linjc16/ctgov huggingface dataset:
Evaluating Light-tissue Reaction and Transdermal Drug Delivery by Multiphoton Microscopy

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators will evaluate the potential of multiphoton microscopy as a non-invasive imaging modality for monitoring of the radiofrequency-tissue and light-tissue reaction. The investigators will also investigate drug delivery using multiphoton microscopy.

Official Title
-----------------
Evaluating Light-tissue Reaction and Transdermal Drug Delivery by Multiphoton Microscopy

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

Intervention / Treatment
-----------------
* Procedure: laser and radiofrequency


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adults Exclusion Criteria: younger than 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Experimental: laser<br> | Procedure: laser and radiofrequency<br>* different laser and radiofrequency with different fluences<br>* Other names: drug penetration;|
| No Intervention: control<br> | |

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
-----------------
light
Long-term Safety and Efficacy of KUC-7483 in Patients With Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
To investigate the long-term safety, efficacy and pharmacokinetics of KUC-7483 in patients with overactive bladder.

Official Title
-----------------
A Open-label, Long-term Extension Study of KUC-7483 in Patients With Overactive Bladder

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: KUC-7483


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have successfully completed the Phase III double-blind study. Exclusion Criteria: Patients with serious adverse events or clinically significant adverse events in the Phase III double-blind study.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KUC-7483<br> | Drug: KUC-7483<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The long-term safety of KUC-7483 for the treatment of overactive bladder. |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The long-term efficacy of KUC-7483 for the treatment of overactive bladder. |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overactive bladder, Frequency, Micturition, Urgency, Urge urinary incontinence, OAB
Radiation Field, Dose and Fractionation Related to Mandibular Complications

Study Overview
=================
Brief Summary
-----------------
Radiotherapy is inhibiting the healing capacity of the mandibular bone. Late complications as bone exposure, fracture of the jaw, osteoradionecrosis might be a consequence of this vulnerability. A factor that could be involved in the development of complications is field of radiation. There are limited number of studies investigating this relation. Retrospective analysis of a head and neck oncology register with prospectively included patients will be performed. Patients will be related to the University hospitals in Lund, Umea, Orebro, Stockholm. A thorough analysis of the medical journals in this group of patients will be performed. Included patients have been treated with combination of surgery and radiotherapy to treat malignancies in the head and neck region. At least 12 months follow up period is needed for inclusion. The scientific aim is to investigate weather the field of radiation and fractionation is crucial for developing the formentioned complications.

Official Title
-----------------
Is the Radiation Field, Dose and Fractionation Crucial for the Development of Mandibular Complications When Treating Malignancies in the Oropharyngeal Region?

Conditions
-----------------
Head and Neck Neoplasms, Osteoradionecrosis, Radiotherapy; Complications

Intervention / Treatment
-----------------
* Radiation: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of the head and neck malignancy Must have recieved radiotherapy as primary treatment alone or combination treatment together with surgery Exclusion criteria less than 12 months follow up Under 18 years of age

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Radiotherapy|Radiotherapy site, time perspective and dose|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications related to dose, time and position of radiotherapy | Complications as Osteoradionecrosis will be identified and compared with the dose of radiation, how long ago since the radiotherapy was given and where in the mouth the complication has developed. | The measurements will be done from the end of radiotherapy and atleast 1 year postoperatively. |
RG2133 (2',3',5'-Tri-O-Acetyluridine) in Mitochondrial Disease

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to determine the safety and tolerability of RG2133 in patients with Mitochondrial Disease.

Official Title
-----------------
An Open-Label Dose-Escalation Phase I Study to Asses the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RG2133 (2',3',5'-Tri-O-Acetyluridine) in the Treatment of Inherited Mitochondrial Diseases

Conditions
-----------------
Mitochondrial Diseases

Intervention / Treatment
-----------------
* Drug: RG2133 (2',3',5'-tri-O-acetyluridine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Mitochondrial Disease

Ages Eligible for Study
-----------------
Minimum Age: 3 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: RG2133 (2',3',5'-tri-O-acetyluridine)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to define clinical and demographic features within the population suffering from cervical deformity to assist health professionals to make important treatment decisions.

