linjc16/ctgov huggingface dataset:
Study Investigating the Pharmacokinetic Properties of the Drug Lu AF35700 in Subjects With Liver Impairment and in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the impact of mild to moderate hepatic impairment on the pharmacokinetics of a single oral dose of Lu AF35700

Official Title
-----------------
Interventional, Open-label, Three-group, Single-dose Study Investigating the Pharmacokinetic Properties of Lu AF35700 in Subjects With Hepatic Impairment (Mild or Moderate) and in Healthy Subjects

Conditions
-----------------
Hepatic Impairment

Intervention / Treatment
-----------------
* Drug: Lu AF35700


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with hepatic impairment disease stage Child-Pugh's Criteria A (mild) or Child-Pugh's Criteria B (moderate) and healthy subjects with normal hepatic function Subjects have a body mass index between 18.5 and 34 kg/m2 (inclusive) Exclusion Criteria: Subjects previously been dosed with Lu AF35700 Other protocol defined inclusion and exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with mild hepatic impairment (Group1)<br> | Drug: Lu AF35700<br>* Single oral dose of 10 mg Lu AF35700<br>|
| Experimental: Patients with moderate hepatic impairment (Group 2)<br> | Drug: Lu AF35700<br>* Single oral dose of 10 mg Lu AF35700<br>|
| Experimental: Healthy subjects (Group 3)<br> | Drug: Lu AF35700<br>* Single oral dose of 10 mg Lu AF35700<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the Lu AF35700 plasma concentration-time curve from zero to infinity (AUC0-inf) | Area under the Lu AF35700 plasma concentration-time curve from zero to infinity (AUC0-inf) | Predose to day 57 postdose | 
| Maximum observed plasma concentration (Cmax) of Lu AF35700 | Maximum observed plasma concentration (Cmax) of Lu AF35700 | Predose to day 57 postdose |
Bevacizumab Versus Combined Bevacizumab and Triamcinolone for Refractory Diabetic Macular Edema; a Randomized Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy and safety of intravitreal injection of bevacizumab alone versus bevacizumab combined with triamcinolone for treatment of refractory diabetic macular edema.

Detailed Description
-----------------
According to the early treatment diabetic retinopathy study (ETDRS), the treatment of choice for diabetic macular edema is laser therapy, which may be neither effective nor curative in some patients. Corticosteroids may have a beneficial effect on diabetic macular edema. Other newly introduced medications for macular edematous lesions are anti-VEGF vascular endothelial growth factor)drugs. In this randomized, sham-controlled, multicenter, three-arm clinical trial,we try to evaluate the safety and efficacy of intravitreal bevacizumab alone and in combination with intravitreal triamcinolone in the treatment of refractory diabetic macular edema.

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: Triamcinolone, Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases with clinically significant macular edema (CSME) with persistent retinal thickening after initial or supplemental macular photocoagulation Exclusion Criteria: Monocularity, History of vitrectomy, Glaucoma or ocular hypertension, Significant media opacity, Existence of traction on the macula
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

| Intervention/Treatment |
| --- |
|Drug: Triamcinolone, Bevacizumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  |  | 
| Central macular thickness |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cataract progression |  |  | 
| Intraocular pressure |  |  | 
| Anterior chamber reaction |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intravitreal bevacizumab, Cystoid macular edema, Diabetic macular edema, Hard exudates, Intravitreal triamcinolone, Macular thickness
Trial of Argon Plasma Coagulation Versus APC and APC and Hemospray in the Treatment of Radiation Proctitis

Study Overview
=================
Brief Summary
-----------------
Randomized trial of Argon Plasma Coagulation compared with Argon Plasma Coagulation and Hemospray in the therapy of bleeding from Radiation Proctitis

Detailed Description
-----------------
20 patients with Radiation Proctitis will be randomized to receive either Argon Plasma Coagulation therapy alone or therapy with APC followed by Hemospray administration ;the treatment in each arm is administered during a sigmoidoscopic examination

Official Title
-----------------
Randomized Trial of Argon Plasma Coagulation Versus Argon Plasma Coagulation and Hemospray in the Therapy of Radiation Proctitis

Conditions
-----------------
Rectal Bleeding

Intervention / Treatment
-----------------
* Other: Hemospray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bleeding from radiation proctitis Exclusion Criteria: pregnancy bleeding diathesis

