linjc16/ctgov huggingface dataset:
Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia

Study Overview
=================
Brief Summary
-----------------
the aim of this study is to evaluate the effect of Spirulina compared to Amlodipine on cardiac iron overload and cardiac functions in multi-transfused children with beta thalassemia major

Detailed Description
-----------------
the aim of this study is to evaluate the effect of Spirulina compared to Amlodipine on cardiac iron overload using magnetic resonance imaging and cardiac functions in multi-transfused children with beta thalassemia major

Official Title
-----------------
Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia

Conditions
-----------------
Beta Thalassemia Major

Intervention / Treatment
-----------------
* Drug: Spirulina
* Drug: Amlodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients on regular blood transfusions. iron overload with no perspective of changing the chelation therapy in the following three months Exclusion Criteria: formal contraindication to magnetic resonance examinations implantable cardiac device advanced cardiomyopathy or conduction block other types of hemolytic anemias

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>chelation therapy plus Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months | Drug: Spirulina<br>* Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months<br>|
| Experimental: Group 2<br>chelation therapy plus Amlodipine in a dose of 5 mg/day orally for 3 months | Drug: Amlodipine<br>* Amlodipine in a dose of 5 mg/day orally for 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac iron concentration by magnetic resonance imaging |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac troponin 1 |  | 3 months | 
| N-terminal pro-brain natriuretic peptide |  | 3 months |
Ultrasound Guided Erector Spinae Plane Block in Breast Surgery

Study Overview
=================
Brief Summary
-----------------
hyalorounidase will be added to local anaesthetics in patients undergoing mastectomy and effect on local anaesthetic spread will be studied under floroscope

Detailed Description
-----------------
two groups will be enrolled the control group will receive local anaethetic only and the spread will be observed by floroscope. the seconed group, hyaloronidase will be added to local anaesthetics and the spread will be studied under image.

Official Title
-----------------
Effect of Hyalorounidase on the Spread of Local Anaesthetics in Erector Spinae Plane Block

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Local anesthetic
* Drug: Hyaluronidase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female ASA I, II, III Elective surgery Exclusion Criteria: Patient refusal Infection at injection site Allergy to the given drugs

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| Sham Comparator: local anaesthetic group<br> | Drug: Local anesthetic<br>* ultrasound guided erector spine plane block (ESP) will be done in patients under going mastectomy with local anaesthetics only<br>|
| Active Comparator: hyalorounidase group<br> | Drug: Hyaluronidase<br>* hyaluronidase will be added to ultrasound guided erector spine plane block (ESP) will be done in patients under going mastectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of local anaesthetics spread after injection in both group | spread of local anaesthics will be examined under floroscopic guide | 10 minutes after block |
Influence of Acupuncture to Ocular Microcirculation in Patients With Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the influence of specific eye acupuncture to the ocular microcirculation in diabetic and healthy subjects.

Detailed Description
-----------------
Diabetes is combined with severe vascular damage at the different stages of the disease, causing reduction in retinal perfusion. Acupuncture is supposed to regulate the perfusion. We propose a study to evaluate the effect of acupuncture to the vascular auto regulation in patient with Diabetes, compared to healthy people without vascular or retinal diseases. The perfusion of the retinal vessel will be examined by Retinal vessel analyzer (RVA), Heidelberg retinal Flowmeter (HRF) and the Ocular blood Flowmeter (OBF) before, during and after standardized specific acupuncture at healthy volunteers and patients with diabetes.

Official Title
-----------------
Influence of Acupuncture to Ocular Microcirculation in Patients With Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Procedure: acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: persons over 18 years, men or women, diabetic diagnostics within the last year Exclusion Criteria: medical use of anticoagulative substances, use of dorzolamide, use of immunosuppressive medication psychiatrics, epileptics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: diabetics<br>subjects with HbA1c >7,0 and pathological glucose tolerance testing | Procedure: acupuncture<br>* acupuncture of the eye in traditional chinese schematics<br>* Other names: acupuncture therapy;|
| Active Comparator: healthy<br>healthy subjects with HbA1c <7,0 and negative glucose tolerance testing | Procedure: acupuncture<br>* acupuncture of the eye in traditional chinese schematics<br>* Other names: acupuncture therapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retinal perfusion by HRF/OBF/RVA |  | post acupuncture (one day measurement) |
Tissue Oxygenation of the Tibial Anterior Muscle After Clamping of the Femoral Artery

Study Overview
=================
Brief Summary
-----------------
Ischemic preconditioning is defined as protection from cell damage induced by prolonged ischemia by preceding cycles of short ischemia. Hence, ischemic preconditioning could reduce ischemic lesion during clamping a femoral artery for vascular surgery. In this prospective, randomized pilot study is investigated if clamping of the femoral artery leads to ischemia of the calf measurable by near-infrared spectroscopy. In addition to this, the effect of sevoflurane preconditioning on ischemia of the calf is measured.