Official Title
-----------------
Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study

Conditions
-----------------
Cervical Deformity, Kyphosis, Scoliosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult 18 years of age or greater Cervical deformity (kyphosis C2-7 greater than 10 degrees or scoliosis with coronal cobb greater than 10 degrees) Plans for surgical correction of cervical deformity Exclusion Criteria: Active tumor or infection Acute trauma Unwillingness to provide consent or complete study forms Prisoner Pregnant or planning to get pregnant during study period

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 |
| --- | --- |
| adults, cervical deformity, surgical treatment<br>Adults 18years or older at time of enrollment, cervical deformity to include kyphosis (C2-7 greater than 10 degrees) or scoliosis (coronal cobb greater than 10 degrees), plans for surgical treatment of cervical deformity | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographs | Changes in the degree of deformity post surgical correction and assessment of fusion. | Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Disability Index (NDI) | Changes related to worsening/improved neck pain as regards ability to manage everyday life. | Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop | 
| Numeric rating scale (NRS) | Changes in level of neck and back pain within the past month | Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop | 
| CSRS SWAL-QOL | Changes with swallowing problems affecting day-to-day quality of life | Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop | 
| EQ-5D3L | Changes in current health state | Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop | 
| mJOA | Changes in neck pain regarding ability fo function in everyday life | Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop |
Efficacy of Cyclosporine Rescue Therapy in Acute Ulcerative Colitis.

Study Overview
=================
Brief Summary
-----------------
The efficacy and safety of Cyclosporine A as rescue therapy for acute severe ulcerative colitis in long-term follow-up.

Detailed Description
-----------------
All UC patients treated with CyA in Tampere University Hospital between 2009 and 2018 were reviewed from patient records and analyzed. Amelioration of UC was defined as clinical response for rescue therapy with no need for colectomy or third-line rescue therapy at the same hospitalization as index flare. Relapse was defined as requiring further Cs treatment, re-hospitalization, biologicals, small molecules, or colectomy later in follow-up. Patients were followed-up from the date of index flare until colectomy, death, or the end of observation period. Adverse events related to treatment were assessed throughout the duration of treatment. Surgical complications were defined by using Clavien-Dindo classification (grade III-V classified as severe complications). The surgical complications in Cyclosporine-treated patients were compared to all patients operated for treatment refractor UC in Tampere University Hospital within the same follow-up period.

Official Title
-----------------
Long-term Outcome of Patients With Acute Ulcerative Colitis Treated With Cyclosporine Rescue Therapy.

Conditions
-----------------
Ulcerative Colitis Acute

Intervention / Treatment
-----------------
* Drug: Cyclosporine A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to hospital for acute flare of UC and treated with CyA rescue therapy. Age 16 or over Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cyclosporine A|Rescue therapy in acute severe ulcerative colitis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response | Clinical response for CyA with no need for colectomy or further enhancement of treatment with infliximab at the same hospitalization ad index flare | From january 2009 to december 2018 | 
| Remission | Remission was defined as no need for further corticosteroids, re-hospitalization, enhancement of treatment with biologicals or small molecules or colectomy within follow-up. | From january 2009 to december 2018 | 
| Adverse events | Reported treatment related adverse events. | From january 2009 to december 2018 | 
| Surgical complications | Reported surgical complications. | From January 2009 to December 2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cyclosporine A, Rescue therapy
Diurnal Intraocular Pressure and Peripapillary Retinal Blood Flow in Medically Controlled Open-Angle Glaucoma

Study Overview
=================
Brief Summary
-----------------
Diurnal fluctuations of intraocular pressure (IOP) and peripapillary retinal blood flow may have distinctive patterns in medically well-controlled open-angle glaucoma patients. In the results, we found a unique pattern, 'Latent asymmetric IOP', defined as the IOP which differs between the eyes only when placed in the supine position. Unique effects of this latent asymmetric IOP on Visual field and diurnal IOP fluctuations were studied.

Detailed Description
-----------------
Diurnal fluctuations of intraocular pressure (IOP) and peripapillary retinal blood flow have been implicated to be one of the important factors to affect visual field progression. However, there was no study to investigate them in medically well-controlled open-angle glaucoma patients. So we want to find the unique patterns. Study 1. Subjects : Patients with medically well controlled open angle glaucoma Method : IOP and peripapillary retinal blood flow were measured for 24 hours. The relationship between the two were studied. Study 2. Of the patients enrolled in study 1 , those on the same medical regimen for both eyes were analyzed for the presence of a latent asymmetric IOP and it's influence and association with visual field and diurnal IOP fluctuation.

