linjc16/ctgov huggingface dataset:
Impact of Nutritional Status on Clinical Outcome in PICU

Study Overview
=================
Brief Summary
-----------------
Malnutrition is believed to be associated with clinical outcomes in ill patients and several studies have shown that nutrition status play a major role in disease prognosis in adults . Different authors have described an increase in morbidity and mortality attributable to malnutrition, as it lead to state of partial immunosuppression, delay wound healing ,causes muscular atrophy and increase length of stay.

Detailed Description
-----------------
Several studies have investigated the predictive role of an extremely low body weight on disease prognosis and outcomes among general and critically ill children .They enrolled all patients consecutively admitted to pediatric intensive care unit PICU) , therefore , being underweight may have resulted from endocrine diseases, genetic syndromes or other systemic underlying illnesses . The impact of low body weight on outcomes of acutely critically ill but previously healthy children is still unknown. Many studies evaluate the clinical status and outcome by pediatric index of mortality (PIM2) as a popular and reliable predictive score . In this study, we will investigate the impact of being underweight or proper weight on mortality and morbidity among acute critically ill children with no genetic, endocrine, or chronic systemic illness at PICU admission

Official Title
-----------------
the Impact of Nutritional Status on Clinical Outcome of Children Admitted in PICU OF Assuit Children University Hospital

Conditions
-----------------
Nutritional Disorder

Intervention / Treatment
-----------------
* Other: nutritional status


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children admitted to PICU with nutritional disorders Children with acute diseases and anthropometric measurements taken within first 24hours Exclusion Criteria: 1-children with underlying chronic diseases (eg cerebral palsy ,type 1 or 2 diabetes , epilepsy, metabolic diseases, inflammatory bowel disease , liver cirrhosis , immunodeficiency , autoimmune disordes , malignancy , chronic kidney disease) and postoperative patients.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 18 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: nutritional status|impact of nutritional status on clinical outcome of children admitted in PICU|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the correlation between nutritional status of children admitted in PICU and outcomes | nutritional status measured by weight in kilograms and height in meters will be combined to report BMI for Z scoreand outcomes measured by pediatric index of mortality2 (PIM2) | 2 years |
The Effect of Metformin Treatment on Thyroid Hormone Metabolism in Euthyroid Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Aim: To investigate the effects of metformin treatment on thyroid hormone metabolism in euthyroid patients with type 2 diabetes mellitus.

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

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients included in this study were the ones who were newly diagnosed with type 2 diabetes mellitus Exclusion Criteria: Presence of thyroid disorders, positive thyroid autoantibodies and usage of medications affecting thyroid hormones such as amiodarone, lithium were accepted as exclusion criterions

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 78 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Metformin|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
-----------------
The purpose of study was investigated the effect of, metformin on thyroid hormone metabolism in euthyroid patients, with type 2 DM. The results revealed significant decreases, in TSH and fT4
A Study of Recormon (Epoetin Beta) in Anemic Patients With Non-Myeloid Malignancy

Study Overview
=================
Brief Summary
-----------------
This study will examine the efficacy, safety, and effect on hemoglobin levels, of once weekly epoetin beta subcutaneous injections (30,000 International Units [IU]) in anemic patients with solid tumors. The anticipated study duration is 4 months, and the target sample size is 40 individuals.

Official Title
-----------------
Open Multicentric Study to Assess the Hematopoyetic Response in Terms of Increase of Hemoglobin Levels, of Patients With Anemia Reklated to Malignant Tumors, Treated With Erythropoietin B (Recormon) Using the Pre-Filled Syringe With 30,000 IU, as Well as to Quantify Teh Risk Factors of Anemia and Its Impact on Quality of Life Related to Treatment

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: Epoetin Beta


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with a non-myeloid malignancy Anemia Exclusion Criteria: Transfusion of red blood cells within 2 months of study drug Treatment-resistant hypertension Acute or chronic bleeding (requiring therapy) within 3 months of study drug

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epoetin Beta 30000 IU<br>Dosage at Initiation: Subcutaneous injection of 30000 IU epoetin beta administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks. | Drug: Epoetin Beta<br>* Dosage at Initiation: Subcutaneous injection of 30000 IU administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks if a blood transfusion was required or hemoglobin level did not increase by at least 0.5 grams per deciliter (g/dL) versus baseline.<br>* Other names: Recormon;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin Levels at 16 Weeks |  | 16 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Iron Levels |  | 16 Weeks | 
| Quality of Life According to Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument |  | Up to 4 months | 
| Tolerability - Incidence of Adverse Events |  | Up to 4 months | 
| Serum Transferrin Levels |  | 16 Weeks | 
| Percentage of Participants With A Positive Response |  | 16 Weeks | 
| Time To Global Response |  | Up to 4 months | 
| Quality of Life In Relation to Anemia Grade |  | Up to 4 months | 
| Serum Ferritin Levels |  | 16 Weeks |
Fetal Growth Pattern in Short Stature Women

Study Overview
=================
Brief Summary
-----------------
Women of short stature tend to be classified regarding fetal growth by the same criteria as women of normal and tall stature. The objective of the following study is to evaluate fetal growth patterns parallel to women's height and try to make conclusions regarding possible definitions of subjective Intra-uterine growth restriction.

