linjc16/ctgov huggingface dataset:
An Open Dose-finding Study of Oral Applied Hexaminolevulinate (HAL) Imaging in Patients With Suspicion or High Risk of Neoplasia in the Colon

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if it is possible to detect more pre-cancerous lesions in colon when using fluorescence technology.

Detailed Description
-----------------
Carcinoma of the lower GI-tract is among the leading malignancies in the western world causing a substantial morbidity, mortality and consequently a large burden to the health care system in the diagnosis, treatment and follow-up of these patients. The primary objectives of this study is to determine carcinoma- and adenoma lesion true detection rate of HAL fluorescence colonoscopy in patients with known or strong suspicion of neoplasia in the colon. The secondary objective and endpoints are to determine carcinoma- and adenoma lesion false detection rate of HAL fluorescence colonoscopy, to compare carcinoma- and adenoma lesion true detection rates and the false detection rates of fluorescence with standard colonoscopy and to characterize the safety profile of HAL fluorescence colonoscopy.

Conditions
-----------------
Colon Cancer

Intervention / Treatment
-----------------
* Drug: hexaminolevulinate HCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female and Male subjects with known or strong suspicion iof adenoma or carcinoma of the colon after screening of follow-up colonoscopy Female and male patients with verified neoplastic lesions Exclusion Criteria: Known or strong suspected porphyria Contraindications to colonoscopy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hexaminolevulinate<br> | Drug: hexaminolevulinate HCl<br>* 200mg hexaminolevulinate HCl capsule 6 hours before colonoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the carcinoma- and adenoma lesion true detection rate |  | Baseline |
The Assessment of Survival After In-hospital Cardiac Arrest for 2 Years in Tertiary Hospital

Study Overview
=================
Brief Summary
-----------------
Define the frequency and survival pattern of cardiac arrests in relation to the hospital day of event and etiology of arrest.

Detailed Description
-----------------
Define the frequency and survival pattern of cardiac arrests in relation with event and etiology of arrest. Investigators aims to evaluate the outcome of in-hospital cardiac arrests, focusing on the relationship between etiology and outcome.

Official Title
-----------------
The Assessment of Survival After In-hospital Cardiac Arrest for 2 Years in Tertiary Hospital

Conditions
-----------------
Cardiac Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases where the cardiac arrest team is called Exclusion Criteria: Lack of data records of patients
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of in-hospital cardiac arrest | Incidence of in-hospital cardiac arrest | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
In-hospital Cardiac Arrest
The Impact of Vitamin D Status on in Vitro Fertilization (IVF) Outcomes

Study Overview
=================
Brief Summary
-----------------
Infertility is a common and psychologically devastating problem for 20% of Canadian couples. Approximately, 20% of infertile couples are diagnosed with unexplained infertility and left without an explanation for their inability to have a baby. Pathological uterine receptivity and embryo implantation are hypothesized mechanisms underlying sub-fertility in these couples. Embryo implantation requires a complicated sequence of events involving the differentiation of endometrial cells to attain uterine receptivity and the synchronized interaction between maternal and embryonic tissues. Vitamin D has been hypothesized to play a role in this poorly understood process. Vitamin D is a known regulator of signal transduction pathways involved in embryo implantation and its receptors are involved in calcium-regulation in various reproductive tissues including, the ovary, uterus, and placenta. In Canada, the prevalence of Vitamin D insufficiency is approximately 34-50%. The goal of the proposed study is to determine the prevalence of vitamin D insufficiency in an infertile population and whether this prevalence is higher than in average Canadian reproductive age women. More importantly, we will investigate whether vitamin D insufficiency in our infertile population translates to impaired implantation and reduced clinical pregnancy rates. Insight into vitamin D's role in reproduction is essential not only to provide scientific understanding of the mechanism underlying embryo implantation, but also because vitamin D supplementation could provide an easy and safe means of treating infertility.

Official Title
-----------------
The Impact of Vitamin D on Implantation and Clinical Pregnancy Rates Following in Vitro Fertilization

Conditions
-----------------
Vitamin D Status

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18, < 40 Day 3 FSH < 10 Capable of providing informed consent Exclusion Criteria: BMI > 35 Untreated uterine pathology ie. fibroids, septum, polyps Unable to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Vitamin D deficient<br> | |
| Vitamin D sufficient<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation rates following IVF |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rates following IVF |  | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, In vitro Fertilization
Factors Associated With Mortality in Neonates

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to better understand the factors associated with mortality and identify potentially preventable causes of death in neonates who die after receiving health care. As a result, an improved neonatal mortality classification system may be defined.

