linjc16/ctgov huggingface dataset:
Study of Omalizumab in Moderate to Severe Bronchial Asthma

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of omalizumab up to 16 weeks in adult patients with moderate to severe bronchial asthma.

Official Title
-----------------
Study of Omalizumab in Moderate to Severe Bronchial Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Omalizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Allergic asthma patients Inadequately controlled patients Exclusion Criteria: - History of severe anaphylactoid or anaphylactic reactions Previous treatment with omalizumab History of cancer or cancer Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Omalizumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morning peak expiratory flow (PEF) at baseline and end of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function parameters measured by spirometer |  |  | 
| Frequency of rescue medication use |  |  | 
| Symptom score |  |  | 
| Activities of daily living score |  |  | 
| Nighttime sleep score |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, IgE, Omalizumab
Early Pregnancy Antioxidant Supplementation in the Prevention of Preeclampsia

Study Overview
=================
Brief Summary
-----------------
Use of Juice Plus+ food supplements, when initiated in the first trimester and used continuously thereafter, will result in a lower incidence of preeclampsia and pregnancy complications. This is a prospective randomized and blinded placebo controlled study sponsored by NSA, LLC of Memphis, TN.

Detailed Description
-----------------
Not desired

Official Title
-----------------
Minimizing Early Pregnancy Oxidative Stress to Maximize Healthy Pregnancy Outcome: Reducing Preeclampsia and Reproductive Loss With Antioxidant-Rich Tablet Supplementation Initiated in the First Trimester

Conditions
-----------------
Preeclampsia, Pregnancy Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant Patients seen in first trimester with low or high risk pregnancy Exclusion Criteria: Pregnant patients first seen after the first trimester Unlikely to continue care in our system Unwilling to comply with rigor of taking food supplements throughout gestation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Low Risk Pregnancy, Placebo | |
| 2<br>Low Risk Pregnancy, Active Food Supplement | |
| 3<br>High Risk Pregnancy, Placebo | |
| 4<br>High Risk Pregnancy, Active Food Supplement | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of preeclampsia during pregnancy |  | Preeclampsia at any time during gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The observed incidence of preterm labor, premature rupture of membranes, perinatal loss |  | First, second and third trimester | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preeclampsia, Prevention, Food Supplement
Postoperative Positioning After Surgery for Macular Holes

Study Overview
=================
Brief Summary
-----------------
Idiopathic macular holes are an important cause of visual loss. Macular holes can be treated by surgically removing the vitreous gel and injecting intraocular gas. Following macular hole surgery, face-down positioning is often advised with the aim of improving the likelihood of macular hole closure. The current evidence of postoperative positioning protocols is insufficient to draw firm conclusions and guide practice. The investigators wish to compare non-face-down positioning and face-down positioning after surgery for macular holes in a randomized trial. Hypothesis: Non-face-down positioning is equivalent to face-down positioning after surgery for macular holes.

Official Title
-----------------
A Randomized Clinical Trial of Face-down Protocol Versus Non-face-down Protocol After Surgery for Macular Holes.

Conditions
-----------------
Macular Holes

Intervention / Treatment
-----------------
* Procedure: Vitrectomy & Intraocular gas fill
* Procedure: Postoperative face-down positioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic macular hole stage II-IV Informed consent Duration of symptoms ≤ 24 months Exclusion Criteria: Previous vitreomacular surgery Myopia ≥ 8 diopters Ocular trauma Disease affecting visual function (proliferative diabetic retinopathy, diabetic macular edema, exudative macular degeneration)

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Active Comparator: Face-down positioning<br>Patients advised face-down positioning after surgery for macular hole. | Procedure: Vitrectomy & Intraocular gas fill<br> <br> Procedure: Postoperative face-down positioning<br> <br> |
| Experimental: Non-face-down positioning<br>Patients advised non-face-down positioning after surgery for macular hole. | Procedure: Vitrectomy & Intraocular gas fill<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular hole closure rate | Macular hole closure rate assessed by optical coherence tomography | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ETDRS Visual Acuity Gain |  | 3 months | 
| Degree of postoperative head incline | Position Sensor | 3 days | 
| Degree of ocular gas fill |  | 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Macular Holes, Non face down positioning, Face down positioning
Biomarkers in Acute Cardiac Care

Study Overview
=================
Brief Summary
-----------------
The primary aim of the study is to investigate new cardiac biomarkers and algorithms to diagnose acute coronary syndrome in patients with suspected acute myocardial infarction.