Detailed Description
-----------------
Based on a patient registry, women of short stature tend to be classified regarding fetal growth by the same criteria as women of normal and tall stature. The objective of the following study is to evaluate fetal growth patterns parallel to women's height and try to make conclusions regarding possible definitions of subjective Intra-uterine growth restriction. Informed consent is not required due to the retrospective nature of the study. Patient information including medical, obstetric and general background will be collected.

Official Title
-----------------
Fetal Growth Pattern in Short Stature Women as a Model for True Intrauterine Growth Restriction Prediction.

Conditions
-----------------
Intrauterine Growth Restriction

Intervention / Treatment
-----------------
* Other: Analysis of a patient registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women under 1.6 meters of height. Singleton pregnancy. Low risk pregnancy. Accurate dating. Exclusion Criteria: Women over 1.6 meters of height. Multiple pregnancy. High risk pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Women of short stature<br>Women that are under 1.6 meters. | Other: Analysis of a patient registry<br>* Analysis of a patient registry.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated fetal weight changes. | Changes in estimated fetal weight during pregnancy. | Up to 1 year from admission. |
Immunoblotting and Goldmann-Witmer Coefficient for Ocular Toxoplasmosis

Study Overview
=================
Brief Summary
-----------------
Ocular toxoplasmosis (OT) is a common cause of posterior uveitis worldwide. The diagnosis of OT is based on clinical findings, but in most cases, laboratory tests are required to confirm the etiology, especially when other diseases are suspected. The aim of this study was to evaluate which methods, between the Goldmann-Witmer coefficient (GWC) and immunoblotting (IB) with both IgG and IgA, in aqueous humour (AH) samples, can be the most sensitive to diagnose OT, in current practice, especially in the first three weeks.

Detailed Description
-----------------
Goldmann-Witmer coefficient (GWC): compares the levels of intraocular antibody (igG) production to that serum, as measured by ELISA. GWC = (Level of specific IgG in aqueous humour/level of specific IgG in serum)/(Total IgG in aqueous humour/Total IgG in serum) 0.5 to 2: No intraocular antibody production, 2 to 4: Suggestive of intraocular antibody production, > 4: Diagnostic of intraocular antibody production to a specific microbial pathogen

Official Title
-----------------
Comparison of Immunoblotting (IgA and IgG) and the Goldmann-Witmer Coefficient for Diagnosis of Ocular Toxoplasmosis in Immunocompetent Patients

Conditions
-----------------
Ocular Toxoplasmosis

Intervention / Treatment
-----------------
* Procedure: Aqueous humour sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had underwent aqueous humor and serum sample for ocular toxoplasmosis diagnosis Exclusion Criteria: Immunocompromised patients
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 Ocular Toxoplasmosis<br> | Procedure: Aqueous humour sampling<br>* Aqueous humour sampling with Goldman-Witmer coefficient and immunoblotting<br>|
| Patients without Ocular Toxoplasmosis<br> | Procedure: Aqueous humour sampling<br>* Aqueous humour sampling with Goldman-Witmer coefficient and immunoblotting<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Goldmann-Witmer coefficient and immunoblotting results | All tests realized in patients were performed before their repartition in the two groups as well as the biologist could not know the status of the patient. Sensitivity and specificity were calculated for each test. | Assessment of each test result at the inclusion of the patient |
Probiotics in IgA Nephropathy

Study Overview
=================
Brief Summary
-----------------
Recent studies have shown an increased gastrointestinal reactivity and increased intestinal permeability in IgA nephropathy (IgAN). Probiotic supplementation is known to impact the gastrointestinal immune system possibly by improvement of both the immunologic and the non-immunologic intestinal barrier. Probiotic supplementation should thus theoretically have an effect on IgAN. In this study the investigators will study the efficacy and safety of Lactobacillus reuteri.

Official Title
-----------------
Proof-of-concept Study of Efficacy and Safety of Dietary Supplementation With Probiotics in IgAN Patients

Conditions
-----------------
IgA Nephropathy

Intervention / Treatment
-----------------
* Dietary Supplement: ProTectis
* Dietary Supplement: Gastrus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Above 18 years Primary IgAN, verified by biopsy Albuminuria > 0.75 g/24 h (verified by at least four sample results within a two years period prior to inclusion) Serum creatinine less than 200 umol/L (verified by at least four sample results within a two years period prior to inclusion) Having signed informed consent form Exclusion Criteria: Participation in another clinical intervention trial Patients with celiac disease Patients with secondary IgAN Creatinine clearance below 30 ml/min (mean of 3 measurements) Introduction of an ACE inhibitor or angiotensin II receptor blocker during the last three months prior to inclusion Patients treated with immunosuppressive or systemic corticosteroid drugs within the last twelve months Patients using probiotic products within the last three months (includes probiotic milk products) Known allergy or intolerance to any of the ingredients in the probiotic product

