linjc16/ctgov huggingface dataset:
The Efficacy of a Novel, Non-contact EKG in the NICU

Study Overview
=================
Brief Summary
-----------------
We will be comparing a novel, non-contact EKG waveform and heart rate to the standard of care, contact-based EKG waveform and heart rate in neonates, who have sensitive skin.

Official Title
-----------------
The Efficacy of a Novel, Non-contact EKG in the NICU

Conditions
-----------------
Electrocardiogram Electrode Site Reaction

Intervention / Treatment
-----------------
* Diagnostic Test: non-contact EKG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Apgar at 5 min >/= 7 Admitted to the NICU Indication for standard EKG monitoring Exclusion Criteria: Apgar < 7 at 5 min Not in the NICU Not being monitored with standard EKG monitors

Ages Eligible for Study
-----------------
Maximum Age: 30 Days

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: non-contact EKG|ultra-sensitive, non-contact EKG pad will be placed beneath the infant|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in heart rate | we will compare the two heart rate figures from both EKG sources | 1 hour |
Nerve Growth Factor in Chronic Pancreatitis

Study Overview
=================
Brief Summary
-----------------
This study is to understand the role of nerve growth factor(NGF) and other cytokines in the pancreatic fluid of patients with chronic pancreatitis. Hypothesis: Pain does not correlate with changes in the PD morphology suggesting that pain in CP is not only a mechanical problem Pain in CP correlates better with the levels of NGF in the pancreatic juice. NGF is variably expressed in different morphological stages of CP and regulates the sensitivity of the peptidergic nociceptors and is upregulated in pancreatic inflammation.

Official Title
-----------------
Nerve Growth Factor in Chronic Pancreatitis

Conditions
-----------------
Chronic Pancreatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with established CP and none of the exclusion criteria mention below. Exclusion Criteria: Failure to obtain consent. Any comorbid condition with expected survival < 1 year. Patients with pacemaker, implanted metallic prosthesis or other contraindications to do MRCP. Patients < 18 years of age at time of consent

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 |
| --- | --- |
| Chronic pancreatitis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The levels of NGF in subjects with different morphological stages of chronic pancreatitis (CP) will be compared to the controls and in each morphological stage of CP will be correlated with pain scores. |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate the expression of NGF and other inflammatory cytokines in the pancreatic juice in each morphological stage of CP. |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tio identify role of NGF in pain in CP, Identify biomarkers related to progression of CP
Cicatrix Cream in Post Surgical Scars and Epidermic Burn

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the effect of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of epidermic burns or post surgical scars. The duration of this phase 2 clinical trial will be two months.

Official Title
-----------------
Effect the Cicatrix Cream in in Treatment of Post Surgical Scars and and Epidermic Burn.

Conditions
-----------------
Post Surgical Scars, Epidermic Burn

Intervention / Treatment
-----------------
* Other: Cicatrix cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with lesions characteristic of the investigated illness. Signed informed consent Exclusion Criteria: Patient that refer manifestations of high sensibility to the medication or to some of the components of the product Patient that don't want to participate in the study Patient not very cooperative Family responsible not very cooperative

Ages Eligible for Study
-----------------
Maximum Age: 18 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: A<br>Cicatrix cream | Other: Cicatrix cream<br>* We will be carried out the topical application of the product (Cicatrix cream) in the epidermic burns or post surgical scars by administration fo the patients twice a day during two months to a dose of 0,1 ml of cream for each cm of surface, being controlled by the specialist in biweekly consultations. To the patient will be explained the technique of the application.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of the areas of lesions at 2 months (end of the treatment) |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coloration of the lesions at 2 months (end of the treatment) |  | 2 months | 
| Adverse effects |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post surgical scars, Epidermic burn, Cicatrix cream
Evaluate Immune Response Approximately 5 to 6 Years After Receiving Different Formulations of GSK Bio Hep B Vaccine

Study Overview
=================
Brief Summary
-----------------
To evaluate the persistence of antibodies against hepatitis B, approximately 5 to 6 years after the first dose of the hepatitis B in the primary vaccination study.

Detailed Description
-----------------
All subjects who participated in the primary vaccination study, where subjects who received GSK Biologicals' hepatitis B vaccine and who will consent to participate in this long-term follow-up study, approximately 5 to 6 years after the primary vaccination study. The study will be conducted in only 3 centres out of the 4 centres in the primary vaccination study.