Official Title
-----------------
Diurnal Intraocular Pressure and Peripapillary Retinal Blood Flow in Medically Controlled Open-Angle Glaucoma

Conditions
-----------------
Open-Angle Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Open-angle glaucoma Topical anti-glaucoma medications Exclusion Criteria: Ocular surgery history Other ocular disease history Oral glaucoma medications

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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
-----------------
open-angle glaucoma, diurnal fluctuation, intraocular pressure, peripapillary retinal blood flow, latent asymmetric intraocular pressure
Clinical Comparison of Bulk-fill and Incremental Composite

Study Overview
=================
Brief Summary
-----------------
The clinical performance of a 5-mm bulk-fill and an incremental resin composite in class II restorations will be evaluated and compared. After recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. All caries lesions will be removed before restoring. Cavities will be divided into two groups: a 5 mm bulk-fill composite resin [Filtek™ Bulk Fill Posterior, 3M ESPE, St. Paul MN, USA (FB)] and an incremental posterior composite resin [Filtek Ultimate Universal, 3M ESPE, St. Paul MN, USA (FU)] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.

Official Title
-----------------
Clinical Comparison of Bulk-fill and Incremental Composite Resin Restorations

Conditions
-----------------
Tooth Disease

Intervention / Treatment
-----------------
* Device: Filtek Bulk-Fill Posterior
* Device: Filtek Ultimate Universal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age range will be 18 to 65 patients should have at least 2 approximal caries lesions require restoration healthy periodontal status a good likelihood of recall availability Exclusion Criteria: poor gingival health adverse medical history potential behavioral problems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bulk-Fill<br>Filtek™ Bulk Fill Posterior, 3M ESPE, St. Paul MN, USA (FB) | Device: Filtek Bulk-Fill Posterior<br>* Bulk-fill restorative composite<br>|
| Experimental: Incremental<br>Filtek Ultimate Universal, 3M ESPE, St. Paul MN, USA (FU) | Device: Filtek Ultimate Universal<br>* Incremental restorative composite<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performances of different restorative systems according to USPHS criteria | Two year results according to USPHS criteria | two years |
Intravenous-Morphine and Glucagon-Usage Enhanced MR Cholangiography

Study Overview
=================
Brief Summary
-----------------
Morphine can induce constriction of sphincter of oddi and glucagon can facilitate bile secretion and dilatation of bile duct. We conduct this randomized double blinded study to evaluate the effect of enhancement in MRCP using intravenous morphine and glucagon.

Detailed Description
-----------------
Morphine can induce constriction of sphincter of oddi and glucagon can facilitate bile secretion and dilatation of bile duct. We conduct this randomized double blinded study to evaluate the effect of enhancement in MRCP using intravenous morphine and glucagon.

Conditions
-----------------
Liver Disease

Intervention / Treatment
-----------------
* Drug: morphine and glucagon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal volunteer living liver donor Exclusion Criteria: COPD chronic liver disease hypersensitive to glucagon DM insulinoma glucagonoma pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: morphine and glucagon|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRCP visibility |  |  |
Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction: Cardiovascular Effects.

Study Overview
=================
Brief Summary
-----------------
Heart failure (HF) is among the most common causes of death in patients with type 2 diabetes (T2D). Ketones, 3-hydroxybutyrate (3-OHB), have shown to have beneficial hemodynamics effect in patients with hearth failure with reduced ejection fraction. However, this have never been investigated in patients with heart failure with preserved ejection fraction (HFpEF). In this study we would like to investigate the effect of 14 days modulation of circulating ketone body levels on cardiac function and exercise capacity in patients with HFpEF and T2D.

Official Title
-----------------
Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction: Cardiovascular Effects.

Conditions
-----------------
Heart Failure With Preserved Ejection Fraction, Diabetes Mellitus, Type 2, Ketonemia

Intervention / Treatment
-----------------
* Dietary Supplement: Ketone ester
* Dietary Supplement: Placebo drink


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes LVEF > 40 % a clinical diagnosis of HFpEF and/or left ventricular hypertrophy (posterior wall thickness > 12 mm) and/or previous myocardial infarction age ≥ 18 years old, one of the following criteria (a-d) should be fulfilled: Echocardiographic signs of diastolic dysfunction E/e' > 8 Septal e ́< 7 cm/s and/or lateral e ́ < 10 cm/s Left atrium volume index ≥34 mL/m2 and/or left atrial diameter > 4 cm NT-proBNP > 125 pg/ml. Exclusion Criteria: Insulin treatment, inability to give 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketone ester<br> | Dietary Supplement: Ketone ester<br>* Commercially available ketone supplement<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo drink<br>* Isocaloric placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Output (L/min) | Right heart catheterization | 14 days ketone ester treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonal wedge capillary Pressure (PCWP) | Right heart catheterization | 14 days ketone ester treatment | 
| Exercise capacity (METs) | Cardiopulmonary exercise test | 14 days ketone ester treatment |