linjc16/ctgov huggingface dataset:
Study of Scaling Disorders and Other Inherited Skin Diseases

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify the genes responsible for certain scaling disorders and other inherited skin diseases and to learn about the medical problems they cause. In some cases, these may include problems affecting organs other than the skin, such as the eyes, teeth and bones. Patients with inherited skin disorders, including Darier's disease (keratosis follicularis), lamellar ichthyosis, epidermolysis bullosa, cystic acne, and others, and their relatives may be eligible for this study. Patients will have a medical history, physical examination with particular emphasis on the skin, and routine blood tests. Additional procedures for patients and unaffected relatives may include: Blood sample collection Dental exam with X-ray of the jaw Eye examination X-rays of the skull, ribs, chest, hands, feet, spine, arms, or legs Bone density scan Photographs of the skin Skin biopsies (removal of a small tissue sample under local anesthetic) Buccal sample (gentle brushing inside the cheek to collect a cell sample) for gene studies Patients who request the results of their gene testing will be provided this information.

Detailed Description
-----------------
We propose to investigate the genetics of the scaling disorders and other genodermatoses which are believed to behave in a Mendelian manner. Families for study will be ascertained through articles in the Ichthyosis Focus, (the newsletter of the Foundation for Ichthyosis and Related Skin Types), physician referrals, and patient self-referrals. Efforts will be made to further characterize the clinical findings in both affected persons and unaffected gene carriers. Using candidate genes, especially those known to be involved in structural abnormalities of skin, we will attempt to map and isolate major genes contributing to expression of the disease phenotype. Failing this direct approach, a random search of the genome (so-called, reverse genetics) will be utilized. In addition, normal and diseased skin will be used in cell culture and animal experiments (under a separate protocol) to test new therapeutic modalities.

Official Title
-----------------
Clinical and Genetic Studies of the Scaling Disorders and Other Selected Genodermatoses

Conditions
-----------------
Genetic Skin Disease, Keratosis Follicularis, Lamellar Ichthyosis

Participation Criteria
=================
Eligibility Criteria
-----------------
No steroid sulfatase deficiency.
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
-----------------
DNA Markers, Family Studies, Gene Mapping, Ichthyosis, Keratin, Linkage Analysis, Scaling Disorders, Skin
The Utility of Circulating Tumor Cells as Confirmation of Pathologic Diagnosis in Patients With Suspected Early Stage Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine whether circulating tumor cells (CTCs) can be used as a non-invasive means of confirming pathologic diagnosis in early-stage (Stage I) non-small cell lung cancer (NSCLC). Patients scheduled to undergo surgical intervention will have blood samples obtained to test for CTCs. Presence of CTCs will be compared to final pathologic diagnosis based on surgical specimens to assess the sensitivity of using CTCs alone to make a definitive diagnosis.

Official Title
-----------------
The Utility of Circulating Tumor Cells as Confirmation of Pathologic Diagnosis in Patients With Suspected Early Stage Non-small Cell Lung Cancer

Conditions
-----------------
Non-small Cell Lung Cancer (NSCLC)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of stage I NSCLC a. Only patients with a pathologically confirmed NSCLC will be retained for data analysis b. Should pathologic diagnosis reveal a more advanced stage, these subjects will remain in the study 18 years of age Ability to read and sign informed consent Both men and women and members of all races and ethnic groups are eligible for this trial. Exclusion Criteria: Prior cancer diagnosis, excluding previously treated non-melanoma skin cancer Prior or ongoing treatment of the clinically diagnosed cancer

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 |
| --- | --- | --- |
| Number of adverse events |  | 2.5 years |
Psychological Impact of Quarantine in Osteoporosis Patient During COVID-19 Outbreak

Study Overview
=================
Brief Summary
-----------------
In the context of quarantine with COVID-19, we wish to study the experience and psychological impact in adult patients living with osteoporosis.

Official Title
-----------------
Psychological Impact of Quarantine in Osteoporosis Patient During COVID-19 Outbreak

Conditions
-----------------
Sars-CoV2, Osteoporosis

Intervention / Treatment
-----------------
* Other: questionnaire assesment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with osteoporosis Patient in confinement Patient with sufficient understanding of the French language Exclusion Criteria: Non adult patient patient without quarantine

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 |
| --- | --- |
| osteoporosis patient<br> | Other: questionnaire assesment<br>* questionnaire assesment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patient with feeling of disabilities |  | maximum 1 week from baseline on | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psychological impact, COVID-19
Impact of Best Practice Alerts in Cardiology Outpatient Clinics

Study Overview
=================
Brief Summary
-----------------
This quality improvement intervention seeks to implement two Best Practice Alerts (BPAs) for use in cardiology clinics while simultaneously evaluating the impact of each BPA- one for patients with uncontrolled blood pressure and one for patients with atrial fibrillation not on anticoagulation.

