linjc16/ctgov huggingface dataset:
Effect of Intrathecal Administration of Hematopoietic Stem Cells in Patients With Amyotrophic Lateral Sclerosis (ALS)

Study Overview
=================
Brief Summary
-----------------
Autologous cell therapy in patients with ALS can stimulate neuroplasticity, modifying the neurodegenerative process and stops the clinical progression of disease.

Detailed Description
-----------------
There is no more extensive information

Official Title
-----------------
Effect of Intrathecal Administration of Hematopoietic Stem Cells in Patients With Amyotrophic Lateral Sclerosis (ALS)

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Biological: Intrathecal autologous stem cell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with a confirmed diagnosis of ALS according to El Escorial criteria. Diagnosis-time less than four years. Over 18 years old. Forced vital capacity ≥ 40%. One year of evolution. Adequate nutritional state Exclusion Criteria: Severe bulbar ALS involucre. Inadequate nutritional status. Spondylotic myelopathy, or abnormalities in imaging study. Having concomitant neurological or psychiatric disease. Systemic disease with poor-control. History of treatment with steroids or immunoglobulins in the last year. Participate in the past three months in a Clinical Trial. History of malignancy or cancer today. Intracranial hypertension. Clinical suggestive data of infection in the site of lumbar puncture. Tracheostomy. Use of mechanical ventilation. Forced vital capacity less than 40%. HIV-seropositive or presence of antibodies against hepatitis B or C in the serological studies.

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: Intrathecal autologous stem cells<br>Intrathecal stem cells will be administered to patients that fulfill the inclusion criteria. | Biological: Intrathecal autologous stem cell<br>* Mobilization and collection of stem cells for intravenous and intrathecal administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of autologous intrathecal administration of hematopoietic stem cells in patients with ALS. |  | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of intrathecal administration of hematopoietic stem cells in patients with ALS. |  | During the procedure and at 1st, 2nd, 3rd, 6th and 12 th month after the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALS, stem cells
Correlation Between Hepatic Fibrosis and Cardiovascular Risk Evaluated by Non-invasive Tests in Patients With NAFLD

Study Overview
=================
Brief Summary
-----------------
This study aims to examine the link between Non-Alcoholic Fatty Liver Disease (NAFLD) and cardiovascular diseases by studying the association between liver fibrosis degree and cardiovascular risk factors. The study would clarify the value and the role of the Coronary calcium score (CAC score) in the screening for coronary disease in this population at high cardiovascular risk.

Detailed Description
-----------------
Hepatic Fibrosis and Cardiovascular Risk are evaluated by non invasive tests

Official Title
-----------------
Study of Correlation Between Hepatic Fibrosis and Cardiovascular Risk Evaluated by Non-invasive Tests in Patients With Nonalcoholic Fatty Liver Disease

Conditions
-----------------
NAFLD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NAFLD patients regardless of disease stage of severity (from simple steatosis to cirrhosis) Patient without known heart disease Patient agreeing to participate and who has given his non opposition Exclusion Criteria: Association with another cause of liver disease Already known coronary artery disease Pregnancy or breastfeeding in progress

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 |
| --- | --- | --- |
| Coronary calcium score | Score in Agatston IU of coronary atherosclerosis risk;ranging from 0 to 100 : low risk; 100 to 400 : intermediate risk and > 400 : high risk of coronary atherosclerosis. | At inclusion | 
| Shear wave liver elastography | Hepatic elasticity assessed in kPa : <5 Kpa : normal; 5 to 8 kPa : low to moderate fibrosis ; > 8 kPa : advanced fibrosis; >15 kPa : cirrhosis | At inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ARFI Hepatic elasticity | Hepatic elasticity assessed by Acoustic radiation force impulse (ARFI) (in kPa) Hepatic elasticity assessed in kPa : <5 Kpa : normal; 5 to 8 kPa : low to moderate fibrosis ; > 8 kPa : advanced fibrosis; >15 kPa : cirrhosis . | At inclusion | 
| Cardiovascular risk | Systemic Coronary Risk Estimation (SCORE) ranging from <1% very low risk to >15% very high risk of cardiovascular mortality | At inclusion | 
| Coronary heart disease | Diagnosis of coronary heart disease | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CAC score, Liver fibrosis, Cardiovascular risk, Metabolic syndrome
Simplifying First Trimester Medical Abortion Follow-up

Study Overview
=================
Brief Summary
-----------------
This study evaluates the usability of the multilevel pregnancy test among women undergoing medical abortion.

