linjc16/ctgov huggingface dataset:
Establishing a Repository of Blood and DNA Samples From People With Sickle Cell Disease (Comprehensive Sickle Cell Centers Collaborative Genotype-Phenotype Database and Sample Repository)

Study Overview
=================
Brief Summary
-----------------
Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease that can cause intense pain episodes. The purpose of this study is to collect, test, and archive blood and DNA samples from children and adults with SCD to study the role that genes play in SCD. Blood and DNA samples will be stored for use in future SCD studies.

Detailed Description
-----------------
SCD is an inherited blood disorder that is caused by an abnormal type of hemoglobin. Symptoms include anemia, infections, organ damage, and intense episodes of pain, which are called sickle cell crises. The Comprehensive Sickle Cell Centers (CSCC) is a network of 10 centers that conduct research to improve health care and treatment options for people with SCD. The Collaborative Data Project (C-Data) is a CSCC study that is establishing a comprehensive database of children and adults with SCD who are receiving medical care at participating CSCC research centers. This study will initiate the development of a centralized laboratory that will collect, test, and archive blood and DNA samples from participants in the C-Data project for use in future SCD studies. The collection of blood and DNA samples will provide researchers with an important resource to better define the genetic diversity of SCD. In the future, genotype-phenotype correlation studies, population studies, and various other genetic studies may be conducted. This study will enroll participants taking part in the C-Data project. For this study, participants will undergo a blood collection. The blood sample will then be sent to a lab to characterize the red blood cells and hemoglobin. DNA will be analyzed to identify genes that influence the severity of SCD. Blood and DNA will be stored for future genetic research in SCD and closely related disorders.

Official Title
-----------------
Comprehensive Sickle Cell Centers (CSCC) Collaborative Genotype-Phenotype Database and Sample Repository

Conditions
-----------------
Anemia, Sickle Cell

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participating in the C-Data project Exclusion Criteria: Unable to undergo blood collection
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
-----------------
Sickle Cell Disease, Sickle Cell Anemia, DNA
Design of Optimally-diagnostic Skin Test Solutions for Diagnosis of Sensitisation to a Pollen and Dust Mite Mixture.

Study Overview
=================
Brief Summary
-----------------
Multicenter Skin Prick Test

Official Title
-----------------
Design of Optimally-diagnostic Skin Test Solutions for Diagnosis of Sensitisation to a 6-grass Pollen Mixture, House Dust Mite (Dermatophagoides Pteronyssinus), Birch Pollen, and Mugwort Pollen

Conditions
-----------------
Type I Allergy

Intervention / Treatment
-----------------
* Other: Skin Prick Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: anamnesis referring to suspicion of an IgE-mediated allergy positive Skin Prick Test in the medical history to at least one of the investigational allergens with an existing anamnesis Exclusion Criteria: serious chronic diseases Other perennial allergies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental: 1<br>Skin Prick Test | Other: Skin Prick Test<br>* Skin Prick Test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal trade-off between sensitivity and specificity |  | December 2007 - December 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the documentation of adverse events |  | January - December 2008 |
The Effect of Postoperative Therapy on the Quality of Life of Patients With Early Cervical Cancer Research

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the women's quality of life, who accepted chemotherapy,radiotherapy, concurrent radiochemotherapy or who didn't accept therapy, after operation.

Detailed Description
-----------------
The study projects to follow up 180-200 early stage cervical cancer patients after operation and assess the women's quality of life by the scales: ECOG, Functional Assessment of Cancer Therapy, EuroQol-5 Dimensions, and Kupperman index.

Official Title
-----------------
The Effect of Postoperative Therapy on the Quality of Life of Patients With Early Stage Cervical Cancer

Conditions
-----------------
Uterine Cervical Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≮ 18 years, cervical cancer verified by pathology， IIA stage, accepted the operation ( Piver III and pelvic lymph node dissection) as initial therapy， obtained the patient's agreement Exclusion Criteria: the patient had accepted chemotherapy or radiotherapy before operation

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

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

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 |
| --- | --- | --- |
| Quality of life for the women with early stage cervical cancer who underwent operation |  | up to 12 months after operation |
Treatment Regimens for Mifegyne and Cytotec

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test two regimens of mifegyne and cytotec for medical abortion. The investigators hypothesize that administration of both medications during one hospital visit will not compromise effectiveness.

Official Title
-----------------
Comparison of the Effectiveness of Abortive Measures From the Administration of Mifegyne and Cytotec at One and Two Visits

Conditions
-----------------
Medical Abortion

Intervention / Treatment
-----------------
* Drug: mifegyne and cytotec


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: above age 18, for whom Mifegyne and cytotec are indicated. Exclusion Criteria: inflammation of oral cavity.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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 |
| --- | --- |
| Experimental: one-visit<br> | Drug: mifegyne and cytotec<br>* One day dosage versus two days dosage<br>* Other names: Comparison of one day dosing to two days dosing;|
| Active Comparator: two-visit<br> | Drug: mifegyne and cytotec<br>* One day dosage versus two days dosage<br>* Other names: Comparison of one day dosing to two days dosing;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of complete abortion |  | one month |
Study Of Airway Physiology In Adults. SERETIDE DISKUS® Inhaler and FLIXOTIDE® Inhaler Are Trademarks of GSK Croup of Companies.