Detailed Description
-----------------
The primary aim of the study is to detect and evaluate new cardiac biomarkers, evaluate and improve acute coronary syndrome (ACS) risk scores, which takes into account clinical, gender specific, psycho-social and lifestyle-risk factors, protein patterns and genetic variability in addition to the classical risk factors with respect to the primary endpoint of acute myocardial infarction. Secondary study aims are : To provide estimates for the incidence of ACS in patients presenting with recent onset chest pain; To provide accurate, quantifiable measures of precursors of ACS; DNA, RNA, cells, and serum/plasma for comprehensive genetic, gene expression and proteomic studies To explore the impact of ACS candidate genes on cardiovascular risk stratification by using genome-wide analyses and a biological systems approach; To explore proteins relevant for ACS; To allow the identification of new therapeutic targets; To evaluate the impact of socio-economic factors on ACS and CAD risk. Patients will be followed up during the hospital stay. Afterwards a telephone follow-up will take place after 30 days, 6, 24 and 48 months.

Official Title
-----------------
Biomarkers in Acute Cardiac Care

Conditions
-----------------
Acute Coronary Syndrome, Myocardial Infarction, Chest Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptoms suggestive of acute myocardial infarction Ability to provide written informed consent in accordance with Good epidemiological Practice and local legislation Individuals at least 18 years old Exclusion Criteria: - Insufficient knowledge of the German language (able to understand and write the German language)

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 |
| --- | --- |
| Suspected acute myocardial infarction<br>Patients with recent onset symptoms suggesting acute myocardial infarction | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute myocardial infarction as index event | The primary endpoint of the study is acute myocardial infarction | Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AMI, Mortality, heart failure and quality of life | The secondary endpoint of the study is mortality, heart failure, quality of life. | Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
troponin, myocardial infarction, acs, AMI, biomarker, BACC, high-sensitivity
Comparisone of Iminoral Versus Neoral in Prevention of Acute Rejection in Renal Transplantation

Study Overview
=================
Brief Summary
-----------------
Cyclosporine is the key drug in organ transplantation. In Iran the investigators have more than 2500 new renal transplantation each year and because of this the government pay a huge amount of money for subsiding the imported cyclosporine in the form of Neoral. Recently an Iranian drug company introduced this drug in the name of Iminoral which has been approved by different authorities in Iran and abroad, (including the Ministry of Health in Iran and also European Directorate for the Quality of Medicines Certification Unit and FDA(Department of Health and Human Services,Center for Drug Evaluation and Research)). The investigators study is the first clinical trial to compare the effect of Iminoral versus Neoral in preventing acute rejection in renal transplantation and also to compare the side effects of these two drugs.

Official Title
-----------------
The Comparison Between Clinical and Paraclinical Effect of Iminoral Vs Neoral in Prevention of Acute Rejection in the First Year Afer Transplantation in De Novo Renal Transplant Patients

Conditions
-----------------
End Stage Renal Disease, Renal Transplantation

Intervention / Treatment
-----------------
* Drug: Iminoral
* Drug: Neoral


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: renal transplantation candidates written consent not taking participate in any other clinical trial in last 3 months Exclusion Criteria: primary FSGS hyperoxaluria age under 18 multi organ transplantation any malignancy in 5 years PRA > 25% use of Tacrolimus hyper acute rejection

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>taking Iminoral | Drug: Iminoral<br>* Iminoral in form of capsules 25,50 and 100 mg giving in the dose of 3-7 mg/kg twice daily<br>|
| Active Comparator: 2<br>taking Neoral | Drug: Neoral<br>* Neoral in form of capsules 25,50 and 100 mg giving in the dose of 3-7 mg/kg twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transplanted kidney acute rejection |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cyclosporine side effects |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iminoral, Neoral, Acute renal transplant rejection
Glycemic Index/ Load and Mental Disorders

Study Overview
=================
Brief Summary
-----------------
A total of 300 adults would be included in the present cross-sectional study. glycemic index (GI) and glycemic load (GL) would be assessed by using a validated self-administered dish-based semi-quantitative food frequency questionnaire. Validated Iranian versions of Hospital Anxiety and Depression Scale and General Health Questionnaire-12 would be used to assess anxiety, depression and psychological distress.

Detailed Description
-----------------
Frequency of 5 food groups will be asked in dish-based semi-quantitative food frequency questionnaire and they would be converted to grams. GI and GL will be estimated by using international table of GI and GL. Validated Iranian versions of Hospital Anxiety and Depression Scale and General Health Questionnaire (GHQ)-12 were used to assess anxiety, depression and psychological distress. Possible score range for anxiety and depression is from 0 to 21. Scores of 8 or higher on either section were considered as the presence of anxiety or depression and scores of 7 or less were considered as normal status. In the present study, participants who got scores of 4 or more from GHQ were considered to have psychological distress.

Official Title
-----------------
Glycemic Index, Glycemic Load and Common Psychological Disorders

Conditions
-----------------
Depression, Anxiety, Psychological Distress

Intervention / Treatment
-----------------
* Other: GI/GL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged 18-75 years of free-living individuals. Exclusion Criteria: Over or underestimating of total energy intake Uncompleted questionnaire (more than 30% of questions)

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Isfahani adults<br>GI/GL | Other: GI/GL<br>* GI and GL would be categorized as tertile. due to cross-sectional design of this study, intervention would not be applicable.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| odds ratio for having depression resulted from statistical analysis |  | up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depression score resulted from Hospital Anxiety and Depression Scale |  | up to 6 months |
Interest of the Nefopam and PCA Morphine Combination for Postoperative Analgesia in Patients Undergoing Colon Surgery

Study Overview
=================
Brief Summary
-----------------
This study analyses interest of iv nefopam in combination with paracetamol after major abdominal surgery because the effect of morphine-sparing is discussed when combined these agents.

