linjc16/ctgov huggingface dataset:
Pegfilgrastim for Stem Cell Mobilization in Children (Meg-5)

Study Overview
=================
Brief Summary
-----------------
Hypothesis : pegfilgrastim at 200 µg/kg between 12 and 18 days after previous chemotherapy provides an efficient stem cell mobilization in children with malignancies Design: phase 2 study. Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed

Detailed Description
-----------------
Patients: consecutively referred for HSC mobilization. 12 to 18 days after the previous chemotherapy. No haematological growth factor during the 8 previous days. Mobilization: one sc injection of 200 µg/kg pegfilgrastim (Neulasta, Amgen) Evaluation during the study: CD34 circulating cells from day 3 to day 7 ; AE recording Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed) Analysis: sequential Bayesian study

Official Title
-----------------
Haematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 200µg/kg After Chemotherapy

Conditions
-----------------
Solid Malignancies

Intervention / Treatment
-----------------
* Drug: Pegfilgrastim (Neulasta, Amgen)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 0 to 18 years solid malignancy Lansky score >70% 12 to 18 days since the beginning of the last chemotherapy cycle no administration of any hematopoietic growth factor in the previous 8 days Exclusion Criteria: clinical or biological conditions precluding the mobilization or collection procedure

Ages Eligible for Study
-----------------
Maximum 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: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pegfilgrastim (Neulasta, Amgen)|sequential Bayesian study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed) |  | less than 3 blood volume processed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects Number of apheresis required to achieved a graft of at least 5x10e6 CD34 cells |  | at least 5*10e6CD34cells | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Children, cancer, Bone marrow transplantation, Stem cell mobilization, G-CSF, Children with solid malignancies
Study Of Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and effectiveness of different doses of an investigational medication in women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy.

Official Title
-----------------
A Twelve-Week, Randomized, Double Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of 0.5 mg QD, 1 mg QD and 1 mg BID of Alosetron in Female Subjects With Severe Diarrhea-predominant IBS Who Have Failed Conventional Therapy

Conditions
-----------------
Irritable Colon, Irritable Bowel Syndrome (IBS)

Intervention / Treatment
-----------------
* Drug: Alosetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS). Failed conventional therapy. Willing to make daily calls on a touch-tone telephone. Exclusion criteria: History of or current chronic or severe constipation. Bloody diarrhea, abdominal pain with rectal bleeding. Thrombophlebitis. Abnormal thyroid stimulating hormone (TSH) value. Alcohol and/or substance abuse within past two years. Pregnant or lactating. History/treatment of malignancy within past five years.

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

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

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: Alosetron|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject self assessment of improvement between treatment groups using the IBS Global Improvement Scale; comparison of safety and tolerability between treatment groups with respect to adverse events & laboratory abnormalities. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of treatment groups with respect to subject relief of IBS pain & discomfort. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dose-ranging, Diarrhea-Predominant Irritable Bowel Syndrome, d-IBS, IBS, Irritable Bowel Syndrome
Protocol for Radiofrequency Ablation of Pulmonary Neoplasms

Study Overview
=================
Brief Summary
-----------------
This research trial involves the development of a new treatment for lung tumors. It is for patients whose tumor cannot be surgically removed, have refused surgery, or the tumor has not responded well to other forms of treatment. This treatment uses a needle probe to deliver energy into the lung tumor. This probe is placed utilizing a CT scan image. The energy heats the tumor causing tumor cell death.

Official Title
-----------------
Protocol for Radiofrequency Ablation of Pulmonary Neoplasms

Conditions
-----------------
Pulmonary Neoplasms

Intervention / Treatment
-----------------
* Procedure: Radiofrequency Ablation of pulmonary neoplasms


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients enrolled in this study should be judged to have sufficient survival to benefit from control of local disease and include at least one of the following: unresectable primary or metastatic lung tumors may benefit from multiple modalities of therapy chemotherapeutic or radiation oncologic options have been exhausted Exclusion Criteria: 1. co-existing morbidities that preclude the use of surgery

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Radiofrequency Ablation of pulmonary neoplasms|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Intra-parotid Facial Nerve Tractography

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate concordance between the facial nerve's path in the parotid evaluated by radiologist in preoperatively and the facial nerve's path in the parotid evaluated by surgeon in peroperatively.

Detailed Description
-----------------
Surgery is the main treatment for parotid tumol, benign or malignant pathologies. The procedure requires a trunk search and a facial nerve dissection along its intraparotid length. This intervention entails a risk of facial paralysis. MRI tractography is a new imaging technique that can characterize nerve fibers and their path. The interest would be to allow the surgeon to best prepare the parotidectomy by locating the tumor in relation to the trunk and all the branches of the facial nerve.

