linjc16/ctgov huggingface dataset:
Effectiveness of Group Based Schema Therapy in the Treatment of Personality Disorders

Study Overview
=================
Brief Summary
-----------------
This study intends to compare the effectiveness of schema therapy with standard psychiatric outpatient care for patients with borderline or avoidant personality disorder.

Official Title
-----------------
Effectiveness of Group Based Schema Therapy in the Treatment of Borderline Personality Disorder and Avoidant Personality Disorder

Conditions
-----------------
Personality Disorder, Borderline, Avoidant Personality Disorder

Intervention / Treatment
-----------------
* Behavioral: Schema Therapy
* Behavioral: standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Avoidant or Borderline personality disorders Exclusion Criteria: Do not speak Scandinavian languages Antisocial personality disorder Narcissistic personality disorder Affective bipolar disorder I Schizophrenia Mental impairment/organic brain disorder Substance dependence Planned pregnancy Serious somatic illness Anorexia Nervosa

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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: schema therapy<br> | Behavioral: Schema Therapy<br>* group based schema therapy<br>|
| Active Comparator: standard care<br>standard psychiatric out-patient care | Behavioral: standard care<br>* standard psychiatric out-patient care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | Self-report measures | 5 years | 
| depression | Self-report measures | 5 years | 
| anxiety | Self-report measures | 5 years | 
| suicidal ideation | Self-report measures | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of psychotropic medication |  | 5 years |
A Study of MHAA4549A to Assess Safety And Pharmacokinetics in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This randomized, double-blind, placebo-controlled, single-ascending dose study will assess the safety, tolerability and pharmacokinetics of ascending doses of MHAA4549A in healthy volunteers. Volunteers will be randomized to receive a single dose of MHAA4549A or matching placebo.

Official Title
-----------------
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MHAA4549A in Healthy Volunteers

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: MHAA4549A
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Body mass index (BMI) between 18 and 32 kg/m2, inclusive Weight 40 to 100 kg In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs Clinical laboratory evaluations should be within the reference range for the test laboratory unless deemed not clinically significant by the investigator and Sponsor Volunteers agree to use acceptable contraceptive measures Exclusion Criteria: History or clinically significant manifestations of disorders History of anaphylaxis, hypersensitivity or drug allergies History or presence of an abnormal ECG History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit History of significant drug abuse within 1 year prior to screening Current tobacco smokers Positive drug screen at screening or at check-in Positive pregnancy test result at screening or Day -1 or breast feeding during the study

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MHAA4549A Arm<br> | Drug: MHAA4549A<br>* Single-ascending dose of MHAA4549A<br>|
| Placebo Comparator: Placebo Arm<br> | Drug: Placebo<br>* Placebo to MHAA4549A<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of anti-therapeutic antibodies |  | 120 days | 
| Pharmacokinetics: Serum concentration-time profile of MHAA4549A |  | Pre-dose on day 1 to day 120 post-dose |
Contact Lenses and Infiltrative Keratitis

Study Overview
=================
Brief Summary
-----------------
To quantify and compare baseline tear proteins and ocular response in contact lens wearers with a history of corneal infiltrative events, to those without a history of complications. This will be accomplished via measurement of select anti-inflammatory tear proteins before, during and after contact lens wear.

Official Title
-----------------
Contact Lenses and Infiltrative Keratitis

Conditions
-----------------
Keratitis

Intervention / Treatment
-----------------
* Device: senofilcon A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Soft contact lens wearers Healthy (control), or with history of infiltrative keratitis (case) Has a wearable pair of glasses Refractive error between +8.00 D and -12.00 D, with less than 1.50 D of astigmatism Exclusion Criteria: Smoker Pregnant or nursing Systemic disease that would effect tear proteins Punctal plugs Use of eye drops in the last week

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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: history of corneal infiltrative events<br>To quantify and compare baseline tear proteins and ocular response in contact lens wearers with a history of corneal infiltrative events | Device: senofilcon A<br> <br> * Other names: Acuvue Oasys;|
| Active Comparator: without a history of corneal infiltrative events<br>To quantify and compare baseline tear proteins and ocular response in contact lens wearers without a history of corneal infiltrative events. | Device: senofilcon A<br> <br> * Other names: Acuvue Oasys;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear protein levels |  | After 4-6 hours of daily wear and after one night extended wear | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contact lenses
Efficacy and Safety of Topical Essential Oil Extracted From Zingiber Cassumunar Rokb in Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to assess short term efficacy and safety of of topical preparation of essential oil extracted from ZINGIBER CASSUMUNAR ROXB in patients suffering from osteoarthritic pain