Official Title
-----------------
Evaluate the Anti-HBs Antibody Persistence, in Subjects Who Received GSK Biologicals' Preservative-free or Thiomersal-free Engerix™-B or Engerix™-B Containing Thiomersal, Approximately 5 to 6 Yrs Earlier

Conditions
-----------------
Hepatitis B

Intervention / Treatment
-----------------
* Biological: Hepatitis B vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects should have participated in the primary study and should have received the first primary dose of vaccination more than five years ago and less than six years ago before blood sampling in this long-term follow-up study. Written informed consent obtained from the subject for the long-term follow-up.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Hepatitis B vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Combination of Local Therapy and Target Therapy for Brain Metastases With EGFR Mutation

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to learn about the survival benefit of local therapy combination with target therapy in lung cancer brain metastases with EGFR mutation. The main questions it aims to answer are: Is local therapy performed before or after target therapy would provide survival benefit ? What kind of local therapy combining with target therapy would provide survival benefit, neurosurgical resection or radiotherapy?

Official Title
-----------------
Survival Benefit of Combination of Local Therapy and Target Therapy for Brain Metastases With EGFR Mutation: A Multicenter Retrospective Study

Conditions
-----------------
Brain Metastases

Intervention / Treatment
-----------------
* Other: Surgery or Radiotherapy
* Other: before or after target therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Evidence of pathological diagnosis of primary tumor. Brain metastases confirmed by enhanced magnetic resonance imaging. Gene test indicated that EGFR mutation. Complete clinical information. Exclusion Criteria: If surgical treatment is accepted, the surgical treatment is not tumor resection, but ventricle puncture, biopsy and other non-tumor reducing surgery. Patients with 2 or more types of tumors. Incomplete clinical information.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| target therapy + local therapy group vs target therapy alone group<br> | Other: Surgery or Radiotherapy<br>* Participants who underwent target therapy and surgery or radiotherapy were divided into target therapy + local therapy group. Participants who underwent target therapy alone were divided into target therapy alone group<br>|
| local therapy before target therapy group vs local therapy after target therapy group<br> | Other: before or after target therapy<br>* Participants who underwent surgery or radiotherapy before target therapy were divided into local therapy before target therapy group. Participants who underwent surgery or radiotherapy after target therapy were divided into local therapy after target therapy group.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall survival | From date of first follow-up until the date of documented death from any cause, assessed up to 120 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression-free survival | From date of first follow-up until the date of first documented progression, assessed up to 120 months |
Efficacy and Tolerability of Two Different Administration Routes With SLITonePLUS Birch

Study Overview
=================
Brief Summary
-----------------
Multicentre Phase II trial, comparing two different administration routes of SLITonePLUS Birch in regard to pharmacodynamic efficacy and tolerability.

Official Title
-----------------
A Multicentre Randomised Phase II Clinical Pilot Study to Compare the Pharmacodynamic Efficacy and Tolerability of the Sublingual and the Vestibular Administration Route for SLITonePLUS® Birch

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Biological: oral immunotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A history of Birch pollen allergy Positive skin prick test to birch Positive specific IgE to birch Exclusion criteria: Uncontrolled or severe asthma (FEV1<70% of predicted value in spite of adequate pharmacologic treatment) Previous treatment by immunotherapy with birch or a cross-reactingtree pollen allergen within the previous 5 years Concomitant SLIT with any allergen

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: sublingual administration<br>oral immunotherapy with drops applied once daily by single dose containers (200 STU per dose) | Biological: oral immunotherapy<br>* orally applied specific immunotherapy<br>* Other names: SLITone birch;|
| Active Comparator: vestibular administration<br>oral immunotherapy with drops applied by single dose containers (200 STU per dose) | Biological: oral immunotherapy<br>* orally applied specific immunotherapy<br>* Other names: SLITone birch;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic efficacy of two different administration routes of SLITonePLUS Birch | specific antibody determination | after 4, 8, 12, 24, 36 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the two administration routes with regard to safety aspects | adverse events | 36 weeks |
Oxaliplatin in Unresectable Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
Primary: To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-Fluorouracil/Leucovorin Secondary: Safety and tolerability of this regimen in these patients

Official Title
-----------------
Phase II Study of Eloxatin + 5-Fluorouracil/Leucovorin in Patients With Unresectable Hepatocellular Carcinoma

