linjc16/ctgov huggingface dataset:
German Corneal Cross Linking Register

Study Overview
=================
Brief Summary
-----------------
Corneal Cross Linking is new treatment modality for patients with keratoconus. A keratoconus is characterized by progressive bulging and thinning of the eye's cornea. Keratoconus is a potentially severely sight impairing condition that may necessitate corneal transplantation in the progressive state. Corneal Cross Linking is designed to increase the cornea's mechanical stability to stop progression of bulging and thinning of the cornea to prevent the need for corneal transplantation Corneal Cross Linking is performed by Applying Riboflavin (Vitamin B2) eye drops every 2 minutes for 30 minutes to the cornea Illuminating the cornea with UV-light This register of Corneal Cross Linking procedures performed in Germany serves to gather long-term results detect rare complications and side-effects evaluate the efficacy in a large number of patients

Official Title
-----------------
German Corneal Cross Linking Register

Conditions
-----------------
Keratoconus

Intervention / Treatment
-----------------
* Procedure: CCL (Corneal Cross Linking)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with keratokonus and treated with corneal cross Linking in Germany Exclusion Criteria: Non-ectatic conditions
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>Cross linked eyes | Procedure: CCL (Corneal Cross Linking)<br>* Apply Riboflavin 0.1% in Dextran 500 20% in NaCl solution Illuminate with UV-light of 365 nm wave-length and 3.0 mW/cm² intensity at 5 cm distance<br>* Other names: 3C-L;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Keratometry |  | yearly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slit-lamp biomicroscopical findings |  | yearly | 
| Best corrected Visual Acuity |  | Yearly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
keratoconus, cornea, cross linking, UV-light, riboflavin
School Gardens and Physical Activity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether school gardens affect children's physical activity.

Detailed Description
-----------------
New York State schools were randomly assigned to receive school gardens and associated curriculum or to serve on the wait list control group that received gardens and curriculum at the end of the 2-year study. Baseline data were collected in Fall 2011. Garden interventions began in Spring 2012. Follow-up data were collected at 6, 12, 18 months following baseline data collection.

Official Title
-----------------
School Gardens and Physical Activity

Conditions
-----------------
Physical Activity

Intervention / Treatment
-----------------
* Behavioral: garden


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: schools had at least 50% of enrolled children qualifying for free + reduced price meals (FRPM) schools did not already have a school garden Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: garden intervention<br>garden kit and access to garden-based lessons | Behavioral: garden<br> <br> |
| No Intervention: no garden<br>control - receives garden and lessons at end of study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in physical activity | Physical activity was measured using a survey measure, accelerometry, and direct observation. | change from baseline to follow-ups at 6, 12, 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in time spent outdoors | Time spent outdoors was measured by lux using accelerometry | baseline to follow-ups at 6, 12, 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
school, garden, physical activity, children
Sexual Function During COVID 19 Pandemic

Study Overview
=================
Brief Summary
-----------------
The outbreak of a new Coronavirus disease (COVID-19), caused by the 2019-nCoV infection in December 2019 is one of the most severe global epidemic health problems.The rapid contagion of this Novel virus has provoked the World Health Organization (WHO) to classifying the outbreak as a Public Health Emergency of International Concern on January 30 2020 to a Pandemic on March 11th 2020

Official Title
-----------------
Sexual Function Among Egyptian Healthcare Professionals During COVID 19 Pandemic

Conditions
-----------------
Sexual Dysfunction

Intervention / Treatment
-----------------
* Other: Electronic questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: health care staff working during the outbreak Exclusion Criteria: refuse to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| study group<br>health care staff, regardless of gender, who is actively working during the outbreak | Other: Electronic questionnaire<br>* Assess the current sexuality according to the gender using sexual questionnaires for men and women were adapted from the Arabic validated version of the five-item International Index of Erectile Function which is a validated, multidimensional, self-administered questionnaire used for the clinical assessment of erectile dysfunction.and for female Arabic validated version of the Female Sexual Function Index<br>|
| control group<br>age matched group of non-health worker individuals. | Other: Electronic questionnaire<br>* Assess the current sexuality according to the gender using sexual questionnaires for men and women were adapted from the Arabic validated version of the five-item International Index of Erectile Function which is a validated, multidimensional, self-administered questionnaire used for the clinical assessment of erectile dysfunction.and for female Arabic validated version of the Female Sexual Function Index<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of study participants diagnosed with sexual dysfunction | The diagnosis will be made based on the score results | one month |
Molecular Processes of the Relaxation Response in Older Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the molecular (nitric oxide) and biochemical (epinephrine, norepinephrine, cortisol and ACTH) parameters that are associated with RR elicitation and which may counteract the effects of acute stress in the elderly.

