linjc16/ctgov huggingface dataset:
Predictive Variables of the Hemodynamic Effect During the Laparoscopic Surgery in Children

Study Overview
=================
Brief Summary
-----------------
This prospective observational study aimed to identify the intraoperative variables to predict the hemodynamic change according to intra-abdominal pressure in the children undergoing laparoscopic surgery. The intraoperative variables includes Pulse pressure variation (PPV), systolic pressure variation (SPV), stoke volume variation (SVV), Pulse oximeter plethysmographic waveform amplitude (△POP),and pleth variability index (PVI).

Official Title
-----------------
Study on the Predictive Variables Able to Predict the Hemodynamic Effect of Intra-abdominal Pressure in the Children Undergoing Laparoscopic Surgery

Conditions
-----------------
Laparoscopic Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients undergoing laparoscopic surgery Exclusion Criteria: known arrhythmia known lung disease known cardiac dysfunction (Ejection fraction less than 30%)

Ages Eligible for Study
-----------------
Maximum Age: 7 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 |
| --- | --- |
| Hemodynamically stable<br> | |
| Hemodynamically unstable<br>Hemodynamically unstable patients are defined as those with a 20% decrease in systolic blood pressure according to the change of intraabdominal pressure. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pleth variability index(PVI) |  | Outcome measure will be assessed before the CO2 desufflation for about 2minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic pressure variation(SPV) |  | Outcome measure will be assessed before the CO2 desufflation for about 2minutes. | 
| Pulse pressure variation(PPV) |  | Outcome measure will be assessed before the CO2 desufflation for about 2minutes | 
| Pulse oximeter plethysmographic waveform amplitude (△POP) |  | Outcome measure will be assessed before the CO2 desufflation for about 2minutes |
Iron Absorption in Haiti

Study Overview
=================
Brief Summary
-----------------
The government of Haiti plans to introduce a flour fortification program. The aim of the project it to inform the authorities on the most suitable iron compound for this fortification program. For this purpose, iron absorption from wheat flour using different iron compounds will be investigated.

Official Title
-----------------
Iron Absorption From Wheat Flour in Haiti

Conditions
-----------------
Iron Deficiency

Intervention / Treatment
-----------------
* Other: NaFeEDTA
* Other: Ferrous fumarate
* Other: NaFeEDTA + ferrous fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Mother-child pairs will be recruited! Inclusion criteria for mothers : Women of reproductive age (18 to 45 years) Generally healthy Consenting to study participation Exclusion criteria for mothers : Pregnancy or lactation Weight >65 kg Chronic illnesses which may influence iron absorption Severe anemia (Hb<10 g/dl) Inclusion criteria for children: Age 4 years +/- 12 months Generally healthy Exclusion criteria for children : Severe anemia (Hb<10 g/dl) Weight for height < -2 Z scores (wasting) Height of age < -2 Z score (stunting) Furthermore, the following exclusion criteria apply to both mothers and children : Chronic illnesses or medication which may influence iron absorption (will be judged by investigator) Consumption of vitamin or mineral supplement (unless they agree to discontinue using them two weeks before beginning of the study until the las visit) Allergies or intolerances relevant to the test meal (gluten) Blood donation or major blood losses during the 2 months prior to the study Illness during the 4 weeks prior to the study (will be judged by investigator)

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NaFeEDTA<br>NaFeEDTA | Other: NaFeEDTA<br> <br> |
| Experimental: Ferrous fumarate<br>Ferrous fumarate | Other: Ferrous fumarate<br> <br> |
| Experimental: NaFeEDTA + ferrous fumarate<br>NaFeEDTA + ferrous fumarate | Other: NaFeEDTA + ferrous fumarate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron absorption |  | 14 days after test meal consumption |
Assessment of Prepulse Inhibition for Shock Pain Reduction

Study Overview
=================
Brief Summary
-----------------
Patient tolerance of pain from discharges of implantable cardioverter defibrillators (ICD's) is highly variable. It can be influenced by psychological factors, physical condition and the number of shocks delivered. It has been shown that cutaneous pain perception can be reduced by delivery of a weak , low voltage pulse (prepulse)prior to the delivery of a stronger shock. A prepulse delivered before a high voltage ICD shock will decrease discomfort compared to a shock of equal energy without a prepulse.

Official Title
-----------------
Assessment of Prepulse Inhibition for Shock Pain Reduction- Ventricular

Conditions
-----------------
Pain Awareness From ICD Shocks

Intervention / Treatment
-----------------
* Device: Arbitrary Waveform Defibrillator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18+ Approved indication for implantation of an ICD Able and willing to provide informed consent Independently complete and understand the Mini Mental State Evaluation Exclusion Criteria: Pregnancy Cannot understand English or French Contraindicated for defibrillation testing because of risk of thromboembolism Deaf or hard of hearing, making the acute testing difficult to conduct having pain or anxiety to the extent that, in the opinion of the investigator, the results would be confounded. Having a Class I bradycardia pacing indication, requiring ongoing pacing support. Visual problems which preclude reading the computer screen for the VAS test Severe musculoskeletal disorder that makes it difficult to undergo testing in the recumbent position Do not achieve a score >24/30 on a Mini Mental State Exam

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 88 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: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Arbitrary Waveform Defibrillator|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment from pain perception from a shock preceded by a prepulse compared to a non prepulsed shock |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prepulse, Defibrillator
Arterial Stiffness and Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
Researchers are trying to determine whether arterial stiffness detected by ultrasound can predict outcomes in the development and recurrence of atrial fibrillation.