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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: argon plasma coagulation<br>argon plasma coagulation of radiation proctitis | Other: Hemospray<br>* hemospray is used after argon coagulation to stop bleeding<br>|
| Experimental: argon plasma coagulator and hemospray<br>treatment of radiation proctitis with argon plasma coagulator followed by application of hemospray | Other: Hemospray<br>* hemospray is used after argon coagulation to stop bleeding<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cessation of rectal bleeding | treatment of one group of patients with Radiation Proctitis with Argon Plasma Coagulator ( APC) and a second group will be treated with APC and Hemospray | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of treatments required to achieve cessation of rectal bleeding |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiation proctitis, bleeding, therapy
Time-dependent Improvement of Functional Outcome Following Oxford Medial Unicondylar Knee Replacement

Study Overview
=================
Brief Summary
-----------------
The objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome Score (KOOS) and (2) the time course of range of motion (ROM) the first six years following Oxford Medial Unicondylar Knee prosthesis. Improvement of patient self-reported pain and daily function during the study period, are of particular interest.

Detailed Description
-----------------
The objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome Score (KOOS) and (2) the time course of range of motion (ROM) the first six years following Oxford Medial Unicondylar Knee prosthesis. Improvement of patient self-reported pain and daily function during the study period, are of particular interest. Thats it!

Official Title
-----------------
Time-dependent Improvement of Functional Outcome Following Oxford Medial Unicondylar Knee Replacement - A Prospective Longitudinal Study With Repetitive Measures of KOOS in 100 Patients

Conditions
-----------------
Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with medial knee osteoarthritis admitted for unicondylar knee replacement age 50-80 years Exclusion criteria rheumatoid arthritis previous knee infection

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Patients with knee osteoarthritis<br>Patients with knee osteoarthritis that are about to get an operation with oxford unicondylar knee | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score | Patient relevant knee score. Validated score with 5 arms. 0-100, 100 is best. | Preoperative until 2 years postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion |  | Preoperative until 2 years postoperatively | 
| Oxford Knee Score |  | Preoperative until 2 years postoperatively | 
| UCLA Score |  | Preoperative until 2 years postoperatively | 
| Knee Injury and Osteoarthritis Outcome Score |  | 10 years postoperatively | 
| Oxford Knee Score |  | 10 years postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Unicondylar Knee Replacement
Pharmacokinetic Study of Aerosolized Colimycin in Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
Pharmacokinetics of colimycin will be assessed during 12 hours after administration of 2M UI colimycin either as an aerosol or after IV injection, the administration being separated by 5 to 10 days intervals

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: COLIMYCINE inhalation
* Drug: COLIMYCINE injectable


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females, adults. Suffering from stable cystic fibrosis Colonized by P. aeruginosa Having given informed consent. Able to follow the protocol Having a social insurance Exclusion Criteria: Renal insufficiency Allergy to colistin or polymixins Myasthenia Recent severe hemoptysis Liver cirrhosis and hepatic insufficiency Hypoalbuminemia Colonization by Burkholderia cepaea or Stenotrophomonas maltophilin Pregnancy

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COLIMYCINE injectable<br> | Drug: COLIMYCINE injectable<br>* 2 MILLIONS UI<br>|
| Experimental: COLIMYCINE inhalation<br> | Drug: COLIMYCINE inhalation<br>* 2 MILLION UI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome

Study Overview
=================
Brief Summary
-----------------
Comparison of the efficacy and safety of T2750 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome

Official Title
-----------------
Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Device: T2750
* Device: Vismed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed and dated informed consent Male or female aged from ≥ 18 years old. Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study selection. Exclusion Criteria: Best far corrected visual acuity < 1/10 Severe blepharitis Severe Dry Eye Eyelid malposition Known hypersensitivity to one of the components of the study medications or test products. Pregnant or breast-feeding woman. Woman of childbearing age (neither menopausal, nor hysterectomised, nor sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant or condoms). Inability of patient to understand the study procedures and thus inability to give informed consent. Non compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance). Already included once in this study. Patient under guardianship.

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 |
| --- | --- |
| Experimental: T2750<br> | Device: T2750<br>* 1 drop in each eye 3 to 6 times daily during 84 days<br>|
| Active Comparator: Vismed<br> | Device: Vismed<br>* 1 drop in each eye 3 to 6 times daily during 84 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Ocular Staining (With Oxford Scale - Ranges :0-15) | Change from baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome) | Baseline and 35 days |
Retrospective Review of Xen Gel Stent Implantation With Open vs. Closed Conjunctiva Approach

Study Overview
=================
Brief Summary
-----------------
To measure surgical success of open vs closed conjunctiva with Xen implantation.

