linjc16/ctgov huggingface dataset:
Pre-eclampsia and Biochemical Markers

Study Overview
=================
Brief Summary
-----------------
In view of both endothelial injury in pre-eclampsia, high blood pressure and kidney impairment characteristics, a recent study demonstrated that the serum levels of NGAL increased at the end of the second trimester in women who subsequently developed pre-eclampsia compared to the control group. This correlates well with the endothelial damage that occurs during pre-eclampsia and thus NGAL can be considered as a promising marker in predicting both early and late onset pre-eclampsia. It may be required to combine one or more biomarker with NGAL to increase the precision, and sensitivity for detection of risk and reliability of using biomarkers for pre-eclampsia.

Official Title
-----------------
Correlation Between Complications of Pre-eclampsia and Detection of Novel Biochemical Markers

Conditions
-----------------
Detection of Preeclampsia Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20-40 years. Gestational age >20 weeks. Exclusion Criteria: Patients with preexisting renal disease,hypertension, diabetes mellitus, gestational hypertension. Patients Refuse to participate in the study Patients already have complicated preeclampsia.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- |
| Eclampsia<br>pregnant women with eclampsia will be diagnosed by the occurrence of seizures on top of preeclampsia. | |
| severe preeclampsia<br>pregnant women with severe preeclampsia will be diagnosed according to blood pressure ≥160/110 mmHg with proteinuria detection by boiling method +3,+4. | |
| healthy<br>matched normotensive pregnant women. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of circulating NGAL |  | 24 hours |
Adalimumab in Combination With Ciprofloxacin/Placebo Treatment of Perianal Fistulas in Crohn's

Study Overview
=================
Brief Summary
-----------------
To assess whether a combination of ciprofloxacin and adalimumab is more effective than adalimumab alone for the treatment of perianal fistulas in Crohn's disease

Detailed Description
-----------------
Dutch multicenter, randomized, double-blind study with two arms. 146 patients will be included.

Official Title
-----------------
Adalimumab for the Treatment of Perianal Fistulas in Crohn's Disease More Effective Alone or Combined to Ciprofloxacin

Conditions
-----------------
Crohn's Disease With Perianal Fistulas

Intervention / Treatment
-----------------
* Drug: adalimumab
* Drug: ciprofloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: proven Crohn's disease Single or multiple draining perianal fistulas Exclusion Criteria: Abscesses Infliximab, cyclosporine, tacrolimus and antibiotics for Crohn's disease within past 3 months active viral infection significate cardiovascular dysfunction Pregnancy, Lactation Surgical bowel resection to be expected within 6 months Positive stool culture for enteric pathogens Total parental nutrition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Active Comparator: 1<br>Adalimumab | Drug: adalimumab<br>* 24 weeks: 160 mg, 80 mg, and than 40mg every 2 weeks<br>* Other names: Humira;|
| Placebo Comparator: 2<br>ciprofloxacin | Drug: ciprofloxacin<br>* 12 weeks; daily 2 x 500mg<br>* Other names: Cipro;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas. |  | 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients in remission |  | 12 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perianal fistulas, Crohn's disease
Early-onset Obesity and Cognitive Impairment in Children With Pseudohypoparathyroidism

Study Overview
=================
Brief Summary
-----------------
Pseudohypoparathyroidism type 1a (PHP1a) is a rare disease that causes childhood obesity and learning difficulties. This study will investigate eating behaviors and perform cognitive testing on children with PHP1a. The investigators will compare their results to those of healthy siblings and other obese children.

Detailed Description
-----------------
Pseudohypoparathyroidism type 1a (PHP1a) is a genetic disorder that causes early-onset, syndromic obesity and cognitive impairment. This study aims to evaluate eating behaviors, cognition and executive function in children with PHP1a, compared with healthy siblings and matched obese controls.

Official Title
-----------------
Early-onset Obesity and Cognitive Impairment in Children With Pseudohypoparathyroidism

Conditions
-----------------
Pseudohypoparathyroidism, Albright Hereditary Osteodystrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of PHP1a, sibling of a patient with PHP1a or matched obese control Exclusion Criteria (PHP1a): Treatment with appetite-altering drug or initiation of a new weight loss program in the past 3 months Type 2 diabetes Exclusion Criteria (Controls): Obesity due to a genetic syndrome, growth hormone deficiency, untreated hypothyroidism, Cushing syndrome or exogenous glucocorticoid administration Weight loss greater than 10% over the previous 6 months Autism or other significant learning disorder Type 2 diabetes Other significant medical condition