Detailed Description
-----------------
Best Practice Alerts based will be created for hypertension and atrial fibrillation. Outpatient cardiology providers will be randomly allocated into one of three groups. The first group will receive the BPA for hypertension alone. The second group will receive the BPA for atrial fibrillation alone. The final group will receive both BPAs. The rate of blood pressure control for all patients and anticoagulation in patients with atrial fibrillation in each group will be evaluated prior to and after the implementation of the BPAs to determine the effect of the BPA.

Official Title
-----------------
Impact of Best Practice Alerts in Cardiology Outpatient Clinics

Conditions
-----------------
Hypertension, Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: Best Practice Alert based in the Electronic Medical Record


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients seen routinely by cardiologists at Duke Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Atrial Fibrillation BPA<br>The alert will notify providers when patients with atrial fibrillation are not on anticoagulation | Other: Best Practice Alert based in the Electronic Medical Record<br> <br> |
| Other: Hypertension BPA<br>The alert will notify providers when patients have elevated blood pressure | Other: Best Practice Alert based in the Electronic Medical Record<br> <br> |
| Other: Atrial Fibrillation and Hypertension BPA<br>Providers in this arm will receive both alerts | Other: Best Practice Alert based in the Electronic Medical Record<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of anticoagulation among patients with atrial fibrillation |  | 1 year | 
| Rates of hypertension control among patients seen by cardiology |  | 1 year |
Blood and Saliva Sample Collection for AREDS 2

Study Overview
=================
Brief Summary
-----------------
Background: - The Age-Related Eye Disease Study 2 (AREDS 2) is looking at different eye diseases. Study participants will provide blood and saliva samples. The samples will be stored for research on eye diseases. Objectives: - To collect blood and saliva samples for AREDS 2 research. Eligibility: - AREDS 2 research study participants. Design: Participants will provide blood and saliva samples. The samples will be submitted with personal and medical information. This information will be collected during the AREDS 2 procedures.

Detailed Description
-----------------
AREDS2 is a multi-center, Phase III, randomized clinical trial designed to assess the effects of oral supplementation of high doses of macular xanthophylls (lutein and zeaxanthin) and/or omega-3 long-chain polyunsaturated fatty acids (LCPUFAs) as a treatment for age-related macular degeneration (AMD), cataract and moderate vision loss. In addition to this objective, the AREDS2 study will provide information on the clinical course, prognosis, and risk factors for development and progression of both AMD and cataract. Other study goals include the evaluation of eliminating beta-carotene and/or reducing zinc in the original AREDS formulation on the progression and development of AMD. AREDS2 will also seek to validate the fundus photographic AMD scale developed from AREDS. The objective of this protocol is to have AREDS2 participants submit blood and saliva samples to the AREDS2 Genetic Repository (Fisher BioServices, Rockville, MD) in order to provide further materials for the study of the genetic and biochemical bases for eye disease and possibly other diseases.

Official Title
-----------------
Blood and Saliva Sample Collection and Submission to the Age-Related Eye Disease Study 2 (AREDS2) Genetic Repository

Conditions
-----------------
Age-Related Macular Degeneration, Eye Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Participants will be eligible if they were enrolled in the AREDS2 protocol and willing to have their blood drawn and saliva collected. EXCLUSION CRITERIA: Participants will not be eligible if they were not enrolled in AREDS2 and are not willing to have their blood drawn and saliva collected.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 85 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Age-Related Macular Degeneration (AMD), Eye Diseases
LymphoVenous Anastomosis to Prevent Breast Cancer Related Lymphedema

Study Overview
=================
Brief Summary
-----------------
Lymphedema is defined as a chronic condition, caused by lymphostasis. A major part in the Western world consists of iatrogenic lymphedema caused by surgery to the lymph nodes of the axilla or groin. Prophylactic lymphovenous anastomosis (LVA) could be beneficial in the prevention of lymphedema of the extremities.

Detailed Description
-----------------
The investigator is performing a blinded randomized prospective study on 80 patients undergoing an axilla dissection for their breast cancer treatment. One group will receive a LVA at the time of their axilla dissection. Other group will receive standard of care. Follow-up is 2 year.

Official Title
-----------------
Lymfo-Veneuse Anastomosen Ter Preventie Van Lymphoedeem

Conditions
-----------------
Lymphedema, Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Axilla dissection + Lymphovenous anastomosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lymph node + breast cancer requiring dissection Exclusion Criteria: previous lymphedema BMI >35

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: blinded randomized prospective
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Axilla dissection + Lymphevenous Anastomosis<br>Surgical bypass between lymphatic vessel and vein | Procedure: Axilla dissection + Lymphovenous anastomosis<br>* surgical bypass between lymphatic vessel and vein<br>|
| No Intervention: Standard surgery<br>Standard surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The volume via circumferential measurements: swelling < 5% | Comparing the volume of the arm at each study visit via circumferential measurements: swelling < 5% | 2 years |
A Trial Investigating the Pharmacokinetic Properties of FIAsp in Japanese Subjects With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Japan. The aim of the trial is to evaluate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the trial drug on the body) properties of FIAsp (faster-acting insulin aspart) and the currently marketed insulin aspart (NovoRapid®) in Japanese subjects with type 1 diabetes.

