linjc16/ctgov huggingface dataset:
Effects of Allergen Inhalation on Adenosine Receptor Expression in Sputum and Peripheral Blood

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether asthmatics have different adenosine receptor expression profiles than healthy controls. We hypothesize that asthmatics will have increased adenosine receptor expression versus control subjects. We also want to study the effects of allergen inhalation on adenosine receptor expression in asthmatics. We believe that adenosine receptor expression will be upregulated after allergen inhalation. Both hypotheses are being tested in sputum and peripheral blood.

Official Title
-----------------
Effects of Allergen Inhalation on Adenosine Receptor Expression and Mast Cell Activation in Peripheral Blood and Sputum of Asthmatics and Healthy Subjects

Conditions
-----------------
Asthma, Healthy

Intervention / Treatment
-----------------
* Behavioral: allergen inhalation
* Behavioral: withdrawal of medication
* Procedure: sputum induction


Participation Criteria
=================
Eligibility Criteria
-----------------
Asthmatic Subjects - Inclusion Criteria: Clinical diagnosis of asthma Steroid naive or subjects not using their inhaled steroids for the last 4 weeks, short-acting beta-agonist for rescue medication FEV1 > 70% of predicted Positive skin prick test for house dust mite, cat or grass pollen PC20 methacholine or histamine < 8 mg/ml Asthmatic Subjects - Exclusion Criteria: Use of systemic steroids in the previous 6 weeks Asthma exacerbations in the previous 6 weeks Current or ex-smokers with ≥ 10 pack-years (≥ 2 pipe pack-years), ex smokers who stopped less than 1 year ago Healthy Subjects - Inclusion Criteria: No airway complaints FEV1 > 90% of predicted Negative skin prick test PC20 methacholine or histamine > 8 mg/ml Healthy Subjects - Exclusion Criteria: Use of steroids in the previous 6 weeks Current or ex-smokers with ≥ 10 pack-years (≥ 2 pipe pack-years), ex smokers who stopped less than 1 year ago

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: allergen inhalation|nan|
|Behavioral: withdrawal of medication|nan|
|Procedure: sputum induction|nan|

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
-----------------
Adenosine receptors, asthma, sputum, peripheral blood, healthy
CREMS Prostate Biopsy Pain Relief Study

Study Overview
=================
Brief Summary
-----------------
The current standard for pain relief during prostate biopsy is the injection of local anesthetic agents into or around the prostate at various sites including apex, base, lateral aspects and into the prostate itself. Despite such anesthetic injection, some men still experience severe pain and often at the base of the penis. The study audits current practices comparing the degree of pain relief provided by injection at basal versus basal+apical sites. All these injection sites are standard practice at our hospital.

Official Title
-----------------
Pain Relief With Local Anesthetic at Time of Prostate Biopsy: Comparing Apical and Basal Injection Versus Basal Injection Alone

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

Intervention / Treatment
-----------------
* Procedure: anesthetics injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men who come for prostate biopsy Exclusion Criteria: Men who are unwilling or unable to consent and fill in the forms

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: basal injection<br>basal injection of anesthetics | Procedure: anesthetics injection<br>* Basal injection of anesthetics or basal + apical injection of anesthetics.<br>|
| Active Comparator: basal + apical injection<br>basal + apical injection of anesthetics | Procedure: anesthetics injection<br>* Basal injection of anesthetics or basal + apical injection of anesthetics.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores comparing two groups. | Pain questionnaires will be asked to filled in before the procedure, within 20 minutes of the procedure, at 2-4 weeks and at 6-month post procedure. | post prostate biopsy procedure up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of side effects and complications. | Questionnaires will be asked to filled in to assess side effects and complications at 2-4 weeks and at 6-month post procedure. | post prostate biopsy procedure up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate biopsy, pain
Dyspareunia in Women With Endometriosis: Impact of Surgery on Sexual Health

Study Overview
=================
Brief Summary
-----------------
Endometriosis is a disease that affects different areas of individual functioning, including the area of sexual life. Women with endometriosis have an impairment of desire and sexual arousal, orgasmic capacity reducted because of the pain and deep dyspareunia. The aim of the study is to evaluate the effectiveness of surgery on dyspareunia in women with endometriosis, taking into account other variables involved in determining dyspareunia: the quality of the couple relationship, anxiety and depression, body image, coping strategies and resilience.

