linjc16/ctgov huggingface dataset:
Study on the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women With Uterine Myoma

Study Overview
=================
Brief Summary
-----------------
The investigators want to know whether the intravenous ascorbic acid would reduce the blood loss during laparoscopic myoma surgery. The investigators randomized patients into intravenous ascorbic acid group and placebo group and examined the blood loss in both groups.

Official Title
-----------------
Placebo-controlled,Doubled,Randomized Trial Evaluating the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women Undergoing Laparoscopic Myomectomy

Conditions
-----------------
Uterine Leiomyoma

Intervention / Treatment
-----------------
* Drug: ascorbic acid
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: uterine myoma be planning to laparoscopic myomectomy images ; the number of myoma <4 images ; the diameter of the largest myoma <9cm Exclusion Criteria: be planning other surgery in addition to laparoscopy clinically significant coagulation abnormality
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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ascorbic acid<br>ascorbic acid 2g in normal saline 500ml IV start 2hours before the operation | Drug: ascorbic acid<br>* ascorbic acid 2g in normal saline 500ml IV start 30min before the operation and infusion for 2 hour<br>Drug: Normal saline<br>* normal saline 500ml IV<br>|
| Placebo Comparator: Control<br>Normal saline 500ml IV infusion for 2hour | Drug: Normal saline<br>* normal saline 500ml IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss |  | during laparoscopic myomectomy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uterine leiomyoma, laparoscopic myomectomy, intraoperative blood loss, ascorbic acid
Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to assess the incidence of safety outcomes in patients treated with Pipeline™ Flex embolization device with Shield Technology™.

Official Title
-----------------
Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study

Conditions
-----------------
Aneurysm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements. Age 18-80 years. Subject has already been selected for flow diversion therapy as the appropriate treatment. Subject has an unruptured target intracranial aneurysm (IA). Subject has a target IA located in the anterior or posterior circulation. Exclusion Criteria: Major surgery in the past 30 days. Any known contraindication to treatment with the Pipeline™ Flex embolization device with Shield Technology™ per Instructions for Use. Pregnant or breast-feeding women or women who wish to become pregnant during the length of study participation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of major stroke or neurological death |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device related neurologic adverse event rate |  | 1 year |
A Randomised, Controlled Study of Bimesh, Pelvicol for Vaginal Wall Prolapse

Study Overview
=================
Brief Summary
-----------------
Anterior vaginal wall prolapse is a common problem. Until now many different surgical techniques have been evaluated but so far recurrence is often still observed. Therefore, synthetic mesh or biomesh for vaginal prolapse reconstruction have been introduced.

Detailed Description
-----------------
Anterior vaginal wall prolapse is a common problem. Until now many different surgical techniques have been evaluated but so far recurrence is often still observed. Therefore, synthetic mesh or biomesh for vaginal prolapse reconstruction have been introduced. However, is is now known whether these methods are superior to the replication of the pubocervicale fascia, a method which is well described and have been used for many years. Furthermore, most studies evaluating the used of mesh for anterior vaginal wall prolapse have not been controlled studies and been irrespective to whether the repair was a primary or secondary operation.

Official Title
-----------------
A Randomised, Controlled Study of Bimesh, Pelvicol for Vaginal Wall Prolapse

Conditions
-----------------
Vaginal Prolapse

Intervention / Treatment
-----------------
* Device: Pelvicol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anterior vaginal wall prolapse greater than grade 2 ICS qualifications, International Continence Society Committee for Standardisation of Terminology Exclusion Criteria: Recurrent vaginal prolapse, wault prolapse

Ages Eligible for Study
-----------------
Minimum Age: 55 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Pelvicol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in POP-Q measurements for vaginal prolapse |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Affect on bladder function after surgery for anterior vaginal wall prolapse |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anterior vaginal wall prolapse, Pelvicol, biomesh, Anterior vaginal wall prolapse
Detecting Recurrent Prostate Cancer With 11C-choline Positron Emission Tomography

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to use a new imaging drug called 11C-choline that is used with a PET/CT scan to see prostate cancer when it cannot be seen well on other scans, such as bone scans, CT or MRI.

