linjc16/ctgov huggingface dataset:
68Ga-labeled NY108 PET Imaging in Patients

Study Overview
=================
Brief Summary
-----------------
This is a single arm study to evaluate the safety and biodistribution of 68Ga-labeled NY108 (68Ga-NY108) PET Imaging in patients.

Official Title
-----------------
68Ga-labeled NY108 PET Imaging in Patients

Conditions
-----------------
Prostatic Cancer

Intervention / Treatment
-----------------
* Drug: 68Ga-labeled NY108


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients voluntarily signed informed consent; Age 18-75, male; Patients diagnosed with prostatic cancer confirmed by histopathology or cytology; At least one measurable solid lesion has been examined according RECIST1.1 standard; Patients with biopsy-proven PSMA positive; ECOG score 0 3; Life expectancy of at least 3 months; Exclusion Criteria: Recovery from major trauma (including surgery) within 4 weeks prior to study treatment; Patients with systemic or locally severe infections, or other serious coexisting diseases; Patients with allergies or allergies to any component of the imaging agent or antibody; Patients who cannot perform PET/CT imaging scan; Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines; Patients with autoimmune diseases, including rheumatoid arthritis; Inadequate control of arrhythmias, including atrial fibrillation; Uncontrolled hypertension; Syphilis, HBV, HCV, or HIV positive subjects; Male subjects of reproductive age cannot take effective contraceptive measures; Patients with a history of mental illness or related conditions; Other subjects considered unsuitable by researchers.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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 |
| --- | --- |
| Experimental: 68Ga-Anti-PSMA mAbs<br> | Drug: 68Ga-labeled NY108<br>* Patients will receive a tracer (20-40mcg, IV) dose of 68Ga (2-5mCi) labelled NY108.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of tissue distribution of 68Ga-Anti-PSMA mAbs(NY108) | Biodistribution of 68Ga-Anti-PSMA mAbs(NY108) evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 68Ga-PET scans will be reported. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | Safety will be assessed by evaluation of incidence of adverse events. | 1 year |
Characterizing a 5P-Linked BHR Susceptibility Locus

Study Overview
=================
Brief Summary
-----------------
To identify the predisposing genes responsible for asthma and bronchial hyperresponsiveness (BHR) at region 5p13.3 in an inbred Hutterite community.

Detailed Description
-----------------
BACKGROUND: Asthma is the most common chronic disease in industrialized nations, affecting more than10 million people in the U.S. alone. Familial aggregation and concordance rates in monozygotic twins have suggested a genetic component to asthma. Dr. Ober and colleagues have been conducting studies on the genetics of asthma and atopy in the Hutterites, an inbred population of European origins that practices a communal lifestyle. A genome-wide screen with 564 markers (average spacing 6 cM) was completed in an extended pedigree of 717 Hutterites who were well characterized with respect to asthma, atopy, and related phenotypes. These individuals are descendants of only 64 ancestors who lived in the early 1700's to the early 1800's. Evidence for linkage with bronchial hyperresponsiveness (BHR) by the likelihood ratio test extended over 30 centimorgans (cM) on chromosome 5p, with P-values as small as 0.001. Additional evidence for linkage at this same location was evident by the transmission disequilibrium test (P=0.0061). Typing additional markers in this region identified a critical region of 2.4 cM, corresponding to 1.5 Mb of DNA, and a high risk haplotype that is over transmitted to affected individuals. The study was conducted in response to a Request for Applications, Positional Candidate Approaches in Asthma Gene Discovery released in Ocatober, 1999. DESIGN NARRATIVE: Dr. Ober and colleagues characterized the 5p-linked BHR susceptibility locus in the inbred Hutterites by positional cloning and replicating these findings in outbred, ethnically diverse populations. They examined single nucleotide polymorphisms (SNPs) spaced about 10 kb apart in each gene, and assessed the evidence for over transmission to affected offspring with each SNP and SNP haplotypes. Associations in the Hutterites were replicated in two outbred samples (a Caucasian sample from Germany, and an African American sample from Chicago). The functional effects of associated variants were assessed by in vitro assays as well as by genotype-phenotype studies in outbred samples that had been evaluated for asthma and atopy phenotypes. Identifying asthma or BHR susceptibility loci may identify novel pathways in asthma pathogenesis, thereby allowing for the development of new therapies and intervention strategies for these common diseases.

Conditions
-----------------
Asthma, Lung Diseases

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

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Restoration of Disc Height Reduces Chronic Low Back Pain

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that a 6-week treatment of non-invasive spinal decompression reduces discogenic low back pain (LBP), increases lumbar disk height, and that an increase in lumbar disc height is associated with decreased LBP.

