linjc16/ctgov huggingface dataset:
Auscultation and Pulse Oximetry Combined Screening of Neonatal Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
The investigators conducted this retrospective study in a large single center with an annual birth of more than 20,000 newborns, from January 1, 2018 to December 31, 2019, to confirm the applicability and accuracy of pulse oximetry (POX) combined cardio-auscultation to screen congenital heart disease for neonates.

Detailed Description
-----------------
All consecutive newborn babies were eligible, irrespective of gestational age, NICU admission, symptom presence or prenatal diagnosis. This study was approved by institutional ethical review board of Linyi Maternal and Child Healthcare Hospital. Spoken informed consent was obtained from the participating babies' parents. Physicians from departments of neonatal medicine and developmental medicine undertake auscultation screening. When abnormal murmur occurred, an echocardiography would be requested to confirm if the newborn has CHD or not. Physicians from obstetrics department and nursing staff from neonatal department undertake POX measurement. If a positive POX occurred, an echocardiography would be requested to confirm if the newborn has CHD or not. Physicians from department of ultrasonography undertake echocardiography confirmation for newborns deemed positive by auscultation or POX.

Official Title
-----------------
The Effectiveness of Cardio-auscultation and Pulse Oximetry Combined Screening of Congenital Heart Disease in Newborns

Conditions
-----------------
Congenital Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive newborn babies delivered in the study center were eligible, irrespective of gestational age, NICU admission, symptom presence or prenatal diagnosis. Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Minimum Age: 0 Hours
Maximum Age: 72 Hours

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 |
| --- | --- | --- |
| Severe congenital heart disease | Patients who present as severely ill in the newborn period or early infancy, including those with cyanotic heart disease and acyanotic lesions like AVSD, large VSD, large PDA, critical or severe AS, severe PS, critical coarc. | The first 24 hours after birth. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulse oximetry, Auscultation, Congenital Heart Disease, Screening
The Effect of Gabapentin (Neurentin) and Pregabalin (Lyrica) in Pain Reduction After Photorefractive Keratectomy

Study Overview
=================
Brief Summary
-----------------
The studied patients will be given randomly one of three following drugs1:Gabapentin2: Pregabalin or placebo for 3 days after Photorefractive keratectomy surgery. The pain will be measured based on visual analog scale(VAS) on the day of operation and on the 3 rd day (morning, evening) and then compared among three groups.

Conditions
-----------------
Refractive Errors

Intervention / Treatment
-----------------
* Drug: Pregabalin
* Drug: Pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients candidate for PRK, 17<age<70 Exclusion Criteria: use of any systemic analgesic drugs, drug intolerance, need of systemic or topical administration of NSAIDs or eye drops for allergy and glaucoma, dry eyes, pregnancy, breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 17 Years

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gabapentin<br> | Drug: Pregabalin<br> <br> |
| Active Comparator: Pregabalin<br> | Drug: Pregabalin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain degree based on visual analog scale(VAS) |  |  |
Lung Health After Tuberculosis: Clinical and Functional Assessment in Post Pulmonary Tuberculosis Egyptian Patients.

Study Overview
=================
Brief Summary
-----------------
Some of pulmonary tuberculous patients who completed their medication course experience lung function impairment

Detailed Description
-----------------
Some of pulmonary tuberculous patients who completed their medication course experience lung function impairment which may influence their quality of life. However, the pattern and nature of post-tuberculosis lung impairment is still not identified. Thus, the aim of this study was to determine the type and degree of lung physiology changes in previously treated tuberculous patients which latter may affect their quality of life; thus helping clinicians for early diagnosis of lung impairment, especially in tuberculous endemic areas.

Official Title
-----------------
Lung Health After Tuberculosis: Clinical and Functional Assessment in Post Pulmonary Tuberculosis Egyptian Patients.

Conditions
-----------------
Pulmonary Tuberculoses, Pulmonary Function; Newborn, Abnormal

Intervention / Treatment
-----------------
* Diagnostic Test: spirometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient completed an outpatient course of standard first line anti-tuberculosis therapy and declared as cured Exclusion Criteria: Smoker (to avoid spirometry biases). Extrapulmonary tuberculosis cases Multidrug resistant tuberculosis known contraindications to spirometry testing Individuals with chest wall deformities or neuromuscular diseases Patients who failed to achieve acceptability and reproducibility criteria of the spirometry test Defaulter cases or irregular treatment, known coexisting chronic lung disease as history of asthma or interstitial lung diseases A history of illicit drug use Patients with comorbidities: renal and hepatic insufficiency, heart diseases and metabolic disorders.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cured pulmonary Tuberculosis patients<br>6 months after a completed course of anti-tuberculosis therapy | Diagnostic Test: spirometry<br>* Patient do spirometry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post tuberculosis lung functional impairment | spirometry abnormality either: restrictive, obstructive, or mixed | 6 months | 
| post tuberculosis persistent clinical symptoms | either cough , sputum , breathlessness, hemoptysis | 6 months | 
| Grading of obstruction function: | grading according to GOLD : mild , moderate , severe , very severe | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulmonary Tuberculosis, Spirometry, Pulmonary Function
The Prediction Biomarkers of Survival Outcome for Severe Immune-related Hepatitis

Study Overview
=================
Brief Summary
-----------------
Immune checkpoint inhibitors have revolutionized lung cancer (LC) treatment, demonstrating a significant improvement in overall survival. However high-grade immune-related adverse events (irAEs) may result in harmful and serious clinical outcomes, even death. Immune-related hepatitis (IRH) is a potentially serious complication of checkpoint blockade, with an incidence of 5%-10% for ICIs monotherapy, including 1%-2% with grade 3 or higher. Therefore, it is particularly important to explore new and better prognostic and predictive biomarkers for IRH.