Official Title
-----------------
Intra-parotid Facial Nerve by MRI Tractography: Clinical vs Radiologic Description in Parotid Tumors

Conditions
-----------------
Parotid Tumor

Intervention / Treatment
-----------------
* Radiation: MRI with Facial nerve tractography


Participation Criteria
=================
Eligibility Criteria
-----------------
inclusion criteria : Major patient Patient with initial parotid mass or recurrent Parotidian mass with surgical indication Benign or malignant With or without preoperative facial paralysis Patients consenting the protocol exclusion criteria : Parotidian masses without surgical indication Patient with a classic contraindication to MRI

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients operated on for parotid tumor<br>All consecutive patients operated on for parotid tumor. | Radiation: MRI with Facial nerve tractography<br>* MRI with Facial nerve tractography in addition to T1 imaging, T1 gadolinium imaging and T2 imaging.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial nerve's path | Relations between the facial nerve's (the facial nerve's trunk s and the facial nerve's dissections) and the parotid gland will be studied. The nerve will be in front of the mass or behind the mass below the mass or above the mass outside the mass or inside the mass | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parotidetomy, Tractography, Facial nerve, Facial palsy, Tumor of parotid gland
Handgrip Strength (HGS) With HGS Asymmetry Are Associated With All-cause Mortality and Hospital Readmissions

Study Overview
=================
Brief Summary
-----------------
Adding the handgrip strength (HGS) asymmetry to the existing measurements of low HGS may improve the assessment of muscle function.

Detailed Description
-----------------
We sought to explore the associations between maximal HGS with HGS asymmetry and mortality, hospital readmissions, total complications, and prolonged length of stay (PLOS) among elderly patients with gastric cancer.

Official Title
-----------------
Handgrip Strength (HGS) With HGS Asymmetry is Associated With All-cause Mortality and Hospital Readmissions Among Elderly Patients With Gastric Cancer.

Conditions
-----------------
Gastric Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: with gastric cancer aged ≥60 years were scheduled to undergo radical surgery for the first time Exclusion Criteria: received preoperative radiotherapy or chemotherapy combined with other types of malignant tumors
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Full robust<br>no low HGS without HGS asymmetry | Other: No intervention<br>* This is an observational study with no intervention.<br>|
| low HGS alone<br>low HGS without HGS asymmetry | Other: No intervention<br>* This is an observational study with no intervention.<br>|
| HGS asymmetry alone<br>no low HGS with HGS asymmetry | Other: No intervention<br>* This is an observational study with no intervention.<br>|
| low HGS with HGS asymmetry<br>non | Other: No intervention<br>* This is an observational study with no intervention.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | within 3 months after surgery, collected from telephone follow-up | about 3 months | 
| Hospital readmissions | wihthin 3 months after surgery, collected from telephone follow-up | about 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total complications | during hospitalization, collected from medical records | about 3 months | 
| prolonged length of stay | during hospitalization, collected from medical records | about 3 months |
Study of Physical Health for Women With Posttraumatic Stress or Depression

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain a better understanding of how stress is related to health risks.

Detailed Description
-----------------
Participants complete up to two study visits of approximately 3-4 hours each. The first study visit involves an interview about life experiences and emotions. If the participant is eligible for the second assessment, the average length of time between visit 1 and visit 2 will be 1-7 days. The second visit included physical measurements such as cholesterol and blood pressure, performing math and speaking tasks, and surveys to help us learn about healthy behaviors and emotions. No further follow-up of participants is conducted beyond the two study visits.

Official Title
-----------------
Cardiovascular Risk in Relation to Posttraumatic Stress Disorder in Young Women

Conditions
-----------------
Healthy, Stress, Psychological, Depression, Posttraumatic Stress Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-menopausal Must be able to speak and read English fluently Exclusion Criteria: Specific medications and chronic diseases History of heart attack (myocardial infarction) Pregnant or given birth in last 3 months Peri-menopausal or post-menopausal

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Posttraumatic Stress<br> | |
| Depression<br> | |
| Healthy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Cardiovascular Risk Factors | This primary outcome will be assessed at the second study visit (1-7 days from first study visit for those who are eligible). | Single assessment timepoint |
Post Market Clinical Follow-up of Dual-mobility Acetabular Cup EUROSCUP MOBILE

Study Overview
=================
Brief Summary
-----------------
EUROSCUP MOBILE is intended for use in primary and revision total hip replacement surgery. Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. As part of post market vigilance, EUROS will collect data on EUROSCUP MOBILE performances and safety

Detailed Description
-----------------
Post market observational study. This study is retropective and prospective, non comparative.

