linjc16/ctgov huggingface dataset:
ICE-SENSE™ Cryotherapy for Breast Fibroadenoma Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the Ice-Sense, a novel cryotherapy system (a system that freezes tissues), is safe and effective in the treatment of benign breast tumors such as fibroadenoma.

Official Title
-----------------
Evaluation of Safety and Feasibility of the ICE-SENSE™, a Cryotherapy Device for Office-based Ultrasound-guided Treatment of Breast Fibroadenoma

Conditions
-----------------
Fibroadenoma

Intervention / Treatment
-----------------
* Device: Ice-Sense


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is above 18 years old. Patient has breast fibroadenoma, proven by biopsy (Core Biopsy). Patient's fibroadenoma can be visualized with ultrasound. Patient's fibroadenoma size is between 0.5cm and 3cm at its largest dimension. Patient is able to visit the clinic as needed during the 12-month follow-up period following the cryoablation procedure. The patient has been informed of the study and agrees to its provisions, and has signed an IRB/EC approved written informed consent, including data privacy authorization. Exclusion Criteria: Patients with history of breast cancer. Women with known pregnancy. Patients with superficial fibroadenoma very close to the skin. Patient has undergone major surgery within the previous 12 weeks. Patients with any terminal illness, or with a life expectancy <2 year. Patients carrying contagious diseases such as Tuberculosis Hepatitis or AIDS. Patient participating in other trials using drugs or devices.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breast Fibroadenoma<br> | Device: Ice-Sense<br>* Ice-Sense Cryoprobe<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| engulfment of the tumor by the ice-ball as seen under ultrasound imaging |  | during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| any device related adverse events or complications that may occur |  | one year |
One-Leg Standing Radiograph: A Novel Technique to Evaluate the Severity of OA Knee

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is assess the severity of osteoarthritic knee between one-leg and both-leg standing radiograph in primary OA knee

Detailed Description
-----------------
All patients were performed digital radiographs which one-leg and both-leg standing anteroposterior view. Medial and lateral joint space width were measured. The severity of OA knee was identified by the Kellgren-Lawrence (KL) classification.

Official Title
-----------------
One-Leg Standing Radiograph: A Novel Technique to Evaluate the Severity of Knee Osteoarthritis

Conditions
-----------------
Severity of OA Knee, Difference of Joint Space Width Between One-leg and Both-leg Standing Radiograph

Intervention / Treatment
-----------------
* Procedure: radiographic of standing knee


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bilateral knee pain more than 3 months Exclusion Criteria: Inflammatory OA knee previous knee injury previous knee infection previous knee surgery pregnant women unable to bear weight on one leg

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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 |
| --- | --- |
| One-leg standing view<br> | Procedure: radiographic of standing knee<br>* the patients stand on their one leg with pillar support and both-leg then shoot the x-ray beam to their knee<br>|
| both-leg standing view<br> | Procedure: radiographic of standing knee<br>* the patients stand on their one leg with pillar support and both-leg then shoot the x-ray beam to their knee<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of joint space with between one-leg standing and both-leg standing radiographs in OA knee patients |  | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of radiographic grading between one-leg and both-leg standing AP views in OA knee patients |  | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kellgren-Lawrence classification, Joint space width, One-leg standing view, Osteoarthritis of the knee, Weight bearing radiograph
Comparison of Limb Size of Transverse Coloplasty Pouch

Study Overview
=================
Brief Summary
-----------------
The aim of the study is the comparison of pouch function with two different sizes of limb of transverse coloplasty pouch after rectal resection and total mesorectal excision.

Detailed Description
-----------------
No detailed description necessary, see brief summary.

Official Title
-----------------
Prospective Randomised Study for Comparison of the Size of Limb of Transverse Coloplasty Pouch After Low Rectal Resection With Total Mesorectal Excision

Conditions
-----------------
Colon Cancer

Intervention / Treatment
-----------------
* Procedure: Transverse coloplasty pouch (Long limb)
* Procedure: Transverse coloplasty pouch (Short limb)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients in need of rectal resection due to benign or malign disease >=18 years Exclusion Criteria: anamnestic rectal resection life expectancy of less than 2 years pregnancy <18 years missing informed consent

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transverse coloplasty pouch (Short limb)<br>The short limb is the standard technique of transverse coloplasty pouch. | Procedure: Transverse coloplasty pouch (Short limb)<br>* Transverse coloplasty pouch with short limb<br>|
| Experimental: Transverse coloplasty pouch (Long limb)<br>The long limb relates to straight coloanal anastomosis. | Procedure: Transverse coloplasty pouch (Long limb)<br>* Transverse coloplasty pouch with long limb<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pouch function 4 month after closure of protective ileostomy. |  | 4 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pouch function 2 and 12 month respectively after closure of protective ileostomy. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
size, limb, transverse coloplasty pouch, rectal resection, mesorectal excision, treatment outcome
Clinical Trial in Patients With Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The objectives of this trial are to determine if CoFactor in combination with 5-FU are effective in the treatment of metastatic colorectal cancer and to determine the side effects observed with the administration of CoFactor and 5-FU.

