linjc16/ctgov huggingface dataset:
Validity of Cow's Milk-related Symptom Score Among Children Suspected to Have Cow's Milk Protein Alergy

Study Overview
=================
Brief Summary
-----------------
Cow's milk protein allergy is a sensitivity reaction against cow's milk protein and and is calcified as IgE-medaited, non- IgE mediated and mixed type according to the underlying immunological mechanism. Cow's Milk related Symptom Score ( CoMiSS) Considers general manifestation and dermatological, gastrointestinal and respiratory symptoms.

Official Title
-----------------
Validity of Cow's Milk-related Symptom Score Among Children Suspected to Have Cow's Milk Protein Allergy.

Conditions
-----------------
Cow's Milk Allergy

Intervention / Treatment
-----------------
* Other: stool analysis , CBC, specific IgE FOR Cow milk protein allergy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : Age: from birth up to five years... Sex: both Males and females All children who suspected to have Cow's Milk Allergy that have the following symptoms (chronic unexplained failure to thrive, regurgitation , chronic abdominal distension, skin manifestation such as urticaria & eczema and respiratory symptoms such as chronic cough, recurrent wheezy chest). Exclusion criteria Functional GIT disorders such irritable bowel syndrome , Gastroesophageal reflux disease according to Rome IV criteria in children Organic gastrointestinal diseases like coeliac disease , cystic fibrosis. Chronic gastrointestinal infections as parasitic infections.

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 5 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patient with cow milk protein allergy<br>apply CoMiSS on patient suspected to have cow milk protein allergy. | Other: stool analysis , CBC, specific IgE FOR Cow milk protein allergy<br>* apply CoMiSS and food challenge test on patient whom suspected to have cow milk protein allergy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient who are diagnosed as cow milk protein allergy by CoMiss | measure the accuracy percentage (%) of the Cow's milk-related symptoms score in diagnosis of cow milk allergy at pediatrics department in Sohag hospital university | one year | 
| interpretation of the Cow's milk-related symptoms score | The scoring ranges from 0 to 33. Each symptom has a maximal score of 6, except respiratory symptoms where the maximal score is 3. If final score > 12, the symptoms are likely cow's milk related. This could potentially be CMPA. If final score < 12, the symptoms are less likely related to cow's milk. Look for other causes. CMPA diagnosis can only be confirmed by an elimination diet followed by an oral food challenge. | one year | 
| Food Challenge Test | positive or negative Food Challenge Test | one year |
Diastolic Function in Myotonic Dystrophy Type 1

Study Overview
=================
Brief Summary
-----------------
Myotonic dystrophy type 1 (DM1) is a neuromuscular disorder in relation with an unstable expansion of CTG repeat. Patients with DM1 are at risk of arrhythmia and conduction disorders. Mortality are mainly related to respiratory failure and sudden death. Patients with DM1 may suffer from obesity, arterial hypertension, diabetes mellitus and sleep apnea. These comorbidities are classically associated with left ventricular diastolic dysfunction (DD) . The investigators aim to assess the prevalence of left ventricular diastolic dysfunction in patients with myotonic dystrophy type 1 , the distribution of DD grading as well as the long-term prognosis of DM1 patients with a left ventricular diastolic dysfunction.

Official Title
-----------------
Diastolic Function in Myotonic Dystrophy Type 1

Conditions
-----------------
Diastolic Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with genetic proven myotonic dystrophy type 1 who experienced a Doppler- Echocardiography including an assessment of the left ventricular diastolic function Exclusion Criteria: wall motion basal abnormalities significant valvular disease
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of arrhythmia |  | 7 years | 
| acute heart failure |  | 7 years |
Phase III Clinical Trial of DA-5212 in Patients With Functional Dyspepsia

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate efficacy and safety of DA-5212 in patients with functional dyspepsia

Official Title
-----------------
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DA-5212 in Patients With Functional Dyspepsia

Conditions
-----------------
Functional Dyspepsia

Intervention / Treatment
-----------------
* Drug: DA-5212
* Drug: DA-5212-R


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women ≥ 19 years of age Patients who diagnosed with functional dyspepsia Patients with no organic cause for digestive symptoms found by upper gastrointestinal endoscopy at screening visit Exclusion Criteria: Patients with organic disease or medical history that may cause dyspepsia within 6 months before screening visit Patients who have a history of drugs or alcohol abuse and dependence within 6 months before screening visit Patients with hypersensitivity to investigational drugs and similar drugs Pregnant or breastfeeding women

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DA-5212<br>administered once daily for 4weeks | Drug: DA-5212<br>* Test drug: DA-5212<br>|
| Other: DA-5212-R<br>administered once daily for 4weeks | Drug: DA-5212-R<br>* Control drug: DA-5212-R<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in NDI-K functional dyspepsia score |  | Change from baseline at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in overall treatment score of patients |  | Change from baseline at 4 weeks |
Biomarkers and Prediction of Tigecycline Induced Coagulation Dysfunction

Study Overview
=================
Brief Summary
-----------------
This study is to screen out the biomarkers and establish the model to predict coagulation dysfunction induced tigecycline

Detailed Description
-----------------
The critically ill patients treated with tigecycline in in tensive care unit will be recruited and divided into tigecycline-induced coagulation dysfunction group and non-coagulation dysfunction group. The multi-omics will be used to screen out biomarkers for early prediction of coagulation dysfunction caused by tigecycline. Afterwards, machine learning methods will be adopted to establish the the early prediction model of tigecycline-induced coagulation dysfunction.

