linjc16/ctgov huggingface dataset:
Reduced-dose Alemtuzumab for Kidney Transplant Rejection

Study Overview
=================
Brief Summary
-----------------
Prospective, follow-up study of kidney transplant recipients treated with alemtuzumab anti-rejection therapy for severe or glucocorticoid-resistant kidney transplant rejection.

Detailed Description
-----------------
Study design: Prospective observational cohort study. Study population: Adult patients who are treated with alemtuzumab for severe or glucocorticoid-resistant kidney transplant rejection. Intervention (if applicable): Not applicable. Main study parameters/endpoints: Lymphocyte (subtype) repopulation, serious infections, one-year graft survival, alemtuzumab plasma levels, intra-cellular signalling of repopulated T and B cells, cytokine-levels, donor-specificity of repopulated T cells, differences pre- and post-treatment of donor-derived cell-free DNA, plasma nucleosomes, urinary chemokines, urinary extracellular vesicles, breath-pattern analysis.

Official Title
-----------------
The Effects of Reduced Dose Alemtuzumab for Severe Kidney Transplant Rejection

Conditions
-----------------
Kidney Transplant Rejection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Treatment for severe or glucocorticoid-resistant kidney transplant rejection with alemtuzumab. Exclusion Criteria: Treatment with a different lymphocyte depleting agent (e.g. rATG) prior to treatment with alemtuzumab for the same rejection episode. Recipients who have T cell counts below 200 × 106/L before the start of therapy (for instance, because of lymphocyte depleting induction therapies). Inability to provide written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Proportion of patients with lymphocyte repopulation | Outcome reporting of the proportion of patients that has repopulation of T and B lymphocytes, defined as cell counts of >200 10E6/L for T lymphocytes and > 100 10E6/L for B lymphocytes. | 6 months and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of graft loss | Cumulative incidence of graft loss at specified time-points with death as competing risk, computed by cumulative incidence functions. | 6 months, 1 year | 
| Serious infections | Necessitating hospital admission, or hospital-acquired | 6 months, 1 year | 
| Patient survival | Proportion of patients who survived at specified time-points, computed with kaplan-meier estimates at specified time-points. | 6 months, 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alemtuzumab
Gait Control in Parkinson Disease

Study Overview
=================
Brief Summary
-----------------
Previous work has shown that a statistical property of gait characterised by long-range autocorrelation functions is altered in Parkinson disease (PD). On the other hand it has been suggested that the same property is linked to the ability in healthy humans to co-regulate the amplitude and cadence of strides towards maintaining a constant speed. Here the investigators want to better understand why it is altered in PD by measuring the transitions between gait instructed by a metronome, and gait without metronome. The experimental conditions will allow the comparisons between these transitions across PD and healthy groups of volunteers, and assess differences based on statistical and computational modelling. The link with potential freezing episodes will also be studied to assess whether the statistical determinants of gait control in this population can be used as a proxy or predictor of the occurence of freezing episodes.

Official Title
-----------------
Flexible Control of Gait in Parkinson Disease: Effect of Task Instruction on the Exploitation of Redundancy in Speed Control.

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Other: Walking test
* Other: Disease assessement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients and volunteers able to walk for 20mins and without other neurological disorders. Exclusion Criteria: Patients or volunteers unable to walk for 20mins and with other neurological disorders.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| PD<br>Patients with Parkinson's disease | Other: Walking test<br>* Walk with and without a metronome<br>Other: Disease assessement<br>* Disease stage assessed by a doctor<br>|
| Control<br>Healthy volunteers | Other: Walking test<br>* Walk with and without a metronome<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stride cadence | Time between two consecutive heel strikes. Units are seconds. | Measured during the entire experiment (an average of 4.5 years) | 
| Stride amplitude | Distance between two consecutive heel strikes. Units are meters. | Measured during the entire experiment (an average of 4.5 years) |
Prediction Model for Anemia After Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
To develop and validate a prediction model for estimating the short and long-term risk of anemia after bariatric surgery.

Detailed Description
-----------------
This study aims to develop and validate a prediction model for estimating the probability of anemia for patients with obesity one, three, and five years after sleeve gastrectomy and Roux-en-Y gastric bypass, using preoperative clinical and laboratory data.

Official Title
-----------------
Prediction Model for Anemia After Bariatric Surgery

Conditions
-----------------
Anemia, Bariatric Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged between 16-70 years; body mass index (BMI) ≥ 27.5 kg/m2; complete preoperative and follow-up data. Exclusion Criteria: vegetarian; other bariatric procedures; renal failure at baseline; postoperative bleeding (it was defined as a drop in hemoglobin levels > 3 g/dL or a confirmed blood loss requiring treatment after surgery); incomplete preoperative and follow-up data.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCs of the prediction model at 1, 3, 5 years | This metric shows the discrimination ability of the prediction model. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brier score | This metric shows the calibration of the model. The Brier score (on a scale ranging from 0 to 1), which calculates the difference between the estimated and observed risk for malignancy with values closer to 0 indicating better calibration, was used to evaluate model calibration. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anemia, Bariatric surgery, Prediction model
Dermogenesis With Mesenchymal Stem Cells

