linjc16/ctgov huggingface dataset:
Cytokines of Patients With Transversus Abdominis Plane Block After Laparoscopic Colonic Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators designed a study to determine whether with combined general-transversus abdominis plane block anesthesia or standard general anaesthetic would provide same level of cytokines in patients undergoing Laparoscopic Colonic Surgery.

Detailed Description
-----------------
The investigators designed a study to determine whether combined general-transversus abdominis plane block anesthesia or standard general anaesthetic would provide same level of cytokine in patients undergoing Laparoscopic Colonic Surgery.

Official Title
-----------------
Cytokines of Patients After Laparoscopic Colonic Surgery

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

Intervention / Treatment
-----------------
* Drug: transversus abdominis plane block
* Drug: transversus abdominis plane block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: •Participants were deemed eligible if they were candidates for spinal anesthesia undergoing Laparoscopic Colonic Surgery Exclusion Criteria: •Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24 (of the 30 possible points) A history of neurological and psychiatric diseases including stroke, and psychosis Severe visual or hearing impairment Unwillingness to comply with the protocol or procedures

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: a standard general anesthesia<br>a standard general anesthesia and with transversus abdominis plane block 20 ml 0.9% sodium chloride | Drug: transversus abdominis plane block<br>* transversus abdominis plane block with 20 mL saline<br>|
| Experimental: transversus abdominis plane block<br>a standard general anesthesia with transversus abdominis plane block 20 mL 0.25% ropivacaine | Drug: transversus abdominis plane block<br>* transversus abdominis plane block with 20 mL 0.25% ropivacaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of cytokine level in plasma samples | The blood samples were collected before induction of anesthesia and at the end of surgery. | just after anesthesia induction ; at the end of the surgery; 24h after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cytokine Transversus Abdominis Plane Block
Virtual Reality-based Training in Cerebellar Ataxia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate the effects of virtual reality-base training for cerebellar ataxia.

Conditions
-----------------
Cerebellar Ataxia

Intervention / Treatment
-----------------
* Other: Exergaming training
* Other: Physical therapy intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of SCA 1, 2, 3 and 6 by a neurologist ability to walk independently with or without any walking aids age ≥ 20 a score of ≥ 24 on the mini-mental state examination Exclusion Criteria: histories of other neurological, cardiovascular, or orthopedic diseases affecting motor performance and balance uncontrolled chronic diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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: Exergaming training<br>Participants in the exergaming training group received a 4-week exergaming intervention. | Other: Exergaming training<br> <br> |
| Active Comparator: Control training<br>Participants in the control training group received a 4-week conventional training. | Other: Physical therapy intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scale for the Assessment and Rating of Ataxia |  | Change from baseline at 4 weeks | 
| Alternate nose to finger test |  | Change from baseline at 4 weeks | 
| Alternate heel on shin test |  | Change from baseline at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nine-hole peg test |  | Change from baseline at 4 weeks | 
| Walking speed |  | Change from baseline at 4 weeks | 
| Step width |  | Change from baseline at 4 weeks |
Additional Post Hoc Analysis and Clinical Data Collection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect additional Investigational cognitive tasks and additional clinical data for subjects tested with ElMindA's Brain Network Activation (BNA™).

Detailed Description
-----------------
To collect additional Investigational cognitive tasks and additional clinical data for subjects tested with ElMindA's Brain Network Activation (BNA™). The BNA™ technology was developed and is utilized by ElMindA Ltd. The (BNA™) Analysis System is cleared for use by qualified medical professionals for the post hoc statistical analysis of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP').

Official Title
-----------------
Additional Post Hoc Analysis and Clinical Data Collection for Subjects Tested With Brain Network Activation (BNA™) Technology

Conditions
-----------------
Neurological Observations

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed a BNA test in the past Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments. Willingness to participate Exclusion Criteria: Significant Sensory deficit

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| engineering development according to clinical assessments | The study is designed to collect data that will aid in future scientific and engineering exploration of correlations between clinical assessments and BNA scores. The results are primarily intended for scientific inquiry and engineering development purposes. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neurology
68Ga-PSMA PET/CT Imaging in Assessment of Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Dual-time point 68Ga-PSMA PET/CT could increase the lesion detection in PCa patients, it remains difficult to perform in clinical practice. The possibility of one-time point 68Ga-PSMA PET/CT imaging could be achieved using a total-body PET/CT.

Official Title
-----------------
68Ga-PSMA PET/CT Imaging in Assessment of PCa: Feasibility of Delayed Acquisition on Total-body PET/CT Scanner?

