linjc16/ctgov huggingface dataset:
Register for New Oral Anticoagulants

Study Overview
=================
Brief Summary
-----------------
Patients, who are adjusted to a new oral anticoagulant (Dabigatran, Rivaroxaban, Apixaban, Edoxaban) in routine treatment will recorded in this register. Within this register a characterization of patients (with regard to demography and indication) and therapy (with regard to medication, dose and duration) will be done. On basis of defined clinical relevant end points the long-term efficacy and safety will be evaluated.

Official Title
-----------------
Prospective Register Study to Record Safety and Efficacy of New Oral Anticoagulants

Conditions
-----------------
Anticoagulation Treatment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication for treatment with long term anticoagulation initial adjustment or change to nex oral anticoagulant within routine treatment indication for treatment with long term anticoagulation within the register: permanent anticoagulation in arterial fibrillation intended anticoagulation in acute venous thromboembolism for min. 3 months other anticoagulation for min. 3 months within the approved indication Exclusion Criteria: missing Informed Consent Form missing phone number for telephone follow up contraindication for therapy with new oral anticoagulant (Dabigatran, Rivaroxaban, Apixaban, Edoxaban) according to Summary of Product Characteristics

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 |
| --- | --- |
| Dabigatran<br>in atrial fibrillation | |
| Rivaroxaban<br>in atrial fibrillation and VTE | |
| Apixaban<br>in atrial fibrillation and VTE | |
| Edoxaban<br>in atrial fibrillation and VTE | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Bronchoreversibility and Radiologic Morphology of Emphysema

Study Overview
=================
Brief Summary
-----------------
To assess response to bronchodilation with tiotropium plus salbutamol in patients with severe emphysema and analyze relationships between bronchoreversibility response and semiquantitative computed-tomography based emphysema severity measures.

Official Title
-----------------
Response to Bronchodilation With Tiotropium Plus Salbutamol Correlates With Radiologic Morphology of the Lung in COPD of the Emphysematous Phenotype

Conditions
-----------------
Emphysema, COPD

Intervention / Treatment
-----------------
* Drug: Bronchodilators


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Radiologic evidence of severe heterogeneous emphysema GOLD COPD class III-IV No other significant pulmonary comorbidity Quit smoking since at least 4 months

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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 |
| --- | --- |
| Bronchodilators<br>Patients with severe heterogeneous emphysema selected as potential candidtes for lung volume reduction surgery. Bronchodilators employed for the study include albuterol 200µg and tiotropium bromide 18 µg administered by puffs following a first spirometry and plethysmography performed after a washout period of 48h from all bronchodilators and subsequently repeated within 30 min after bronchodilators administration. | Drug: Bronchodilators<br>* Administration of both albuterol and tiotropium bromide after a 48h period of washout from all bronchodilators, followed by spirometry and plethysmography<br>* Other names: Tiotropium bromide;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-bronchodilator FEV1 change | Assessed by spirometry carried out before and after administration of bronchodilators | 1 h | 
| post-bronchodilator change in FVC | Assessed by spirometry carried out before and after administration of bronchodilators | 1h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Emphysema, COPD, bronchoreversibility, ventilatory obstruction, lung volume reduction surgery, LVRS
National Mammography Database

Study Overview
=================
Brief Summary
-----------------
The National Mammography Database (NMD) leverages data that radiology practices are already collecting under federal mandate by providing them with comparative information for national and regional benchmarking. Participants receive semi-annual feedback reports that include important benchmark data such as cancer detection rates, positive predictive value rates and recall rates. Participation in the NMD is free to Breast Imaging Center of Excellence (BICOE) facilities.

Conditions
-----------------
Breast Cancer Screening and Diagnosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Exclusion Criteria: None

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women<br>All women having mammograms | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer Detection Rate | This outcome measure is measured using one year of follow-up after a mammogram is performed on a woman, and is aggregated by interpreting physician. Because the NMD is a registry and screening mammograms are annual exams for most patients, this measure is calculated each year using one year of follow-up. | 1 year |
Using Indirect Calorimetry for Liver Transplants Patients

Study Overview
=================
Brief Summary
-----------------
Although predicted REE calculated using the Penn state 1988 method agreed (ICC 0.61, p=0.00014) with the measured REE, all three predictive equations had a fixed bias and appeared to be inaccurate for predicting REE for liver transplant recipients. Therefore, precise measurements using indirect calorimetry may be helpful when treating critically ill patients to avoid underestimating or overestimating their metabolic needs.

Detailed Description
-----------------
Rationale: The aim of this study was to compare predictive equations with indirect calorimetry and identify the appropriate energy expenditure requirement of liver transplant(LT) recipients in South Korea. Methods: This prospective observational study was conducted in a surgical ICU in an academic tertiary hospital over three months. Thirty mechanically ventilated patients who had received liver transplants and were expected to stay in the ICU more than 2 days were studied. Resting energy expenditure(REE) was measured 48 hours after ICU admission using open-circuit indirect calorimetry. Theoretical REE was estimated using three predictive equations: Harris-Benedict methods, lreton-Jones ventilated, and Penn state 1988. The REEs derived from each predictive equation were compared with the measured REE using an intraclass correlation coefficient (ICC) and a Bland-Altman plot.

