over 24 hours|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study to Evaluate The Analgesic Efficacy and Safety of Intravenous Paracetamol in Subjects With Postoperative Pain After Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The main purpose is to evaluate the analgesic efficacy of 1g of intravenous (Iv) paracetamol versus i.v. placebo, administered every 6h, as measured by the reduction of the 24-hour cumulative dose of the opioid tramadol in the treatment of postoperative pain following total hip arthroplasty.

Official Title
-----------------
A Phase IV, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Analgesic Efficacy And Safety of IV Paracetamol Versus Placebo in Subjects With Postoperative Pain After Total Hip Arthroplasty

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Paracetamol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spinal anesth BMI 10-35 No pain conditions/concom med may alter pain quantif. Exclusion Criteria: Other add. surgery Liver/Renal function altered coagulation alterations Respir / Cardiac insufficiency Agents affecting microsomal syst

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: Paracetamol<br>* IV Solution, Intravenous, 100 mL (10 mg/mL), 4 times at 6-hour intervals, 24 hours<br>* Other names: Perfalgan;|
| Placebo Comparator: B<br> | Drug: Placebo<br>* IV Solution, Intravenous, 100 mL (0 mg/mL), 4 times at 6-hour intervals, 24 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour cumulative dose of tramadol |  | 24 hours, defining TO as the start time of the first dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sum of tramadol and Boluses number, Time from study drug start to tramadol start, total opioid use, Pain intensity scores/diff. from baseline, Global efficacy evaluation, Number of AE, Sedation level, Nausea/Vomiting, Antiemetic needs. |  | 24 hours, defining TO as the start time of the first dose of study drug | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subjects with postoperative pain after Total Hip Arthroplasty
The Role of Stem Cells on Immune Cells in the Development of Cardiovascular Diseases

Study Overview
=================
Brief Summary
-----------------
An observational pilot proof-of-principle study. 15 patients with significant coronary artery disease and 15 matched controls. To investigate whether long-term activation of the innate immune system, named 'trained innate immunity', occurs at the level of the bone marrow progenitor cells in patients with significant coronary artery disease and whether this correlates with the proinflammatory phenotype of monocytes.

Official Title
-----------------
Phenotypic and Epigenetic Trained Immunity Characteristics of Hematopoietic Stem and Progenitor Cells in Patients With Established Atherosclerosis

Conditions
-----------------
Atherosclerosis, Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 and ≤75 years With or without significant coronary artery disease on CCTA Written informed consent Exclusion Criteria: Chronic infections Diabetes mellitus Medical history of any disease associated with immune deficiency Clinically significant infections within 3 months prior to study entry Recent hospital admission or surgery with general anaesthesia Known chronic kidney or liver disease Previous vaccination within 3 months prior to study entry Inability to personally provide written informed consent Inability to undergo PET-CT scanning Chronic use of anti-inflammatory drugs such as NSAIDs History of haematological malignant disease Documented bleeding diathesis or thrombocytopenia Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Atherosclerosis group<br>Patients with significant coronary artery disease. | |
| Control group<br>Healthy controls without confirmed coronary artery disease. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phenotypical characteristics of HSPC's | Phenotypical characteristics of HSPC's populations of patients with and without significant coronary artery disease by flowcytometry in percentages. | Study day 2 for patients | 
| Cytokine response of circulating monocytes | Cytokine response of monocytes of patients with and without significant coronary artery disease after 24 hour stimulation with several stimuli measured in cytokine levels. | Study day 2 for patients | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hematopoietic Stem Cells
Bioequivalency Study of Zidovudine Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to assess the bioequivalence of Roxane's zidovudine 300 mg tablet compared to GlaxoSmithKline's Retrovir® 300 mg tablet under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Official Title
-----------------
A Single Dose, Two Treatment, Two Period, Two Sequence, Crossover Bioequivalency Study of 300 mg Zidovudine Tablets Under Fed Conditions

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

Intervention / Treatment
-----------------
* Drug: Zidovudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Participation in a clinical trial within 30 days prior to study initiation. Positive blood screen for HIV or Hepatitis B and C. History of allergic or adverse responses to zidovudine.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zidovudine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, Three day washout | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV
Effectiveness of Two Maxillary Expanders in Improving the Transverse Skeletal and Dental Dimensions in Patients With Cleft Lip and Palate

Study Overview
=================
Brief Summary
-----------------
This randomized controlled trial is designed to compare between quadlelix appliance vs hyrax expander regrading the their effectiveness in maxillary expansion in patients with cleft.

