linjc16/ctgov huggingface dataset:
Follow-Up Study of Mesenchymal Stem Cells for Bronchopulmonary Dysplasia

Study Overview
=================
Brief Summary
-----------------
This is a follow-up study to investigate the long-term safety and efficacy of human umbilical cord -derived mesenchymal stem cells (hUC-MSCs), for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the PhaseⅠtrial (NCT03558334 ) will be followed-up until 48 months after the hUC-MSCs transplantation.

Detailed Description
-----------------
Subjects who completed the initial stage of the PhaseⅠclinical trial will be followed-up at 5 additional visits: 1, 3, 6, 12 and 24 months after the hUC-MSCs transplantation.

Official Title
-----------------
Follow-Up Study of Safety and Efficacy of Mesenchymal Stem Cells in Preterm Infants With Moderate or Severe Bronchopulmonary Dysplasia

Conditions
-----------------
Bronchopulmonary Dysplasia

Intervention / Treatment
-----------------
* Drug: transplantation of hUC-MSCs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject who completed the safety and efficacy evaluations in hUC-MSCs PhaseⅠ clinical trial Subject with a written consent form signed by a legal representative or a parent Exclusion Criteria: Subject whose parent or legal representative does not agree to participate in the study subject who is considered inappropriate to participate the study by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 5 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 |
| --- | --- |
| Experimental: Mesenchymal Stem Cell<br>A single intravenous transplantation of Mesenchymal Stem Cell (Dose A - 1 million cells per kg, Dose B - 5 million cells per kg) | Drug: transplantation of hUC-MSCs<br>* Human umbilical cord-derived mesenchymal stem cells had given to preterm infants through intravenous infusion.<br>* Other names: intravenous infusion of hUC-MSCs;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission rate |  | within two years | 
| Duration of the hospital stay due to respiratory infection |  | within two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Survival |  | within two years | 
| Incidence of Tumorigenicity |  | within two years | 
| Growth measured by Z-score |  | within two years | 
| Number of neurological developmental delay |  | within two years | 
| Number of blindness and deafness |  | within two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchopulmonary Dysplasia, human umbilical cord -derived mesenchymal stem cells
Safety and Effect of Low-Energy Extracorporeal Shockwave Therapy (ESWT) on the Renal Allograft in Transplant Recipients.

Study Overview
=================
Brief Summary
-----------------
The aim is to investigate the safety and potential effect of Low-energy Shockwave Therapy (ESWT) on the transplanted kidney. The treatment consist of ESWT two times a week for three weeks, six treatments in total. The hypothesis is that ESWT with improve the renal function, by reducing proteinuria (in a 24-hour urine collection test) and improving renal clearance of 51Cr-EDTA. The safety of ESWT on the renal allograft will be assessed during and after treatments.

Official Title
-----------------
Safety and Effect of Low-Energy Extracorporeal Shockwave Therapy (ESWT) on the Renal Allograft in Transplant Recipients - a Pilot Study.

Conditions
-----------------
Transplant Dysfunction

Intervention / Treatment
-----------------
* Device: Extracorporeal Shockwave Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum 1 year ago since last kidney transplant P-Creatinin under 300, in the last 3 blood-samples U-Albumine/creatinine ratio over 100, in the last 3 urine-samples Exclusion Criteria: Not Danish speaking. Obstructive uropathy Suspected autoimmune disease in the kidney graft Symptomatic urinal tract infection (UTI) Severe psychiatric disorder Pregnant or planning on becoming pregnant

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 |
| --- | --- |
| Experimental: Active treatment<br> | Device: Extracorporeal Shockwave Therapy<br>* 2 treatments a week for 3 weeks consisting of 3000 focused shockwaves of 4Hz and 0,20mJ/mm2 applied over the kidney allograft. Treatment is performed using the STORZ DUOLITH® SD1 T-TOP F-SW ultra<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in renal clearance (GFR) | Comparing GFR before and 3 months after treatment sessions | At baseline and 3 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in albumin/creatine ratio in 24hour urine sample | Comparing the results from a sample of 24-hour urine sample before, 1 month after and 3 months after treatment. | At baseline, 1 month after treatment and 3 months after treatment | 
| Incidens of treatment-related adverse events | The participants answer questions about side-effects before and after each treatment session, at 1 month followup and 3 month followup. After 1 month a ultrasound of the kidney will show if there is any bleeding in the graft-tissue after the 6 treatments. | up to 4 months |
Predictors of Individual Training Effectiveness in Preventive Exercise

Study Overview
=================
Brief Summary
-----------------
Physical exercise elicits beneficial changes in the body. These concern physical performance but also improvements in virtually all known risk factors for cardiovascular disease. Yet, the extent of individual benefit differs considerably even within homogenous groups and the prediction of individual training effectiveness is not yet possible. This study aims to find predictors of individual training effectiveness.

