linjc16/ctgov huggingface dataset:
Pilot Study of (61)CuATSM-PET Imaging in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Hypoxia is a key factor in malignant progression of a neoplasm. It is our aim to explore the basis for quantitative in vivo tumor imaging by Cu-61 diacetyl-bis(N4-methylthiosemicarbazone)PET imaging as a surrogate of tissue hypoxia. We hypothesize that the hypoxia levels are predictive of the tumor response to therapy. Patients will have 2 CU-ATSM PET scans done and the goal is to show spatially stable tracer distributions that correlate with tumor hypoxia. This study will serve as a pilot study for a PO1 submission

Conditions
-----------------
CNS Brain Metastases, Head and Neck Cancer, Lung Cancer, Prostate Cancer, Esophageal Cancer

Intervention / Treatment
-----------------
* Procedure: PET-imaging with CuATSM
* Procedure: PET Imaging
* Procedure: PET CuATSM
* Procedure: PET imaging
* Procedure: PET imaging with CuATSM
* Procedure: PET imaging with CuATSM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to tolerated a PET/CT scan Age 18 or older Patient being considered for XRT for treatment of their cancer Able to provide written informed consent Exclusion Criteria: severe claustrophobia or inability to tolerate the PET scan pregnant or breastfeeding women Patients that need supplemental oxygen Patients enrolled in experimental treatments

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 CNS<br>imaging with CuATSM | Procedure: PET-imaging with CuATSM<br>* imaging with CuATSM<br>Procedure: PET Imaging<br>* Imaging with CuATSM<br>|
| Experimental: 2. Head and Neck<br>Imaging with CuATSM | Procedure: PET CuATSM<br>* Imaging with CuATSM<br>|
| Experimental: 3. Lung<br>imaging with CuATSM | Procedure: PET imaging<br>* imaging with CuATSM<br>|
| Experimental: 4. Prostate<br>PET imaging with CuATSM | Procedure: PET imaging with CuATSM<br>* Imaging with CuATSM<br>|
| Experimental: 5. Esophagus<br>PET imaging with CuATSM | Procedure: PET imaging with CuATSM<br>* Imaging with CuATSM<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To validate the CuATSM-PET imaging by correlation to the serum level of osteopontin, a marker of hypoxia |  | end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test reliability of the CuATSM uptake by quantifying the reproducibility of the pre-treatment CuATSM_PET scans |  | end of study | 
| To assess the technical and logistic feasibility of CuATSM-PET scans in a population of cancer patients |  | end of study |
Study Evaluating Vaccine in Adults With HIV

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn whether the study vaccine and adjuvants (drugs that are used to help improve immune responses) have an acceptable safety profile in treating individuals with HIV. A second purpose of this study is to understand how the immune system responds to the study vaccine and adjuvants.

Official Title
-----------------
A Phase 1 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of an HIV CTL Multi-Epitope Peptide Vaccine Formulated With RC529-SE and GM-CSF Given to HIV-1 Positive Adults on Stable HAART.

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Biological: HIV CTL MEP 1000 micrograms, 19 months per subject


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age diagnosed with HIV and on stable HAART for a minimum of six months CD4 T-cell count greater than and equal to 350/mm3 at screening No reported CD4 T-cell count less than 350/mm3 at any time before screening Viral load less than 50 copies/mL at screening and no viral load greater than 400 copies/mL for a minimum of six months prior to screening Exclusion Criteria: Any chronic symptomatic infection other than HIV Use of any prior HIV vaccine (prophylactic and/or therapeutic) within one year before or during screening Any malignancy that may require systemic therapy Use of any investigational treatment within six months before screening or planned during study enrollment, except for investigational retrovirals obtained through ACTG

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: HIV CTL MEP 1000 micrograms, 19 months per subject|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of the HIV CTL MEP vaccine formulated with adjuvants, administered by intramuscular (IM) injection to HIV Pos adults receiving stable HAART. Subjects will receive vaccinations at months 0, 1, 3, and 6. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the subject immune system responds to the vaccinations. To evaluate RNA and protein patterns in the collected blood samples after vaccination. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Treatment Experienced
24-Hydroxylase Deficiency and CYP24A1 Mutation Patient Registry

Study Overview
=================
Brief Summary
-----------------
You are being asked to take part in this research registry because you or your family member is suspected to have a 24-hydroxylase deficiency.

Detailed Description
-----------------
In this registry we propose to establish and maintain a registry of suspected and confirmed patients with 24 hydroxylase deficiency in an effort to collect data for further investigation. This would be the first and only known registry of its kind. These resources would be made widely available to clinicians and research scientists within Mayo to stimulate advances in the diagnosis and treatment of patients with this disease.

