linjc16/ctgov huggingface dataset:
Treatment of Mild and Subthreshold Depressive Disorders

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy of a SSRI, cognitive-bahavioral-therapy and a free choice between SSRI and CBT in a sample of primary care patients suffering from mild to moderate depression. Hypotheses: SSRI is superior to placebo CBT is superior to a non-specific supporting group therapy

Official Title
-----------------
Behandlung Von Leichten Und Unterschwelligen Depressionen. Eine Randomisierte, Kontrollierte Studie Zum Wirksamkeitsnachweis Eines Serotonin-Wiederaufnahme-Hemmers (SSRI), Einer Kognitiven Verhaltenstherapie Und Einer Freien Therapiewahl (Treatment of Mild and Subthreshold Depressive Disorders. A Randomized, Controlled Trial on the Efficacy of a Serotonin-Reuptake-Inhibitor (SSRI), a Cognitive-Behavioral Therapy and of Free Choice Between SSRI and CBT)

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: Sertralin
* Behavioral: Cognitive-behavioral therapy
* Drug: Placebo
* Behavioral: Non-specific supporting group therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:(e.g.) subthreshold and mild depressive disorders including dysthymia (HAMD: 8-22) informed consent 18 years Exclusion Criteria:(e.g.) severe mood disorders bipolar disorder recurrent brief depression suicidality alcohol or drug dependency obsessive-compulsive disorder schizoaffective disorder / schizophrenia pregnancy

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sertralin|nan|
|Behavioral: Cognitive-behavioral therapy|nan|
|Drug: Placebo|nan|
|Behavioral: Non-specific supporting group therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAMD (changes between baseline and individual endpoint) |  |  | 
| IDS (changes between baseline and individual endpoint) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BDI (changes between baseline and individual endpoint) |  |  | 
| CGI (changes between baseline and individual endpoint) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, primary care
Evaluation of Preoperative Investigations in Patients With Liver Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the diagnostic procedures emission tomography in combination with a CT scan (PET/CT) and endoscopic ultrasonography (EUS) in the preoperative evaluation of resectability of patients with primary or secondary liver cancers.

Official Title
-----------------
Evaluation of Positron Emission Tomography/ CT Scan, Endoscopic Ultrasono¬Graphy, and Laparoscopic Ultrasonography in the Preoperative Assess¬Ment of Resectability in Patients With Primary and Secondary Liver Cancer

Conditions
-----------------
Primary Liver Cancer, Liver Metastasis

Intervention / Treatment
-----------------
* Procedure: PET/CT scan and EUS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients who are referred to The Department of Surgery, Odense University Hospital, for surgical treatment of suspected or biopsy proven primary or secondary liver cancer. Exclusion Criteria: age less than 18 years patients who are not fit for liver surgery because of co-morbidity patients for whom the extra investigations in the study are considered to give an increased risk because of co-morbidity such as Patients with s-creatinin > 150 micromol/l Patients who take peroral antidiabetic drugs or have a poorly regulated diabetes mellitus patients who do not understand the patient information patients who do not want to participate

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 |
| --- |
|Procedure: PET/CT scan and EUS|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
Acromegaly is a disease characterized by excess growth hormone(GH) and insulin like growth factor(IGF)-1. Pituitary GH secreting adenoma is the major cause of acromegaly. Acromegalic cardiomyopathy is one of the leading causes of death in acromegalic patients. No efficient medicine is available for acromegalic cardiomyopathy until now and there were limited studies. Empagliflozin is proved to decrease the risk of heart failure in diabetic patients and independent of blood glucose control. We planed to evaluate the structure of heart by MRI before and after 6 months treatment with empagliflozin in acromegalic patients to investigate the effect of empagliflozin on acromegalic cardiomyopathy.

Official Title
-----------------
A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy

Conditions
-----------------
Acromegaly, Cardiomyopathies

Intervention / Treatment
-----------------
* Drug: Empagliflozin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with pituitary GH adenomas confirmed by surgery active acromegalic patients although treated with surgery,radiation therapy and somatostatin analogs Exclusion Criteria: patients with contraindications to empagliflozin pregnant patients patients with poor control of hypertension(SBP>150mmHg or DBP>95mmHg patients with contraindications to MRI

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: empagliflozin<br>empagliflozin is added on the basis of the original treatment | Drug: Empagliflozin<br>* empagliflozin of 10mg/day is added on the basis of primary care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular mass index | the changes in left ventricular mass index by heart MRI | 6 months |
Cardiovascular Diagnosis Using µ-Cor - an Interventional Pilot Trial

Study Overview
=================
Brief Summary
-----------------
Subjects that are being treated at the Congestive Heart Failure clinic in Nazareth will be given the µ-Cor system to be added to their standard care, and randomized 1:1 to an interventional arm or a control arm.