Official Title
-----------------
Biomarkers and Prediction of Tigecycline Induced Coagulation Dysfunction Based on Multi-omics and Machine Learning Techbology

Conditions
-----------------
Blood Coagulation Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inpatients receiving tigecycline treatment in the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Intravenous tigecycline ≥ 3 days Monitoring the plasma concentration of tigecycline Exclusion Criteria: Missing clinical data

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 |
| --- | --- |
| coagulation dysfunction group<br>The critically ill patients in intensive care unit showed coagulation dysfunction after treated with tigecycline. | |
| non-coagulation dysfunction group<br>The critically ill patients in intensive care unit showed normal coagulation function after treated with tigecycline. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers associated with the coagulation dysfunction induced tigecycline | Multi-omics will be adopted to screen out biomarkers associated with the coagulation dysfunction induced by tigecycline. | January 2023-December 2025 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction model for coagulation dysfunction induced by tigecycline | Machine learning techbology will be adopted to establish the prediction model for coagulation dysfunction induced by tigecycline | January 2023-December 2025 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tigecycline, Blood Coagulation Disorder, multi-omics, machine learning techbology
Determining Individualized Cancer Therapy in Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
This is a non-therapeutic exploratory observational precision oncology study designed to collect and analyze data that demonstrate the clinical efficacy and tolerability of personalized treatments based on molecular tumor profiling assessments (i.e., matched therapy) in adult pancreatic cancer patients. Patient medical records, obtained both retrospectively and prospectively, will be examined for results of molecular profiling obtained through standard of care testing to help understand how well molecular testing might predicts response to therapy. Patient demographic and outcome parameters to be evaluated include, but are not limited to, tumor response, time to treatment failure, patient survival, and toxicity.

Official Title
-----------------
Profile-Related Evidence Determining Individualized Cancer Therapy in Pancreatic Cancer (PREDICT-PANC)

Conditions
-----------------
Pancreatic Neoplasms

Intervention / Treatment
-----------------
* Other: Targeted Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years. Pathologically confirmed pancreatic cancer. Ability to understand a written informed consent document and the willingness to sign it Exclusion Criteria: Age <18 years. Primary cancer diagnosis other than pancreatic cancer.

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

| Intervention/Treatment |
| --- |
|Other: Targeted Therapy|Approved interventions based on the subject's genomic profile will be provided to investigators for consideration for anti-tumor therapy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Receiving Targeted Therapy | This measure is the number of study subject's whose treating physician prescribes and subsequently receives the therapeutic recommendation of the Molecular Tumor Board. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mutation, Genomics, Targeted Therapy, Cancer, Pancreas
Frailty in Critical Care Unit's Patients

Study Overview
=================
Brief Summary
-----------------
In the study ,investigator aim to evaluate the frailty syndrome in critically ill patients, in both young and old populations,to determine its imapct on outcome, and impact of ICU in fraility

Official Title
-----------------
Frailty in Critical Care Unit's Patients

Conditions
-----------------
CFS

Intervention / Treatment
-----------------
* Other: Assesment of CFS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All ICU patients >18 years Exclusion Criteria: Age <18 years

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 |
| --- | --- |
| Age above 60 eldery<br>group will be assessed using the Clinical Frailty Scale (CFS) giving patients who are very fit score one and those who are terminally ill score nine. | Other: Assesment of CFS<br>* Assesment of CFS<br>|
| age between 18:60 young<br>group will be assessed using the Clinical Frailty Scale (CFS) giving patients who are very fit score one and those who are terminally ill score nine. | Other: Assesment of CFS<br>* Assesment of CFS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detect the impact of frailty on outcome(hospital stay and mortality).In Critical care units patients. | evaluate the frailty syndrome in critical care unit ,in young and old populations.CFS will report patient's basal score[ pre intervention] on day of admission and the outcome score at day of discharge [5day],score 1better than higher | the CFS before hospital admission and at day up to 1 week of discharge from CCU, CFS mininum 1 ,maximum 9 patient's basal score[ pre intervention] on day of admission and the outcome score at day of discharge [5day],score 1better than higher |
8.4% Sodium Bicarbonate Locks in Intestinal Failure

Study Overview
=================
Brief Summary
-----------------
We plan to include children with intestinal failure, a condition where the gut is not functioning properly, leading these children to need central venous catheters (line that goes through the skin into the blood stream) for nutritional support and hydration. Such patients have a very high risk for catheter infection. The study will include placing an agent (sodium bicarbonate) into the central catheter when the catheter is not in use. This is referred to as a lock. The lock would be used daily and removed when patients start their nutritional support and hydration through the catheter.