Conditions
-----------------
PET/CT, Prostate Specific Membrane Antigen, IMAGE

Intervention / Treatment
-----------------
* Device: total-body PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary staging of pathology-confirmed PCa or evidence of BCR with PSA value > 0.2 ng/ml positive 68Ga-PSMA findings both standard and delayed scans were performed on the total-body PET/CT Exclusion Criteria: only one scan was performed negative PSMA results
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCa patients underwent 1 h p.i. PSMA PET/CT imaging and 3 h p.i. PSMA imaging<br> | Device: total-body PET/CT<br>* PCa patients who underwent PSMA PET/CT in our clinical center received two-time points scans at 1 h p.i. and 3 h p.i. on a total-body PET/CT scanner.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Only one-time point scan is possible for PSMA PET/CT | By the use of total- body PET/CT scanner, the imaging quality between the 1 h p.i. and 3 h p.i. imaging acquisition are compared. And the different lesion detection rates at 3 h p.i. and 1 h p.i. are also discussed. The uptake value differences of all lesions are compared. | 8 months |
Open Label Trial of Fluoxetine for the Treatment of Depression in Patients With End Stage Renal Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test whether once-weekly prozac therapy leads to reduction in depression in patients requiring kidney dialysis.

Detailed Description
-----------------
Once-weekly Prozac is a psychiatric medicine, approved by the FDA for the use in treatment of psychiatric disorders. This study will test whether once-weekly Prozac leads to reduced symptoms of depression. Patients requiring dialysis often report symptoms of depression either due to the presence of major depression, a relatively common psychiatric disorder, or due to depression secondary to kidney failure.

Official Title
-----------------
A 12-Week Open-Label Trial of Once-Weekly Fluoxetine for the Treatment of Depression in Patients With End-Stage Renal Disease

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: Fluoxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of chronic renal failure and end stage renal disease Ongoing need for regular dialysis treatment Diagnosis of depression based on DSMIV Age tween 19-65 years Exclusion Criteria: Inability to provide informed consent Medically or psychiatrically unstable, as defined by requiring inpatient treatment Pregnancy, nursing or refusal to use a reliable method of birth control in women Patients with known allergy to fluoxetine, or previous treatment failure of fluoxetine

Ages Eligible for Study
-----------------
Minimum Age: 19 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fluoxetine|Fluoxetine will be dosed at 90 mg once a week|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the efficacy and tolerability of once-weekly fluoxetine in patients with End Stage Renal Disorder who have been diagnosed with depression |  | Patients will come in for once weekly visits for 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, chronic renal failures, end stage renal disease
Microalgae as an Alternative Protein Source in Human Nutrition.

Study Overview
=================
Brief Summary
-----------------
Protein is an essential part of the human diet. But with a growing global population and climate emergency, current sources of dietary protein are unable to continue to sustainably meet the global demand. To ensure future food security, new sustainable protein sources are required. Microalgae - a group of plant-like single cells - are thought to be a good option due to their sustainable farming methods and naturally high protein content. Long term health benefits of eating microalgae have been seen in humans. However, the time directly following microalgae ingestion has not been well studied but is an important period when considering a protein source. This research will compare the period after ingestion of three preparations and/or types of microalgae to a traditional source of protein.

Official Title
-----------------
Microalgae as an Alternative Protein Source in Human Nutrition.

Conditions
-----------------
Nutrition, Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Protein shake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 18.5 -30 kg/m2 age 18 - 40 years healthy non-smoker Exclusion Criteria: BMI <18.5 or >30 kg/m2 smoker metabolic disease relevant food intolerance using medications known to affect metabolism

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Milk protein<br> | Dietary Supplement: Protein shake<br>* Participant will drink a protein shake made using each of the four protein types.<br>|
| Experimental: Whole cell chlorella<br> | Dietary Supplement: Protein shake<br>* Participant will drink a protein shake made using each of the four protein types.<br>|
| Experimental: Cracked cell chlorella<br> | Dietary Supplement: Protein shake<br>* Participant will drink a protein shake made using each of the four protein types.<br>|
| Experimental: Spirulina<br> | Dietary Supplement: Protein shake<br>* Participant will drink a protein shake made using each of the four protein types.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma amino acids | Amino acid concentrations measured in participant plasma following the ingestion of protein drinks. | 5 hours postprandial |
A Study Comparing Imatinib and Imatinib/Pegylated Interferon in Chronic Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
Patients with chronic myeloid leukemia in imatinib induced CHR are randomized between imatinib 400 mg daily and imatinib 400 mg daily + PegIntron 30 ug weekly. Primary endpoint: To compare at 12 months between the treatment arms the rate of Major Molecular Response (=99,9% tumour reduction) at 12 months

Detailed Description
-----------------
130 patients registered, 112 randomized. 56 pats in each treatment arm. 12 months study duration. Rate of Major Molecular Response was at 12 months 53 vs 82 % (p=0.002) in favour of the combination arm.

