linjc16/ctgov huggingface dataset:
Open Label Phase 1 Pharmacokinetics and Tolerability Study of Single TAB08 Administration in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess safety and tolerability of ascending dosed of TAB08 after single i.v. infusion to the adult healthy volunteers. Additionally were assessed infusion speed tolerability, pharmacokinetics and pharmacodynamics of TAB08 after single i.v. infusion and to explore TAB mechanism-of-action biomarkers.

Official Title
-----------------
Open Label Phase 1 Pharmacokinetics and Tolerability Study of Single TAB08 Administration in Healthy Volunteers

Conditions
-----------------
Adult Healthy Volunteers

Intervention / Treatment
-----------------
* Biological: TAB08


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult man aged from 18 to 40 years, who agreed to use adequate contraception. Body mass is at least 60 kg and BMI is within 20-27 Volunteer is in good physical and mental health, as per his medical history and assessment results Volunteer's laboratory values are normal (or not clinically significant as per Investigator discretion) at screening, including baseline cytokines levels as per RESTORE test results Volunteer has signed the informed concent. Exclusion Criteria: Any chronic or relapsing illness in the medical history Any abnormal assessment or laboratory result at screening, which is clinically significant as per Investigator discretion Active tuberculosis at the time of screening Any acute illness at the time of study enrollment Any blood donation within 4 weeks before Study Day 1 Positive result for HBsAG, Hepatitis C, HIV Continuous use af any medications Use of any medications within 72 hours before study drug infusion Use of an investigational treatment within 4 weeks before screening, or within a period of 5 half-lives of the investigational treatment, whichever is longer High inflammatory cytokines levels as per RESTORE test results after ex vivo PBMC testing

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

Sexes Eligible for Study
-----------------
Male

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: TAB08<br>Single TAB08 i.v. infusion | Biological: TAB08<br>* monoclonal antibody<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dose-limiting toxicity in every dose cohort |  | From study drug infusion (Day 1) untill the end of study (Day 71/141) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TAB08, healthy volunteers
GlideScope® Versus Macintosh Laryngoscope for Post-thyroidectomy Assessment of Vocal Cord Mobility

Study Overview
=================
Brief Summary
-----------------
Vocal cord dysfunction is a serious post-thyroidectomy complication. This can lead to various postoperative clinical consequences as hoarseness of voice, aspiration or stridor . It is also one of the common reasons for post-thyroidectomy malpractice claims. This study will compare GlideScope® with Macintosh laryngoscope regarding accuracy of assessment of post-thyroidectomy vocal cord mobility.

Official Title
-----------------
GlideScope® Versus Macintosh Laryngoscope for Post-thyroidectomy Assessment of Vocal Cord Mobility

Conditions
-----------------
Complication, Postoperative

Intervention / Treatment
-----------------
* Device: conventional Macintosh laryngoscope
* Device: GlideScope®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I and II, Elective thyroid surgery with Normal thyroid profile Exclusion Criteria: History of previous thyroid surgery, Preoperative vocal cord dysfunction Predicted difficult airway

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: conventional Macintosh laryngoscope|After closure of surgical, anesthesiologist will perform the conventional Macintosh laryngoscope to assess post-thyroidectomy vocal cord mobility.|
|Device: GlideScope®|Patient will be left for a while until hemodynamic stabilization then examination with GlideScope® will be commenced to assess postthyroidectomy vocal cord mobility by another experienced anesthesiologist|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vocal cord dysfunction | newly recorded reduction in the postoperative vocal cords mobility compared with the preoperative status. | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of traumatic complications | traumatic complications as swelling in the mouth, tongue, or throat, teeth injury, bleeding or hoarseness of voice | First 24 hours postoperatively |
A Pharmacokinetic Study of YM178 in Normal Subjects and Those With Mild, Moderate, and Severe Renal Impairment

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess and compare the pharmacokinetic properties of YM178 in normal subjects and those with mild, moderate and severe renal impairment.

Official Title
-----------------
A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Assess the Effect of Mild, Moderate and Severe Renal Impairment on the Pharmacokinetics of YM178

Conditions
-----------------
Renal Impairment

Intervention / Treatment
-----------------
* Drug: YM178


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: good health other than renal impairment body mass index (BMI) between 18 and 40 kg/m2 Exclusion Criteria: subject with renal impairment has not been on stable dose of concomitant medication for at least 2 weeks subject has liver enzyme abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. Severe renal impairment<br>severe renal impairment | Drug: YM178<br>* oral<br>* Other names: mirabegron;|
| Experimental: 2. Moderate renal impairment<br>moderate renal impairment | Drug: YM178<br>* oral<br>* Other names: mirabegron;|
| Experimental: 3. Mild renal impairment<br>mild renal impairment | Drug: YM178<br>* oral<br>* Other names: mirabegron;|
| Experimental: 4. Normal renal function<br>normal renal function | Drug: YM178<br>* oral<br>* Other names: mirabegron;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pharmacokinetics parameters |  | day 1 - day 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolite analysis |  | day 1 - day 6 | 
| Assessment of safety and tolerability |  | day 1 - day 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mild, moderate, and severe renal impaired subjects, normal renal function subjects, Glomerular filtration rate (GFR), Modification of Diet in Renal Disease (MDRD) formula, pharmacokinetics, YM178
Risk Perception of Periodontal Disease