Detailed Description
-----------------
This retrospective, single-arm multicenter study included >100 eyes (>100 patients) with glaucoma refractory to medical therapy. All surgeries were performed by two groups of surgeons at Johns Hopkins University and the sub-investigator group at New York University. Group 1: Xen with open conjunctiva for positioning and application of mitomycin. The Xen was placed through the sclera either ab-interno or ab-externa. Group 2 had Xen placed ab-interno or ab-externa (trans conjunctival), but the conjunctiva was not opened for positioning or application of mitomycin-C. Success rates will be determined based on need for re-intervention and intraocular pressure control.

Official Title
-----------------
Retrospective Review of Xen Gel Stent Implantation With Open vs. Closed Conjunctiva Approach

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

Intervention / Treatment
-----------------
* Device: Xen Gel Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Require surgery for uncontrolled glaucoma Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Xen Gel Stent|Ab-interno or Ab-Externa Xen with closed or open conjunctiva.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| re-intervention rate | This will be assessed as the proportion of patients that will need fibrosis relief by stent re-implantation | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intraocular pressure | will be assessed as a % change in intraocular pressure | 1 day, 1 week, 1 month and 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma surgery, Xen Gel Stent
Study Evaluating Bazedoxifene/CE in Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to study the blood levels of a drug (conjugated estrogens) in the body from one dosage form compared to another. The four formulations of the study drug that eligible participants will receive will contain the same amounts of the same medications. In addition, information will also be obtained regarding the safety and tolerability of the formulations given to healthy postmenopausal women.

Official Title
-----------------
An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of Clinical and Commercial Formulations of Bazedoxifene/Conjugated Estrogens in Healthy Postmenopausal Women

Conditions
-----------------
Postmenopause

Intervention / Treatment
-----------------
* Device: Bazedoxifene/Conjugated Estrogens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women aged 35 to 70 years. Spontaneous or surgical amenorrhea for at least 6 months. Body mass index (BMI) in the range of 18.0 to 35.0 kg/m2 and body weight greater than or equal to 50 kg. Exclusion Criteria: Hypertension or elevated supine blood pressure (>139 mm Hg systolic or >89 mm Hg diastolic). History of any clinically important drug allergy. Use of any prescription or investigational drug within 30 days before test article administration.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 Years

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

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Bazedoxifene/Conjugated Estrogens|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The plasma concentration data and pharmacokinetic (PK) parameters of BZA and CE. |  |  |
Investigating the Sleeping Habits of Patients With Haemophilia

Study Overview
=================
Brief Summary
-----------------
This investigation aims to explore sleeping habits in patients with haemophilia. These patients often suffer from joint pain, which leads to restricted physical activity. Further, many of the patients suffer from psychological strains, such as depression. Both depression and restricted physical activity can result in sleeping disorders. Thus it is aimed to find out which factors and comorbidities do play a role within sleeping habits in patients with haemophilia.

Official Title
-----------------
Investigating the Sleeping Habits of Patients With Haemophilia

Conditions
-----------------
Sleep Disorder, Psychological, Activity, Motor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult (≥ 18 years) patients with haemophilia (all severities) or Von-Willebrand-Disease (Typ III) female carriers signed informed consent Exclusion Criteria: patients with other bleeding disorders patients with acute injuries, psychological disorders or Prior surgeries (in the last 6 weeks) no signed 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with haemophilia<br>This investigation includes patients with haemophilia of all seventies (mild, moderate, severe), as well as female carriers and patients with Von-Willebrand-Disease (Typ III) | |
| Healthy controls<br>The control group consists of adult healthy female and male subjects. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleeping habits | Questionnaire on sleeping habits (SF/BR B) | 15 Minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | Questionnaire on physical activity level (self-developed Questionnaire) | 10 Minutes | 
| Psychological distress | Health survey of psychological distress (PHQ9) | 10 Minutes | 
| Kinesiophobia | Tampa Scale of Kinesiophobia (scale 1-5) | 5 Minutes | 
| Subjective pain perception | Questionnaire on Pain Sensitivity | 5 Minutes | 
| Adherence to prophylactic treatment | Questionnaire on adherence to prophylactic Treatment (VERITAS-Pro) | 5 Minutes |