Official Title
-----------------
Cardiovascular Diagnosis Using µ-Cor - an Interventional Pilot Trial

Conditions
-----------------
Congestive Heart Failure

Intervention / Treatment
-----------------
* Device: uCor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women 20-90 years old. New York Heart Association (NYHA) class III-IV heart failure Followed by the Congestive Heart Failure (CHF) clinic in Nazareth Left ventricular ejection fraction <35% Requiring treatment with >40mg/day of furosemide* orally or with repeated bolus or intravenous infusion of furosemide* (*or equivalent bumetanide or torasemide). Exclusion Criteria: Pregnancy Subjects who have received a heart transplant. Subjects who are unable or unwilling to follow the study requirements. Patients with allergies or skin sensitivities to electrode hydrogel and/or acrylic based adhesive. Patients with skin breakdown in areas on the chest where device and electrode placement is required

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>For subjects in the Control arm, the parameters measured by the (µ-Cor) µ-Cor system will not be analysed or made available to the investigator. | |
| Experimental: uCor<br>For subjects in the Interventional arm, all of the parameters measured by the (µ-Cor) µ-Cor system will be available to the investigator and will remain blinded to the subjects. The investigator will use µ-Cor information to aid in therapy adjustment decisions during the study period. | Device: uCor<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite of all-cause death or hospitalizations due to heart failure in the Interventional arm compared to the Control arm. |  | 30 days to 3 months |
Impaired Preoperative Nutritional Status as a Risk Factor for Postoperative Clinical Outcome

Study Overview
=================
Brief Summary
-----------------
The aim of this retrospective observational study is to determine the impact of preoperative nutritional status on postoperative outcome. Elective surgical patients were screened with Bio-Impedance-Analysis, Malnutritional Universal Screening Tool, and other variables for body composition. Outcome parameters were collected by patient chart review.

Official Title
-----------------
Impaired Preoperative Nutritional Status as a Risk Factor for Postoperative Clinical Outcome (PreopBIA)

Conditions
-----------------
Nutritional Status

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective surgical intervention Patients must be 18 years or older Ambulation ASA-Score I-IV bioelectrical impedance analysis to determine the phase angle Exclusion Criteria: Emergency surgery Pregnancy ASA Score V-VI Amputated limbs Pacemaker and defibrillators Cerebrovascular events Tattoos on the electrode locations

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 |
| --- | --- |
| Elective surgical patients<br>Elective surgical patients in the Charité University Berlin Campus Charité Mitte | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase-angle |  | preoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight |  | preoperative | 
| body mass index (BMI) |  | preoperative | 
| preoperative weight loss |  | 3 month weight loss before operation | 
| hip/waist ratio |  | preoperative | 
| Malnutrition Universal Screening Tool (MUST) | The MUST is recommended by ESPEN as the preferred screening tool for patients in the community (Kondrup J et al., Clinical Nutrition 2003; 22: 415-421) | preoperative | 
| postoperative complications | The Clavien-Dindo Classification of Surgical Complications (Dindo D., Demartines N., Clavien P.A.; Ann Surg. 2004; 244: 931-937) | postoperative | 
| Length of hospital stay |  | participants will be followed for the duration of hospital stay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malnutrition, Post-operative outcome, Phase angle, MUST, Clavien Dindo classification, Bioelectrical impedance analysis
320-slice Coronary Computed Tomography (CT) Angiography

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to determine the potential utility of 320-slice volume-CT for obtaining adequate diagnostic accuracy while at the same time improving image quality compared with previous generations of CT scanners and simultaneously enabling a reduction in both radiation exposure and contrast agent amount required.

Official Title
-----------------
Coronary Artery Imaging With 320-slice Computed Tomography

Conditions
-----------------
Coronary Artery Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 40 years of age sinus rhythm Exclusion Criteria: prior conventional coronary angiography unstable presentation coronary artery bypass graft or stent pregnancy or breast-feeding creatinine > 2.0 mg per deciliter

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
EFficacy of Prophylactic Clip Application in Decrease of Immediate Postpolypectomy Bleeding and Delayed Postpolypectomy Bleeding After Colonoscopic Removal for a Large Pedunculated Polyps

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the efficacy of prophylactic clip application after colonoscopic removal for a large pedunculated polyp (> 1cm) in preventing immediate postpolypectomy bleeding (IPPB) and delayed postpolypectomy bleeding (DPPB).

Official Title
-----------------
Does a Prophylactic Clip Application Decrease IPPB(Immediate Postpolypectomy Bleeding) and DPPB(Delayed Postpolypectomy Bleeding) After Colonoscopic Removal for a Large Pedunculated Polyps (>1cm)?

