linjc16/ctgov huggingface dataset:
Effects of Water-Based Exercise on Lipid Profile and Lipoprotein Lipase of Dyslipidemic Premenopausal Women

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to investigate the effects of water-based exercises on lipid profile (LP) and lipoprotein lipase (LPL) levels in premenopausal dyslipidemic women. It was hypothesized that a water-based aerobic interval-training period would decrease plasma concentrations of atherogenic lipoproteins and concomitantly increase HDL and LPL levels, as well as maximal oxygen uptake (VO2max) values.

Official Title
-----------------
Effects of Water-Based Exercise on Lipid Profile and Lipoprotein Lipase of Dyslipidemic Premenopausal Women: A Randomized Controlled Trial

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Other: Water Aerobics Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premenopausal Sedentary Dyslipidemic Aged between 40 and 50 years old Exclusion Criteria: Smokers Hypolipemic drugs users

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Water Aerobics Training<br>The training period was composed by a 12-week macrocycle with two sessions per week. The macrocycle was divided into three four-week mesocycles that were, in turn, divided into four one-week microcycles composed by two training sessions. Each training session took 45 min. Nine different water-aerobics exercises were used during the training period. These exercises were performed alternating the right and left limbs. Exercise intensities were controlled using the Borg Scale. Interval training was used alternating intensities ranged between 9 (easy) and 15 (hard). During the first mesocycle, participants performed sets of 3min at intensity 13 interspersed by 2min at intensity 9; during the second mesocycle, sets of 3min at intensity 15 followed by 2min at intensity 9 were performed; finally, sessions of the third mesocycle were composed by sets of 3min at intensity 15 followed by 2min at intensity 11. | Other: Water Aerobics Training<br> <br> * Other names: HA;|
| No Intervention: Control<br>No training, no intervention. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid Profile Levels (total cholesterol, LDL, HDL, triglycerides) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipoprotein Lipase Levels |  | 12 weeks |
Pharmacokinetics of Ceftazidime-avibactam Among Critically-ill Patients Receiving CVVHDF

Study Overview
=================
Brief Summary
-----------------
Ceftazidime-avibactam is used for treatment of invasive Gram-negative bacterial infections among critically ill patients, including those on continuous venovenous hemodiafiltration . However, dosing of ceftazidime-avibactam for these patients remains undefined. The purpose of this study was to evaluate the pharmacokinetics of ceftazidime and avibactam among critically-ill patients, including those receiving CVVHD. This is a registration of Dr. Shields' exempt project under IRB approved research study STUDY19040363

Detailed Description
-----------------
Patients who received ceftazidime-avibactam as part of their clinical care were consented. EMR data was collected as well as PK sampling around their dosing to include the following samples immediately pre-dose, then at the following times thereafter: 1, 2, 4, 6, and 8 hours. Blood samples were collected in lithium-heparin tubes from a central venous catheter that is not being used for the continuous venovenous hemodiafiltration. The tubes were centrifuged at 2500 rpm for 10 minutes within 1 hour from collection and the samples will be frozen at 80°C. The total concentrations of ceftazidime and avibactam were determined simultaneously from plasma by using a validated HPLC-tandem MS assay. Noncompartmental pharmacokinetics were calculated using the linear-up and logarithmic-down trapezoidal method, based on the assumption of first-order elimination.

Official Title
-----------------
Pharmacokinetics of Ceftazidime-avibactam Among Critically-ill Patients Receiving Continuous Venovenous Hemodiafiltration

Conditions
-----------------
Bacterial Infections

Intervention / Treatment
-----------------
* Drug: Ceftazidime-avibactam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients receiving ceftazidime-avibactam as standard care Exclusion Criteria: Less than 18 years-old

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 |
| --- | --- |
| invasive bacterial infections<br>patients who are receiving Ceftazidime-avibactam are asked to provide blood samples around a dosing of the medication for analysis of samples | Drug: Ceftazidime-avibactam<br>* collection of blood samples around clinical dosing immediately pre-dose, then at the following times thereafter: 1, 2, 4, 6, 8, and 12 hours and EMR review.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Levels of Ceftazidime and Avibactam Among Critically-ill Patients | PK samples obtained around standard of care dosing regimens immediately before and at 1, 2, 4, 6, and 8 hours after administration | 8 hours |
PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)

Study Overview
=================
Brief Summary
-----------------
A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; study valve), the next generation Ascendra™ transapical delivery system, and crimper accessories.

