linjc16/ctgov huggingface dataset:
Improvement of Liver Function in Liver Cirrhosis Patients After Autologous Mesenchymal Stem Cell Injection:a Phase I-II Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The methods for separation of mesenchymal stem cell were established in 2001. These cells can differentiate to osteocytes, hepatocytes, chondrocytes, myocytes and etc,. In this study the investigators try to separate mesenchymal stem cell from end stage liver disease, then these cells will be differentiated to progenitor of hepatocytes, finally , the investigators injected these cells into portal vein under ultrasound guide. The investigators determine the effects of injected cells in reestablishment of liver function.

Official Title
-----------------
A Phase One/Two Clinical Trial on the Use of Autograft Mesenchymal Stem Cells Differentiated Into Progenitor of Hepatocytes for the Salvage Treatment of Patients With End-stage Liver Disease

Conditions
-----------------
Liver Failure, Cirrhosis

Intervention / Treatment
-----------------
* Procedure: injection of progenitor of hepatocyte drived from Mesenchymal stem cell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: MELD score of at least 10 Patent portal vein on color Doppler examination of the liver Normal alpha-feto protein serum levels Age more than 18 Filling inform consent by patients and first degree family members Exclusion criteria: Any evidence of hepatocellular carcinoma on liver ultrasound studies Patients want to exclude from study

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: injection of progenitor of hepatocyte drived from Mesenchymal stem cell|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver function test |  |  | 
| MELD score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cirrhosis mortality after 6 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mesenchymal stem cell, end stage liver disease, Cirrhosis, stem cell therapy
Early Post-marketing Study of Eliquis (Apixaban)

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to identify and describe any suspected (AEs) in all patients with NVAF treated with Apixaban, as a request of the National Center of Pharmacovigilance (CNFV) in Mexico.

Official Title
-----------------
Early Post-marketing Study of Eliquis (Apixaban)

Conditions
-----------------
Non-valvular Atrial Fibrillation (NVAF)

Intervention / Treatment
-----------------
* Drug: Apixaban


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: All patients with NVAF at the sentinel site for the CNFV in Mexico who received at least 1 dose of Apixaban to reduce the risk of stroke or systemic embolism during the specified 24-month study period Exclusion Criteria: Subjects who received Apixaban as part of a clinical trial Subjects who received Apixaban for any indication other than local approval (ie, to reduce the risk of stroke and systemic embolism in patients with NVAF)

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 |
| --- | --- |
| NVAF patients in Mexico treated with Apixaban<br>All patients with NVAF at the sentinel site for the CNFV in Mexico who received at least 1 dose of Apixaban to reduce the risk of stroke or systemic embolism during the specified 24-month study period | Drug: Apixaban<br> <br> * Other names: Eliquis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the reporting rate of on-treatment adverse events (AEs) by the treating physicians |  | Up to 24 month study period | 
| Identify, describe, and report any suspected AEs that occur while on treatment with Apixaban or preventing stroke and systemic embolism in patients with NVAF |  | Up to 24 months |
Probiotic Administartion to Mothers of Preterm Infants to Prevent Necrotizing Enterocolitis and Sepsis

Study Overview
=================
Brief Summary
-----------------
We hypothesize that supplementing maternal diet with probiotics will decrease the incidence of feeding intolerance, necrotizing enterocolitis and sepsis in preterm infants fed breastmilk.

Detailed Description
-----------------
Oral probiotics have previously been shown to prevent necrotizing enterocolitis in preterm infants. A few reports of sepsis by a probiotic bacteria have impeded implementation of oral probiotic supplementation in most NICUs. Considering the proven immunomodulatory effect of maternal probiotics on breastfed infants of atopic mothers, we would like to explore the indirect effects of maternal probiotics on preterm infants

Official Title
-----------------
Probiotic Administartion to Mothers of Preterm Infants to Prevent Necrotizing Enterocolitis and Sepsis

