linjc16/ctgov huggingface dataset:
Apatinib Combined With Vinorelbine for Non-driver Gene Mutation Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and effectiveness of Apatinib Combined With Vinorelbine Used for Driver Gene Mutation Negative Third-line and Third-line Posterior Advanced Non-small Cell Lung Cancer

Detailed Description
-----------------
This efficacy and safety research plan to explore the use of Apatinib combined with Vinorelbine to driven gene mutation negative three line and three line later non-small cell lung cancer.According to the result of TAX317,the investigators expect the effective rate is 20% and 80% of degree of assurance.Single arm bilateral experiment's sample size is calculated 27, according to 10% censoring,the expected sample size is 30.

Official Title
-----------------
the Effectiveness and Safety Study on Apatinib Combined With Vinorelbine Used for Driver Gene Mutation Negative Third-line and Third-line Post Progression Advanced Non-small Cell Lung Cancer

Conditions
-----------------
Advanced Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Apatinib Combined With Vinorelbine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18，Pathologically proven non small cell lung cancer Adenocarcinoma，No-drive gene mutaion (EGFR、ALK、ROS1） by NGS Squamous cell carcinoma，no gene detection Progress after second line PS score >2 Exclusion Criteria: Patients received apatinib or Vinorelbine treatment before EGFR, ALK or ROS1 mutation Patients with contraindication of chemotherapy Pregnant or breast feeding women

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apatinib Combined With Vinorelbine<br>Apatinib Combined With Vinorelbine Used for Driver Gene Mutation Negative Third-line and Third-line Post Progression Advanced Non-small Cell Lung Cancer | Drug: Apatinib Combined With Vinorelbine<br>* Vinorelbine 60mg/m2 d1qweek , Apatinib 500mg po Qd,evaluate every 2months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | To measure the patients's overall response rate | Approximately 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival | Approximately 1 years | 
| OS | Overall survival | Approximately 1 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Apatinib plus Vinorelbine, NSCLC
Clinical Tumor Anemia Registry (TAR)

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to record information of routine treatment of anemia in cancer patients in Germany. An overview of the current treatment of anemia in German outpatient centers and hospitals will be provided. Primary outcome parameters, e.g. improvement in hemoglobin levels and changes in QoL, as well as patient characteristics of different treatments will be analyzed.

Official Title
-----------------
Clinical Registry Describing Treatment Reality of Patients With Cancer-(Therapy)-Induced Anemia

Conditions
-----------------
Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed malignant disease Hemoglobin level < 11 g/dl (female) or < 12 g/dl (male) Start of antianemic therapy no more than 7 days prior to informed consent Performance status 0 - 3 (Karnofsky-Index >= 40%) Minimum age: 18 years Informed written consent Exclusion Criteria: Hypersensitivity against antianemic therapies Myelodysplastic Syndrome Experimental antianemic therapy

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 |
| --- | --- | --- |
| Documentation of therapies | Overview on the current routine treatment of anemia in cancer patients in Germany | 12 weeks per patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin levels and QoL | Effectiveness of different antianemic treatments is investigated by measuring increase of hemoglobin levels and QoL (FACT-An and FACT-GP). Baseline in hemoglobin (before treatment) is compared with hemoglobin levels after treatment. Each patient is followed for a maximum of 12 weeks to obtain data about the course of the treatment. | 12 weeks per patient | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anemia, Erythropoiesis-Stimulating Agents (ESA), Cancer, Hemoglobin, Quality of Life, FACT-An, FACT-GP, Epoetin, Ferric Carboxymaltose, Blood Transfusions
Affect Management for Early Adolescents

Study Overview
=================
Brief Summary
-----------------
Adolescents are at risk for HIV because of sexual and drug use behavior initiated during early adolescence, and those with mental health problems appear to be particularly susceptible. Problems with managing emotions may make it difficult for early adolescents to make good decisions about sexual and substance use behaviors. This project will develop and evaluate interventions for early adolescents with mental health issues. An intervention focused on teaching affect management skills will be compared to an intervention addressing a variety of health topics to determine which intervention best reduces risk behavior among this at-risk population.

Official Title
-----------------
Affect Management Intervention for Early Adolescents With Mental Health Problems

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Behavioral: Affect Management
* Behavioral: General Health Promotion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Seventh graders identified by counselors at participating public school. Exclusion Criteria: Adolescent is HIV positive. Adolescent is developmentally delayed. Adolescent is pregnant. Adolescent has a history of sexual crime.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 14 Years

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

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

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 |
| --- | --- |
| Active Comparator: General Health Promotion<br> | Behavioral: General Health Promotion<br>* 12-session group intervention including health information on a variety of developmentally relevant health topics.<br>|
| Experimental: Affect Management<br> | Behavioral: Affect Management<br>* 12-session group intervention including affect management training as well as sexual health skills training.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adolescent-reported sexual activity |  | 30 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adolescent-reported condom use |  | 30 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV Prevention
Comparison of DisCoVisc and Hydroxypropylmethylcellulose 2%

Study Overview
=================
Brief Summary
-----------------
This prospective study was performed to compare two ophthalmic viscosurgical devices, DisCoVisc (hyaluronic acid 1.6% - chondroitin sulfate 4.0%) and hydroxypropylmethylcellulose 2% in terms of their overall clinical performance during phacoemulsification.