Study Overview
=================
Brief Summary
-----------------
This study aimed at understanding the impact of educational pamphlet on Risk Perception of Periodontal Disease using A Randomised Clinical Trial model among patients in a Nigerian outpatient dental clinic

Detailed Description
-----------------
This study aimed at understanding the impact of educational pamphlet on Risk Perception of Periodontal Disease using A Randomised Clinical Trial model among patients in a Nigerian outpatient dental clinic. The outcome will help activate a success oriented periodontal disease prevention model

Official Title
-----------------
Risk Perception of Periodontal Disease: A Randomised Clinical Trial

Conditions
-----------------
Periodontal Diseases

Intervention / Treatment
-----------------
* Behavioral: Exposure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consenting dental patients Exclusion Criteria: non consenting dental patients

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 60 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
Interventional Model Description: randomised
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: without pamphlet<br>a group not exposed to pamphlet | |
| Experimental: With pamphlets<br>a group exposed to pamphlet | Behavioral: Exposure<br>* Exposure to pamphlet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk perception | Questionnaire | 1month |
Electroencephalogram Dynamics in Children During Different Levels of Anesthetic Depth

Study Overview
=================
Brief Summary
-----------------
As part of the clinical routine of the Department of Anesthesiology and Intensive Care Medicine CVK/CCM in the Charité - University Medicine Berlin intraoperative electroencephalography data and clinical routine data are recorded and evaluated in surgical children and adolescents according to different age groups.

Official Title
-----------------
Electroencephalogram Dynamics in Children During Different Levels of Anesthetic Depth

Conditions
-----------------
Depth of Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children and adolescents undergoing surgery procedure Exclusion Criteria: Neurosurgery Pre-existing neurological conditions

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Children and adolescents<br>Children and adolescents for elective surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electroencephalography monitoring changes |  | Up to the end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthetic depth |  | Up to the end of surgery |
Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the safety of isotretinoin in patients with recessive dystrophic epidermolysis bullosa.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients receive oral isotretinoin daily for 8 months in the absence of disease progression or unacceptable toxicity. Completion date provided represents the completion date of the grant per OOPD records

Conditions
-----------------
Epidermolysis Bullosa

Intervention / Treatment
-----------------
* Drug: isotretinoin


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of recessive dystrophic epidermolysis bullosa (RDEB) RDEB Hallopeau-Siemens OR RDEB non-Hallopeau-Siemens Concurrent enrollment in the National Epidermolysis Bullosa Registry No regional or distant metastasis in patients with previous or concurrent squamous cell carcinoma --Patient Characteristics-- Hepatic: No clinically significant hypertriglyceridemia No clinically significant hepatic dysfunction Renal: No clinically significant renal dysfunction Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: isotretinoin|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
-----------------
dermatologic disorders, epidermolysis bullosa, genetic diseases and dysmorphic syndromes, rare disease
Blood-aqueous Barrier Integrity in Eyes Undergoing Intravitreal Bevacizumab Therapy to Treat Neovascular AMD

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the effect of repeated intravitreal bevacizumab injections on blood-aqueous barrier permeability in eyes with neovascular age-related macular degeneration (AMD).

Official Title
-----------------
Blood-aqueous Barrier Integrity in Eyes Undergoing Intravitreal Bevacizumab Therapy to Treat Neovascular Age-related Macular Degeneration

Conditions
-----------------
Exudative Age-related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Bevacizumab Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: active AMD-associated choroidal neovascularization (CNV) confirmed with fluorescein angiography (FA) and optical coherence tomography (OCT) Exclusion Criteria: history of uveitis, vitreous hemorrhage, neovascular glaucoma, corneal opacities, recent ocular surgery (within 3 months), or prior anti- vascular endothelial growth factor (VEGF) injections
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| treated with intravitreal bevacizumab.<br> | Drug: Bevacizumab Injection<br> <br> |
| control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior chamber (AC) inflammation evaluated with laser flare photometry. | All patients were examined before and 1 day and 1 month after each intravitreal bevacizumab injection. Subjects were followed for a period of 4 months in both the study and control groups. The final flare photometry value was automatically calculated by averaging 5 individual measurements. A total of 7 measurements were obtained, but the highest and lowest measurement values were excluded by the flare meter. All statistical analyses were performed using STATISTICA 12 statistical software. | 4 months |
Supra-spinatus Rehabilitation Program Comparison

Study Overview
=================
Brief Summary
-----------------
Through a prospective randomized study the aims of this study is to analyze the impact of 3 types of rehabilitation protocols on the Optimization of the post-operative clinical and anatomic healing of the rotator cuff. After an arthroscopic repair of a stage 1 or 2 supra-spinatus tendon rupture, patients will be included in 3 groups (98 patients per group): strict immobilization for 6 weeks then active rehabilitation, or 3 weeks of immobilization then 3 weeks of passive motion before active rehabilitation, or immediate passive motion for 6 weeks and then active rehabilitation. Patients will be evaluated clinically at 6 weeks, 3 months, 6 months and 1 year and an arthro-CT will be performed at 1 year. The investigators will evaluate: constant score and rate of tendon healing.

