linjc16/ctgov huggingface dataset:
A Preference Study Comparing Kristalose® and Liquid Lactulose

Study Overview
=================
Brief Summary
-----------------
This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.

Detailed Description
-----------------
This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.

Official Title
-----------------
A Preference Study Comparing Kristalose® and Liquid Lactulose in the Treatment of Constipation

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Drug: lactulose (Kristalose®)
* Drug: liquid lactulose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with recently diagnosed chronic constipation requiring treatment. Exclusion Criteria: Patients with galactosemia (galactose-sensitive diet). Patients less than 18 years of age. Patients currently on lactulose therapy. Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]) and agree to abide by the study restrictions.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Kristalose®, as prescribed, for 7 days. | Drug: lactulose (Kristalose®)<br>* Crystals to be dissolved in water and taken as prescribed.<br>* Other names: Kristalose®;|
| Experimental: 2<br>Liquid lactulose, as prescribed, for 7 days. | Drug: liquid lactulose<br>* Liquid to be taken as prescribed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
constipation, laxative, lactulose, Kristalose®
Telavancin Pediatric PK Study (Ages >3 Months to 17 Years)

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, open-label, single-dose pharmacokinetic (PK) study. Infants, children, and adolescents will receive a single 10 mg/kg dose of telavancin infused intravenously (IV) over 60 minutes

Official Title
-----------------
An Open-Label Study of the Pharmacokinetics of a Single Dose of Telavancin in Pediatric Subjects Aged 3 Months to 17 Years

Conditions
-----------------
Gram-Positive Bacterial Infections

Intervention / Treatment
-----------------
* Drug: Telavancin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is aged >3 months to 17 years (inclusive) and has a weight within the 3rd to 97th percentile (inclusive) for age and sex Subject requires or recently completed systemic antibiotic therapy for the treatment or prevention of a known or suspected bacterial infection Exclusion Criteria: Subject has an estimated creatinine clearance <50 mL/min/1.73 m2 (Schwartz equation) Subject has a history of allergies or hypersensitivities to glycopeptide antibiotics (e.g., vancomycin), telavancin, or the formulation excipients Subject has clinically relevant cardiac abnormality, in the opinion of the investigator Subject was treated with an investigational drug within 30 days or five half-lives, whichever is longer, before study entry

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telavancin<br>Telavancin 10 mg/kg IV administered over one hour one time. | Drug: Telavancin<br> <br> * Other names: TD-6424;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics- AUC (area under curve) |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics- Cmax |  | 24 hours | 
| Pharmacokinetics- Tmax |  | 24 hours | 
| Pharmacokinetics- t1/2 |  | 24 hours | 
| Pharmacokinetics- CLp (plasma clearance) |  | 24 hours | 
| AEs (adverse events) |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gram positive bacteria, Telavancin, VIBATIV, Pediatric, Pharmacokinetics
Human Milk Fortifier and Cytokine Profile

Study Overview
=================
Brief Summary
-----------------
This is a research study investigating if adding human milk fortifier to a preterm babies breast milk feedings affects the baby's immune system.

Detailed Description
-----------------
In very low birth weight (VLBW) infants and preterm infants human milk fortifier (HMF) is often added to breast milk feedings in order to add extra calories, vitamins, and minerals. It is well known that breast milk feedings are easier to digest and have immune benefits compared to formula feedings. Cytokines, marker of immune function, can be found in blood, stool, and breast milk. This study involves collection of blood and stool samples to monitor cytokines. The purpose of this study is to understand whether human milk fortifier alters infants' cytokines.

Official Title
-----------------
Alterations in the Cytokine Profile of Premature Infants After Human Milk Fortifier

Conditions
-----------------
Infant, Very Low Birth Weight

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants born weighing less than 1500 grams exclusive breast milk feedings with intention to fortify with human milk fortifier Exclusion Criteria: positive blood culture history of necrotizing enterocolitis significant lung disease at the start of the study

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

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 |
| --- | --- |
| 1<br>Very low birth weight and preterm infants who will likely receive fortification of breast milk with HMF | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine profile pre and post initiation of HMF |  | up to 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Very low birth weight infants, HMF, immune system function
Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism

Study Overview
=================
Brief Summary
-----------------
This is a clinical study comparing targeted levothyroxine dosing based on thyroid anatomy as visualized on ultrasound (normal vs. ectopic/sublingual vs. athyreosis) to empiric levothyroxine dosing in infants with congenital hypothyroidism. Patients enrolled in the study for targeted dosing will be compared to controls obtained by retrospective chart review. The main outcome is to determine if there is a difference in the frequency of over-treatment and under-treatment during the first 6 months of therapy.