Official Title
-----------------
Assessing the Appropriate Energy Expenditure Requirement Using Indirect Calorimetry for Liver Transplant Recipients

Conditions
-----------------
Indirect Calorimetry

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mechanically ventilated patients who had received liver transplants and were expected to stay in the ICU more than 2 days were studied. Exclusion Criteria: Refusal patients who were extubated before 36 hrs

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 |
| --- | --- |
| Indirect calorimetry measurement<br>Using indirect calorimetry for measure resting energy expenditure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing REE with the measurement for each predictive equation and indirect calorimetry | The REEs derived from each predictive equation were compared with the measured REE using an intraclass correlation coefficient (ICC) and a Bland-Altman plot. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
indirect calorimetry, energy expenditure assessment, intensive care unit
Epidemiological Investigation and Cohort Study on Food Allergy in Children Aged 3 to 6 Years in Wenzhou and Taizhou Urban Areas

Study Overview
=================
Brief Summary
-----------------
Objective To investigate the status of food allergy among children aged 3 to 6 in Wenzhou and Taizhou urban areas. To obtain the self-reported rate of parents or guardians of food allergy among children aged 3 to 6 in Wenzhou and Taizhou urban areas. To obtain the prevalence of food allergy among children aged 3 to 6 in Wenzhou and Taizhou urban areas by conducting skin prick test (SPT), blood eosinophil (EOS) count, total immunoglobulin E (tIgE) measurement and serum specific IgE (sIgE) determination in children who self-reported food allergy, and conducting the open food challenge (OFC) if it is needed for further diagnosis. Methods The preschool children aged 3 to 6 from kindergartens in Wenzhou and Taizhou urban areas were selected by cluster sampling and random sampling to conduct a preliminary screening questionnaire. Then telephone interviewe the children who had diseases or problems caused by certain food or certain types of food. Make them finish further food allergy questionnaires, SPT, EOS, tIgE detection, sIgE detection. SPT has 17 kinds of food allergens including milk, egg white, egg yolk, shrimp, crab, wheat, mackerel, perch, cod, peanut, cashew nut, soybean, peach, pineapple, mango, orange and kiwifruit. sIgE has 10 kinds of food allergens including milk, egg white, shrimp, crab, soybean, peanut, wheat, nut mixed group and food mixed group. Children whose results of SPT and/or sIgE didn't meet the diagnostic criteria and children whose results of SPT and sIgE were negative but its history strongly supported food allergy need to conduct OFC. Descriptive analysis and risk factor analysis were carried out on the results, and SPSS 18.0 statistical software was used in statistics analyzation.

Official Title
-----------------
Epidemiological Investigation and Cohort Study on Food Allergy in Children Aged 3 to 6 Years in Wenzhou and Taizhou Urban Areas

Conditions
-----------------
Food Hypersensitivity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The date of birth is in the range of 2011.9.1-2015.8.31 Exclusion Criteria: The date of birth is not in the range of 2011.9.1-2015.8.31 or the children who's parents cannot cooperate

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 6 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 |
| --- | --- | --- |
| the prevalence of food allergy |  | 3 years |
Pilot Study of OXP001 and Brufen in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Oxford Pharmascience (the sponsor) is developing a new formulation of Ibuprofen (OXP001 - the study drug) which it is proposed will have less of the side effects than are currently reported with standard prescription strength Ibuprofen. This study will compare the study drug to an already marketed formulation of prescription strength Ibuprofen (the reference product) by looking at how the drug is taken up by the body and also by performing a specialist procedure called an endoscopy (or more specifically a gastroscopy). The safety and tolerability of the study drug will also be assessed. The study will involve approximately 44 healthy male and female subjects. Subjects will be randomly assigned to receive either the study drug or reference product for 8 days. On Day 1, subjects will receive a single 800 mg dose of ibuprofen. On Days 2 to 9, subjects will receive 800 mg ibuprofen three times a day.

