linjc16/ctgov huggingface dataset:
Treatment for Patients With Non-Small Cell Lung Cancer Who Developed Anemia Due to Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia Treatment (PSQ-AT) in non small cell lung cancer patients treated with darbepoetin alfa or recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.

Official Title
-----------------
An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Patient With Non-Small Cell Lung Cancer Treated With Darbepoetin Alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy

Conditions
-----------------
Non-Small Cell Lung Cancer, Anemia

Intervention / Treatment
-----------------
* Drug: darbepoetin alfa
* Drug: recombinant human erythropoietin (rHuEPO)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Subjects receiving multi-cycle chemotherapy for non-small cell lung cancer - Anemia due to chemotherapy (hgb less than or equal to 11.0 g/dL) - Expected to receive greater than or equal to 8 additional weeks of chemotherapy as part of their planned treatment - Karnofsky Performance Scale (KPS) greater than or equal to 50% - Adequate renal function - Adequate liver function Exclusion Criteria: - Iron deficiency - Unstable cardiac disease - Known positive test for human immunodeficiency virus (HIV) infection

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: darbepoetin alfa|nan|
|Drug: recombinant human erythropoietin (rHuEPO)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anemia correction |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient preference |  |  | 
| Activities of daily living |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-small cell lung cancer, darbepoetin alfa, Amgen
UI-EWD for Endoscopic Hemostasis of Bleeding Peptic Ulcers and Bleeding After EMR/ESD

Study Overview
=================
Brief Summary
-----------------
UI-EWD (NextBiomedical Co, Incheon, South Korea), a new hemostatic powder for endoscopic treatment of high-risk bleeding peptic ulcers and bleeding after ESD/EMR.

Detailed Description
-----------------
UI-EWD (Endoscopic Wound Dressing) is adhesive absorbable powder as a new hemostasis material, the therapeutic effect and safety in endoscopic application will be verified. This study has been designed to observe comparing UI-EWD versus the submucosal epinephrine injection for endoscopic hemostasis of bleeding peptic ulcers and bleeding after EMR/ESD.

Official Title
-----------------
A Prospective, Multicenter, Single-blind, Controlled Clinical Trial to Confirm the Efficacy and Safety of 'UI-EWD', a Wound Dressing Used for Wound Protection and Hemostasis After Ulcer Bleeding Due to Peptic Ulcer, EMR and ESD

Conditions
-----------------
Upper Gastrointestinal Bleeding

Intervention / Treatment
-----------------
* Device: UI-EWD Hemostatic system
* Drug: epinephrine endoscopic injection (conventional therapy)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of bleeding peptic ulcer and active bleeding after ESD/EMR Exclusion Criteria: Coagulation disorder (PLT < 50*10^9/L, INR > 2) Connot stop taking the antiplatelet drug, NSAID, Anticoagulant drug, and Aspirin during endoscopic treatment and after 72h endoscopy

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UI-EWD Hemostatic system<br>Patients with upper gastrointestinal bleeding treated with UI-EWD | Device: UI-EWD Hemostatic system<br>* Adhesive endoscopic hemostats, powder type<br>|
| Active Comparator: epinephrine<br>Patients with upper gastrointestinal bleeding treated with submucosal epinephrine injection | Drug: epinephrine endoscopic injection (conventional therapy)<br>* endoscopic submucosal injection of epinephrine (1: 10,000)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent bleeding rate | Rebleeding rate up to 3 days was obtained by clinical manifestations such as melana; decreased hemoglobin > 2g/dL; hemodynamic instability or active bleeding from mucosal defect under endoscope. | 3 days |
Nasal Nitric Oxide Levels in Eosinophilic Esophagitis (EoE)

Study Overview
=================
Brief Summary
-----------------
This study is aimed at understanding whether oral nitric oxide levels can be used as a non-invasive marker for the diagnosis and management of patient with eosinophilic esophagitis (EoE).

Detailed Description
-----------------
Nitric oxide (NO) is produced by activated eosinophils and oral NO levels are known to be elevated in asthma and eosinophilic bronchitis. The measurement of oral NO is a non-invasive,easy to perform low cost procedure that is used frequently in the diagnosis and management of asthma. The diagnosis of eosinophilic esophagitis (EoE) requires conscious sedation, an upper endoscopy with biopsy, and histologic evaluation of the biopsy specimen. This is a costly and somewhat invasive procedure. If oral NO was elevated as a result of activity of esophageal eosinophils in EoE, the measurement of oral NO may potentially be a very convenient and useful test in the evaluation and treatment of EoE. We propose a pilot study to determine if oral NO levels are elevated in patients with eosinophilic esophagitis.