Official Title
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Restoration of Disk Height Through Non-Invasive Spinal Decompression is Associated With Decreased Discogenic Low-Back Pain: A Retrospective Cohort Study

Conditions
-----------------
Chronic Low Back Pain

Intervention / Treatment
-----------------
* Device: DRX9000


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 18 years of age; consented for the 6 weeks treatment protocol; presented with discogenic low back pain of at least 3 out of 10; AND current CT scan not older than 2 months. Exclusion Criteria: metastatic cancer; previous spinal fusion or placement of stabilization hardware; instrumentation or artificial discs; neurologic motor deficits, bladder, or sexual dysfunction; alcohol or drug abuse; OR litigation for a health-related claim (in process or pending for workers' compensation or personal injury). Limitations of the spinal decompression system also led to the exclusion of patients with extremes of height (< 147 cm or > 203 cm) and body weight (> 136 kg).

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 |
| --- | --- |
| DRX9000<br> | Device: DRX9000<br>* DRX9000 - non-invasive spinal decompression. Treatments 28 min 5 x/wk x 2wks, 3x/wk x 2 wks, 2x/wk x 2 wks for a total of 20 treatments in a 6-week period<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect on Metabolic Parameters of Abilify in SPR

Study Overview
=================
Brief Summary
-----------------
To measure the long-term changes in weight and plasma lipids after switching antipsychotic treatment to aripiprazole

Detailed Description
-----------------
To measure the long-term changes in weight, plasma lipids and fasting blood glucose after switching antipsychotic treatment to aripiprazole, 1 year, open label studies in out and in-patients with schizophrenia. The measurement of weight and lipid profile and fasting blood glucose will be measured at baseline and every 3 months for 1 year.

Official Title
-----------------
The Effects of Metabolic Parameters of Aripiprazole in Patients With Schizophrenia

Conditions
-----------------
Schizophrenia, Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV diagnosis with schizophrenia who signed an informed consent Exclusion Criteria: comorbid with substance abuse or substance dependence pregnancy or lactation

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| observational<br>patients with schizophrenia who want to change an antipsychotics due to metabolic side effect | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight lipid profile : HDL, LDL, total-cholesterol, triglyceride fasting blood glucose |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prolactin ECG |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, metabolic syndrome, aripiprazole
Efficacy and Safety Study of Lumiracoxib in Patients With Primary Hip Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy, tolerability, and safety of the investigational drug, lumiracoxib as compared to celecoxib and placebo in subjects with hip osteoarthritis. Both lumiracoxib and celecoxib belong to the same class of drug (COX-2 selective nonsteroidal anti-inflammatory drugs [NSAIDs]).

Official Title
-----------------
A 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Trial of Lumiracoxib (COX189) 100 mg o.d. in Patients With Primary Hip Osteoarthritis Using Celecoxib (200 mg o.d.) as a Positive Control

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

Intervention / Treatment
-----------------
* Drug: Lumiracoxib (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of primary hip osteoarthritis Qualifying pain intensity in the hip joint Requiring NSAID therapy Exclusion Criteria: Rheumatoid arthritis or other inflammatory joint disease Disease or disorder that may interfere with pain assessment of the hip Open knee/hip surgery within the last year Past history of heart attack, stroke or angina (chest pain) Liver disorder History of severe adverse reactions of any kind under lumiracoxib or celecoxib treatment Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- |
|Drug: Lumiracoxib (drug)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC 3.1 LK questionnaire after 13 weeks of treatment |  |  | 
| Patient's global assessment of disease activity (VAS) after 13 weeks of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall OA pain intensity (VAS)by visit |  |  | 
| Physician's global assessment of disease activity (VAS) by visit |  |  | 
| Response to treatment according to OARSI criteria by visit |  |  | 
| Actual OA pain intensity at 12 hours post-dose by visit |  |  | 
| Number of rescue tablets taken during the study |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Hip, Lumiracoxib, Efficacy, Safety
Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures Reduction Using Patient Specific Guide (PSG) Versus Conventional Technique

Study Overview
=================
Brief Summary
-----------------
Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures reduction Using Patient Specific Guide (PSG) Versus Conventional Technique

Official Title
-----------------
Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures Reduction Using Patient Specific Guide (PSG) Versus Conventional Technique

Conditions
-----------------
Zygomatic Fractures

Intervention / Treatment
-----------------
* Procedure: patient specific guide
* Procedure: conventional technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Zygomatic Fracture Type III, IV and V according to rowe and killey classification(13) Age (18-60 years) Recent fracture (less than 2 weeks) Exclusion Criteria: • Zygomatic Fracture Type I, II and VI according to rowe and killey classification(13) Medical compromised patient Patient on radiotherapy Bone disease

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: (ZMC) Fractures reduction Using Patient Specific Guide (PSG)<br> | Procedure: patient specific guide<br>* patient specific guide reduction<br>|
| Active Comparator: (ZMC) Fractures reduction Using Conventional Technique<br> | Procedure: conventional technique<br>* conventional anatomical reduction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy of reduction of the fractured zygoma ( facial asymetry ) | assessed by ct | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operation time | in hours | up to 6 months |
Microbiologic Findings of Acute Facial Palsy in Children

