linjc16/ctgov huggingface dataset:
Indices of Severity and Prognosis for Sickle Cell Disease

Study Overview
=================
Brief Summary
-----------------
To develop a clinical severity index that could prospectively identify sickle cell disease patients who were at high risk for a turbulent clinical course and a poor prognosis.

Detailed Description
-----------------
DESIGN NARRATIVE: Using the database, univariate analysis showed that factors associated with the occurrence of cerebrovascular accident (51 patients) included hematocrit, rate of change of pocked red cell count, and polymer fraction at 40 percent oxygen saturation (PF40). Only low hematocrit was predictive of death in the pediatric cohort. There were 45 disease-related deaths. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Anemia, Sickle Cell, Blood Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Analyzing the Composition of Tears and Blood for Discovery of Novel Signatures of Aggressive Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to compare profiles in the blood and tears of patients with and without prostate cancer with the goal of developing a method of separating men with aggressive and non-aggressive disease.

Official Title
-----------------
Analyzing the Composition of Tears and Blood for Discovery of Novel Signatures of Aggressive Prostate Cancer

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, 35-85 years old Patients who present for the evaluation of an abnormal exam or test (elevated PSA, abnormal DRE, etc.) Patients who present for the evaluation of a palpable nodule or induration on prostate exam Patients who meet the requirements of Group 1, 2, or 3 of the protocol Exclusion Criteria: Patient < 35 or > 85 years of age Concurrent eye infection or trauma, including active conjunctivitis Abnormal production of tears (too much or too little) Any other conditions the PI or staff feels will not fulfill the criteria for study entry or will place the subject in a harmful environment Atypia on prostate biopsy report

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No treatment<br>No Tx, this is observational | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Sample | Tear sample will be taken at the initial clinic visit | 1 day |
Arizona Cancer Center Biospecimen Repository

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Collecting and storing samples of tissue and blood from patients with cancer to test in the laboratory may help the study of cancer in the future. PURPOSE: This research study is collecting and storing tumor, tissue, and blood samples from patients with pancreatic cancer.

Detailed Description
-----------------
OBJECTIVES: Provide cancer investigators access to a wide variety of tissues and biospecimens for translational studies in cancer. Collect and preserve tissue from the primary organ site (uninvolved and involved with cancer), from the metastases, from patient blood (serum and lymphocytes), and from patient urine. Provide quality-controlled storage and management of the specimen bank. Collect relevant clinical and pathologic information with appropriate privacy protection. Contribute to the development of a comprehensive database annotated with relevant clinical data, pathology, and research findings. OUTLINE: This is a multicenter study. Tumor samples, lymph node samples, and normal pancreas tissue samples are collected. Blood samples are also collected prior to surgery, six months after the initial blood draw and tissue sample collection, and every six months thereafter for two years.

Official Title
-----------------
Arizona Cancer Center Biospecimen Repository

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

Intervention / Treatment
-----------------
* Other: biologic sample preservation procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Patient who is seen at the Arizona Cancer Center or University Medical Center and will undergo any surgery or procedure for cancer PATIENT CHARACTERISTICS: NA PRIOR CONCURRENT THERAPY: NA As this is a biospecimen repository, participation is open to all cancer patients being treated at the Arizona Cancer Center or University Medical Center by investigators on this protocol.

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 |
| --- |
|Other: biologic sample preservation procedure|biologic sample preservation procedure|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provision of tissue samples and biospecimens for translational study | An electronic record of the specimens is kept in a secure, web-based database. Follow-up information from patients will be obtained from the patient medical record, and updated every 6 months | July 2024 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer
Quality of Life (QOL) Registry for Patients With AL Amyloidosis

Study Overview
=================
Brief Summary
-----------------
This is an online registry to document the psychometric properties of SF-36v2 among patients with AL Amyloidosis, to document patients' burden of disease, to better understand the patient's experience and to follow quality of life issues using a variety of QOL measures.

