linjc16/ctgov huggingface dataset:
Nicotine and Cotinine Levels in Smokers With Schizophrenia and Schizoaffective Disorder - 2

Study Overview
=================
Brief Summary
-----------------
Nicotine dependence is very common among individuals with schizophrenia and schizoaffective disorder. Cotinine is a chemical that is made by the body from nicotine. Measuring levels of nicotine and cotinine is an accurate way to determine how much cigarette smoke enters a person's body. The purpose of this study is to measure nicotine and cotinine levels in smokers with schizophrenia or schizoaffective disorder to determine if such individuals absorb more nicotine per cigarette than smokers without schizophrenia-related disorders.

Detailed Description
-----------------
Schizophrenic individuals have higher urinary cotinine levels compared to non-schizophrenic individuals with a similar smoking history. This suggests that schizophrenic individuals may absorb higher doses of nicotine. The purpose of this study is to determine whether smokers with schizophrenia or schizoaffective disorder have higher serum nicotine and cotinine levels in comparison to smokers without schizophrenic-related disorders. This observational, case-control study will enroll 150 participants, of which 100 will be smokers with schizophrenic-related disorders and 50 will be smokers without a mental illness. Upon completing baseline assessments, participants will smoke a single cigarette. Approximately two minutes following, 3 to 4 ounces of blood will be analyzed for nicotine and cotinine levels. An expired carbon monoxide reading will also be measured. This measurement correlates with the amount of smoke inhalation. Individual participant studies will be completed in 1 to 2 hour-long sessions.

Official Title
-----------------
Nicotine and Cotinine Levels in Smokers With Schizophrenia and Schizoaffective Disorder

Conditions
-----------------
Schizophrenia and Disorders With Psychotic Features, Tobacco Use Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets DSM-IV diagnostic criteria for nicotine dependence and possibly schizophrenia or schizoaffective disorder Stable on current antipsychotic regimen(s) for participants with schizophrenia or schizoaffective disorder Exclusion Criteria: At serious risk of suicide, including recent suicidal behavior or attempt within the thirty days prior to study entry Current use of clonidine, bupropion, or any other nicotine products (including nicotine patch, gum, inhaler, lozenge or nasal spray)

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?
-----------------
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
-----------------
nicotine dependence
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 (UVAPF) Minimal Persistent Pigment - Darkening Dose (MPPD)

Conditions
-----------------
Sunscreening Agent

Intervention / Treatment
-----------------
* Drug: Coppertone (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(Self 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: BAY987516<br>Each test site area is divided into test subsite 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: Coppertone (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 Number- SR15-60-Z15-030).<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 |
Study on the Reduction of Catheter-related Infections by Use of Self-disinfecting Venous and Arterial Access Caps

Study Overview
=================
Brief Summary
-----------------
Observational study on the reduction of catheter-related Infections by use of self-disinfecting venous and arterial access caps (Curos caps ;3M, Saint Paul, MN, USA)

Official Title
-----------------
Study on the Reduction of Catheter-related Infections by Use of Self-disinfecting Venous and Arterial Access Caps

Conditions
-----------------
CLABSI - Central Line Associated Bloodstream Infection, Catheter-Related Blood Stream Infection

Intervention / Treatment
-----------------
* Device: 70% isopropyl alcohol-impregnated catheter caps


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: every patient in the hemato-oncological department who received at least one CVC was included in the study Exclusion Criteria: none

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 |
| --- | --- |
| Control<br>All central-line-associated blood stream infections (CLABSI) diagnosed during the year previous the implementation of 70% isopropyl alcohol-impregnated Curos catheter caps | |
| CUROS<br>All central-line-associated blood stream infections (CLABSI) diagnosed during the year after the implementation of 70% isopropyl alcohol-impregnated Curos catheter caps | Device: 70% isopropyl alcohol-impregnated catheter caps<br>* Implementation of 70% isopropyl alcohol-impregnated catheter caps in order to assess the number of CLABSI diagnosed during 1 Year<br>* Other names: self disinfecting catheter caps;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of CLABSI | To assess the clinical efficacy of Curos in preventing CLABSI in a high-risk department (oncology and ICU) | 12 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLABSI, CRBSI, Blood Stream Infection
Quality of Life of Periodontitis Patients Visiting Supportive Periodontal Therapy

Study Overview
=================
Brief Summary
-----------------
The present prospective study aims to assess the QoL of periodontitis patients during supportive treatment and to relate it to periodontal health (clinical and radiographic data) and treatment stability. Follow-ups after the first cross-sectional assessment are planned after approximately 2.5, 5, 7.5, and 10 years.