Study Overview
=================
Brief Summary
-----------------
Comparison of two asthma treatments by lung function measures.

Detailed Description
-----------------
Single centre, randomised, double-blind, comparator study to demonstrate superiority of salmeterol/fluticasone propionate combination product 50/100mcg bd over fluticasone propionate 100mcg bd with respect to improvements in airway physiology (sRAW) in adults with persistent asthma treated for 4 weeks.

Official Title
-----------------
Randomised, Double Blind, Parallel Group Study to Assess the Bronchodilative and Bronchoprotective Properties of SERETIDE DISKUS® Inhaler 50/100 mcg Twice Daily vs FLIXOTIDE® Inhaler 200 mcg Twice Daily

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Salmeterol/fluticasone propionate and fluticasone propionate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Physician documented diagnosis of asthma which has been present for at least 6 months. Receiving a total daily dose of 200-500mcg/day beclomethasone dipropionate or equivalent for at least 4 weeks prior to the start of the run-in period. Exclusion: Has had 3 or more courses of oral corticosteroids in the 12 months previous to visit 1

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Salmeterol/fluticasone propionate and fluticasone propionate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific airway resistance (sRAW kPa.L.s) measured before the study medication dose at the end of treatment (week 4) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sRAW measured post-dose at Week 2 and week 4. % symptom-free days over Weeks 1-4. % symptom-free nights over Weeks 1-4. Type and frequency of adverse events. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inhaled corticosteroids, Asthma
An Interventional Multidisciplinary Approach to Individualize Blood Pressure Treatment

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate and explore the most important aspects of drug-adherence in the treatment of hypertension in order to improve treatment and blood pressure control, implying that new knowledge will reduce morbidity and mortality.

Official Title
-----------------
Individualized Blood Pressure Treatment: a Multidisciplinary Approach to Uncontrolled Hypertension in Order to Reduce Morbidity and Mortality

Conditions
-----------------
Uncontrolled Hypertension

Intervention / Treatment
-----------------
* Diagnostic Test: Therapeutic drug monitoring
* Device: Home blood pressure monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Uncontrolled hypertension A stable medication regimen for at least 4 weeks of ≥ 2 antihypertensive agents No planned changes in antihypertensive drugs Exclusion Criteria: Withdrawal of consent 24-h systolic ambulatory blood pressure >/= 170 mmHg Patients with inadequate Norwegian language skills Positive pregnancy test Known alcohol or drug abuse estimated glomerular filtration rate <30 mL/min/1.73m2 Albumin/creatinin ratio >300 mg/mmol Any reason why, in the opinion of the investigator, the patient should not participate

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Study Group intervention: Therapeutic drug monitoring. | Diagnostic Test: Therapeutic drug monitoring<br>* Therapeutic drug monitoring will be performed.<br>|
| Active Comparator: Control Group<br>Control Group intervention: No intervention first 3 months. After 3 months of follow-up, half of the patients in the Control Group will be randomized to perform home blood pressure monitoring as an intervention. No intervention in the other half. | Device: Home blood pressure monitoring<br>* Patients will perform home blood pressure monitoring at home.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure control | Change in systolic daytime ambulatory blood pressure. | 3 months after baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adherence, Therapeutic Drug Monitoring, Patient perspective
Real-time Monitoring of Concentration and Size Variations of Circulating Plasma Free DNA to Predict Early Response to Immunotherapies in Patients With Different Types of Cancer.

Study Overview
=================
Brief Summary
-----------------
Immunotherapy, which can be represented by the immune checkpoint blockade, is a milestone in the progress of the ongoing struggle against cancer. However, the emergence of unexpected tumor response patterns, such as pseudo-progression or hyper-progression, might complicate the management of patients receiving these immune checkpoint inhibitors. A reliable standardized biomarker that can be used in clinical practice for predicting response to treatment, monitoring tumor evolution and evaluating treatment efficacy has not yet been established. The general aim of this study is to assess the interest of the plasmatic free circulating DNA (cfDNA) on the clinical response for patients with different types of cancer treated with immunotherapies. The primary objective is to assess the performance of the plasmatic free circulating DNA using the estimation of the receiver operating characteristic (ROC) curve and calculation of the area under the curve (AUC) on the response rate.

Official Title
-----------------
Real-time Monitoring of Concentration and Size Variations of Circulating Plasma Free DNA to Predict Early Response to Immunotherapies in Patients With Different Types of Cancer.