Official Title
-----------------
Intraindividual Randomized Clinical Comparison of DisCoVisc and Hydroxypropylmethylcellulose 2% in Phacoemulsification

Conditions
-----------------
Corneal Edema, Intraocular Pressure

Intervention / Treatment
-----------------
* Drug: Hyaluronic Acid and hydroxypropylmethylcellulose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bilateral age-related cataract Grade 1-3 lens opacities classification system (LOCS III) Pupil dilatation greater than 7.0 mm Exclusion Criteria: Black, brunescent, traumatic or subluxated cataract Corneal endothelial disease (endothelial cell count less than 2.000 cells/mm3) Glaucoma, uveitis Previous ocular surgery

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Hyaluronic Acid and hydroxypropylmethylcellulose|Hyaluronic Acid 1.6% was used to performed phacoemulsification in one eye and hydroxypropylmethylcellulose 2% was used in the fellow eye.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal endothelial cell count |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Corneal Thickness |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phacoemulsification, Corneal Edema, Corneal Endothelium, Viscoelastic Substances
Investigation of the Pharmacokinetic Properties of Biphasic Insulin Aspart 50 in Healthy Chinese Subjects

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia. The aim of this clinical trial is to investigate the pharmacokinetic properties (the rate at which the trial drug is eliminated from the body) after a single subcutaneous (under the skin) injection of biphasic insulin aspart 50 (BIAsp 50). In addition, the safety and tolerability of BIAsp 50 will be observed

Official Title
-----------------
A Trial Investigating the Pharmacokinetic Properties of Biphasic Insulin Aspart 50 (BIAsp 50) in Healthy Chinese Subjects

Conditions
-----------------
Diabetes, Healthy

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 50


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the Investigator (the Physician) Body Mass Index (BMI): 19.0-24.0 kg/m2 (both inclusive) Exclusion Criteria: Clinically significant abnormal haematology, biochemistry, lipids or urinalysis screening tests, as judged by the Investigator (the Physician) A history of any illness that, in the opinion of the Investigator (the Physician), might confound the results of the trial or a pose risk in administering the trial product to the subject Subject who has donated any blood or plasma in the past month or more than 400 mL within 3 months prior to screening (trial entry) Not able or willing to refrain from smoking during the inpatient period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: A<br> | Drug: biphasic insulin aspart 50<br>* A single dose of 0.3 U/kg BIAsp 50 for subcutaneous (under the skin) injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin aspart concentration-time curve from 0 to 24hours |  | 24 hours profile after single dose of trial drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin aspart concentration-time curve between different time intervals |  | 24 hours profile after single dose of trial drug | 
| Maximum observed serum insulin aspart concentration |  | 24 hours profile after single dose of trial drug | 
| Number of adverse events. |  | After 3-10 days of treatment | 
| Number of hypoglycaemic events |  | After 3-10 days of treatment |
The Clinical Efficacy and Safety of Drug-coated Balloon

Study Overview
=================
Brief Summary
-----------------
Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel coated on the balloon. Treating in-stent restenosis (ISR) with the DCB has the theoretical advantage of avoiding multiple stent layers and respecting the vessel anatomy. DCB has shown promising results for the treatment of ISR. Currently, DCB has a Class I indication to treat ISR recommended by European Society of Cardiology (ESC) guidelines. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice. Although some small sample size RCTs and observational studies have suggested that the clinical prognosis of DCB in primary large vessels is non-inferior to drug-eluting stent (DES), there is no large-scale RCT or cohort studies to compare the clinical effects of DCB and DES. Despite several theoretical benefits of DCB, the procedural-related complications cannot be entirely prevented, such as acute elastic retraction and severe dissection, which would affect coronary blood flow or lead to acute vascular occlusion. Some studies have suggested that optimization of the procedural technique can reduce the occurrence of complications and target lesion failure in the long-term. Proposed criteria include adapting cutting or scoring balloon for pre-dilatation, residual stenosis<30% post-DCB, maintaining TIMI flow=3, DCB dilation time<60s, and appropriate balloon to vessel ratio> 0.91. However, such proposed technique and criteria have not been evaluated in the real-world clinical practice. This current study is designed to investigate the efficacy and safety of DCB in the real world and exploring the optimal procedural configurations.

