linjc16/ctgov huggingface dataset:
18475 - Sun Protection Factor Assay

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: Treatment
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 number - Y49-103)<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 |
Sympathetic Activity and Renal Denervation

Study Overview
=================
Brief Summary
-----------------
Primary hypothesis: Catheter-based renal denervation reduces central sympathetic activation in patients with refractory hypertension. Secondary hypotheses: The magnitude of the individual depressor response after catheter-based renal denervation depends on the extent of sympathoinhibition. Both, the reduction in arterial pressure and in central sympathetic activation are sustained over time up to 24±3 months after catheter-based renal denervation. Catheter-based renal denervation resets the sympathetic baroreflex to lower blood pressure values.

Official Title
-----------------
Influences of Catheter-based Renal Denervation on Central Sympathetic Nervous System Regulation in Refractory Hypertension

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Refractory hypertension (as defined by the WHO: poorly controlled hypertension (>140/90 mmHg) despite adequate doses of at least three antihypertensive drugs including a diuretic) Men or women aged >18 years Intact peroneal nerve Written informed consent Exclusion Criteria: Diseases, dysfunctions, or medications (such as NET inhibitors) that exclude a participation in the study according to the investigator. Legal incompetence or circumstances that interfere with the patient´s ability to fully understand scope, relevance, and/or consequences of participation in this study. People in custody hypersensitivity to clonidine, phenylephrine, or nitroprusside-sodium sick sinus syndrome, second or third degree AV block, bradycardia < 50 bpm (contraindication for clonidine) endogenous depression (contraindication for clonidine)

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 |
| --- | --- | --- |
NUsurface Implant Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this active post-market surveillance clinical registry study is to further characterize the therapeutic effect, the long-term safety and effectiveness of the NUsurface® meniscus implant in the real-world post-marketing setting

Detailed Description
-----------------
Patients eligible for the Registry includes any patient who received or is scheduled to receive the NUsurface® meniscus implant and meets the Registry inclusion criteria (Evidence of a personally signed and dated informed consent document). The NUsurface Implant Regitstry is about data collection only and under routine standard of care by treating physician. Data collection points are pre-op (i.e. baseline), surgery and multiple times after surgery during the first 6 months to correspond to clinic standard of care schedules, 6 months, 1 year post-operatively and then yearly thereafter out to 10 years.Surveys used are KOOS; Knee injury and Osteoarthritis Outcome Score & WOMET; Western Ontario Meniscal Evaluation Tool.

Official Title
-----------------
A Long-term Non-interventional Registry Study to Assess the Effectiveness and Safety of the NUsurface® Meniscus Implant

Conditions
-----------------
Meniscus; Degeneration, Knee Osteoarthritis, Knee Pain Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New or current treatment with the NUsurface® meniscus implant Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the Registry. Exclusion Criteria: There are no protocol exclusion criteria; all subjects who meet the inclusion criteria are eligible for enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| KOOS (Knee Osteoarthritis Outcome Score) Pain improvement | a responder is defined as a patient with an increase of at least 20 points on the KOOS pain assessment | 24 months | 
| WOMET (Western Ontario Meniscus Evaluation Tool) score improvement | a responder is defined as a patient with an increase of at least 12 points on the WOMET assessment | 24 months |
Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study

Study Overview
=================
Brief Summary
-----------------
In an earlier study, sildenafil citrate administered to patients of PAH led to improvement in pulmonary arterial pressure, cardiac output, quality of life, and other parameters as compared to placebo. This protocol provides mechanism for patients who have clinical deterioration on other PAH approved therapies to have access to sildenafil prior to marketing authorization in India.

Official Title
-----------------
A Local, Multi-centre, Open Label Access Study, To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study In India Or Ongoing In A1481269 Study Who Continue To Receive Benefit From Sildenafil Therapy.

