linjc16/ctgov huggingface dataset:
Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis

Study Overview
=================
Brief Summary
-----------------
Immunoglobulin G4-related disease (IgG4-RD) is an uncommon inflammatory disorder that may affect multiple organ systems, including the biliary tree. IgG4-sclerosing cholangitis (IgG4-SC) can be difficult to distinguish from primary sclerosing cholangitis (PSC) or cholangiocarcinoma (CCA). The investigators aim to evaluate the sensitivity and specificity of bile for the diagnosis of IgG4-SC. Bile samples of patients with biliary strictures of various causes, including IgG4-SC, PSC, and CCA, will be collected during clinical cholangiography procedures. IgG4 will be measured in bile specimens and bile IgG4 concentrations compared between IgG4-SC, PSC, CCA, and other types of biliary strictures.

Detailed Description
-----------------
This study will recruit cases from Mayo Clinic Rochester and Japanese institutions such as Nagoya City University Hospital, Nagoya Daini Red Cross Hospital, and Kurashiki Central hospital. Participants will be individuals who will receive endoscopic retrograde cholangiography (ERC), endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) or percutaneous transhepatic cholangiography (PTC). Bile samples collected from the target cases will be assayed for IgG4 concentration.

Official Title
-----------------
Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis

Conditions
-----------------
IgG4-related Sclerosing Cholangitis, IgG4-related Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The presence of a biliary stricture 18 years and older Consented to IRB 707-03 Exclusion Criteria: Younger than 18 years of age Unable to collect a bile sample Abnormal postsurgical anatomy preventing collection of a bile sample

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 |
| --- | --- |
| IgG4-related sclerosing cholangitis<br>Patients with IgG4-related sclerosing cholangitis (also called IgG4 associated cholangitis, IgG4 related cholangitis, or biliary IgG4-related disease) | |
| Controls<br>cholangiocarcinoma, PSC, and other patients with biliary strictures | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability of bile IgG4 concentration to distinguish between IgG4-SC, PSC, and CCA. | Bile concentration of IgG4 will be measured in cases and controls, and the groups will be compared using appropriate statistical methods | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between bile and serum IgG4 concentrations. | The relationship between Bile and serum IgG4 concentrations will be assessed for case and controls, using appropriate statistical methods | 2 years |
Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This is a trial of 5 fraction SBRT combined with androgen deprivation therapy for patients with localized high-risk or unfavorable intermediate risk prostate cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Radiation: SBRT
* Drug: Androgen deprivation therapy (ADT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed primary non-metastatic adenocarcinoma of the prostate High-risk or unfavorable intermediate-risk as defined below: High-risk localized prostate cancer, as defined by any one of the following factors: Pre-biopsy or any PSA ≥20 prior to enrollment, or Gleason score 8 or higher on any biopsy core, or cT3a or higher. Unfavorable intermediate risk localized prostate cancer, as defined as any of the following factors: Gleason score of 4+3 or higher on any biopsy core, or Gleason score 3+4 and >50% biopsy cores positive, or The presence of any two of the following: PSA>10, cT2b-c, Gleason score 3+4 in any core No pelvic nodal metastases (based on CT or MRI findings) No distant metastases, based upon: CT scan or MRI of the pelvis within 120 days prior to registration, Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis Age ≥ 18 KPS ≥ 70 (or ECOG 0-2) Ability to understand, and willingness to sign, the written informed consent Exclusion Criteria: Patients with low-risk or favorable intermediate-risk prostate cancer do not meet inclusion criteria (these patients would be eligible for SBRT off-trial as a standard of care option) Patients with any evidence of distant metastases Hormonal therapy (LHRH agonist or oral anti-androgen) exceeding 7 months prior to registration Prior cryosurgery, HIFU or brachytherapy of the prostate Prior pelvic radiotherapy History of Crohn's Disease or Ulcerative Colitis
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBRT and ADT<br>Patients undergo SBRT to a dose of 40 Gy in 5 fractions to prostate, and optional 25 Gy in 5 fractions to SVs and Pelvic LNs, with 9 months of Androgen Deprivation Therapy | Radiation: SBRT<br> <br> Drug: Androgen deprivation therapy (ADT)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival | progression is defined by biochemical (phoenix definition), clinical, or radiographic | 5 years |
Laparoscopic Cholecystectomy for Acute Calculous Cholecystitis in the Elderly: A Retrospective Study.

Study Overview
=================
Brief Summary
-----------------
With the progressive aging of the population in industrialized countries, acute calculous cholecystitis (ACC) has been constantly increasing among elderly. Because ACC is the most common complication of biliary gallstone disease and the population will become older, ACC in elderly is expected to increase. In 2017, the incidence of gallstone disease in Italian population is was 18.8% in women and 9.5% in men; the prevalence was 15% and 24% at 70 years and 24% and 35% at 90 years for males and females respectively. Since the increase in age is often associated with an increase in comorbidity, fragility, surgery related complications, morbidity and mortality, the surgical indication for gallstone is still debated and often based on anesthetic risk. In order to avoid surgery for elderly and high-risk patients, alternative treatments to surgery have been developed. The present study aimed to compare two groups of patients with acute calculous cholecystitis undergone laparoscopic cholecystectomy, under and over 70 years old and to assess whether laparoscopy can offer the same safety and efficacy to older people.