Official Title
-----------------
The Prediction Biomarkers of Survival Outcome for Severe Immune-related Hepatitis in Lung Cancer

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Drug: PD-1/PD-L1 inhibitors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The lung cancers were diagnosed by pathological evaluation. The PD-1/PD-L1 inhibitors were administered in all patients. Grade 3-5 immune-related hepatitis had occurred. The pre-treatment tissues or peripheral blood were available. Exclusion Criteria: The pathological type was not lung cancers. Grade 1-2 immune-related hepatitis would be excluded. The any-grade hepatitis were induced by chemotherapy or virus.

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 |
| --- |
|Drug: PD-1/PD-L1 inhibitors|PD-1/PD-L1 inhibitors (the dosage calculation according to dosing instructions)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Immune-Related Hepatitis | Number of participants with Grade 3-4 IRH graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 2 years | 
| Number of Participants Deaths | Number of participants with Grade 3-4 immune-related hepatitis by CTCAE 4.0 who still died after the corticosteroid (2mg/kg) and/or mycophenolate mofetil treatment. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Laboratory Abnormalities in Liver Tests | Number of participants with laboratory liver tests based on Hunan Cancer hospital to determine the safety of immunotherapy. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: ALT or AST >5-20 ULN, and > 20 x ULN;Total bilirubin > 3-10 ULN and > 10 x ULN | 2 years |
Phase II Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy, safety and pharmacokinetics profile of KPS-0373 in patients with SCD

Official Title
-----------------
An Open-label, Phase II Study of KPS-0373 in Patients With SCD

Conditions
-----------------
Spinocerebellar Degeneration

Intervention / Treatment
-----------------
* Drug: KPS-0373


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SCD with mild to moderate ataxia Exclusion Criteria: Patients with secondary ataxia Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 20 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: 1<br> | Drug: KPS-0373<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scale for the assessment and rating of ataxia (SARA), ADL(Flow-FIM), Patient Improvement Impression |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinocerebellar degeneration, Thyrotropin-Releasing Hormone (TRH), SCD
Pheno- & Genotyping POF (WHO III)

Study Overview
=================
Brief Summary
-----------------
This study focuses on the phenotyping and genotyping of women with hypergonadotropic ovarian dysfunction (WHO III status).

Detailed Description
-----------------
First goal of the study is to phenotype patiens with hypergonadotropic ovarian dysfunction (WHO III) adequately. This group includes women with premature ovarian failure (POF), incipient ovarian failure (IOF), poor response after ovarian hyperstimulation, early menopause and hypergonadotropic primary amenorrhea. The standardized phenotyping consists of a questionnaire focusing on reproductive, medical, and family history; ultrasonography to assess ovarian reserve and/or antral follicle count and obtaining an extra blood sampling during routine endocrine screening for genotyping. Phenotyping of patients presenting with ovarian dysfunction is of crucial importance when genotyping will be performed. The goal of this genotyping will be the identification of genetic factors associated with the (premature) depletion of the stock of ovarian follicles. It will be performed for isolated WHO III patients in an association (case-control) study for known candidate genes. In familial WHO III cases, genome wide linkage analysis will be performed.

Official Title
-----------------
Phenotyping and Genotyping of Women Presenting With Ovarian Dysfunction Associated With a Hypergonadotropic Hypo-estrogenic Hormonal Status (WHO III) and Their First and Second Degree Relatives

Conditions
-----------------
Premature Ovarian Failure (POF), Incipient Ovarian Failure, Poor Response After Ovarian Hyperstimulation, Early Menopause, Hypergonadotropic Amenorrhea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: POF; defined as secondary amenorrhea before 40 years of age and basal FSH > 40 IU/L Incipient ovarian failure; defined as normo-ovulatory cycles, raised basal FSH > 12 IU/L Poor response patients; defined as less than 4 oocytes retrieved or cancellation in case of absent follicle growth after ovarian hyperstimulation with 300 IU gonadotropins or cancellation in case of absent follicle growth Women with early menopause (between 40-45 years) Hypergonadotropic primary amenorrhea Exclusion Criteria: Primary amenorrhea with early development disorders causing absence of ovaries and Swyer syndrome (XY)

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

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
POF, IOF, Poor response, early menopause, Primary amenorrhea
An Extension Study for Patients Previously Treated With ARQ 501

