linjc16/ctgov huggingface dataset:
A Pilot Clinical Trial to Evaluate the Effects of Acupuncture in Patients on Prolonged Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the role of acupuncture use on: 1) decrease the requirements for pharmacologic analgesic, 2) improve patient-reported pain, 3) expedite recovery process, and 4) improve the quality of life.

Official Title
-----------------
A Pilot Prospective Randomized Study to Evaluate the Effects of Acupuncture in Patients on Prolonged Mechanical Ventilation

Conditions
-----------------
Mechanical Ventilation Complication

Intervention / Treatment
-----------------
* Procedure: Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive male and post-menopausal female patients expected to require more than 24 hours of mechanical ventilation will be included. Exclusion Criteria: Children < 18 years of age Patients with active resuscitation (fluid boluses greater than 2 Liter per hour, rapid transfusions, titration of vasoactive medication) Patients with hemodynamic instability: heart rate less than 40/min or greater than 120/min, SBP < 90 or > 180 mm Hg for longer than 2 continuous hours Patients who are pregnant or pre-menopausal Patients with expected survival less than 6 3 months Major deformities of the upper or lower extremities and/or any active skin lesions or ulcers in acupuncture treatment areas. Patients with a pacemaker or other implanted electronic device

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real acupuncture<br>Real acupuncture group | Procedure: Acupuncture<br>* Patients on mechanical ventilation greater than two days will be randomly assigned to real acupuncture group or sham acupuncture group<br>|
| Sham Comparator: Sham acupuncture<br>Sham acupuncture group | Procedure: Acupuncture<br>* Patients on mechanical ventilation greater than two days will be randomly assigned to real acupuncture group or sham acupuncture group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RASS (Richmond Agitation Sedation Scale) |  | baseline to six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ABPS (Aberdeen Back Pain Scale) |  | baseline to six months | 
| Pain Scale |  | baseline to six months |
Low-dose Dasatinib as First-line Treatment for Chronic Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
Our goal is to demonstrate that 50mg of dasatinib is as effective as the full dose to induce molecular response as first line therapy in CML.

Detailed Description
-----------------
We will give 50mg of dasatinib daily since the diagnosis for up to 6 months, for the first 2-4 weeks we will evaluate hematic biometry to registry hematic response, at months 3 and 6 a BCR/ABL PCR will be taken to evaluate molecular response.

Official Title
-----------------
Low-dose Dasatinib as First-line Treatment for Chronic Myeloid Leukemia

Conditions
-----------------
Chronic Myelogenous Leukemia

Intervention / Treatment
-----------------
* Drug: Dasatinib 50 MG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of BCR-ABL positive CML in early chronic phase CML. Except for hydroxyurea, patients must have received no or minimal prior therapy, defined as <2 weeks (14 days) of prior FDA approved TKI. ECOG performance of 0-2 Adequate end organ function, defined as the following: total bilirubin <1.5x ULN, SGPT <2.5x ULN, creatinine <1.5x ULN. Patients must sign an informed consent indicating they are aware of the investigational nature of this study. Exclusion Criteria: NYHA cardiac class 3-4 heart disease or previous pleural effusion. Pregnancy and lactation Patients with active, uncontrolled psychiatric disorders

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

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

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: Arm1 Low Dose Dasatinib<br>We will give 50mg of dasatinib orally daily for 6 months | Drug: Dasatinib 50 MG<br>* 50mg of dasatinib orally daily<br>* Other names: Sprycel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular Response at 6 months | Molecular Response define as BCR/ABL <1% | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Molecular Response at 3 and 6 months | Early Molecular Response define as <10% | 3 and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dasatinib
Prognostic Interest of Leucocyte Immunophenotyping During the Acute Phase of Sepsis

Study Overview
=================
Brief Summary
-----------------
Septic shock is still a major cause of death in ICU. Sepsis diagnosis is linked with many clinical, hemodynamic and biological criteria which have a low sensitivity and specificity if they are considered separately. The extensive experimental data which have been published contrast with the hematological data collected by the physician at patient's bedside especially regarding neutrophils and platelets levels. When there is no obvious clinical sign, a biological tool reflecting the patient's immune status could be useful to understand the physiopathology of Sepsis and to predict the progression of the disease in the patient. On the long-term it could also help to define management strategies.

