linjc16/ctgov huggingface dataset:
Intravenous VAL-1221 Lafora Expanded Access Protocol

Study Overview
=================
Brief Summary
-----------------
Only qualified physicians treating a Lafora Disease patient may request VAL-1221 Expanded Access treatment under the Parasail Lafora Expanded Access Protocol (LEAP). According to FDA guidance, this protocol can enroll up to 10 patients. However, individual patient inclusion will ultimately be dependent on protocol eligibility, site geography, treatment requirements, and available supply of the investigational therapy. Inquiring physicians can submit a request by contacting the Central Contact personnel listed below in Contacts/Locations.

Official Title
-----------------
Intravenous VAL-1221 Lafora Expanded Access Protocol (LEAP)

Conditions
-----------------
Lafora Disease

Intervention / Treatment
-----------------
* Drug: VAL-1221


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented genetic diagnosis of Lafora Disease (LD) based on likely pathogenic or pathogenic variants in both alleles of either the EPM2A or the EPM2B gene Mid-stage in evolution of LD between 12 and 28 years of age Able and willing to comply with the protocol, including travel to Protocol Center, procedures, measurements and visits, including: Adequately supportive psychosocial circumstances, in the opinion of the Investigator Caregiver/trial partner committed to facilitate patient's involvement in the study who is reliable, competent, at least 18 years of age Exclusion Criteria: Have any other conditions, which, in the opinion of the Investigator or Sponsor would make the participant unsafe for inclusion or could interfere with the participant participating in or completing the protocol

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 28 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: VAL-1221|VAL-1221 20mg/kg intravenous (IV) infusion every other week|

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
-----------------
Glycogen Storage Diseases, Polyglucosan Disorders, Progressive Myoclonic Epilepsy
Otoferlin Patient Registry and Natural History Study

Study Overview
=================
Brief Summary
-----------------
This registry is designed to collect comprehensive information about the molecular genetic diagnoses of individuals with otoferlin-associated hearing impairment and clinical information to support a natural history study.

Detailed Description
-----------------
A patient registry, in both German and English languages, has been established for patients with hereditary hearing impairment due to variants in otoferlin (OTOF). The study is conducted in accordance with the current version of the Declaration of Helsinki. The study protocol and database structure have been approved by the Ethics Committee of the University Medical Center Göttingen. Main objective criterion: To increase understanding of natural history, types of genetic variants and to facilitate clinical and basic research on otoferlin-associated hearing impairment. Secondary objective criterion: To improve knowledge to better characterize individuals with otoferlin-associated hearing impairment in the long term and create prerequisites for improved, patient tailored therapy and care.

Official Title
-----------------
Patient Registry for Individuals With Otoferlin-Associated Hearing Loss

Conditions
-----------------
Otoferlin-related Auditory Synaptopathy, Hearing Impairment

Intervention / Treatment
-----------------
* Diagnostic Test: Molecular genetic testing and audiometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A molecular genetic diagnosis involving biallelic variants in otoferlin (OTOF) and audiometry Exclusion Criteria: Patients with evidence of non-OTOF molecular genetic diagnoses
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Otoferlin participant group<br>Individuals with hearing impairment who have a molecular genetic diagnosis involving otoferlin | Diagnostic Test: Molecular genetic testing and audiometry<br>* Genetic testing and audiometry are the interventions of interest<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pure-tone audiometry | Audiological characteristics | 1 year, year 1, according to participant consent | 
| Speech audiometry | Audiological characteristics | 1 year, year 1, according to participant consent | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Otoacoustic emission thresholds | Electrophysiological characteristics | 1 year, year 1, according to participant consent | 
| Auditory brainstem response | Electrophysiological characteristics | 1 year, year 1, according to participant consent | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Otoferlin patient registry, Natural history study
The Role of Autoimmunity and Obesity in Polycystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to detect autoantibodies in the serum of the women with PCOS and evaluate the obesity markers to investigate the the role of autoimmunity and obesity in PCOS

Official Title
-----------------
The Role of Autoimmunity and Obesity in Polycystic Ovary Syndrome

Conditions
-----------------
Polycystic Ovary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed with PCOS according to the Rotterdam (2003) criteria. Exclusion Criteria: Patients with other causes of hyperandrogenism as congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia, virilizing ovarian or adrenal tumors and those taking drugs affecting insulin resistance, such as estrogens, oral contraceptives and corticosteroids during the previous three months before the study.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 55 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 |
| --- | --- |
| patients with PCOS<br> | |
| control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measuring serum anti-ovarian, anti-nuclear, anti-double stranded and anti-thyroid antibodies | Theses markers will be measured using ELISA technique | 3 months after recruitment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autoimmunity, obesity, Polycystic ovary syndrome
Prospective Ultrafast MRI Radiomics for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The goal of this prospective study is to investigate the performance of ultrafast MRI radiomics in classifying histological factors and subtypes of breast cancer compared with standard MRI among radiologists with varying experience. The written informed consent was obtained from all participant. We extracted 1618 radiomic features from ultrafast and standard contrast-enhanced MRI before treatment. Classification of hormonal receptors, human epidermal growth factor receptor 2, and Ki67 status and subtypes was evaluated using the area under the receiver-operating characteristic curve (AUC) with the DeLong test.