Conditions
-----------------
Carcinoma, Hepatocellular

Intervention / Treatment
-----------------
* Drug: Oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have histologically confirmed hepatocellular carcinoma Patients must have measurable disease by CT scan Patients with unresectable, recurrent or metastatic disease may be chemonaive or may be previously treated by chemotherapy. The period of washout of prior chemotherapy must be greater than 4 weeks from date of randomization. The prior chemotherapy should not include platinum compounds. WHO performance status: 0 to 2 Patients must have adequate organ and marrow function as defined below: Leukocytes : ≥ 3,000/μl Absolute neutrophil count :≥ 1,500/μl Platelets : ≥ 80,000/μl Total bilirubin : < 3.0g/dl ASAT/ALAT : ≤ 3 times the upper normal limits of the institute Creatinine : < 120μmol/l Patients with no evidence of clinically significant neuropathy. Exclusion Criteria: Documented allergy to platinum compound or to others study's drugs Pregnant or lactating women or women of childbearing potential (e.g. not using adequate contraception) Hematological disorder or malignancies Metastasis to central nervous system Other serious illness or medical conditions: Active infectious disease Congestive heart failure, or angina pectoris. Previous history of myocardial infarction within 1 year from study entry; uncontrolled hypertension or arrhythmia. Concurrent treatment with any other anticancer therapy Concurrent treatment with other experimental drugs. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Tumor Progression (TTP) and Response Rate: evaluated by RECIST |  | During the Study Conduct | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events collections and evaluation |  | From the signature of the informed consent up to the end of the study |
Lower Urinary Tract Symptoms Screening Questionnaire

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the validity of a screening tool which has been designed to detect the presence or absence of lower urinary tract symptoms in the general female population.

Official Title
-----------------
Lower Urinary Tract Symptoms Screening Questionnaire Validation STudy

Conditions
-----------------
Cystocele

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy participants, 18 years of age and older with any gynecological symptoms Exclusion Criteria: Patients with lower urinary tract symptoms and pelvic floor dysfunction

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| observation<br>Healthy participants | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or absence of lower urinary tract symptoms in the general female population | To validate the effectiveness of a screening tool in detecting the presence or absence of lower urinary tract symptoms in the general female population. | Five years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urinary tract
Efficacy and Safety Evaluation of IBI188 in Combination With Demethylating Agents in Treatment of Patients With Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
The study is to evaluate safety, tolerability and composite CR of IBI188 plus Demethylating Agents in acute myeloid leukemia

Official Title
-----------------
A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Demethylating Agents in Subjects With Acute Myeloid Leukemia

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: IBI188
* Drug: Azacitidine
* Drug: Decitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AML patients diagnosed according to WHO AML diagnostic criteria in 2016 (except M3-type and BCR-ABL positive AML). Relapsed// refractory AML( ≥18 ys) or newly diagnosed elderly AML unfit for intensive chemotherapy( ≥60 ys). Age ≥18 years old, gender not limited. ECOG score of 0-2. Adequate organ function. Exclusion Criteria: Acute promyelocytic leukemia, myeloid sarcoma, acute heterozygous leukemia, CMML(accelerated phase and blast phase). A history of myeloproliferative diseases (including myelofibrosis, primary thrombocytosis, and true red) Cytosis, chronic myelocytic leukemia) or acute myeloid white blood with BCR-ABL1 translocation Patients. Major surgery and vaccine treatment within 4 weeks. Uncontrolled concurrent diseases. Pregnant or breastfeeding female subjects.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBI188+azacitidine<br>1L unfit AML receive IBI188 every week by intravenous(IV) and azacitidine daily in Day 1-7 of each four weeks(Q4W) by subcutaneous(IH) | Drug: IBI188<br>* anti-CD47 Monoclonal antibody<br>Drug: Azacitidine<br>* Demethylation drugs<br>|
| Experimental: IBI188+decitabine<br>R/R AML receive IBI188 every week by intravenous(IV) and decitabine daily in Day 1-10 of each four weeks(Q4W) by subcutaneous(IH) | Drug: IBI188<br>* anti-CD47 Monoclonal antibody<br>Drug: Decitabine<br>* Demethylation drugs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite complete rate | Composite CR including complete remission rate and morphologic complete remission with incomplete blood count recovery | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytogenetic CR |  | 24 weeks |