Official Title
-----------------
A Randomised, Open Label, Evaluator Blinded, Multiple Dose, Parallel Arm, Phase I Pilot Study of OXP001 Ibuprofen 400 mg Tablets and Brufen 400 mg Tablets in Normal, Healthy, Adult, Human Subjects Under Fasting Conditions to Assess The Incidence of Upper Gastrointestinal Irritation

Conditions
-----------------
NSAID Related Gastric Irritation

Intervention / Treatment
-----------------
* Drug: OXP001
* Drug: Ibuprofen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Aged 18-55 years Normal, healthy upper gastrointestinal tract Exclusion Criteria: History of or concurrent gastric irritation or ulcers History of allergy to non-steroidal anti-inflammatory drugs (NSAIDs)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: OXP001<br>OXP001 | Drug: OXP001<br> <br> |
| Active Comparator: Ibuprofen<br>Brufen | Drug: Ibuprofen<br> <br> * Other names: Brufen;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric irritation as measured by a Lanza score |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of erosions |  | 7 days | 
| Number of ulcers |  | 7 days | 
| Incidence of gastric irritation |  | 7 days | 
| Lanza score in stomach and duodenum |  | 7 days |
Efficacy of H2 Receptor Antagonist in Prevention of Thienopyridine-related Peptic Ulcer

Study Overview
=================
Brief Summary
-----------------
Whether H2 receptor antagonist can prevent thienopyridine-related peptic ulcer remains unclear.

Detailed Description
-----------------
The aim of the prospective, randomized study is investigate the efficacy of H2 receptor antagonist in prevention of thienopyridine-related peptic ulcer and gastrointestinal bleeding in patients with an ulcer history. We plan to enroll 236 thienopyridine (clopidogrel or ticlopidine) users with a peptic ulcer history who don't have baseline gastroduodenal ulcers at initial endoscopy . The patients will be randomly assigned to receive either (1) famotidine (40 mg qd) plus thienopyridine used previously or (2) placebo plus thienopyridine treatment alone for 6 months. The ulcer recurrence rate between the treatment gruops will be compared.

Official Title
-----------------
Efficacy of H2 Receptor Antagonist in Prevention of Thienopyridine-related Peptic Ulcer

Conditions
-----------------
Peptic Ulcer

Intervention / Treatment
-----------------
* Drug: histamine-2 receptor antagonist
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The past history of gastroduodenal ulcer and underwent endoscopy for dyspeptic symptoms. thienopyridine users without baseline gastroduodenal ulcer at initial endoscopy. They are adult patients aged least 20 years of age. Exclusion Criteria: They have a history of gastric or duodenal surgery other than oversewing of a perforation. They require long-term treatment with non-steroidal anti-inflammatory drugs. serious disease.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: histamine-2 receptor antagonist group<br>famotidine 40mg qd for 6 months. | Drug: histamine-2 receptor antagonist<br>* famotidine 40 mg qd plus thienopyridine<br>* Other names: famotidine 40 mg qd;|
| Placebo Comparator: placebo group<br>placebo for 6 months. | Drug: Placebo<br>* placebo plus thienopyridine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Healed Peptic Ulcer | Follow-up endoscopy was performed at the end of the 6th month | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
histamine-2 receptor antagonist, peptic ulcer, thienopyridine, prevention
Selective Bronchial Intubation (SBI)

Study Overview
=================
Brief Summary
-----------------
Difficult orotracheal intubation carries a risk of hemodynamic collapse, neurological sequelae secondary to cerebral anoxia or death. Anesthetic scores and predictive indices are used to predict difficulties and avoid complications for usual tracheal intubation. However, existing indices are not adapted to selective bronchial intubations. The aim of the study is to determine the incidence of unexpected difficult SBI using conventional screening tests. It is a prospective descriptive epidemiological monocentric study comparing two groups of patients (selective vs. non selective intubations).

Official Title
-----------------
Selective Bronchial Intubation (SBI) at Marie Lannelongue Hospital (HML) : Epidemiology of Expected and Unexpected Difficult Intubations.

Conditions
-----------------
Selective Bronchial Tube

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For adult patients : age greater than or equal to 18 years Patients with thoracic, cardiac, vascular or plastic surgery Exclusion Criteria: Intubations performed before admission to the operating room or catheterization room; Patient whose age is less than 18 years Traditional re-intubation at the end of the procedure after a selective lung IOT; Selective re-intubation in a patient previously intubated on arrival at the operating theater; IOT in other departments of the HML (intensive care, Pulmonary Postoperative Unit (UPOP), bronchoscopy, hospitalization services, Intensive Care Unit (ICU), etc.).

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 |
| --- | --- | --- |
| Rate of difficult selective bronchial intubation | Rate (percentage) | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive factors of difficult selective bronchial intubation | questionnaire | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
difficult orotracheal intubation, selective lung intubation, unexpected difficult selective lung intubation
Patient-Derived Organoids for Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the feasibility of establishing patient-derived organoids from pre-treatment rectal adenocarcinoma biopsies.

Official Title
-----------------
Feasibility of Establishing Patient-Derived Organoids for Rectal Cancer: A Biospecimen Collection Protocol

Conditions
-----------------
Rectum Cancer

Intervention / Treatment
-----------------
* Other: Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Age ≥18 years old. Able to provide informed consent. Undergoing proctoscopy. Exclusion 1. Patient not planned to receive neoadjuvant radiotherapy

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Organoid<br> | Other: Biopsy<br>* Tissue biopsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Biopsies That Form Spherical Organoids |  | Baseline |