Official Title
-----------------
Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism

Conditions
-----------------
Congenital Hypothyroidism

Intervention / Treatment
-----------------
* Drug: Levothyroxine
* Device: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborns diagnosed with congenital hypothyroidism (CH). Newborns with CH who are treated by a pediatric endocrinologist at Riley Hospital for Children or satellite location. Newborns with CH who have thyroid imaging performed (thyroid ultrasound or technetium scan) at diagnosis. Exclusion Criteria: Newborns who do not have CH. Newborns with CH who have not had thyroid imaging performed at diagnosis.

Ages Eligible for Study
-----------------
Maximum Age: 2 Weeks

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Targeted dosing<br>Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy on ultrasound as follows: 10 mcg/kg for normal gland, 12 mcg/kg for ectopic gland, 15 mcg/kg for athyreosis. | Drug: Levothyroxine<br>* Levothyroxine dose will be adjusted at the first clinic visit based on thyroid anatomy on ultrasound.<br>Device: Ultrasound<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose Adjustments | Thyroid labs (TSH and fT4/T4) will be monitored per standard care: 2 weeks after initiation of levothyroxine and once monthly during the first 6 months of treatment. The number of dose adjustments required per participant during the first 6 months of treatment were recorded. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adjustments Due to Overtreatment in Subjects With Athyreosis, Ectopic and Eutopic Thyroid Glands Compared With Controls | Whether the dose adjustment was made for overtreatment was noted as based on TSH and fT4/T4 results | 6 months |
Malnutrition Associated With Complications After Ileostomy Reversal

Study Overview
=================
Brief Summary
-----------------
An ileostomy is a surgical opening established by bringing the end or a loop of the ileum to discharge directly outside the body. This is typically done when part or the entire colon is removed because of IBD, cancer, or familial adenomatous polyposis. Reversal of this procedure, an ileostomy closure, may be done if possible. Ileostomy closure involves reconnecting the ileum to the remaining colon, allowing normal bowel movements again. This study will look at the outcomes of these surgeries in patients who were seen and operated on by the investigators.

Detailed Description
-----------------
This study focused on outcomes and complications after ileostomy closure. An ileostomy is a surgical opening established by bringing the end or a loop of the ileum to discharge directly outside the body. This is typically done when part or the entire colon is removed because of IBD, cancer, or familial adenomatous polyposis. Reversal of this procedure, an ileostomy closure, may be done if possible to reconnect the ileum to the remaining colon and allow normal bowel movements again. This study looked at the outcomes for these surgeries in patients who were seen and operated on by the investigators. Patients were identified from the files and schedules of the investigators, and Epic was used to collect the information needed to determine perioperative clinical characteristics and post-operative outcomes. This data was kept in a secure electronic database, with identifiers removed as soon as all of the data was collected for a patient.

Official Title
-----------------
Postoperative Complications in Patients With Inflammatory Bowel Disease: A Retrospective Cohort Study

Conditions
-----------------
Inflammatory Bowel Diseases, Ileostomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ileostomy closure procedure Exclusion Criteria: none
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 |
| --- | --- |
| Ileostomy Closure<br>Patients who have undergone an ileostomy closure procedure. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Complications | Number of any post operative complication | up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inflammatory bowel disease, ileostomy, ileostomy reversal, stoma reversal
Northern Survey on Therapeutic Oxygen Prescription

Study Overview
=================
Brief Summary
-----------------
This is a prospective multicenter observational trial. Included patients and attending physician complete a standardized questionnaire.

Official Title
-----------------
Northern Survey on Therapeutic Oxygen Prescription

Conditions
-----------------
Oxygen Toxicity

Intervention / Treatment
-----------------
* Other: 17 items questionaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic lung disease, age > 18 years Established domiciliary LTOT > 4 weeks Scheduled for control of oxygen therapy with arterial/capillary Exclusion Criteria: No informed consent Pulmonary exacerbation within the last 2 weeks Signs of heart failure (edema, congestion)

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

| Intervention/Treatment |
| --- |
|Other: 17 items questionaire|This is a prospective multicenter observational trial. Included patients and attending physician complete a standardised questionnaire.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of indication of Long-term Oxygen therapy (LTOT) | Aim of this study is to observe the real-world handling with longterm Oxygen treatment in northern Germany | 12 month |
Deep Brain Stimulation (DBS) Retrospective Outcomes Study

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to characterize real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of de-identified patient records.

Detailed Description
-----------------
The purpose of this study is to characterize 1. real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of de-identified patient records.

