linjc16/ctgov huggingface dataset:
A Clinical Investigation of the Oxford® Partial Knee System

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective data collection is to document the performance and clinical outcomes of the Oxford® Partial Knee System.

Official Title
-----------------
A Prospective, Non-controlled, Clinical Investigation of the Oxford® Partial Knee System

Conditions
-----------------
Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For use in individuals with osteoarthritis or avascular necrosis limited to the medial compartment of the knee. The implant is intended to be implanted with bone cement. Exclusion Criteria: Infection Use in the lateral compartment of the knee Rheumatoid arthritis or other forms of inflammatory joint disease Revision of a failed prosthesis, failed upper tibial osteotomy or post-traumatic arthritis after tibial plateau fracture Insufficiency of the collateral, anterior, or posterior cruciate ligaments which would preclude stability of the device Disease or damage to the lateral compartment of the knee Uncooperative patient or patient with neurologic disorders who is incapable of following directions Osteoporosis Metabolic disorders which may impair bone formation Osteomalacia Distant foci of infections which may spread to the implant site Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram Vascular insufficiency, muscular atrophy, neuromuscular disease Incomplete or deficient soft tissue surrounding the knee Charcot's disease A fixed varus deformity (not passively correctable) of greater than 15 degrees A flexion deformity greater than 15 degrees
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oxford® Partial Knee System<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score |  | 6 weeks, 3 months, 1 year, 3 years, 5 years | 
| Oxford-12 Self Assessment Form |  | 6 weeks, 3 months, 1 year, 3 years, 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of revisions and removals |  | Any time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Partial Knee Arthroplasty, Partial Knee Replacement, Arthritis of Medial Compartment of the Knee, Oxford Knee
Family Activation and Communication About Errors and Safety (FACES)

Study Overview
=================
Brief Summary
-----------------
Miscommunications are a leading cause of serious medical errors in hospitals, contributing to more than 60% of sentinel events, the most serious adverse events reported to the Joint Commission. Efforts to improve patient safety in hospitals have centered on improving communication between providers. While provider-focused communication interventions have led to reductions in patient harm, patients and families have been notably absent from most interventions to improve patient safety. This proposal seeks to develop a family safety reporting intervention.

Official Title
-----------------
Family Activation and Communication About Errors and Safety (FACES)

Conditions
-----------------
Family Reported Errors and Adverse Events

Intervention / Treatment
-----------------
* Behavioral: Family safety reporting intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary caregiver of a child hospitalized on the study units during the study period or hospital employee who works on the study unit(s) Country of Origin: United States Primarily English- or Spanish-speaking Exclusion Criteria: International patients

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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: pre-post intervention study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pre-intervention arm<br>This arm is the pre-intervention arm of parents and providers before the family safety reporting bundle has been implemented. | |
| Experimental: Post-intervention arm<br>This arm is the post-intervention arm of parents and providers after the family safety reporting bundle has been implemented on the study units. | Behavioral: Family safety reporting intervention<br>* family safety reporting intervention for families and providers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| family safety reporting rates |  | 12 months | 
| experience with safety reporting |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital safety culture scores |  | 12 months |
Evaluation of the Intraoperative Accuracy of 3D-planned and Guided Osteotomies of the Hand and Forearm

Study Overview
=================
Brief Summary
-----------------
Target of the study is to evaluate the reduction accuracy of 3D computer-planned osteotomies that are performed with patient-specific instruments. Due to the higher accuracy achieved it is expected that complaints can be resolved or effectively revealed. The Research hypothesis to prove is The medical product permits the surgical reduction of deformed bones of the hand and forearm (radius, ulna, distal humerus, carpal, metacarpal, and finger bones) by corrective osteotomy within an accuracy of 2 mm and 2º. Secondary outcome is an assessment of the surgical outcome using the Disabilities of the Arm, Shoulder and Hand (DASH) and the Patient related wrist Evaluation (PRWE) scores.