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pseudohypoparathyroidism type 1a<br>Study group | |
| Healthy siblings<br>Control group | |
| Obese patients<br>Control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intelligence Quotient | Intelligence quotient as measured by Kaufman Brief Intelligence Test, 2nd Edition. This scale yields standard scores where the mean is 100 and one standard deviation is 15. Higher scores indicate better function. | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric obesity, pseudohypoparathyroidism, Albright Hereditary Osteodystrophy
Topical Agent for Treatment of Red Skin

Study Overview
=================
Brief Summary
-----------------
SR-01 may reduce facial redness. it is a topically applied product. The agent will be applied to local skin areas of subjects with red facial skin to assess affect, and then applied to the whole face to assess efficacy and safety

Official Title
-----------------
Proof of Concept Trial:SR-01 for the Treatment of Rosacea

Conditions
-----------------
Rosacea, Bilaterally Symmetric Red Skin on Cheeks

Intervention / Treatment
-----------------
* Drug: Topical SR-01


Participation Criteria
=================
Eligibility Criteria
-----------------
Bilaterally symmetric red skin on cheeks Caucasian Age 18-60 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Topical SR-01|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of redness |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  |  | 
| Cosmetic acceptability |  |  |
Sodium Intake in Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
Recently, it has been shown that salt (ClNa, sodium chloride) can modulate the differentiation of human and mouse TH17 cells. Indeed, mice feed with high sodium diet were described to develop more aggressive course of EAE (Experimental Autoimmune Encephalitis). However, the role of sodium intake in MS has not been investigated. In this study we investigate the effect of sodium intake in Multiple Sclerosis (MS) clinical and radiological activity.

Official Title
-----------------
Effect of Sodium Intake in Multiple Sclerosis Disease Activity

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is between 18 and 50 years old Subject has diagnosis of relapsing-remitting MS according to McDonald criteria (2010) Exclusion Criteria: Patient who had hyponatremia in the last 90 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| MS patients<br>MS patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exacerbation rate | Number of disease relapses during follow up time according to salt consumption | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological activity | Number of new lesions in MRI | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Salt, Multiple Sclerosis
Early Diagnosis of Therapy-associated Cardiotoxicity Basing on PET/CT in Lymphoma

Study Overview
=================
Brief Summary
-----------------
To explore the value of 18F-fluorodeoxyglucose (FDG) PET/CT imaging in early diagnosis of treatment-related cardiotoxicity (TACT) of lymphoma using visual method and semi-quantitative method.

Detailed Description
-----------------
First of all, the cardiac 18F-FDG uptake in patients with lymphoma will be observed by visual method: according to the uptake site, it will be divided into left ventricular uptake and biventricular uptake, and according to the degree of uptake, it will be divided into equal uptake (myocardial uptake is lower than cardiac blood pool uptake), moderate uptake (myocardial uptake is between cardiac blood pool uptake and liver uptake) and high uptake (myocardial uptake is higher than liver uptake). According to the uptake pattern, it can be divided into diffuse and segmental uptake.Then,using the region of interest method to mesure the value of myocardial uptake of 18F-FDG.The difference value of heart's SUVmax (Δ SUVmax- heart) and% Δ SUVmax- heart before and after chemotherapy or immunotherapy will be calculated. And SUVmax- heart / SUVmax- mediastinum ratio, SUVmax- heart / SUVmax- liver ratio and SUVmax- heart / SUVmax- background ratio (left gluteal muscle) after treatment. Taking the abnormality of ECG (early TACT) as the end point.

Official Title
-----------------
Early Diagnosis of Therapy-associated Cardiotoxicity Basing on PET/CT in Lymphoma

Conditions
-----------------
Positron-Emission Tomography

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No previous history of heart disease. normal echocardiography, ECG and laboratory tests (creatine kinase, myoglobin, troponin, brain natriuretic peptide) before treatment. 3.18F-FDG PET/CT examination before and after treatment - Exclusion Criteria: 1.receiving radiotherapy and chemotherapy at the same time. 2.previous chest radiotherapy. 3. with severe hepatic or renal dysfunction. -

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUVmax | the standardized uptake value | 150 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUVR | the ratio of the standardized uptake value for the heart to the normal tissue such as hepatic blood poor and gluteus | 150 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiotoxicity, early
Multicenter Registry Study of Aortic Valve Stenosis in Zhejiang Elderly（Mrs AVS）

Study Overview
=================
Brief Summary
-----------------
Aortic valve stenosis (AVS) is becoming more and more frequent with the aging, which has brought a heavy burden to the world. However, the prevalence and prognosis of valvular heart disease are not so clear, especially in the developing countries such as China etc. Because of the slow and progressive nature of AVS, symptoms might not be too severe to be diagnosed on time. Our retrospective survey (Int J Cardiol. 2016 Nov 25) indicated that severe aortic valve stenosis are very common in China. Hence, we design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of Chinese elderly patients with aortic valve stenosis.