Official Title
-----------------
Prospective Observational Study Measuring the Short-Form36 ( SF-36v2) and Other QOL Tools in an AL Amyloidosis Population

Conditions
-----------------
AL Amyloidosis, Amyloidosis

Intervention / Treatment
-----------------
* Other: non-interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have AL Amyloidosis Exclusion Criteria:

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 |
| --- |
|Other: non-interventional|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychometric evaluation of short-form 36 (SF-36v2) in patients with AL Amyloidosis |  | Change from Baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculate burden of illness from participants using SF-36 Mental Component Score (MCS) and Physical Component Score (PCS) compared with sample from US general population and three other chronic conditions: Congestive Heart Failure, Lymphoma and COPD | The comparison is made to other populations from the baseline cross-sectional measurements. There is no timeframe, except baseline | Baseline- cross sectional | 
| Assess the pathway to diagnosis and treatment through a disease history specific questionnaire collecting organ involvement, initial symptoms, diagnosis duration, treatment received and other disease characteristics | The analysis is done atbaseline . | Baseline- cross sectional | 
| Psychometric evaluation of Kansas City Cardiomyopathy Questionnaire (KCCQ-12) in patients with AL Amyloidosis |  | Change from Baseline to 12 months | 
| Psychometric evaluation of Patient Global Impression-Severity Scale (PGI-S) in patients with AL Amyloidosis |  | Change from Baseline to 12 months | 
| Psychometric evaluation of Patient Global Assessment of Functioning (GAF) Scale in patients with AL Amyloidosis |  | Change from Baseline to 12 months | 
| Psychometric evaluation of Hematology Patient Reported Symptom Screen (HPRSS) in patients with AL Amyloidosis |  | Change from Baseline to 12 months | 
| Psychometric evaluation of Work Productivity and Activity Questionnaire: Specific Health Problem V2.0 (WPAI:SHP) in patients with AL Amyloidosis |  | Change from Baseline to 12 months | 
| Psychometric evaluation of MOS 6-Item Sleep Scale Standard in patients with AL Amyloidosis |  | Change from Baseline to 12 months |
ZOSTAVAX(R) Local Registration Trial (V211-019)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain safety and immunogenicity data for the refrigerator-stable formulation of ZOSTAVAX(R) in taiwanese adults.

Official Title
-----------------
A Phase III Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of ZOSTAVAX(R) in Healthy Adults in Taiwan

Conditions
-----------------
Varicella Virus Infection

Intervention / Treatment
-----------------
* Biological: Zoster Vaccine, Live, (Oka-Merck)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject Is Older Than 50 Years Of Age On Day Of Signing Informed Consent All Females Must Be Postmenopausal Or Have A Negative Serum Or Urine Pregnancy Test Postmenopausal Is Defined As 6 Months Of Spontaneous Amenorrhea With Serum Follicle Stimulating Hormone (Fsh) Levels In The Postmenopausal Range As Determined By The Laboratory, Or 12 Months Of Spontaneous Amenorrhea A Subject Who Is Of Reproductive Potential Must Agree To Remain Abstinent Or Use (Or Have Her Partner Use) 2 Acceptable Methods Of Birth Control For Three Months After Vaccination Acceptable Methods Of Birth Control Are: Intrauterine Device, Diaphragm With Spermicide, Contraceptive Sponge, Oral Contraceptive Pills, Condom, Tubal Ligation, And Vasectomy Subject Must Sign Informed Consent Prior To Any Study Procedure Subject Must Be afebrile (<38.3 °C Oral) On Day Of Vaccination Any Underlying Chronic Illness Must Be In Stable Condition

