linjc16/ctgov huggingface dataset:
A Study Based on Data From German Sick Funds That Looks at the Costs of Treatment of Type-2 Diabetic Patients With Empagliflozin vs. DPP-4 Inhibitors vs. GLP-1 Receptor Agonists

Study Overview
=================
Brief Summary
-----------------
Empagliflozin vs. Dipeptidyl Peptidase 4 (DPP-4) Inhibitors and Glucagon-like Peptide-1 Receptor Agonists (GLP-1-RA) Cost of Care Study: a German claims data analysis

Official Title
-----------------
The Empagliflozin vs. DPP-4 Inhibitors and GLP-1 Receptor Agonists Cost of Care Study: a German Claims Data Analysis

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

Intervention / Treatment
-----------------
* Drug: Empagliflozin
* Drug: DPP-4i
* Drug: Sitagliptin
* Drug: GLP-1-RA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Continuous insurance by the sickness fund for the entire period (01/01/2014 - 31/12/2018; death of a patient is the only accepted exception from this rule) At least two outpatient T2DM diagnoses (ICD E11.-) in two different quarters and/or at least one inpatient T2DM diagnosis (ICD E11.-) in the period 01/01/2014 to 31/12/2016, but before or on index date (i.e. first Empagliflozin or DPP-4i /Sitagliptin prescription). At least one prescription of Empagliflozin or a DPP-4i /Sitagliptin in the inclusion period (01/01/2015 - 31/12/2016) Exclusion Criteria: At least one prescription of a sodium glucose transporter 2 inhibitor (SGLT-2i), DPP-4i or GLP-1-RA in the baseline period (01/01/2014 - 31/12/2014) During follow-up, patients will be censored if they switch to any SGLT-2i, DPP-4i or GLP-1-RA or initiate a concomitant use of any SGLT-2i, DPP-4i or GLP-1-RA (free or fixed-dose combinations).
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients who started an Empagliflozin therapy<br> | Drug: Empagliflozin<br>* film coated tablet<br>|
| All patients who started a DPP-4 inhibitor therapy<br> | Drug: DPP-4i<br>* film coated tablets<br>|
| All patients who started a Sitagliptin therapy<br> | Drug: Sitagliptin<br>* film coated tablet<br>|
| All patients who started a GLP-1 receptor agonist therapy<br> | Drug: GLP-1-RA<br>* subcutaneous injection or tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Direct healthcare cost | (hospital cost, outpatient cost, drug cost, remedies and aids cost) | up to 48 months | 
| Indirect healthcare cost |  | up to 48 months |
Black Cohosh Extract in Postmenopausal Breast Health

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if black cohosh extract (BCE) administration in symptomatic postmenopausal women results in estrogenic stimulation of the breast, as determined by estradiol, pS2, FSH, LH, and PSA levels in nipple aspirate fluid.

Detailed Description
-----------------
As in Brief Summary

Official Title
-----------------
The Effect of Black Cohosh Extract on the Human Breast

Conditions
-----------------
Menopause, Hot Flashes

Intervention / Treatment
-----------------
* Drug: Black Cohosh Extract (BCE)


Participation Criteria
=================
Eligibility Criteria
-----------------
Postmenopausal females 20 months since any breastfeeding Active postmenopausal symptoms, i.e., hot flashes At least 6 months since last menstrual period or have had a hysterectomy with both ovaries removed Able to make 4 visits during the trial to the study clinic in Columbia, Missouri
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Black Cohosh Extract (BCE)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
estrogen stimulation, relief of hot flashes, nipple aspirate fluid, body fluid levels of black cohosh
Clinical Test for Blood Pressure Meter of CH-101

Study Overview
=================
Brief Summary
-----------------
Blood pressure meter model CH-101 was to be assessed against the standard mercury sphygmomanometer according to the protocol of the ANSI/AAMI SP-10.

Official Title
-----------------
Clinical Test of Blood Pressure Meter of CH-101

Conditions
-----------------
Blood Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 85 subjects with a wide range of blood pressure were selected. Exclusion Criteria: Subjects could be taking antihypertension medication, but excluded in atrial fibrillation or with any sustained arrhythmia.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 84 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the accuracy of blood pressure meter model CH-101 assessed against the standard mercury sphygmomanometer according to the protocol of ANSI/AAMi SP-10. |  | 30 minutes. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood pressure
RHYTHMIA vs CARTO in Redo Ablation Procedures for Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The MAP-AF study will compare RHYTHMIA vs CARTO in redo ablation of paroxysmal AF with assessment of both acute procedural profiles and clinical outcomes.

Detailed Description
-----------------
Pulmonary venous conduction recovery is found in most patients undergoing redo ablation procedures for atrial fibrillation (AF). Identifying gaps in prior ablation lines is essential to achieve successful outcomes. High density mapping systems have been proposed to allow the identification of such gaps with speed and accuracy. The MAP-AF study will compare RHYTHMIA vs CARTO in redo ablation of paroxysmal AF with assessment of both acute procedural profiles and clinical outcomes.