Conditions
-----------------
Sepsis, Necrotizing Enterocolitis

Intervention / Treatment
-----------------
* Drug: Probiotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mothers of preterm infants Pumping breast milk Exclusion Criteria: Neonatal congenital anomalies
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Probiotics|Lactobacillus acidophilus, b.lactis capsule. Once daily.2X 10 by the power of 10 bacteria per dose.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality at three months of age |  | 3 months | 
| incidence and severity of necrotizing enterocolitis by Bell's staging at Three months |  | 3 months | 
| occurrence of bacterial or fungal infection per blood,csf or urine cultures at three months |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of BPD, PVL, ROP |  | 36 weeks | 
| maternal adverse effects during treatment |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
probiotic, preterm, lactation, breast feeding, necrotizing enterocolitis, sepsis, bacterial cultures, lactating mother, breast feeding of at least 50% of enteric feeding volume, Infant, very low birth weight
Transcutaneous Bilirubinometry in Neonates With the Bilicare System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the performance of a new transcutaneous (measured through skin) bilirubin device (BiliCare™) to measure bilirubin levels. The investigators plan to evaluate the clinical performance of this device as a point of care test. If the investigators can validate the BiliCare™ with bilirubin from your baby's blood they could verify a non-invasive alternative for measuring bilirubin.

Official Title
-----------------
Transcutaneous Bilirubinometry in Neonates With the Bilicare System

Conditions
-----------------
Transcutaneous Bilirubinometry

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parental informed consent Male and female newborns with a GA ≥ 35 wks Enrollment at age > 6 hrs until neonatal discharge Pre-phototherapy Exclusion Criteria: Infants requiring respiratory assistance (such as mechanical ventilation) Severe or life-threatening congenital anomalies Hematomas at the point of measurement on both ears Neonates undergone blood transfusion

Ages Eligible for Study
-----------------
Minimum Age: 35 Weeks

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 |
| --- | --- | --- |
| In This Study, the Investigators Plan to Test the Performance of a Novel Transcutaneous Device (BiliCareTM) to Screen for Bilirubin Levels at Postnatal Age of 12 to 48 Hours. |  | 12 to 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neonates, Bilicare System
Dynamic Postural Control After Exercise

Study Overview
=================
Brief Summary
-----------------
The aim was to analyze the influence of fatigue on the dynamic postural control in one-leg standing and in jump landing, followed by stabilization or side jumps, and to compare athletes of different levels with control subjects.

Official Title
-----------------
Influence of an Exercise on the Dynamic Postural Control in Athletes

Conditions
-----------------
Postural Control

Intervention / Treatment
-----------------
* Other: treadmill run


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: competitive level (participation in any league) for the high performance athletes group participation in sport for 0.5-4 hours per week for the recreationally active subjects Exclusion Criteria: current history of a lower extremity injury requiring training cessation on the day of testing neurological diseases vestibular or visual disturbances cardiovascular diseases medication affecting balance

Ages Eligible for Study
-----------------
Minimum Age: 14 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>All participants had to run 20min on their individual anaerobic threshold | Other: treadmill run<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of force ratio of ground reaction forces in/after landing from baseline |  | 1, 5, 10, 15, 20 min after exercise | 
| Change of the velocity of the center of pressure (COP) from baseline |  | 1, 5, 10, 15, 20 min after the exercise | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of rate of perceived exertion (Borg Scale) from baseline |  | every 10 min during and 1, 5, 10, 15, 20 min after exercise |
Epidemiology Controls Using Healthy Participants

Study Overview
=================
Brief Summary
-----------------
The goal of this research study is to identify biologic and lifestyle factors that may increase a person's risk of developing certain types of cancer.

Detailed Description
-----------------
For this study, you will be asked to complete a personal interview. During the interview, you will be asked questions about your demographics (age, sex, etc.), certain environmental exposures, your medical history, family history, your diet, and your smoking and alcohol use histories. It should take around 50 minutes to complete the interview. You will also have around 2 ½ tablespoons of blood drawn for special tests. These tests will look for any biologic factors associated with certain cancers. The interview and blood draw will be scheduled at the time and place of your convenience. You will not be informed of the results of any of the testing done with your samples. There is a possibility that you might be contacted in the future about if researchers need clarification on any of information already collected. You are free to refuse any further participation if you wish. This is an investigational study. Up to 1,500 participants will take part in this study.

Official Title
-----------------
Epidemiology Controls Using Healthy Participants

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Behavioral: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals ages 18 and over with no prior cancer Willing and able to complete an administered questionnaire Willing and able to donate 30 mL of blood Exclusion Criteria: Individuals with prior cancer Individuals under the age of 18

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Person with no history of cancer. | Behavioral: Questionnaire<br>* 50 Minute Interview<br>* Other names: Survey;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify biologic and lifestyle factors that may increase a person's risk of developing certain types of cancer. |  | 6 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epidemiology, Questionnaire, Controls
Angiogenesis Inhibitors and Hypertension: Clinical Aspects

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to find simple clinical and laboratory parameters to predict the development of hypertension and to elucidate the mechanism of hypertension during treatment with the tyrosine kinase inhibitor Sunitinib.

