linjc16/ctgov huggingface dataset:
Sun Protection Factor Assay (SPF Assay 199/2016)

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: BAY987516


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: BAY987516<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: BAY987516<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: Z46-092)<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 |
Potential Causes of Retained Items During Surgery

Study Overview
=================
Brief Summary
-----------------
to understand and analyze the potential causes of retained items (sponge and instruments) during surgery, which include room preparations, initial count, adding sponges, removing sponges, first closing count, final closing count.

Official Title
-----------------
Potential Causes of Retained Items During Surgery

Conditions
-----------------
Foreign Bodies, Surgical Sponge, Retained

Intervention / Treatment
-----------------
* Other: online survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • operating room staff of hail hospital cluster Exclusion Criteria: • none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: online survey|online survey|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| study potential causes of retained item during surgery | to understand participant opinion about the potential causes of retained item which include :room preparation with needed operating room equipment according to the specialty, initial count of sponges and instruments, adding sponges by event recording in a chart, removing sponges by event recording in a chart, first closing count in a chart , final closing count in a chart. | 20 days |
Peri-implant Marginal Bone and Soft Tissue Conditions Around Single Laser-Lok Implants Placed in Regenerated Extraction Sockets and in Native Bone: A 2-years Results of RCT

Study Overview
=================
Brief Summary
-----------------
The aim of present study was to compare peri-implant marginal bone loss and soft tissues conditions around single Laser-Lok implants placed in alveolar

Detailed Description
-----------------
Records of 20 consecutive patients treated with dental implants placed in post-extraction sockets augmented with porcine derived bone and 20 consecutive patients with implants placed in native bone were reviewed. For each implant, the radio- graphs from the surgical appointment were compared to those from the last follow-up visit and evaluated regarding changes of marginal bone level over time.

Official Title
-----------------
Peri-implant Marginal Bone and Soft Tissue Conditions Around Single Laser-Lok Implants Placed in Regenerated Extraction Sockets and in Native Bone: A 2-years Results of RCT

Conditions
-----------------
Partially Edentulous Maxilla, Partially Edentulous Mandible

Intervention / Treatment
-----------------
* Device: dental implants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mono-edentulism, age ≥ 18 years, good general health, without contraindications to implant surgery Exclusion Criteria: lack of a periodontal chart and periapical radiograph at the beginning and at the end of follow-up period, alcohol and drug abuse, pregnancy, or uncontrolled metabolic disorders, tobacco smoking (> 10 cigarettes/day), full mouth plaque score (FMPS), and full mouth bleeding score /FMBS) ≥25%, teeth adjacent to the implant area (mesial and distal) affected by untreated periodontal and/or endodontic infections.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| dental implants<br> | Device: dental implants<br>* extraction sockets regenerated with xenograft<br>* Other names: porcine derived bone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peri-implant marginal bone loss |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peri-implant soft tissue conditions |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
regenerated bone, native bone, dental implant
Measurement of Cerebral Oxygenation Using NIRS Method in the Preterm Infants With Intracranial Haemorrhagia

Study Overview
=================
Brief Summary
-----------------
The aim of the study was investigated the cerebral tissue oxygenation index (c-TOI) measured by near infrared spectroscopy (NIRS)in the preterm infants with intracranial haemorrhagia.

Conditions
-----------------
Cerebral Oxygenation, Intracranial Haemorrhagia

Intervention / Treatment
-----------------
* Device: device:INVOS 5100


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: .<34 gestation week preterm infants with intracranial haemorrhagia Exclusion Criteria: sepsis NEC congenital abnormalities hydrocephalus intracranial infections