Official Title
-----------------
RHYTHMIA vs CARTO in Redo Ablation Procedures for Atrial Fibrillation: MAP-AF Study

Conditions
-----------------
Paroxysmal Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: CARTO
* Device: RHYTHMIA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (18-90 years of age) undergoing redo ablation procedures for paroxysmal AF regardless of the systems or energy sources used during the pre-study ablation procedure(s). Paroxysmal AF: defined as AF terminating within 7 days of onset either spontaneously or with electrical or medical cardioversion. Exclusion Criteria: Persistent AF Prior cardiac surgery Patients with only AFL or AT as the documented recurrent arrhythmia after the pre-study AF ablation(s).

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Mapping with CARTO<br>CARTO (Biosense Webster) in conjunction with CONFIDENSE mapping module and PENTARRAY catheter | Device: CARTO<br>* Redo-ablation of paroxysmal AF with high density mapping system, CARTO, in conjunction with CONFIDENSE mapping module and PENTARRAY catheter<br>|
| Mapping with RHYTHMIA<br>RHYTHMIA (Boston Scientific) in conjunction with the 64-electrodes ORION mini-basket catheter. | Device: RHYTHMIA<br>* Redo-ablation of paroxysmal AF with high density mapping system, RHYTHMIA, in conjunction with the 64-electrodes ORION mini-basket catheter.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System is able to accurately identify gaps | Incidence of accurate identification of gaps in prior ablation lines by the system | At the time of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success | Freedom from AF recurrence | Up to 12 months |
Clinical Trial to Evaluate the Safety and Efficacy of MONOFIX® PGCL Suture in Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
Clinical Trial to Evaluate the Safety and Efficacy of MONOFIX® PGCL Suture Compared to Quill MonodermTM Suture in Laparoscopic Surgery

Official Title
-----------------
A Multicenter, Randomized, Single-blinded, Active Controlled, Non-inferiority, Post Marketing Clinical Trial to Evaluate the Safety and Efficacy of MONOFIX® PGCL Suture Compared to Quill MonodermTM Suture in Laparoscopic Surgery

Conditions
-----------------
Laparoscopic Hysterectomy

Intervention / Treatment
-----------------
* Device: MONOFIX® PGCL
* Device: Quill Monoderm™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patients scheduled for hysterectomy by laparoscopic surgery Patients who are scheduled to undergo hysterectomy after being diagnosed with benign tumors in the uterus, including uterine myoma, according to the medical judgment of the investigator Laparoscopic surgery includes general laparoscopic surgery and robotic surgery.) Exclusion Criteria: Patients with contaminated wounds Diseases that may affect wound healing When gynecological malignancy or intra-abdominal metastasis is confirmed at the time of enrollment

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MONOFIX® PGCL<br>An absorbable suture | Device: MONOFIX® PGCL<br>* An absorbable suture made of polyglycapron (PGCL) used for soft tissue suture.<br>|
| Active Comparator: Quill Monoderm™<br>An absorbable suture | Device: Quill Monoderm™<br>* An absorbable suture made of polyglactin used for soft tissue suture.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time used for suturing the surgical site during laparoscopic hysterectomy | Time used from when the first suture is started to when the last suture is finished and the suture is cut | 0Day |
Study to Evaluate Oral Mucosa Absorption of IN-C004 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
To evaluate whether IN-C004 absorbs oral mucosa in healthy volunteers.

Detailed Description
-----------------
An Open-label, Single-dose Clinical Study

Official Title
-----------------
An Open-label, Single-dose Clinical Study to Evaluate Oral Mucosa Absorption of IN-C004 in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: IN-C004


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) ≥19.0 kg/m2 and ≤27.0 kg/m2 with a body weight ≥ 45 kg at screening. Exclusion Criteria: History or evidence of clinically significant disease History of drug/alcohol abuse Participated in other studies and received investigational products within 6 months prior to the first study dose. Not able to use a medically acceptable contraceptive method throughout the study.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IN-C004<br>IN-C004 | Drug: IN-C004<br>* One time dose of IN-C004 taken orally.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt of tegoprazan | Area under the plasma concentration-time curve of tegoprazan | pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2 hours | 
| Cmax of tegoprazan | Maximum Plasma Concentration at Steady State of tegoprazan | pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2 hours | 
| Tmax of tegoprazan | Time to reach Cmax | pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2 hours |
Ex Vivo Evaluation of Laser Induced Thermal Tissue Damage

Study Overview
=================
Brief Summary
-----------------
This clinical study has been initiated to assess the effect of laser exposure on human skin and determine the threshold for tissue damage. The tissue specific effects will be evaluated through histological evaluation. Excess skin from corrective surgery (gastric bypass or similar) will be donated for this study. Skin samples will be subjected to titrating laser treatment with varying laser intensity and exposure time.