Official Title
-----------------
Evaluation of the Quality of Life of Periodontitis Patients Visiting Supportive Periodontal Therapy - A Prospective Study

Conditions
-----------------
Quality of Life, Periodontal Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients returning for supportive therapy on a regular basis after active periodontal treatment will be asked for participation if they are in supportive therapy for at least 1 year.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 130 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 |
| --- | --- | --- |
| disease specific OHRQoL (ParoQoL) |  | at baseline | 
| disease specific OHRQoL (ParoQoL) |  | after 2.5 years | 
| disease specific OHRQoL (ParoQoL) |  | after 5 years | 
| disease specific OHRQoL (ParoQoL) |  | after 7.5 years | 
| disease specific OHRQoL (ParoQoL) |  | after 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral Health Impact Profile (OHIP) |  | at baseline | 
| perceived stress scale (PSS) |  | at baseline | 
| overall health status of the patients (EQ5D-5L) |  | at baseline | 
| Oral Health Impact Profile (OHIP) |  | after 2.5 years | 
| perceived stress scale (PSS) |  | after 2.5 years | 
| overall health status of the patients (EQ5D-5L) |  | after 2.5 years | 
| Oral Health Impact Profile (OHIP) |  | after 5 years | 
| perceived stress scale (PSS) |  | after 5 years | 
| overall health status of the patients (EQ5D-5L) |  | after 5 years | 
| Oral Health Impact Profile (OHIP) |  | after 7.5 years | 
| perceived stress scale (PSS) |  | after 7.5 years | 
| overall health status of the patients (EQ5D-5L) |  | after 7.5 years | 
| Oral Health Impact Profile (OHIP) |  | after 10 years | 
| perceived stress scale (PSS) |  | after 10 years | 
| overall health status of the patients (EQ5D-5L) |  | after 10 years |
Compass Device CVC Trial

Study Overview
=================
Brief Summary
-----------------
This is a single-arm observational trial of a device (Compass Vascular Access, Centurion Medical Products, Williamston MI). The device is a compact, sterile, single-use extravascular blood pressure transducer. This pressure measurement aids in confirmation of appropriate venous access. The investigators plan to enroll 40 consenting patients with BMI ≥35 who require central venous catheterization for clinical reasons independent of the existence of this study. The primary outcome is operator satisfaction.

Detailed Description
-----------------
Forty (40) consenting patients meeting inclusion/exclusion criteria for this single-arm observational trial will be prepared as usual for central venous catheter (CVC) placement. The Compass pressure measurement device will be included in the CVC placement apparatus as per the manufacturer's directions. Data will be recorded on the placement procedure, operator satisfaction, routine patient demographics, and incidence of inadvertent arterial puncture.

Official Title
-----------------
Central Venous Catheterization in Obese Patients With Compass Device

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Device: Extravascular blood pressure transducer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI ≥35 Exclusion Criteria: Pregnant women Adults unable to consent Non-English speakers Prisoners

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 |
| --- | --- |
| Enrolled Patients<br>Procedure: Central venous catheter placement with extravascular blood pressure transducer | Device: Extravascular blood pressure transducer<br>* Listed device is included in central venous catheter placement apparatus for consenting patients, according to manufacturer directions<br>* Other names: Compass Vascular Access;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operator Satisfaction | Operator satisfaction (0-10 scale; 0=totally dissatisfied, 10=totally satisfied) | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial puncture incidence | Incidence of arterial puncture | 15 minutes | 
| Implement used at time of arterial puncture, if any | Incidence of artery puncture with either needle, guidewire, or catheter | 15 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Operator satisfaction with device
Role of Office Hysteroscope in Premenopausal Uterine Bleeding

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to photographically characterize the endometrium in patients presenting with abnormal uterine bleeding at age group from 20 to 45 years old. and compare dilatation and curettage with hysteroscopy in obtaining an accurate diagnosis of the etiology of abnormal uterine bleeding.

Detailed Description
-----------------
Menstrual dysfunction is the cause of discomfort and disturbed healthy lifestyle. Abnormal uterine bleeding (AUB) is considered as a common problem in premenopausal women. AUB is defined as bleeding from the uterine that is abnormal in volume, regularity, and/or timing. There are various diagnostic modalities available in the market, ranging from traditional dilation and curettage (D&C), transvaginal sonography, hysteroscopy and saline infusion sonography. Dilation and curettage is the most widely used simple day care procedure for histological evaluation of the endometrial. It was once considered as the gold standard of investigating women with AUB. Office hysteroscopy is a very useful technique for diagnosis and treatment of uterine pathology in an office-based environment. It is directly related to the technological explosion, which during the last years has further evolved and given us the opportunity to perform hysteroscopy without providing general anesthesia or sedation to the patients, due to the narrow width of the latest generation hysteroscopes. Hysteroscopic inspection of uterine cavity is a simple and well accepted method. The direct real time visualization, real-color, hydrated, well-illuminated, and augmented vision of the uterine cavity make this diagnostic tool very accurate to detect minute focal endometrial pathology and small lesions and helping us to take well guided direct biopsies.