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 3 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| study group, control group<br> | Device: device:INVOS 5100<br>* Continuous wave NIRS is a method for measurement of cerebral oxygenation and haemodynamics. This method is non-invasive, continuous, and can also be used as bedside monitoring. With continuous wave NIRS only changes in concentration of oxyhaemoglobin (O2Hb) and deoxyhaemoglobin (HHb) can be measured, not the absolute level of these parameters. It has been shown that changes in concentration of HbD (O2Hb - HHb) reflect changes in CBF. So, continuous monitoring of changes in concentration of HbD can be used as an indicator of changes in CBF, but changes in CBV will also influence the HbD signal, as will changes in arterial O2 saturation (saO2) and changes in cerebral metabolic rate for oxygen.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cerebral oxygenation |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preterm infant,cerebral oxygenation, intracranial haemorrhagia
TVMR With the Innovalve System Trial - Pilot Study in Italy

Study Overview
=================
Brief Summary
-----------------
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Official Title
-----------------
TVMR With the Innovalve System Trial - Pilot Study in Italy

Conditions
-----------------
Mitral Valve Regurgitation (Degenerative or Functional)

Intervention / Treatment
-----------------
* Device: Innovalve TMVR system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically significant, symptomatic mitral regurgitation High risk for open-heart surgery Meets anatomical criteria Exclusion Criteria: Unsuitable anatomy Patient is inoperable EF <30%

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: MV replacement with Innovalve MR system<br>MV replacement with Innovalve MR system | Device: Innovalve TMVR system<br>* Innovalve TMVR system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of implant or delivery related serious adverse events at 30 days | Absence of implant or delivery related serious adverse events at 30 days | 30 days |
Study of Exercise and Heart Function in Patients With Heart Failure and Pulmonary Vascular Disease

Study Overview
=================
Brief Summary
-----------------
Heart Failure with Preserved Ejection Fraction (HFpEF) and Pulmonary Hypertension (PH) can be diagnosed noninvasively by Exercise Echocardiography (ExE) and Cardiopulmonary Exercise Testing (CPX) as compared with gold standard invasive hemodynamic assessment.

Detailed Description
-----------------
The broad objective of this proposal is to characterize the dynamic changes in cardiopulmonary mechanics during stress in patients with exertional dyspnea, establishing a comprehensive multimodality diagnostic approach to the evaluation of exercise intolerance. The specific objective is to prospectively compare established and novel parameters derived from echocardiography and CPX with simultaneous, gold standard invasive measures of cardiovascular hemodynamics at rest and with exercise stress to define the role of noninvasive testing in the diagnostic workup. The primary hypothesis is that combined ExE and CPX can noninvasively identify HFpEF.

Official Title
-----------------
Evaluation of Exercise Intolerance and Right Heart Function in Patients With Heart Failure and Pulmonary Vascular Disease

Conditions
-----------------
Exercise Tolerance, Dyspnea, Heart Failure, Pulmonary Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: exertional intolerance/dyspnea of unknown etiology referral to cardiac catheterization laboratory undergoing invasive hemodynamic evaluation for clinical purposes Exclusion Criteria: hypertrophic cardiomyopathy constrictive pericarditis infiltrative myopathy (e.g. amyloid) congenital heart disease resting LVEF <50% > moderate mitral annular calcification moderate or greater left-sided valvular stenosis or regurgitation prior valve surgery basal septal wall motion abnormalities >70% epicardial coronary artery stenosis right ventricular infarction pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Diagnostic Utility ExE and CPX |  | Same day as clinically indicated Right Heart Catheterization (RHCath) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple integrated measures of cardiovascular function derived from RHCath, ExE and CPX along with rest/exercise natriuretic peptide levels |  | Same day as clinically indicated RHCath | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac catheterization, echocardiography
RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain

Study Overview
=================
Brief Summary
-----------------
To compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice, when used according to the applicable Directions for Use - and - To evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice

Detailed Description
-----------------
The study is a prospective, multi-center, global registry of Boston Scientific neurostimulation systems for pain. The study treatment will consist of neurostimulation trial therapy with any commercially approved Boston Scientific Corporation neurostimulator for pain. Positive trials, subjects with a successful trial outcome, may progress to permanent implant of a neurostimulation system. Individualization of neurostimulation therapy for pain will be determined according to investigator discretion and site routine care, and in accordance with inclusion and exclusion criteria.