Official Title
-----------------
A Trial Investigating the Pharmacokinetic Properties of FIAsp in Japanese Subjects With Type 1 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: Faster-acting insulin aspart
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer Body mass index (BMI) 18.5-28.0 kg/m^2 (both inclusive) Exclusion Criteria: Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily) Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FIAsp<br>Each subject will be randomly allocated to one of the two treatment sequences consisting of 2 dosing visits | Drug: Faster-acting insulin aspart<br>* Single dose injected subcutaneously (s.c, under the skin)<br>Drug: insulin aspart<br>* Single dose injected subcutaneously (s.c, under the skin)<br>|
| Active Comparator: NovoRapid®<br>Each subject will be randomly allocated to one of the two treatment sequences consisting of 2 dosing visits | Drug: Faster-acting insulin aspart<br>* Single dose injected subcutaneously (s.c, under the skin)<br>Drug: insulin aspart<br>* Single dose injected subcutaneously (s.c, under the skin)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin aspart concentration-time curve |  | From 0-1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin aspart concentration-time curve |  | From 0-12 hours | 
| Area under the glucose infusion rate (GIR) curve |  | From 0-1 hour | 
| Area under the glucose infusion rate (GIR) curve |  | From 0-12 hours |
Safety/Efficacy of Intravenous Zoledronic Acid When Added to Standard Therapies in Patients With Breast Cancer and Metastatic Bone Lesions

Study Overview
=================
Brief Summary
-----------------
Zoledronic acid selectively binds to bone and protects it from being metastasized by tumor cells. This study evaluates the safety and efficacy of zoledronic acid when added to standard therapies in breast cancer patients with metastatic bone lesions.

Official Title
-----------------
Efficacy and Tolerability of Intravenous Zoledronic Acid 4mg as an Adjunct to Standard Therapies Including Conversion From Pamidronate in Breast Cancer Patients With Metastatic Bone Lesions. A Prospective, Randomised, Open-label, Clinical Study

Conditions
-----------------
Breast Cancer With Bone Metastasis

Intervention / Treatment
-----------------
* Drug: Zoledronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Confirmed diagnosis of Breast Cancer with at least one breast cancer-related bone lesion No treatment with bisphosphonates within 6 months prior to inclusion into the study Good health status (ECOG Performance status 0-2) Exclusion criteria Patients who do not have at least one breast cancer-related bone lesion that is detectable on conventional radiographs of bone (plain film) at screening Abnormal renal function History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism Pregnancy and lactation Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures, recent (within 6 weeks) or planned dental or jaw surgery (e.g..extraction, implants)

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zoledronic acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of a switch over from pamidronate therapy (2 infusions) to a treatment with zoledronic acid 4mg every 4 weeks (10 infusions) for 44 weeks in patients with breast cancer-related bone lesions |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the safety, tolerability, and efficacy in the treatment arms |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Palliation, Bone metastasis, Zoledronic acid
Intrabdominal Pressure in Small Bowel Obstruction as a Possible Predictor for the Need of Operation

Study Overview
=================
Brief Summary
-----------------
Small bowel obstruction (SBO) is a common surgical diagnosis. Most of SBO are related to post operative adhesions and most of them resolve without the need of surgical intervention. The most important thing dealing with SBO is to identify the more complex obstructions that need surgery. Some clinical, physiological and radiological signs are recognized as markers of a more complex obstruction. The pathophysiology of bowel obstruction is explained as damage created by pressure on the abdominal wall causing ischemia. Yet there are no studies, as far as we know, that measure intra-abdominal pressure in SBO patients and it relation to the severity of the obstruction. In this study we will measure the intra-abdominal pressure in SBO patients systematically and we will examine if more severe obstructions are accompanied by elevated intra-abdominal pressure.

Official Title
-----------------
Intrabdominal Pressure in Small Bowel Obstruction as a Possible Predictor for the Need of Operation

Conditions
-----------------
Small Bowel Obstruction

Intervention / Treatment
-----------------
* Device: urine folly catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18 , diagnosis of small bowel obstruction Exclusion Criteria: younger then 18 , pregnant women, large bowel obstruction, incarcerated hernia, large ventral hernia

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: operated patients<br>small bowel obstrucion patients who needed surgery for treatment of obstruction. | Device: urine folly catheter<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intra abdominal pressure | serial intraabdominal pressure will be measured during hospitalisation up to discharge or operation. | up to 1 week |