Official Title
-----------------
Dyspareunia in Women With Endometriosis: Impact of Surgery on Sexual Health

Conditions
-----------------
Dyspareunia, Endometriosis

Intervention / Treatment
-----------------
* Behavioral: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women affected by endometriosis with dyspareunia; Women in waiting list for surgery Exclusion Criteria: Severe underlying comorbidities (gynecological, cardiovascular, respiratory, renal, hematological, endocrine, hepatic, gastrointestinal, neurological) Psychiatric diseases Refusal or inability to sign the informed consent Pregnancy Previous gynecological surgery End of couple relationship

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Couples<br>Women, with their partners, referred to the Obstetrics and Gynecological Department of the University Hospital for surgical treatment of endometriosis. | Behavioral: Questionnaires<br>* Questionnaires<br>|
| Women<br>Women referred to the Obstetrics and Gynecological Department of the University Hospital for surgical treatment of endometriosis. | Behavioral: Questionnaires<br>* Questionnaires<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of sexual life |  | Cases were administered and fulfilled the questionnaires at the moment of diagnosis of endometriosis up to 4weeks; Change from baseline were evalueted 2 months after surgery |
Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy

Study Overview
=================
Brief Summary
-----------------
Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall objective of the study is to evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Active Comparator, Forced-Titration Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 20 or 40 mg Simvastatin With 40 mg Simvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 20 mg Simvastatin Alone

Conditions
-----------------
Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: Fenofibrate/Simvastatin
* Drug: Fenofibrate/Simvastatin
* Drug: Simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mixed dyslipidemia Exclusion Criteria: Known hypersensitivity to fenofibrate or simvastatin Pregnant or lactating women Contra-indication to fenofibrate or simvastatin Unstable or severe cardiac disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: 1<br> | Drug: Fenofibrate/Simvastatin<br>* Combination of Fenofibrate 145mg and Simvastatin 20mg<br>|
| Experimental: 2<br> | Drug: Fenofibrate/Simvastatin<br>* Combination of Fenofibrate and Simvastatin 40 mg<br>|
| Active Comparator: 3<br> | Drug: Simvastatin<br>* Simvastatin 40 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline to 24 weeks of treatment in Triglycerides |  | 12 weeks | 
| Percent change from baseline to 24 weeks of treatment in HDL-C |  | 12 weeks | 
| Percent change from baseline to 24 weeks of treatment in LDL-C |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline to 24 weeks of treatment in Triglycerides |  | 24 weeks | 
| Percent change from baseline to 24 weeks of treatment in HDL-C |  | 24 weeks | 
| Percent change from baseline to 24 weeks of treatment in LDL-C |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin
Metabolism Study to Investigate the Impact of a Sequential Oral Contraceptive

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm the safety of SH T00658ID with regard to plasma lipids, hemostatic variables, and carbohydrate metabolism. In addition, the pharmacokinetic parameter following the long term administration of SH T00658ID will be assessed.

Detailed Description
-----------------
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Official Title
-----------------
A Single-center, Open-label, Controlled, Randomized Study to Investigate the Impact of a Sequential Oral Contraceptive (SH T00658ID) as Compared to a Sequential Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D00264A) on Plasma Lipids, Hemostatic Variables, and Carbohydrate Metabolism in Healthy Female Volunteers Aged 18-50 Years Over 7 Treatment Cycles, Including the Pharmacokinetics

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)
* Drug: SH D00264A (Triquilar)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy female volunteers between 18 and 50 years requiring contraception Exclusion Criteria: Pregnancy or lactation Any conditions that might interfere with the outcome as well as all contraindications for OC use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)<br>* 7 treatment cycles of 28 days each (no tablet-free intervals); Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 8-24: 2.0 mg EV + 3.0 mg DNG; Days 25-26: 1.0 mg EV; Days 27 - 28: Placebo<br>|
| Active Comparator: Arm 2<br> | Drug: SH D00264A (Triquilar)<br>* 7 treatment cycles of 28 days each (no tablet-free intervals);Days 1-6: 0.03 mg EE + 0.05 mg LNG; Days 7-11: 0.04 mg EE + 0.075 mg LNG; Days 12-21: 0.03 mg EE + 0.125 mg LNG;Days 22-28: Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on metabolic parameters (e.g. hemostatic parameters) after 6 month treatment |  | Baseline, Cycle 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of PK parameters |  | Cycle 4, Cycle 7 |
Efficacy and Safety of Intravitreal Bevacizumab for Threshold ROP.

Study Overview
=================
Brief Summary
-----------------
Prospective study to evaluate the efficacy and safety of intravitreal bevacizumab In retinopathy of prematurity (ROP). Bevacizumab 0.75 mg in 0.03 ml was given to stage 2+ or stage 3+ ROP in Zone I or Zone II.

Conditions
-----------------
Stage 2+ or Stage 3+ Retinopathy of Prematurity in Zone I or Zone II.