Official Title
-----------------
Interest of the Nefopam and PCA Morphine Combination for Postoperative Analgesia in Patients Undergoing Colon Surgery

Conditions
-----------------
Colonic Neoplasms, Diverticulosis, Colonic

Intervention / Treatment
-----------------
* Drug: Nefopam
* Other: saline solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient with a score ASA between I and III Patient scheduled for elective major abdominal surgery (by laparotomy) for cancer or diverticulosis Patient that signed the consent form Exclusion Criteria: - Patient treated in emergency situation Patient with chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis) Patient that needs a surgery for restoration of continuity Patient pregnant, breastfeeding, or during periods of genital activity using no contraception. Patient with contraindications to nefopam, morphine, or paracetamol Patient with chronic obstructive pulmonary disease, renal or severe hepatic impairment Patient under analgesics treatment Patient who participated in a clinical study in the previous 6 months.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br> | Other: saline solution<br>* The Control group received 120 mg placebo infusion (saline solution) by continuous iv infusion over the study period (48h).<br>|
| Experimental: Nefopam group<br> | Drug: Nefopam<br>* The nefopam group received 120 mg nefopam (Acupan, Pharmbio, France) by continuous iv infusion over the study period (48h)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate morphine consumption | mg | over 48 hours |
Improved Operation of Low Intraocular Pressure in Phacoemulsification for Patients With High Myopia Complicated With Cataract

Study Overview
=================
Brief Summary
-----------------
Approximately 60 participants at Eye Hospital of Wenzhou Medical University during October,2021 to January 2022 will be enroll in the investigators' study. And dived them randomly into 2 groups:High myopia with axial length between 26 mm and 28 mm and High myopia with axial length more than 28 mm (30 eyes) .

Official Title
-----------------
Improved Operation of Low Intraocular Pressure in Phacoemulsification for Patients With High Myopia Complicated With Cataract

Conditions
-----------------
High Myopia, Low Intraocular Pressure

Intervention / Treatment
-----------------
* Procedure: Supplement of perfusion fluid through the subiris suspensory ligament space from the lateral incision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients with high myopia and cataract who plan to receive cataract surgery in our hospital Surgery without complications Exclusion Criteria: Patients who had other ocular diseases or had undergone internal eye surgery Patients with a history of myopic laser surgery Previous history of eye trauma Previous use of medications/eye drops that may alter IOP
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: High myopia with axial length between 26 mm and 28 mm<br>The patients' axial length is between 26 mm and 28 mm | Procedure: Supplement of perfusion fluid through the subiris suspensory ligament space from the lateral incision<br>* After the capsule is filled with viscoelastic material, if the IOP is less than 10 mmHg, the investigators will supply the perfusion fluid through the subiris suspensory ligament space from the lateral incision.<br>|
| Experimental: High myopia with axial length more than 28 mm<br>The patients' axial length is more than 28 mm | Procedure: Supplement of perfusion fluid through the subiris suspensory ligament space from the lateral incision<br>* After the capsule is filled with viscoelastic material, if the IOP is less than 10 mmHg, the investigators will supply the perfusion fluid through the subiris suspensory ligament space from the lateral incision.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure | Measurement of intraocular pressure during cataract surgery by iCare rebound tonometer | two minutes |
A Viveve Experience Normalizes Untreated Selective Serotonin Reuptake Inhibitor (SSRI) Sexuality Syndrome

Study Overview
=================
Brief Summary
-----------------
A pilot study to investigate non-surgical treatment for women who suffer from sexual complaints secondary to SSRI Sexuality Syndrome.

Official Title
-----------------
A Viveve Experience Normalizes Untreated Selective Serotonin Reuptake Inhibitor (SSRI) Sexuality Syndrome

Conditions
-----------------
Sexual Dysfunction

Intervention / Treatment
-----------------
* Device: Viveve System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently using SSRI for 3 months at a stable dose Exclusion Criteria: Pregnant, currently breastfeeding, or breast-fed within the last 6 months Has any implantable electrical device that could potentially be affected by use of radiofrequency.

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

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Active treatment<br> | Device: Viveve System<br>* Radiofrequency device utilized in general surgical procedures for electrocoagulation and hemostasis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Adverse Events | safety of treatment of female sexual dysfunction secondary to SSRI sexuality syndrome | baseline to 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Female Sexual Function Index (FSFI) | Female Sexual Function Index total score (Minimum: 2.0) (Maximum: 36), Higher scores are better outcome. | baseline to 3 and 6 months |