linjc16/ctgov huggingface dataset:
Evaluation of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Following OptiMARK Injection

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to prospectively monitor the incidence of adverse drug reactions, specifically NSF during routine use of gadoversetamide in a large number of patients with moderate renal insufficiency (eGFR 30-59) and severe renal insufficiency or end-stage renal disease requiring dialysis (eGFR <30).

Official Title
-----------------
A Prospective Study for the Detection of Nephrogenic Systemic Fibrosis in Patients With Renal Impairment Undergoing Gadoversetamide-enhanced Magnetic Resonance Imaging

Conditions
-----------------
Nephrogenic Systemic Fibrosis, Renal Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referred for contrast-enhanced MRI using gadoversetamide; Have a documented estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m2 within the past 6 months or ESRD requiring dialysis; and Willing and able to provide written consent (themselves or by a legally authorized representative) and agree to abide by study requirements, including being seen by a dermatologist and undergoing a skin biopsy if NSF is suspected. Exclusion Criteria: Have experienced a previous hypersensitivity reaction to a GBCA; Have pre-existing NSF or NSF-like symptoms; or Have been exposed to a GBCA within 12 months prior to the index procedure; or Has a medical condition or other personal situation that would prevent providing follow-up information, completing clinic visits or otherwise supplying meaningful data to meet study objectives.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Subjects with moderate renal insufficiency defined as an eGFR 30-60 mL/min/1.73 m2 | |
| 2<br>Subjects with severe renal insufficiency defined as an eGFR <30 mL/min/1.73 m2 and ESRD defined as requiring dialysis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure will be the diagnosis of NSF based on clinical assessments and patient telephone calls through 24 months of follow-up. |  | 1, 3, 6, 12, 18 and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nephrogenic Systemic Fibrosis, Renal Insufficiency, Gadoversetamide, OptiMARK, Magnetic Resonance Imaging
Sun Protection Factor Assay (SPF Assay 204/2016)

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: BAY987521


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female. Aged between 18-70 years old. Good health as determined from the HRL SHF (Subject History Form). Signed and dated Informed Consent Form. Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form. An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.)which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma, diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY987521<br>Each test site area is divided into test sub site areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: BAY987521<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code:Z09-054)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
A Single Ascending Dose Study of CD101 IV in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
A single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 IV

Detailed Description
-----------------
This is a Phase 1, single-center, prospective, randomized, double-blind study of ascending single doses of CD101 Injection administered IV to healthy adult subjects. In this study, subjects in 4 cohorts of 8 subjects, each will be randomized to receive single IV doses of CD101 Injection or placebo. Dose levels of CD101 to be assessed will follow an ascending single-dose regimen.

Official Title
-----------------
A Phase 1, Randomized, Double-Blind, Single-Dose, Dose Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD101 Injection in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: CD101 IV
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males surgically sterilized or using contraception, No significant findings on physical, ECG, clinical laboratory tests, BMI between 18.5 - 32.0, Must provide informed consent Exclusion Criteria: Females of child bearing potential, Signs and or symptoms of an acute or chronic illness, Use of prescription medications within 28 days, Use of OTC, supplements, and herbals within 14 days, Current smoker Previous participation in a clinical study within 28 days

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CD101 IV<br>single intravenous infusion ascending dose | Drug: CD101 IV<br>* antifungal<br>|
| Placebo Comparator: Placebo<br>normal saline | Drug: Placebo<br>* normal saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with clinically significant adverse events (AEs) |  | Up to 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Profile as measured by: maximum plasma concentration (Cmax), time to Cmax (Tmax), area under the curve (AUC), clearance (CL), volume of distribution (Vz), elimination rate constant (^z), terminal half-life (t1/2) |  | Up to 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subjects
Efficacy of a New Topical Anesthetic

Study Overview
=================
Brief Summary
-----------------
A new topical anesthetic which contains 5% lidocaine and a disinfection ingredient has been developed and is tested in this study (LidoDyn). The study examines the efficacy of LidoDyn by comparing it with an already proven anesthetic agent (EMLA crème).

Official Title
-----------------
A Single-blind, Randomized, Controlled Trial to Assess the Efficacy of a New Topical Anesthetic in Reducing Pain Associated With Venipuncture in Children.