Official Title
-----------------
A Prospective, Multicenter,Registry Study of Aortic Valve Stenosis in Zhejiang Elderly

Conditions
-----------------
Valvular Heart Disease

Intervention / Treatment
-----------------
* Other: Our study type is observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patients over 60 years old meet the following condition moderate or above aortic stenosis as defined by echocardiography: Aortic stenosis, moderate or above, or valve area≤1.5cm2, or maximal jet velocity ≥3.0m/sec, or mean pressure gradient≥20mmHg Exclusion Criteria: Patients cannot be followed up for any reasons. Patients in critical condition may be die in one year. Patients have been enrolled in this study.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Our study type is observational|Our study type is observational|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality,disabling strokes and Surgical or transcatheter aortic valve replacement | time from enrolled to first occurrence of any of the components of the composite outcome | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization for heart failure | time from enrolled to first occurrence of the outcome | one year | 
| Surgical or transcatheter aortic valve replacement | time from enrolled to first occurrence of the outcome | one year | 
| Cardiovascular death | time from enrolled to first occurrence of the outcome | one year |
Stem Cell Related Donor Safety Study

Study Overview
=================
Brief Summary
-----------------
The study tests the hypothesis that related hematopoietic stem cell donors are at a higher risk for acute medical and psychological toxicity associated with the donation process compared to adult unrelated hematopoietic stem cell donors. The study will also assess the hypothesis that young (<18 years) and older (>60 years) related donors are at increased risk for toxicity associated with donation compared to younger adult donors by describing the adverse events reported in these populations. An ancillary study of the psychological impact of donation on health-related quality of life (HRQoL) will enroll related donors and compare them to an age-matched normative cohort.

Official Title
-----------------
A Multicenter Study of Hematopoietic Stem Cell Donor Safety and Quality of Life

Conditions
-----------------
Related Hematopoietic Stem Cell Donors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Donors of any age providing either a first or second BM or PBSC donation Meet donation criteria per institution policies and procedures Willing to receive phone follow-up at 1, 6, and 12 months Signed informed consent for study participation For the HRQoL ancillary study, inclusion criteria: Related donors age greater than or equal to 5, eligible and consented to the primary trial by the above listed inclusion criteria Donors competent to answer psychological assessment questions by themselves, or if a child, should be able to respond to psychological assessment questions and have an appropriate proxy also able to complete the HRQoL proxy interview English speaking Access to a telephone Willing to participate in pre-donation, 1 month and 1 year follow-up interviews Signed informed consent for study participation in ancillary study Exclusion Criteria: Per institutional guidelines Donors providing unstimulated peripheral blood stem cells or lymphocytes For the HRQoL ancillary study, exclusion criteria: Children less than or equal to 4 years of age
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Related Donors<br>Related Hematopoietic Stem Cell Donors | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluation of BAL Procedure With Ambu aScope 3 Large in Patients in an ICU Setting

Study Overview
=================
Brief Summary
-----------------
An Investigation to determine the single-use scope's ability to suction secretion from the lungs to resolve the collapse of the lung.

Detailed Description
-----------------
The purpose of this investigation it to determine the single-use scope's ability to suction secretion from the lungs to resolve the collapse of the lung. The hypothesis is that aScope 3 Large is able to manage the secretion and thereby facilitating the resolution of secretion in the lung.

Official Title
-----------------
Evaluation of a Bronchoalveolar Lavage Procedure With a Flexible Disposable Bronchoscope, Ambu aScope 3 Large in Patients in an Intensive Care Unit Setting

Conditions
-----------------
Atelectasis, Bronchoscopy

Intervention / Treatment
-----------------
* Device: Bronchoscopic procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥18 years Clinical indication and eligible for a BAL procedure, as judged by the investigator Patients being admitted in the ICU at the investigational centre Provision of signed IC by subject, or subject's legal representative e.g. next of kin Exclusion Criteria: Patients where BAL treatment cannot be clinically justified, judged by the investigator ETT >7 mm and ≤8.5 mm in diameter Participating in other interventional clinical investigations or have previously participated in this investigation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: aScope 3 Large<br>Bronchoscopic procedure | Device: Bronchoscopic procedure<br>* Single-use flexible bronchoscope aScope 3 Large<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Oxygenation (PaO2/FiO2 Ratio) After a BAL Treatment | Resolution of atelectasis measured by improvement in oxygenation after a bronchoscopic procedure (bronchoalveolar lavage treatment). PaO2/FiO2 ratio will be compared between baseline and 4 hourst post the BAL procedure. | 4 hours after procedure |