linjc16/ctgov huggingface dataset:
Cryotherapy in Breast B3 Lesions

Study Overview
=================
Brief Summary
-----------------
To determine the feasibility of cryotherapy for B3 fibroepithelial lesions

Official Title
-----------------
Pilot Study on the Feasibility of Cryotherapy as an Alternative Treatment for Phyllodes Tumors/Breast Fibroepithelial Lesions (FELs) Needing Surgery

Conditions
-----------------
Breast Disease, Phyllodes Breast Tumor

Intervention / Treatment
-----------------
* Procedure: cryotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lesion seen on ultrasound core biopsy revealed FEL of B3 lesion </+3.5cm keen for cryotherapy instead of surgery has other breast lesions for followup Exclusion Criteria: cancer patients patients with bleeding diathesis lesions causing visible breast deformity

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

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

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

| Intervention/Treatment |
| --- |
|Procedure: cryotherapy|comparison between cryotherapy and surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence of the lesion | assessed on ultrasound | 2 years from procedure | 
| breast cosmetic outcome | patient self assessment of excellent (1), good (2), fair (3) poor (4). score of 1-4,1 being the best score | at 1 year post procedure | 
| pain score | using pain score scale of 0-10, a higher score indicates a worse outcome | immediate post procedure | 
| pain score | using pain score scale of 0-10, a higher score indicates a worse outcome | at 2 weeks post procedure |
Study of Nutritional Supplement Shakes in People About to Receive Their Debulking Surgery for Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if it is possible to establish a nutritional support program for people who are scheduled to receive primary debulking surgery. Design: This will be a prospective observational study to assess the feasibility of implementing a preoperative nutrition supplementation program.

Official Title
-----------------
Preoperative Nutrition Intervention for Patients Undergoing Primary Surgical Debulking of Ovarian Cancer: A Feasibility Study

Conditions
-----------------
Debulking Surgery for Ovarian Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: Ensure Surgery Immunonutrition Shake supplements
* Other: Daily Food Intake form


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 Scheduled to undergo primary surgical debulking of ovarian, fallopian tube and primary peritoneal cancer Have a sufficient preoperative window during which the intervention can occur, with the last day of supplementation at least one and no more than two days prior to surgery; scheduling of the procedure should not be delayed due to participation in this investigation Exclusion Criteria: Have received neoadjuvant chemotherapy Debulking surgery scheduled less than 8 days from initial visit Are scheduled for a minimally invasive procedure Unable to tolerate oral intake or have gastrointestinal issues that would prevent or prohibit oral supplement consumption Have diabetes mellitus Have allergies to the Ensure Surgery Immunonutrition Shake supplement Have galactosemia

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ensure Surgery Immunonutrition Shake supplements<br>Participants will be provided with and instructed to drink three Ensure Surgery Immunonutrition Shake supplements per day for seven days prior to their scheduled procedure. | Dietary Supplement: Ensure Surgery Immunonutrition Shake supplements<br>* Three Ensure Surgery Immunonutrition Shake supplements per day for seven days prior to their scheduled procedure.<br>Other: Daily Food Intake form<br>* On the day of surgery, the patient will return her Daily Supplement/Food Intake Forms and complete the Day of Surgery Intake Form can also be completed the day before surgery and the Daily Supplement/Food Intake Forms can be returned at the patient's postoperative appointment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of patient participation |  | 30 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nutritional Supplement Shakes, 19-108
The Association Between Pain Catastrophizing Scale Score and Postspinal Headache

Study Overview
=================
Brief Summary
-----------------
This study is aimed to elucidate the association between Pain Catastrophizing Scale Score and Postspinal Headache in Patients Underwent Cesarean Section With Spinal Anesthesia.

Detailed Description
-----------------
This study is aimed to elucidate the association between Pain Catastrophizing Scale Score and Postspinal Headache in Patients Underwent Cesarean Section With Spinal Anesthesia. Patients were asked to fill the questionnaire booklet including Pain Catastrophizing Scale, Beck Depression Inventory and Beck Anxiety Inventory before elective cesarean section in preoperative room in operating theater. In postoperative second and fourth day, patients will call by phone and be asked to have headache or any complaints. The intensity of headache will evaluate by using visual analog scale. Age, gender, and visual analog scale scores will be recorded.

Official Title
-----------------
Is There an Association Between Pain Catastrophizing Scale Score and Postspinal Headache in Patients Underwent Cesarean Section With Spinal Anesthesia?

Conditions
-----------------
Pain, Headache

Intervention / Treatment
-----------------
* Procedure: urgent or elective cesarean section


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists score of I, II, III without a history of cerebrovascular diseases without any presence of psychiatric diseases Exclusion Criteria: severe liver, kidney and cardiovascular diseases peripheral arterial diseases a history of allergy to local anesthetics patients without cooperation not to participate in the study presence of neurologic or neuromuscular diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: urgent or elective cesarean section|a kind of surgical procedure to deliver a baby|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain catastrophizing scale score | numerical value obtained using pain catastrophizing scale score | one time in one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck depression inventory | numerical value obtained using Beck depression inventory | one time in one year | 
| beck anxiety inventory | numerical value obtained using beck anxiety inventory | one time in one year | 
| visual analog scale score | numerical value obtained using visual analog scale score | one time in one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain Catastrophizing Scale
Imaging Control Study, 3D Echo, MR and RHC.