Official Title
-----------------
24-Hydroxylase Deficiency and CYP24A1 Mutation Patient Registry

Conditions
-----------------
24-hydroxylase Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have undergone genetic testing for a CYP24A1 mutation with at least 3 of the following: Urinary Stone Disease Nephrocalcinosis Metabolic Bone Disease Serum Calcium >/= 9.6 mg/dL Parathyroid hormone (PTH) < 30 pg/mL 1,25-dihydroxyvitamin D > 40 pg/mL OR a family member of a patient who meets the above criteria Exclusion Criteria: Patients who have tested negative for a CYP24A1 mutation with an alternative diagnosis that might explain hypercalcemia/hypercalciuria/stone disease: Sarcoidosis Lymphoma Tuberculosis Fungal infections Excessive exogenous calcium or vitamin D intake
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 |
| --- | --- | --- |
| establish and maintain a registry of suspected and confirmed patients with 24 hydroxylase deficiency | This patient registry will expand knowledge of the clinical expression of this disease by systematically accumulating and analyzing information regarding a larger number of patients than have been studied to date. | yearly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved understanding of symptoms and progression of this disease | The goal of the patient registry is to collect data about this rare diseases, provide a better understanding of this conditions and help to develop new treatments. | yearly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CYP24A1 mutation, CYP24A1, 24-hydroxylase deficiency
Immunogenicity Bridge Between an Investigational Monovalent Vaccine and the Equivalent Component of Gardasil (V501) a Quadrivalent Vaccine (V501-012)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if an investigational vaccine with a single component develops an immune response that is similar to the equivalent investigational vaccine with four components to reduce cervical disease.

Official Title
-----------------
Immunogenicity and Safety of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Consistency Lots for 16- to 23-Year-Old Women With and Additional Immunogenicity Bridge to the Monovalent HPV 16 Vaccine Pilot Manufacturing Lot Study-The F.U.T.U.R.E. Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease)

Conditions
-----------------
Cervical Cancer, Genital Warts

Intervention / Treatment
-----------------
* Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 years


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female with an intact uterus with lifetime history of 0-4 sexual partners Exclusion Criteria: Prior Human Papillomavirus Vaccine (HPV) vaccination; Prior abnormal paps; Prior history of genital warts

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 23 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 years|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability and immune responses at week 4 post dose 3. |  |  |
Systemic Vitamin D Supplementation in Dental Implants Patients

Study Overview
=================
Brief Summary
-----------------
Vitamin D plays an essential role in calcium homeostasis and is critical for bone formation and remodeling.

Detailed Description
-----------------
Evidence has demonstrated that vitamin D deficiency plays an important role in dental implants outcomes. Low serum levels of Vitamin D is considered as a risk factor, not only for low mineral bone density but also in other metabolic pathways such as those involved in immune response and chronic inflammatory diseases. There are few studies demonstrating the role that vitamin D deficiency in the etiopathogenesis of oral diseases and the consequences in Dental Implants. Dentists have not yet well understood the importance of a good bone metabolism response for a successful bone regeneration and osseointegration of implants. An insufficient bone response can not guarantee the necessary stability of the implants placed in it, has been one of the biggest problems of implantology. Thus, the aim of this study is to evaluate the efficacy of Systemic vitamin D supplementation in menopausal women cadidates for dental implants.

Official Title
-----------------
Systemic Vitamin D Supplementation in Menopausal Women With Dental Implants

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Vit D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Menopause patients Exclusion Criteria: patients with a past history of neurological disorder; who had received pharmacotherapy for depression within 8 weeks of screening; who were taking medication known to interfere with Vit D; who had recent psychiatricor systemic illness; uncontrolled hypertension (blood pressure > 160/95mmHg); unstable cardiovascular disease; User of psychoactive medications; alcohol excess consumption abuse.

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 5 Years

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

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 |
| --- | --- |
| Other: Vit D<br>Vit D 20 mg/day | Drug: Vit D<br>* 20 mg/day<br>* Other names: Vitamin D;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 25 OH Serum levels | VIT D Serum levels | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osteoporosis condition | Densitometry in patients femur bones | 2 years |
A Pilot Study for Pharmacokinetic/Pharmacodynamic (PK/PD) Parameter of Allopurinol and Its Metabolite-oxypurinol After Once-daily Allopurinol in Chronic Kidney Disease Patient

Study Overview
=================
Brief Summary
-----------------
To know the blood level of allopurinol in chronic kidney disease (CKD) patient.

Detailed Description
-----------------
After the result of this pilot study, we can prescribe the optimal dose of allopurinol in CKD patient.

Official Title
-----------------
A Pilot Study for PK/PD Parameter of Allopurinol and Its Metabolite-oxypurinol After Once-daily Allopurinol in Chronic Kidney Disease Patient