Official Title
-----------------
Detecting Recurrent Prostate Cancer With 11C-choline Positron Emission Tomography: An Expanded Access Study

Conditions
-----------------
Prostate Cancer, Recurrent Prostate Cancer

Intervention / Treatment
-----------------
* Drug: 11C-choline
* Device: PET/CT Scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must have biopsy-proven adenocarcinoma of the prostate initially treated with curative intent (surgery and radiation therapy are most common treatments but other treatments are also eligible). Biochemical recurrence defined as any of the following: PSA ≥ 0.2 ng/mL in at least two sequential tests for patients treated with surgery. PSA ≥ 0.2 ng/mL above the post therapy nadir for patients treated with radiation therapy, brachytherapy or cryotherapy. PSA ≥ 0.2 ng/ml above the most recent therapy nadir for patients who have received additional treatment in the recurrent setting Patient must have undergone standard-of-care restaging that does not clearly identify site(s) of active disease, or such prior studies must show equivocal findings for which further work-up is considered necessary to make clinical decision. Standard staging examinations may include one or more of the following: CT or MRI, bone imaging (either Tc-99m bisphosphonate scintigraphy MDP or F-18 sodium fluoride PET), FDG PET, or In-111 capromab pendetide scintigraphy no older than 3 months of consent date. Age ≥ 18 years. Patient must be able to tolerate PET/CT imaging. Patient must be able to understand and willing to sign a written informed consent document. Exclusion Criteria: Patient must not have claustrophobia that would preclude PET/CT imaging or other contraindications to CT imaging.

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

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 11C-choline|nan|
|Device: PET/CT Scan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
11C-choline, Positron Emission Tomography, 15-117
Safety and Immunogenicity of 2-dose Inactivated COVID-19 Vaccine in Kidney Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has a major impact on transplant recipients, with mortality rates up to 20%. However, immunocompromised individuals have been excluded from studies of SARS-CoV-2 vaccines. In such patients, the immune response to vaccination may be blunted. To better understand the immunogenicity of SARS-CoV-2 vaccines in transplant recipients, we quantified the humoral response to SARS-CoV-2 vaccine in kidney transplant recipients.

Official Title
-----------------
Safety and Immunogenicity of 2-dose Inactivated COVID-19 Vaccine in Kidney Transplant Recipients: a Prospective Cohort Study

Conditions
-----------------
Kidney Transplantation, SARS-CoV-2 Acute Respiratory Disease, Vaccine

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receiving kidney transplantation in West China Hospital, Sichuan University Exclusion Criteria: 1) History of rejection or infection over the previous 3 months; 2) receiving kidney transplantation >3 months; 3) Combined with HBV/HVC/HIV infection in the donor or recipient; 4) Malignancy history in the donor and recipient; 5) organ transplant history in the recipient.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| kidney transplant recipients<br>kidney transplant recipients receiving inactivated SARS-CoV-2 vaccine | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| seropositive anti-COVID-19 antibody | seropositive anti-COVID-19 antibody, including IgM, IgG, and IgA | 2 to 6 weeks after the second injection of inactivated vaccine |
US Expanded Access Program for Magrolimab in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
The goal of this expanded access program is to provide rapid access to magrolimab free-of-cost material, to treat patients in the United States suffering from relapsed or refractory acute myeloid leukemia (AML).

Official Title
-----------------
Expanded Access Program for Magrolimab

Conditions
-----------------
Relapsed/Refractory Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: Magrolimab


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Individuals with confirmation of acute myeloid leukemia (AML) according to WHO 2016 classification who are refractory or relapsed, ineligible for all known drugs with proven efficacy, and ineligible for existing clinical studies; and the treating physician has assessed that the potential benefits of magrolimab outweigh the risks. Eastern Cooperative Oncology Group performance status score of 0 to 3. Treating physician plans to administer magrolimab in combination with azacitadine/venetoclax or magrolimab in combination with azacitadine alone, following the indication-specific combinations described in the protocol. Key Exclusion Criteria: Known hypersensitivity to magrolimab, azacitidine, venetoclax, their metabolites, or formulation excipients, if applicable to planned treatment regimen. Prior treatment with cluster of differentiation (CD)47 or signal regulatory protein alpha (SIRPα)-targeting agents. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Magrolimab|Administered intravenously|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Autonomic Profiles in Pediatric Patients With Cyclic Vomiting Syndrome (CVS), Irritable Bowel Syndrome (IBS),Postural Orthostatic Tachycardia Syndrome (POTS), Functional Abdominal Pain (FAP) or Chronic Nausea

Study Overview
=================
Brief Summary
-----------------
Retrospectively review the charts of all children who had heart rate variability, deep breathing test, valsalva maneuver, tilt table test, thermoregulatory sweat testing, quantitative sudomotor axon reflex test (QSART) completed and were cared for at Children's Hospital of Wisconsin.