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Zostavax | Biological: Zoster Vaccine, Live, (Oka-Merck)<br>* A single dose of 0.65 ml of Zostavax injection was given to each study subject<br>* Other names: Zostavax;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The geometric mean fold rise (GMFR) of subjects VZV antibody titers from prevaccination to 4 weeks postvaccination, and the geometric mean titers (GMTs) at prevaccination and 4 weeks postvaccination, as measured by gpELISA, will be assessed. |  | prevaccination and 4 weeks postvaccination |
Quit4hlth: Enhancing Tobacco and Cancer Control Through Framed Text Messages

Study Overview
=================
Brief Summary
-----------------
This study evaluates a text messaging intervention through a smokers' quitline. Smokers will either receive 30 weeks of tailored, gain-framed text messages or 30 weeks of tailored, standard care text messages, both combined with standard quitline treatment. We hypothesize that the gain-framed text message intervention will increase cessation rates at 30 weeks as compared to standard care text messages.

Official Title
-----------------
Quit4hlth: Enhancing Tobacco and Cancer Control Through Framed Text Messages

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Behavioral: Gain-framed text messages
* Behavioral: Standard care text messages


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) call the Quitline requesting assistance with quitting smoking, 2) be 18+ years old, 3) speak English, 4) have a verified New York address, and 5) opt into the standard Quitline texting protocol. Exclusion Criteria: -

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Text Arm<br> | Behavioral: Gain-framed text messages<br> <br> |
| Active Comparator: Standard Text Arm<br> | Behavioral: Standard care text messages<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survey of smoking status | smoking or abstinent | Week 30 |
Micronutrient and Malnourished Elderly

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the micronutrient status of malnourished elderly after oral nutritional supplementation.

Official Title
-----------------
Évaluation de l'évolution du Statut Nutritionnel en Micronutriment Chez Les Patients âgés dénutris bénéficiant d'Une complémentation Nutritionnelle Orale

Conditions
-----------------
Malnourished Elderly

Intervention / Treatment
-----------------
* Dietary Supplement: Oral nutritional supplement : Renutryl® Booster


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age : above or equal to 70 years AND : Weight loss above or equal to 5% in one month OR weight loss above or equal to 10% in 6 months OR BMI between 18 and 21 OR albuminaemia between 30 and 35 g/L OR MNA-SF less or equal to 7 Exclusion Criteria: Severe malnutrition Contraindication to oral nutrition Severe pathologies Inflammatory syndrome (CRP > 30 mg/L) Severe dementia (Mini Mental Score < 10)

Ages Eligible for Study
-----------------
Minimum Age: 70 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: Interventional<br>Administration of 1 bottle of an oral nutritional supplement, Renutryl® Booster (600 kcal), during 28 days. | Dietary Supplement: Oral nutritional supplement : Renutryl® Booster<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in micronutrients status after 28 days | Biological analyses of micronutrient | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status | Weight, albumin, transthyretin, CRP, Mini Nutritional Assessment Short-Form (MNA-SF) | 28 days | 
| Body composition | Impedance measurement | 28 days | 
| Compliance | Compliance measured by bottle weight before and after consumption | 28 days | 
| Autonomy | Get up and go test | 28 fays |
Fluciclovine-PET/CT for Bone Metastases From Prostate Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
Determine diagnostic accuracy of Axumin-PET positive bone lesion by confirmatory bone biopsy.

Official Title
-----------------
A Pilot Study of F-18 Fluciclovine-PET/CT as A Diagnostic Tool for Bone Metastases in Patients With Hormonal Sensitive and Resistant Prostate Adenocarcinoma

Conditions
-----------------
Prostate Adenocarcinoma

Intervention / Treatment
-----------------
* Diagnostic Test: F-18 fluciclovine-PET/CT scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Be ≥ 18 years of age Diagnosed with prostate cancer Be willing and able to provide informed consent Be informed of the investigational nature of this study Exclusion Criteria: Having a history of severe claustrophobia Weight exceeding 400lbs