Study Overview
=================
Brief Summary
-----------------
Dermogenesis With Mesenchymal Stem Cells in treating Post Acne Depressed Spots

Detailed Description
-----------------
management at two different stages of the course of the disease. First one at the stage of active disease which needs cleansers, antibiotics, retinoids, anti inflammatory agents and hormonal manipulation. Once active disease is over, patients report to clinician with depressed spots which are caused by localized dermal disruption and fat atrophy post inflammation or spontaneous epithelial rupture or scratching by the patient. These acne spots are hard to treat due to many reasons. Firstly, excision is difficult as size of most of them is small and they are in a large in number. Secondly, filling with and without subcision is not adequately addressing the deformity. Currently, a combination of filling with synthetic filler or fat and resurfacing by peeling, LASER or dermabrasion is in practice. In-spite of all, a treatment is still required to address post acne spots (Ice Spec Spots) adequately.

Official Title
-----------------
Dermogenesis With Mesenchymal Stem Cells: A Fabulous Remedy For Post Acne Depressed Spots

Conditions
-----------------
Dermal Regeneration

Intervention / Treatment
-----------------
* Procedure: Autologous Mesenchymal stem cells injection
* Procedure: Homogenized fat injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acne spots Exclusion Criteria: Active acne

Ages Eligible for Study
-----------------
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group A with MSCs Group B with Fat
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesenchymal stem cells<br>Mesenchymal Stem Cells taken from adipose tissue will be used | Procedure: Autologous Mesenchymal stem cells injection<br>* Autologous Mesenchymal stem cells will be seperated from harvested fat and injected in acne scars<br>|
| Experimental: Homogenized fat<br>Adipose tissue will be harvested and used | Procedure: Homogenized fat injection<br>* Autologous fat will be harvested, homogenized and injected.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermal thickness | on microscopy of biopsy section | 3 months |
Near-infrared Spectroscopy: Differences in Placental Oxygenation in Relation to Ultrasound Maturation Grade in physiologIcal Term Pregnancies

Study Overview
=================
Brief Summary
-----------------
The aim was to compare placental oxygenation in low risk, uncompli-cated, term pregnancies measured by near-infrared spectroscopy (NIRS) in relation to the placental maturity grade determined by ultrasound assessment according to Grannum scale. The study included 34 singleton subjects divided into two groups accord-ing to placental maturation: low grade (Grannum 0-1; n=10) and high grade (Gran-num 2-3; n=24). In each study subjects, measurement was performed at two sites: (a) test site above the central part of the placenta, and (b) control site out of placenta on lower abdomen, in medial line, 3 cm from the symphysis. Student's t-test was used to compare tissue oxygenation index (TOI) values among the study groups. The normality of distribution was demonstrated by the Kolmogorov-Smirnov test.

Official Title
-----------------
Near-infrared Spectroscopy: Differences in Placental Oxygenation in Relation to Ultrasound Maturation Grade in physiologIcal Term Pregnancies

Conditions
-----------------
Placenta Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton pregnancies low-risk pregnancies uncomplicated pregnancies term pregnancies (37th to 41+6 weeks of gestation) anterior placental localization abdominal wall of less than 3cm thickness. Exclusion Criteria: complicated pregnancies pre-term pregnancies Abdominal wall tick > 3cm
Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Grannum placental maturity grade 0 and 1 (low maturity level<br>Women with low placental maturity grade (group 1, Grannum 0-1) | |
| Grannum placental maturity grade 2 and 3 (high maturity level)<br>Women with high placental maturity grade (group 2, Grannum 2-3) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Placental oxygenation levels | to compare placental oxygenation in low risk, uncomplicated, term pregnancies measured by near-infrared spectroscopy (NIRS) in relation to the placental maturity grade determined by ultrasound assessment according to Grannum scale. | During the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Near-Infrared Spectroscopy, Placenta oxigenations, Placenta maturity
Evaluation of SNAP-Ed Online Modules to Improve Responsive Feeding Practices of Caregivers

Study Overview
=================
Brief Summary
-----------------
Evaluation of three online modules developed by the Center for Childhood Obesity Research for caregivers of children ages 5-12 years old participating in SNAP-Ed programing.

Detailed Description
-----------------
the Center for Childhood Obesity Research developed three online modules for caregivers of children ages 5-12 years old who are participating in SNAP-Ed programming. These modules were developed to be used within the context of normal programming that participants will receive in any given year. The specific aim are as follows: Aim #1: To examine acceptability of these modules by caregivers participating in SNAP-Ed programming. This will be assessed by evaluating acceptability questions answered by participants after completing the modules. Aim #2: To examine the feasibility of these modules by caregivers participating in SNAP-Ed programming, assessed by >60% completion rate of all three modules. Online module content will focus on topics such as: Shared Responsibility of Feeding: Parent Provides, Child Decides Family Mealtimes Hunger and Fullness Avoiding use of controlling feeding practices