Official Title
-----------------
Post Market Clinical Follow-up of Dual-mobility Acetabular Cup EUROSCUP MOBILE

Conditions
-----------------
Hip Osteoarthritis, Hip Arthropathy, Hip Arthritis, Hip Fractures, Hip Necrosis, Hip Dysplasia

Intervention / Treatment
-----------------
* Device: hip arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who received EUROSCUP MOBILE. Patient informed of its participation to the study Patient aged between 18 and 80 years old (<80). Exclusion Criteria: Patient presenting a contraindication to EUROSCUP MOBILE implantation. Patient who refused to participate to the study Vulnerable subjects

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EUROSCUP MOBILE cementless<br>107 who received cementless version of EUROSCUP MOBILE | Device: hip arthroplasty<br>* Hip prosthesis surgery<br>|
| EUROSCUP MOBILE cemented<br>40 who received cemented version of EUROSCUP MOBILE | Device: hip arthroplasty<br>* Hip prosthesis surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of EUROSCUP MOBILE | Collect the safety of the device trought complications occurence rate | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological performances of EUROSCUP MOBILE | Collect the performances of the device trought radiological evaluation | 1 year | 
| Clinical performances of EUROSCUP MOBILE | Collect the performances of the device trought clinical scores | 1 year | 
| Survival of EUROSCUP MOBILE | Assess the survival rate of the device | 10 year |
Value of 6-minute Walk Test in Grown Ups With Congenital Heart Defects (GUCH)

Study Overview
=================
Brief Summary
-----------------
The six-minute walk test is an established submaximal exercise test. Its role in examination of grown-up patients with congenital heart disease (GUCH) is not studied so far. Objective of this study was a comparison of the 6MWT with other established parameters of functional capacity, in grown-up patients with GUCH.

Official Title
-----------------
The Diagnostic Value of Six-Minute Walk Test in Grown-Up Patients With Congenital Heart Disease (GUCH)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: congenital heart defect > 18 years Exclusion Criteria: mental or physical incapability of exercise testing non-cardiac limitations of physical capacity, as e.g. orthopedic diseases or febrile infections severe psychiatric diseases

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 |
| --- | --- | --- |
| Ranges of six-minute walk distance (6MWD) |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congenital Heart Disease, Six Minute Walk Test, Exercise Testing, Peak oxygen uptake
Phase 3 Study of LY353381 Vs Tamoxifen in Women With Locally Advanced or Metastatic Breast Cancer.

Study Overview
=================
Brief Summary
-----------------
To determine the safety and efficacy of LY353381 when compared to tamoxifen in women with advanced or metastatic breast cancer.

Official Title
-----------------
a Phase 3 Randomized Double Blind Evaluation of LY353381 Compared With Tamoxifen in Women With Locally Advanced or Metastatic Breast Cancer.

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Drug: LY353381
* Drug: tamoxifen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Locally advanced or metastatic breast cancer Bi-dimensionally measurable disease Exclusion Criteria 1. Prior hormonal therapy

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LY353381|nan|
|Drug: tamoxifen|nan|

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
-----------------
cancer, metastatic breast cancer, hormonal therapy
Visual Quality Following Aspheric Intraocular Lens (IOL) Implantation - a Comparative Clinical Study

Study Overview
=================
Brief Summary
-----------------
To evaluate visual acuity and quality of vision in participants undergoing cataract surgery with a Hoya model 751 intra-ocular lens and to compare the visual results to the common monofocal lens in use.

Official Title
-----------------
Visual Quality Following Aspheric and Monovision Lens Implantation - a Comparative Clinical Study

Conditions
-----------------
Aphakia, Cataract

Intervention / Treatment
-----------------
* Device: Study IOL
* Device: Hoya iSert 751
* Device: Negatively aspheric IOL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Senile cataract Patient identified as a candidate for cataract surgery and IOL implantation Willing to sign informed consent document approved by the Ethical Committee Willing to complete all required tests and exams per this protocol Exclusion Criteria: Amblyopia History or evidence of any ocular disease that may affect visual acuity Previous ocular surgery, including refraction surgery Ocular anomalies (e.g. microphthalmos, kerataconous) Subjects with greater than 1.0 D of corneal astigmatism Subjects who experience intraoperative complications that could affect postoperative IOL centration or tilt

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Both Eyes<br>Model 751 IOL implanted in both eyes. | Device: Study IOL<br>* Aspheric IOL for correction of aphakia<br>* Other names: Hoya iSert 751 IOL;|
| Experimental: Single eye<br>Model 751 IOL in one eye | Device: Hoya iSert 751<br>* Model 751 in one eye, standard IOL in other eye<br>* Other names: Hoya iSert Model 751;|
| Active Comparator: Control<br>Aphakia treatment by negatively aspheric IOL implant, Hoya iSert model 251 or equivalent | Device: Negatively aspheric IOL<br>* Negatively aspheric IOL in both eyes<br>* Other names: Hoya iSert model 251 or equivalent;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected Visual Acuity (UCVA) (ETDRS)for distance, intermediate and near |  | Up to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aphakia, Cataract