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to intensify the follow up of patients with pulmonary arterial hypertension via modern imaging guided methods in due consideration of the possibilities of three-dimensional echocardiography in order to optimize their specific therapy. The hypothesis is that the increased use of modern imaging guided tools is essential for the follow up.

Detailed Description
-----------------
It is not possible to perform a magnetic resonance imaging in all patients and as a result echocardiography is not only done at screening but also during the follow up. The imaging technologies made a great progress in the last few years and enable a better assessment of the haemodynamic parameters in our days.

Official Title
-----------------
Prostanoid Therapy in Severe Pulmonary Arterial Hypertension - Imaging Control Study, 3D Echo, MR and RHC.

Conditions
-----------------
Pulmonary Arterial Hypertension WHO Group I

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >17 pulmonary arterial hypertension WHO group I who are going to start a therapy with prostanoid written informed consent Prostanoid naive no change of the pulmonary arterial hypertension therapy within 3 weeks of inclusion into the study Exclusion Criteria: pregnancy and lactation period Women of childbearing potential who do not use an effective and secure method for birth control severe chronic kidney insufficiency (glomerular filtration rate <30), which will remain for more than 3 months liver insufficiency Child C life expectancy shorter than the course of the study (for example because of a malignant disease)

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 |
| --- | --- |
| 3D echocardiography<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| right ventricular ejection fracture | right-sided heart catheterization | month 12 (+/- 7 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| right atrial pressure | right-sided heart catheterization | 12 month (+/- 7 days) | 
| cardiac index (CI)/cardiac output (CO) | right-sided heart catheterization | 12 months (+/- 7 Days) | 
| pulmonary vascular resistance | right-sided heart catheterization | 12 months (+/- 7 days) | 
| mean pulmonary capillary wedge pressure | right-sided heart catheterization | 12 month (+/-7 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulmonary arterial hypertension
Evaluation of the PhageTech Virus BioResistor

Study Overview
=================
Brief Summary
-----------------
To evaluate the effectiveness of the PhageTech Virus BioResistor to detect bladder cancer biomarkers.

Detailed Description
-----------------
This study will sample urine provided by bladder cancer patients as part of their normal routine surveillance screening. No additional effort will be required from the patients and only modest additional effort from the study staff. Some de-identified patient medical information may also be requested, including concominant medications, relevant current or previous diseases, prior bladder cancer interventions and other relevant information to ensure there are no interfering substances or other confounders that could affect study results. There is no risk to patients as the normal diagnostics for bladder cancer will be followed.

Official Title
-----------------
A Pilot Study to Evaluate the PhageTech Virus BioResistor inDetecting Combinations of Bladder Cancer Biomarkers inPatients Under Active BCa Surveillance

Conditions
-----------------
Bladder Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients ≥ 18 years Previous bladder cancer diagnosis; any stage and histological type, undergoing cystoscopy Patients with suspected bladder tumor undergoing surveillance cystoscopy Patients must provide written Informed Consent. Exclusion Criteria: Patients unable or unwilling to sign the informed consent Age < 18 years Known HIV/HCV/HBV (information from clinical history).

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bladder Tumor Positive<br>Patients with previous bladder cancer diagnosis; any stage and histological type, undergoing cystoscopy or suspected bladder tumor undergoing surveillance cystoscopy. | |
| Bladder Tumor Negative<br>Patients with no suspected bladder tumor. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful identification of bladder tumor biomarkersBiomarkers in Patients Under Active BCa Surveillance |  | Up to 1 year |
Inhaled Mannitol and Ciliary Beat Frequency in COPD Patients

Study Overview
=================
Brief Summary
-----------------
The main purpose of the study is to evaluate the effect of mannitol on the cilia's beat frequency (ciliary beat frequency) in COPD patients.

Official Title
-----------------
The Effect of Inhaled Mannitol on Ciliary Beat Frequency in COPD Patients

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD

Ages Eligible for Study
-----------------
Minimum Age: 38 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD
Diabetes Prevention and Control in the Workplace: A Pilot Study

Study Overview
=================
Brief Summary
-----------------
This worksite program for Onondaga County employees is a pilot research study aimed at decreasing the risk of developing diabetes (or improving metabolic control for adults with diabetes). The main goal is to improve the nutrition and physical habits of the participants, and promote weight loss in those who are overweight. The investigators will also examine factors that predict participation in the program and influence a participant's outcome/success in the program.

