linjc16/ctgov huggingface dataset:
Intravenous Iron May Increase Depression Among Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
the aim of this study is to assess whether increased ferritin after intravenous iron therapy will lead to increased prevalence of major depression among treated patients.

Official Title
-----------------
Intravenous Iron May Increase Depression Among Hemodialysis Patients

Conditions
-----------------
Depression, Hemodialysis Complication, Iron Deficiency Anemia

Intervention / Treatment
-----------------
* Other: Intravenous iron therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age was above 19 years, patient on maintenance hemodialysis, patient had iron deficiency anemia (ferritin > 100 ng/ml) Exclusion Criteria: patient has history of depression or already using antidepressant medication, Lack of ferritin level increase ≥ 50% from baseline level before IV iron administration, patient already on oral or intravenous iron supplement

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Intravenous iron therapy|each patient with iron def anemia received an IV syringe of iron sucrose 100 mg every dialysis session for 10 doses|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient health questionnaire-9 score | change in patient health questionnaire-9 score before and after intravenous iron therapy | on day 0 of start of intravenous iron and 1 week after completion of intravenous iron |
Prediction of Preeclampsia & Other Obstetric Complications by Serum Homocysteine & Doppler

Study Overview
=================
Brief Summary
-----------------
Second trimester homocysteine & uterine artery doppler will be assessed& the cases will be followed up till delivery for development of preeclampsia, IUGR(intra-uterine growth retardation) & other obstetric complications.

Detailed Description
-----------------
Spontaneous pregnancies with no risk factors will be included. Fasting plasma total homocysteine level samples will be collected between 15th & 19th weeks. Uterine artery doppler between 18th & 22nd weeks. Method 1: Screen positive cases will be considered if homocysteine level above 6.3umol/l Method 2: Screen positive cases will be considered if they had bilateral notches and a mean resistivity index (RI) above 0.55, or unilateral notches and a mean RI above 0.65, or absence of notches and a mean RI above 0.7. Method 3: Screen positive cases will be considered if they had bilateral notches and a mean RI above 0.55, or unilateral notches and a mean RI above 0.65, or absence of notches and a mean RI above 0.7 combined with homocysteine cut off value of 6.3umol / l.

Official Title
-----------------
Second Trimester Maternal Serum Homocysteine Level & Uterine Artery Doppler for Prediction of Preeclampsia , Intra-Uterine Growth Retardation (IUGR) & Other Obstetric Complications

Conditions
-----------------
Preeclampsia, IUGR

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: spontaneous pregnancies with no risk factors Exclusion Criteria: multiple pregnancies non intact renal function hypertension diabetes folic acid supplements antifolate drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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 |
| --- | --- | --- |
| Number of pregnants who developed preeclampsia, those who developed IUGR alone and those who developed other obstetric complications as preterm labour and placental abruption |  | 4 months |
Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and effectiveness of the CLES in enabling evaluation of potential donor lungs not otherwise used for transplant into subjects with end stage, survival-limiting lung disease in need of lung transplantation. This will be accomplished by evaluating subject survival at the later of 6 months or hospital discharge post-transplant.

Official Title
-----------------
Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility

Conditions
-----------------
Lung Diseases

Intervention / Treatment
-----------------
* Device: Centralized Lung Evaluation System
* Procedure: Lung Transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female; Aged 18 years or older; Informed consent is given for participation in the Study by the patient or patient's designated representative; and Patient undergoes lung transplantation. Exclusion Criteria: Patients listed for same-side lung re-transplantation. Patients listed for multiple organ transplantation including lung and any other organ. Patients listed for live donor lobar lung transplant. Patients positive for human immunodeficiency virus (HIV) or Burkholderia cenocepacia infection. Patient receives a standard of care (non-EVLP) lung transplant but does not match to an EVLP subject based on the criteria for control matching. Participating in another interventional trial

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EVLP<br> | Device: Centralized Lung Evaluation System<br>* Assessment of allograft lung for transplant suitability<br>Procedure: Lung Transplant<br>* Orthotopic single or double lung transplantation.<br>|
| Active Comparator: Control<br> | Procedure: Lung Transplant<br>* Orthotopic single or double lung transplantation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12 month survival |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
organ perfusion, centralized lung evaluation system, united therapeutics, EVLP, ex vivo lung perfusion, CLES
Signature of the Host Response to a Respiratory Viral Infection, in the Prediction of Bronchiolitis Obliterans

Study Overview
=================
Brief Summary
-----------------
Bronchiolitis obliterans (BO) is the well-known manifestation of the chronic pulmonary graft-versus-host disease(GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT). The pathophysiology of BO is, however, poorly known. The available data strongly support the role of respiratory viruses, in particular paramyxoviruses (parainfluenzae virus (PIV), respiratory syncytial virus, metapneumovirus). It is likely that the alloimmune response triggered by the respiratory virus is inadequate and leads to the peribronchiolar fibrotic process. The objective is to analyze the kinetics of profiles of the blood and respiratory host responses resulting from a high or low parainfluenza respiratory infection, in order to evaluate if the occurrence of a BO is associated with a specific signature We will evaluate the predictive signature of a BO after a parainfluenza virus infection by characterizing the differences between the patients evolving and those not evolving to a BO at 2 months after the infection.