Official Title
-----------------
Evaluation of Factors Associated With Mortality in Neonates

Conditions
-----------------
Neonatal Mortality

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonates for whom healthcare was provided Born alive Neonate greater than or equal to 22 0/7 weeks estimated gestational age Exclusion Criteria: Stillborn Fetal demise Neonates less than or equal to 21 6/7 weeks estimated gestational age

Ages Eligible for Study
-----------------
Minimum Age: 22 Weeks
Maximum Age: 44 Weeks

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 |
| --- | --- | --- |
| To better understand the factors associated with mortality and identify potentially preventable causes of death in neonates who die after receiving health care. |  | neonatal outcomes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neonatal mortality, Preterm birth, Low gestational age, VLBW
Effect of Proprioceptive Intervention Training on Power Capacity, Proprioceptive Ability and Technique of Young Swimmers

Study Overview
=================
Brief Summary
-----------------
Many children and adolescents who engage in swimming complain of shoulder pain during or after exercise. This pain may worsen and may lead to a decline in performance as well avoidance of swimming and lastly avoidance of any physical activity whatsoever. The aim of this study is to determine whether proprioceptive intervention training will effect the power capacity, proprioceptive ability and technique of young swimmers.

Conditions
-----------------
Injury Prevention

Intervention / Treatment
-----------------
* Other: Proprioceptive Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Swim 3 times per week Exclusion Criteria: Have not had orthopedic surgery No history of disease

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 20 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Proprioceptive Intervention<br>Strength training on a non-stable surface | Other: Proprioceptive Intervention<br> <br> |
| No Intervention: No Proprioceptive Intervention<br>Conventional strength training | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in proprioceptive ability | Biodex Device which measures joint proprioceptive ability, will measure the change before and after training | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle strength | Biodex Device will measure the change in muscle isokinetic strength before and after training | 8 weeks |
A Study of TCD601 in the Induction of Tolerance in de Novo Renal Transplantation (PERSPECTIVE)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if TCD601 can induce allogeneic tolerance in de novo living donor renal transplant recipients

Official Title
-----------------
A Safety and Tolerability Study of TCD601 (Siplizumab), a Human Anti-CD2 Antibody, Combined With Donor Bone Marrow Cell Infusion and Non-myeloablative Conditioning, Including Fludarabine and Cyclophosphamide, for Tolerance Induction in de Novo Living Donor Renal Transplantation

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Biological: TCD601


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Able to understand the study requirements and provide written informed consent before and study assessment is performed. Male or female patients ≥ 18 to 60 years of age. Recipient of a first or second renal transplant from a non-HLA identical, but at least haploidentical, ABO compatible living donor. Key Exclusion Criteria: Women of child-bearing potential Subjects with a history of cancer Donor-specific antibody

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Arm 1<br>TCD601administered with non-myeloablative conditioning and standard of care immunosuppression | Biological: TCD601<br>* Investigational Product<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety, tolerability and activity of a Siplizumab-based conditioning regimen to induce renal allograft tolerance | The proportion of patients off immunosuppression with good safety and tolerability | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of biopsy proven acute rejection, death, and graft loss |  | 24 months | 
| The incidence of de novo DSA |  | 24 months |
Stapling Versus 8plate for Correction of Genu Valgus

Study Overview
=================
Brief Summary
-----------------
In children with excessive knock knees it may be necessary to use guided growth (small surgical procedure) so the child outgrows the condition before maturity. A new implant is on the market and the investigators compare this implant (8plate) with the old technique (staples) in a randomised setup. The hypothesis is that the 8plate provides a faster correction rate and that this treatment is superior to stapling.

Detailed Description
-----------------
Correcting angulating deformities of the lower limb is a subject of major interest in paediatric orthopaedics. Epiphysiodesis is the technique by which unilateral bone growth is stopped. Traditionally this has been performed with staple technique. The 8-plate technique is new and advocated because it is believed to reduce the risk of premature closure of the growth plate compared to stapling. The benefit of the 8-plate technique has not yet been proven in experimental or randomised clinical studies.