Detailed Description
-----------------
Inhibition of angiogenesis with antibodies against vascular endothelial growth factor (VEGF) and VEGF receptor antagonists has become an established treatment for cancer. An unanticipated side effect of angiogenesis inhibitors is the development of hypertension. The pathogenesis of this hypertension is unknown. Not all patients will develop hypertension. However, it is not known which patient will and which patient will not develop hypertension.

Official Title
-----------------
Angiogenesis Inhibitors and Hypertension: Clinical Aspects

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women, with either renal cell carcinoma or gastro intestinal stromal tumors (GIST) intended to be treated solely with Sunitinib (single-agent treatment) and who are considered fit enough by their treating physician to receive Sunitinib.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, angiogenesis inhibitors, tyrosine kinase inhibitor, Sunitinib
Dexamethasone Reduces Postoperative Emesis by Decreasing PGF2α and LTC4 Levels

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Dexamethasone reduces postoperative emesis in thyroidectomy and mastectomy patients.

Detailed Description
-----------------
This study has been done to further study the effectiveness of dexamethasone in the prevention of postoperative emesis after breast and thyroid surgery and at the same time, the mechanism of action was investigated. In this prospective, randomized controlled trial it was hypothesized that corticosteroids exert their antiemetic effects in postoperative period via plasma prostaglandin F2 alpha (PGF2 α) and plasma leukotriene C4 (LTC4) inhibition.

Official Title
-----------------
Dexamethasone Reduces Postoperative Emesis by Decreasing PGF2α and LTC4 Levels

Conditions
-----------------
Thyroid Cancer, Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: breast and thyroid cancer patients no neoadjuvant treated no NSAID or steroid usage heallthy volunteers, signed the informed consent Exclusion Criteria: ones who did not sign the consent form NSAID or steroid users

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants will be evaluated to show effect of dexamethasone in reducing postoperative emesis | participants will be followed for the duration of hospital stay, till they are discharged in avarage 3 days for postoperative emesis. | up to 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thyroid cancer, Breast cancer, Dexamethasone, Emesis
A Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial was to evaluate the safety and tolerability of SPM 927 when given as iv infusions compared with oral administration of the same dose strengths in subjects who were receiving oral SPM 927 for partial seizures with or without secondary generalization. Trial procedures will include medical history update, physical/ neurological exams, ECGs, blood /urine sample collections and seizure diary completion. Subjects completing the trial will return to the OLE trial to resume dosing with oral SPM 927.

Official Title
-----------------
A Multicenter, Double-blind, Double-dummy, Randomized Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial Seizures With or Without Secondary Generalization

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: iv SPM 927 and oral placebo tablet
* Drug: oral SPM 927 tablet and iv placebo
* Drug: iv SPM 927 and oral placebo tablet
* Drug: oral SPM 927 tablet and iv placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject with partial seizures with or without secondary generalization Exclusion Criteria: Subject had previously received iv SPM 927 Subject met the withdrawal criteria for the open-label extension trial with SPM 927 or was experiencing an ongoing serious adverse event.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Experimental: 1<br> | Drug: iv SPM 927 and oral placebo tablet<br>* 60-minute infusion iv SPM 927 and oral placebo tablet<br>* Other names: Vimpat;|
| Placebo Comparator: 2<br> | Drug: oral SPM 927 tablet and iv placebo<br>* 60-minute infusion placebo and oral SPM 927 tablet<br>* Other names: Vimpat;|
| Experimental: 3<br> | Drug: iv SPM 927 and oral placebo tablet<br>* 30-minute infusion iv SPM 927 and oral placebo tablet<br>* Other names: Vimpat;|
| Placebo Comparator: 4<br> | Drug: oral SPM 927 tablet and iv placebo<br>* 30-minute infusion placebo and oral SPM 927 tablet<br>* Other names: Vimpat;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, Vital signs, electrocardiograms,Physical examination, neurological examination |  | 2 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure counts |  | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epilepsy