linjc16/ctgov huggingface dataset:
Survival in Myelofibrosis Patients After Allogeneic Hematopoietic Stem Cell Transplantation in Five Centers in France

Study Overview
=================
Brief Summary
-----------------
The investigators would like to conduct a retrospective study in five centers in France in the goal to evaluate the survival of patients receiving allogeneic hematopoietic stem cell transplantation for myelofibrosis.

Detailed Description
-----------------
The allogeneic stem cell transplantation is the only curative treatment for myelofibrosis. However, because of complications such as infection, graft-versus-host disease and conditioning toxicity, this procedure is associated with a high morbidity-mortality rate. The discovery of molecular and genetic markers permitted to improve therapeutic strategy and survival of patient in the last few years. In this study, the investigators want to make an overview of survival, incidence of relapse and incidence of acute and chronic graft versus host disease in allogeneic stem cell transplantation for myelofibrosis, in five centers in France, between 2007 and 2017.

Official Title
-----------------
Survival in Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation for Myelofibrosis in Five French Centers

Conditions
-----------------
Myelofibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients receiving allogeneic hematopoietic stem cell transplantation for myelofibrosis in five centers in France (Nancy, Besancon, Strasbourg, Pitie Salpetriere and Lyon) between 2007 and 2017 - Exclusion Criteria: age < 18 years old

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival | incidence of survival in the cohort | at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of relapse | incidence of relapse in the cohort | at 1 year | 
| incidence of acute graft versus host disease | incidence of acute graft versus host disease in the cohort | at 3 months | 
| incidence of chronic graft versus host disease | incidence of chronic graft versus host disease in the cohort | at 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allogeneic hematopoietic stem cell transplantation, survival, graft versus host disease
Safety and Immune Response Study of an Investigational Pneumococcal Vaccine.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and immunogenicity of two doses of GSK Biologicals' 11 PCV vaccine when given to healthy subjects aged 18 to 40 years .

Detailed Description
-----------------
The study is open and subjects will receive two vaccine doses of GSK Biologicals' 11 PCV vaccine. Five blood samples will be taken: prior to and one month after each vaccine dose, and 2 weeks after dose 2.

Official Title
-----------------
An Open, Phase I/II Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' 11PCV Vaccine Given as a 2-Dose Vaccination in Adults Aged 18-40 Years Old.

Conditions
-----------------
Prophylactic Pneumococcal Diseases

Intervention / Treatment
-----------------
* Biological: pneumococcal vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male or female between 18 and 40 years of age 23-valent pneumococcal polysaccharide vaccine naive adults. Exclusion Criteria: Previous vaccination against Streptococcus pneumoniae. History of pneumonia within 3 years prior to the first vaccination Any confirmed or suspected immunosuppressive or immunodeficient condition All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years. Subjects with documented anaemia or iron-deficiency (Hemoglobin level more than 10% below lower limit of normal) History of administration of an experimental/licensed vaccine containing similar adjuvants. History of chronic alcohol consumption and/or drug abuse. Pregnant or lactating female. Female planning to become pregnant or planning to discontinue contraceptive precautions.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: pneumococcal vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of solicited local & general symptoms (Day 0-7) and unsolicited symptoms (Day 0-30) after vaccination. Occurrence of serious adverse events during the entire study; |  |  | 
| Frequencies of IgG PS-specific plasma cells (by B-cell ELISPOT) for 11 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F) prior to & 1 month post dose 1, 2 weeks & 1 month post dose 2 |  |  |
Improving Charge Nurse Conflict Resolution Communication Using Artificial Intelligence

Study Overview
=================
Brief Summary
-----------------
Nurses are being challenged to provide increasingly complex care with more inexperienced nurses due to higher rates of retirement and registered nurse (RN) turnover in general. High-performing charge nurses with excellent interpersonal, conflict management, communication, and leadership competencies are vital to achieving optimal outcomes. Implementing a charge nurse leadership development program focused on improving communication competencies in conflict management situations can support a healthy work environment.

Detailed Description
-----------------
Freedman (2019) asserts that interpersonal conflict in nursing workplaces is a pervasive and complex phenomenon, with implications for patient safety and quality of care (p.594). First-time leaders seldom receive adequate training for effective transition to leadership roles, with 60% reporting having no training (Gentry, Logan, & Tonidandel, 2014). Furthermore, many novice leaders struggle with transitioning from peer to leader, specifically related to interpersonal and communication skills (Basogul, 2020; Radovich, et al., 2011).