Official Title
-----------------
Signature of the Host Response to a Respiratory Viral Infection, in the Prediction of Bronchiolitis Obliterans

Conditions
-----------------
Allogeneic Hematopoietic Stem Cell Recipients, Acute Respiratory Infection, Parainfluenza Virus (PIV)

Intervention / Treatment
-----------------
* Other: samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult recipients of allogeneic HSCT Pulmonary infection with PIV Exclusion Criteria: No health care insurance

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 |
| --- | --- |
| Cases<br>eligible patients with 10% decline in Forced Expiratory Volume (FEV1) at 2 months | Other: samples<br>* blood sample nasal swab<br>|
| Controls<br>eligible patients free of 10% FEV1 decline at 2 months | Other: samples<br>* blood sample nasal swab<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Host response transcriptomic signature in both blood and respiratory tract after PIV infection |  | at the time of BO, through study completion, an average of 1 year |
The Quality Of Life Of Cerebral Palsy Child Carers

Study Overview
=================
Brief Summary
-----------------
Cerebral Palsy (CP) is characterized by a sensory-motor deficiency, involving disturbance of muscle tone, posture and voluntary movement. Children who are afflicted need special intense care for their carers

Detailed Description
-----------------
INTRODUCTION: Cerebral Palsy (CP) is characterized by a sensory-motor deficiency, involving disturbance of muscle tone, posture and voluntary movement. Children who are afflicted need special intense care for their carers. OBJECTIVE: The objective of this study was to analyze the quality of life of CP child carers attended in the physiotherapy sector of a philanthropic institution on Maceió - AL. METHODS: 62 carers were assessed in the period from the 18th to the 29th of February 2008, in which 96.7% were female carers and 3.7% male. The form for the collection of data from the carers, elaborated by the researchers and the WHOQOL-26 quality of life questionnaire were utilized as as instruments.

Official Title
-----------------
Evaluation of the Quality of Life of Cerebral Palsy Child Carers

Conditions
-----------------
Cerebral Palsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children who were attended by Associação dos Pais e Amigos dos Excepcionais (APAE), Maceió, Alagoas They had cerebral palsy Exclusion Criteria: Child who had not cerebral palsy Child under 2 years old

Ages Eligible for Study
-----------------
Minimum Age: 2 Years


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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cerebral Palsy<br>Those kids who have cerebral palsy and are helped by carers | |

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
-----------------
Cerebral Palsy, Caregivers, Quality of Life
Expanded Access to Burosumab

Study Overview
=================
Brief Summary
-----------------
Individual patient expanded access requests may be considered for patients who have no other treatment options

Detailed Description
-----------------
Expanded access may be available outside of the US in countries prior to approval by the local regulatory agencies. For full details, please visit the links provided below.

Conditions
-----------------
X-linked Hypophosphatemia, Tumor-Induced Osteomalacia

Intervention / Treatment
-----------------
* Biological: Burosumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Burosumab|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
-----------------
Expanded Access, Compassionate Use, XLH, TIO
Twenty-Four Hour Combined Multi-Channel Impedance and pH Ambulatory Monitoring: Impedance Reflux Episodes of Patients On and Off Proton Pump Inhibitor Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of proton pump inhibitors (PPIs) on the total number of reflux episodes in the distal esophagus measured by impedance in patients with and without gastroesophageal reflux disease (GERD) based on 24-hour pH testing. In addition to changing the acidity of the refluxate, the investigators hypothesize that PPIs also reduce the total number of reflux episodes due to its anti-secretory effects.

Official Title
-----------------
Twenty-Four Hour Combined Multi-Channel Impedance and pH Ambulatory Monitoring: Impedance Reflux Episodes of Patients On and Off Proton Pump Inhibitor Therapy

Conditions
-----------------
GERD

Intervention / Treatment
-----------------
* Drug: Esomeprazole
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adults patients (age 18 or older) with reflux symptoms willing to participate Exclusion Criteria: Pregnancy Prior esophageal or gastric surgery Achalasia Scleroderma Gastroparesis.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo arm<br>Patients will be randomized to receive either PPI or placebo and then undergo a 24 hour pH study with impedance to measure the number of reflux episodes | Drug: placebo<br> <br> |
| Active Comparator: Esomeprazole<br>Patients were randomly assigned to receive 40 mg esomeprazole twice daily prior to undergoing a 24 hour pH study with impedance to measure the number of reflux episodes | Drug: Esomeprazole<br> <br> * Other names: Nexium;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Impedance Episodes Following PPI and Placebo | Impedance is defined as a 50% decrease from baseline in retrograde movement of liquid from the stomach to the esophagus. In other words, it measures the number of retrograde reflux episodes. | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
impedance, reflux, GERD
Antibodies and Immunity After Vaccination of Recovered Patients With COVID-19 and Long COVID-19 Symptoms

Study Overview
=================
Brief Summary
-----------------
We investigated the association between immune system responsibilities in Long COVID patients and Full recovery patients.