Official Title
-----------------
Simplifying First Trimester Medical Abortion Follow-up

Conditions
-----------------
Medical Abortion

Intervention / Treatment
-----------------
* Device: Semiquantitative Multi-Level Pregnancy Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a first trimester pregnancy with a gestational age of ≤63 days; Desire medical abortion with mifepristone and misoprostol and be medically eligible for that treatment, according to clinic protocol; Be able to read and understand the local language or Russian; Have access to a telephone; Agree to follow all study procedures; Have no contraindication to participation in the study, in the judgment of the site investigator or designee.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Semiquantitative Multi-Level Pregnancy Test|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Understanding of the instructions for the multilevel pregnancy test |  | 14 days | 
| Ability to independently use the multilevel pregnancy tests |  | 14 days | 
| Ability to interpret the results of the multilevel pregnancy test |  | 14 days |
Evaluation of a New Airway Device - the YO2(R) Catheter in Patients Under Sedation

Study Overview
=================
Brief Summary
-----------------
Patients under sedation not uncommonly develop upper airway obstruction or other respiratory complications and no airway device is available to provide reliable maintenance of the airway at present. I believe the YO2(R)airway catheter can improve the maintenance of patent airway in most sedated patients and improve O2 delivery to the airway. In addition it may also greatly facilitate the monitoring of expired CO2, which is widely recognised as the most important monitor of adequacy of breathing, yet frequently impossible to perform satisfactorily in sedated patients at the moment.

Conditions
-----------------
Patients Undergoing Anesthesiologist-administered iv Sedation During Diagnostic/ Therapeutic Procedures

Intervention / Treatment
-----------------
* Device: YO2(R) catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient, age >18 and <80 Undergoing anesthesiologist-administered sedation for diagnostic/ therapeutic procedures Exclusion Criteria: Expected procedure require access to or involve the nostrils. Obesity (BMI >=30) Chronic lung diseases (e.g. COPD) associated with chronic hypoxia Pregnant or lactating women. Known chronic liver or renal disease. Mentally incapable of providing informed consent

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 |
| --- | --- |
| Airway catheter during sedation<br> | Device: YO2(R) catheter<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Efficacy and Safety Evaluation of Teneligliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Empaglyflozin and Metformin

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the efficacy and safety of teneligliptin 20 mg orally administered once daily for 24 weeks compared with placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control with empaglyflozin and metformin

Official Title
-----------------
A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of Teneligliptin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control With Metformin and Empagliflozin

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet
* Drug: Teneligliptin Placebo Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Type II diabetes mellitus aged 19 years or older Subjects with 7.0%≤HbA1c≤10.5% at screening visit Subjects with fasting plasma glucose ≤ 270mg/dL at screening visit Exclusion Criteria: Subjects with type 1 diabetes mellitus or secondary diabetes Subjects with history of diabetic ketoacidosis, diabetic coma or pre-coma, lactic acidosis, and acute or chronic acidosis within 6 months prior to the screening visit Subjects who have been administered with weight-loss drug (e.g., orlistat, phentermine/topiramate, lorcaserin) Body mass index greater than 40 kg/m2 at the screening visit Subjects with heart failure (Class III-IV of NYHA classification) or arrhythmia that requires treatment

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teneligliptin 20 mg<br>Once daily for 24 weeks | Drug: Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet<br>* To be orally administered once daily<br>|
| Placebo Comparator: Teneligliptin placebo<br>Once daily for 24 weeks | Drug: Teneligliptin Placebo Oral Tablet<br>* To be orally administered once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline HbA1c at week 24 |  | Baseline (week 0) and week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline FPG at week 24 |  | Baseline (week 0) and week 24 | 
| Percentage of subjects achieving the HbA1c goals (HbA1c < 7.0% or < 6.5%) at week 24 |  | Baseline (week 0) and week 24 | 
| Changes from baseline in BMI at week 24 |  | Baseline (week 0) and week 24 |
Thromboelastography As A Tool for Possible Clopidogrel Resistance in The Patients Treated With Primary PCI for STEMI

Study Overview
=================
Brief Summary
-----------------
Determine usefulness of thromboelastography (TEG) as a valuable tool in ex-vivo assessing platelet response to aspirin and clopidogrel (dual) treatment and on-treatment platelet reactivity during acute ST segment elevation myocardial infarction (STEMI) in an acute phase during primary PCI (PPCI) and also during recovery been on maintenance medical therapy and to determine the correlation between platelet response to clopidogrel treatment and the outcome of patients.

Detailed Description
-----------------
Dual anti-aggregant therapy is recommended standard of therapy applicable to all patient groups undergoing PPCI. The aspirin-clopidogrel regiment is signed to every patient without assessing therapeutic effect. In face of growing evidence of platelet resistance to the standardized therapy there is a demand for reliable diagnostic tool for rapid and accurate assessment of platelet reactivity. TEG is an established technique to assess the quality of clot formation' used mainly in surgery and obstetrics to determine possible bleeding diathesis. Recently it became to be used in cardiology, where it can be a valuable tool to assess a response to antiplatelet therapy and its association with the outcome. However, there is a few data about use of TEG in STEMI patients undergoing PCI. Our study is designed to assess by TEG the platelet's response to clopidogrel treatment during acute STEMI in patients undergoing primary PCI and the correlation of this response with the long term outcome.