Official Title
-----------------
Improving Charge Nurse Conflict Resolution Communication Using Artificial Intelligence

Conditions
-----------------
Conflict Resolution

Intervention / Treatment
-----------------
* Behavioral: Orai: Master Public Speaking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: RN Clinical Team Leader or Charge Nurse employed at MMMC Exclusion Criteria: Non-employees of MMMC MMMC staff not in the role of Clinical Team Leader or Charge Nurse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Orai: Master Public Speaking|Participants will access the Orai: Master Public Speaking (Sani, Dhamani, & Gupta, 2020) platform with mobile and web-based applications. Communication skill-building moduleswill be assigned using exercises, case scenarios, and AI-assisted feedback debriefing through the Orai application. Participants will also complete case scenarios created with specific nursing conflict issues a charge nurse may encounter in an acute care facility. Upon completion of the competency development program, participants will complete the CMCSS to determine the effect on confidence levels and a brief survey (Appendix C) to assess the amicability of the program.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Charge nurses that have completed the program | The CMCSS is a validated tool, r= α=0.86, measuring nurses' confidence in managing challenging situations | September 2022 to November 2022 |
Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the safety and efficacy of fluvastatin in children diagnosed with heterozygous familial hypercholesterolemia

Official Title
-----------------
Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia

Conditions
-----------------
Heterozygous Familial Hypercholesterolemia, Mixed Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Fluvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 10-16 years old Heterozygous familial hypercholesterolemia Exclusion Criteria: Homozygous familial hypercholesterolemia Pregnant or lactating females Major surgery during the six month prior study Other protocol defined inclusion and exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fluvastatin|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
-----------------
Heterozygous familial hypercholesterolemia, mixed dyslipidemia
Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device

Study Overview
=================
Brief Summary
-----------------
This study observes the continuous measurement of breathing patterns, heart rate, restlessness, and tremor in sleep using the EarlySense ES 16 device as a tool in the management of hypoglycemia in pediatric type I diabetes patients.

Detailed Description
-----------------
The study patients are children, 12-18 years old, suffering from type I diabetes. Each patient will participate in the trial for 30 days. During this period of time the patients' breathing patterns, heart rate, restlessness and tremor in sleep will be measured by the EarlySense device which is put in the patient's bed. These measured values will be compared to: glucose values measured by a Guardian RT device - an approved device for CBGM - Continuous Blood Glucose Measurement; glucose levels tested by SBGM -Self Blood Glucose Measurement. These comparisons will show whether the EarlySense device is applicable in predicting hypoglycemia events in type I diabetes patients.

Official Title
-----------------
Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device

Conditions
-----------------
Type I Diabetes

Intervention / Treatment
-----------------
* Device: EarlySense ES 16


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 12-18 years Diagnosis of type I diabetes for at least a year Home close to participating center Guardian able and willing to cooperate with the trial for at least 1 month and prepared to sign the Informed Consent Form. Exclusion Criteria: Recent (within 3 months) admission to emergency room or intensive care unit (ICU) due to any condition unrelated directly to diabetes. Any other pre-existing medical pathology unrelated to diabetes. Inability of the patient or his guardian to use the Guardian RT.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: EarlySense ES 16|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
-----------------
diabetes, hypoglycemia, monitor, children with Type I Diabetes
Prognostic Value of Androgen Receptor Expression and Mutations Within Oncogenes and Tumor Suppressor Genes in Patients Treated for High Risk Prostate Cancer With Proton Therapy (PRX32)

Study Overview
=================
Brief Summary
-----------------
Retrospective Review Study for Prognostic Transcriptional Output Related to Androgen Receptor Expression in Patients Treated for High Risk Prostate Cancer with Proton Therapy

Official Title
-----------------
Prognostic Value of Androgen Receptor Expression and Mutations Within Oncogenes and Tumor Suppressor Genes in Patients Treated for High Risk Prostate Cancer With Proton Therapy

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (older than 18 years at time of treatment) with high risk prostate cancer who were treated with proton therapy at UFHPTI/Department of Radiation Oncology Patients treated between 6/10/2010 through 4/26/17 with at least 2 years follow up

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

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| Immunohistochemistry of tumor cell proteins will be performed on prostate biopsies to detect for androgen receptors and other protein products related to oncogenes or tumor suppressor genes thought to play a role in radiation or ADT. |  | 2 years follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA sequencing will be performed on prostate tumor DNA to determine the mutational status of several oncogenes and tumor suppressor genes including genes coding androgen receptors. |  | 2 years follow up | 
| RNA sequencing will be performed on several oncogenes and tumor suppressor genes including genes coding androgen receptors to detect RNA expression including genes related to the androgen receptor. |  | 2 years follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Cancer, Proton Radiation
Pharmacological Enhancement for Nocturnal Incontinence in Orthotopic Bladder Substitute

Study Overview
=================
Brief Summary
-----------------
In this randomised trial, we hypothesised that mebeverine could enhance nocturnal continenece of Orthotopic Bladder Substitute (OBS) patients by decreasing the frequency and reduce maximum amplitude of uninhibited contractions of OBS ileum, and consequently it would increase the OBS capacity