Official Title
-----------------
Pilot Study to Find Predictors of Individual Training Effectiveness in Preventive Exercise

Conditions
-----------------
Primary Prevention

Intervention / Treatment
-----------------
* Behavioral: Endurance training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects age 35-60 Exclusion Criteria: Any medical condition requiring medication (except thyroid hormones) Other complaints that might interfere with exercise

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training<br>One month of endurance training (running / walking at 60 % heart rate reserve for 45 min 4 times per week) | Behavioral: Endurance training<br>* running / walking at 60 % heart rate reserve 4 times per week for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation of possible predictors with training effects on cardiovascular risk factors |  | within study periode | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of possible predictors with improvements in physical performance |  | within study period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, healthy subjects
The Bottle Study: Infant Weight Gain During Use of Novel Versus Typical Infant Feeding Bottles

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to pilot test whether a novel infant feeding bottle changes how much formula an infant drinks and how quickly he/she drinks it, as compared to meals provided in a standard bottle. Exclusively formula-fed infants and their caregiver will be provided with the novel feeding bottle and caregivers will be asked to acclimate their infant to this bottle during the next several weeks. Once acclimated, infants will undergo two weighed, timed, and videotaped test meals on two separate days; one with the novel bottle and one with their standard bottle, in random order. It is hypothesized that when the novel bottle is used, infants bottle will consume smaller meals and will have a longer meal duration, as compared to when a standard bottle is used.

Conditions
-----------------
Infant Feeding Behavior

Intervention / Treatment
-----------------
* Behavioral: Podee bottle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, exclusively formula-fed infants aged 1-6 months at enrollment; parent must be at least 19 years of age, able to understand written and verbal English, and provide daytime care for the infant at least 4 days per week. Exclusion Criteria: born < 37 weeks; birth weight < 2500g or > 4000g; current weight < 10th percentile for age; hospitalization > 72 hours following birth or any hospital admission since birth; any health issue that could interfere with feeding and/or growth; use of complementary foods; inability or unwillingness to comply with study-related procedures.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
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 |
| --- | --- |
| Novel bottle<br> | Behavioral: Podee bottle<br>* Infants will acclimate to the Podee bottle over the course of several weeks. All infants will consume meals from the Podee and their usual bottles.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food intake | Rate of intake, volume of intake, duration of meal | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intake, Formula feeding
Leukocyte Esterase Sensor Test

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the diagnostic efficacy of the quantitative electrochemical LE biosensor for periprosthetic joint infection (PJI). The secondary objective of this study is to assess the utility of d-lactase as adjunct biomarker to LE in making a diagnosis of PJI.

Official Title
-----------------
A Research Study to Determine if a Leukocyte Esterase Electrochemical Assay Can be Used as a Marker for Periprosthetic Joint Infection

Conditions
-----------------
Prosthetic Joint Infection

Intervention / Treatment
-----------------
* Diagnostic Test: leukocyte esterase electrochemical assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1: consecutive patients undergoing at least one of the following procedures: presumed aseptic revision arthroplasty, irrigation and debridement, radical resection for periprosthetic joint infection Exclusion Criteria: known active gout flare existing corrosion or metallosis inflammatory arthritis preexisting diagnosis of infection in the same joint patients undergoing second-stage procedure for infection.

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 |
| --- | --- |
| Subjects undergoing revision joint surgery<br> | Diagnostic Test: leukocyte esterase electrochemical assay<br>* A sample of blood drawn for routine standard of care laboratory assessments will be used to also test the new electrochemical assay. This is a validation study and the results of the electrochemical assay will not be used to treat patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receiver Operating Curve (ROC) analysis |  | 20 minutes |
Role of Regulatory T Cells in Pathogenesis of Primary IgA Nephropathy

Study Overview
=================
Brief Summary
-----------------
Along structural IgA abnormalities, hyperproduction of IgA is thought to play a role in the pathogenesis of primary IgA nephropathy. CD4+CD25+Fox3P regulatory T cells are instrumental in suppressing adaptative immune responses, including B cells production of immunoglobulins. We, the researchers at Centre Hospitalier Universitaire de Saine Etienne, will test the hypothesis that IgA production in patients with IgA nephropathy is dysregulated because of a quantitative and/or qualitative defect of CD4+CD25+FoxP3+ regulatory T cells.

