linjc16/ctgov huggingface dataset:
The Effect of Increasing the Mean Arterial Pressure on the Microcirculation and the Prognosis of Patients With Septic Shock

Study Overview
=================
Brief Summary
-----------------
Background： The mean arterial pressure（ MAP） is a key pressure index to improve tissue perfusion. At present, there are no surprising results of large-scale clinical studies on sublingual microcirculation. The changes of sublingual microcirculation were more severe in septic shock non-survivors than survivors. Purpose： This study is mean to increase the MAP in septic shock patients whether with chronic hypertension or not, so as to observe the change of the microcirculation and prognosis. Method： This is a single-center, randomized, prospective cohort study. Eligible patients will be allocated into chronic hypertension or denying chronic hypertension group. These patients will be treat with vasopressors to maintain MAP at 90±5 mmHg and 70±5 mmHg. Outcome： The 28-day all-cause mortality, the 90-day all-cause mortality, the 28-day without organ dysfunction days, the Changes of sublingual microcirculation, SOFA， APACHE-Ⅱ score Will be recorded.

Official Title
-----------------
The Effect of Increasing the Mean Arterial Pressure on the Microcirculation and the Prognosis of Patients With Septic Shock

Conditions
-----------------
Septic Shock

Intervention / Treatment
-----------------
* Other: vasopressors


Participation Criteria
=================
Eligibility Criteria
-----------------
Adult patients (≥18 years) admitted to The Critical Medicine Departments Three of Fujian Provincial Hospital will be considered eligible，who are presence of infection or suspected infection，requiring mechanical ventilation. At the same time, without the vasopressors the MAP would be less than 65mmHg, and the blood lactic acid level is higher than 2mmol/l.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: chronic hypertension group<br>septic patients with chronic hypertension | Other: vasopressors<br>* control the mean arterial pressure with vasopressors<br>|
| Other: denying chronic hypertension group<br>septic patients without chronic hypertension | Other: vasopressors<br>* control the mean arterial pressure with vasopressors<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the 28-day all-cause mortality and Changes of sublingual microcirculation | the 28-day all-cause mortality and Changes of sublingual microcirculation | 28 day |
A Study to Determine the Number of Participants With Rheumatoid Arthritis (RA) Who Meet the Requirements for Treatment With Anti-Tumor Necrosis Factor α (TNFα) in a General Hospital Setting in Korea

Study Overview
=================
Brief Summary
-----------------
This is an observational study to estimate the proportion of patients diagnosed with RA visiting a medical internist in a general hospital in Korea who are candidates for anti-TNF α therapy.

Official Title
-----------------
The Prevalence of Out-patients With Rheumatoid Arthritis Fulfilling the Indication for Anti-tumor Necrosis Factor(TNFa) Therapy in General Hospital Setting in Korea: a Multi-center, Non-interventional, Observational Study

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with RA Visiting a medical internist in a study site during the study period on out patient basis Able to give written informed consent voluntarily Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Number of anti-TNF α agent candidates fulfilling the reimbursement guideline of Korea government in total out-patients with RA |  | Baseline | 
| Number of anti-TNF α agent candidates based on the clinical judgement in total out- patients with RA |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid Arthritis, anti-TNF α
Expanded Access Program for Tofersen in Participants With Superoxide Dismutase 1-Amyotropic Lateral Sclerosis

Study Overview
=================
Brief Summary
-----------------
The objective of this early access program (EAP) is to provide access to tofersen to eligible participants with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene prior to an alternative access mechanism in order to address a high unmet medical need in this population.

Detailed Description
-----------------
Treating healthcare professionals (HCPs) of participants who meet the inclusion/exclusion criteria may request access by emailing medicineaccess@clinigengroup.com. The current EAP structure does not limit participants to receive access at specific sites. Treating HCPs can submit requests on behalf of participants by emailing Clinigen at the email address provided below. Information on the EAP eligibility criteria, including participants and center criteria, will be provided by Clinigen as part of the enrollment request process.

