linjc16/ctgov huggingface dataset:
Pilot Study Describing the Early Evolution of the Sexual Function of Patients Receiving Adjuvant Hormone Therapy for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The 2014-2019 cancer plan emphasizes the need to reduce the impact of cancer on personal life. The impact of cancer on sexuality is multifactorial: fatigue, anxiety, impaired body image, chemotherapy treatment. None of these studies specifically assessed the early impact on the quality of sexual life of patients. The purpose of this study is to describe to describe the early evolution of the quality of sexual life of patients receiving adjuvant hormone therapy for breast cancer.

Official Title
-----------------
Pilot Study Describing the Early Evolution of the Sexual Function of Patients Receiving Adjuvant Hormone Therapy for Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: quality of life questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 years Female gender Histologically proven non-metastatic breast cancer Indication of adjuvant hormone therapy Patient able to understand a newsletter and to agree to participate Exclusion Criteria: Age under 18 years Pregnant woman Adjuvant chemotherapy Patient followed for heavy psychiatric pathology (requiring guardianship or trusteeship) Persons protected or deprived of their liberty Male

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: quality of life questionnaire|QLQ-C30 and BR23 (Quality of Life Questionnaire and Breast 23) Questionnaire FSFI (Female Sexual Function Index)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score FSFI (Female Sexual Function Index) |  | 3 month after adjuvant hormone therapy |
Fluid Shifts in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest

Study Overview
=================
Brief Summary
-----------------
Therapeutic hypothermia after cardiac arrest har shown to improve the rate of survival in a significant way. However hypothermia also causes leak of fluid into the surrounding tissue. This edema could lead to damage to the same tissue, not beneficial for the patients. We therefore try to evaluate if hyperosmolar, hyperoncotic fluid as an alternative to std. treatment (NaCl/RA)could affect the edema in a positive way, and result to a better outcome neurological for the patients.

Detailed Description
-----------------
After the patients are admitted to our hospital we randomise them to either std. fluid therapy (NaCl/RA) or HyperHAES. After PCI we state the rate of cerebral edema by carrying out a cerebral MRI before the cooling starts. We treat the patients with the different fluids for 24 hours. We then evaluate the edema after 24 and 72 hours by the same method. In addition we state the rate of peripheral capillary leak by Wick'S method. The capillary leak is calculated every 8.th hour for the 1. day the patients are treated in our ICU. AFter 1 year, those who survive are invited to a follow-up where we test the patient using Mini MEntal Status, SF-36, in addition to neurophysiological tests as EEG and the P300-test. We then relate the results to the fluid given initially after the cardiac arrest.

Official Title
-----------------
Fluid Shift in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest, and How do They Manage Life Afterwards?

Conditions
-----------------
Cardiac Arrest

Intervention / Treatment
-----------------
* Drug: HyperHAES vs. RA-solution/NaCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Witnessed cardiac arrest, ALS started within 15 min. ROSC within 60 min. Still unconscious, Age 18-80 Exclusion Criteria: Other malignancies, Persons who wake up, Pregnancy

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: HyperHAES vs. RA-solution/NaCl|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  |  | 
| Quality of Life |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days in the ICU |  |  | 
| Neurological test as described |  |  | 
| Grade of Edema |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac arrest, hypothermia, neurologic outcome, edema
Pain Control After Trauma

Study Overview
=================
Brief Summary
-----------------
Using Virtual Reality as a form of pain control for trauma patients.

Detailed Description
-----------------
The purpose of the study is to investigate the effectiveness of virtual reality (a form of distraction) in order to reduce patients' pain from trauma.

Official Title
-----------------
Pain Control After Trauma

Conditions
-----------------
Trauma

Intervention / Treatment
-----------------
* Behavioral: Virtual Reality


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 12 years Compliant and able to complete questionnaires Hospitalization for internal injuries requiring a laparotomy or for orthopedic injuries (closed long bone or calcaneus fractures). A minimum of 3 days hospitalization No history of psychiatric (DSM-IV-R Axis I) disorder Not demonstrating delirium, psychosis or any form of Organic Brain Disorder Able to communicate verbally Able to take oral medications Baseline pain level of >=5/10 English-speaking Exclusion Criteria: Age less than 12 years Not capable of indicating pain intensity Not capable of filling out study measures Hospitalization of less than 3 days Evidence of traumatic brain injury History of psychiatric (DSM-IV-R Axis I) disorder as evidenced in the admitting RN and MD admission notes. Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems. Unable to communicate orally. Unable to take oral medications History of sig. cardiac, endocrine, neurologic, metabolic, respiratory, gastrointestinal or genitourinary impairment Receiving prophylaxis for alcohol or drug withdrawal Developmental disability Mini-mental status score of greater than 20 in patients older than 80 years or suspected of cognitive deficits Non-English Speaking Extreme susceptibility to motion sickness Seizure history