Intervention / Treatment
-----------------
* Procedure: Intravitreal Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stage 2+ or stage 3+ Retinopathy of prematurity in Zone I or Zone II. Informed written consent by parents or guardian. - Exclusion Criteria: Refusal to give consent Critically ill neonates. -

Ages Eligible for Study
-----------------
Minimum Age: 32 Weeks
Maximum Age: 42 Weeks

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Avastin<br>Bevacizumab(Avastin) 0.75mg in 0.03 ml | Procedure: Intravitreal Bevacizumab<br> <br> * Other names: Intravitreal Avastin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regression Of ROP |  | Minimum 6 months follow up after intravitreal Avastin | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of ROP |  | minimum 6 months of follow up. |
Indocyanine Green and Portal Pressure in Viral and Alcoholic Cirrhotic Patients With Hepatocarcinoma

Study Overview
=================
Brief Summary
-----------------
The aim of the investigators' study is to elucidate the relationship between a functional liver test (e.g., ICG) and the PREOPERATIVE value of portal hypertension in the patients with impaired liver function from alcoholic and non-alcoholic aetiologies. Alcoholic and viral cirrhosis present important differences in terms of cellular mechanisms responsible for the disease progression with a distinct and unique gene expression pattern that regulates the type of inflammatory response. These differences probably influence the hepatic functional reserve and the onset of portal hypertension at a comparable clinical and biological level of derangement and the investigators may expect significant differences in the recovery from hepatectomy. The investigators' hypothesis is that at a comparable ICGR-15 rate non-viral cirrhotic liver presents higher portal pressure values and the investigators also argue that alcoholic cirrhotic patients would tolerate a larger hepatic resection than would viral cirrhotic do.

Official Title
-----------------
Makuuchi Versus Barcelona Clinic of Liver Cancer Criteria in Cirrhotic Patients With Hepatocellular Carcinoma. Does Etiology of Cirrhosis Influence the Relationship Between the Portal Pressure and Quantitative Tests of Liver Function?

Conditions
-----------------
Carcinoma, Hepatocellular, Alcoholic Cirrhosis, Viral Cirrhosis, Postoperative Hepatic Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: resectable or amenable to resection HCC in cirrhotic child A patients of alcoholic or viral etiology Exclusion Criteria: cirrhosis Child-Pugh B absence of patient consent psychiatric pathology
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Alcoholic<br>Alcoholic cirrhotic patient with resectable hepatocellular carcinoma | |
| Viral<br>Viral cirrhotic patient with resectable hepatocellular carcinoma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concordance rate between ICGR-15 and Portal Pressure values in patients with resectable HCC and cirrhosis Child A from alcoholic and non-alcoholic origin. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative liver failure. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatic functional reserve, Hepatocellular carcinoma (HCC), Indocyanine Green retention rate at 15 minutes (ICG-R15'), Portal Pressure (PP), Hepatic Portal Venous Gradient (HPVG), Alcoholic and Viral Cirrhosis, Makuuchi criteria, Barcelona Clinic of Liver Cancer (BCLC), Hepatic resection
Neoadjuvant FOLFIRINOX or Nab-paclitaxel With Gemcitabine for Borderline Resectable Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to clarify the efficacy and safety of neoadjuvant FOLFIRINOX and nab-paclitaxel + gemcitabine for borderline resectable pancreatic cancer.

Official Title
-----------------
Phase II Study of Neoadjuvant FOLFIRINOX or Nab-paclitaxel With Gemcitabine for Borderline Resectable Pancreatic Cancer

Conditions
-----------------
Borderline Resectable Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: FOLFIRINOX
* Drug: gemcitabine + nab-paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Borderline resectable pancreatic cancer (based on NCCN guideline version 2.2015) first treatment for pancreatic cancer performance status 0 or 1 adequate one marrow function adequate renal function obtained informed consent Exclusion Criteria: other active concomitant malignancies other severe medical conditions; contraindication of FOLFIRINOX, paclitaxel and gemcitabine pregnant women no informed consent

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FOLFIRINOX<br>4 course of FILFIRINOX before surgery | Drug: FOLFIRINOX<br> <br> |
| Experimental: GEM + nab-PTX<br>2 course of GEM + nab-PTX before surgery | Drug: gemcitabine + nab-paclitaxel<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0 resection rate | surgery is supposed to be performed 3 months after the initiation of chemotherapy | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| completion rate of chemotherapy | chemotherapy is supposed to take 3 months | 3 months | 
| relative dose intensity | chemotherapy is supposed to take 3 months | 3 months | 
| adverse event | chemotherapy is supposed to take 3 months | 3 months | 
| tumor response | tumor response to chemotherapy will be assessed based on Response Evaluation Criteria In Solid Tumor (RECIST). CR: Complete Response, PR: Partial Response, PD: Progression, SD: Stable Disease, NE: Not Evaluable | 3 months | 
| disease free survival |  | 3 years after the surgery | 
| overall survival |  | 3 years after the surgery | 
| surgical complication |  | 1 month after the surgery | 
| quality of the tumor | Chemotherapy is supposed to take 3 months. After the completion of chemotherapy, the quality of the tumor will be assessed by imaging findings, such as CT number and Standardized uptake value. | 3 months |