linjc16/ctgov huggingface dataset:
Sorafenib in Elderly mRCC

Study Overview
=================
Brief Summary
-----------------
This prospective, single arm, multi-center pilot study includes 120 mRCC patients over 65 years, no prior systemic treatment, determined to be candidates for systemic therapy by the investigator. The treatment with Sorafenib should comply with the recommendations written in the local product information. The primary endpoint is overall survival. The secondary endpoints including other effectiveness points, safety and patients characteristics. With 120 completed patients, if the observed survival rate at 12 months is 60%, the width of a 95% confidence interval will be approximately 18%.

Official Title
-----------------
Non-interventional Study of Effectiveness of Elderly Metastatic Renal Cell Carcinoma (mRCC) Treated With Sorafenib

Conditions
-----------------
Carcinoma, Renal Cell

Intervention / Treatment
-----------------
* Drug: Sorafenib (Nexavar, BAY43-9006)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically/cytologically diagnosed metastasis RCC who are candidates for systemic therapy and have decided to accept Sorafenib treatment. >=65 years of age Patients who have signed the informed consent Patients with a life expectancy of ≥12 weeks No prior systemic treatment Exclusion Criteria: The approved local product label must be followed for the exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Group 1<br> | Drug: Sorafenib (Nexavar, BAY43-9006)<br>* treatment (including dose, duration, modification) decided by the investigator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | up to 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria |  | up to 2.5 years | 
| Disease control rate by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria |  | up to 2.5 years | 
| Survival rate by one year |  | up to 1 year | 
| Number of participants with adverse events (AE) and Serious adverse events (SAE) as a measure of safety and tolerability |  | up to 3.5 years | 
| Patient characteristics (birthdate (at least year), sex, weight, height, etc) |  | up to 2.5 years | 
| Response rate (RR) |  | up to 3.5 years | 
| Time to first relief of clinical symptoms and physical signs |  | up to 3.5 years | 
| Treatment pattern |  | up to 3.5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sorafenib, renal cell carcinoma(RCC), elderly, effectiveness, safety
Probiotics in Infants With Cyanotic Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
Infants with congenital heart disease have more frequent infections and exposures to antibiotics than healthy infants. It is unknown how congenital heart disease affects the development of bacterial colonization of the intestines. It is also unknown whether probiotics will change the bacteria in the intestine of infants with heart disease to become more like those of healthy infants without heart disease. This pilot trial is designed to address these two questions.

Detailed Description
-----------------
Infants with cyanotic congenital heart disease will be randomly assigned to receive either a placebo or probiotic Bifidobacterium infantis. Comparisons will be made between the infants receiving the placebo and healthy infants without heart disease and between the infants receiving the placebo and those receiving the probiotic.

Official Title
-----------------
Probiotics in Infants With Cyanotic Congenital Heart Disease

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

Intervention / Treatment
-----------------
* Dietary Supplement: Bifidobacterium infantis
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cyanotic congenital heart disease Term infant Born at or transferred to UC Davis Children's hospital Exclusion Criteria: Congenital anomalies of the intestinal tract

Ages Eligible for Study
-----------------
Maximum Age: 4 Months

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bifidobacterium infantis<br> | Dietary Supplement: Bifidobacterium infantis<br>* 1 billion organisms twice daily either through a feeding tube or by mouth for 4 months<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* A dilute preparation of pregestimil formula (similar in appearance to the probiotic product)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal microbiota |  | Weekly for 4 weeks then monthly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cyanotic heart disease, congenital heart disease, intestinal microbiota, probiotics
Vitamin D Status and Supplementation in Athletes

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are 1) to assess the prevalence of vitamin D deficiency in a group of sub elite athletes and 2) to identify seasonal changes in vitamin D status and the effect that supplementation may have during the course of a year. The study is a double blinded parallel study design.

Detailed Description
-----------------
Study population: 175 elite/ sub elite athletes, male and female, aged 18-60y, from a variety of sport disciplines

Official Title
-----------------
Vitamin D Status and Supplementation in Elite Athletes

Conditions
-----------------
Vitamin D Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: vitamin D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: athletes 19-60y Exclusion Criteria: subjects who take vitamin D supplements

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D dose 1<br>Vitamin D dose 1 | Dietary Supplement: vitamin D<br> <br> |
| Experimental: Vitamin D dose 2<br>Vitamin D dose 2 | Dietary Supplement: vitamin D<br> <br> |
| Experimental: Vitamin D dose 3<br>Vitamin D dose 3 | Dietary Supplement: vitamin D<br> <br> |
| No Intervention: observational<br>No dose | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum 25(OH)D |  | Every 3 months during one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dose-response study
Study to Compare AMG 510 Proposed INN Sotorasib With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).