Official Title
-----------------
A Pilot Study: Nasal Nitric Oxide Levels in Eosinophilic Esophagitis.

Conditions
-----------------
Eosinophilic Esophagitis

Intervention / Treatment
-----------------
* Other: Oral Nitric Oxide testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Subjects with dysphagia and active esophageal infiltration (esophageal eosinophilic count of >/= 15 eos/hpf) Subjects with or without a clinical diagnosis of asthma Exclusion criteria: Subjects with chronic cough Severe CAD MI within the last 3 months Cystic fibrosis Tuberculosis Chronic obstructive pulmonary disease (COPD)

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

| Intervention/Treatment |
| --- |
|Other: Oral Nitric Oxide testing|o Oral nitric oxide is measured by a breathing test where the participant will be seated in a chair and asked to breathe out into a small hand-held instrument for about 6 seconds.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with increase in Oral Nitric Oxide levels | To determine if oral NO correlates to activity of disease in EoE | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dysphagia, trouble swallowing, chest pain
The Immunodynamic Effect of Radiotherapy in Prostate Cancer Patients.

Study Overview
=================
Brief Summary
-----------------
Radiotherapy has an important role in the treatment of prostate cancer both as curative treatment and postoperative or salvage ones. Several studies demonstrated a significant reduction of lymphocytes during RT but there are only a few studies monitoring these cells in the treatment of prostate cancer. This study will enroll 50 patients with hystologically proven prostate cancer who will undergo to radiotherapy according to Institutional protocols. This study aims to evaluate the effect of RT on immuno-regulatory B, NK, T, B and T lymphocyte subpopulations (Breg and Treg) and plasma cells, quantitative / qualitative changes,their correlations with the clinical course of the disease and acute and late toxicity. In parallel, using multicolor panels (12 colors) we will evaluate the expression of inhibitory checkpoints and TGFβ signaling. The final objective is to identify new therapeutic targets to be combined with RT.

Official Title
-----------------
Radioinduced Modifications of Lymphocyte Subpopulations Involved in Resistence and Escape Mechanisms to Radiation Therapy of Localized Prostate Cancer.

Conditions
-----------------
Prostatic Neoplasm

Intervention / Treatment
-----------------
* Diagnostic Test: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically documented prostatic cancer Indication to perform radiotherapy treatment Age over 18 years Informed consent Exclusion Criteria: Hematological diseases Autoimmune diseases Previous neoplasias Prior chemotherapy or other therapies that may have violated the hematopoietic organs Patient's refusal to undergo periodic blood samples

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Blood sample|Pazients will undergo to blood samples at predefined times|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to quantify the variation in lymphocyte subpopulations T, NK, B, Breg and Treg, | quantitative variation | 12 months |
Cigarette and Gastric Contents

Study Overview
=================
Brief Summary
-----------------
The aims of this cross over prospective study are to demonstrate that smoking two cigarettes do not change the gastric contents and volume in fasting volunteers.

Conditions
-----------------
Variation of the Antral Area After Cigarettes Smoking or Not

Intervention / Treatment
-----------------
* Behavioral: 2 cigarettes in 15 minutes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA 1 or 2 Volunteers habitual smokers = 5 cigarettes / day during at least 1 year Exclusion Criteria: Digestive Diseases, gastroparesis Non smokers pregnancy history of diabetes mellitus medication affecting gastric motility previous gastrointestinal surgery

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Controle<br>The volunteer do not smoke any cigarette during the study period | |
| Experimental: smoking<br>the volunteer smokes 2 cigarettes in 15 minutes | Behavioral: 2 cigarettes in 15 minutes<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of the ultrasonographically measured antral area afer smoking or non smoking cigarette |  | every 30 minutes during 2h30 |
Puerarin Effects on Alcohol Drinking

Study Overview
=================
Brief Summary
-----------------
This research is designed to assess the impact of pretreatment with puerarin (NPI-031G), a major ingredient in the plant kudzu, on alcohol drinking. Hypothesis: Short-term treatment with this compound will reduce alcohol self-administration in a simulated natural settings laboratory.

Detailed Description
-----------------
Participants will have an opportunity to drink up to 6 beers, plus water and juice, during a 90 minute afternoon drinking session in our simulated apartment room laboratory. Drinking sessions will be conducted in the afternoon after participants take puerarin or placebo for 7 days.