Official Title
-----------------
Prognostic Interest of Leucocyte Immunophenotyping Using Multiparameter 8-color Flow Cytometry During the Acute Phase of Sepsis

Conditions
-----------------
Sepsis With Acute Organ Dysfunction

Intervention / Treatment
-----------------
* Biological: Blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient older than 18 years old Patient with two criteria of systemic inflammatory response syndrome and a progressive infection which is clinically or microbiologically documented Exclusion Criteria: Pregnancy, progressive solid cancer, HIV infection, history of blood or inflammatory disease, long-term immunosuppressive treatment

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SEPSIS Blood test<br>Patient with two criteria of systemic inflammatory response syndrome and a progressive infection which is clinically or microbiologically documented. | Biological: Blood test<br>* Residue of blood further to NFS.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| expression of the marker CD10 | Expression of CD10 on granulocytes. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progession of SOFA score |  | 48 hours | 
| Expression of the marker CD16 | Expression of CD16 on granulocytes and on monocytes. | 28 days | 
| Expression of the marker CD24 | Expression of CD24 on granulocytes. | 28 days | 
| Expression of the marker CD64 | Expression of CD64 on granulocytes. | 28 days | 
| Expression of the marker CD14 | Expression of CD14 on monocytes. | 28 days | 
| Expression of the marker CD3 | Expression of CD3 on T lymphocytes. | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
The acute phase of Sepsis, multiparameter 8-color flow cytometry
Evaluation of Bacteremia Epidemiology During the COVID Period in One French University Hospital

Study Overview
=================
Brief Summary
-----------------
The main objective of this retrospective cohort is to evaluate the impact of the first epidemic wave during lockdown on bacteremia epidemiology in one French University Hospital.

Official Title
-----------------
Evaluation of Bacteremia Epidemiology During the COVID Period in One French University Hospital

Conditions
-----------------
Bacteremia, Catheter-Related Infections

Intervention / Treatment
-----------------
* Biological: Positive blood culture


Participation Criteria
=================
Eligibility Criteria
-----------------
o Inclusion criteria : Patients with positive blood culture recorded at the microbiology laboratory of University Hospital of Nice Aged 18 years o Exclusion criteria : Patients with negative blood culture recorded at the microbiology laboratory of University Hospital of Nice
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case<br>Patients with positive blood culture recorded at the microbiology laboratory of University Hospital of Nice during the Covid-19 Pandemic lockdown (between 23/03/2020 and 24/05/2020). | Biological: Positive blood culture<br>* Positive blood culture recorded at the microbiology laboratory of University Hospital of Nic<br>|
| Control<br>Patients with positive blood culture recorded at the microbiology laboratory of University Hospital of Nice between 23/03/2019 and 24/05/2019. | Biological: Positive blood culture<br>* Positive blood culture recorded at the microbiology laboratory of University Hospital of Nic<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidemiology of bacteriemia,catheter-related infection and contamination | Describe and compare the incidence and epidemiology of hospital-diagnosed bacteriemia, catheter-related infection and contamination | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of community bacteremia |  | Day 0 | 
| Determined therapeutic actions | Anticipate the diagnostic and therapeutic actions to be taken for future epidemics | Day 0 |
Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether LNG/EE is effective in the treatment of menstrual cycle related symptoms.

Official Title
-----------------
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Levonorgestrel 90 Mcg and Ethinyl Estradiol 20 Mcg in a Continuous Daily Regimen on Menstrual Cycle-Related Symptoms

Conditions
-----------------
Premenstrual Syndrome

Intervention / Treatment
-----------------
* Drug: Levonorgestrel/Ethinyl Estradiol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women aged 18 to 49 years Regular 21 to 35 day menstrual cycles for 3 months prior to study visit 1 History of menstrual cycle related symptoms as determined by the investigator. Exclusion Criteria: Contraindication to combination oral contraceptives Depression requiring hospitalization or associated with suicidal ideation within the last 3 years Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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 |
| --- |
|Drug: Levonorgestrel/Ethinyl Estradiol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of a continuous-use OC regimen containing a combination of LNG/EE in preventing moderate to severe cycle-related symptoms compared with placebo |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects of this LNG/EE regimen on work productivity and subject satisfaction in subjects with moderate to severe cycle-related symptoms at baseline compared with placebo |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Levonorgestrel, ethinyl estradiol, premenstrual syndrome, menstrual cycle related symptoms
DISCOVERY: A Study Examining the Prevalence of TTR Mutations in Subjects Suspected of Having Cardiac Amyloidosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the frequency of TTR mutations in subjects suspected of having cardiac amyloidosis