Official Title
-----------------
The Clinical Efficacy and Safety of Drug-coated Balloon in Coronary Lesions: a Real-World, All-Comers ,Single-center, Prospective Study

Conditions
-----------------
Coronary Heart Disease, Angioplasty, Balloon

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received PCI with one or more drug-coated balloons (DCB) Patients who did not received drug-eluting stent implantation Exclusion Criteria: 1. Currently participating in another trial or participants unable to comply to follow-up
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 |
| --- | --- | --- |
| Patient-oriented Composite Endpoint (PoCE) | POCE is a composite clinical endpoint of all-cause death, any stroke, any non-fatal myocardial infarction (MI), any revascularization | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug-coated balloons, De-novo, All-comers, In-stent stenosis
Training Endoscopists to Perform On-site Rapid Cytological Evaluation for EUS-FNA of Solid Pancreatic Lesions

Study Overview
=================
Brief Summary
-----------------
In China, there is a serious shortage of pathologists who can perform on-site cytological diagnosis. As a result, there are few centers that can conduct ROSE in China, which limits the diagnostic accuracy of EUS-FNA to a certain extent. Previous research reports on whether endoscopists could be trained for ROSE were controversial, which may be related to the lack of standardization of the training of endoscopists. There is no training program for training endoscopists to systematically process pathological specimens, operate microscopes, read the adequacy of cytological specimens, and evaluate the atypia of cytological specimens in China. Therefore, our center intends to carry out a training for endoscopists to compare the improvement of endoscopists' ROSE operating ability before and after the training, and to evaluate the practice of each endoscopist to perform on-site rapid cytology specimens of solid pancreatic lesions.

Official Title
-----------------
Feasibility Study of Training Endoscopists to Perform On-site Rapid Cytological Evaluation for Endoscopic Ultrasound-guided Fine-needle Aspiration of Solid Pancreatic Lesions

Conditions
-----------------
Pancreatic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥18 years diagnosis or suspected of solid pancreatic mass based on previous imaging examination; EUS-FNA is achievable. signed informed consent letter Exclusion Criteria: pregnant female pancreatic cystic lesions anticoagulant/antiplatelet therapy cannot be suspended unable or refuse to provide informed consent coagulopathy (platelet count <50 ×103/uL, international normalized ration >1.5） severe cardiopulmonary dysfunction that cannot tolerate intravenous anesthesia with history of mental disease other medical conditions that are not suitable for EUS-FNA

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 |
| --- | --- | --- |
| Accuracy of endoscopists for interpretation of cytologic specimen adequacy and primary diagnosis of malignancy | The interpretation results of endoscopists will be compared with that of cytopathologist. | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The results of standard specimens-processing, microscope-operating training on endoscopists | Comparison of the score that endoscopists are graded before and after the standard training | 3 months |
Non-surgical Treatment of Knee Osteoarthritis - a Comparison of Effects in 2200 Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether radiographic osteoarthritis severity (OA; Kellgren-Lawrence scale) is associated with self-reported improvement in pain after non-surgical treatments (physiotherapy, pain killers, injection, other treatments). The hypothesis is that radiographic OA severity is inversely associated with self-reported improvement.

Official Title
-----------------
Non-surgical Treatment of Knee Osteoarthritis - a Comparison of Effects in 2200 Patients

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Paracetamol and nonsteroidal antiinflammatory drug (NSAID)
* Other: Physiotherapy
* Drug: Cortisone Injection
* Other: Others


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Not eligible for at total knee arthroplasty Exclusion Criteria: Ipsilateral knee arthroplasty
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-surgical treatment<br> | Drug: Paracetamol and nonsteroidal antiinflammatory drug (NSAID)<br> <br> Other: Physiotherapy<br> <br> Drug: Cortisone Injection<br> <br> Other: Others<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported improvement | Assessed using the question: Has your pain improved? Response categories: pain free; better; unchanged; worse | 2-5 years after consulting orthopedic surgeon |
Mainz Outcome Predictor Studies: An Observational Clinical Trial Investigating Predictors for Postoperative Outcome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether psychological and social factors in addition to medical (physiological) conditions may contribute significantly to the prediction of the postoperative outcome. Postoperative outcome is defined (1) as postoperative complications and organ dysfunction and (2) alteration of quality of life.

Detailed Description
-----------------
Different factors contribute to the recovery process after surgical intervention. However, little is known about the predictive value of single factors. In addition to medical (physical) factors, depression, anxiety, somatization and avoiding coping styles are considered as relevant for the successful recovery process. These factors may be defined as psychological distress and could be used as predictors for perioperative complications and failed surgical treatment. Postoperative outcome is defined (1) as postoperative complications and organ dysfunction and (2) alteration of quality of life. Our sample includes adults undergoing extensive surgical interventions in trauma and orthopaedic surgery, urology, general surgery, and neurosurgery. The defined variables are measured using standardized and validated questionnaires prior to surgery and in follow-up visits.

Official Title
-----------------
Mainz Outcome Predictor Studies: An Observational Clinical Trial Investigating Physiological and Psychological Data as Predictors for Postoperative Outcome.

Conditions
-----------------
Surgery, Psychological Distress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum Age 18 Years German language in speaking and writing Capability of giving consent written informed consent Exclusion Criteria: Delirium, dementia or other mental disorders with significant cerebral dysfunction People under guardianship simultaneous participation in other clinical studies

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 |
| --- | --- | --- |
| Quality of life |  | 6 weeks and 6 months after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgery, Psychosocial Factors, Psychological Distress, Outcome Assessment (Health Care)