Detailed Description
-----------------
Children with intestinal failure who rely on a silicone based central venous catheter for parenteral nutrition to provide nutritional support and hydration will be invited to participate in this study. The intervention will offer use of a specific catheter lock solution (8.4% sodium bicarbonate) when the catheter is not in use. This includes daily lock use with removal of the lock at end of dwell time.

Official Title
-----------------
Sodium Bicarb Locks in Intestinal Failure

Conditions
-----------------
Intestinal Failure, CRBSI - Catheter Related Bloodstream Infection

Intervention / Treatment
-----------------
* Drug: Sodium bicarb lock


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject fulfills diagnosis of intestinal failure with a central venous catheter in place used daily on outpatient basis for intravenous nutrition and /or intravenous hydration Subject is less than 18 years of age at the time of study entry Subject with history of at least 1 documented catheter related blood stream infection (verified by blood culture)

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Baseline<br>Patient on heparin locks when off venous nutrition | Drug: Sodium bicarb lock<br>* 8.4% sodium bicarb locks when off venous nutrition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of catheter related bloodstream infections | Number of infections per 1000 catheter days | Through study completion, an average of 1 year |
Endovascular Repair of AAA

Study Overview
=================
Brief Summary
-----------------
We study differen t endovascular techniques as an alternative to surgical reconstruction to repair AAAS regarding ; success rates, 30-day mortality, endoleak events secondary intervention rates

Official Title
-----------------
Endovascular Abdominal Aortic Aneurysm Repair

Conditions
-----------------
On Abdominal Aortic Aneurysms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 Exclusion Criteria: inflammatory or mycotic AAA

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 day mortality | Total death | 30 days |
Comparative Clinical Study for Two Types of Locator Attachments for Mandibular Implant Supported Overdenture

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the clinical and radiographic outcomes for mandibular implant-supported overdenture using two different types of locator attachment after 3 years of using the two types of locator attachments

Official Title
-----------------
A Comparative Clinical Study for Two Types of Locator Attachments for Mandibular Implant-supported Overdenture; A 3-year Radiographic and Clinical Follow-up Study

Conditions
-----------------
Prosthesis User

Intervention / Treatment
-----------------
* Procedure: implant supported overdenture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. All selected patients have two implants placed in the mandibular interforaminal region. 2. All selected patients have a healthy mucosa and with no clinical complications. 3. All patients are cooperative and approve the proposed treatment protocol Exclusion Criteria: 1. Patients who reject to participate in the study. 2.Patients who need implant placement as a result of previous implant failure

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 70 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: Parallel Assignment
Interventional Model Description: All patients in this study will be divided into two equal groups Group I (control): patients who would be delivered mandibular implant overdenture using conventional locator attachments. Group II (study): patients who would be delivered mandibular implant overdenture using Locator RTX attachments
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I<br>patients who would be delivered a mandibular implant overdenture using conventional locator attachments. | Procedure: implant supported overdenture<br>* patients would be delivered mandibular implant overdenture using conventional locator and Locator RTX attachments<br>|
| Active Comparator: Group II (study)<br>patients who would be delivered mandibular implant overdenture using Locator RTX attachments | Procedure: implant supported overdenture<br>* patients would be delivered mandibular implant overdenture using conventional locator and Locator RTX attachments<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| crestal cone loss | Intraoral radiographs were performed using the long cone paralleling technique to evaluate crestal bone loss | three years | 
| prosthetic complications | prosthetic complications were scored clinically | three years |
Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness

Study Overview
=================
Brief Summary
-----------------
An open label study to investigate the safety and efficacy of tradipitant in participants affected by motion sickness during travel

Detailed Description
-----------------
This is an open label study to investigate the efficacy and safety of tradipitant in motion sickness affected male and female participants during events historically known to cause motion sickness.

Official Title
-----------------
Motion Delos: An Open Label Study to Investigate the Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness During Travel

Conditions
-----------------
Motion Sickness

Intervention / Treatment
-----------------
* Drug: Tradipitant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of Motion Sickness Age 18-75 Exclusion Criteria: Nausea-inducing disorder other than motion sickness BMI > 40 History of intolerance and/or hypersensitivity to Neurokinin-1 Receptor antagonists

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Tradipitant Dose A<br>See Drug | Drug: Tradipitant<br>* Oral Capsule<br>|
| Experimental: Tradipitant Dose B<br>See Drug | Drug: Tradipitant<br>* Oral Capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of tradipitant as measured by reporting of adverse events (AEs). | Safety will be monitored using clinical measures, vital signs, blood chemistry, hematology, urology, and ECGs. | through study completion, approximately 1 year |