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: LidoDyn
* Drug: EMLA creme


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously healthy children of whom venipuncture is needed to be performed. Exclusion Criteria: History of allergic reaction to any local anesthetic. History of chronic disease Patient's condition requires urgent treatment (e.g. severe dehydration, shock) Active local skin infection or skin pathologic condition at the antecubital fossa Tattoo, surgical scar or skin condition that might interfere with skin sight assessment. Patient undergone venipuncture at the antecubital fossa within the pror two weeks. Uncooperative or exceptionally anxious patient.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 16 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: 1<br> | Drug: LidoDyn<br>* Application of 2 gram of LidoDyn to the skin surface the patient's antecubital fossa 60 min prior to venipuncture<br>|
| Active Comparator: 2<br> | Drug: EMLA creme<br>* Application of 2 gram of EMLA creme to the skin surface the patient's antecubital fossa 60 min prior to venipuncture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self report assessment of pain (using the Visual Analog Scale) |  | 60 Min+ 5-10 Min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical staff observational assessment of pain (in a scale of 0 to 10) |  | 60 Min + 5-10 Min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
children
Transvaginal Ultrasound As Predictors of Successful Induction of Labour

Study Overview
=================
Brief Summary
-----------------
To compare the use of transvaginal ultrasound (TVUS) of cervix to the Bishops score prior to induction of labour in term pregnancies, and the ability to predict Caesarean delivery for failure to progress.

Detailed Description
-----------------
The aim of this prospective study is to compare the use of transvaginal ultrasound (TVUS) of cervix to the Bishops score prior to induction of labour in term pregnancies, and the ability to predict Caesarean delivery for failure to progress.

Official Title
-----------------
Pre-Induction Cervical Assessment Using Transvaginal Ultrasound Versus Bishop's Cervical Scoring in Term Pregnancies As Predictors of Successful Induction of Labour

Conditions
-----------------
Induction of Labour

Intervention / Treatment
-----------------
* Diagnostic Test: Transvaginal ultrasound scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nulliparous or multipara Singleton live pregnancy Gestational age between 37 - 42 weeks Cephalic presentation Intact membranes Reactive cardiotocograph tracing Low risk pregnancy Exclusion Criteria: Previous history of uterine surgery Low lying placenta, placenta praevia and vaginal bleeding Multiple pregnancy Preterm Prelabour rupture of membrane/ prelabour rupture of membranes Known allergy towards prostaglandins Intrauterine fetal death Known fetal anomaly Estimated fetal weight >3.8kg by scan Grandmultiparity (more than 5) BMI >40kg/m2 Diabetes and hypertension on treatment Other medical illness on treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Transvaginal ultrasound scan|Transvaginal ultrasound is done to measure the cervical length, as per Fetal Medicine Foundation guidelines|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the optimal cutoff points for cervical length measurement as predictor of successful labour induction | measurement of cervical length in cm | before induction of labour |
Infraorbital Nerve Involvement on Magnetic Resonance Imaging in IgG4-related Ophthalmic Disease

Study Overview
=================
Brief Summary
-----------------
Infraorbital nerve enlargement (IONE) on magnetic resonance imaging is known to be a possible consequence of IgG4-related ophthalmic disease. However this imaging sign can also be found in other conditions causing orbital inflammation. This study aims at comparing the frequency of IONE in patients suffering from IgG4-related ophthalmic disease (IgG4-ROD) versus patients suffering from non-IgG4-related ophthalmic disease (non-IgG4-ROD)

Official Title
-----------------
Infraorbital Nerve Involvement on Magnetic Resonance Imaging in European Patients With IgG4-related Ophthalmic Disease

Conditions
-----------------
IgG4-related Disease, Orbital Infections, Inflammations and Irritations

Intervention / Treatment
-----------------
* Other: no intervention (descriptive study)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : Patient aged 18 and older treated in Fondation Rothschild (tertiary ophthalmology facility, Paris, France) from January 2006 through April 2015 Presence of a clinical orbital inflammation: mass/swelling, pain, exophthalmos, visual loss, ptosis, or diplopia. The presence of at least one pretherapeutic MRI confirming the inflammation of one or more orbital structures: the lacrimal gland, fat, muscles, or infraorbital nerve. The mandatory minimal MRI protocol include the following sequences: T1- and T2-weighted MRI image, in the transverse and coronal plane, and a fat-suppressed T1-weighted image in the coronal plane obtained after intravenous administration of a gadolinium chelate. Completion of at least one orbital biopsy with a pathologic examination and an immunohistochemical screen for IgG4. Exclusion criteria : Clinical and biological signs of thyroid-associated orbitopathy Histologically proven lymphoma Pretherapeutic MRI that is insufficient for an adequate interpretation Absence of IgG4 testing in the pathology examination