Official Title
-----------------
Arterial Stiffness and Atrial Fibrillation

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

Intervention / Treatment
-----------------
* Diagnostic Test: Carotid Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with persistent AF, scheduled for electrical cardioversion Exclusion Criteria: Unable to provide informed consent. Patients with intramural thrombus or other conditions that preclude the performance of electrical cardioversion. Patients with prior carotid stents.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Carotid Ultrasound testing before and after a clinically scheduled cardioversion procedure.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with atrial fibrillation<br>Subjects with atrial fibrillation that have been clinically scheduled for an electrical cardioversion procedure will have carotid ultrasound testing done before and after the procedure | Diagnostic Test: Carotid Ultrasound<br>* Uses sound waves to examine the blood flow through the carotid arteries and to determine the elastic properties or stiffness of the artery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of Atrial Fibrillation following cardioversion | We will follow up by phone or look through medical records to record the number of subjects that have had a recurrence of Atrial Fibrillation. We are also looking if we can correlate the recurrence with arterial stiffness. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of heart failure | Number of subjects to have heart failure following cardioversion | 6 months | 
| Occurrence of stroke | Number of subjects to have a stroke following cardioversion | 6 months | 
| Occurrence of hospitalization | Number of subjects that have been hospitalized following cardioversion | 6 months |
Effects of PEP on IC During IT in Patients With COPD

Study Overview
=================
Brief Summary
-----------------
This study will investigate the effects of positive expiratory pressure (PEP) on hyperinflation in patients with chronic obstructive pulmonary disease (COPD). Inspiratory capacity (IC) is the primary outcome

Detailed Description
-----------------
This is a cross-over intervention assessing the effect of PEP on IC and dyspnea in patients with COPD performing an interval training (IT) session. IC will be measured before, during and immediately after the IT session. Each participant will receive perform IT sessions including either the use of a PEP of 10 cmH2O or a PEP of 1 cmH2O. The effects on IC and dyspnea on both PEP levels will be assessed.

Official Title
-----------------
Effects of Positive Expiratory Pressure on Inspiratory Capacity and Dyspnea in Patients With COPD During Exercise

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Device: PEP-10
* Device: PEP-1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable COPD since 1 month at least Able to understand the instructions Exclusion Criteria: COPD with a forced expiratory volume at one second > 80% of predicted values In exacerbation Orthopedic of neurological condition likely to interfere with the experimentation Contraindication to perform exercise

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 95 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: Arm A<br>In this arm, patients will receive the experimental condition first, then the sham condition | Device: PEP-10<br>* Bottle PEP with a water level of 10 cmH2O<br>Device: PEP-1<br>* Bottle PEP with a water level of 1 cmH2O<br>|
| Experimental: Arm B<br>In this arm, patients will receive the sham condition first, then the experimental condition | Device: PEP-10<br>* Bottle PEP with a water level of 10 cmH2O<br>Device: PEP-1<br>* Bottle PEP with a water level of 1 cmH2O<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inspiratory capacity | Evolution of inspiratory capacity while performing the interval training session | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Borg scale | Evolution of dyspnea while performing the interval training session | 20 minutes |
Anticoagulation and Antiplatelet Management During Perioperative Period

Study Overview
=================
Brief Summary
-----------------
the investigators hypothesize that patients do not understand these therapies, and that they are poorly undertaken. In some cases, the anesthesiologist does not understand correctly the indication of the treatment due to lack of information and therefore does not know how to adapt it to the medical situation.

Detailed Description
-----------------
the investigators hypothesize that patients do not understand these therapies, and that they are poorly undertaken. In some cases, the anesthesiologist does not understand correctly the indication of the treatment due to lack of information and therefore does not know how to adapt it to the medical situation. the investigators want to investigate these transitions: how were they understood by patients, how were they performed, and how does this affect surgery, postoperative morbidity and mortality? Anticoagulation for prevention of thromboembolic events will not be studied in this study. The anesthesia team will not be particularly trained in anticoagulants and antiplatelets management to be close to actual care. In the Hospital the investigators have a guide written in 2013 in order to describe all the cases possible. The control/ goal group will be the patients who have undertaken strictly the protocol described for their cases in the guide.