Official Title
-----------------
Puerarin (NPI-031G) Effects on Alcohol Drinking - A Natural Settings Study

Conditions
-----------------
Alcohol Abuse

Intervention / Treatment
-----------------
* Drug: Puerarin, Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: moderate to heavy alcohol drinkers (20+ drinks per week) Exclusion Criteria: alcohol dependence or treatment-seeking drinkers other drug abuse or dependence psychiatric disorders

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Puerarin<br> | Drug: Puerarin, Placebo<br>* 400 mg, three times a day for 7 days<br>* Other names: Placebo: Sugar beet extract;|
| Placebo Comparator: Placebo<br>Sugar beet filler in capsule | Drug: Puerarin, Placebo<br>* 400 mg, three times a day for 7 days<br>* Other names: Placebo: Sugar beet extract;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Alcohol Consumed |  | During a 90 minute drinking session |
Identification of New Serum Diagnostic Markers of Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify blood markers that have the ability to diagnose liver cancer with improved accuracy, so that it can be used alone or in conjunction with alpha-feto protein (AFP)

Detailed Description
-----------------
Liver cancer is a deadly cancer that is typically hard to diagnose and treat. The currently used blood marker for the clinical diagnosis of liver cancer is alpha-feto protein (AFP), which misses 40-60% of patients with liver cancer because it lacks sufficient specificity and sensitivity. The purpose of this study is to identify blood markers that have the ability to diagnose liver cancer with improved accuracy, so that it can be used alone or in conjunction with AFP. The aim of this study is to identify new blood markers of liver cancer that can be used to increase the rate of accurate diagnosis of this malignancy.

Official Title
-----------------
Identification of New Serum Diagnostic Markers of Hepatocellular Carcinoma

Conditions
-----------------
Liver Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with liver cancer based on biopsy or serum AFP level, associated with characteristic hypervascular liver tumors on triphasic spiral CT scan or MRI. Patients with non-cancer liver conditions such as cirrhosis, adenoma, cholangioma, or nodular hyperplasia. Patients with hepatitis B or hepatitis C viral infections not associated with liver cancer. Exclusion Criteria: -Patients will be excluded if, upon looking through their medical records, information required for data analysis are missing.

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 |
| --- | --- | --- |
| Identify new blood markers of liver cancer | Blood specimens collected through another protocol, Patients would have signed informed consent for that protocol, and agreed to have their blood specimens stored for future research such as this one. | upto 12 months |
Return to Play Criteria After Shoulder Dislocation in Upper Limb Athletes: Critical Analysis Between the Habits of Medical Professionals and the Literature

Study Overview
=================
Brief Summary
-----------------
Purpose: Identify the criteria employed by sports medicine specialists in assessing the aptitude/inaptitude of an overhead athlete to return to competition following an antero-internal dislocation of the glenohumeral joint that has been operated or not. Materials and methods: The target population consisted of French-speaking physicians in orthopedic surgery, physical medicine and rehabilitation or sports medicine. This study was conducted by the means of a questionnaire. The list of the most relevant criteria to be included in the questionnaire was established following a literature review.

Official Title
-----------------
Return to Play Criteria After Shoulder Dislocation in Upper Limb Athletes: Critical Analysis Between the Habits of Medical Professionals and the Literature

Conditions
-----------------
Return to Sport, Survey and Questionnaire, Shoulder Dislocation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Professions: physicians in orthopedic surgery, physical medicine and rehabilitation or sports medicine. Language: French Exclusion Criteria: Other professions

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 |
| --- | --- | --- |
| The return to play criteria | Compare the criteria most used by specialists in clearing an overhead athlete to return to competition after a first episode of antero-internal dislocation of the glenohumeral joint with or without surgery and those mentioned in the literature | The questionnaire will last 15 minutes at most |
FCM Analysis GR in Steroid-Treatment Patients

Study Overview
=================
Brief Summary
-----------------
Monitoring the GR with a GR-MoAb and FITC-Dex probes by FCM would be useful and convenient in determination GR before the steroid treatment in clinical, especially in steroid resistant states, in order to design more efficient clinical treatment protocols.

Detailed Description
-----------------
In order to assess the efficacy of this method, 100 patients with nephrotic syndrome and systemic lupus erythematosus receiving sufficient prednisolone thereafter and 50 age- and sex-matched normal controls will be studied.

Official Title
-----------------
Flow Cytometric Analysis of Glucocorticoid Receptor Using Monoclonal Antibody and Fluoresceinated Ligand Probes in Glucocorticoid-Resistant and -Sensitive Patients

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of SLE and NS Exclusion Criteria: Receiving hormone replacement therapy or had received hormone replacement therapy in three months before start of the study Received drugs or drinks containing alcohol within one month Having symptom such as infection Supersensitivity and endocrine disturbance.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 65 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 |
| --- | --- |
| 1<br>glucocorticoid-resistant patients | |
| 2<br>glucocorticoid-sensitive patients | |
| 3<br>normal controls | |

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
-----------------
glucocorticoid-receptor, flow cytometry, glucocorticoid-resistant, prediction