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 |
| --- | --- |
| IgG4-related orbital inflammation<br>patients with orbital inflammation and positive IgG4 immunostaining in orbital biopsy | Other: no intervention (descriptive study)<br>* no intervention (descriptive study)<br>|
| non IgG4-related orbital inflammation<br>patients with orbital inflammation and negative IgG4 immunostaining in orbital biopsy | Other: no intervention (descriptive study)<br>* no intervention (descriptive study)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with infraorbital nerve involvement in magnetic resonance imaging |  | Within 2 weeks after the first consultation for orbital inflammation |
Surgical Removal of Carotid Body in Patients With Systolic Heart Failure

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to determine safety, tolerability and feasibility of unilateral and bilateral carotid body excision in patients with systolic heart failure and peripheral chemoreceptor hypersensitivity.

Official Title
-----------------
Surgical Removal of Carotid Body in Patients With Systolic Heart Failure.

Conditions
-----------------
Systolic Heart Failure, Peripheral Chemoreceptor Hypersensitivity

Intervention / Treatment
-----------------
* Procedure: Carotid body excision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of heart failure class II-III according to NYHA within at least 6 months prior to inclusion Stable clinical state within at least 4 weeks prior to inclusion Subject >= 18 years old Left ventricular ejection fraction ≤ 45% evaluated by transthoracic echocardiography (Simpson's method) Carotid body present in computer cervical angiotomography History of exacerbated peripheral chemoreceptor sensitivity determined as >0.6L/min/%SpO2 Able and willing to give written informed consent Exclusion Criteria: Unstable angina pectoris, coronary attack, coronary revascularization, exacerbation of heart-failure requiring hospitalization, clinically significant infection, surgery under general anesthesia within 3 months prior to inclusion History of stroke, transient ischemic attack (TIA), or clinically significant chronic neurological disorder History of heart transplant Pregnancy or anticipation of pregnancy Hemodialysis or peritoneal dialysis patients Obstructive carotid atherosclerotic disease with >50% stenosis Severe sleep apnea syndrome diagnosed in PSG COPD stage III and IV according to GOLD 2007 Unable to perform the spiroergometric assessment Any significant anomaly in additional investigation which may increase the risk of study procedure

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carotid body excision<br>Patients undergoing unilateral or bilateral removal of carotid body. | Procedure: Carotid body excision<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral chemosensitivity | Ventilatory response to hypoxia using transient inhalation of nitrogen. | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carotid body, heart failure, chemoreceptor, hypersensitivity
The Bioavailability of Mycoprotein

Study Overview
=================
Brief Summary
-----------------
To evaluate the bioavailability of mycoprotein, compared with a reference animal based protein, in a dose-response manner.

Official Title
-----------------
The Bioavailability of Mycoprotein

Conditions
-----------------
Availability of Mycoprotein

Intervention / Treatment
-----------------
* Other: Mycoprotein ingestion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy and aged 18-40 y BMI between 18 and 30 Exclusion Criteria: On medication Family history of metabolic disease Diagnosed with any metabolic or cardiovascular conditions BMI < 18 or > 30

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Milk<br>Acute ingestion of 20 g milk protein | Other: Mycoprotein ingestion<br> <br> |
| Experimental: 20g<br>Acute ingestion of 20 g mycoprotein | Other: Mycoprotein ingestion<br> <br> |
| Experimental: 40g<br>Acute ingestion of 40 g mycoprotein | Other: Mycoprotein ingestion<br> <br> |
| Experimental: 60g<br>Acute ingestion of 60 g mycoprotein | Other: Mycoprotein ingestion<br> <br> |
| Experimental: 80g<br>Acute ingestion of 60 g mycoprotein | Other: Mycoprotein ingestion<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma total amino acid concentrations |  | 4 hours |