linjc16/ctgov huggingface dataset:
A Clinical Trial to Assess the Potential of LEO 130852A Gel to Reduce Steroid Induced Skin Atrophy on Healthy Skin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effect of LEO 130852A gel 1% in maintaining skin thickness in healthy skin treated with steroid.

Official Title
-----------------
A Prospective, Randomised, Investigator-Blinded, Vehicle-Controlled, Phase I Clinical Trial With Intra-Individual Comparison of Treatments to Assess the Potential of LEO 130852A Gel to Reduce Steroid Induced Skin Atrophy on Healthy Skin

Conditions
-----------------
Skin Tissue Diseases, Connective Tissue Diseases

Intervention / Treatment
-----------------
* Drug: Clobetasol propionate 0.05% ointment
* Drug: LEO 130852A gel 1%
* Drug: LEO 130852A placebo gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers, 25 to 50 years old inclusive Healthy skin on volar arms with a hairless area sufficient for measurements Exclusion Criteria: Clinical skin atrophy, telangiectasia or striae on volar arms Presence of any skin condition or colouration that would interfere with test sites or the response or assessment Fitzpatrick skin type IV - VI History or current evidence of infection, eczema or other relevant skin disease

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Drug<br>Clobetasol propionate 0.05% ointment | Drug: Clobetasol propionate 0.05% ointment<br> <br> |
| Experimental: Experimental Drug<br>LEO 130852A gel 1% | Drug: LEO 130852A gel 1%<br> <br> |
| Placebo Comparator: Placebo Drug<br>LEO 130852A placebo gel | Drug: LEO 130852A placebo gel<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin thickness measured by sonography and histology |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical assessments measured by atrophy score |  | 4 weeks | 
| Clinical assessments measured by telangiectasia score |  | 4 weeks |
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Caesarean Section

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 % versus Ropivacaine 0.2 % versus Placebo in patients undergoing elective caesarean section. The hypothesis is that systemic local infiltration will reduce pain and postoperative opioid consumption.

Official Title
-----------------
Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Ropivakain 0,2 % Versus Placebo Efter Sectio Caesarea: et Prospektivt, Dobbeltblindet, Placebokontrolleret Studie.

Conditions
-----------------
Pain, Postoperative, Postoperative Nausea and Vomiting, Cesarean Section

Intervention / Treatment
-----------------
* Drug: Ropivacaine
* Drug: Ropivacaine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: eligible for elective caesarean section able to speak and understand Danish able to give informed consent Exclusion Criteria: alcohol or medical abuse allergies to local anesthetics age < 18 years intolerance to opioids

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Local infiltration with Ropivacaine | Drug: Ropivacaine<br>* Ropivacaine 0.5%<br>|
| Active Comparator: 2<br>Local infiltration with Ropivacaine | Drug: Ropivacaine<br>* Ropivacaine 0.2%<br>|
| Placebo Comparator: 3<br>Local infiltration with NaCl | Drug: placebo<br>* Isotonic NaCl<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea and vomiting (PONV) |  | 24 hours |
Bispectral Index as an Analgesia Monitoring in Severely Ill Patient: Effect of Remifentanyl

Study Overview
=================
Brief Summary
-----------------
The aim of this protocol is to study the prophylactic effect of remifentanil on bispectral index variation during a nociceptive stimuli.

Detailed Description
-----------------
Pain is difficult to estimate in ICU because most of the patients are sedated. Bispectral index could be helpful in detecting this pain in ICU patients. Remifentanil is a morphinomimetic product with short half life that could be interesting for short nociceptive stimuli, as bronchoalveolar lavage. The purpose of this study is to evaluate the impact of remifentanil infusion on bispectral index (BIS) variations during bronchoalveolar lavage. It is a prospective, double blind study, versus placebo on 40 sedated and critically ill patients. The hypothesis is that BIS can study analgesia in sedated patient.

Official Title
-----------------
Bispectral Index as an Analgesia Monitoring in Severely Ill Patient: Effect of Remifentanyl

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

Intervention / Treatment
-----------------
* Drug: remifentanyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sedated patient with mechanical ventilation with suspected nosocomial pneumonia Exclusion Criteria: Pace maker Neurologic illness Hemodynamic instability Hypothermia

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: remifentanyl|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BIS variation during bronchoalveolar lavage |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure, diastolic blood pressure, heart rate viation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bispectral index, sedation, remifentanyl, Bronchoalveolar lavage, Intensive care, Nociceptive stimuli, Sedated patient, BIS variation
Study to Investigate the Seropersistence of TBE Virus Antibodies Approx. 3 Years After a Booster Vaccination With FSME-IMMUN 0.25 mL JUNIOR in Children

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the TBE antibody persistence approximately three years after administration of a TBE booster vaccination with FSME-IMMUN 0.25 ml Junior in children who received either 0.25 mL or 0.5 mL TicoVac for their primary vaccination series in Study 146A.