Official Title
-----------------
Endometrial Characterization Using Office Hysteroscopy in Women Presenting With Abnormal Uterine Bleeding

Conditions
-----------------
Uterine Bleeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Perimenopausal women complaining of abnormal uterine bleeding. Exclusion Criteria: Active pelvic infections Medical disorders Bleeding tendency Hormonal treatment Pregnancy Contraceptive treatment

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hysteroscopic assessment of endometrial pathology | Patterns of endometrial pathology after histopathological examination of the curretings in patients with abnormal uterine bleeding | 7 days |
Bariatric and Obstructive Lung Disease Study II

Study Overview
=================
Brief Summary
-----------------
The prevalence of obesity and asthma has significantly increased over the past two decades. The purpose of this study is to try and understand the mechanism by which obesity leads to airway hyperresponsiveness (AHR), one of the defining features of asthma. This research is being done to determine how weight or body size affects airway size and airway smooth muscle (ASM) tone and function. The goal of the study will be to look at if and how, weight might affect lung functioning. The investigators hypothesize that low lung volumes in obesity lead to AHR by reducing airway caliber causing increased ASM tone with impairment in deep inspiration (DI) response similar to what is seen in asthma.

Official Title
-----------------
Effects of Obesity on Airway Caliber and Airway Smooth Muscle Tone

Conditions
-----------------
Obesity, Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older BMI over 35 kg/m2 (Bariatric) or BMI between 25 and 28 kg/m2 (Control) Physician diagnosis of asthma and on active asthma medication (if asthmatic) Exclusion Criteria: Weight greater than 450 lbs Unstable cardiovascular disease Uncontrolled hypertension Renal failure on dialysis Cirrhosis Pregnant or lactating Bleeding disorders or Coumadin use Recent hospitalization for asthma in the past 3 months Active smoking or more than 10 pack year smoking history

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bariatric, nonasthma<br>Participants that will have had a bariatric surgery but do not have asthma. | |
| Bariatric, asthma<br>Participants that will have had a bariatric surgery and have been physician diagnosed with asthma prior to the surgery. | |
| Control, nonasthma<br>Healthy participants that who will not be getting a bariatric surgery and who do not have asthma. | |
| Control, asthma<br>Healthy participants that will not be having a bariatric surgery but do have asthma. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Examination of Gastric Emptying in Children

Study Overview
=================
Brief Summary
-----------------
Background: Fasting is mandatory for safety of anesthesia in elective surgery and imaging but gives rise to discomfort, hunger and thirst especially in children. Internationally accepted fasting times are often prolonged because of organisational delay in operating theatre. Hypothesis: Clear fluids can be ingested until an imaginary anesthesia induction time without enlarging the residual gastric contents compared to overnight fast. There is no difference between residual gastric contents after 4 hours of fasting after a light meal compare to 6 hours in healthy children. Examination of gastric volume using magnetic resonance imaging after overnight fasting and subsequent scans after either clear fluid intake or intake of a standard breakfast are performed in children aged 6 - 12 years. Time course after fluid intake is followed with scans every half hour for 2 hours. In the breakfast group 4 versus 6 hours fasting time will be simulated, e. g. intake of clear fluid is allowed for 2 versus 4 hours after the meal. Volume of gastric contents will be compared with a standardized ultrasonographic view of the stomach.

Official Title
-----------------
Examination of Gastric Emptying With Magnetic Resonance Imaging and Ultrasonography

Conditions
-----------------
Gastric Emptying

Intervention / Treatment
-----------------
* Dietary Supplement: clear fluid, light breakfast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 6 - 12 years ASA I or II Exclusion Criteria: gastrointestinal pathology claustrophobia implants like pacemaker, ventriculoperitoneal shunt etc symptomatic or relevant cardiac, renal or metabolic disease

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy children aged 6 - 12 years<br> | Dietary Supplement: clear fluid, light breakfast<br>* clear fluid 7 ml/kg, breakfast consisting of yoghurt, muesli, mild<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying time | Time after food/fluid ingestion when gastric volume after overnight fast is achieved, as measured by volumetry of magnetic resonance scans | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastric volume after fasting |  | 6 hours | 
| gastric antral area |  | 6 hours | 
| visual analog scale of thirst/hunger |  | 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric emptying, children, gastric fluid volume, preoperative fasting