Official Title
-----------------
Pharmacological Enhancement for Nocturnal Incontinence in Orthotopic Bladder Substitute. A Randomised Controlled Trial

Conditions
-----------------
Incontinence, Urinary Incontinence, Urinary Bladder Cancer

Intervention / Treatment
-----------------
* Drug: mebeverine 200 mg sustained-release (Coloverine® SR, Chemipharm pharmaceutical, Egypt) one time/day at the evening.
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nocturnal enuresis Exclusion Criteria: daytime incontinence Orthotopic Bladder Substitute (OBS) reconstruction surgery ≤2 years chronic kidney disease local tumor recurrence adjuvant chemotherapy and/or radiotherapy chronic retention requiring use of clean intermittent catheterization or indwelling urethral catheterization suspected or known narrow-angle glaucoma sensitivity to mebeverine.

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

Sexes Eligible for Study
-----------------
Male

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mebeverine<br>Mebeverine 200 mg sustained-release (Coloverine® SR, Chemipharm pharmaceutical, Egypt) one time/day at the evening. | Drug: mebeverine 200 mg sustained-release (Coloverine® SR, Chemipharm pharmaceutical, Egypt) one time/day at the evening.<br>* mebeverine 200 mg sustained-release (Coloverine® SR, Chemipharm pharmaceutical, Egypt) one time/day at the evening. 200 mg sustained-release (Coloverine® SR, Chemipharm pharmaceutical, Egypt) one time/day at the evening.<br>* Other names: Coloverine® SR;|
| Placebo Comparator: Placebo<br>Placebo one time/day at the evening. | Drug: Placebo<br>* Placebo one time/day at the evening.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess the 3-months nocturnal continence rate | comparing Urinary function domain from the bladder cancer index (BCI) questionnaire | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Incontinence
A Study To Determine If Two Different Versions Of Topotecan Have The Same Potency In Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the bioequivalence of the new oral capsule formulation to the currently used oral capsule formulation of topotecan.

Official Title
-----------------
A Study to Determine the Bioequivalence of an Oral Formulation of Topotecan Containing the Drug Substance Manufactured by New Process Relative to the Current Study Formulation of Topotecan in Patients With Advanced Solid Tumors (4C)

Conditions
-----------------
Lung Cancer, Small Cell

Intervention / Treatment
-----------------
* Drug: topotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with advanced solid tumors. At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery. Subjects must be free of post-treatment side effects. Exclusion Criteria: Women who are pregnant or lactating Subjects with uncontrolled emesis, regardless of etiology, active infection.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All treated subjects<br>Subjects were randomized to receive 4 mg of a new formulation and current formulation of oral topotecan on Days 1 and 8 of Course 1. | Drug: topotecan<br>* topotecan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of blood levels of topotecan following oral and IV dosing; blood samples will be drawn on Day 1 and Day 8 of Courses 1 and 2. |  | Days 1, 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of clinical laboratory tests, cardiac monitoring and disease progression. Comparison of blood levels of topotecan when taken orally with and without food; blood samples will be drawn on Day 1 |  | Up to 38 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Any Solid Tumor
Cytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors

Study Overview
=================
Brief Summary
-----------------
Neuronal injury is evident in elective craniotomy for space occupying lesions. Surgical trauma and mechanichal impact of the tumor causes neuronal injury. Neurosreroid progesterone is a neurotransmittern , trail to use in abolishing neurotoxcicty

Detailed Description
-----------------
Progesterone is a natural neurosteroid that we are trying to use to impede both direct neuronal injury cauesd by and indirectly by surgical trauma. Progesterone can decreas vasogenic brain oedema. Our primary outcome is to ameliorate microscopic cytoplasmic injury and decrease brain oedema exploited by biopsy from brain tumor interface. Exclusion criteria demonstratd as refusal to participate in the trial , emergency craniotomy, recurrent brain tumor.

Official Title
-----------------
Cytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors

Conditions
-----------------
Diffuse Traumatic Cerebral Edema

Intervention / Treatment
-----------------
* Drug: Progesteron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All elective brain tumors elligible for craniotomy Exclusion Criteria: Refusal to participare Emergency craniotomy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Control group receiving conventional treatment without progesterone | |
| Active Comparator: progesterone group<br>1mg pregesterone intramusculer given 7 days pre and post operative , Biopsy was achieved from brain tumor interface | Drug: Progesteron<br>* intramusculer progesterone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With craniotomy-Related Adverse Events | Degree of microscopic cellular injury and brain odema in brain biopsy | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with neuronal deficit | Sensory, motor or autonomic dysfunction | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brain tumor, Progesterone, Neuronal biopsy