linjc16/ctgov huggingface dataset:
A Study of the Effects of Probiotics in Children Grades 1-3

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine the appropriate study design for a full-scale claims support study to evaluate the impact of 2 probiotics on healthy days in elementary school children relative to a placebo control.

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled Study of the Effects of Probiotics in Children Grades 1-3

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

Intervention / Treatment
-----------------
* Other: Placebo
* Other: Lactobacillus (Probiotic 1)
* Other: Lactobacillus and Bifidobacterium (Probiotic 2)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be in good general health as reported by their parent(s)/legal guardian; Be willing to refrain from ingesting any product that contains fermented live bacteria (other than their test product) during the study as confirmed by their parent(s)/legal guardian(s); Be willing to continue their current dietary habits for the duration of the study as confirmed by their parent(s)/legal guardian(s) Exclusion Criteria: Have a known hypersensitivity or allergy to any product ingredient to be ingested during the study, as reported by their parent(s)/legal guardian(s)

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 9 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: 1<br> | Other: Placebo<br>* oral, placebo, once/day for 12 weeks<br>|
| Experimental: 2<br> | Other: Lactobacillus (Probiotic 1)<br>* oral, Lactobacillus, once/day for 12 weeks<br>|
| Experimental: 3<br> | Other: Lactobacillus and Bifidobacterium (Probiotic 2)<br>* oral, Lactobacillus and Bifidobacterium, once/day for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of healthy days. |  | 12 weeks |
Local Treatment of Metastatic Melanoma With Autologous Lymphocytes and the Bispecific Antibody rM28

Study Overview
=================
Brief Summary
-----------------
Phase I/II clinical trial to analyze safety and efficiency of intralesional application of the bispecific single chain antibody rM28 and autologous PBMCs in patients with metastatic melanoma stage III/IV and unresectable metastasis.

Detailed Description
-----------------
Phase I/II clinical trial to analyze safety and efficiency of intralesional application of the bispecific single chain antibody rM28 and autologous PBMCs in patients with metastatic melanoma stage III/IV and unresectable metastasis. The antibody is directed against epitops of human CD28 and the melanoma associated surface antigen HMV-MAA. Treatment over 5 days with dose escalation.

Official Title
-----------------
Local Treatment of Metastatic Melanoma With Autologous Lymphocytes and the Bispecific Antibody rM28

Conditions
-----------------
Malignant Melanoma

Intervention / Treatment
-----------------
* Drug: rM28
* Drug: autologous PBMCs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: malignant melanoma stage III/IV injectable soft tissue metastasis informed consent given Karnofsky >= 70% Exclusion Criteria: additional chemotherapeutical treatment systemic glucocorticoids brain metestasis other malignancies

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antibody<br> | Drug: rM28<br> <br> Drug: autologous PBMCs<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicity |  |  | 
| clinical response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mRNA, vaccination, melanoma
Casopitant (Oral) And ZOFRAN To Prevent Postoperative Nausea And Vomiting In Women

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to see if adding GW679769 (casopitant) to ZOFRAN will significantly decrease the number of patients who experience nausea and vomiting after surgery.

Official Title
-----------------
A Phase III, Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of 50mg Oral Dosing With the Neurokinin-1 Receptor Antagonist GW679769 for the Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for Emesis

Conditions
-----------------
Nausea and Vomiting, Postoperative

Intervention / Treatment
-----------------
* Drug: GW679769 (casopitant)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: History of PONV and/or motion sickness. Have not smoked for the last 6 months. Having certain types of abdominal, breast or shoulder surgeries. Exclusion criteria: Pregnant or breastfeeding. Taking certain medications. Have certain pre-existing medical conditions.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: GW679769 (casopitant)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of vomiting and retching |  | after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of nausea. Blood test results. |  | after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative nausea and vomiting PONV antiemetics NK-1 5HT3 casopitant mesylate ZOFRAN ondansetron hydrochloride
Ability of Hypotension Prediction Index to Predict Hypotension Events in Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
Investigators design this prospective observational study to exam the ability of hypotension prediction index in predicting intraoperative hypotension events in each phase of thoracic surgery

Detailed Description
-----------------
Hypotension prediction index is a novel introduced monitoring-tool that aims to predict hypotension events before their occurence, and has been reported to have superior predictive ability than the commonly measured perioperative hemodynamic variables. To date, there is no information regarding its ability to predict hypotension events in each phase of thoracic surgery.

