linjc16/ctgov huggingface dataset:
Iressa vs Placebo as Maintenance Therapy in Locally Advanced NSCLC

Study Overview
=================
Brief Summary
-----------------
The aim of the study if to determine if Iressa can prolong the period of time without any disease worsening (Time to progression) in patients previously treated with combined therapy such as surgery and chemotherapy with or without radiotherapy or chemotherapy and radiotherapy

Official Title
-----------------
A Phase III, Double-Blind, Randomised Study Comparing ZD1839 (IressaTM) Versus Placebo As Maintenance Therapy In Subjects With Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) After Combined Modality Therapy

Conditions
-----------------
Non Small Cell Lung Carcinoma

Intervention / Treatment
-----------------
* Drug: Iressa (Gefitinib)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically Confirmed Non Small Cell Lung Cancer. Locally advanced disease previously treated with combined therapy (chemotherapy and surgery with or without radiotherapy, or chemotherapy and radiotherapy). Chemotherapy with regimens containing cisplatin or carboplatin is mandatory Response to combined therapy Exclusion Criteria: No previous treatment with ZD1839 or any other EGFR-targeted therapy No progressive disease after combined therapy for locally advanced NSCLC No presence of metastatic disease No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ Any unresolved chronic toxicity from previous anticancer 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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Iressa (Gefitinib)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression (2 years after Last patient in) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modalities of relapse or progression (2 years after Last patient in) |  |  | 
| Overall survival (2 years after Last patient in) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Locally Advanced Non Small Cell Lung Cancer (Stage IIIA and IIIB)
Evaluation of a Ionic Silver and Honey Preparation to Treat Chronic Wounds of the Lower Legs

Study Overview
=================
Brief Summary
-----------------
In this open study, the primary objective is to study the efficacy and clinical outcome of the chronic wounds treated with this preparation for 8 weeks on 30 adults. Evaluation will be based on standardised photographs and clinical data. The secondary objectives are to evaluate the tolerance and side effects of the honey based preparation in the management of chronic wounds.

Official Title
-----------------
Open Label Study (Phase 2) to Evaluate the Safety, Tolerance and Efficacy of a Ionic Silver and Honey Preparation to Treat Chronic Wounds of the Lower Legs

Conditions
-----------------
Leg Ulcer

Intervention / Treatment
-----------------
* Device: ApisSept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Chronic wounds due to arterial or venous insufficiency stages 1 to 3 and difficult to heal with the usual treatments and Written informed consent Exclusion Criteria: Refuse to give written informed consent. Patient suffering from mental disorder that may interfere with the treatment. Known allergy or intolerance to any of the products used in the formulation. Having received systemic antibiotics within 7 days of starting treatment with honey based formulation. Arterial insufficiency stage IV of the lower limbs.

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: Honey and ionic silver dressing<br> | Device: ApisSept<br>* honey and ionic silver based dressing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Granulation and /or epithelial tissue progression | Granulation and /or epithelial tissue progression as observed by standardised photography (colour-based and analysis of the wound). | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance | Tolerance: Evaluate for signs and symptoms of irritation,inflammation, allergy or pain in and around the treated zone by clinical observation. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wound healing, granulation tissue, Varicose Ulcer
Investigating Physiological Adaptations to Weight Loss

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effect of diet-induced weight loss on the levels of circulating nutrients and hormones which are involved in feelings of hunger and satiety.

Official Title
-----------------
An Investigation of Physiological Adaptations Contributing to Weight Regain After Weight Loss

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Optifast VLCD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males and post-menopausal females aged over 18 years BMI 27-40kg/m2 weight-stable Exclusion Criteria: major comorbid medial condition (including diabetes) taking medications known to affect weight smoking

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

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Optifast VLCD|Meal replacement, three times daily for 8 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in fasting and/or post-prandial hormone levels following weight loss and after weight maintenance compared with baseline |  | 2, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in fasting and/or post-prandial hormone levels in ketotic compared with non-ketotic state |  | week 8 vs week 10 | 
| Correlation of fasting and post-prandial hormone levels with ratings of hunger and satiety |  | 0, 2, 6 and 12 months | 
| Association of psychosocial factors with successful weight maintenance |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight loss, Weight maintenance
Prognosis of Lung Transplant Candidates

Study Overview
=================
Brief Summary
-----------------
The purposes of the study are (1) to analyze the baseline patient characteristics cross-sectionally, (2) to analyze the prognosis and its predictive factors and (3) to examine the longitudinal clinical course in the lung transplant candidates in Japan.