Official Title
-----------------
Diabetes Prevention and Control in the Workplace: A Pilot Study

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Diabetes Prevention and Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult employees of Onondaga County Exclusion Criteria: Not an employee of Onondaga County Less than age 18

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A, 1<br>Intervention: Immediate 3 month program | Behavioral: Diabetes Prevention and Control<br>* The program will be delivered over 3 months in 12 one hour weekly mid-day sessions at the worksite. The curriculum has been adapted from the Diabetes Prevention Program, the National Diabetes Education Program and Conversation maps from Healthy Interactions Inc. Topics relate to healthy eating, physical activity, coping with disease and depression, and cardiovascular disease prevention. Additional topics may be included per feedback and need of the participants. After completion of the 3 month program, there will be monthly meetings.<br>|
| No Intervention: A, 2<br>Wait-List Control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight | Weight loss in kg | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Glucose Level | Fasting glucose (mg/dL) | Baseline | 
| Fasting Lipid Profile | LDL-cholesterol (mg/dL) | Baseline | 
| Hemoglobin A1c | hemoglobin A1c (%) | baseline | 
| Waist Circumference |  | baseline, 3, 6, 12 months | 
| Questionnaires |  | baseline, 3, 6, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes mellitus, obesity, prevention
Magnetic Resonance Cholangio-pancreatography (MRCP) for Suspected Bilio-pancreatic Disease

Study Overview
=================
Brief Summary
-----------------
The interpretation of Magnetic Resonance Cholangio-pancreatography (MRCP)-findings is primarily performed by radiologists who only in some cases have experience with the interpretation of endoscopic retrograde cholangiopancreatography (ERCP)-images. It is unclear if MRCP-interpretation by the radiologist is sufficient to decide which additional endoscopic procedures might be necessary in an individual case or if an additional MRCP-interpretation by the endoscopist renders any clinical impact.

Official Title
-----------------
Magnetic Resonance Cholangio-pancreatography (MRCP) for Suspected Bilio-pancreatic Disease: Should the Endoscopist Take a Second Look?

Conditions
-----------------
Suspected Bilio-pancreatic Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 years or older who were referred for pancreato-biliary endoscopy to our unit based on actual MRCP-findings. In all cases MRCP should have been performed within 4 weeks prior admittance and a written radiological report as well as the digital images must be available. Exclusion Criteria: Patients who had any endoscopic interventions in our institution before and also patients who underwent MRCP at our hospital were excluded.

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 |
| --- | --- | --- |
| Endoscopic management | Did the MRCP-interpretation by the gastroenterologist alter the scheduled endoscopic interventions ? | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRCP-interpretation | Are there differences in the MRCP-interpreatation beween the radiologist and the gastroenterologist. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRCP, ERCP, EUS, Image interpretation, MRCP findings, endoscopic intervention(s)
UMBRELLA - Incidence of Arrhythmias in Spanish Population With a Medtronic Implantable Cardiac Defibrillator Implant

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to analyze the different patient profiles implanted with an Implantable Cardiac Defibrillator (ICD) in Spain (guidelines adoption) and the patient prognosis as a function of clinical profile, implant indication, arrhythmias incidence, treatments or device programming.

Detailed Description
-----------------
Umbrella is a prospective and retrospective cohort study.

Official Title
-----------------
UMBRELLA - Incidence of Arrhythmias in Spanish Population With a Medtronic ICD Implant

Conditions
-----------------
Cardiomyopathies, Cardiac Arrhythmias, Cardiac Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a Medtronic Implantable Cardiac Defibrillator (ICD) according to guidelines. Patients with CareLink home Telemonitoring System. Exclusion Criteria: Unwillingness or inability to sign study written informed consent and/or CareLink consent.

Ages Eligible for Study
-----------------
Minimum Age: 13 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 |
| --- | --- | --- |
| To assess the number of ventricular and atrial arrhythmias, and atrial fibrillation burden detected by ICD. |  | End of the study, an expected duration of 5 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Defibrillators, Implantable, Cardiac arrhythmias, Heart Disease
Barriers in the Process of Achieving Informed Consent From Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
The study will explore barriers in the process of achieving informed consent from critically ill patients

Detailed Description
-----------------
The barriers will be divided into four major categories: Practical barriers Medical barriers Legal barriers Ethical barriers

Official Title
-----------------
Barriers in the Process of Achieving Informed Consent From Critically Ill Patients

Conditions
-----------------
Critically Ill, Ethics, Informed Consent, Study Recruitment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients considered for inclusion in the NORIDES study Exclusion Criteria: None

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 |
| --- | --- | --- |
| Study recruitment barriers, Medical | Number (%) of patients unable to give consent or to sign | 2018-2022 | 
| Study recruitment barriers, Ethical | Number (%) of patients not asked to give consent due to ethical issues | 2018-2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study recruitment barriers, Practical | Number (%) of cases where practical reasons made consent impossible | 2018-2022 | 
| Study recruitment barriers, Legal | Number (%) of patients where legal issues made consent impossible | 2018-2022 |