Official Title
-----------------
Multicenter Phase IV Study to Investigate the Seropersistence of TBE Virus Antibodies Approx. 3 Years After a Booster Vaccination With FSME-IMMUN 0.25 mL JUNIOR in Children

Conditions
-----------------
Encephalitis, Tick-borne

Intervention / Treatment
-----------------
* Biological: Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female children who participated in Study 146A if: they and/or their parents/legal guardians understand the nature of the study and agree to its provisions written informed consent is available from the child (according to age and capacity of understanding) and the parents/legal guardians they received the complete 3-immunization primary vaccination series with either 0.5 ml or 0.25 ml TicoVac in Study 146A they received FSME-IMMUN 0.25 ml Junior for their first booster vaccination approximately 3 to 4 years after their third vaccination in Study IMAG-146A Exclusion Criteria: Subjects who received any further TBE vaccination since their first TBE booster vaccination Subjects with a history of infection with, or vaccination against, other flaviviruses (e.g. dengue fever, yellow fever and/or japanese B encephalitis virus) since their third vaccination in Study 146A Subjects who have suffered from a disease (e.g. autoimmune disease) or have undergone a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions within 30 days before and after their first TBE booster vaccination Subjects who have been known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination in Study 146A Subjects who have received a blood transfusion or immunoglobulins within 30 days of study entry

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 11 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl|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
-----------------
tick-borne encephalitis
High Sensitivity Cardiac Troponin T in Patients With Atrial Fibrillation Admitted to an Emergency Department (ED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to collect data on the prevalence and clinical significance of elevated cardiac troponin in a large registry of unselected patients with atrial fibrillation presenting to an emergency department.

Official Title
-----------------
High Sensitivity Cardiac Troponin T in Patients With Atrial Fibrillation Admitted to an Emergency Department (ED)

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: documented atrial fibrillation in admission EKG or diagnosis of atrial fibrillation at admission. Exclusion Criteria: no patients are excluded.
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 |
| --- | --- | --- |
| vascular and non-vascular death | Assessment via review of inpatient- and outpatient visit reports, patient phone calls, postal queries with standardised questionnaires, contact with primary care physicians and resident registration office inquiries. | up to 60 months | 
| nonfatal myocardial infarction | Assessment via review of inpatient- and outpatient visit reports, patient phone calls, postal queries with standardised questionnaires, contact with primary care physicians and resident registration office inquiries. | up to 60 months | 
| stroke/transitory ischemic attack (TIA) | Assessment via review of inpatient- and outpatient visit reports, patient phone calls, postal queries with standardised questionnaires, contact with primary care physicians and resident registration office inquiries. | up to 60 months |
Detection of Pulmonary Embolism With CECT

Study Overview
=================
Brief Summary
-----------------
To compare the vascular enhancement of the two contrast agents in pulmonary Multi-detector CTA

Official Title
-----------------
Detection of Pulmonary Embolism Comparing Isovue-370 and Visipaque 320 Using 64-Slice Multi-Detector Computed Tomographic Angiography

Conditions
-----------------
Pulmonary Embolism

Intervention / Treatment
-----------------
* Drug: Isovue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 yrs or older With suspected PE Referred for MDCTA of pulmonary arteries Signed informed consent Exclusion Criteria: Pregnant and lactating females History of hypersensitivity to iodinated contrast agents Hyperthyroidism or pheochromocytoma Severe CHF Renal impairment Weight greater than 300 lbs Pacemaker Swan Ganz catheter Defibrillator or other intrathoracic metallic vascular device Received an investigational compound within 30 days of being in the study

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Isovue|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hounsfield Units (HU) measured at various levels of pulmonary arteries |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of artifacts; global enhancement |  |  |
CalFitness Smartphone-Delivered Physical Activity Intervention

Study Overview
=================
Brief Summary
-----------------
The overall goal of this study is to test personalized mobile phone-based physical activity interventions among staff members at the University of California, Berkeley. Most physical fitness applications for smartphones and activity trackers use a constant goal for the number of steps each day. However, if the step goals are dynamically adjusted according to past behavior, then the corresponding goals may encourage individuals to increase their physical activity level. This study consists of a randomized controlled trial in which we are assessing the efficacy of two different algorithms for calculating personalized goals for the number of steps each day.