Official Title
-----------------
CT-based Evaluation of the Intraoperative Implementation Accuracy of 3D-planned Osteotomies of the Hand and Forearm Performed With Patient-specific Instruments

Conditions
-----------------
Posttraumatic or Congenital Bone Deformity

Intervention / Treatment
-----------------
* Device: EUDAMED CIV-14-03-011940


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Posttraumatic or congenital bone deformity or pseudoarthrosis in the field of hand Surgery requiring correction by corrective osteotomy Clinical indication for a computer tomography scan of the forearms > 18 years old written informed consent Exclusion criteria pregnant or nursing women other clinical significant accompanying symptoms (Tumor, infection) non-compliance of the patient to follow the clinical study protocol, drug or alcohol abuse Participation in a different clinical trial within the last 30 days before inclusion or during the study

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 99 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>3D-planned osteotomies with patient-specific guides | Device: EUDAMED CIV-14-03-011940<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3D difference between preoperative plan and surgery | For each reduced fragment the 3D difference in all 6 degrees of freedom (3xrotation, 3xtranslation) is quantified by comparing pre- and postoperative CT. | 42 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Outcome | The surgical outcome is assessed by comparing DASH- and PRWE-scores pre- and postoperatively. | 42 month |
Using the Digital EEG Spectral Analysis in Assessing Neuroelectrical Processing Abnormalities in Autism

Study Overview
=================
Brief Summary
-----------------
Individuals with Autism Spectrum Disorder will have abnormal DESA® results. Our objective is to use neuroelectrical measures to determine the degree of processing abnormalities in individuals with Autism. The study will survey processing patterns and will locate and evaluate the degree(s) of abnormalities for further study. The abnormal results of comprehensive neuroelectrical evaluations of individuals with Autism when compared to the normative database will provide objective, verifiable, neurophysiological information with which to form novel approaches to the disorder.

Detailed Description
-----------------
The research method will be: gathering, analyzing and utilizing data. We will observe research subjects through neuroelectrical instrumentation, then, compare results to retrospective information collected from research subjects and a normative database. A qualified neurologist thoroughly familiar with electrophysiology will interpret the data, and analyze it to explore the abnormalities. The hypothesis will be evaluated. We will, then, utilize the results to find data-based forms of treatment for those with the disorder.

Official Title
-----------------
Using the Digital EEG Spectral Analysis in Assessing Neuroelectrical Processing Abnormalities in Autism

Conditions
-----------------
Autistic Disorder, Autism, Early Infantile, Autism, Infantile, Asperger Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study will include children between the ages of five and eighteen, adults from the age of nineteen to twenty-five, and those with the diagnosis of Autism and Autism Spectrum Disorders. Exclusion Criteria: those with mental retardation those with any other neurological disorder those that cannot sit in a chair for one hundred and fifty minutes those that have been previously diagnosed with a seizure disorder those who are blind and/or deaf those who are not ambulatory those who cannot understand English those that are not a resident of Los Angeles County

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 25 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 |
| --- | --- |
| 1<br>Year one | |
| 2<br>Year two | |

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
-----------------
Evoked Potentials, Evoked Potentials, Auditory, Evoked Potentials, Visual, Electroencephalography, Brain Mapping
Drugs Brain and Behavior (DDP)

Study Overview
=================
Brief Summary
-----------------
In this project, we will examine individual differences in the effects of a stimulant drug, methamphetamine (MA), on mesolimbic reward function using fMRI.

Official Title
-----------------
Drugs Brain and Behavior

Conditions
-----------------
Stimulant Use

Intervention / Treatment
-----------------
* Drug: Methamphetamine
* Drug: placebo oral tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 19 and 26 Right Handed Less than 4 alcohol or caffeinated beverages a day. Exclusion Criteria: High blood pressure Any medical condition requiring regular medication Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis Individuals with a history of dependence on stimulant drugs Women who are pregnant or trying to become pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo Then Methamphetamine<br>Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive 20 mg methamphetamine. | Drug: Methamphetamine<br>* Participants will be given 20 mg of Methamphetamine.<br>Drug: placebo oral tablet<br>* Participants will be given a placebo capsule that will only contain lactose.<br>|
| Experimental: MethamphetamineThen Placebo<br>Participants first receive 20 mg methamphetamine at their first session in the laboratory Then will return to the laboratory 72 hours later and will receive placebo. | Drug: Methamphetamine<br>* Participants will be given 20 mg of Methamphetamine.<br>Drug: placebo oral tablet<br>* Participants will be given a placebo capsule that will only contain lactose.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in SUbjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Sub-scales of Drug Effects Questionnaire (DEQ). | Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective stimulant profile. The Dug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: Feel Drug, Feel High, Like Drug, and Want More. All sub-scales are scored on a visual analogue scale (Scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome. | Time Frame: Day 1(baseline), 3 |
Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the pharmacokinetics of a single dose of BAY73-4506 in healthy male volunteers.