Official Title
-----------------
A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain

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

Intervention / Treatment
-----------------
* Device: neurostimulation system


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Study candidate is scheduled to be trialed, on-label, with a commercially approved Boston Scientific neurostimulation system for pain, per local directions for use Signed a valid, IRB/EC-approved informed consent form 18 years of age or older Key Exclusion Criteria: Contraindicated for Boston Scientific neurostimulation system Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments

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 |
| --- | --- |
| Boston Scientific SCS Systems<br>Subjects permanently implanted with a Boston Scientific neurostimulation systems | Device: neurostimulation system<br>* Trial stimulation period, followed by permanent implant of a neurostimulation system for subjects with a positive trial outcome<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
-----------------
stimulation, implantable, pulse generator, back pain, chronic pain, leg pain
Clinical Impact of Dedicated MR Staging of Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
The only chance of cure for patients with advanced stage ovarian cancer is complete cytoreductive surgery (CRS). The only way to determine whether complete CRS can be achieved is by a laparoscopy. However, diffusion-weighted magnetic resonance imaging (DW-MRI) has a very high sensitivity to detect small volume malignant disease, making it a potentially suitable staging tool. Aim of this study is to determine the performance of DW-MRI for predicting whether complete CRS can be achieved.

Official Title
-----------------
Clinical Impact of Dedicated MR Staging of Ovarian Cancer

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Other: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with advanced stage (FIGO stage III or IV) ovarian cancer scheduled for primary or interval cytoreductive surgery Age >18 years Written and signed informed consent WHO 0-2 Able to read and write Dutch Exclusion Criteria: Patients with contraindications for MRI Patients with contraindications for CRS Known additional malignancy

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Patients will undergo an additional MRI, including a diffusion-weighted sequence, for assessing the extent of peritoneal carcinomatosis. Whether or not cytoreductive surgery is feasible will be scored using the peritoneal cancer index on diffusion-weighted magnetic resonance imaging
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DW-MRI<br>Patients with undergo an additional diffusion-weighted MRI in addition to the standard diagnostic work-up | Other: MRI<br>* In addition to the standard diagnostic work-up patients will receive an additional MRI scan 0-21 days prior to their scheduled surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of DW-MRI to predict a complete cytoreductive surgery | Patients will undergo an additional MRI, besides their regular diagnostic workup, for assessing the extent of peritoneal carcinomatosis. Whether or not complete cytoreductive surgery is feasible will be determined on DW-MRI independently by two radiologists. The outcome wil be defined as the number of cytoreductive procedures correctly predicted by DW-DWI. | 1 month |
Ropinirole XR (Extended Release) In Patients With Restless Legs Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of ropinirole XR in the treatment of adults with Restless Legs Syndrome (RLS).

Official Title
-----------------
A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients With Restless Legs Syndrome

Conditions
-----------------
Restless Legs Syndrome

Intervention / Treatment
-----------------
* Drug: Ropinirole Extended Release (XR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosed with RLS using the International RLS Study Group Diagnostic Criteria with a total score of 15 or greater on the International RLS Rating Scale. Have evening and nighttime symptoms of RLS, significant sleep impairment due to RLS symptoms, and symptoms requiring treatment prior to bedtime, but no earlier than 5:00PM. Exclusion criteria: Have secondary RLS. Have any medical conditions that may impact efficacy assessments or that may present a safety concern.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ropinirole Extended Release (XR)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the change from baseline in the International RLS Study Group Rating Scale total score at Week 12. |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess safety, tolerability, and patient-reported outcomes, including changes in the Clinical Global Impression Scale Scores and changes in the Medical Outcomes Study Sleep Scale at Week 12. |  | 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Restless Legs Syndrome, RLS