Official Title
-----------------
Ultrafast MRI Radiomics to Classify Histological Factors and Subtypes of Breast Cancer

Conditions
-----------------
Breast Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with invasive breast cancer Exclusion Criteria: Diagnosed with other cancer

Ages Eligible for Study
-----------------
Minimum Age: 27 Years
Maximum Age: 86 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: MRI|MRI based classification of breast cancer histological factors and subtypes|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The signal intensity of MRI according to histological factors and subtypes of breast cancer | Quantitative image values obtained from ultrafast MRI show similar performance in classifying histological factors and subtypes compared with standard MRI. | Baseline, pre-surgery |
Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This trial is a multicenter, open-label, phase II trial conducted at 23 centers in China. High-risk HER2 positive patients receive pyrotinib 400mg/day for one year or half year for extented adjuvant therapy.

Detailed Description
-----------------
Patients must meet one of the following criteria: N stage ≥1; T stage ≥2; did not achieve pathological complete response (pCR) after neoadjuvant therapy; had pCR after neoadjuvant therapy but with tumor size ≥ 5cm or N stage ≥2; or tumor size less than 2cm but with high Ki67; histologic grade 3 or with lymph node micrometastasis.

Official Title
-----------------
Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer: an Open-label, Multi-center Trial

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Pyrotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 18-75 years old HER2 positive breast cancer ECOG PS 0-1 Known hormone receptor status Completed 1 year of trastuzumab-based adjuvant therapy within 6 months Patients at high risk Exclusion Criteria: Serious heart disease or discomfort Inability to swallow, intestinal obstruction, or the presence of other factors that interfere with drug administration and absorption Known allergic history of drug components of this regimen A history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation Pregnant and lactating female patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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: Pyrotinib 400mg/day<br>High risk HER2 positive patients receive pyrotinib 400mg/day for half or one year | Drug: Pyrotinib<br>* Patients receive pyrotinib 400mg/day for half or one year<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iDFS | INVASIVE DISEASE FREE SURVIVAL | From date of receiving drug until the date of first documented invasive disease or date of death from any cause, whichever came first, assessed up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall Survival | From date of receiving drug until the date of death from any cause, assessed up to 60 months | 
| Adverse events | frequency of adverse events | through study completion, an average of 5 years |
A Retrospective Study Reveals the Relationship Between gp42-IgG Epitopes and EBV-associated NPC

Study Overview
=================
Brief Summary
-----------------
Epstein-barr virus (EBV) infection is a necessary factor of nasopharyngeal carcinoma (NPC). The incidence of NPC in endemic regions reaches 24.60/100,000 people, far higher than that of the worldwide average. However, no EBV prophylactic vaccines is clinically available so far, which is largely hampered by the difficulties in selecting optimal vaccine design target out of 13 glycoproteins on the surface of EBV. In this study, we utilized humanized gp42-IgG antibodies to explore the dominant epitopes of gp42, one of the functional EBV glycoproteins during virus entry, to facilitate prophylactic vaccine design.

Official Title
-----------------
A Retrospective Study Reveals the Relationship Between gp42-IgG Epitopes and EBV-associated NPC

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

Intervention / Treatment
-----------------
* Diagnostic Test: Epitope exploration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Controls underwent physical examinations or primary NPC cases confirmed by pathology or cytology. If cases, at stage I-IVB diagnosed by radiology according to AJCC/UICC 8th. If cases, Karnofsky score (KFS)≥70, estimated survival span>12 months. If cases, no disordered of major organs is found; blood test, liver, and kidney functions are basically normal. If cases, at least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. Exclusion Criteria: History of other malignant diseases. History of severe systemic diseases or heart, lung, liver, or kidney disfunction. History of severe neurological, metal, endocrine diseases. History of HBV, HCV, HIV, TP, or TB infection. If controls, physical examination reveals systemic diseases including malignant diseases. If cases, incomplete blood and pathological sample data. If cases, not receiving primary treatment in this facility. Other individuals investigators find not suitable for the trial.
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 |
| --- | --- |
| Case<br> | Diagnostic Test: Epitope exploration<br>* Explore the epitope landscape of gp42-IgG of cases in comparison with that of controls.<br>|
| Control<br> | Diagnostic Test: Epitope exploration<br>* Explore the epitope landscape of gp42-IgG of cases in comparison with that of controls.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dominant gp42-IgG epitopes in cases | Dominant gp42-IgG epitopes revealed by ELISA with non-competitive monoclonal humanized antibodies against gp42 will be compared between cases and controls. | Baseline |
Incorporation of Protein Induced by Vitamin K Absence or Antagonist-II Into Transplant Criteria Expands Beneficiaries of Liver Transplantation for Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
This is a multi-center study in China to investigate the role of PIVKA-II in HCC recipient selection and prognostic stratification by analyzing the data of 522 recipients with HCC registered in the China Liver Transplant Registry.