Official Title
-----------------
Global Early Access Program to Provide Tofersen To Patients With Amyotrophic Lateral Sclerosis (ALS) Associated With a Mutation in the Superoxide Dismutase 1 (SOD1) Gene

Conditions
-----------------
Superoxide Dismutase 1-Amyotropic Lateral Sclerosis

Intervention / Treatment
-----------------
* Drug: Tofersen


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Medically able to undergo the program procedures, as determined by the treating healthcare professional (HCP). Weakness attributable to ALS and associated with a mutation in the SOD1 gene (SOD1-ALS). Key Exclusion Criteria: Previous or current participation in a clinical trial of tofersen. Use of an investigational medicinal product (IMP) for amyotrophic lateral sclerosis (ALS) within 5 half-lives of the IMP before the first dose of tofersen. Participant's primary place of residence is outside of the country of treatment. 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: Tofersen|Administered as intrathecal bolus injection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Improving the Assessment of Hypersomnolence

Study Overview
=================
Brief Summary
-----------------
The overall purpose of this study is to employ a pragmatic, multidimensional assessment of hypersomnolence that piggybacks on routine clinical care in patients with suspected disorders of central nervous system (CNS) hypersomnia, to determine whether these additional objective and subjective assessments are useful in the diagnosis and management of these patients.

Official Title
-----------------
Improving the Assessment of Hypersomnolence

Conditions
-----------------
Disorders of Excessive Somnolence

Intervention / Treatment
-----------------
* Device: Pupillometry
* Behavioral: Psychomotor Vigilance Task
* Other: Auditory Evoked Potential
* Behavioral: Hypersomnia Severity Index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-89 Referred for polysomnography/multiple sleep latency test at Wisconsin Sleep, the sleep medicine clinic and laboratory of the University of Wisconsin-Madison Exclusion Criteria: unstable medical condition that, in the opinion of the investigators, would make it unsafe for the subject to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- |
| Patients with Hypersomnolence<br>Patients referred for polysomnography and multiple sleep latency test | Device: Pupillometry<br>* Measures pupillary dynamics in darkness and light conditions<br>Behavioral: Psychomotor Vigilance Task<br>* Response time task measuring neurobehavioral alertness<br>Other: Auditory Evoked Potential<br>* Measure of electroencephalographic response to standardized auditory tones<br>Behavioral: Hypersomnia Severity Index<br>* Self-report measure of hypersomnolence<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Categorized with Hypersomnolence | Multiple measurements will be aggregated to arrive at the primary outcome of proportion of patients categorized as having hypersomnolence using either standard assessments or standard assessments plus additional novel hypersomnolence measures of pupillometry, psychomotor vigilance task, and auditory evoked potentials. Proportion of patients with hypersomnolence using standard measures will be calculated as number of patients with mean sleep latency (MSL) on multiple sleep latency test (MSLT) <8 minutes divided by total number of patients. Proportion of patients categorized as having hypersomnolence with additional novel hypersomnolence measures will be calculated as the number of patients with MSL<8 minutes, and/or pupillary unrest index (PUI) >8.9 on pupillometry, and/or PVT lapses >3, and/or P300 delay/sleep negativity during auditory evoked potentials divided by total number of patients. | 2 Years |
The Finnish Faecal Microbiota Transplantation Study (FINFMT)

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to follow up the long term effects of faecal microbiota tranplantation (FMT). All the over 18 years old patients receiving FMT and not included in other trials meet inclusion criteria to this study. Patients will be asked for a written consent. The outcome and possible side effects of the FMT will be followed by blood and feces samples for one year and with questionaires up to ten years after the FMT.