Official Title
-----------------
Laparoscopic Cholecystectomy for Acute Calculous Cholecystitis in the Elderly: More Complex But Equally Safe and Effective. A Retrospective Study on 879 Patients.

Conditions
-----------------
Acute Cholecystitis

Intervention / Treatment
-----------------
* Procedure: Laparoscopic Cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute calculous cholecystitis Exclusion Criteria: tumors of the biliary tract

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| UNDER 70 Y-O<br> | Procedure: Laparoscopic Cholecystectomy<br>* Laparoscopic Cholecystectomy<br>|
| OVER 70 Y-O<br> | Procedure: Laparoscopic Cholecystectomy<br>* Laparoscopic Cholecystectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital morbidity |  | 30 day | 
| In-hospital mortality |  | 30 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| conversion to open rate |  | 30-day | 
| length of stay |  | 30-day | 
| major complication rate |  | 30-day |
Study of Atenolol Influence on Blood Pressure During Resistance Exercise

Study Overview
=================
Brief Summary
-----------------
The study was designed to investigate if atenolol is able to blunt blood pressure increase during resistance exercise in hypertensive subjects.

Detailed Description
-----------------
The study compared intra-arterial blood pressure responses during leg-extension resistance exercise performed to fatigue at 40, 80 and 100% of 1 RM in hypertensive patients receiving placebo (first) and atenolol (second) on a single blind manner.

Official Title
-----------------
Blood Pressure Response During Resistance Exercise in Hypertensives: Influence of Beta-blockers

Conditions
-----------------
Blood Pressure, Exercise

Intervention / Treatment
-----------------
* Drug: atenolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hypertension with blood pressure levels below 160/105 mmHg under placebo. age between 30 and 60 years nonobese Exclusion Criteria: target organ lesion cardiovascular risk factor cardiovascular disease physically active

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: atenolol<br>subjects received 6 weeks of atenolol | Drug: atenolol<br>* 25 mg/day, twice a day for 6 weeks<br>* Other names: beta-blockers;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure during resistance exercise |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
resistance exercise, beta-blockers, blood pressure
Long-term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia

Study Overview
=================
Brief Summary
-----------------
Itopride is a compound already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms of functional dyspepsia. Patients suffering from this condition have difficulties digesting food. Patients feel full after eating, they have bloating and have stomach pain. The goal of this study is to see if Itopride helps to relieve the symptoms of functional dyspepsia on a long-term basis.

Detailed Description
-----------------
All patients having completed study ITOFD04-01 will be offered to continue to be treated with itopride for a period of up to one year in duration. A target of 300 patients will be followed up for 6 months. Of these, a target of 100 patients will be kept on treatment for an additional 6 months. Patients will need to come to the clinic for evaluations every 8 weeks during the trial. Evaluations done at these visits will include: lab tests, evaluation of the heartburn condition, and a questionnaire needed to be completed by the patient to see if the drug is helpful in relieving their symptoms.

Official Title
-----------------
A Multicentre, Open-label Extension Phase to Study the Long-term Safety and Efficacy of Itopride HCl in Patients Suffering From Functional Dyspepsia

Conditions
-----------------
Dyspepsia

Intervention / Treatment
-----------------
* Drug: Itopride hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have completed the 8 week double-blind study ITOFD04-01 Female patients must not be pregnant (must have a negative serum pregnancy test) Exclusion Criteria: Patients with any newly occurring medical condition which was an exclusion criterion at ITOFD04-01 study entry

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Itopride hydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term relief of symptoms |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abdominal Symptom relief, Fullness, Bloating, Indigestion, Functional dyspepsia
Central Serous Chorioretinopathy: Etiology, Course and Prognosis

Study Overview
=================
Brief Summary
-----------------
Pathogenesis of central serous chorioretinopathy is not entirely understood yet, therefore further investigations are needed. During this study patients with an acute episode of central serous chorioretinopathy are observed with established ophthalmologic methods (multimodal imagine) every 6 weeks until subretinal fluid is reabsorbed to gain further insides in etiology, course and prognosis of this disease.

Detailed Description
-----------------
Patients with central serous chorioretinopathy are recruited from the Department of Ophthalmology at the Medical University of Vienna. All patients undergo ETDRS visual acuity measurement, Pelli-Robson contrast examination, Amsler-Grid testing, questionnaire testing, ophthalmologic examination, SD-OCT and polarization-sensitive OCT, fundus autofluorescence, fluorescein angiography, indocyanine-green angiography, fundus photo and microperimetry. Patients are re-examined after an interval of 6 weeks until subretinal fluid is entirely reabsorbed to gain further insides in etiology, course and prognosis of this disease.