Study Overview
=================
Brief Summary
-----------------
Objective: Microbiologic etiologies of facial palsy in children were investigated. Study design: Prospective clinical study. Methods: Forty-six children aged 0-16 years with facial palsy comprised the study group. Paired serum samples and cerebrospinal fluid were tested to find indications (antibodies, growth of the microbe, or nucleic acids) of microbes putatively associated with facial palsy. The microbes tested were herpes simplex virus-1 and -2, varicella-zoster virus, human herpesvirus-6, Mycoplasma pneumoniae, Borrelia burgdorferi, influenza A and B-, picorna-, cytomegalo-, parainfluenza-, respiratory syncytial-, coxsackie B5-, adeno-, and enteroviruses, Chlamydia psittaci, and Toxoplasma gondii. Besides the routine tests in clinical practice, serum and cerebrospinal fluid samples were tested with a highly sensitive microarray assay for DNA of herpes simplex virus-1 and -2, human herpesvirus-6A , -6B, -7, Epstein-Barr-, cytomegalo-, and varicella-zoster viruses.

Official Title
-----------------
Microbiologic Findings of Acute Facial Palsy in Children

Conditions
-----------------
Facial Paralysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 0-16 Facial palsy

Ages Eligible for Study
-----------------
Maximum Age: 16 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
-----------------
facial paralysis, facial nerve, borreliosis, Bell's palsy
Effectiveness of a Vaccination Program in the Community Ob/Gyn Setting

Study Overview
=================
Brief Summary
-----------------
PURPOSE To develop, implement, and evaluate the effectiveness of a program designed to assist community Ob/Gyns in vaccinating adolescent and adult women against vaccine-preventable diseases. SPECIFIC AIMS Determine the feasibility of implementing a successful vaccination program for adolescent and adult women in Ob/Gyn offices by direct assessment of medical personnel & office staff on their: Attitudes towards vaccination of women against preventable diseases Perceived barriers to implementing a program to vaccinate women in their offices Ideas on how to overcome barriers to successful program implementation Current vaccination practices and office-specific administrative processes Design & implement a program for Ob/Gyns to vaccinate women against human papillomavirus, influenza, & pertussis Determine the effectiveness of the vaccination program based on Pre- and post-program vaccination rates Program satisfaction amongst Ob/Gyn providers and office staff Willingness to continue and possibly extend the program to additional vaccines Quantify the level of support and resources needed to develop and implement the vaccination program

Official Title
-----------------
Effectiveness of a Vaccination Program in the Community Ob/Gyn Setting

Conditions
-----------------
Influenza Vaccine, Papillomavirus Infection, Pertussis

Intervention / Treatment
-----------------
* Other: Vaccination Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 4-5 community Ob/Gyn practices

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 26 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Vaccination Program|Design & implement a program for Ob/Gyns to vaccinate women against human papillomavirus, influenza, & pertussis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation and measurement of a health services intervention in community or private Ob/Gyn practices to improve the delivery of standard clinical care to vaccinate women against human papillomavirus, influenza, & pertussis. |  | Full-scale program implementation will cover a 12 month period, tentatively planned to begin in April 2009. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HPV vaccine, Tdap vaccine
A Bioavailability Study of Rifabutin and Lopinavir/Ritonavir in Healthy Adult Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the safety, tolerability and pharmacokinetics of rifabutin dosing with lopinavir/ritonavir tablets in healthy volunteers.

Official Title
-----------------
A Comparison of the Bioavailability of Rifabutin With and Without Lopinavir/Ritonavir in Healthy Adult Subjects

Conditions
-----------------
HIV, Tuberculosis

Intervention / Treatment
-----------------
* Drug: lopinavir/ritonavir
* Drug: rifabutin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Male or Female 18-55 yrs. Subject has provided written consent. Subject is in general good health. If female, subject is postmenopausal. If female, subject is not pregnant and is not breast-feeding. Subject must use birth control methods or be surgically sterile. Exclusion Criteria: Subject is HAV-IgM, HBsAg or HIV Ab positive. Positive screen for drugs of abuse, alcohol, or smoking. Cannot be on any medication, including over the counter drugs. Cannot have previous history of alcohol or drug abuse. Cannot have history of any major diseases or disorders.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A, B<br>Group 1 receives regimen A and B. A: Healthy volunteers, receiving one 150 mg rifabutin QD alone. B: Healthy volunteers, receiving 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID. | Drug: lopinavir/ritonavir<br>* lopinavir/ritonavir tablet; see arm for intervention description<br>* Other names: Kaletra;Drug: rifabutin<br>* rifabutin capsule; see arms for intervention description<br>|
| Experimental: C<br>Group 2 receives regimen C. C: 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID. | Drug: lopinavir/ritonavir<br>* lopinavir/ritonavir tablet; see arm for intervention description<br>* Other names: Kaletra;Drug: rifabutin<br>* rifabutin capsule; see arms for intervention description<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of pharmacokinetic variables will be computed for each sampling time and each parameter. |  | Approximately 0.5 - 1 month | 
| Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs. |  | Approximately 0.5 - 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV co-infected with tuberculosis