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients starting anti-PD1 immunotherapy as part of marketing authorization alone or in combination (melanoma, clear cell renal cancer, urothelial carcinomas of the bladder, squamous cell carcinomas of the head and neck and non-small cell lung cancer). No contraindications to immunotherapy Non-pregnant patient Patient not opposed to participation in this study Exclusion Criteria: HIV seropositivity Patient with psychiatric or other conditions that may compromise his or her ability to give non opposition or to follow study procedures

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Melanoma<br> | |
| clear cell renal cancer<br> | |
| Urothelial Carcinoma of the bladder<br> | |
| squamous cell carcinomas of the head and neck<br> | |
| non-small cell lung cancer<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interest of the plasmatic free circulating DNA (cfDNA) | The primary objective is to assess the performance of the plasmatic free circulating DNA using the estimation of the receiver operating characteristic (ROC) curve and calculation of the area under the curve (AUC) on the response rate | At first evaluation, then 1 administration over 2 for 1 year then at 18 months and an additional sample will be taken at the time of recurrence |
The Association Between Nephrolithiasis and Periodontal Status

Study Overview
=================
Brief Summary
-----------------
Dental calculus is a calcified deposits firmly attached to teeth and implants surfaces. Dental calculus is strongly associated with periodontitis and considered to have indirect role in the pathogenesis of periodontal diseases. Dental calculus composed primarily of calcium phosphate mineral salts originated in the saliva covered by unmineralized bacterial layer. Composition of calculus varies from person to person and influenced by numerous variables such as: age, gender systemic disease and ethnic background. Nephrolithiasis (kidney stones) are composed of insoluble salts of constituents of the forming urine. The most two frequent stone types are: Calcium oxalate (with a frequency of 15% -35%) and Calcium phosphate (5% -20%). The prevalence of kidney stones varies with race, sex, and geographic location. In the United States for men, kidney stone rates vary between 4%-9%, and for women, kidney stone rates range between 2%-4%. Previous studies dealt with the connection between sialolithiasis and nephrolithiasis were inconclusive. To the authors' best knowledge no studies were done to examine the associations between nephrolithiasis and dental calculus. Thus, the aim of this study is to compare the mineral composition of both dental calculus and nephrolithiasis and determine whether nephrolithiasis composition may be linked to the periodontal status.

Official Title
-----------------
The Association Between Nephrolithiasis and Periodontal Status

Conditions
-----------------
Periodontal Diseases, Nephrolithiasis

Intervention / Treatment
-----------------
* Procedure: Scaling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with nephrolithiasis Over 18 years old Exclusion Criteria: Pregnant woman, uncontrolled diabetes (HbA1c > 7.5%), patients who received periodontal treatment in the past 6 months, smokers

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Scaling|Scaling of dental calculus|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the composition of both specimens | The X-ray diffraction of both kidney stone and dental calculus will result in the composition of the two, and comparison will be done | the analysis will take 9 months |
Identification and Analysis of Immunomodulatory Molecules in Patients With Hematologic Disorders and Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This research study goal is to analyze the plasma and the cells that make up part of the immune system. We want to learn how the plasma and cells work. These may influence why one person will develop an infection and another will not, or why one person develops severe symptoms of a disease while others remain without symptoms.

Detailed Description
-----------------
This research study goal is to analyze the plasma and the cells that make up part of the immune system. These cells, called white cells or leukocytes, are present in blood. We want to learn how these cells work to prevent infection and how they respond after an infection occurs. We also want to study certain molecules present on the plasma, on or in these cells, and the genetic material that allows these molecules to be made. These molecules may influence why one person will develop an infection and another will not, or why one person develops severe symptoms of a disease while others remain without symptoms. This study may increase our understanding of a variety of diseases including infections such as HIV, allergic diseases such as asthma, joint diseases such as rheumatoid arthritis, certain cancers, and the rejection process that sometimes occurs after transplantation of an organ.

Official Title
-----------------
Identification and Analysis of Immunomodulatory Molecules From Leukocytes in Patients With Hematologic Disorders and Healthy Volunteers

Conditions
-----------------
Hematologic Diseases, Healthy Volunteers

Intervention / Treatment
-----------------
* Genetic: Isolation of genomic DNA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be able to give blood Must be able to give informed consent Signed, written informed consent Exclusion Criteria: Individuals with a history severe anemia, inadequate venous access, severe blood or coagulation disorders. Pregnant women are excluded because it is a unique immunotolerant state and will alter the profile of immunomodulatory molecules.

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

| Intervention/Treatment |
| --- |
|Genetic: Isolation of genomic DNA|One time blood draw|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repository collection of plasma and serum for future analysis. |  | 12 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hematologic Diseases, Genomics, Cytokines, Chemokines, Receptors