Official Title
-----------------
Incorporation of Protein Induced by Vitamin K Absence or Antagonist-II Into Transplant Criteria Expands Beneficiaries of Liver Transplantation for Hepatocellular Carcinoma: A Multi-center Retrospective Cohort Study in China

Conditions
-----------------
Cancer of Liver

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The HCC patients received LT with pre-operative PIVKA-II records performed from January 2015 to December 2020, whose clinicopathological data were registered in the CLTR. Exclusion Criteria: (1) patients who received split LT or simultaneous transplantation, (2) patients who received re-transplantation, (3) patients with macroscopic portal vein tumor thrombosis or other macrovascular invasion, (4) patients with incomplete follow-up or incomplete important parameters records.

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 |
| --- | --- |
| Recipients with preoperative PIVKA-II≤240mAU/mL<br> | Other: No intervention<br>* No intervention<br>|
| Recipients with preoperative PIVKA-II>240mAU/mL<br> | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | the overall survival of liver transplant recipient with HCC | January 2015 to December 2020 |
The Effect of Low-Level Laser Therapy as an Adjunct to Non-surgical Therapy in Different Age Groups

Study Overview
=================
Brief Summary
-----------------
the summary is to evaluate The Effect of Low-Level Laser Therapy as an Adjunct to Non-surgical Therapy on Inducible Nitrous Oxide Synthase Salivary Levels in Different Age Groups of Chronic Periodontitis Patients

Detailed Description
-----------------
2 ml of unstimulated saliva will be collected using spitting method, the collected samples will then be analyzed using Elisa technique for salivary Inducible nitrous oxide synthase levels.

Official Title
-----------------
The Effect of Low-Level Laser Therapy as an Adjunct to Non-surgical Therapy on Inducible Nitrous Oxide Synthase Salivary Levels in Different Age Groups of Chronic Periodontitis Patients (A Randomized Clinical Trial)

Conditions
-----------------
Periodontal Inflammation

Intervention / Treatment
-----------------
* Other: diode laser
* Other: non surgical scaling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males and females aged below 40 or above 60 periodontitis stage 2 no tooth loss due to periodontitis Exclusion Criteria: smoking habits history of antibiotics history of systemic diseases

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 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: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: old age group<br>old age group above 60 years old | Other: diode laser<br>* low level diode therapy<br>Other: non surgical scaling<br>* non surgical scaling using ultrasonic<br>|
| Placebo Comparator: young aged group<br>young age group below 40 years old | Other: diode laser<br>* low level diode therapy<br>Other: non surgical scaling<br>* non surgical scaling using ultrasonic<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical parameters (gingival index) | measurement if the gingival index using scoring system. A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation. | 6 months | 
| clinical parameters (clinical attachment loss) | measurement of clinical parameters clinical attachment loss in millimeters | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of inducible nitrous oxide synthase levels | measurement of inducible nitrous oxide synthase levels in different age groups before the procedure and after using Elisa kit. | 3 months |
Cardioprotective Effects of Cardiopeptides for Injection in Patients With Non-severe Cardiac Disease: a Single-center Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The study was a single-center, randomized controlled trial. To explore the cardioprotective effect of cardiopeptide on non-heart disease patients with severe cardiac injury by comparing whether cardiopeptide was used.

Official Title
-----------------
Cardioprotective Effects of Cardiopeptides for Injection in Patients With Non-severe Cardiac Disease: a Single-center Randomized Controlled Trial

Conditions
-----------------
Myocardial Injury, ICU

Intervention / Treatment
-----------------
* Drug: Cardiopeptides


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years old The high-sensitive troponin T index was higher than the normal value during ICU hospitalization Obtain the informed consent of the subject or legal agent Exclusion Criteria: Patients who are expected to die within 48 hours of ICU admission previous diagnosis of acute coronary syndrome, chronic cardiomyopathy, pulmonary heart disease, acute myocarditis, pericardial tamponade and other diseases that have been confirmed to cause myocardial injury cardiopulmonary resuscitation and/or electrical defibrillation before admission patients with acute ischemic stroke patients with stage 5 chronic kidney disease during pregnancy or breastfeeding

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiopeptides<br>Cardiopeptide was administered intravenously once a day with 60mg of cardiopeptide for 3 days | Drug: Cardiopeptides<br>* Cardiopeptide was administered intravenously once a day with 60mg of cardiopeptide for 3 days<br>|
| No Intervention: Empety<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypersensitive troponin T | Hypersensitive troponin T | On the day of enrollment, 1/3/6/13 days after enrollment，up to two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac adverse events | Cardiac adverse events | In hospital, until the patient is discharged. |