Official Title
-----------------
Long Term Safety and Efficacy of Faecal Microbiota Transplantation: a Nationwide Obeservational Study

Conditions
-----------------
Faecal Microbiota Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years age receiving FMT for rCDI or any other madical condition written consent Not included in other FMT trials Exclusion Criteria: Unable to provide written consent < 18 years age Included in other FMT-trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 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 |
| --- | --- | --- |
| The long term effects of FMT -questionnaire | The questionnaire has 52 questions. Weight and height are asked and appearance of certain symptoms. The answers are mostly yes or no. The questionnaire is not validated and it is descriptive and the answers are not scored. | 10 years |
Vitamin D3 Supplementation in Participants Diagnosed With Early-Stage Prostate Cancer Who Decide to Undergo Active Surveillance Treatment Regimen.

Study Overview
=================
Brief Summary
-----------------
This clinical trial is aimed at measuring the effect of vitamin D3 supplementation on serum prostate-specific antigen (PSA) levels in patients diagnosed with early stage, low-grade, low-risk prostate cancer (Gleason score less than/equal to 6; PSA less than/equal to 10; clinical stage T1C or T2a), who elect to have their disease monitored through active surveillance for at least one year.

Official Title
-----------------
Vitamin D and Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: cholecalciferol
* Dietary Supplement: cholecalciferol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lowgrade prostate cancer serum PSA less than/equal to 10 ng/ml Gleason score less than/equal to 6 referred from their treating physician with treatment plan of active surveillance for one year serum creatinine less than/equal to 2.0 mg/dL serum phosphate (measured as phosphorus)greater than 2.3 and less than 4.8 mg/dL serum calcium greater than 8.5 and less than 10.5 mg/dL Exclusion Criteria: concurrent malignancy, except non-melanoma skin cancer history of sarcoidosis history of high dose (greater than 1,000 IU daily) vitamin D3 supplementation history of hypercalcemia treatment with lithium medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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: open-label vitamin D3<br>One arm: open-label receiving vitamin D3 4,000 IU daily | Dietary Supplement: cholecalciferol<br>* 4,000 I.U. softgel daily orally for 48 weeks<br>* Other names: vitamin D3;Dietary Supplement: cholecalciferol<br>* cholecalciferol or vitamin D3 4,000 IU daily for 48 weeks<br>* Other names: vitamin D3;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of vitamin D3 supplementation on prostate specific antigen levels in patients diagnosed with early stage, low-grade, low-risk prostate cancer. |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of subjects (determined by safety lab values every 8 weeks: serum Creatinine, Ca, Phosphorus, PTH, vit D3; CBC with differential; and urine Ca/Creat ratio) taking vitamin D3 supplementation (4,000 I.U.) daily. |  | 48 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate, cancer, vitamin D3, early stage, active surveillance
A Phase III Open-Label, Multi-Center, Long-Term Extension Study of Depakote ER in Subjects Who Either Completed or Prematurely Discontinued Due to Ineffectiveness From Study M02-488.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if long-term treatment, up to 1 year, with Depakote ER is safe in the reduction of occurrence of migraine headaches in adolescents.

Official Title
-----------------
The Safety of Divalproex Sodium Extended Release Tablets in Migraine Prophylaxis: An Open-Label Extension Study in Adolescents

Conditions
-----------------
Migraines

Intervention / Treatment
-----------------
* Drug: divalproex sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject and subject's legal representative have voluntarily signed and dated an IRB-approved informed assent form and an IRB-approved informed consent form, respectively, before any study-specific procedures or tests are performed; The subject was randomized into Study M02-488 and either completed the study or prematurely discontinued due to ineffectiveness; and The subject is male or non-pregnant, non-lactating female Exclusion Criteria Female, of childbearing potential, and not using an effective method of birth control (e.g., total sexual abstinence or contraceptives). Experienced a serious adverse event in Study M02-488 which the investigator considered possibly or probably related to study drug; or In the investigator's opinion, long-term treatment with Depakote ER for migraine prophylaxis is contraindicated. For any reason, subject is considered by the investigator to be an unsuitable candidate to receive divalproex sodium or to participate in this study.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: divalproex sodium|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety outcome measure |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine headache rate |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraines, Depakote ER, divalproex sodium
Pentoxifylline in the Treatment of NEC in Premature Neonates

Study Overview
=================
Brief Summary
-----------------
Pentoxifylline improves microcirculation and decreases TNF alpha levels associated with sepsis, rendering it of potential therapeutic value in necrotizing enterocolitis in premature neonates.