Official Title
-----------------
Molecular Processes of the Relaxation Response in Older Adults

Conditions
-----------------
Stress

Intervention / Treatment
-----------------
* Behavioral: Relaxation response


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 60-80 years of age healthy individuals willing and able to attend treatment sessions willing to learn how to do and practice the relaxation-response access to a working telephone read and write English Exclusion Criteria: Major medical or psychiatric illness asthma or seasonal allergies (resulting in nitric oxide levels >60 ppb) smoking previous relaxation-response practice current use of the following medications:systemic corticosteroids, anti-convulsants/psychotics, immunosuppressants, cytotoxic therapy, anabolic steroids, antidepressants (other than SSRIs), dicyclomine, bile acid binding resins, or sympathomimetic medication

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 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

| Intervention/Treatment |
| --- |
|Behavioral: Relaxation response|8 weeks of relaxation response training|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A primary goal of this study is to quantify the magnitude of relaxation response elicitation by comparing oxygen consumption during rest versus during elicitation of the relaxation response in a sample of healthy older adults. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A second area of interest is the relationship between exhaled levels of nitric oxide (NO) and oxygen consumption (VO2) during relaxation response elicitation. |  | 8 weeks |
Detecting the Most Efficient Residency Time for Laparoscopic Simulators

Study Overview
=================
Brief Summary
-----------------
Laparoscopic surgeries is one of the most common surgery in gynecologic procedures. Nowadays there are many laparoscopic simulators for training residents. In this study it is aimed to determine the most efficient residency year for laparoscopic simulators. This study planned as a prospective study. There will be three group which include ob/gyn residents. The residents will choose based on their residency year and surgery skills. 1. The residents who makes surgeries both laparoscopic and laparotomic, 2. The residents who makes surgeries only laparotomic, 3. The residents who won't any gynecologic surgery The data of surgery time, complications and movement numbers will take from the simulator. Tubal ligation and salpingooferectomy choose for the surgery examples. The simulation results of participants will compare and try to find the best improvement term for residency.

Official Title
-----------------
Determination of the Most Efficacious Period for the Use of Laparoscopic Simulators in Obstetrics and Gynecology Specialty Training

Conditions
-----------------
Laparoscopy, Simulation Training

Intervention / Treatment
-----------------
* Other: There is no intervention planning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Should be an ob/gyn resident Should except to participate study Exclusion Criteria: Not to complete all simulations

Ages Eligible for Study
-----------------
Minimum Age: 24 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There is three group based on the surgical skills and ob/gyn residency years.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>Have surgical experience both laparoscopy and laparotomy and senior resident | Other: There is no intervention planning<br>* There is no intervention planning<br>|
| Other: Group 2<br>Have surgical skills only laparotomic gynecologic procedures and in the middle of his/her residency | Other: There is no intervention planning<br>* There is no intervention planning<br>|
| Other: Group 3<br>Have no surgical experience on gynecologic procedures and newbie residents | Other: There is no intervention planning<br>* There is no intervention planning<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laparoscopic surgical procedures time |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement number for laparoscopic procedures |  | 6 months | 
| Complication during laparoscopic surgery simulations |  | 6 months |
Outcome EnduRo Versus LINK SL Rotating Hinge Knee

Study Overview
=================
Brief Summary
-----------------
Randomized clinical outcome study of two rotating hinge knee prosthesis in knee surgery. Hypothesis: No difference in the clinical outcome for 1 year after the operation. Clinical follow-ups at 3, 10, 90 and 360 days after surgery. Measurement of clinical parameters

Conditions
-----------------
Knee Arthrosis,

Intervention / Treatment
-----------------
* Procedure: LINK SL versus EnduRo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: rotating hinge knee indicated Exclusion Criteria: infection, malignant tumor, rheumatism
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 |
| --- | --- |
| LINK SL<br>Patients | Procedure: LINK SL versus EnduRo<br> <br> |
| EnduRo<br>Patients | Procedure: LINK SL versus EnduRo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford knee score |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
knee revision surgery,, rotating hinge prosthesis
Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Stomach

Study Overview
=================
Brief Summary
-----------------
A patient referred to have a lesion in the stomach removed. The aims of this study are to collect information on the technique of endoscopic removal of such lesions. By collecting information on a large number of patients undergoing this procedure the investigators can determine the best ways of diagnosing and removing these lesions safely and effectively.

Official Title
-----------------
Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Stomach.