Official Title
-----------------
Efficacy and Safety of Topical Preparation of Essential Oil Extracted From Zingiber Cassumunar Rokb in Patients With Osteoarthritis

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

Intervention / Treatment
-----------------
* Drug: Cream from Zingiber cassumunar Roxb. extract
* Drug: Placebo cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis: osteoarthritis of the knee at least on side with standard radiologic method within 6 weeks (Kellgren-Lawrence radiographic grading scale at least 1) Pain visual analog scale at rest at least 40 mm No previous analgesic treatment or receiving stable dose of analgesic drugs at least 2 weeks. If previously treated with antidepressants, glucosamine, chondroitin or diacerein, dosage should be stable for at least 3 months. Agree to attain non-pharmacologic treatment as prior to participate the study Exclusion Criteria: having an open wound or abnormal skin at site of application having diagnose with other chronic arthritis such as rheumatoid arthritis history of allergy to the extraction of Zingiber cassumunar Roxb pregnancy or breastfeeding

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo cream<br>Placebo cream | Drug: Placebo cream<br> <br> |
| Experimental: Plai cream<br>Cream from Zingiber cassumunar Roxb. extract | Drug: Cream from Zingiber cassumunar Roxb. extract<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of The WOMAC (Western Ontario and McMaster Universities) index |  | week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Pain visual analog scale (PVAS) |  | week 8 | 
| Change from baseline of Global assessment of disease status (GADS) |  | week 8 | 
| Clinical global impression of change (CGIC) |  | Week 8 | 
| Patient global impression of change (PGIC) |  | Week 8 | 
| Adverse events |  | Week 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Moderate ot severe pain, ZINGIBER CASSUMUNAR ROXB
Prospective Study for Prognostic Biomarkers of Nasopharyngeal Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research project is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in nasopharyngeal carcinoma.

Detailed Description
-----------------
Objectives: Primary: Evaluation of failure-free survival after three years of patients of nasopharyngeal carcinoma. Secondary: Evaluation of overall survival after three years of patients of nasopharyngeal carcinoma. Outline: This is a multicenter observational study. Tumor tissue specimens are obtained from the Sun Yat-sen University Cancer Center and Affiliated Hospital of Guilin Medical University. The samples are analyzed for biomarkers. The biomarkers are correlated with clinical outcomes (failure-free survival, overall survival, tumor response to treatment, distant metastasis, recurrence and death). The aim of the analysis is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in nasopharyngeal carcinoma. This will lead to the definition of risk groups and stratification of patients and will help to precision medicine of nasopharyngeal carcinoma.

Official Title
-----------------
Prospective Study for Prognostic Biomarkers of Nasopharyngeal Carcinoma

Conditions
-----------------
Nasopharyngeal Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with newly histologically confirmed nasopharyngeal carcinoma No evidence of distant metastasis (M0) Written informed consent Exclusion Criteria: Treatment with palliative intent
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 |
| --- | --- | --- |
| Failure-free Survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 3 years |
A Study of An Approved Vaccine at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age (V205C-007)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the mumps virus strength at the end of shelf-life (expiration date) of an approved vaccine.

Official Title
-----------------
A Study of M-M-R(TM) II at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age

Conditions
-----------------
Measles, Mumps, Rubella, Varicella

Intervention / Treatment
-----------------
* Biological: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live
* Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children 12 to 18 months of age Exclusion Criteria: History or prior exposure to measles, mumps, rubella or varicella History of anaphylactoid reactions or hypersensitivity to any component of the vaccine, including gelatin and neomycin

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 18 Months

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>M-M-R(TM) II at current release potency | Biological: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live<br>* 0.5 mL subcutaneous injection of one of three sub-lots on Day 0<br>Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)<br>* 0.5 mL subcutaneous injection on Day 0<br>|
| Experimental: Mumps Expiry Group 1<br>M-M-R(TM) II at intermediate expiry potency | Biological: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live<br>* 0.5 mL subcutaneous injection of one of three sub-lots on Day 0<br>Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)<br>* 0.5 mL subcutaneous injection on Day 0<br>|
| Experimental: Mumps Expiry Group 2<br>M-M-R(TM) II at expiry potency | Biological: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live<br>* 0.5 mL subcutaneous injection of one of three sub-lots on Day 0<br>Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)<br>* 0.5 mL subcutaneous injection on Day 0<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutralizing antibodies to mumps at 6 weeks postvaccination |  | 6 weeks postvaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean titers to mumps by ELISA at 6 weeks and at 1 year postvaccination |  | 6 weeks and 1 year postvaccination |
LUNG ULTRASONOGRAPHY DECREASES RADIATION EXPOSURE