Official Title
-----------------
Stapling Versus 8plate for Correction of Genu Valgus. A Randomised Clinical Study

Conditions
-----------------
Deformity, Genu Valgus

Intervention / Treatment
-----------------
* Device: 8plate
* Device: Staples (Richards, Smith & Nephew)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic genu valgus At least one year of remaining growth Exclusion Criteria: Unilateral conditions

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 15 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Staples<br>Old implant type | Device: Staples (Richards, Smith & Nephew)<br>* Staples (3 on each side)<br>* Other names: Richards staples, Smith & Nephew;|
| Active Comparator: 8plate<br>New implant type | Device: 8plate<br>* 12 mm or 16 mm plate. 24 mm or 36 mm screw<br>* Other names: 8plate system;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment time | Will be followed with repeated clinical examinations until correction of deformity. | up to 104 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological correction | After correction of deformity. | up to 104 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
genu valgus, lower limb, paediatric, epiphysiodesis
Tislelizumab in the Systematic Treatment of Advanced Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
Study purpose: To evaluate the efficacy and safety of Tislelizumab in combination with advanced hepatocellular carcinoma in the real world; Study design: Non-intervention, single center, case registration, real-world study; Number of registrations: 40; Source of data: This project is a non-interventionary real world case follow-up registration. All registration data are from real clinical practice cases. The collected data include the following requirements: Age ≥18 years old; Unresectable hepatocellular carcinoma confirmed by histological examination or clinical diagnosis; Plan or have received systemic therapy combined with Tiralizumab; No participation in other clinical studies; Access to Tislelizumab treatment and other clinical records; Primary endpoint: Overall response rate; Secondary endpoint: Disease control rate, progress free survival, overall survival, safety; Exploratory endpoint: To explore the predictive value of multiple Biomarker combinations, such as PD-L1, TMB, MSI, DDR, POLE/POLD, in HCC immunotherapy response.

Official Title
-----------------
Real-world Study of Tislelizumab in the Systematic Treatment of Advanced Hepatocellular Carcinoma

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

Intervention / Treatment
-----------------
* Drug: Tislelizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
This project is a non-interventionary real world case follow-up registration. All registration data are from real clinical practice cases. The collected data include the following requirements: Age ≥18 years old; Unresectable hepatocellular carcinoma confirmed by histological examination or clinical diagnosis; Plan or have received systemic therapy combined with Tislelizumab; No participation in other clinical studies; Access to Tislelizumab treatment and other clinical 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 |
| --- | --- |
| Tislelizumab group<br> | Drug: Tislelizumab<br>* Tislelizumab 200mg iv q3w<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate | overall response rate | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease control rate | disease control rate | 6 weeks | 
| progress free survival | progress free survival | 6 weeks | 
| overall survival | overall survival | 6 weeks | 
| Safety (the incidence of adverse events and serious adverse events) | the incidence of adverse events and serious adverse events | 3 weeks |
Study on the Current Situation and Related Factors of Hypertension Management in a Poor County in Shanxi Province

Study Overview
=================
Brief Summary
-----------------
This project aims to understand the current situation of hypertension management in a poor county in Shanxi Province, and explore the factors that affect patients' blood pressure control based on local reality, and provide a basis for further promoting the standardized management of hypertension in poor areas and the comprehensive prevention and control of chronic diseases at the national grassroots level.

Official Title
-----------------
Study on the Current Situation and Related Factors of Hypertension Management in a Poor County in Shanxi Province

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Other: questionnaire survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: （1）Clinical diagnosis of hypertension (2) Permanent population or floating population who have lived for more than 6 months in the area; (3) In the case of not taking antihypertensive drugs, after 3 different daily blood pressure measurements, the systolic blood pressure ≥140 mmHg and/or the diastolic blood pressure ≥90 mmHg were achieved in all 3 times, and it has been diagnosed by the community and above medical institutions in the past. Residents with high blood pressure; (4) As of October 2020, all research subjects have been included in the national basic public health service projects by medical institutions and have received standardized management of hypertension for one full year. Exclusion Criteria: Pregnant and lactating women; Those who are critically ill, mentally ill, cognitively impaired, etc.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questionnaire survey|Understand the current situation of hypertension management in a poor county in Shanxi Province through questionnaire surveys, and explore the factors that affect patients' blood pressure control based on local conditions|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| questionnaire survey | General demographic characteristics, lifestyle, medication status, health knowledge awareness | 6 months |