Conditions
-----------------
Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: from 18yrs to 80yrs , man and women the patient who are taking allopurinol On screening, the patient shows that the level of protein/creatinine ratio is over 3.0 On screening, the patient shows that MDRD GFR >= 30 ml/min and <= 60 ml/min the patient sign on the concent form Exclusion Criteria: the patient have experience to take medication that have an effect on renal function the patient have experience to take cyclosporin within 3month At least, the average level of two separate blood pressure ( 2min interval ) shows that SBP <= 100 mmHg or >=160 mmHg and DBP <=60 mmHg >=100 mmHg, or Heart rate < 40 beats/min or > 90 beats/min uncontrolled hypertension pregnancy or anticipate pregnancy with 6 month hypersensitivity to allopurinol acute hepatitis or the level of AST or ALT is over 2times of normal range or the level of bilirubin is over 2.0 mg/dL serum albumin < 3.5 mg/dL or > 5mg/dL urinary retension, prostatic hyperplasia the patient show gout attack on taking allopurinol the patient who have gastro-intestinal disease ( ex, crohn's disease, acute or chronic pancreatitis, ulcer )or who have the surgical history of gastrointestine. the patient who should take azathioprine, mercaptopurine, cyclophosphamide, Losartan, benzbromarone,fenofibrate,furosemide ,probenecid the patient who had taken part in the other study within 3months the patient who had gotten blood transfusion pregnant, breast feeding

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?
-----------------
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
-----------------
allopurinol, chronic kidney diseae
Transient Elastography in Hepatectomy for Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether liver transient elastography performed before the surgical procedure is able to predict liver failure in patients undergoing hepatectomy for hepatocellular carcinoma.

Official Title
-----------------
Value of Transient Elastography in Predicting Postoperative Liver Failure in Patients Undergoing Liver Resection for Hepatocellular Carcinoma.

Conditions
-----------------
Surgery, Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Procedure: FibroScan (Transient Elastography measurement)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients already scheduled to undergo liver resection fo hepatocellular carcinoma
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 |
| --- | --- |
| Other: Preoperative FibroScan<br> | Procedure: FibroScan (Transient Elastography measurement)<br>* Preoperative evaluation of liver stiffness through FibroScan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cut-off value of liver stiffness measured in kilopascal (kPa) able to predict the occurrence of postoperative liver failure. | Definition of the cut-off value in kPa able to predict postoperative liver failure, i.e. the presence of at least one of the following variables: ascites causing a delay in the removal of surgical drainages and/or requiring paracentesis; increase of bilirubin levels >3 mg/dL; alteration of coagulation factors requiring plasma infusion with an INR above 1.50 (with serum bilirubin levels <12mg/dL); renal impairment, defined as blood urea nitrogen >2.00 g/L and/or increase of serum creatinine >2.00 mg/dL requiring only loop diuretics, dopamine/terlipressin, or dialysis. | Participants will be followed for the duration of postoperative hospital stay, an expected average of 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatocellular carcinoma, Cirrhosis, Liver resection, FibroScan
The Efficacy of Permethrin 5%, Fusidic Acid 1% and Synthomycine 5% for Demodex - Blepharitis

Study Overview
=================
Brief Summary
-----------------
The study aims to investigate the effect of Permethrin 5% treatment on Signs and symptoms of Demodex-blepharitis in comparison to Synthomycine 5% and Fucithalmic (fusidic acid 1%) .

Detailed Description
-----------------
3 arms study. 75 patient total, 25 patients in each group. Group A (study group) patients will apply facially Permethrin 5% every night for 3 months. Group B patients will apply on the eyelids Fusidic acid 1% every night for 3 months. Group C patients will apply on the eyelids Synthomycine 5% every night for 3 months Follow up Evaluation will be made after one week, one month, two months, three months, 4 months and half a year.

Official Title
-----------------
The Efficacy Of Lyclear (Permethrin 5%) Vs Fusidic Acid1% and Synthomycine 5% for Demodex -Blepharitis Treatment, Prospective-Randomized Trial.

Conditions
-----------------
Inflammation of the Eyelids

Intervention / Treatment
-----------------
* Drug: Permethrin 5%
* Drug: Synthomycine 5%
* Drug: Fusidic Acid 1% M/R Eye Drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Adult (Age ≥18Y) individuals clinically diagnosed with Demodex- blepharitis. Exclusion Criteria: - Known sensitivity to all study medications or components. Pregnant women and individuals deemed unfit to provide informed consent. Systemic steroid use.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Permethrin 5%<br>Contains permethrin 5% w/w (equivalent to 50 mg/g), formaldehyde solution 0.278% w/w and butylated hydroxytoluene (E321) 0.02% w/w. | Drug: Permethrin 5%<br>* Facial skin application once a night for 3 months.<br>|
| Active Comparator: Synthomycine 5%,<br>Contains chloramphenicol 5%. | Drug: Synthomycine 5%<br>* Eye ointment, eyelids and eyelashes application (chloramphenicol), once a night for 3 months.<br>|
| Active Comparator: Fusidic Acid 1%<br>Contains 1% w/w fusidic acid anhydrous (as the hemihydrates) and 0.011% w/w. | Drug: Fusidic Acid 1% M/R Eye Drops<br>* viscous eye drops application once a night for 3 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in demodex infestation in group A (permethrin 5%). | significant decrease in demodex infestation in comparison to group B and C. | 2 months | 
| Improvement in symptoms and complaints in group A. | OSDI Questionnaires that describe the severity of the ocular surface disease condition are filled in each visit. | 2 months |