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine F-18 fluciclovine-PET/CT scan<br>This arm will consist of prostate cancer patients who have had an F-18 fluciclovine-PET/CT scan for routine standard of care for biochemical recurrence. These patients would be asked to participate in the study only if there is a need for a standard of care bone biopsy. | |
| Active Comparator: Research F-18 fluciclovine-PET/CT scan<br>This arm will consist of prostate cancer patients who would not ordinarily obtain an Axumin-PET scan for routine standard of care but have a need for bone biopsy. This will include patients with metastatic castrate resistant prostate cancer. For example, a patient with known lymph node recurrence of prostate cancer and suspicious finding on a bone scan would be asked to participate in the study and get a F-18 fluciclovine-PET/CT scan prior to the standard of care bone biopsy. | Diagnostic Test: F-18 fluciclovine-PET/CT scan<br>* PET/CT imaging with F-18 fluciclovine<br>* Other names: Axumin-PET scan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| True Positive and False Positive Rates of F-18 Fluciclovine-PET/CT Findings Compared to Bone Biopsy | True positive and false positive rates of positive findings in the skeleton on F-18 fluciclovine-PET/CT scan compared to gold standard pathology from bone biopsy | 1 year |
Dosage of Metal Ions in the Blood of Different Metal-on-metal Prostheses, in Correlation With Physical Activity

Study Overview
=================
Brief Summary
-----------------
Prospective study including 6 groups of 20 patients with a total hip prosthesis. Five different types of metal-on-metal prostheses are studied, and 1 group with ceramic-on-ceramic prostheses acts as control group. Patients undergo a clinical evaluation and blood sampling preoperatively, and 3, 6, 12 and 24 months postoperatively.

Official Title
-----------------
Dosage of Metal Ions in the Blood of Different Metal-on-metal Prostheses, in Correlation With Physical Activity

Conditions
-----------------
Hip Osteoarthritis

Intervention / Treatment
-----------------
* Device: metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hip osteoarthritis Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hip prosthesis<br> | Device: metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis<br>* metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of metal ions in the blood |  | preoperatively, and 3, 6, 12 and 24 months postoperatively. |
Functional MRI (fMRI) in CGRP Induced Migraine

Study Overview
=================
Brief Summary
-----------------
In patients known with migraine without aura a migraine headache or migraine like headache will be induced by infusion of calcitonin gene related peptide (CGRP). The patients will then be stimulated with noxious heat via a thermode placed at the forehead. At the same time the Blood-oxygenation-level-dependent (BOLD) response will be measured via functional magnetic resonance imaging (fMRI), to estimate the central-nervous pain response. The regions of interest (ROI) will be thalamic region and medulla oblongata. Then the patients will be given pain relif in form of injection of sumatriptan and the effect of this will also be registered via measuring the BOLD response at the RIO's previously defined. A 3-Tesla MRI scanner will be used in this trail. This study will give us key knowledge of the trigeminal pain pathway and the central processing i.e sensitization during a migraine attach.

Official Title
-----------------
Functional MRI (fMRI) in Patients With Migraine Without Aura Provoked by

Conditions
-----------------
Migraine Without Aura

Intervention / Treatment
-----------------
* Drug: infusion of calcitonin gene related peptide (CGRP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients know with migraine without aura. No less then 1 migraine attach pr month and no more then 6 attaches per month. Weight 50-100 kg. Women must be using secure birthcontrol. Exclusion Criteria: Tension type headache more then 1 day/month. All other prim. og sec. headache types then migraine without aura. Daily use of medication other then birthcontrol pills. Pregnant and lactation women. Headache on the trail day or 5 days previous to the trail day. Contraindications to MRI-scans. Hypertension or hypotension. Known heart or lung condition. Mental illness or substance abuse. Other considerable conditions judged by the including doctor.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: infusion of calcitonin gene related peptide (CGRP)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in BOLD response before and after CGRP infusion. |  |  | 
| Changes in BOLD response before and after injection of sumatriptan. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
migraine with out aura