Official Title
-----------------
Anticoagulation and Antiplatelet Management During Perioperative Period : a Daily Practice Cohort Prospective Study

Conditions
-----------------
Anticoagulants and Bleeding Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years old Able to consent Taking anticoagulants or antiplatelet drugs in the long term. Exclusion Criteria: Incapacitated adults Minor patients
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 |
| --- | --- | --- |
| Ratio of well treated patient | Ratio of well treated patient | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding consequence (volume in mL) | bleeding consequence (volume in mL) | 30 days | 
| Mortality Consequence | percentage of death | 30 Days | 
| Blood Test Consequence | deviation in percentage on INR | 30 Days | 
| Morbidity | percentage of rehospitalisation | 30 days |
A Study of the Safety, Pharmacokinetic Drug Interaction and Efficacy of ETC-1002 and Atorvastatin in Subjects With Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety, atorvastatin pharmacokinetics, and LDL-C lowering efficacy of ETC-1002 versus placebo in hypercholesterolemic subjects on background therapy of atorvastatin 10 mg.

Official Title
-----------------
A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Drug Interaction Study to Evaluate the Safety, Tolerability and Effect on Atorvastatin Pharmacokinetics of ETC-1002 Added to Atorvastatin 10 mg/Day in Subjects With Hypercholesterolemia

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: ETC-1002
* Drug: Placebo
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For subjects on current daily statin therapy - LDL-C 100-220 mg/dL and triglycerides <350 mg/dL (prior to switching to sponsor -provided atorvastatin 10 mg/day and stopping all other lipid-regulating drugs and supplements) at the S1 Visit, For subjects not on current daily statin therapy - LDL-C ≥ 110 mg/dL and ≤ 220 mg/dL Exclusion Criteria: Acute significant cardiovascular disease Uncontrolled hypertension

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ETC-1002<br>ETC-1002 treatment group, oral once daily | Drug: ETC-1002<br>* Week 1-2, 60 mg/day; Week 3-4, 120 mg/day; Week 5-6, 180 mg/day; Week 7-8, 240 mg/day<br>Drug: Atorvastatin<br>* Atorvastatin 10mg once daily for 8 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo treatment group, oral once daily | Drug: Placebo<br>* Placebo once daily for 8 weeks<br>Drug: Atorvastatin<br>* Atorvastatin 10mg once daily for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) of atorvastatin and its active metabolites |  | 4 and 8 weeks | 
| Peak plasma concentration (Cmax) of atorvastatin and its active metabolites |  | 4 and 8 weeks | 
| Number of subjects with adverse events, clinical lab abnormalities and other safety findings |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in LDL-C |  | 2, 4, 6 and 8 weeks | 
| Percent change in other lipids and cardio-metabolic risk factors |  | 2, 4, 6 and 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atorvastatin, Drug-drug interaction, Combination therapy
Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
Stem cell transplantation has emerged as a relatively popular treatment that can help to regulate immunity, repair injury, and control inflammation. Several studies have used autologous stem cells or adipose-derived stem cells to treat Crohn's disease and its associated complications, and have achieved good efficacy. Thus far, the use of umbilical cord mesenchymal stem cells (UC-MSCs) to treat Crohn's disease has rarely been reported. In this study, UC-MSCs were used to treat patients with hormone-controlled Crohn's disease. We observed the disease control conditions, corticosteroid dosage changes, and treatment-related adverse reactions.

Official Title
-----------------
Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease: A Randomized Controlled Clinical Trial

Conditions
-----------------
Crohn Disease

Intervention / Treatment
-----------------
* Other: UC-MSCs by peripheral intravenous infusion
* Drug: received hormone maintenance therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: above 18 years of age moderate to severe Crohn's disease (Crohn's disease activity index (CDAI) between 220 and 450) had received hormone maintenance therapy for more than 6 months Exclusion Criteria: active tuberculosis malignancy HIV syphilis hepatitis B hepatitis C

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UC-MSCs<br>UC-MSCs by peripheral intravenous infusion | Other: UC-MSCs by peripheral intravenous infusion<br> <br> |
| Active Comparator: control<br>received hormone maintenance therapy | Drug: received hormone maintenance therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crohn's disease activity index |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harvey-Bradshaw index |  | 12 months | 
| Corticosteroid dosage |  | 12 months |
Recombinant Human Erythropoietin Dose, Serum Adiponectin, and All-Cause Mortality in Patients Beginning Hemodialysis

Study Overview
=================
Brief Summary
-----------------
Decreased body fat mass, possibly mediated through the effects of elevated serum adiponectin levels, may be associated with requirements for higher recombinant human erythropoietin doses and a subsequent worse prognosis in patients beginning hemodialysis.

Conditions
-----------------
Hemodialysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who started hemodialysis therapy from August 2000 to May 2001 in 11 dialysis centers in the Shizuoka prefecture area, and who survived for more than 3 months after the start of hemodialysis. Exclusion Criteria: Nothing particular.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
The relationship between all-cause mortality in patients introduced hemodialysis and recombinant human erythropoietin dose and serum adiponectin level