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Virtual Reality Hypnosis | Behavioral: Virtual Reality<br>* Using Virtual Reality for pain control<br>|
| Experimental: 2<br>Virtual Reality Distraction | Behavioral: Virtual Reality<br>* Using Virtual Reality for pain control<br>|
| Experimental: 3<br>Standard treatment. | Behavioral: Virtual Reality<br>* Using Virtual Reality for pain control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and Anxiety |  | up to 3 times a day |
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 on Minimal Persistent Pigment-Darkening Dose

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

Intervention / Treatment
-----------------
* Drug: Coppertone (BAY987518)


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 Signed and dated Informed Consent Form Signed and dated HIPAA Form An unambiguous MED 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: BAY987518<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 (BAY987518)<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: SR15-76_V27-006)<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 |
Autologous Bone Marrow Transplanted Via Transendocardial Catheter to Chronic Myocardial Infarct Border Zone

Study Overview
=================
Brief Summary
-----------------
The object of this open-labeled, uncontrolled pilot study was to investigate the safety and feasibility of percutaneously transplanting autologous bone marrow (ABM) cells into the myocardium using the helical needle transendocardial (TE) delivery system in stable coronary patients with ventricular dysfunction due to chronic myocardial infarction (MI). A secondary goal was to assess the possibility that such cell injections could improve ejection fraction (EF).

Official Title
-----------------
Autologous Bone Marrow Transplanted Via Transendocardial Catheter to Chronic Myocardial Infarct Border Zone

Conditions
-----------------
Ventricular Dysfunction, Myocardial Infarction

Intervention / Treatment
-----------------
* Procedure: Transendocaridal Transplantation of Autologous Bone Marrow


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be 18 years of age or older Able to give informed consent Must have documentation of prior myocardial infarction with left ventricular ejection fraction of less than 40 percent at baseline Must be a candidate for percutaneous heart catheterization Must have identifiable area of transmural scar within the left ventricle Exclusion Criteria: Be a candidate for concurrent ventricular surgical restoration, AICD placement or valvular surgery Clinical evidence of infection Other complicating cardiovascular abnormalities Clinically significant electrocardiographic abnormalities Active malignancy Recent history or drug or alcohol abuse Pregnancy, planned or current Artificial aortic valve Ejection fraction less than 30 percent at baseline Myocardial infarction in the past 4 weeks

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

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Transendocaridal Transplantation of Autologous Bone Marrow|Single treatment, harvest and transplant of patients own bone marrow. Cells are delivered to the myocardium via transendocardial delivery catheter.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of treatment |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone marrow, autologous, ejection fraction, left ventricle, heart attack, myocardial infarction, left ventricular dysfunction post myocardial infarction
Genetic and Functional Analysis of Aplasia Cutis Congenital (ACC)

Study Overview
=================
Brief Summary
-----------------
The goal of this research study is to identify genes and regulatory elements on chromosomes that cause ACC. The investigators also study tissue samples from patients to learn about the processes that lead to this disorder.

Detailed Description
-----------------
Aplasia cutis congenita (ACC) or congenital scalp defect is a very rare disorder that affects bone and skin. The definition for ACC is the localized absence of (normal) skin at the time of birth (congenital). The skin appears thinner and the underlying structures are visible. We study mostly the isolated form of ACC with the lesion often being at the vertex of the skull (at or close to the top of the skull). The bone underlying the lesion is sometimes thinner as well. For this study we will: Send out study participation kits and consent by phone Collect a saliva sample from eligible individuals Obtain information regarding ACC Document disorder with photos and doctor's letters If patients undergo surgery for ACC we ask to obtain some tissue that would otherwise be discarded Isolate DNA from the saliva sample Perform genetic analyses of the DNA with the most up-to-date methods available to identify genetic variations Study in the laboratory why the genetic variations cause the disorder