Detailed Description
-----------------
Ischemic preconditioning is performed by clamping of the femoral artery for five minutes in 40 patients. In 20 patients sevoflurane preconditioning is performed five minutes before ischemic preconditioning by inducing sevoflurane anesthesia for five minutes. Muscle tissue oxygenation is measured bilaterally in the anterior tibial muscle by near-infrared spectroscopy (INVOS, SOMANETICS, Troy, Michigan/ USA) during preconditioning and following ischemia.Clinically relevant ischemia was defined as a decrease of tissue oxygen saturation to 95 % of baseline.

Official Title
-----------------
Influence of Sevoflurane Preconditioning on Tissue Oxygenation of the Tibial Anterior Muscle Measured by Near-infrared Spectroscopy After Clamping of the Femoral Artery for Vascular Surgery

Conditions
-----------------
Tissue Oxygen Saturation

Intervention / Treatment
-----------------
* Procedure: Sevoflurane preconditioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:vascular surgery with clamping of a femoral artery. - Exclusion Criteria: -

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sevoflurane<br>Sevoflurane Preconditioning | Procedure: Sevoflurane preconditioning<br>* Preconditioning by transient application of sevoflurane<br>|
| No Intervention: No Sevoflurane<br>No Sevoflurane Preconditioning | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of tissue oxygen saturation below 95 % of baseline | Decrease of tissue oxygen saturation below 95 % of baseline | 4 hours |
Gas Embolism With Use of Argon Plasma Coagulation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to use transesophageal echocardiography (TEE) to determine the incidence, severity, and clinical significance of gas bubbles during argon plasma coagulation (APC).

Detailed Description
-----------------
Gas embolism is a rare but serious complication of APC. We will use TEE to monitor for gas bubbles during APC. APC will be terminated if gas bubbles are associated with ischemic heart rhythms, wall motion abnormalities, or if large gas bubbles are noted in the left ventricle.

Official Title
-----------------
Gas Embolism With Use of Argon Plasma Coagulation

Conditions
-----------------
Embolism, Air

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (male and female) 18 years of age or older Clinical indication for bronchoscopy (hemoptysis, airway obstruction, tumor excision, granulation tissue that is impairing endobronchial stent performance) Ability of the patient or proxy to read, comprehend, and sign informed consent document. Exclusion Criteria: Presence of esophageal disorders that may complicate transesophageal echocardiography (strictures, varices, fistula, prior esophageal surgery) Presence of coagulopathy or other bleeding diathesis Inability to tolerate brief periods of apnea Presence of pulmonary vascular disease Pregnant women will not be included in this study because the potential fetal hypoxemia is not an acceptable risk. No exclusions will be made based on gender or race.

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 |
| --- | --- | --- |
| incidence of gas bubbles with use of APC |  | end of procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Embolism, Argon
Efficacy and Safety of Different Concentrations of Mapracorat Ointment Over 4 Weeks in Atopic Dermatitis (AD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of three concentrations of a development drug compared to ointment base (vehicle) in subjects with Atopic Dermatitis (AD).

Official Title
-----------------
Double-blind, Randomized, Vehicle-controlled, Multicenter, Multinational, Parallel-group Study of the Efficacy and Safety of Mapracorat Ointment in Three Concentrations Over Max. 4 Weeks in Subjects With Atopic Dermatitis (AD)

Conditions
-----------------
Atopic Dermatitis, Eczema

Intervention / Treatment
-----------------
* Drug: Mapracorat
* Drug: Vehicle without active


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent Diagnosis of atopic dermatitis according to Hanifin and Rajka Criteria Willingness of subject to follow all study procedures Willingness to avoid excessive exposure of diseased areas to natural or artificial sunlight Exclusion Criteria: Pregnancy and breast-feeding Clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results Clinically manifested immunosuppressive disorder or known history of malignant disease History of relevant drug and/or food allergies

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mapracorat 0.01% Ointment<br>Lowest concentration | Drug: Mapracorat<br>* Daily topical application<br>|
| Active Comparator: Mapracorat 0.03% Ointment<br>Middle concentration | Drug: Mapracorat<br>* Daily topical application<br>|
| Active Comparator: Mapracorat 0.1% Ointment<br>Highest concentration | Drug: Mapracorat<br>* Daily topical application<br>|
| Placebo Comparator: Vehicle without active<br> | Drug: Vehicle without active<br>* Daily topical application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eczema Area and Severity Index (EASI) |  | Over all study visits for up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects´ assessment of pruritus | Subjects´ assessment of pruritus using a visual analog scale (VAS) | At baseline and after 4 weeks of treatment |
Vitamin D Supplementation in Physical Performance

Study Overview
=================
Brief Summary
-----------------
This study was performed to evaluate the efficacy of weekly vitamin D supplementation on athletic performance in Iranian athletes

Detailed Description
-----------------
Seventy subjects were enrolled in the study. The athletes were randomly divided into two groups: vitamin D supplement (D; received 50,000 IU of vitamin D supplement weekly) and control (P, received a placebo weekly). Duration of the study was eight weeks. Anthropometric, dietary, athletic performance and biochemical evaluations were performed for all subjects in the beginning and in the end of the intervention period.