Official Title
-----------------
Deep Brain Stimulation (DBS) Retrospective Outcomes Study

Conditions
-----------------
Dystonia, Parkinson Disease, Essential Tremor

Intervention / Treatment
-----------------
* Device: Deep Brain Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be previously treated with or eligible for implantation with a deep brain stimulation system Exclusion Criteria: No Exclusion Criteria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parkinson's Disease<br>Subjects with Parkinson's disease, implanted with a Boston Scientific Deep Brain Stimulation System | Device: Deep Brain Stimulation<br>* Deep Brain Stimulation in patients with Parkinson Disease, Dystonia and Essential Tremor.<br>|
| Essential Tremor<br>Subjects with Essential Tremor, implanted with a Boston Scientific Deep Brain Stimulation System | Device: Deep Brain Stimulation<br>* Deep Brain Stimulation in patients with Parkinson Disease, Dystonia and Essential Tremor.<br>|
| Dystonia<br>Subjects with dystonia, implanted with a Boston Scientific Deep Brain Stimulation System | Device: Deep Brain Stimulation<br>* Deep Brain Stimulation in patients with Parkinson Disease, Dystonia and Essential Tremor.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS III) at up to 5 years post implant compared to baseline | Improvement in disease symptoms as assessed by Unified Parkinson's Disease Rating Scale (UPDRS III) at up to 5 years post implant compared to baseline | 5 yrs. post implant |
Clinical Studies of New Model Haploidentical Hematopoietic Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
Building a new haploid transplanted model with high-dose CTX、CD19-CART,donor CD34+ hematopoietic stem cell and Tregs,to prevent graft-versus-host disease(GVHD),reduce the infection,promote the rate of immune reconstruction，seperate graft versus leukemia（GVL）and GVHD，then to reduce the relapse rate after hematopoietic stem cell transplantation（HSCT）for relapsed and/or refractory B cell acute lymphoblastic leukemia（r/r-B-ALL）.

Detailed Description
-----------------
compare the new haplo-HSCT model with the traditional haplo-HSCT in DFS、OS、RFS、CR and the degree of GVHD.etc.for the r/r B-ALL patients.

Official Title
-----------------
Clinical Studies of New Model Haploidentical Hematopoietic Stem Cell Transplantation

Conditions
-----------------
CD19-chimeric Antigen Receptor T Cells, Relapsed and/or Refractory Acute Lymphoblastic Leukemia, the Haploidentical Hematopoietic Stem Cell Transplantation

Intervention / Treatment
-----------------
* Procedure: the new model of haplo-HSCT for r/r B-ALL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the r/r B-ALL patients have the healthy allo-HSCT donor voluntary and signed the treatment protocol Exclusion Criteria: not match the inclusion criteria important organ is dysfunction, such as heart and/or renal dysfunction,liver failure Pregnancy or breast-feeding women has virus infection,such as HIV,hepatitis virus,and can not be cleared with anti-virus treatment
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: new model of haplo-HSCT<br>use the new model of haplo-HSCT to treat the r/r B-ALL patients matching the inclusion criterion | Procedure: the new model of haplo-HSCT for r/r B-ALL<br>* take advantage of high-dose CTX、CD19-CART、donor CD34+HSC and Tregs to create a new model of haplo-HSCT for the patients in r/r B-ALL,to improve the quality of HSCT.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival at six months | the disease free survival of the new model haplo-HSCT will be assessed at 6 months. | six months | 
| acute graft-versus-host disease | we will examine the treatment-related acute GVHD at 3 months. | three months |
Stress Cardiac MRI in Ischemic Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the diagnostic accuracy of CMR feature-tracking (FT) at rest & during stress with low dose dobutamine (LDD) in the evaluation of viability in ischemic cardiomyopathy (ICM) patients and compare it with delayed gadolinium enhancement (DGE).

Official Title
-----------------
Assessment of Myocardial Viability by Cardiac Magnetic Resonance Feature Tracking at Rest and During Stress by Low Dose Dobutamine

Conditions
-----------------
Ischemic Cardiomyopathy

Intervention / Treatment
-----------------
* Diagnostic Test: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients recruited into the study have chronic LV systolic dysfunction due to coronary artery disease (CAD) Exclusion Criteria: All patients with a contraindication to MR study: Patients with implanted non-MRI compatible electronic devices (e.g. Cardiac pacemakers, intracranial metallic clips, implanted hearing aids, etc.) Patients with foreign bodies in the eye. Claustrophobic patients. Patients diagnosed with recent acute coronary syndrome within 4 weeks. Patients who had contraindications for MRI or contrast agents, and those with poor image quality due to either inadequate breath holding or arrhythmias

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: MRI|the patients will underwent dobutamine stress cardiac MRI|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of myocardial strain with late gadolinium enhancement | analysis of the myocardial strain by low dose dobutamine and test if it can assess myocardial viability | Baseline |