linjc16/ctgov huggingface dataset:
(Bispecific) Antibodies in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this project is to provide (bispecific) antibodies to individual patients with advanced solid and hematological malignancies without any available approved treatment options.

Detailed Description
-----------------
Ethics: Patient treatment will be conducted according to §13 Absatz 2b, AMG (German law). All (bispecific antibodies) applied are developed and manufactured by the principle investigator Prof. Helmut Salih.

Official Title
-----------------
(Bispecific) Antibodies in Cancer Patients (InHeAb01)

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

Intervention / Treatment
-----------------
* Biological: Bispecific antibodies (bsAB)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of advanced malignant disease Advanced malignant disease without any available standard of care treatment option Live expectancy > 3 month Ability to understand and voluntarily sign an informed consent form. Ability to adhere to the visit schedule and other protocol requirements Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2. Exclusion Criteria: Pregnant or lactating females. Treatment regimens inducing severe T cell deficiencies Treatment-related side effect from prior cancer treatment > CTC grade 2 (CTCAE V5.0) Participation in any clinical study or having taken any investigational therapy, which would interfere with the studys primary and secondary end points within 2 weeks prior to Ab treatment.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Bispecific antibodies (bsAB)|BsAbs equipped with a target-specificity directed to a TAA and an effector-specificity for an activating receptor on T cells, such as CD3 or CD28, are applied intravenously in repeated cycles until disease progression or dose limiting toxicity.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Static Stretching on Postural Sway and Plantar Pressures

Study Overview
=================
Brief Summary
-----------------
Risk for falls has been associated with falls efficacy and postural balance. The objective was to compare the effects on the footprint and the stabilometry of the continuous stretch and the intermittent. Subjects were randomly assigned to an intermittent stretching protocol group or continuous stretch group both of them loading passive plantar flexor stretching. Static footprint and stabilometry were measured before and after both protocols.

Official Title
-----------------
The Acute Effects of Intermittent Versus Continuous Bilateral Ankle Plantar Flexors Static Stretching on Postural Sway and Plantar Pressures During Standing

Conditions
-----------------
Muscle Stretching Exercise; Postural Balance; Stabilometry; Platform

Intervention / Treatment
-----------------
* Other: Intermittent stretching protocol
* Other: Continuous stretch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-trained individuals Healthy subjects Exclusion Criteria: Previous surgery on the lower extremities Injuries Musculoskeletal conditions

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: Intermittent stretching protocol<br>Intermittent stretching protocol including five sets at 1 minute and 15 second rest. | Other: Intermittent stretching protocol<br>* Intermittent stretching protocol of five sets of 1 minute and15 second rest<br>|
| Experimental: Continuous stretch<br>2 minutes continuous stretch | Other: Continuous stretch<br>* 2 minutes continuous stretch<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot plantar pressure | Maximum foot plantar pressure measured as K Pa | Change from foot plantar pressure at 2 minutes |
Do Low High Density Lipoprotein (HDL) Levels Predict Treatment Outcome in Patients With Chronic Hepatitis C Viral Infection?

Study Overview
=================
Brief Summary
-----------------
The working hypothesis is that the low HDL serum level predict favorable response to anti viral treatment in chronic HCV (genotype 1) viral infection. This might be used to improve the rate of sustained virologic response.

Detailed Description
-----------------
Lipoproteins are closely connected to the process of hepatitis C virus (HCV) infection. Metabolic syndrome predicts negative treatment outcome in HCV infection. Aim: to assess the association between lipids components of the metabolic syndrome and sustained viral response (SVR).

Official Title
-----------------
Do Low HDL Levels Predict Treatment Outcome in Patients With Chronic Hepatitis C Viral Infection?

Conditions
-----------------
Chronic Hepatitis C Viral Infection

Intervention / Treatment
-----------------
* Other: Responders
* Other: Non Responders


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic HCV genotype 1 naive patients Exclusion Criteria: Co infection with HBV, HIV, HDV Decompensated liver disease

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 |
| --- | --- |
| Non Responders<br>Non Responders | Other: Non Responders<br>* Non Responders<br>|
| RESPONDERS<br> | Other: Responders<br>* Responders<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sustained viral response | achieving SVR | 72 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SVR, Cholesterol level, fibrosis score, HDL
A Research Study to Evaluate the Safety and Effectiveness of MK0686 for the Treatment of Postherpetic Neuralgia (Also Known as PHN or Post Shingles Pain) (0686-005)

Study Overview
=================
Brief Summary
-----------------
The purpose of this Study is to test the Safety and Effectiveness of MK0686 in relieving neuropathic (chronic) pain as experienced by patients with Postherpetic Neuralgia (Also Know as PHN or Post Shingles Pain). This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Official Title
-----------------
Proprietary Information - Exploratory (Non-confirmatory) Trial