Conditions
-----------------
Polyp of Large Intestine

Intervention / Treatment
-----------------
* Procedure: prophylactic clip application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have a large pedunculated polyp(>1cm) in the colon Exclusion Criteria: Age under 20 years Subjects who are taking anticoagulants Subjects who have an abnormal coagulogram (platelet count, international normalized ratio, or activated partial thromboplastin time) Subjects who have inflammatory bowel diseases

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endoclip<br>The group of patients who undergo prophylactic clip application after colonoscopic polypectomy of a large pedunculated polyp(>1cm). | Procedure: prophylactic clip application<br>* prophylactic clip application after colonoscopic polypectomy<br>|
| No Intervention: no endoclip<br>The group of patients who do not undergo prophylactic clip application after colonoscopic polypectomy of a large pedunculated polyp(>1cm). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the occurrence of immediate post-polypectomy bleeding | At 1 day after endoscopic polypectomy, CBC will be done. | 1 day | 
| the occurrence of delayed post-polypectomy bleeding | At 2 weeks after endoscopic polypectomy, history of hematochezia will be taken at outpatient clinic. | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colon polyp, endoscopic polypectomy, postpolypectomy bleeding, prophylactic clip application
Lactobacillus Plantarum: Thumb Osteoarthritis Following Orange Peeling

Study Overview
=================
Brief Summary
-----------------
Case Description osteoarthritis + amputation of the distal phalanx of the right thumb caused by Lactobacillus plantarum after an orange peel. The natural habitat of the bacteria being the orange zest and the bacteria is considered harmless.

Detailed Description
-----------------
Case Description osteoarthritis + amputation of the distal phalanx of the right thumb caused by Lactobacillus plantarum after an orange peel. The natural habitat of the bacteria being the orange zest and the bacteria is considered harmless.

Official Title
-----------------
Lactobacillus Plantarum: Thumb Osteoarthritis Following Orange Peeling

Conditions
-----------------
Lactobacillus Plantarum

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of an osteoarthritis, Amputation of the distal phalanx of the right thumb Exclusion Criteria: Not exclusion criteria
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of Lactobacillus plantarum | This study was conducted like a case report to describe osteoarthritis + amputation of the distal phalanx of the right thumb caused by Lactobacillus plantarum after an orange peel. The natural habitat of the bacteria being the orange zest and the bacteria is considered harmless | Day 1 |
Prevalence of EED and Quality of Life Evaluated by Gastroesophageal Reflux Disease (GERD)-Q in Korean GERD Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to asses the EED symptom prevalence in Koran GERD patients with typical reflux symptom and to evaluate quality of life with the scales including Gerd Q.

Official Title
-----------------
Prevalence of EED and Quality of Life Evaluated by Gastroesophageal Reflux Disease (GERD)-Q in Korean GERD Patients

Conditions
-----------------
Gastroesophageal Reflux Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: GERD patients who have experienced heartburn or acid regurgitation during past 7 days GERD patients who have already undergone endoscopy before enrolment Exclusion Criteria: Involvement in the planning and conduct of the programme The person who took the medicine such as PPI or H2RA during the last 7 days Severe systemic disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| The primary variable is the total rate of GERD patients who had EED symptom and effect on their quality of life. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary variable is the comparison of the EED symptom frequency in ERD and NERD patients. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, Korea, typical symptom, quality of life, Naturalistic, epidemiological
Iron Absorption From GDS Capsules II

Study Overview
=================
Brief Summary
-----------------
Slow release iron capsules containing ferrous sulfate have been designed based on the gastric delivery system. Iron absorption from those capsules administered with and without meals will be measured using stable iron isotopes.

Official Title
-----------------
Iron Absorption Mechanism From a Slow Release Iron Capsule Using the Gastric Delivery System (Ferrous Sulfate)

Conditions
-----------------
Iron Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: GDS capsule with meal
* Dietary Supplement: Ferrous sulfate with meal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female, age 18-50 years, max. body weight 65 kg, serum ferritin < 30 µg/l Exclusion Criteria: pregnancy, lactation, regular intake of medication, blood donation or significant blood losses over the past 4 months

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GDS (gastric delivery system), meal<br>GDS capsule with meal | Dietary Supplement: GDS capsule with meal<br>* GDS capsule with meal<br>|
| Active Comparator: Ferrous sulfate, meal<br>Ferrous sulfate with meal | Dietary Supplement: Ferrous sulfate with meal<br>* Ferrous sulfate with meal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional iron absorption |  | 2 weeks after test meal consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum isotope appearance |  | 1, 2, 4 and 8 hours on days 1 and 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iron absorption, Slow release iron, Gastric delivery system, Iron deficiency