Official Title
-----------------
Central Serous Chorioretinopathy: An Observational Study About Etiology, Course and Prognosis

Conditions
-----------------
Central Serous Chorioretinopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent form Age over 18 years acute episode of Central Serous Chorioretinopathy Symptoms for less than two weeks no treatment on study eye Exclusion Criteria: bad compliance protected patient group (pregnant women)

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 |
| --- | --- | --- |
| Clinical Outcome | OCT, Visus | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subclinical Data | FA findings, retinal sensitivity in Microperimetry, contrast sensitivity, Amsler Grid Test | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CCS, CSC, Subretinal Fluid, multimodal imaging
Cologne Cohort of Neutropenic Patients (CoCoNut)

Study Overview
=================
Brief Summary
-----------------
The Cologne Cohort of Neutropenic Patients (CoCoNut) is a non-interventional cohort study assessing risk factors, interventions, and outcome of immunosuppressed patients with or without opportunistic infections.

Detailed Description
-----------------
This prospective cohort was established with the aim of a comprehensive data collection of all patients developing neutropenia after receiving chemotherapy for any kind of malignant disease, treated in the University Hospital of Cologne.

Official Title
-----------------
The Cologne Cohort of Neutropenic Patients (CoCoNut) - a Non-interventional Cohort Study Assessing Risk Factors, Interventions, and Outcome of Immunosuppressed Patients With or Without Opportunistic Infections

Conditions
-----------------
Hematological Malignancies, Cancer, Chemotherapy, Neutropenia, Immunosuppression

Intervention / Treatment
-----------------
* Drug: Antiinfectives


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: immunosuppressed patients Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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 |
| --- | --- |
| Antiinfectives<br>To analyze the efficacy of antiinfectives at high risk patients | Drug: Antiinfectives<br>* To analyze to efficacy of (novel) drug therapies<br>* Other names: Antifungals, Antibacterials, Antivirals;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term survival of hematology and oncology patients following neutropenia |  | 2 years following last follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hematological malignancies, cancer, chemotherapy, anti-infectives, treatment, outcome
Comparative Study of the Wearing Satisfaction of Two Soft Contact Lens Designs.

Study Overview
=================
Brief Summary
-----------------
To evaluate the wearing satisfaction of a new design of the PureVision soft contact lenses.

Official Title
-----------------
Comparative Study of the Wearing Satisfaction of Two Soft Contact Lens Designs

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: PureVision 1
* Device: PureVision 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is myopic Subjects who wear soft contact lenses that are exchanged at least biweekly at the time consent is obtained. Exclusion Criteria: Systemic disease affecting ocular health Using pharmaceuticals that may affect the function of the eyes or lenses. Subject possessing corneal infiltrate or corneal ulcers.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PureVision 1<br>PureVision soft contact lens design #1. | Device: PureVision 1<br>* Currently marketed PureVision soft contact lens.<br>|
| Experimental: PureVision 2<br>PureVision soft contact lens design #2 | Device: PureVision 2<br>* Alternate design soft contact lens.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction |  | 4 weeks |
BETERNet Notch Signaling and Novel Biomarkers for Barretts Esophagus

Study Overview
=================
Brief Summary
-----------------
This research study hopes to identify new molecular markers in the tissue of Barrett's esophagus that will help physicians better understand and manage this condition. Patients undergoing an upper endoscopy will be asked to complete a gastroesophageal reflux disease (GERD) questionnaire, provide a blood sample and allow additional biopsies to be taken during the procedure.

Detailed Description
-----------------
This research study hopes to identify new molecular markers in the tissue of Barrett's esophagus that will help physicians better understand and manage this condition. Currently there is very little understanding as to how Barrett's esophagus develops and why some people with Barrett's esophagus go on to develop esophageal cancer. The purpose of this study is to develop a better understanding of how these processes occur. The investigators also hope to use the information from this study to identify new molecular markers that the investigators can use to better determine who will or will not go on to develop esophageal cancer. Patients who have been diagnosed in the past with Barrett's esophagus will be asked to participate. Patients without Barrett's esophagus will be asked to take part so that the investigators can compare tissue from patients without the conditions to those with the conditions.

Official Title
-----------------
Notch Signaling and Novel Biomarkers for Barretts Esophagus

Conditions
-----------------
Barrett's Esophagus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For BE patients: History of histologically confirmed BE, defined as endoscopically-suspected BE with intestinal metaplasia with globlet cells on esophageal biopsies, BE length C1M1 or C0M2 Age 18 years Exclusion Criteria: History of gastric or esophageal surgery Inability to give informed consent Erosive esophagitis seen on upper endoscopy History of prior endoscopic therapy for BE 5 (for controls) History of intestinal metaplasia on previous esophageal, GE junction or cardia biopsies.

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 |
| --- | --- |
| With Barrett's Esophagus<br>Patients who have been diagnosed in the past with Barrett's Esophagus | |
| Without Barrett's Esophagus<br>Patients without Barrett's Esophagus will be asked to take part so that comparison can be made with patients' tissue for those with the condition and those without the condition. | |

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
-----------------
Barrett's esophagus