Official Title
-----------------
Autonomic Profiles in Pediatric Patients With Cyclic Vomiting Syndrome, Irritable Bowel Syndrome, Postural Orthostatic Tachycardia Syndrome, Functional Abdominal Pain or Chronic Nausea

Conditions
-----------------
Vomiting Syndrome, Irritable Bowel Syndrome, Postural Orthostatic Tachycardia Syndrome, Abdominal Pain, Chronic Nausea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatient services Exclusion Criteria: Inpatient services

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum 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 |
| --- | --- |
| 1<br>Cyclic Vomiting Syndrome | |
| 2<br>Irritable Bowel Syndrome | |
| 3<br>Postural Orthostatic Tachycardia Syndrome | |
| 4<br>Functional Abdominal Pain | |
| 5<br>Chronic Nausea | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To gather preliminary data to characterize autonomic function in children and adolescents with functional gastrointestinal disorders. |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chart must reveal the following procedures:, Heart rate variability,, Deep Breathing Test,, Valsalva maneuver,, Table test,, Thermoregulatory Sweat Testing,, Quantitative Sudomotor Axon Reflex Test (QSART),, Vital signs,, postural changes in heart rate and blood pressure,, composite autonomic score
Cardiovascular Benefits of Acai Polyphenols in Volunteers at Risk of Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to carry out a randomized double blind controlled trial in 30 male subjects to investigate the effect of acai consumption on acute changes in vascular function, and to other cardiovascular markers. As a secondary aim the study will allow us to characterize the absorption and metabolism of acai polyphenols in humans over a 24 hour period.

Official Title
-----------------
Cardiovascular Benefits of Acai in Volunteers at Risk of Metabolic Syndrome.

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Dietary Supplement: Acai puree, frozen blended it with banana
* Dietary Supplement: Control Macronutrient matched


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, 30-65 aged, BMI 25-35 kg/m2, Cholesterol <8 mmol/l. Exclusion Criteria: Female, BMI <25 or >35 kg/m2, Cholesterol >8mmol l-1, elevated fasting blood sugar > 6.5 mmols l-1 , elevated systolic blood pressure >150 mmHg, history of stroke or heart attack within the previous 12 months, current smoking, taking lipid lowering, blood pressure lowering or anti-blood clotting medication or taking micronutrient supplements.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 150g of acai fruit<br>150g of acai fruit in fruit smoothie form | Dietary Supplement: Acai puree, frozen blended it with banana<br>* 150g of acai fruit, frozen blended it with banana.<br>|
| Placebo Comparator: Placebo control<br>The control will be a smoothie-like drink matched for major macro- and micro-nutrients | Dietary Supplement: Control Macronutrient matched<br>* Macronutrient matched control in water and also prepared with banana.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow-mediated dilation |  | Change from baseline to 2h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma polyphenol metabolites |  | Change from baseline to 24h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
flow-mediated dilation, Acai polyphenols
Long Term Safety Assessment of SER120 in Patients With Nocturia

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this study is that SER120 is safe and well tolerated for use in nocturic patients.

Official Title
-----------------
A Phase III Open-Label Extension Study to Investigate the Safety of SER120 Nasal Spray Formulations in Patients With Nocturia Completing Study SPC-SER120-DB1-200901 or Study SPC-SER120-DB2-200902

Conditions
-----------------
Nocturia

Intervention / Treatment
-----------------
* Drug: SER120


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients completed SPC-SER120-DB1-200901 and SPC-SER120-DB2-200902 studies Willing to provide consent for the study Exclusion Criteria: Incontinence Diabetes Insipidus, Diabetes Mellitus CHF Renal Insufficiency Significant medical history which make participation unacceptable

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 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: SER120 (desmopressin)<br> | Drug: SER120<br>* once a day treatment of nocturia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Serum Sodium | Change in mean serum sodium on Day 8, Day 15, Day 22, Week 4, Week 8, Week 12, Week 20, Week 28 and Week 40 compared to Baseline | 40 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
decrease in the number of nocturic episodes for patients with nocturia
Sicilian Administrative Data Base Study in Acute Coronary Syndrome Patients

Study Overview
=================
Brief Summary
-----------------
Thi is an observational, non interventional, cohort analysis by using administrative databases (drugs treatment, laboratory and diagnostic tests, specialist visits and hospitalizations) of Sicilia region to evaluate treatment patterns of patients after Acute Coronary Syndrome (ACS) event.

Detailed Description
-----------------
HEALTH-DB ACS

Official Title
-----------------
Sicilian Administrative Data Base Study in Acute Coronary Syndrome Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects discharged alive from hospitalization for ACS Exclusion Criteria: All patients that don't have a continuative presence as beneficiaries of the region between January 1st, 2007 and December 31st 2011 will be excluded from analysis.

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 |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic path for each patient included in the analysis will be described by using all prescription for laboratory test (eg. total cholesterol, LDL cholesterol) and/or diagnostics tests (eg. electrocardiogram) during the observation period. |  | up to 2 years | 
| The drugs treatment path will be described by using all prescriptions of antihypertensive drugs, lipid-lowering drugs and antiplatelet drugs during the observation period. |  | up to 2 years | 
| Adherence to treatment will be calculated in the manner suggested by the literature and used in previous publications. Different methods of assessment will, however, used in order to study the variability of results. The analysis will be conducted over |  | up to 2 years | 
| The chronological analysis of the requirements will allow the identification of potential therapeutic combinations or substitutions. |  | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ACS, AMI