Official Title
-----------------
COFU: A Multi-Center Phase II Clinical Trial to Evaluate the Safety and Efficacy of Weekly Treatment With CoFactor and 5-Fluorouracil in Patients With Metastatic Colorectal Carcinoma

Conditions
-----------------
Colon Cancer, Rectal Cancer

Intervention / Treatment
-----------------
* Drug: CoFactor and 5FU


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have surgically incurable colon or rectal adenocarcinoma Karnofsky Performance Status of 60% or greater Patients may have symptomatic neuropathy Patients must have a life expectancy of at least 4 months Patients must be alimenting, receiving at least 1500Kcal/day nutrition, by any route Patients must have bidimensional measurable disease for response assessment Patients may have received adjuvant chemotherapy with fluoropyrimidine therapy Patients must have recovered from the toxicities of prior therapy, at least 4 weeks since prior adjuvant chemotherapy and major surgery Serum creatinine less than 2.4mg%, serum bilirubin less than 3.0mg%, WBC greater than 3,200/mm2, AGC greater than 1,500/mm3, platelet count greater than 90,000/mm3 and SGOT (AST) and SGPT (ALT) less than 3 times the upper limit of normal Male and non-pregnant, non-lactating female patients must be >18 years old. Exclusion Criteria: Concurrent infection Failure of the patient or the patient's legal representative to sign the Informed consent Inability to obtain Informed Consent because of psychiatric or complex medical problem Patients with unstable oncologic emergency Patients with unstable medical conditions such as angina, transient ischemic attacks, rising creatinine, accelerated hypertension, etc. Cerebellar neurologic syndromes such as Parkinson's Disease, multiple sclerosis and amyotonia Known intolerance to fluoropyrimidine therapy suggestive of dihydropyrimidine dehydrogenase deficiency.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CoFactor and 5FU|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Formulation Comparison in Normal Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a double-masked, single-center, crossover study in which normal volunteers will be randomized to receive one of two formulations of 0.5% AR-12286 Ophthalmic Solution for 8 days. Subjects will undergo a minimum 7-day washout, and then receive the alternate treatment for 8 days.

Detailed Description
-----------------
Not desired.

Official Title
-----------------
A Double-masked, Crossover Study Assessing the Ocular and Systemic Safety and Systemic Absorption of Two Formulations of 0.5% AR-12286 Ophthalmic Solution in Normal Volunteers

Conditions
-----------------
Normal Volunteers

Intervention / Treatment
-----------------
* Drug: AR-12286


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal volunteers Exclusion Criteria: Active ophthalmic or systemic disease

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formulation A<br>AR-12286 Ophthalmic Solution Formulation A | Drug: AR-12286<br>* Ophthalmic Solution<br>|
| Experimental: Formulation B<br>AR-12286 Ophthalmic Solution Formulation B | Drug: AR-12286<br>* Ophthalmic Solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular safety | The primary safety endpoints will be visual acuity, objective biomicroscopic and ophthalmoscopic examination, and subjective comfort as measured by adverse events in response to subject symptom queries. | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Normal Volunteers
Investigating the Safety Profile of Liraglutide Under Normal Conditions of Use in Korean Subjects With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia. The aim of this study is to investigate the safety profile of liraglutide (Victoza®) under normal conditions of use in Korean subjects with type 2 diabetes mellitus.

Official Title
-----------------
A 6-month, Multi-centre, Open Labelled, Non-randomized, Non-interventional, Safety Study of Liraglutide (Victoza®) in Subjects With Type 2 Diabetes Mellitus in Korea

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

Intervention / Treatment
-----------------
* Drug: liraglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with T2DM (Type 2 Diabetes Mellitus), including newly-diagnosed subjects, who require treatment with Victoza® according to the clinical judgment of their treating physician Subjects (and/or parents or the subject's legally acceptable representative) who are capable of giving study-specific signed informed consent before any collection of information Exclusion Criteria: Subjects with a hypersensitivity to Victoza® or to any of the excipients Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the study periods Subjects with personal or family history of medullary thyroid carcinoma (MTC) Subjects with multiple endocrine neoplasia syndrome type 2 (MEN2)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Liraglutide<br> | Drug: liraglutide<br>* Administered either alone or in combination therapy according to the package insert (PI). Self-administered once daily, at any time subcutaneously (s.c., under the skin) in the abdomen, thigh or upper arm).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of SADRs (Serious Adverse Drug Reactions) |  | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (Glycosylated haemoglobin) change |  | Month 0, month 6 | 
| Percentage of subjects reaching the target of HbA1c below 7.0% |  | Month 6 | 
| Change in body weight |  | Month 0, month 6 | 
| Number of SAEs/ ADRs (Serious Adverse Events/Adverse Drug Reactions) |  | Up to 6 months |
Caring Hand Massage - an Intervention in Cancer Patients Undergoing Chemotherapy in an Outpatient Setting - a Pilot Study

Study Overview
=================
Brief Summary
-----------------
Since there is a limited amount of evidence on the feasibility and outcomes on the use of hand massage in patients undergoing cancer treatment, the purpose of this study is to evaluate the feasibility and outcomes of hand massage therapy in cancer patients undergoing chemotherapy, and to measure its influence on their symptoms.