Detailed Description
-----------------
Purpose: The purpose of this trial is to evaluate the acute safety and effectiveness of the SAPIEN XT™ study valve and next generation Ascendra™ delivery components. Follow-up Intervals: Subject data collection will include clinical information at baseline and during the index procedure. Subjects will undergo clinical follow-up at discharge, 30 days, 6 month annually for 5 years.

Official Title
-----------------
Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical)

Conditions
-----------------
Aortic Valve Stenosis

Intervention / Treatment
-----------------
* Device: SAPIEN XT™ Transapical aortic valve replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: EuroSCORE of ≥ 15 % Severe senile degenerative aortic valve stenosis Symptomatic aortic valve stenosis Informed consent Compliance Exclusion: Logistic Euroscore > 40 % Evidence of an acute myocardial infarction Congenital unicuspid or congenital bicuspid valve/ non-calcified Mixed aortic valve 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: TAVR-TA<br>Transcatheter valve replacement with transapical access | Device: SAPIEN XT™ Transapical aortic valve replacement<br>* Transcatheter aortic valve implantation via the transapical approach<br>* Other names: Next generation Ascendra delivery system inclusive accessory;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Deaths | Number of death at 30-days from the index procedure. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Stroke | Total Number of Participants with a Stroke. | 30-days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sapien XT Valve, Valvular Heart Disease, Aortic Stenosis, Heart Valve Therapy, Transapical, Transcatheter
Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients

Study Overview
=================
Brief Summary
-----------------
The main study purpose is to demonstrate the non-inferiority of T4032 compared to Lumigan® 0.01% in terms of efficacy.

Official Title
-----------------
Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Bimatoprost Ophthalmic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent dated and signed. Both eyes diagnosed open-angle glaucoma or ocular hypertension Exclusion Criteria: History of trauma, infection, clinically significant inflammation within the previous 3 months Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s) Pregnancy or breast-feeding

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T4032<br> | Drug: Bimatoprost Ophthalmic<br>* Eyedrops<br>|
| Active Comparator: Lumigan<br> | Drug: Bimatoprost Ophthalmic<br>* Eyedrops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP. | Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP at three time points (8:00 a.m.; 10:00 a.m.; 4:00 p.m.) in the study eye. | up to Week12 |
Psychiatric Assessment Of Parents Of Children With ADHD

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to carry out a psychological evaluation for the parents of children diagnosed with attention deficit hyperactivity disorder (ADHD) and parents of children without ADHD as control to detect any psychological problems in those of children with ADHD . These problems may be a precipitating factor to cause ADHD in their child or have a genetic predisposition to be passed to their children. On the other hand these psychological problems may be caused by the difficulties they encounter in raising their ADHD child. The exact relation needs more researches and to be more investigated.

Official Title
-----------------
Psychiatric Assessment Of Parents Of Children With Attention Deficit Hyperactivity Disorder

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents of children diagnosed with ADHD according to the American Psychiatric Association's Diagnostic and Statistical Manual (DSM-V). Children are between 4 and 16 years of age for both sexes. Children with normal IQ > 70%. Parents are able to give informed consent and able to complete the research assessments. Exclusion Criteria: Parents having chronic debilitating diseases e.g. chronic liver cirrhosis. Parents were participating in other clinical research. Refusal to participate.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| Parents of children with ADHD<br>100 parents of 50 children who were diagnosed with ADHD and | |
| Parent of children without ADHD<br>100 parents of 50 children who are ADHD free as a control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychiatric Assessment of the parents | Detection of personality disorders, anxiety and depressive symptoms | 2 years |
Clinical Evaluation of the Use of an mHealth Intervention on Quality of Care

Study Overview
=================
Brief Summary
-----------------
Under the World Health Organization's (WHO) integrated community case management (iCCM) Rapid Access Expansion Program (RAcE), World Vision Niger and Canada supported the Niger Ministry of Public Health to implement iCCM in four health districts in Niger in 2013. Community health workers (CHWs), known as Relais Communautaire (RCom), were deployed in their communities to diagnose and treat children under five years of age presenting with diarrhea, malaria and pneumonia and refer children with severe illness to the higher-level facilities. Two of the districts piloted RCom using smartphones equipped with an application to support quality case management and provide good timely clinical data. A two-arm cluster randomized trial assessed the impact of use of the mHealth application mainly on quality of care (QoC), but also on motivation, retention and supervision

Official Title
-----------------
Clinical Evaluation of the Use of an mHealth Intervention on Quality of Care Provided by Community Health Workers in Southwest Niger

Conditions
-----------------
Malaria, Diarrhea, Acute Respiratory Infection

Intervention / Treatment
-----------------
* Other: mHealth Intervention for Quality of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children presenting symptoms of illness Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 59 Months