Conditions
-----------------
Adenoma, Villous

Intervention / Treatment
-----------------
* Procedure: Endoscopic Mucosal Resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stomach lesion > 10mm Lesion limited to the mucosal and/or submucosal layer (T1 lesion) Aged 18 years or older Exclusion Criteria: Lesion less than 10mm Stomach lesion involves the muscularis propria (T2 lesion) on other staging modalities such as endoscopic ultrasonography (EUS) Aged younger than 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Endoscopic Mucosal Resection<br>Patients who are referred for Endoscopic Mucosal Resection of Stomach Lesions will be included in this cohort. | Procedure: Endoscopic Mucosal Resection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed procedural data: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of the costs of this procedure compared to previous treatments | Perform cost-utility analyses comparing different treatment approaches for stomach lesions | 14 days |
VASO-AM :Impact of Oral Appliance Therapy on Endothelial Function in Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled study evaluating the impact of 2 months of oral appliance therapy on endothelial function in patients with severe obstructive sleep apnea syndrome intolerant to continuous positive airway pressure (CPAP) therapy.

Official Title
-----------------
VASO-AM :Impact of Oral Appliance Therapy on Endothelial Function in Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea Syndrome

Intervention / Treatment
-----------------
* Device: AMO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AHI > 30 Intolerance to CPAP therapy Signed informed consent Exclusion Criteria: Epworth sleepiness scale > 16/24 Severe cardiac and/or respiratory disease BMI>32 kg/m2 Dental contraindication to oral appliance

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMO<br>Adjustable mandibular repositioning appliance | Device: AMO<br> <br> |
| Placebo Comparator: placebo<br>placebo device in upper jaw | Device: AMO<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline to 2-months in reactive hyperemia index (RHI), a validated measurement of endothelial function. |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline to 2-months in markers of OSA severity |  | 2 months | 
| change from baseline to 2-months in blood pressure |  | 2 months | 
| change from baseline to 2-months in symptoms of OSA |  | 2 months | 
| evaluate treatment compliance objectively measured by an embedded micro sensor |  | 15 weeks |
Exhaled Breath Analysis in Human Subjects

Study Overview
=================
Brief Summary
-----------------
Identification of exhaled breath pattern of human subjects

Detailed Description
-----------------
Breath analysis with mass spectormetry as a non-invasive method to identfy exhaled breath patterns.

Official Title
-----------------
Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS) in Human Subjects

Conditions
-----------------
Exhaled Breath Pattern After Medication Intake, in OSA Patients, or Other Pulmonary Diseases

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >= 18 years Informed consent Exclusion Criteria: specific exclusion criteria for different subgroups

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exhaled breath pattern | mass spectrometric profile of exhaled breath pattern of human subjects | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemical structure of exhaled breath molecules | The identification of the chemical structure of exhaled breath molecules | baseline | 
| Body fluids | The correlations of identified molecules in exhaled breath with body fluids | baseline | 
| Disease marker | The correlation of a distinct disease marker with a breath print or breath feature | baseline | 
| Distinguish between disease | The use of a breath print to distinguish between disease and/or health state | baseline | 
| Health state | The correlation of breath prints to subjective health state and/or quality of life | baseline | 
| Medication | Response to medication and toxicity as a function of blood/breath drug concentrations | baseline | 
| Excretion of drugs | Correlation between lung function and the excretion of drugs in exhaled breath | baseline |
Pilot Study of 89-Zr Panitumumab in Pancreas Cancer

Study Overview
=================
Brief Summary
-----------------
The main purpose of the study is to assess the safety of 89Zr-panitumumab as a molecular imaging agent in patients with (metastatic) pancreas cancer.

Official Title
-----------------
Pilot Study of 89Zr Panitumumab in Pancreas Cancer

Conditions
-----------------
Pancreas Cancer

Intervention / Treatment
-----------------
* Drug: 89Zr-panitumumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of pancreatic cancer. Exclusion Criteria: Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment. History of infusion reactions to monoclonal antibody therapies. Pregnant or breastfeeding. Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis. Severe renal disease or anuria. Known hypersensitivity to deferoxamine or any of its components.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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 |
| --- | --- |
| Experimental: 89Zr-Panitumumab<br>Subjects will be injected with 1 mCi (+/- 20%) of 89Zr-panitumumab followed by PET/CT imaging 4-7 days after study drug injection. | Drug: 89Zr-panitumumab<br>* Imaging Agent<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment emergent adverse events assessed by CTCAE v5 | Safety is defined by the number of CTCAE v5 grade 2 or higher adverse events by Day 7 determined that are significant, definitely, probably or possibly related to 89Zr-panitumumab. Safety data will be summarized by grade, severity, and type. | 7 days |