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ProTectis<br> | Dietary Supplement: ProTectis<br> <br> |
| Experimental: Gastrus<br> | Dietary Supplement: Gastrus<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in albuminuria |  | Baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in renal function |  | Baseline and 3 months | 
| Change in IgA/IgG immune complexes |  | Baseline and 3 months | 
| Change in hematuria |  | Baseline and 3 months | 
| Change in immunological markers in blood |  | Baseline and 3 months | 
| Change in IBS (irritable bowel syndrome) symptoms |  | Baseline and 3 months |
Gentamicin in Preventing Post Endoscopic Retrograde Cholangiopancreatography (ERCP) Cholangitis in Non-calculus Stenting

Study Overview
=================
Brief Summary
-----------------
Cholangitis is the most prevalent infectious complication of ERCP. Stenting of biliary strictures and stenosis is one of important risk factors for post-ERCP cholangitis. Adding antibiotics to contrast media has proposed in some studies for prevention of cholangitis but remains controversial. In this study we compare effect of adding gentamicin versus placebo in preventing cholangitis in patients who undergone endoscopic stenting for non-calculus strictures and stenosis.

Official Title
-----------------
Comparing Addition of Gentamicin vs. Placebo in Preventing Post ERCP Cholangitis in Non-calculus Stenting

Conditions
-----------------
Cholangitis

Intervention / Treatment
-----------------
* Drug: gentamicin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with non-calculus biliary obstruction who need palliative treatment Exclusion Criteria: Fever (> 37.8 Celsius) Leukocytosis (WBC > 10,000 /mm3) Not candidate for surgical cure of obstruction
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: gentamicin<br>adding 10mg gentamicin to every 10 ml of contrast media | Drug: gentamicin<br>* 10mg per 10ml of contrast media<br>* Other names: Brand name: Gentamicin;|
| Placebo Comparator: Placebo<br>Identical placebo | Drug: gentamicin<br>* 10mg per 10ml of contrast media<br>* Other names: Brand name: Gentamicin;Drug: Placebo<br>* Distilled water<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Cholangitis | After Endoscopic Retrograde CholangioPancreatography (ERCP) in 3 following days we check all participants for syptoms of cholangitis (fever, chills, right upper qudrant (RUQ) pain, leukocytosis) and ruling out other diagnoses than cholangitis | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholangitis; Cholangiopancreatography, Endoscopic Retrograde; stents; cholestasis
Safety, Tolerability, and Pharmacodynamic Profile of Oral 2101 in Secondary Raynaud's Disease

Study Overview
=================
Brief Summary
-----------------
To investigate the severity of secondary Raynaud's disease-related attacks during the 14 days 2101 dosing period.

Detailed Description
-----------------
Number and cumulative duration of Raynaud's attacks. Adverse events and changes in vital signs. SLx-2101 pharmacokinetic parameters derived after dosing on Day 1 and Day maximum plasma concentration (Cmax), area under the plasma concentration-time curve (AUC0-4), time to Cmax (tmax), and accumulation ratio

Official Title
-----------------
A Randomized, Double Blind, Placebo-controlled, Cross-over Pilot Study to Examine the Safety, Tolerability and Pharmacodynamic Profile of Repeat Oral Doses of SLx-2101 Once Daily for up to 14 Days in Subjects With Secondary Raynaud's Disease.

Conditions
-----------------
Raynaud's Disease

Intervention / Treatment
-----------------
* Drug: SLx-2101
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male and female ages 18 and 65 y.o. BMI Body weight within a body mass index range of 17 - 30 kg/m2 (inclusive). Exclusion Criteria: Hypersensitivity to the active substance of SLx-2101or to any of the excipients. Past or present disease that is judged by the Investigator to have the potential to interfere with the study procedures, compromise safety, or affect the pharmacokinetic and pharmacodynamic evaluations

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>SLx-2101 | Drug: SLx-2101<br> <br> |
| Placebo Comparator: 2<br>Matching Placebo Dose | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Raynaud's condition scores after 14 days of SLx-2101 |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  | 14 days |
Osteogenesis and Dental Eruption Through Electrical Stimuli

Study Overview
=================
Brief Summary
-----------------
The closure of the alveolar cleft as part of cleft lip and palate deformities is a procedure that, to this date, still demands great efforts from plastic surgeons. The feasibility of periosteoplasty for reconstruction of the alveolar arcade as well as the use of electrical stimulation in order to increase osteoneogenesis have been proven in the past. The present study attempts to combine both procedures that have only been reported separately worldwide. The objective of this study is to increase the osteogenic capacity and hence, dental eruption.

Official Title
-----------------
Osteogenesis and Dental Eruption Through Electrical Stimuli Following Periosteoplasty for Alveolar Clefts in Patients With Cleft Lip and Palate Deformities. A Preliminary Report.

Conditions
-----------------
Cleft Lip

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with unilateral cleft lip and palate deformities and alveolar defects Exclusion Criteria: Patients without alveolar cleft Patients with syndromes that did not require periosteoplastic procedures as well as patients with systemic illnesses that may affect the result of the study (for instance diabetes)
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteogenesis [G07.700.320.500.325.377.625.100.729], Tooth Eruption [G10.549.235.726]