Official Title
-----------------
Prospective Randomized Study Comparing 3 Post-operative Rehabilitation Programs After Arthroscopic Supra-spinatus Tendon Repair

Conditions
-----------------
Rotator Cuff Tear

Intervention / Treatment
-----------------
* Procedure: Arthroscopic rotator cuff repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female between 40 and 65 years old non-retracted supra-spinatus tendon tear-pre-operative clinical examination and ct scan-arthroscopic single-row tendon repair Exclusion Criteria: patient with a stiff shoulder previous surgery of the shoulder stage 3 or 4 fatty infiltration insufficient repair of the cuff

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Passive group<br>Rehabilitation program is immediate. Active range of motion rehabilitation is started at the sixth week. | Procedure: Arthroscopic rotator cuff repair<br>* Arthroscopic rotator cuff repair for all groups<br>|
| Other: Immobilization group<br>No passive Rehabilitation program is started. An active protocol is started after the sixth week | Procedure: Arthroscopic rotator cuff repair<br>* Arthroscopic rotator cuff repair for all groups<br>|
| Other: Delayed group<br>Rehabilitation program is delayed to the third week. Active range of motion rehabilitation is started at the sixth week. | Procedure: Arthroscopic rotator cuff repair<br>* Arthroscopic rotator cuff repair for all groups<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study Assessing the Effect of 3-week Treatment With One of Three Oral Doses of Quinagolide

Study Overview
=================
Brief Summary
-----------------
Women included in this study are undergoing controlled ovarian hyperstimulation for assisted reproductive technologies (ART) and present with signs of moderate risk of developing OHSS.

Detailed Description
-----------------
No data to be entered.

Official Title
-----------------
A Randomised, Double-blind, Parallel Groups, Dose-finding, Placebo-controlled, Multi-centre, Proof of Concept Study Assessing the Effect of 3-wk Treatment With 1 of 3 Oral Doses of Quinagolide & Placebo in Preventing Ovarian Hyperstimulation Syndrome in Women Undergoing Controlled Ovarian Hyperstimulation.

Conditions
-----------------
Ovarian Hyperstimulation Syndrome

Intervention / Treatment
-----------------
* Drug: Norprolac
* Drug: Norprolac
* Drug: Norprolac
* Drug: Norprolac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Signed Informed Consent Form, prior to screening evaluations In good physical and mental health Pre-menopausal females between the ages of 21-37 years (both inclusive) at the time of randomisation Infertility for at least 1 year before randomisation, except for proven bilateral tubal infertility Exclusion Criteria Any clinically significant systemic disease Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) History of recurrent miscarriage Undiagnosed vaginal bleeding

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 37 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Daily Tablets Dosing | Drug: Norprolac<br>* Placebo<br>|
| Experimental: 2<br>Daily Tablets Dose | Drug: Norprolac<br>* Quinagolide<br>|
| Experimental: 3<br>Daily Tablets Dosing | Drug: Norprolac<br>* Quinagolide<br>|
| Experimental: 4<br>Daily Tablets Dosing | Drug: Norprolac<br>* Quinagolide<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OHSS |  | 41 days after hCG injection |
Effect of Timi3 Ultrasound on Myocardial Blow Flow in the Hibernating Myocardium

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether the use application of low frequency ultrasound, administered by the Timi3 ultrasound device, increases myocardial blood flow to the heart, in subjects with reduced myocardial blood flow at rest (hibernating myocardium). The primary endpoint of the trial is to assess the increase in myocardial blood flow from baseline to post Timi3 Ultrasound treatment in a hypoperfused region of myocardium. Positron emission tomography (PET) imaging will be used to noninvasively evaluate cardiac blood flow. The hypothesis is that ultrasound increases blood flow in hibernating myocardium.

Official Title
-----------------
Evaluation of the Effect of T3US on Myocardial Blow Flow in the Hibernating

Conditions
-----------------
Myocardial Ischemia

Intervention / Treatment
-----------------
* Device: Timi3 Transthoracic ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >/= 18 years Must have reversible resting ischemia, resting non-reversible blood flow defect, or stress-induced ischemia. Females with childbearing potential must not be pregnant at the time of the study Must provide written informed consent Exclusion Criteria: Unable or unwilling to cooperate with study procedures Currently enrolled in another clinical study for which the follow-up period is not complete

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Timi3 Transthoracic ultrasound|Low frequency ultrasound over the chest using Timi3 ultrasound device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in myocardial blood flow from baseline to post ultrasound treatment |  | immediate post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hibernating Myocardium, Blood Flow, Ultrasound, PET imaging