Official Title
-----------------
Identification of Mutations That Lead to Aplasia Cutis Congenita in Families and Isolated Cases and Studies of Cellular and Molecular Mechanisms

Conditions
-----------------
Aplasia Cutis Congenita

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ACC; unaffected individuals only if part of a participating ACC family Exclusion Criteria: No ACC unaffected individuals only as part of a participating ACC family
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| affected, unaffected<br>Individuals with diagnosed ACC | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of genetic elements | The goal is to identify relevant genes or genetic elements that cause the disease or contribute to the disease progression and severity. | at time of identification | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aplasia cutis congenita, bone, osteoblast, osteoclast, skin
Continued Access Study to Evaluate Performance of the Organ Recovery Systems _LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT™_CA)

Study Overview
=================
Brief Summary
-----------------
To provide continued access for the LLT system to provide additional safety data in support of the PILOT pivotal efficacy and safety trial

Detailed Description
-----------------
To provide continued access for the LLT System with Vasosol® for the preservation of whole explanted livers, thereby providing additional safety data in support of the PILOT pivotal efficacy and safety trial

Official Title
-----------------
A Prospective Multi-Center Continued Access Protocol for the Use of the LifePort® Liver Transporter (LLT) System With Vasosol® in Orthotopic Liver Transplants (PILOT™_CA: Perfusion to Improve Liver Outcomes in Transplantation_ Continued Access Arm)

Conditions
-----------------
Liver Transplantation

Intervention / Treatment
-----------------
* Device: Hypothermic Machine Perfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
≥18 years of age. Active on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation. De novo liver transplant recipient. Written informed consent required. Exclusion Criteria: Subject is a multi-organ transplant recipient. Subject is antibodies blood group (ABO) liver incompatible. Subject has severe systemic infection. Subject is Human Immunodeficiency Virus (HIV) positive. Subject has acute/fulminant liver failure. Subject is pregnant.

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: Hypothermic Machine Perfusion<br>Hypothermic Machine Perfusion with Organ Recovery Systems LifePort Liver Transporter system | Device: Hypothermic Machine Perfusion<br>* Organ Recovery Systems LifePort® Liver Transporter (LLT) System and Vasosol® Machine Perfusion Solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Allograft Dysfunction (EAD) | EAD defined as total bilirubin ≥ 10 mg/dL or International Normalized Ratio (INR) ≥ 1.6 or Aspartate Aminotransferase (AST) >2000IU/L or Alanine Aminotransferase (ALT) > 2000 IU/L | 7 days |
NAC Trial for Anosmia

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to evaluate the use of NAC in the treatment of anosmia (a loss of the sense of smell). This drug is already approved by the Food and Drug Administration (FDA) for oral or pulmonary (lung) inhaled use for other medical conditions. However, there is research evidence that the medication may promote nerve recovery (help nerves work better after they are damaged). Since anosmia involves nerve problems, we believe the nasal spray may help treat anosmia. The medication has been in use for many years for other conditions, without safety problems.

Official Title
-----------------
Pilot Study of Topical Intranasal N-acetyl Cysteine Administration for the Treatment of Anosmia

Conditions
-----------------
Anosmia

Intervention / Treatment
-----------------
* Drug: N-acetyl cysteine (NAC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults at least 18 years of age with documented microsmia or anosmia by University of Pennsylvania Smell Identification Test. patients must have no evidence of active sinonasal disease by nasal endoscopy or CT or MRI negative CT or MRI Exclusion Criteria: adults unable to consent individuals who are not yet adults (infants, children, teenagers) pregnant women, prisoners, employees or subordinates, patients with known sensitivity to NAC or severe asthma patients with sinus or central disease on CT or MRI imaging.

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: NAC arm<br>Topical intranasal N-acetyl cysteine (NAC 200 mg/2 ml vials) BID for one month | Drug: N-acetyl cysteine (NAC)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Smell Identification Test score | Sense of smell is measured using the Smell Identification Test (a standardized 40-item forced choice self administered microencapsulated odor scratch-and-sniff style test ) | Baseline and three months after completion of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sino-Nasal Outcome Test (SNOT-20) score | Validated quality of life assessment tool for nasal and sinus disease patients | Baseline and three months after completion of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Loss of Smell, Olfaction, Hyposmia