Detailed Description
-----------------
This retrospective cohort study compared immunogenicity post COVID-19 between individuals (aged 18-65 years and had confirmed SARS-CoV-2 infection from January to May 2022 ) with residual Long COVID-19 symptoms (LC) and ones with full recovery (Full) related to pathophysiology, immunology and clinical consequence.

Official Title
-----------------
SARS-CoV-2 Neutralizing Antibodies and Immunity After Vaccination of Recovered Patients With COVID-19 and Correlation With Immunity and Long-COVID-19 Symptoms

Conditions
-----------------
Long COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Long COVID group; at longer than 1-month post COVID-19 based the presence of one of the three following symptoms: fatigue/myalgia, breathlessness, and anorexia Full recovery group; patients with asymptomatic symptoms post COVID-19 they had not received any additional COVID vaccine Exclusion Criteria: people who received additional vaccination after leaving quarantine before the day of the immunization test pregnant patients, people who had a history of allergic reactions after COVID-19 vaccination or any drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Anti-SARS-CoV-2 RBD IgG | anti-SARS-CoV-2 receptor-binding domain immunoglobulin G(BAU/mL) | Baseline | 
| Anti-SARS-CoV-2 NP | surrogate Virus Neutralization Test (sVNT) (PRNT50 titer) | Baseline | 
| Microneutralization assays | Microneutralization assays using the authentic SARS-CoV-2 viruses | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of vaccine injection | Number of vaccine injection | Baseline | 
| Prevalence of Long COVID-19 symptoms | Number of participants with major Long COVID-19 symptoms including fatigue/myalgia, breathlessness, and anorexia by using the questionnaire | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Long COVID-19, antibody responsibility, immunogenicity
Preventive Medicine Study of Childhood Atopic Diseases

Study Overview
=================
Brief Summary
-----------------
Under environmental intervention programs, to explore the associations between Environmental Tobacco Smoke (ETS) and changes of pulmonary function, cytokines and new-onset asthma between different groups.

Detailed Description
-----------------
Environmental intervention programs: We will both interview by telephone and mail the health education leaflets, in order to achieve the following aims: -Smokers living with the children will change where smoking takes place for reducing the children's ETS exposure. Data collection: We will contact participants individually to get informed consent before data collection. No matter what intervention, non-intervention or reference group, all participants will test as follows: Blood sample collection: We will test the total IgE, specific IgE, cytokines, such as IL-4, IL-13, TNF-α, ECP and EOS. Questionnaire collection Pulmonary function test After intervention programs applied, all participants will test pulmonary function, and total IgE, specific IgE and cytokines by blood sample after six months by school approaches. Then, we can compare the pulmonary function, total IgE, specific IgE and cytokines before and after intervention programs.

Official Title
-----------------
Preventive Medicine Study of Childhood Atopic Diseases

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Behavioral: Health promotion and health education for smoking habits


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only one smokers living in the same household Having smoking exposure during the past 12 months while questionnaire surveying Child without smoking habit Exclusion Criteria: None of above
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Health promotion and health education for smoking habits|We provide the education to intervention group.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urine cotinine level |  | six months, one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, educational intervention, Environmental Tobacco Smoke(ETS), children
Associations Between Periodontitis and Autoimmune Antibodies in Rheumatoid Arthritis Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this case control study is to explore the possible association between periodontal destruction and serum anti-CCP antibodies in RA patients and healthy subjects.

Detailed Description
-----------------
In patients with RA, the anti-CCP antibody titer seems positively correlated to their periodontal destruction and disease activity in comparison with healthy subjects.

Official Title
-----------------
Associations Between Periodontitis and Autoimmune Antibodies in Rheumatoid Arthritis Disease

Conditions
-----------------
Periodontitis, Rheumatoid Arthritis, Autoimmunity,

Participation Criteria
=================

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Serum level of anti-cyclic citrullinated peptide/protein antibody | Lower then 7 Unit/milliliter: negative 7-10 Unit/milliliter: weak positive Higher then 10 Unit/milliliter: positive | Base line | 
| Periodontal pocket depth and clinical attachment level | Lower then 4 millimeter: normal Higher then 4 millimeter: diseased/previously diseased | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum level of tumor necrotic factor alpha | Recorded in picogram per milliliter | Baseline | 
| Serum level of anti-mutated citrullinated vimentin | Recorded in Unit per milliliter | Baseline | 
| Serum level of interleukin 6 | Recorded in picogram per milliliter | Baseline | 
| Serum level of interleukin 17 | Recorded in picogram per milliliter | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dentistry