Conditions
-----------------
Neuralgia, Postherpetic

Intervention / Treatment
-----------------
* Drug: MK0686


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of postherpetic neuralgia with pain having lasted at least 6 months Able to complete study questionnaires, patient diary, and comply with daily study medication Patient is not satisfied with current treatment for pain control Exclusion Criteria: Pregnant or nursing female History of evidence of a condition that in the opinion of the investigator, may interfere with the study results (e.g., diabetic neuropathy of fibromyalgia) or pose undue risk to undergo the course of medication required by the study (e.g., unstable heart disease, morbid obesity, kidney or liver disease)

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0686|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proprietary information - exploratory (non-confirmatory) trial |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proprietary information - exploratory (non-confirmatory) trial |  |  |
Men of Color Fatherhood Education and Violence Prevention Project

Study Overview
=================
Brief Summary
-----------------
A 16 session curriculum, developed for noncustodial African American and Latino fathers to improve knowledge, attitudes and skills and enable participants to remain non-violent towards their partners will be evaluated.

Official Title
-----------------
Men of Color Fatherhood Education and Violence Prevention Project

Conditions
-----------------
Spouse Abuse

Intervention / Treatment
-----------------
* Behavioral: Father Friendly Initiative


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Noncustodial fathers African American or Latino At high risk for violence (prior perpetration, un/underemployment) Exclusion Criteria: Substance abusers

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

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

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Father Friendly Initiative|nan|

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
-----------------
batterers, prevention, African American, Latino
Korea Atherosclerosis Study-3

Study Overview
=================
Brief Summary
-----------------
Multidetector-row Computed Tomography (CT) has been introduced for use in the diagnosis of coronary heart disease. The investigators aimed to characterize coronary artery disease in subjects with cardiovascular risk or not, and in particular plaque natures depending on different status of cardiovascular risk. Especially,the investigators will evaluate the relationships between the pericardial fat and severity of stenosis as well as plaque characteristics using logistic regression models.

Official Title
-----------------
Evaluation of Coronary Artery Disease With Multidetector-Row Cardiac Computed Tomography in Positive Cardiovascular Risk or Not

Conditions
-----------------
Cardiovascular Mortality, Cardiovascular Diseases, All-cause Mortality

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Korean capable of Multidetector-Row Cardiac Computed Tomography (MDCT) Exclusion Criteria: malignancy infection shock

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High risk group<br>positive cardiovascular risk group | |
| Low risk group<br>negative cardiovascular risk group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of coronary artery disease |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary artery disease, cardiovascular risk, pericardial fat
Child Pneumococcal Serotype Epidemiology In Greece

Study Overview
=================
Brief Summary
-----------------
Streptococcus pneumoniae is a major cause of pneumonia, sepsis, bacteremia, and pneumococcal meningitis among infants and children worldwide. The 7-valent conjugate pneumococcal vaccine (Prevenar) has been introduced in the Greek Market in 2004. Additionally, as of 2006 Prevenar has been included in the Greek National Immunization Program. The effect of the mass vaccination on the incidence of pneumococcal serotypes involved in the occurring invasive pneumococcal disease, is an important factor to consider for the introduction of the 13-valent pneumococcal conjugate vaccine.

Detailed Description
-----------------
open label, one group Purposive sampling of hospitalized children ≤14 years of age with confirmed IPD

Official Title
-----------------
Incidence And Serotypes Of Invasive Pneumococcal Disease, After The Introduction Of The Heptavalent Conjugated Vaccine In Greece

Conditions
-----------------
Pneumococcal Disease

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 14 years old or less. Hospitalized in a participating healthcare facility with an IPD. IPD will be confirmed by isolation of S. pneumoniae from a sterile body site. Exclusion Criteria: Children > 14 years of age Unconfirmed IPD

Ages Eligible for Study
-----------------
Maximum Age: 14 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 |
| --- | --- |
| group 1<br>Hospitalized children ≤14 years of age with invasive pneumococcal disease | Other: no intervention<br>* There is no intervention. This is a non interventional study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The serotype distribution of invasive S. pneumoniae isolates of hospitalized children up to 14 years of age after the introduction of the 7-valent conjugate pneumococcal vaccine |  | yearly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serotype distribution of resistant S. pneumoniae isolates |  | yearly | 
| Serotype distribution of IPD between immunized and non immunized children ≤14 years of age |  | yearly | 
| Antimicrobial susceptibilities of IPD isolates and rates of resistance to penicillin |  | yearly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Invasive Pneumococcal Disease (IPD), pneumococcal serotypes
Open Label Study of OTO-104 in Subjects With Meniere's Disease

Study Overview
=================
Brief Summary
-----------------
This is a 1-year, multicenter, Phase 2, open-label safety study in subjects with unilateral Meniere's disease. Subjects will receive 1 intratympanic (IT) injection of 12 mg OTO-104 at 3-month intervals for a total of 4 injections total.