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: Sildenafil citrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject who complete the A1481244 study and require Sildenafil (Revatio TM) 20 mg TID therapy. All women of childbearing potential must use adequate contraception throughout the study and four weeks after completion of the study Exclusion Criteria: Pregnant or lactating women Participation in other studies during study participation Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation

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

| Intervention/Treatment |
| --- |
|Drug: Sildenafil citrate|20 mg tablet to be taken thrice daily for 1 year|

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 label access, sildenafil, pulmonary arterial hypertension
A Randomized, Open-label, Two-way Crossover Trial to Determine the Pharmacokinetics of Metoclopramide When Administered as the Orally Disintegrating Tablet Compared to Reglan® Tablets in Subjects With Diabetic Gastroparesis

Study Overview
=================
Brief Summary
-----------------
To determine whether a new Orally Disintegrating Tablet of Reglan (metoclopramide) is metabolized faster than the conventional Reglan tablet in patients with diabetic gastroparesis, pharmacokinetics following a single 10 mg dose of each formulation are being compared. Subjects must be 18 or older, have Type 1 or 2 diabetes with documented gastroparesis and agree to withhold medications for gastroparesis for 3 days prior to each dosing. Exclusion criteria include serum glucose >300 mg/dL, Hb1Ac >10%, and concurrent illness interfering with gastrointestinal motility. Subjects will stay in the clinic overnight, and pharmacokinetic sampling will continue for 8 hours after the first morning dose. The time (Tmax) and amount (Cmax) of peak concentration and the area under the curve (AUC) from time zero to 8 hr will be compared for the 2 formulations.

Detailed Description
-----------------
See approved Package Insert for Adverse Event information.

Official Title
-----------------
A Randomized, Open-label, Two-way Crossover Trial to Determine the Pharmacokinetics of Metoclopramide When Administered as the Orally Disintegrating Tablet Compared to Reglan® Tablets in Subjects With Diabetic Gastroparesis

Conditions
-----------------
Diabetic Gastroparesis

Intervention / Treatment
-----------------
* Drug: Reglan ODT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be 18 or older, have Type 1 or 2 diabetes with documented gastroparesis Exclusion Criteria: Serum glucose >300 mg/dL, HbA1C >10%, and concurrent illness interfering with gastrointestinal motility

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Reglan ODT|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical and Urodynamic Evaluation of Surgical Repair of Pelvic Organ Prolapse Associated With Lower Urinary Tract Symptoms

Study Overview
=================
Brief Summary
-----------------
To assess the urinary symptoms and urodynamic findings concomitant with Pelvic organ prolapse before and after surgical treatment and to define the role of urodynamic study in treatment decision making.

Detailed Description
-----------------
Pelvic organ prolapse (POP) is a prevalent problem that affects women's quality of life women with POP may present with a variety of lower urinary tract symptoms (LUTS). For POP patients with concomitant urinary symptoms, urodynamic (UDN) testing is proposed for proper evaluation of cases and identification of the pathophysiologic events in each case individually. In this prospective study, the investigators aim to describe the urinary symptoms and urodynamic findings concomitant with POP before and after surgical treatment of POP. We also aimed at defining the role of UDN in decision-making regarding the treatment of POP when associated with LUTS.

Official Title
-----------------
Clinical and Urodynamic Evaluation of Surgical Repair of Pelvic Organ Prolapse Associated With Lower Urinary Tract Symptoms

Conditions
-----------------
Pelvic Organ Prolapse

Intervention / Treatment
-----------------
* Diagnostic Test: Urodynamic study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with anterior pelvic organ prolapse (POP) associated with Lower urinary tract symptoms Exclusion Criteria: Patients with POP less than POP-Q grade II, POP not in need for surgical repair, neurological diseases that could possibly affect voiding functions, pelvic infections, congenital bladder disorders, history of urinary fistula, history of malignancy, and patients on current medical treatment for voiding dysfunction.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: All patients were subjected to clinical evaluation and urodynamic testing before surgery. All cases underwent surgical repair of pelvic organ prolapse. Follow-up clinical examination was performed at 1, 3, and 6 months postoperatively, and urodynamic examination was repeated 6 months after repair.
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Urodynamic study|comparison between the urodynamic study of the patients before pelvic prolapse surgical repair and 6 months later.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urodynamic study evaluation for the participants | evaluation of the urodynamic study after the surgical repair of the pelvic organ prolapse and comparison to the preoperative results. | 6 month after the procedure |
The Role of Deep Cerebral Vein Variation in Patients With Angiographic Negative Subarachnoid Hemorrhage

Study Overview
=================
Brief Summary
-----------------
The incidence of Rosenthal basilar vein (BVR) variants (deep venous drainage variants) was relatively increased in patients with AN-SAH compared with patients with aneurysms. However, the inclusion criteria for AN-SAH patients in these studies were different. Some studies have investigated both PAN-SAH and NPAN-SAH, while some studies have only investigated PAN-SAH patients. However, we believe that NPAN-SAH may be the bleeding caused by non-BVR variation. Although previous studies did not find any association between NPAN-SAH and BVR variants, the results in their study were different, which may be due to the limited number of cases.