Detailed Description
-----------------
The significance of assessing patient reported measurements including health status, dyspnea and psychological status has not been well investigated in the lung transplant candidates. Therefore, in the present study, we aim to examine (1) contributive factors to their health status based on baseline data, (2) whether patient reported measurements would predict patients' prognosis and (3) how they would change for 5 years as compared to physiological measurements.

Official Title
-----------------
Analysis of Prognosis and Patient Reported Outcomes in Lung Transplant Candidates

Conditions
-----------------
Lung Transplantation, Respiratory Failure

Intervention / Treatment
-----------------
* Procedure: Lung transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New lung transplant candidates Exclusion Criteria: Heart and lung transplant candidates Uncontrolled severe comorbidities

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Transplantation<br>Lung transplantation candidates | Procedure: Lung transplantation<br>* Lung transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognosis/Mortality |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health status |  | At entry and every year for 5 years | 
| Dyspnea |  | At entry and every year for 5 years | 
| Psychological status |  | At entry and every year for 5 years | 
| Sleep quality |  | At entry and every year for 5 years | 
| Pulmonary function |  | At entry and every year for 5 years | 
| Arterial blood gas |  | At entry and every year for 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung transplant candidates, Health-related quality of life, patient reported outcome, Prognosis
Study of a Pandemic Influenza Vaccine

Study Overview
=================
Brief Summary
-----------------
The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza H5N1 virus strain is the leading candidate to cause the next avian influenza pandemic. This study will test the safety and immunogenicity of a H5N1 pandemic influenza vaccine in healthy adults.

Official Title
-----------------
Phase Ia Study of a Pandemic Influenza Vaccine

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: Pandemic influenza vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults Exclusion Criteria: History of Guillain-Barre syndrome or active neurological disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Pandemic influenza vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and immunogenicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaccine, Pandemic, Influenza, Prevention, Prevention of Pandemic Influenza
The Influence of Postoperative Postures on Persistent Sub-foveal Fluid After Scleral Buckle Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether postoperative postures influence persistent sub-foveal fluid after scleral buckle surgery

Detailed Description
-----------------
In this study, we are to compare the difference of influence of two postoperative postures on the incidence and duration of persistent sub-foveal fluid after scleral buckle surgery for macula-off retinal detachment

Official Title
-----------------
The Influence of Postoperative Postures on the Incidence and Duration of Persistent Sub-foveal Fluid After Scleral Buckle for Macula-off Retinal Detachment

Conditions
-----------------
Retinal Detachment

Intervention / Treatment
-----------------
* Behavioral: postoperative postures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: rhegmatogenous retinal detachment (RRD) macula off treated by successful scleral buckle surgery recent onset with symptom within 1 month Exclusion Criteria: with failed previous surgery intraoperative or postoperative injection of long-acting gas with other eye diseases than RRD
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 |
| --- | --- |
| Experimental: supine<br>postoperative postures: patients in this arm are assigned to adopt supine position for 24 hours after the surgery | Behavioral: postoperative postures<br>* two postoperative postures: supine and temporal-lateral<br>|
| Experimental: temporal lateral<br>postoperative postures: patients in this arm are assigned to adopt temporal lateral position for 24 hours after the surgery | Behavioral: postoperative postures<br>* two postoperative postures: supine and temporal-lateral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of absorption of persistent sub-foveal fluid after surgery | time interval from surgery to the date of disappearance of sub-foveal fluid on OCT | Time from the date of operation until the date of absorption of sub-foveal fluid determined by OCT. The estimated period of time over which the event (absorption of sub-foveal fluid ) is assessed is up to 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| best corrected visual acuity |  | 6 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
macula-off retinal detachment, scleral buckle, persistent sub-foveal fluid, postoperative postures, optical coherence tomography (OCT)
NGS for HLA Typing of Donors and récipients oh Hematopoietic Stem Cells

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to realize the typing of all HLA loci and validate this technique with continued optimization of next-generation sequencing technology (NGS).