Study Overview
=================
Brief Summary
-----------------
A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation

Official Title
-----------------
A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C

Conditions
-----------------
KRAS p, G12c Mutated /Advanced Metastatic NSCLC

Intervention / Treatment
-----------------
* Drug: AMG 510
* Drug: Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women greater than or equal to 18 years old. ECOG ≤ 1 Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through central testing or have documentation of KRAS p.G12C mutation through Amgen Study 20190294 prior to enrollment Exclusion Criteria: Active brain metastases Myocardial infarction within 6 months of study day 1 Gastrointestinal (GI) tract disease causing the inability to take oral medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMG 510<br> | Drug: AMG 510<br>* 21 day cycles<br>|
| Active Comparator: Docetaxel<br> | Drug: Docetaxel<br>* 21 day cycles<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) | PFS was defined as the time from randomization (baseline) until disease progression or death from any cause, whichever occurred first for all participants. Progression was based on blinded independent central review (BICR) of disease response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). As pre-specified in the statistical analysis plan, for participants who crossed over from docetaxel to AMG 510, the participant's response post first progression or post crossover was not used for the primary analyses. Data are presented per original treatment randomized. | Baseline up to primary analysis data cut-off date (02 August 2022); max time on study as of primary analysis data cut off was 24.3 months |
Anti-Carbamylated Protein Antibodies in Psoriatic Arthritis

Study Overview
=================
Brief Summary
-----------------
Anti-carbamylated protein (anti-CarP) antibodies are present in approximately one-fourth of the patients who are seronegative for both rheumatoid factor and anti-citrullinated protein antibody and who may therefore have psoriatic arthritis. The investigators hypothesized that detection of anti-CarP antibodies in serum may be useful for diagnosis of psoriatic arthritis.

Official Title
-----------------
Diagnostic Value of Antibodies Against Carbamylated Proteins in Psoriatic Arthritis.

Conditions
-----------------
Psoriasis, Arthritis, Psoriatic

Intervention / Treatment
-----------------
* Diagnostic Test: Serum anti-CarP antibodies detection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Controls : Patients with a psoriasis confirmed by a dermatologist and with absence of psoriatic arthritis confirmed by a rheumatologist. Cases : Patients with psoriatic arthritis fulfilling the classification criteria for psoriatic arthritis (CASPAR), with a diagnosis confirmed by a rheumatologist and associated with personal or familial psoriasis. Exclusion Criteria: Controls: Presence of any chronic rheumatic inflammatory disease such as psoriatic arthritis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Controls<br>Patients with psoriasis and without psoriatic arthritis. | Diagnostic Test: Serum anti-CarP antibodies detection<br>* Serum anti-CarP antibodies detection using an enzyme-linked immunosorbent assay (ELISA) from Inova Diagnostics.<br>|
| Other: Cases<br>Patients with psoriatic arthritis and with personal or familial psoriasis. | Diagnostic Test: Serum anti-CarP antibodies detection<br>* Serum anti-CarP antibodies detection using an enzyme-linked immunosorbent assay (ELISA) from Inova Diagnostics.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of anti-carbamylated protein antibodies for the diagnosis of psoriatic arthritis in the psoriatic population |  | Anti-CarP antibodies will be assessed in the sera collected at the recruitment visit |
A Single-center Prospective Cohort Study for Pure Pulmonary Ground Glass Nodules in Women Preparing for Pregnancy

Study Overview
=================
Brief Summary
-----------------
In this study, about 200 pure GGO in women preparing for pregnancy will be included for a 5-year follow-up. The aim of this study is to elucidate the biological nature of pulmonary GGO lesion in women preparing for pregnancy and provide evidence for GGO treatment.

Official Title
-----------------
A Single-center Prospective Cohort Study for Pure Pulmonary Ground Glass Nodules in Women Preparing for Pregnancy

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

Intervention / Treatment
-----------------
* Other: pure pulmonary ground glass nodules in women preparing for pregnancy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - 20-45 years' old found pulmonary GGO with chest CT scan and CT follow-up after 3 months shows that the GGO remains Diameter of GGO > 5mm and < 3cm Exclusion Criteria: - receiving immunosuppressor or steriods receiving chemo- or radio- therapy can not receive regular follow-up

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: pure pulmonary ground glass nodules in women preparing for pregnancy|pure pulmonary ground glass nodules in women preparing for pregnancy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline GGO diameter | Changes from baseline GGO diameter | 6 months, 1year, 2 years, 3 years, 4 years and 5 years | 
| Changes from baseline GGO CT index. | Changes from baseline GGO CT index. | 6 months, 1year, 2 years, 3 years, 4 years and 5 years |
Cryoablation for Advanced Bone and Soft Tissue Tumors

Study Overview
=================
Brief Summary
-----------------
This is a single-center, open, retrospective clinical study of patients with metastatic/surgically unresectable bone and soft tissue sarcoma undergoing cryoablation of selected tumor lesions. All eligible patients were enrolled. Basic data and treatment methods of these patients were collected, and efficacy and safety were evaluated.