Official Title
-----------------
Effectiveness of Two Rapid Maxillary Expanders (Quadhelix vs Hyrax) in Improving the Transverse Skeletal and Dental Dimensions in Patients With Cleft Lip and Palate: A Randomized Clinical Trial

Conditions
-----------------
Cleft Lip and Palate, Maxillary Expansion

Intervention / Treatment
-----------------
* Device: Maxillary Expansion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mixed dentition stage; Both males and females; Lip repair performed between 3 and 6 months of age and palate repair performed between 12 and 24 months of age; Presence of maxillary constriction and posterior crossbite and need for maxillary expansion previous to the secondary bone graft; Permanent first maxillary molars present; Good periodontal health; No previous orthodontic treatment; and Exclusion Criteria: Presence of a syndrome in companion with the present cleft defect. Previous secondary alveolar bone grafting. Taking medications affecting growth.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quadhelix Group<br> | Device: Maxillary Expansion<br>* 2 appliances to expand the maxillary arch<br>|
| Active Comparator: Hyrax Group<br> | Device: Maxillary Expansion<br>* 2 appliances to expand the maxillary arch<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maxillary Expansion | Amount of Maxillary Expansion to be measured as distances (mm) on CBCTs and dental models. | 6 months | 
| Maxillary Expansion | mount of Maxillary Expansion to be measured as angles (degrees) on CBCTs and dental models. | 6 months |
Fetal RhD Genotye Non Invasive Prenatal Determination

Study Overview
=================
Brief Summary
-----------------
Actually, our center is doing the prenatal determination of RhD fetal genotype in all RhD negative pregnant women. The investigator want to demonstrate that this is an useful and efficient method.

Detailed Description
-----------------
This is a retrospective observational study that pretend to demonstrate that the prenatal determination of RhD fetal genotype is useful and efficient in our clinical practice. I'm going to check the clinical history of all negative RhD pregnant women since January 2013 until December 2015. I'll check if prenatal determination matches with postnatal RhD determination of newborn. Usually, when a RhD negative woman is pregnant we administrate gammaglobulin in 28 gestation weeks, after invasive procedures and after delivery if the baby is positive RhD. Althought, the investigators know that the 40 percent of RhD negative pregnant have a negative RhD baby. This study will do posible to know how many gammaglobulins hasn't been necessary thanks to prenatal determination. This is an important thing because gammaglobulin is an humanoid product ( it isn't without heatlth risks,...) and because is expensive. For this reason, if the investigators do universal determination of RhD fetal genotype the investigators can avoid the administration of humanoid product in pregnant women. I want to demonstrate that this practice is very useful and efficient in our population.

Official Title
-----------------
Aplicación en la práctica clínica de la determinación Prenatal no Invasiva en el Genotipo RhD Fetal Durante el Primer Trimestre de la gestación en Gestantes RhD Negativas

Conditions
-----------------
Pregnant Women, Rh-Hr Blood-Group System

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant RhD negative women Exclusion Criteria: Pregnant RhD positive women
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Prenatal determination fetal RhD genotype | RhD negative/ RhD positive | Ten months |
Prevalence and Effect of Detecting Common Mental Disorders in Long-term Sickness Absence

Study Overview
=================
Brief Summary
-----------------
The hypothesis was that a large fraction of individuals with common mental disorders were undetected in long-term sickness and that detection of the disorders by screening, a psychiatric diagnostic examination and feedback to the individuals, primary care, and rehabilitation officers improved return to work, improved quality of life and reduced psychological distress.

Official Title
-----------------
Prevalence and Effect of Detecting Common Mental Disorders in Long-term Sickness Absence

Conditions
-----------------
Psychiatric Disorders, Common Mental Disorders, Depression, Anxiety, Somatoform Disorder

Intervention / Treatment
-----------------
* Procedure: psychiatric examination and feedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First sick-listing between August 30, 2004 and August 29, 2005 in six municipalities (118,000 inhabitants) Exclusion Criteria: Unable to understand Danish and absence due to pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: care as usual<br> | Procedure: psychiatric examination and feedback<br> <br> |
| Experimental: psychiatric examination and feedback<br> | Procedure: psychiatric examination and feedback<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration until return to work | Included individuals were followed until payment of sickness absence compensation was ended | 1-2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological distress by subscales of Hopkins Symptom Checklist Revised (SCL-90-R) | At baseline when entering long-term sickness absence (eight weeks of continuous sickness absence) the psychological distress was measured | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sickness absence, return to work, psychiatric examination, feedback, psychological distress, quality of life, attrition analysis, multiple imputation