Official Title
-----------------
A Randomized Study Comparing Imatinib And Imatinib/Pegylated Interferon Alpha-2B in Newly Diagnosed Non-high Risk Chronic Myeloid Leukemia Patients in Complete Hematological Remission After Imatinib Induction Therapy

Conditions
-----------------
Health Care Quality, Health Care Evaluation

Intervention / Treatment
-----------------
* Drug: imatinib and pegylated interferon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic myeloid leukemia in imatinib induced complete hematological remission. Intermediate/low risk, ECOG < 2 Exclusion Criteria: Les than CHR after 3 months imatinib high risk More than 6 months from diagnosis ECOG > 2 Pregnancy -

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: imatinb + pegIntron<br> | Drug: imatinib and pegylated interferon<br>* imatinib 400 mg p.o. daily pegylated interferon 50 ug s.c. weekly<br>* Other names: PegIntron;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of rate Major Molecular Response between treatment arms | Molecular response | 2004 - 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of complete cytogenetic response between the treatment arms at 12 months | Cytogenetic response | 2004 - 2009 | 
| Comparison rate complete cytogenetic response between the treatment arms at 12 months | Hematologic response | 2004 - 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic myeloid leukemia, imatinib, interferon
Lactoferrin Efficacy Versus Ferrous Sulfate in Treatment of Patients With Iron Deficiency Anemia

Study Overview
=================
Brief Summary
-----------------
Lactoferrin (Lf) is a mammalian cationic iron binding glycoprotein belonging to the transferrin family which was discovered 70 years ago, and isolated simultaneously from human and bovine milks in 1960. It is widely distributed in all biological fluids and is also expressed by immune cells, which release it under stimulation by pathogens

Official Title
-----------------
Lactoferrin Efficacy Versus Ferrous Sulfate in Treatment of Patients With Iron Deficiency Anemia

Conditions
-----------------
Iron Deficiency Anemia Treatment

Intervention / Treatment
-----------------
* Drug: Lactoferrin Bovine
* Drug: Ferrous Sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:all patients with iron deficiency anemia from 2 to 15 years old - Exclusion Criteria: Anemia rather than iron deficiency anemia. Family history of blood disease. Patients with thalassemia trait. Patients with chronic illness.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 15 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 |
| --- | --- |
| Active Comparator: lactoferrin<br>Oral bovine lactoferrin (bfl) 100 mg once daily on empty stomach | Drug: Lactoferrin Bovine<br>* treatment for 30 days<br>* Other names: Pravotin sachet;|
| Active Comparator: ferrous sulfate<br>Oral ferrous sulfate 3-6 mg/kg of elemental iron/day in divided doses | Drug: Ferrous Sulfate<br>* treatment for 30 days<br>* Other names: ferrovit syrup;|
| Active Comparator: combined<br>combined therapy (both lactoferrin and ferrous sulfate) | Drug: Lactoferrin Bovine<br>* treatment for 30 days<br>* Other names: Pravotin sachet;Drug: Ferrous Sulfate<br>* treatment for 30 days<br>* Other names: ferrovit syrup;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of efficacy of lactoferrin versus ferrous sulfate tharapy in treatment of patients with iron deficiency anemia. | Complete blood count will be done before and after therapy to detect the effect of the therapy on serum hemoglobin(g/d) | 30 days | 
| Comparison of efficacy of lactoferrin versus ferrous sulfate tharapy in treatment of patients with iron deficiency anemia. | Total serum iron(ug/d) will be done before and after therapy to detect effect of the therapy on total serum iron level (ug/d) | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iron deficiency anemia, Lactoferrin, Ferrous sulfate
To Investigate the Effect of Montelukast on Behavior Problems in Children With Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of the study to investigate whether montelukast lead to behavior problems in children with asthma.

Official Title
-----------------
Phase 4 Study of to Investigation the Effect of Montelukast on Behavior Problems in Children With Asthma

Conditions
-----------------
Asthma, Behavior Problem, Montelukast

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To have asthmatic children aged 18-60 months To have that receive prophylactic treatment for asthma Healthy children will be enrolled among those being brought for routine controls Exclusion Criteria: Children with other chronic disease Children with chronic drug use (except for the treatment of asthma)

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 60 Months

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 |
| --- | --- | --- |
| To investigate the effect of montelukast on behavior problems in children with asthma | Montelukast frequently used in the treatment of asthmatic children. However, we believe that montelukast lead to behavior problems. In this study, we aimed to investigate that intake of montelukast whether lead to behavior problems. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the effects of inhaled corticosteroids and montelukast on the behavior problems. | In this study, it will be compared the effect on behavior changes between intake of inhaled steroid and montelukast. | 8 months |