Detailed Description
-----------------
The dosimetry of laser induced hyperthermia and threshold for tissue damage will be evaluated. A dose escalation study will be performed by varying irradiance (mW) and time (minutes). Surface temperature will be monitored concurrently. Acute lesions occurring within 5 minutes of irradiation will be assessed and histological damage will be observed microscopically in slice sections of punch biopsies and qualitative assessed. Irradiation regimes above the anticipated threshold will be employed to properly titrate the irradiation necessary to elicit a thermal damage response.

Official Title
-----------------
Ex Vivo Evaluation of Laser Induced Thermal Tissue Damage

Conditions
-----------------
Gastric Bypass Surgery

Intervention / Treatment
-----------------
* Radiation: Non-ionising radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subject 18 years of age or older Gastric bypass operated or similar Excess abdominal skin to be removed surgically Abdominal skin tone 4 or below Exclusion Criteria: Extensive skin changes, tattoos or diseases on skin explant to be donated Medical history or any condition that may in investigator's opinion compromise the subject's ability 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?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Excess skin from corrective surgery will be evaluated ex vivo.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser irradiation regimes<br>Non-ionising radiation intervention will be applied to skin explants | Radiation: Non-ionising radiation<br>* Laser regimes will be applied to ex vivo skin samples.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thermal damage threshold | Quantitative evaluation of laser induced damage by histological lesion in epidermis and dermis. | Within 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ex vivo, Gastric bypass
Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the extent of systemic absorption of PEP005 when applied topically for the treatment of actinic keratoses.

Detailed Description
-----------------
Actinic keratoses (AK) is a common skin condition characterized by rough, scaly patches or sores on the top layer of the skin which if left untreated can progress to skin cancer. Current treatments can cause scarring and hypopigmentation, be inconvenient, or require long treatment duration. Non-invasive alternative therapy for treatment of AK lesions is thus being researched.

Official Title
-----------------
A Phase I, Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005, When Applied as 0.05% PEP005 Topical Gel to a 100 cm2 (5 cm x 20 cm) Contiguous Actinic Keratosis(AK) Treatment Area on the Extensor (Dorsal Aspect) Forearm.

Conditions
-----------------
Actinic Keratoses

Intervention / Treatment
-----------------
* Drug: PEP005


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients at least 18 years of age. A contiguous 100 cm2 treatment area containing at least 5 AK lesions, on the either the right or left extensor (dorsal aspect) forearm. Written informed consent has been obtained. Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study package.

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

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: 1<br>Two days consecutive days of application of 0.05% PEP005 Topical Gel to a 100cm2 contiguous AK treatment area of the arm. | Drug: PEP005<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the extent of systemic absorption of PEP005 when applied as 0.05% Topical Gel on two consecutive days (Day 1 and Day 2) to a 100 cm2 (5 cm x 20 cm) contiguous AK treatment area on the extensor (dorsal aspect) forearm. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of two consecutive days of application of 0.05% PEP005 Topical Gel, when applied to a 100 cm2 (5 cm x 20 cm) contiguous AK treatment area on the extensor (dorsal aspect) forearm. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetic study, Actinic Keratosis, Topical, Dermatology
Noninvasive Electrical Stimulator as a Pain Control Treatment Post-ureteroscopy

Study Overview
=================
Brief Summary
-----------------
The investigators will assess the use of Transcutaneous Neurostimulation (TENS), a pharmacological alternative, for treatment of ureteral stent pain post-ureteroscopy. The primary aim for the investigators is to determine if use of a TENS unit will reduce post-operative pain and nausea associated with the ureteral stent. Secondary aim will be to assess if it can help minimize narcotic use.

Official Title
-----------------
Noninvasive Electrical Stimulator as an Adjunct for Pain Control After Ureteroscopic Stone Management

Conditions
-----------------
Kidney Stone, Ureteral Calculi, Nephrolithiasis

Intervention / Treatment
-----------------
* Device: TENS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients undergoing standard of care ureteroscopy and laser lithotripsy for urinary stone disease Patients receiving a stent following their ureteroscopy and laser lithotripsy Exclusion Criteria: Children Pregnant patients Patients unable to answer pain questionnaire Patients undergoing PCNL Patients being treated for Urologic malignancy with ureteroscopy Patients who require long term or chronic ureteral stent management Patient with implantable stimulators Patient with epilepsy Patients undergoing laser lithotripsy without stent placement

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br>Participants will follow standard care until the ureteral stent is removed | |
| Experimental: TENS device<br>Participants will use the TENS device until the ureteral stent is removed | Device: TENS<br>* TENS device used four times a day for 60 minutes each time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on 11-point Visual Analog Score scale for each day until Ureteral Stent removed | VAS is a validated tool widely used to assess pain intensity. Possible scores range from 0 (no pain) to 10 (worst possible pain) | 3-10 days |