Official Title
-----------------
A 1-Year, Phase 2, Open-Label Safety Study of OTO-104 Given at 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease

Conditions
-----------------
Meniere's Disease

Intervention / Treatment
-----------------
* Drug: OTO-104


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria includes, but is not limited to: Subject has a diagnosis of definite unilateral Meniere's disease. Subject agrees to maintain their current standard of care treatments for Meniere's disease while on-study. Exclusion Criteria includes, but is not limited to: Subject has an infection in the ear, sinuses, or upper respiratory system. Subject is pregnant or lactating. Subject has a history of immunodeficiency disease. Subject has active or recent (<1 month prior to screening) middle ear disease, including but not limited to: chronic otitis media, acute otitis media, middle ear effusions, middle ear atelectasis, or cholesteatoma. Subject has experienced an adverse reaction to intratympanic injection of steroids.

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTO-104<br>12 mg dexamethasone | Drug: OTO-104<br> <br> * Other names: Single intratympanic injection 12 mg OTO-104;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of adverse events as a measure of safety and tolerability |  | Up to 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hearing from baseline as assessed by audiometry |  | Up to 1 Year | 
| Changes in patient condition assessed by otoscopy |  | Up to 1 Year | 
| Changes in patient condition assessed by tympanometry |  | Up to 1 Year |
SPRINT - Randomized Trial of Tibial Fracture Fixation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if there is a difference in the rate of healing of a tibia fracture treated with an intramedullary nail based on whether or not the bone was reamed prior to nail insertion.

Detailed Description
-----------------
Patients with tibia fractures that are amenable to being treated with both a reamed and an unreamed nail will be randomized via telephone to one of the two groups. These patients then will be followed for a year with clinical, as well as subjective, outcome follow-up questionnaires. Time to healing, as well as repeat interventions and adverse events, will be tracked. The rationale for doing a large sample size multi-center trial is the hope that a clear answer to whether or not one of these two methods is significantly better than the other will become apparent and thus aid surgeons in making a more informed operative treatment choice.

Official Title
-----------------
Study to Prospectively Evaluate Reamed Intramedullary Nails in Tibial Shaft Fractures (SPRINT)

Conditions
-----------------
Tibial Fracture

Intervention / Treatment
-----------------
* Procedure: Intramedullary nail implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fractured tibia requiring fixation using an intramedullary nail

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Experimental: 1<br>Participants will receive reaming of the intramedullary canal prior to insertion of an intramedullary nail. | Procedure: Intramedullary nail implant<br>* Insertion of an intramedullary nail during tibial fracture fixation with or without prior reaming of the intramedullary canal.<br>|
| Experimental: 2<br>Participants will receive insertion of an intramedullary nail without prior reaming of the intramedullary canal. | Procedure: Intramedullary nail implant<br>* Insertion of an intramedullary nail during tibial fracture fixation with or without prior reaming of the intramedullary canal.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Necessity for additional operation |  | Months 6, 9, and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to work, functional status, and health-related quality of life |  | Months 6, 9, and 12 |
Natural History and Biological Study of Netherton Syndrome

Study Overview
=================
Brief Summary
-----------------
This study aims at studying the natural history of Netherton syndrome (NS), to identify the consequences of LEKTI deficiency on the immune system and to characterize new molecular mechanisms involved in the disease.

Official Title
-----------------
Syndrome de Netherton : Aspects Cliniques, Physiopathologiques et Identification de Cibles thérapeutiques

Conditions
-----------------
Netherton Syndrome, Healthy

Intervention / Treatment
-----------------
* Other: Biopsy
* Other: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult or child (no age limit) Confirmed diagnosis of Netherton syndrome Signed informed consent form for the patient or his legal representative Exclusion Criteria: Bleeding disorder precluding skin biopsy
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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Netherton syndrome<br>Patients with Netherton syndrome | Other: Biopsy<br> <br> Other: Blood sample<br> <br> |
| Active Comparator: Healthy controls<br>healthy controls | Other: Biopsy<br> <br> Other: Blood sample<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of seric cytokines levels |  | 3 months after patient recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pattern of skin abnormalities |  | 3 months after patient recruitment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Netherton syndrome, Immune system, Skin barrier