Official Title
-----------------
Caring Hand Massage - an Intervention in Cancer Patients Undergoing Chemotherapy in an Outpatient Setting - a Pilot Study

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Behavioral: Caring Hand Massage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age 18 - 80 Patient receiving treatment on Mayo Clinic's Chemotherapy Outpatient Clinic Able to speak English and complete surveys Able to read, understand and sign inform consent. Exclusion Criteria: Patient has rash, sores, wounds, incision or other skin conditions on hands Unable to give consent or complete the surveys Already having received previous hand massage Pregnant women. (As verbalized by participant)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cancer patients receiving hand massage<br>Caring Hand massage will be provided to the outpatients undergoing chemotherapy | Behavioral: Caring Hand Massage<br>* Caring Hand Massage is a hand massage therapy program with several steps and techniques.<br>* Other names: Hand Massage Therapy Program;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of symptom scores | We will record the number of patients approached hand massage to those that accept and were able to get a full hand massage during their time in the chemotherapy area | baseline to 45 minutes. |
Improvement of Facial Nerve Monitoring in Parotid Surgery by Sugammadex

Study Overview
=================
Brief Summary
-----------------
To investigate the effectiveness of rapid reversal of rocuronium-induced neuromuscular block by sugammadex during IONM of facial nerve during parotid surgery

Detailed Description
-----------------
Intraoperative neuromonitoring (IONM) of facial nerve has been applied in identifying and preserving facial nerve during parotid surgery. In this setting, even a single dose of nondepolarizing muscle relaxant may lead to delayed and weakened electromyography (EMG) signal in facial nerve monitoring during parotid surgery. The aim of this study was to investigate the effectiveness of rapid reversal of rocuronium-induced neuromuscular block by sugammadex during IONM of facial nerve during parotid surgery

Official Title
-----------------
Influence of Sugammadex on Facial Nerve Monitoring in Parotid Surgery

Conditions
-----------------
Injury to Nerve During Surgery

Intervention / Treatment
-----------------
* Drug: sugammadex (Bridion)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing parotid surgery Exclusion Criteria: facial nerve injury, renal failure, liver cirrhosis, neuromuscular disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Control group<br>did not receive muscle relaxant during anesthesia | |
| Sugammadex group<br>received single dose of rocuronium for anesthesia and sugammadex at skin incision | Drug: sugammadex (Bridion)<br>* single dose of sugammadex at skin incision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evoked EMG amplitude of facial nerve |  | up to first post-op day |
Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity

Study Overview
=================
Brief Summary
-----------------
Ascorbic acid (Vitamin C) could protect renal toxicity from colistin.

Detailed Description
-----------------
Renal toxicity due to colistin therapy is common. Ascorbic acid (vitamin C) has been shown to prevent colistin associated renal toxicity in animals. This study is conducted to determine if acorbic acid can prevent Colistin-Associated Nephrotoxicity.

Official Title
-----------------
Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity

Conditions
-----------------
Drug Safety

Intervention / Treatment
-----------------
* Drug: Colistin
* Drug: Colistin + Ascorbic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years hospitalized patient who needs colistin for therapy of nosocomial infection Exclusion Criteria: pregnant woman lactating mother allergy to ascorbic acid receiving non-steroidal antiinflammatory drugs (NSAID), aminoglycosides, vancomycin, cisplatin, amphotericin-B received radiocontrast media within 1 week renal stone G-6-PD deficiency

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Active Comparator: Colistin<br>Colistimethate sodium 2.5-5mg/kg iv | Drug: Colistin<br>* Colistimethate sodium 2.5-5mg/kg iv per day<br>* Other names: Colistate;|
| Experimental: Colistin + Ascorbic acid<br>Colistimethate sodium 2.5-5mg/kg iv and ascorbic acid 2 grams iv every 12 hours | Drug: Colistin + Ascorbic acid<br>* Colistimethate sodium 2.5-5mg/kg iv per day and ascorbic acid 2 grams iv q 12 hours<br>* Other names: vitamin c;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with Renal toxicity associated with colistin | Renal toxicity associated with colistin according to RIFLE criteria | up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of subjects with cure or improvement | cure improvement worse death | up to 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colistin, ascorbic acid, renal toxicity