Official Title
-----------------
Role of CD4+CD25+FoxP3+ Regulatory T Cells in Pathogenesis of Primary IgA Nephropathy

Conditions
-----------------
Glomerulonephritis, IGA

Intervention / Treatment
-----------------
* Procedure: gene transcription and cytometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pathogenesis of Berger's disease confirmed by renal biopsy Glomerular filtration > 60 ml/min/1,73m2 Written informed consent Patient affiliated to social insurance Exclusion Criteria: Immunosuppressor treatment within 6 months before the study inclusion Clinical infection within 2 months before the study inclusion C-reactive protein (CRP) > 10 mgL-1

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Patient affected by Berger's disease confirmed by renal biopsy with increased rate of Ig A | Procedure: gene transcription and cytometry<br>* samply of 30 ml of blood<br>|
| Other: 2<br>Patient affected by Berger's disease with normal rate of Ig A | Procedure: gene transcription and cytometry<br>* samply of 30 ml of blood<br>|
| Other: 3<br>Healthy volunteers | Procedure: gene transcription and cytometry<br>* samply of 30 ml of blood<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion averages of cells CD4+CD25+CD127 low T in peripheral blood |  | inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average relative expression of genes FoxP3, CTLA4, GITR, IL10, TGF-B, OX40, TIM-1, and TIM-3 |  | inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IgA, kidney, Berger'disease, regulatory T cells, pathogenesis of Berger's disease
Ultrasound Use for Difficult Lumbar Punctures in Pediatric Oncology Patients

Study Overview
=================
Brief Summary
-----------------
Hematology-oncology patients may require frequent lumbar puncture for diagnosis, assessment and therapy. When LP is difficult, the patient may endure multiple attempts, prolonged anesthesia time, and with failure of LP may require fluoroscopy-guidance with associated radiation exposure. This investigation will evaluate lumbar punctures performed in the intraoperative setting by oncologists with ultrasound guidance performed by the anesthesiologist in the leukemic pediatric population. The investigators hypothesis is that anesthesiologist guided ultrasound assistance will decrease intraoperative time, number of attempts and need to have the procedure done with fluoroscopy minimizing radiation exposure.

Official Title
-----------------
Ultrasound Imaging Facilitates Lumbar Punctures in Pediatric Oncology Patients With Difficult Surface Landmarks and/or a History of Difficult Lumbar Puncture

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Procedure: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing LP as per Heme-Onc clinic who have been deemed to be difficult LP placements. Exclusion Criteria: Patients having concomitant procedures (bone marrow bx, etc.)
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: Ultrasound<br> | Procedure: Ultrasound<br>* Ultrasound guidance for difficult lumbar punctures in the leukemic pediatric population.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of punctures | Number of punctures required to obtain cerebral spinal fluid. | 1 day |
Magnitude of Osteoarthritis disadVantage on pEoples liveS

Study Overview
=================
Brief Summary
-----------------
Estimate the prevalence of self-reported osteoarthritis and its characterization in adults over 45 years of age: Characterization of self-reported patients with OA (socio-demographic, comorbidities, VAS for intensity of pain) Characterization of OA diagnosis in patients with self-reported OA Impact of self-reported OA in the working abilities, quality of life and functionality (SF-12 v2.0) Characterization of treatment approaches (therapeutic and non-therapeutic) for self-reported patients with OA Patient perception of impact of OA in its life and importance given to disease

Detailed Description
-----------------
Magnitude of Osteoarthritis disadvantage on peoples lives.

Official Title
-----------------
Magnitude of Osteoarthritis disadVantage on pEoples liveS

Conditions
-----------------
Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Adults over 45 years old with self-reported osteoarthritis Exclusion Criteria: - NA

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- | --- |
| Estimate the prevalence of self-reported osteoarthritis (OA) in adults over 45 years of age by direct interview. |  | Single interview at the only one patient contact | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of self-reported patients with OA by collecting socio-demographic information through direct interview. |  | Single interview at the only one patient contact | 
| Characterization of self-reported patients with OA by collecting comorbidities information through direct interview. |  | Single interview at the only one patient contact | 
| Characterization of self-reported patients with OA by collecting information for intensity of pain through direct interview. |  | Single interview at the only one patient contact | 
| Characterization of OA diagnosis in patients with self-reported OA by direct interview. |  | Single interview at the only one patient contact | 
| Impact of self-reported OA in the working abilities, quality of life and functionality using Questionnaire SF-12 v2.0 |  | Single interview at the only one patient contact | 
| Patient perception of impact of OA in its life and importance given to disease by direct interview. |  | Single interview at the only one patient contact | 

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