Official Title
-----------------
The Role of Deep Cerebral Vein Variation in Patients With Angiographic Negative Subarachnoid Hemorrhage

Conditions
-----------------
Subarachnoid Hemorrhage, Aneurysmal

Intervention / Treatment
-----------------
* Drug: nimodipine and euvolemia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with negative subarachnoid hemorrhage diagnosed by DSA Exclusion Criteria: In patients with aneurysms, external ventricular drainage (EVD) alone or decompression craniotomy alone or conservative treatment was performed Have a history of trauma or prior brain injury (stroke, cerebral hemorrhage, etc., with associated chronic changes on CT) Patients with loss of imaging data and severe comorditions prior to onset of SAH

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: nimodipine and euvolemia|administered nimodipine to prevent vasospasm, and euvolemia was maintained via intravenous hydration|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| favorable or poor outcome | poor outcome (mRS 2-6) or favorable outcome (mRS 0-1). | 1 year |
Impact of an Operating Room Nurse Pre-operative Dialogue in Patients Undergoing Major Visceral Surgery

Study Overview
=================
Brief Summary
-----------------
Single-center, open label, randomized controlled trial of a preoperative nursing dialogue in patient undergoing major visceral surgery aiming in evaluating its impact on patients' anxiety, satisfaction and early postoperative outcomes.

Official Title
-----------------
Impact of an Operating Room Nurse Pre-operative Dialogue on Anxiety, Satisfaction and Early Postoperative Outcomes in Patients Undergoing Major Visceral Surgery - a Single Center, Open-label, Randomized Controlled Trial

Conditions
-----------------
Anxiety, Post Operative Pain, Postoperative Nausea, Postoperative Complications, Satisfaction, Patient

Intervention / Treatment
-----------------
* Behavioral: Preoperative nurse dialogue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient undergoing elective major visceral surgery Hospitalization the day before surgery Sufficient command of French language Exclusion Criteria: emergency procedures (after unplanned admission) inability to obtain informed consent or refusal inability to follow intervention

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single center, Open-label, Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional group<br> | Behavioral: Preoperative nurse dialogue<br>* Performance of a preoperative nurse dialogue prior major visceral surgery<br>|
| No Intervention: Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative anxiety | State-Trait Anxiety Inventory Form Y (STAI-Y) | 5-10 minutes after intervention |
Antibiotic Prophylaxis When Removing Ureteric Stent After Stone Surgery

Study Overview
=================
Brief Summary
-----------------
Is there anything to gain in giving antibiotics as prophylaxis when removing ureteric stents cystoscopically after stone surgery?

Detailed Description
-----------------
Many patients undergoing stone surgery receive a ureteric stent that should be removed after 14 days. This stent is removed cystoscopically and today this is done without giving antibiotics. Some patients get urinary tract infections subject to this. However the investigators do not know how many of these patients get UTI as most are followed by their primary care doctor. With this study the investigators would like to find out whether it is possible to avoid such infections and also find out how many actually do get infected.

Conditions
-----------------
Ureteric Stent After Stone Surgery

Intervention / Treatment
-----------------
* Drug: Trimetoprim-Sulfa (Bactrim)
* Other: No antibiotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stone surgery patients with ureteric stent that should be removed after 14 days Exclusion Criteria: ongoing antibiotic treatment, allergy to trimetoprim-sulfa
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Antibiotics<br>will receive antibiotics | Drug: Trimetoprim-Sulfa (Bactrim)<br> <br> |
| Active Comparator: No antibiotics<br>will not receive antibiotics | Other: No antibiotics<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 14 days infection rate w/wo antibiotics |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infection rate with ureter stent wo antibiotics |  | 14 days |