Official Title
-----------------
A Phase I, Non-Randomized, Open Label Study to Determine the Effetc of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of Regorafenib (BAY73-4506) in Healthy Volunteers

Conditions
-----------------
Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects between 18 and 45 years of age, inclusive BMI between 18 and 32 kg/m2 inclusive Exclusion Criteria: Subjects with evidence of disease, conditions affecting drug absorption or metabolism Treatment with other investigational drug within 30 days History of regular alcohol or recreational drug consumption Use of prescription drugs within 14 days Use of nonprescription drugs and dietary supplement within 7 days Blood donation within 30 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm1<br> | Drug: Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole<br>* Treatment 1: A single 160 mg dose of BAY73-4506. Treatment 2: Ketoconazole 400 mg once daily from Day -4 to Day 3. A single 160 mg dose of BAY73-4506 on Day 1.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve from zero to infinity ( Plasma AUCinf) of BAY73-4506 given alone or with ketoconazole. |  | 1 month | 
| Peak plasma concentration (Cmax) of BAY73-4506 given alone or with ketoconazole |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma AUCinf of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole. |  | 1 month | 
| Plasma Cmax of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole. |  | 1 month | 
| Number of subjects with adverse events following a single oral dose of BAY73-4506, adminstered alone and concomitantly with ketoconazole. |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
drug interactions, ketoconazole, pharmacokinetics, human volunteers
Can Resistance Enhance Selection of Treatment? (CREST)

Study Overview
=================
Brief Summary
-----------------
To compare two commercially available platforms for assessment of HIV drug resistance to determine which provides superior virological results. We hypothesise that one test will be significantly superior to the other.

Official Title
-----------------
A Randomised Comparator Study to Assess the Relative Efficacy of Genotypic Versus Virtual Phenotypic Resistance Tests in Treatment Experienced Patients With HIV Infection for Whom a Change in Therapy is Indicated

Conditions
-----------------
HIV Infection

Intervention / Treatment
-----------------
* Device: HIV drug resistance tests based upon genotype testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infected patients taking combination antiretroviral therapy, with plasma HIV RNA> 2000copies/mL, who were willing to change ARVs and who provided informed consent. Exclusion Criteria: Patients who were ARV naïve, who were experiencing an acute illness or judged to be unable to comply with the protocol requirements.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: HIV drug resistance tests based upon genotype testing|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The comparison between randomly assigned study arms in the mean area under the curve plasma HIV RNA at 48 weeks. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with undetectable plasma HIV RNA, Changes in CD4+ cell count, use of resistance test result in selecting new ART regimen |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV drug resistance testing, Treatment Experienced
Evaluation of Prognostic Monitoring for Breast Cancer Patients With Recurrence and Metastasis After Surgery

Study Overview
=================
Brief Summary
-----------------
The relationship between immune inflammation-related protein complexes in blood and recurrence or metastasis of breast cancer with completed standard treatment will be studied.

Detailed Description
-----------------
200 patients with breast cancer and recurrence or metastasis after surgery will be followed up. Peripheral venous blood was collected every 3 to 6 months. Change regularity of breast cancer-specific immune inflammation-related protein complexes in blood at different follow-up time points will be studied. The relationship between disease-specific protein complexes and pathological state of patients will be analyzed.

Official Title
-----------------
Evaluation of Prognostic Monitoring for Breast Cancer Patients With Recurrence and Metastasis After Surgery Via Analysis of Immunoinflammation-related Protein Complexes in Blood

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female invasive breast cancer patients confirmed by postoperative pathology after surgery for breast lump Breast cancer-related chemotherapy and radiotherapy completed breast cancer patients with recurrence and metastasis after surgery Exclusion Criteria: Male Aged above 60 Breast Carcinoma in situ Women in pregnancy or breastfeeding Suffering from other malignant tumors Non-compliant patient

Ages Eligible for Study
-----------------
Minimum Age: 36 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| recurrence and metastasis<br>breast cancer patients with recurrence and metastasis after surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immune inflammation-related protein complexes | The change of immune inflammation-related protein complexes which is measured by gel permeation chromatography. | 2 years | 
| blood markers | The expression of CA153, CEA, CA125 in the blood of the patients, which are measured by electro-chemiluminescence immunoassay. | 2 years |