Official Title
-----------------
Efficacy of Vitamin D Supplementation in Physical Performance of Iranian Elite Athletes

Conditions
-----------------
Healthy, Athletes

Intervention / Treatment
-----------------
* Dietary Supplement: vitamin D supplement
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy professional athletes Exclusion Criteria: receiving vitamin D supplement in past 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin D supplement<br>D | Dietary Supplement: vitamin D supplement<br>* D; received 50,000 IU of vitamin D supplement weekly<br>* Other names: D;|
| Placebo Comparator: control<br>P | Other: Placebo<br>* placebo<br>* Other names: P;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline serum 25-hydroxy vitamin D at eight weeks | nmol/L | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline Truncal Fat at eight weeks | percent | 8 weeks | 
| Changes from baseline visceral fat at eight weeks | percent | 8 weeks | 
| Changes from Strength leg press at 8 weeks | percent | 8 weeks | 
| Changes from Ergojump at 8 weeks | percent | 8 weeks | 
| Changes from baseline Vertical jump at 8 weeks | percent | 8 weeks | 
| Change from baseline Agility at 8 weeks | percent | 8 weeks | 
| changes from Speed at 8 weeks | percent | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin D, atletes, physical performance
Microendoscopic Lumbar Discectomy: A Study of 100 Cases

Study Overview
=================
Brief Summary
-----------------
Evaluate the outcome of micro endoscopic discectomy (MED) by tubular retractors on safety and efficacy of the technique.

Detailed Description
-----------------
Evaluate the outcome of micro endoscopic discectomy (MED) by tubular retractors on safety and efficacy of the technique.Patients who underwent surgery for herniated disc using the tubular retractors. The results were evaluated by using VAS (Visual Analog Scale 0-5) for back and leg pain and ODI (Oswestry Disability Index). Patients were followed up at intervals of 1 week, 6 weeks, 3 months, 6 months, 12 months and 2 years after surgery.

Official Title
-----------------
Microendoscopic Lumbar Discectomy: A Prospective Study of 100 Cases

Conditions
-----------------
Lumbar Disc Herniation

Intervention / Treatment
-----------------
* Procedure: micro endoscopic discectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with at least 6 weeks of conservative treatment with positive nerve root tension signs, radicular pain Patients are diagnosed with lumbar disc herniation by MRI Patients who underwent surgery for herniated disc using the tubular retractor Exclusion Criteria: Patients with large central disc herniation, chronic discogenic pain, discitis, multi-level disease, presence of instability or history of lumbar surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| micro endoscopic discectomy<br>the patients with lumbar disc herniation | Procedure: micro endoscopic discectomy<br>* the patients receive micro endoscopic discectomy surgery therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index | The efficacy of surgery were evaluated by using Oswestry Disability Index. | 2 years after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index | The efficacy of surgery were evaluated by using Oswestry Disability Index. | preoperative evaluation and 1 week, 6 weeks, 3 months, 6 months, 12 months after operation | 
| Visual Analog Scale | The efficacy of surgery were evaluated by using Visual Analog Scale for back and leg pain. | preoperative evaluation and 1 week, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperative follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lumbar Disc Herniation, Micro Endoscopic Discectomy
Support of the Sexual Health in Oncology

Study Overview
=================
Brief Summary
-----------------
Implementation of sexual health support program in oncology department. This program is organized in 3 axes. One is to inform the side effects of treatment on sexual health. There is a counselling team (nurse, esthetician,sexologue..etc) to raise the subject with patient and partner . Finally, the oncologist continue during the treatment to evaluate the benefit of this program and adapt their counselling according to the needs

Official Title
-----------------
Support of the Sexual Health in Oncology

Conditions
-----------------
Oncology, Sexual Health

Intervention / Treatment
-----------------
* Other: Program of support of the sexual health


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patient consulting in oncology service age > 18 years accepting to participate Exclusion Criteria: Age< 18 years Refusing to participate

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 |
| --- | --- |
| patient consulting in oncology ervice<br>Program of support of the sexual health in oncology by questionnaire | Other: Program of support of the sexual health<br>* Patients included in the study have to answer to a questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Benefit of the care measurement program | assessment of data recorded on questionnaire | Day 1 |