Official Title
-----------------
DISCOVERY: A Study Examining the Prevalence of TTR Mutations in Subjects Suspected of Having Cardiac Amyloidosis

Conditions
-----------------
Familial Amyloidotic Cardiomyopathy (FAC)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females >18 years old History of evidence suggestive of cardiac amyloidosis Subject is willing and able to comply with protocol required assessments and provide written informed consent Exclusion Criteria: Known diagnosis of primary (AL) amyloidosis Known diagnosis of hereditary cardiomyopathy or cardiomyopathy due to aortic stenosis Patient is currently pregnant

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Familial Amyloidotic Cardiomyopathy (FAC)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with of Transthyretin (TTR) mutations | Blood will be sequenced for the presence of TTR gene mutations | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the presence of amyloid in tissue | An optional fine-needle aspirate of the abdominal fat pad will be collected | Day 30 | 
| Quantification of biomarkers of cardiac function in serum | Biomarkers that assess cardiac function will be quantified from serum | Day 30 | 
| Measurement of echocardiogram parameters | Cardiac structure and function will be measured by echocardiogram | Day 30 | 
| New York Heart Association (NYHA) Functional Classification | NYHA Functional Classification will be determined | Day 30 | 
| Results from 6-Minute Walk Test | Total distance walked in 6 minutes will be measured | Day 30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiomyopathy, Heart Failure, Amyloid, Transthyretin (TTR), FAC
Photon/Proton Radiation Therapy for Carcinoma of the Skin of the Head and Neck

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect information from the questionnaire and your medical records to see what effects the proton radiation has on you and your cancer and collect and analyze morbidity outcomes: Incidence of xerostomia (dry mouth) and tumor control.

Detailed Description
-----------------
Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.

Official Title
-----------------
A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Carcinoma of the Skin of the Head and Neck With Perineural Invasion

Conditions
-----------------
Malignant Neoplasm of Skin Head and Neck

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Carcinoma of the skin of the head and neck region with incidental or symptomatic perineural invasion. Biopsy-proven squamous cell carcinoma. Will receive treatment with proton radiation. Exclusion Criteria: Evidence of distant metastasis. Previous irradiation for head and neck cancer.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Photon/Proton Radiation Therapy<br>Data consolidation and analysis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect and analyze morbidity outcomes: Incidence of grade 3 or higher xerostomia (dry mouth) |  | 1 year following the completion of radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect and analyze tumor control outcomes. |  | When each patient has been followed for a minimum of 6 months and then again at 24 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carcinoma of the skin of the head and neck, Proton radiation, Outcomes
Adherence to New Oral Anticoagulation Therapy in Turkey

Study Overview
=================
Brief Summary
-----------------
This study will compose a national database of drug adherence and investigate the factors that affect drug adherence in patients taking new oral anticoagulation therapy in Turkish Population.

Detailed Description
-----------------
NOACs have several clinical and pharmacological advantages over warfarin however suboptimal adherence is one of the most common causes of failure to respond to medications and outcomes. This observational multicenter, retrospective study, will compose a national database of drug adherence and investigate the factors that affect drug adherence in patients taking new oral anticoagulation therapy in Turkey. Social support and adherence to therapy factors that may affect drug adherence and adverse events will be assessed by self-report questionnaires. Non-adherence will be tested for demographic, clinical, awareness of NOAC therapy and socioeconomic factors.

Official Title
-----------------
Drug Adherence in Patients Taking New Oral Anticoagulation Therapy in Turkey

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients >18 years old Outpatients using a NOAC for at least 3 months duration, with a primary diagnosis of new-onset, non-valvular atrial fibrillation Patients signed patient informed sheet and informed consent form Exclusion Criteria: Patients under 18 years old Patients refused to sign informed consent form

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 |
| --- | --- | --- |
| Compliance of NOACs in Turkish Population | Factors that may affect drug adherence and adverse events will be assessed by self-report questionnaires. Non-adherence will be tested for demographic, clinical, awareness of NOAC therapy and socioeconomic factors. The validity of the Morisky Adherence Scale had already been demonstrated with regard to medication adherence in patients receiving vitamin K antagonists. An extended 8-item Morisky scale was used instead of the original 4-item Morisky scale in order to better identify the situations and the conditions that could affect medication adherence and to better assess the psychometric features.The reliability and the validity of the 8-item Morisky Adherence Scale translated into Turkish had been demonstrated in Turkish population by previous studies. | 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation Drug Adherence, New Oral Anticoagulants, Drug Adherence