Detailed Description
-----------------
Preterm neonates with a clinical suspicion of necrotizing enterocolitis (NEC) will potentially be candidates for study. After obtaining parental consent, the infants will be prospectively and randomly assigned to one of two groups: 1. Treatment group: to receive IV pentoxifylline (5 mg/kg/hour to run over 6 hour x 6 days) and 2. Placebo group: to receive an equal volume of ½ normal saline to run over 6 hours x 6 days.

Official Title
-----------------
Pentoxifylline in the Treatment of Necrotizing Enterocolitis in Premature Neonates

Conditions
-----------------
Necrotizing Enterocolitis

Intervention / Treatment
-----------------
* Drug: Pentoxifylline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infants <1750 gm. birth weight Abdominal x-ray consistent with NEC (dilated loops, bowel wall edema, fixed or persistent dilated loop with (or without pneumatosis) Exclusion Criteria: Abdominal perforation
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 |
| --- | --- |
| Placebo Comparator: A<br> | Drug: Pentoxifylline<br> <br> |
| Experimental: B<br> | Drug: Pentoxifylline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate that fewer of the babies who are treated with PTX will progress to serious NEC related morbidity, ie. perforation, surgery [including peritoneal drain placement], and/or death related to NEC. |  | Three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate lower levels of TNF alpha,fecal calprotectin;Improved SMA blood flow;Quicker radiographic resolution; Decreased feeding intolerance after acute NEC episode; and lower NEC associated long term morbidity. |  | Three years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NEC, Premature Infants, TNF, Pentoxifylline
inflAmmatory maRkers in Blood and Thrombus Aspirated From Patients With acutE myocaRdial Infarction With St-segment elevAtion

Study Overview
=================
Brief Summary
-----------------
The prognostic value of inflammatory markers in acute coronary syndrome has been extensively demonstrated, however it is still unknown whether there is an association between circulating and local (thrombus) inflammatory molecules, and the subset of molecules that provide better prognostic information in patients with ST-elevation acute coronary syndrome.

Conditions
-----------------
Patients Admitted With the Diagnosis of ST-elevation Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Other: Biomarkers to analyze both intracoronary thrombi as blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: They include patients of both sexes, without limits of age, with a diagnosis of STEMI within 12 hours after the beginning of symptoms. ST-elevation myocardial infarction was defined in the presence of symptoms consistent, persistent elevation (> 20 min) ST segment ≥ 1 mm in at least two contiguous leads or in the presence of left bundle branch block presumably new onset and cardiac troponin I elevation Exclusion Criteria: Injury significant common core of left coronary artery (stenosis greater than or equal to 50% of the vessel lumen). Pre-Fibrinolysis percutaneous coronary intervention. Previous coronary bypass surgery. Thyrotoxicosis. Having an inflammatory systemic or local inflammatory process. Malignant neoplasm. Any disease that seriously compromise the prognosis and / or systemic inflammatory response generated. No thrombotic material obtained in the thrombus or insufficient for performing biochemical determinations.

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 |
| --- | --- |
| ST-elevation acute coronary syndrome<br>ARTERY is a prospective, multicenter, which will include patients admitted with the diagnosis of ST-elevation acute coronary syndrome and thrombus aspiration is performed during primary angioplasty | Other: Biomarkers to analyze both intracoronary thrombi as blood<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of the study is to find out whether there is an association between certain inflammatory markers in blood and intracoronary thrombus and whether these markers are associated with the composite of all-cause mortality |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myocardial infarction, Inflammation, Thrombus, Coronary angioplasty.