Study Overview
=================
Brief Summary
-----------------
We aimed to decrease in the number of chest X-rays in newborns with respiratory distress, with the use of lung ultrasonography. From January 2019 to June 2020, 104 newborn infants with respiratory distress enrolled in this study. We used bed side ultrasound as the first line tecnique for lung imaging. X-ray were taken in cases with increasing respiratory distress in spite of treatment according to diagnosis depending on USG findings. We calculated decreased number of chest X-ray for every patient and evaluated the estimated decrease in radiation exposure.

Detailed Description
-----------------
Background: Chest X-ray is commonly used as first line imaging method to diagnose the reason of respiratory distress in NICUs. Lung ultrasound is a new diagnostic tool for lung imaging, and this method has been used more common recently in NICUs. Objectives: We aimed to determine the decrease in the number of chest X-rays in newborns with respiratory distress, with the use of lung ultrasonography. Methods: From January 2019 to June 2020, 104 newborn infants with respiratory distress enrolled in this study. We used bed side ultrasound as the first line tecnique for lung imaging. X-ray were taken in cases with increasing respiratory distress in spite of treatment according to diagnosis depending on USG findings. We calculated decreased number of chest X-ray for every patient and evaluated the estimated decrease in radiation exposure.

Official Title
-----------------
LUNG ULTRASONOGRAPHY DECREASES RADIATION EXPOSURE

Conditions
-----------------
Newborn Rds, Transient Tachypnea of the Newborn, Pneumonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term or preterm neonates with respiratory distress that started within the first 24 h after birth were included if they showed at admission signs of respiratory distress defined as: tachypnea (respiratory rate >60 breaths/min), intercostal/subcostal retractions, grunting, or FiO2 requirement >0.21. Exclusion Criteria: Patients with a diagnosis of major malformations or chromosomal abnormalities, inherited metabolic diseases, congenital muscle disease-hypotonicity, hypoxic ischemic encephalopathy were not enrolled.

Ages Eligible for Study
-----------------
Maximum Age: 2 Days

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 |
| --- | --- | --- |
| Reduced radiation exposure | We aimed to decrease in the number of chest X-rays in newborns with respiratory distress, with the use of lung ultrasonography. | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung ultrasonography, chest x ray, newborn
The Dose-Response Relationship of Rocuronium in Patients Taking Pyridostigmine

Study Overview
=================
Brief Summary
-----------------
Pyridostigmine is a medication that is used in certain heart rate and blood pressure conditions. This medication, as a side effect, is known to also cause changes in the junction between a nerve and muscle. The changes caused at the nerve muscle junction by pyridostigmine could alter the effect of muscle relaxants (a medication used during surgery and anesthesia). The investigators are conducting this study to see whether patients taking pyridostigmine are more or less sensitive to rocuronium (a muscle relaxing medication used during surgery).

Detailed Description
-----------------
No subjects enrolled. No data collected.

Official Title
-----------------
The Dose-response Relationship of Rocuronium in Patients Taking Pyridostigmine Preoperatively Compared With Age and Sex Matched Controls

Conditions
-----------------
Muscle Relaxants

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who take pyridostigmine for any reason or those who are matched by age, sex and weight to subjects taking pyridostigmine Patients who will be administered rocuronium during elective procedures as standard clinical care. Exclusion Criteria: Allergy to rocuronium Known neuromuscular disorder, patients suffering from myasthenia gravis Subjects taking medications known to impact neuromuscular transmission (ex. gentamicin).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| pyridostigmine<br>administration of rocuronium to determine its potency. | |
| control arm (no pyridostigmine)<br>determination of potency of rocuronium in patients not taking pyridostigmine | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose of the muscle relaxant rocuronium that will lead to 50% decrease in the force of the evoked muscle contraction in patients taking pyridostigmine. | Rocuronium used to produce muscle weakness or paralysis during surgery. Its potency is measured as ED50, the dose necessary to cause a 50% reduction in the force of evoked muscle contraction. We intend to determine this measure of potency (ED50 for rocuronium) in patients taking pyridostigmine and compare it with control subjects. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
muscle relaxants, pyridostigmine, pharmacodynamics, potency