Detailed Description
-----------------
The number of patients waiting allograft of hematopoietic stem cells is constantly evolving. Similarly, the number of voluntary donors of hematopoietic stem cells on all global file has exceeded the threshold of 22 million donors since the end of 2013. Despite this, the search for a matched unrelated donor HLA for a patient remains sometimes a long and difficult, especially for patients with rare HLA alleles. It is important to increase the number of donors in the global file, increase HLA diversity of registrants and resolution HLA typing. More HLA typing of a donor registered on the file will be accurate, more research and the recruitment of a donor in order to achieve an allograft in a patient waiting will be fast. The constant evolution of the number of HLA alleles and the number of ambiguities quickly demonstrates the limits of current typing techniques. The study of exons and introns that would significantly refine the level of resolution HLA typing, reaching a level of allelic resolution. That level of resolution would also identify all null alleles (alleles from which the protein is not expressed). The search for an HLA with a patient will be made easier by reducing the financial impact and time of the search. In addition, numerous studies have shown that tissue compatibility narrowest possible between the donor and recipient of an allogeneic haematopoietic stem cells can improve patient survival by reducing the incidence and severity of disease graft against the host and to improve engraftment. In addition, analysis capability of the many sample using this technique should induce the decrease in HLA typing costs and thus facilitate the registration of anonymous bone marrow donors on the national register of the Biomedicine Agency .

Official Title
-----------------
Next Generation Sequencing (NGS) Application for HLA Typing of Donors and Recipients of Hematopoietic Stem Cells

Conditions
-----------------
Next Generation Sequencing for HLA Typing

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bone marrow donors from Brest University Hospital Bone marrow recipients of Brest University Hospital Exclusion Criteria: No bone marrow donors from Brest University Hospital No bone marrow recipients of Brest University Hospital

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HLA high resolution sequencing for loci HLA-A, HLA-B, HLA-C, HLA-DRB1, HLA-DQB1 and HLA-DPB1. |  | 10 months |
A Study of LY3305677 in Participants With Obesity Or Overweight

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to learn about the safety and tolerability of LY3305677 when given to participants with obesity or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive injections of LY3305677 or placebo given just under the skin. For each participant, the study will last about approximately 28 weeks.

Official Title
-----------------
A Multiple Dose Titration Study in Participants With Obesity or Overweight to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677

Conditions
-----------------
Overweight, Obesity

Intervention / Treatment
-----------------
* Drug: LY3305677
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants who are overtly healthy as determined by medical evaluation Participants with stable weight for 3 months and body mass index of 27.0 and 50.0 kilograms per square meter (kg/m²) Exclusion Criteria: Have history of type 1 diabetes mellitus or type 2 diabetes mellitus, ketoacidosis, or hyperosmolar state or coma

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3305677<br>LY3305677 administered subcutaneously (SC) | Drug: LY3305677<br>* Administered SC<br>|
| Placebo Comparator: Placebo<br>Placebo administered SC | Drug: Placebo<br>* Administered SC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through Week 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3305677 | PK: Cmax of LY3305677 | Predose up to 72 hours postdose | 
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3305677 | PK: AUC of LY3305677 | Predose up to 72 hours postdose | 
| Pharmacodynamics (PD): Percentage change in Body Weight | PD: Percentage change in Body Weight | Baseline through Week 20 |
Resting Energy Expenditure Using a Handheld Calorimeter

Study Overview
=================
Brief Summary
-----------------
High prevalence of obesity in children has increased associated complications such as type 2 diabetes, hypertension and fatty liver disease. Dietitians develop a meal plan that restricts caloric intake by estimating the resting and total daily energy expenditures.Estimation of energy needs is most commonly done using predictive equations. Reliable and valid energy requirements can be obtained using a traditional metabolic system, however this is an expensive option. Handheld indirect calorimeters may be a good alternative to measure energy needs. Several studies have been conducted to determine the validity and accuracy of handheld calorimeters in adults and health children, however, to the best of our knowledge, there are no such studies in the overweight and obese pediatric population. The purpose of this study is to validate a handheld indirect calorimeter against a traditional metabolic system in overweight and obese children. If handheld calorimeters can accurately measure resting energy expenditure in overweight and obese adolescents, dietitians will have an opportunity to tailor pediatric weight management interventions based on parameters that are unique to each individual.

Official Title
-----------------
Validating a Handheld Indirect Calorimeter in Overweight and Obese Pediatric Population

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 13-18y of age BMI 85th percentile or more No severe illness, neurological and development issues not on insulin Able to fast overnight Exclusion Criteria: not 13-18y of age BMI under 85th percentile ill or have neurological and development issues on insulin

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum 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 |
| --- | --- |
| Obese children<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting Energy Expenditure as measured by the traditional Indirect Calorimeter(metabolic cart) and the handheld indirect calorimeter in standardized conditions |  | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resting energy expenditure, Handheld calorimeter, Obese and overweight, Pediatrics