Detailed Description
-----------------
This is a single-center, open, retrospective clinical study of patients with metastatic/surgically unresectable bone and soft tissue sarcoma undergoing cryoablation of selected tumor lesions. Clinical data of eligible patients were scheduled to be retrospectively collected from December 2016 to February 28, 2022. All patients eligible for inclusion. Basic data and treatment methods of these patients were collected, and efficacy and safety were evaluated.

Official Title
-----------------
Safety and Efficacy of Cryoablation in the Treatment of Advanced Bone and Soft Tissue Tumors: a Single-center Retrospective Study

Conditions
-----------------
Sarcoma, Cryoablation

Intervention / Treatment
-----------------
* Procedure: Cryoablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No age restriction, male or female. The pathological diagnosis was a subtype of bone and soft tissue sarcoma. The clinical stage was determined to be metastatic or locally unresectable bone and soft tissue sarcoma. At least one cryoablation of tumor lesions was performed in our hospital. Target lesions can be evaluated according to the efficacy evaluation criteria for solid tumors (RECIST; Version 1.1) Measure diameter changes. Follow-up data were complete. Exclusion Criteria: Not applicable.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cryoablation<br>Cryoablation of selected tumor lesions | Procedure: Cryoablation<br>* Cryoablation of selected tumor lesions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rates | 1-year survival rate | 12 months after surgery | 
| There was no local recurrence survival rate | The 1-year survival rate without local recurrence | 12 months after surgery |
Radial Artery Bypass Graft Study of Tromsø

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to answer, among others, the following questions: 1) What are the outcomes when using the radial artery as a bypass graft in coronary artery bypass surgery (CABG)? 2) Can multidetector computed tomography (CT) be used to reliably evaluate coronary artery bypass graft patency?

Detailed Description
-----------------
Radial arteries have been used as aortocoronary conduits with varying results. The study is based on the first 119 patients operated with this graft at our institution, aiming to answer the following questions: What is the short-term patency (2-3 years) of radial artery bypass grafts in CABG (comparisons are made with saphenous veins and internal thoracic artery grafts)? What complications occur and what in what frequency? What are the clinical outcomes and patient satisfaction after using radial arteries in CABG? (n=119 pt.) Can multidetector CT be used to reliably evaluate coronary artery bypass graft patency? (n=45 pt.) Methods: Questionnaires, record review, coronary angiography.

Official Title
-----------------
Radial Artery Bypass Graft Study of Tromsø

Conditions
-----------------
Coronary Arteriosclerosis, Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Operated with radial artery coronary bypass at our department during April 2001 - October 2004 Written informed consent Exclusion Criteria: For the angiography procedures, standard contraindications are adhered to

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radial artery, angina pectoris, infarction, bypass, angiography
The Bread Trial: Effects of Bread Fortified With Folic Acid and Vitamin B12

Study Overview
=================
Brief Summary
-----------------
In the Netherlands fortification of food products is not yet mandatory. One of the major arguments of the Dutch Health Council to advise against mandatory fortification is the possibility of masking of a vitamin B12 deficiency. A possible solution to overcome the possibility of masking is: fortification of foods with both folic acid and vitamin B12. In this study we want to assess the effects of this fortification strategy on markers of folate and vitamin B12 status.

Detailed Description
-----------------
During a 12 week period subjects will consume bread fortified with folic acid and vitamin B12 or placebo bread (not fortified) Bread consumption has to be at least 3 slices per day, fortification level is 100mcg folic acid and 6mcg vitamin B12 per 3 slices. We will study the effect of this fortification strategy on markers of folate and vitamin B12 status.

Official Title
-----------------
The Bread Trial: a Demonstration Trial to Show Effects of Fortification of Food With Both Folic Acid and Vitamin B12

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Procedure: consumption of fortified bread


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 50-75y Exclusion Criteria: consumption of < 3 slices of bread/day use of B-vitamins in the period three months prior to the study treatment with B12-injections in the last 5y illness or use of medication interfering with folate or vitamin B12 metabolism

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: consumption of fortified bread|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum B12 status |  |  | 
| serum folate status |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| erythrocyte folate; |  |  | 
| homocysteine; |  |  | 
| MMA; |  |  | 
| holoTC |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
no specific conditions