Official Title
-----------------
Ability of Hypotension Prediction Index to Predict Future Hypotension Events in Each Phase of Thoracic Surgery: an Observational Pilot Study

Conditions
-----------------
Perioperative/Postoperative Complications

Intervention / Treatment
-----------------
* Diagnostic Test: hypotension prediction index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults undergoing scheduled VATS surgery Exclusion Criteria: pregnant women patients in intensive care units patients with the underlying disease including respiratory failure(FEV1/FVC < 70 % and FEV1 < 50%), heart failure(NYHA score =III、IV), kidney failure(eGFR< 60 ml.min-1.1.73m-2), liver failure patients with ongoing infection

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observation<br>monitor intraoperative hypotension prediction index as well as hemodynamic variables to exam the ability in predicting hypotension events of each variable | Diagnostic Test: hypotension prediction index<br>* monitor intraoperative hypotension prediction index as well as hemodynamic variables to exam the ability in predicting hypotension events of each variable<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ability of hypotension prediction index in predicting hypotension events | to calculate the sensitivity/specificity and AUROC of hypotension prediction index in predicting hypotension events | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ability of dynamic parameters in predicting hypotension events | to calculate the sensitivity/specificity and AUROC of dynamic parameters in predicting hypotension events | 3 hours |
Noninvasive Optical Measurement of Critical Care Neonates

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether reflections of light can be used to provide real-time pictures of blood vessel formation around infants' heads. This study device is called laser speckle imaging.

Detailed Description
-----------------
The researchers can use the laser speckle imaging device to image superficial cerebral blood flow in the infant's head. The researchers can quantify blood flow and measured vessel diameter, versus actual diameter assessed with conventional digital camera imaging.

Official Title
-----------------
Noninvasive Optical Measurement of Critical Care Neonates

Conditions
-----------------
Signs and Symptoms

Intervention / Treatment
-----------------
* Device: Laser Speckle Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New born or infant Exclusion Criteria: non- new born or infant

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 6 Weeks

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 |
| --- | --- |
| Diagnostic tool<br>Laser Speckle Imaging of Critical Care Neonates | Device: Laser Speckle Imaging<br>* Laser Speckle Imaging of Critical Care Neonates<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical tool | Laser Speckle Imaging device to image superficial cerebral blood flow in the infant's head | up to 12 months |
Renal Denervation in Chronic Heart Failure

Study Overview
=================
Brief Summary
-----------------
Renal denervation can be carried out for heart failure

Detailed Description
-----------------
There are theoretical reasons why renal denervation might be beneficial for patients with chronic heart failure. It is not known whether they would suffer large drops in blood pressure which might compromise safety. This pilot study required patients to remain in hospital for one week during which they had careful monitoring of blood pressure with the ability to halt the trial if any patient suffered any dangerous effect such as a large drop in blood pressure. It also monitored blood pressure after discharge for six months.

Official Title
-----------------
Renal Denervation in Chronic Heart Failure

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Renal denervation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients were required to have chronic symptomatic systolic heart failure (NYHA class III or IV) on maximal tolerated medical therapy, including beta-blocker, ACE inhibitor or angiotensin receptor blocker, and spironolactone. Exclusion Criteria: Clinically unstable patients or those with significant valvular disease An estimated glomerular filtration rate <35 ml/min Unfavourable renal anatomy Tortuous femoral arteries were not eligible
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: Renal denervation<br>renal denervation | Device: Renal denervation<br>* Renal denervation<br>* Other names: Symplicity Renal Denervation System;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Renal denervation had been reported to cause a 30 mmHg fall in blood pressure when used in hypertension. Although in principle renal denervation might be favourable for physiology in chronic heart failure, numerous theoretical possibilities exist for the procedure causing deterioration in clinical status, including the possibility of a large fall in blood pressure. A deterioration in symptomatic status or occurrence of an event such as presyncope or syncope would be considered a primary outcome event. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure | Monitored as inpatient for 5 days, then as outpatient for 6 months | 6 months | 
| Serum Creatinine |  | 6 months | 
| Serum sodium |  | 6 months | 
| Serum potassium |  | 6 months | 
| 6 minute walk distance |  | 6 months |
A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021

Study Overview
=================
Brief Summary
-----------------
This study is a 1-year open label extension study to collect long term efficacy and safety data from patients who have completed approximately 2 years of dosing in Study CL0600-021.