Study Overview
=================
Brief Summary
-----------------
To provide ongoing treatment with ARQ 501 for patients who have benefited from prior treatment with ARQ 501

Official Title
-----------------
An Extension Study for Patients Previously Treated With ARQ 501

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

Intervention / Treatment
-----------------
* Drug: ARQ 501


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent Has previous participated in a clinical trial with ARQ 501 and is eligible for continued treatment Exclusion Criteria: Have not received previous treatment with ARQ 501 under a treatment protocol Uncontrolled intercurrent illness, uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ARQ 501|Treatment with ARQ 501 or ARQ 501 as combination therapy at the dose and regimen previously received|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide ongoing treatment with ARQ 501 for patients who have benefited from prior treatment with ARQ 501 |  | No time frame | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect additional safety and tolerability information for ARQ 501 treatment |  | No time frame | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, solid tumor
COVID-19 Recovered Volunteer Research Participant Pool Registry

Study Overview
=================
Brief Summary
-----------------
This is a prospective observational registry of COVID-19 recovered patients who are no longer symptomatic. This Registry is intended to serve as a pool of individuals that can participate in studies associated with serological testing, characterization of immunity and immune response, vaccine development, and convalescent plasma donors.

Official Title
-----------------
COVID-19 Recovered Volunteer Research Participant Pool Registry

Conditions
-----------------
Recovered From COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients seen the in emergency room, admitted patients, or seen in outpatient clinics that are: Tested Positive for COVID-19 and recovered Suspected to have COVID 19 and validated with serological testing Suspected to have COVID 19 by symptoms, clinical course, and laboratory testing ruling out other respiratory viral disease

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serological testing of COVID patients | Testing may be done on registry participants who agree to participate future studies | Up to 20 years | 
| Immune response | Testing may be done on registry participants who agree to participate future studies | Up to 20 years |
Treatment of Hidradenitis Suppurativa Using Etanercept

Study Overview
=================
Brief Summary
-----------------
Therapy with etanercept, a TNF inhibitor will reverse the inflammation, symptoms and quality of life and allow healing of HS.

Official Title
-----------------
Treatment of Hidradenitis Suppirativa With Etanercept Injection

Conditions
-----------------
Hidradenitis Suppurativa

Intervention / Treatment
-----------------
* Drug: etanercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic HS for > 6months defined as tender and/or painful, red nodules and/or plaques (confluent nodules) with or without scarring, foul odor, or draining sinuses clinically with HS Localizes to skin folds including any of axillx, breast, abdomen and groin active disease Negative pregnancy test within 7 days before the first dose of study drug Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study Exclusion Criteria: Concurrent active infection including tuberculosis Concurrent therapy or therapy 30 days prior with systemic corticosteroids, systemic immunosuppressants, systemic retinoids or ant-TNF agents Severe comorbidities (diabetes mellitus requiring insulin, Q F of any severity, MI, unstable angina eectoris, uncontrolled hypertension, oxygendependent severe pulmonary disease, history of cancer *thin 5_ years except cutaneous basal cell or squamous cell carcinoma or in situ cervical carcinoma, history of TB or TB exposure, chronic hepatitis B or C, SLE, history of multiple sclerosis, transverse myelitis, optic neuritis or epilepsy Currently enrolled or enrolled within 90 days prior in any trial for treatment of HS Known HIV positive Contraindication to etanercept as defined in package insert

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| placebo controlled<br>A randomized, double-blind trial of 3 months duration comparing etanercept 50 mg sc twice weekly to placebo in 20 patients with HS. Patients will be randomized with equal allocation to the two treatment groups. | Drug: etanercept<br>* etanercept 50 mg sc twice weekly<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician global assessment of HS of clear or mild at week 12 |  | Week 12 |
Post-marketing Surveillance of Lenvatinib Mesylate (Lenvima Capsule) in Patients With Unresectable Thyroid Cancer (Study LEN01T)

Study Overview
=================
Brief Summary
-----------------
This study is a post-marketing surveillance of lenvatinib in participants with unresectable thyroid cancer. The objectives of this study are to capture unknown adverse reactions, incidences of adverse drug reaction, efficacy, factors considered to have effect to safety and effectiveness, and incidences of hypertension, hemorrhagic events and thromboembolic event, and liver disorder.

Official Title
-----------------
Post-marketing Surveillance of Lenvatinib Mesylate (Lenvima Capsule) in Patients With Unresectable Thyroid Cancer (Study LEN01T)

Conditions
-----------------
Thyroid Neoplasms

Intervention / Treatment
-----------------
* Drug: Lenvatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. All participants with unresectable thyroid cancer and administrated Lenvatinib.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm 1<br>A prospective, centrally registered investigation will be conducted. The new administering participants are to be registered at the time of administration. | Drug: Lenvatinib<br>* 24mg once daily oral dosing to Unresectable thyroid cancer patients<br>* Other names: E7080, Lenvima;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs)/adverse drug reactions (ADRs) |  | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thyroid Cancer, Lenvima, Post-marketing surveillance, LEN01T, All-Patient Investigation, Lenvatinib Mesylate