Conditions
-----------------
Myocardial Infarction, Cardiovascular Disease

Intervention / Treatment
-----------------
* Procedure: Blood Sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years old STEMI patients admitted to ICCU and in whom the primary PCI is elected as treatment strategy would be enrolled Exclusion Criteria: Patient received thrombolytic therapy, chronic renal failure (GFR<40 ml/min), any known hematological dyscrasia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 88 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Blood Sample|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Preimplantation Genetic Screening in Women Over 35 Year

Study Overview
=================
Brief Summary
-----------------
In view of insufficient evidence to routinely use Preimplantation Genetic Screening (PGS) to improve success rates after IVF, we test the hypothesis that patients with advanced maternal age (AMA) have a higher implantation rate (IR) after embryo transfer (ET) of chromosomally normal embryos following PGS compared to patients who had an ET without PGS. In a randomized controlled trial (RCT) in patients with AMA (≥ 35 years), the clinical IR per embryo transferred will be compared after ET on day 5 or 6 between the PGS group (embryo biopsy and analysis of chromosomes 13, 16, 18, 21, 22, X and Y) and the control group without PGS.

Official Title
-----------------
Preimplantation Genetic Screening for Aneuploidy in Embryos After in Vitro Fertilization in Women Over 35: a Prospective Controlled Randomized Study.

Conditions
-----------------
In Vitro Fertilization

Intervention / Treatment
-----------------
* Procedure: Preimplantation genetic screening after embryo biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All couples with a medical indication for IVF and with a female age of at least 35 years are invited to participate in the study. Exclusion Criteria: Cycles were excluded from the study if ≤ 2 fertilized oocytes were available on day 1 after oocyte retrieval (OR), or if ≤ 2 ≥ 6c stage embryos were available on day 3 after OR.

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PGS group<br> | Procedure: Preimplantation genetic screening after embryo biopsy<br>* Preimplantation genetic screening after embryo biopsy<br>|
| No Intervention: control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical implantation rate per embryo transferred |  | end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate per transfer |  | end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aneuploidies in 7 chromosomes increased with advanced maternal age
Surveillance For New Lung Primaries

Study Overview
=================
Brief Summary
-----------------
The primary goal of this study is to determine the prevalence of tracheobronchial carcinomas in patients with a history of squamous cell cancer of the aerodigestive tract who have been treated with a curative intent and remain disease free. Detection of pre-invasive and invasive lesions (moderate to severe dysplasia, CIS) with fluorescence bronchoscopic surveillance may help to define the natural history of these lesions and allow earlier intervention should they progress to invasive lesions.

Official Title
-----------------
Fluorescence Bronchoscopic Surveillance For New Lung Primaries After Curative Therapy for Squamous Cell Carcinoma of the Aerodigestive Tract

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History squamous cell NSCLC who have undergone complete resection or definitive chemotherapy Exclusion Criteria: History of an aerodigestive tract carcinoma of non-squamous histology Patients who have Stage IIIA, IIIB or IV squamous cell lung cancer that have undergone resection or chemotherapy within three years Patients who have Stage I or II squamous cell lung cancer that have undergone resection or chemotherapy within one year Patients who have received external beam radiation therapy for treatment of a squamous cell cancer of the lung
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fluorescence bronchosopy with sputum cytology<br>Patients undergo surgery with Fluorescence bronchosopy and sputum cytology. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pain Reducing Effect of Transcutaneous Electrical Nerve Stimulation in Patients With Chronic Low Back Pain or Lumbo-radiculalgia

Study Overview
=================
Brief Summary
-----------------
Prior studies showed contradictory results about the best type of TENS in chronic pain pathology. Therefore we want to evaluate the efficacy assessment of TENS on patients with chronic low back pain or chronic lumbo-radiculalgia. The functional ability score is evaluated by the Roland scale at 6 weeks.

Official Title
-----------------
Pain Reducing Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Patients With Chronic Low Back Pain or Chronic Lumbo-radiculalgia and Followed in Pain Treatment Centers

Conditions
-----------------
Chronic Low Back Pain, Chronic Lumbo-radiculalgia

Intervention / Treatment
-----------------
* Device: CEFAR PRIMO TENS Class IIA (active)
* Device: CEFAR PRIMO TENS Class IIA (no active)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable chronic low back pain or stable chronic lumbo-radiculalgia Patients with a pain score at least superior or equal to 4 Patients followed in pain clinics Written informed consent Exclusion Criteria: Prior ambulatory TENS practice Lumbo-radiculalgia pathology surgery within 3 months before inclusion Acute low back pain or bilateral lumbo-radiculalgia Acute radiculalgia Surgery planned within 6 months Pacemaker Symptomatic low back pain

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: 1<br>transcutaneous electrical nerve stimulation | Device: CEFAR PRIMO TENS Class IIA (active)<br>* Active TENS. 4 sessions per day during 3 months.<br>|
| Placebo Comparator: 2<br>No transcutaneous electrical nerve stimulation | Device: CEFAR PRIMO TENS Class IIA (no active)<br>* Placebo TENS. 4 sessions per day during 3 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional ability |  | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain relief |  | Week 6 and Month 3 | 
| functional repercussions by Roland scale |  | Month 3 | 
| functional repercussions by Dallas scale |  | Month 3 | 
| quality of life |  | Day 1 and Month 3 | 
| global satisfaction of cares |  | Month 3 | 
| medical consumption |  | From Day 1 to Month 3 | 
| TENS observance |  | from Day 1 to Month 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TENS, chronic low back pain, chronic lumbo-radiculalgia, placebo, Roland scale