Detailed Description
-----------------
This study served as a 1-year extension study for those US patients who have completed the CL0600-021 study.

Official Title
-----------------
A One-Year, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition-dependent Short Bowel Syndrome Who Completed Study CL0600-021

Conditions
-----------------
Short Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: Teduglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At completion of Study CL0600-021, subjects will be invited to participate in this trial if they meet the following criteria: Completion of the 24-month study, CL0600-021, regardless if fully weaned from PN/I.V. support Signed and dated informed consent form (ICF) to participate before any study-related procedures of Study TED-C11-001 are performed Exclusion Criteria: None

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: Teduglutide<br>0.05 mg/kg/day | Drug: Teduglutide<br>* 0.05 mg/kg/day subcutaneously taken once per day for 12 months<br>* Other names: Gattex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of Treatment-emergent Adverse Events | As the primary intent of this study was to collect additional safety data, this outcomes measure will provide a summary of the treatment emergent adverse events. Based on the start date of each subject in this study and the study end date, not all subjects reached 12 months. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TPN, Parenteral nutrition, HPN, PN, SBS, Short bowel syndrome
HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy in Spain

Study Overview
=================
Brief Summary
-----------------
The study purpose is to investigate plasma HIV-1 RNA dynamics in subjects initiating raltegravir-based salvage therapy and quantify the corresponding changes in levels of cellular HIV-1 DNA.

Detailed Description
-----------------
First- and second-phase decay rates of plasma HIV-1 RNA and changes in the intracellular levels of HIV-1 proviral DNA and LTR circles will be measured in subjects starting salvage antiretroviral therapy including raltegravir in Spain.

Official Title
-----------------
HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy in Spain

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Salvage antiretroviral therapy including raltegravir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have limited or no treatment options due to extensive antiretroviral drug resistance or drug intolerance. Subjects initiating raltegravir plus another fully active antiretroviral drug. Exclusion Criteria: Pregnancy, or fertile women willing to be pregnant. Active substance abuse or major psychiatric disease.

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: 1<br>HIV-1-infected subjects initiating raltegravir-including salvage therapy | Drug: Salvage antiretroviral therapy including raltegravir<br>* Initiation of raltegravir-including salvage antiretroviral therapy<br>* Other names: RAL;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in viral load from day 0 to 7 |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracellular levels of HIV-1 proviral DNA and LTR circles |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Raltegravir, HIV, dynamics, viral load, Treatment Experienced
Preclinical Project on the Traitment of Acute Lymphoblastique Leukemia With NVP-BEP800, an Inhibitor of the Heat Shock Protein HSP90

Study Overview
=================
Brief Summary
-----------------
NVP-BEP800, a new HSP90 inhibitor, has particularly interesting therapeutic potential and represents hope in cancer pathologies. While it is currently being tested for solid cancers, no preclinical study has yet demonstrated its effectiveness in acute lymphoblastique leukemia (ALL). The investigators wish to study the effects of NVP-BEP800 on two different types of ALL (T and B-ALL).

Official Title
-----------------
Preclinical Project on the Traitment of Acute Lymphoblastique Leukemia With NVP-BEP800, an Inhibitor of the Heat Shock Protein HSP90

Conditions
-----------------
Acute T Lymphoblastic Leukemia (T-ALL), Acute B Lymphoblastic Leukemia (B-ALL)

Intervention / Treatment
-----------------
* Drug: injection of BEP 800
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient suffering from acute lymphoblastic leukaemia whose biological samples are kept at the Biology Technical Platform. Exclusion Criteria: Patient over 80 years of age

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 |
| --- | --- |
| T-ALL<br> | Drug: injection of BEP 800<br>* injection of BEP 800<br>Other: Control<br>* no injection of BEP 800<br>|
| B-ALL<br> | Drug: injection of BEP 800<br>* injection of BEP 800<br>Other: Control<br>* no injection of BEP 800<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viability on primary ALL samples | The effect of BEP-800 after 48 hours of treatment on T-ALL and B-ALL will be evaluated by counting viable cells by flow cytometry with a viability marker and specific antibodies to detect leukemia cells. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on SRC phosphorylation | The effect of BEP-800 on T-ALL and B-ALL will be evaluated by flow cytometry by measuring HSP90 and SRC (phosphorylated), by intracellular labeling after permeabilization of the cells, 18 hours after treatment with BEP-800. | 2 years |