Official Title
-----------------
Mobile Phone-Based Physical Activity Intervention on University Staff

Conditions
-----------------
Sedentary Lifestyle, Physical Activity

Intervention / Treatment
-----------------
* Behavioral: Step Goal Delivery by Smartphone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intent to become physically active own an iPhone willing to keep the iPhone in pockets during the day willing to install and use the intervention app every day for 4 months ability to speak and read English. Exclusion Criteria: known medical conditions or physical problems that require special attention in an exercise program planning an international trip during the next 4 months, which could interfere with daily server uploads of mobile phone data pregnant/gave birth during the past 6 months severe hearing or speech problem history of an eating disorder current substance abuse current participation in lifestyle modification programs or research studies that may confound study results history of bariatric surgery or plans for bariatric surgery in the next 12 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized Steps Goal<br>Step Goal Delivery by Smartphone | Behavioral: Step Goal Delivery by Smartphone<br> <br> |
| Active Comparator: Constant Steps Goal<br>Step Goal Delivery by Smartphone | Behavioral: Step Goal Delivery by Smartphone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Steps Taken Per Day |  | 10 weeks |
Ureteroscopy With and Without Safety Guidewire

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the impact of a safety guidewire (SGW) on the results of ureteroscopy for urolithiasis. Study hypothesis: Routine use of SGW has no impact on the results of ureteroscopic treatment of urolithiasis.

Detailed Description
-----------------
The use of SGW is generally recommended at any ureteroscopic procedure in order to facilitate the introduction of the endoscope and to secure placement of internal tubes for drainage of urine after the procedure. However, SGW may be an obstacle to efficient disintegration and retraction of calculi in the narrow ureter. The intention of this study is to compare the results of endoscopic stone treatment with and without the use of SGW.

Official Title
-----------------
Ureteroscopy With and Without Safety Guidewire:. A Prospective, Randomized Study of the Results of Endoscopic Treatment of Urolithiasis.

Conditions
-----------------
Urolithiasis

Intervention / Treatment
-----------------
* Procedure: Ureteroscopy with and without safety guidewire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with urolithiasis planned for ureterorenoscopic treatment

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: B - without SGW<br>Ureteroscopy without SGW in place. | Procedure: Ureteroscopy with and without safety guidewire<br>* In study arm A - with SGW, endoscopic treatment is performed with a safety guidewire in place. In study arm B - without SGW, the ureteroscopy is performed without SGW.<br>|
| Active Comparator: A - with SGW<br>Ureteroscopy with SGW in place. | Procedure: Ureteroscopy with and without safety guidewire<br>* In study arm A - with SGW, endoscopic treatment is performed with a safety guidewire in place. In study arm B - without SGW, the ureteroscopy is performed without SGW.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone free-rate |  | 3 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay |  | Up to 1 week after the operation | 
| Complication rate |  | Until 3 months after the procedure | 
| Operating time |  | Up to 1 day after the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ureteroscopy
Selection of Antibiotic Resistance by Azithromycin and Clarithromycin in the Oral Flora

Study Overview
=================
Brief Summary
-----------------
Resistance to antibiotics is a major public-health problem and studies linking antibiotic use and resistance have shown an association not a causal effect. Utilizing the newer macrolides, azithromycin and clarithromycin that are commonly prescribed for respiratory infections, we investigated the direct impact of antibiotic exposure on resistance at the individual level.

Detailed Description
-----------------
Resistance to antibiotics is a major public-health problem and studies linking antibiotic use and resistance have shown an association not a causal effect. Utilizing the newer macrolides, azithromycin and clarithromycin that are commonly prescribed for respiratory infections, we investigated the direct impact of antibiotic exposure on resistance at the individual level. 203 healthy cohorts were treated with azithromycin, clarithromycin, or a placebo in a randomised, double-blind trial. Pharyngeal swabs were collected pre- (day 0) and post-antibiotic administration (days 8, 14, 28, 42, 180) and proportions of macrolide-resistant streptococci (MRS) were determined at each time-point.

Official Title
-----------------
Impact of Azithromycin and Clarithromycin Therapy on Pharyngeal Carriage of Macrolide-Resistant Streptococci Among Healthy Volunteers: A Randomised, Double-Blind, Placebo-Controlled Trial

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

Intervention / Treatment
-----------------
* Drug: Macrolides (azithromycin or clarithromycin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adults (≥ 18 years of age) non-pregnant free of any respiratory tract infection not having been administered any antibiotic at least in the past three months Exclusion Criteria: <18 years of age pregnant having a respiratory tract infection having been administered any antibiotic at least in the past three months

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Macrolides (azithromycin or clarithromycin)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in proportions of macrolide-resistant streptococcal (MRS) carriage in the oropharynx |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variations in the carriage of macrolide-resistance genes due to macrolide exposure. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy volunteers, Antibiotic exposure, Resistance selection