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RCom equipped with a smartphone<br> | Other: mHealth Intervention for Quality of Care<br>* Does use of a specially equipped smartphone make a difference in the diagnosis and treatment by RCom of malaria, pneumonia and diarrhea in children aged 2 to 59 months<br>|
| No Intervention: RCom with paper-based system<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Care (QoC) provided by RCom | The maximum QoC score was 31 points; the score was weighted with two-thirds of the score allocated to screening questions and correct identification of the danger signs and signs/symptoms of serious conditions A perfect score was achieved when RComs asked all 10 health screening questions and correctly classified 4 major danger signs and 6 serious symptoms, made appropriate referral, and provided advice to caregivers. | 30 weeks |
RCT on Ketorolac and Tramadol in Bone Fractures Pain of Child

Study Overview
=================
Brief Summary
-----------------
Randomized double blind Trial with the aim to estimate effectiveness of two therapeutic regimes per os on pain due to not compound bone fractures in child 4-17 years old: ketorolac 0,5 mg/kg (1 drop every 2 Kg) tramadol 2,5 mg/Kh (1 drop every 2 Kg) Intensity of pain will be estimated with linear 1 to 10 or analogic McGrath type scale every 20 min. The main objectives are the evaluation of pain decreasing in every group, the time of decreasing, the intensity of pain during procedures (ex. Xray) and the occurrence of side effects Secondary outcomes are comparison between the two groups on effectiveness on pain and on side effects

Official Title
-----------------
Randomized Controlled Trial on Effectiveness of Ketorolac and Tramadol in Not Compound Fractures of Child

Conditions
-----------------
Fracture, Pain

Intervention / Treatment
-----------------
* Drug: ketorolac
* Drug: tramadol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children 4-17 years old with not compound bone fracture presenting in emergency room Exclusion Criteria: Compound fracture Occurring pain still treated Contraindicated ketorolac or tramadol use Informed consensus not obtained

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 17 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 |
| --- | --- |
| Active Comparator: 1<br>children 4-17 y. old with not compound bone fracture treated with ketorolac | Drug: ketorolac<br>* 0,5 mg/kg per os one time<br>|
| Experimental: 2<br>children 4-17 y. old with not compound bone fracture treated with tramadol | Drug: tramadol<br>* 2,5 mg/ kg per os in one dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estimation of pain reduction in every arm of the trial with linear 1-10 pain scale or for children 4 - 6 years old with analogic MacGrath type scale |  | 6 hours (or until the end of procedures) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison between the two groups on effectiveness on pain, measured with linear and analogic scale (see above) |  | 6 hours or until the end of procedures | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone fracture, ketorolac, tramadol
Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study In Subjects With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis (ALPINE 2/3)

Study Overview
=================
Brief Summary
-----------------
This is a multi-center evaluation of NGM282 in a randomized, double-blind, placebo-controlled study administered for 24 weeks in participants with histologically confirmed NASH and F2/F3 Fibrosis.

Official Title
-----------------
A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Three Doses of NGM282 Administered for 24 Weeks for the Treatment of Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)

Conditions
-----------------
NASH - Nonalcoholic Steatohepatitis

Intervention / Treatment
-----------------
* Biological: NGM282
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed NASH diagnosis as defined by the NASH CRN Total liver fat content of ≥ 8% as measured by MRI-PDFF Exclusion Criteria: Clinically significant acute or chronic liver disease of an etiology other than NASH Evidence of drug-induced steatohepatitis secondary to amiodarone, corticosteroids, estrogens, methotrexate, tetracycline, or other medications known to cause hepatic steatosis History or presence of cirrhosis (compensated or decompensated) as determined by histology and/or relevant medical complications and/or laboratory parameters Prior or pending liver transplantation Other protocol-defined inclusion/exclusion criteria could apply.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NGM282 Dose 1<br>Administered by subcutaneous injection | Biological: NGM282<br>* NGM282<br>|
| Experimental: NGM282 Dose 2<br>Administered by subcutaneous injection | Biological: NGM282<br>* NGM282<br>|
| Experimental: NGM282 Dose 3<br>Administered by subcutaneous injection | Biological: NGM282<br>* NGM282<br>|
| Placebo Comparator: Placebo<br>Administered by subcutaneous injection | Other: Placebo<br>* Placebo for NGM282<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving a histologic treatment effect (histologic response) as determined by the NASH CRN criteria after 24 weeks of NGM282 or matched placebo. |  | 24 weeks | 
| Evaluate safety and tolerability of NGM282 in participants with NASH as a function of dose level after up to 24 weeks of treatment with NGM282. |  | 24 weeks |