Official Title
-----------------
Evaluation of SNAP-Ed Online Modules to Improve Responsive Feeding Practices of Caregivers

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

Intervention / Treatment
-----------------
* Behavioral: Online Modules


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary caregiver of a child between the ages of 2 to 16 years Over the age of 18 English-speaking Have a reliable internet source and active email account so they can access the online modules Exclusion Criteria: Are not the primary caregivers of a child between the ages of 2 to 16 years Are under the age of 18 Are not English-speaking Do not have a reliable internet source or email address

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: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: A single pilot group of participants will complete the online modules and evaluate their effectiveness using pre and post surveys.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Receive Online Modules<br>All participants receiving the same online modules intervention. | Behavioral: Online Modules<br>* Participants receive modules to improve responsive feeding practices of caregivers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeding Practices | Pre/post Feeding Practices surveys | 1 month |
Effect of Screening Using Imaging (CT/ EUS) on Early Detection of Pancreatic Ductal Adenocarcinoma (PDAC) in Patients With New Onset Diabetes (NOD) - A Prospective Pilot Observational Study

Study Overview
=================
Brief Summary
-----------------
To assess whether EUS (Endoscopic Ultrasound) can serve as a valuable diagnostic tool for identifying PDAC at an early stage in individuals who have recently been diagnosed with diabetes. Purpose: To improve the rates of early detection of pancreatic cancer. Pancreatic ductal adenocarcinoma (PDAC) is a type of cancer that starts in the pancreas, a gland located in your abdomen. It happens when some cells in the pancreas start growing abnormally and form a cancer.

Official Title
-----------------
Effect of Screening Using Imaging (CT/ EUS) on Early Detection of Pancreatic Ductal Adenocarcinoma (PDAC) in Patients With New Onset Diabetes (NOD) - A Prospective Pilot Observational Study

Conditions
-----------------
Pancreatic Ductal Adenocarcinoma (PDAC)

Intervention / Treatment
-----------------
* Procedure: A blood sample for CA 19-9 (cancer detection test)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 50 years Patients diagnosed with diabetes based on FBS/ PPBS/ HbA1C Presence of atleast 1 FBS parameter measured in the past 6-18 months which was not > 125 mg/dl END-PDAC score > 2 Exclusion Criteria: Known or newly detected chronic pancreatitis Past history of pancreatic cancer History of steroid use Contraindications for EUS

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- |
|Procedure: A blood sample for CA 19-9 (cancer detection test)|A blood sample for CA 19-9 (cancer detection test) levels will be taken at baseline. Contrast CT abdomen - Pancreas protocol will be done at baseline. EUS (Endoscopic Ultrasound) under moderate sedation will be done at baseline to you. If suspicious lesion is found on examination, Fine Needle Aspiration - FNA will be done.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of PDAC at 3 years |  | 3yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Incidence of PDAC at baseline • Incidence of resectable PDAC at baseline • Incidence of resectable PDAC at 3 years |  | baseline and 3yrs |
BESPONSA Injection 1 mg Special Investigation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn about the safety and effectiveness of BESPONSA. BESPONSA is approved for treatment of relapsed or refractory CD22-positive acute lymphocytic leukemia. Registration criteria for this study is all patients who starting BESPONSA from its launch to the market to April 30, 2020. All patients in this study will receive BESPONSA according to the prescriptions. Patients will be followed up as follow. 52 weeks for patients who did not have a HSCT (Hematopoietic Stem Cell Transplant) within 52 weeks after starting BESPONSA. Up to 52 weeks after a HSCT for patients who had a HSCT within 52 weeks after starting BESPONSA.

Official Title
-----------------
BESPONSA® INJECTION 1 MG SPECIAL INVESTIGATION

Conditions
-----------------
Acute Lymphocytic Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients prescribed BESPONSA Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |
| The incidence of adverse drug reactions | The observation period will be 52 weeks for patients not undergoing HSCT within 52 weeks after the start of BESPONSA treatment or until 52 weeks following HSCT for patients undergoing it within 52 weeks after the start of BESPONSA treatment. | Up to 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug use investigation in Japan
LYNPARZA Breast Cancer in the Adjuvant Setting Japan Post-Marketing Surveillance (PMS)

Study Overview
=================
Brief Summary
-----------------
To evaluate the frequency of bone marrow suppression Adverse Drug Reactions (ADRs) in patients with BRCA mutated HER2 negative high recurrent risk breast cancer treated with LYNPARZA for adjuvant treatment in the actual post-marketing use.

Detailed Description
-----------------
To evaluate the frequency of bone marrow suppression Adverse Drug Reactions (ADRs) in patients with BRCA mutated HER2 negative high recurrent risk breast cancer treated with LYNPARZA for adjuvant treatment in the actual post-marketing use. This investigation will be conducted for application for re-examination specified in Article 14-4 of the Pharmaceutical Affairs Law.

Official Title
-----------------
LYNPARZA Tablets 100mg, 150mg General Drug Use-results Study in Patients With BRCA Mutated HER2 Negative High Recurrent Risk Breast Cancer in the Adjuvant Setting

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who started treatment with LYNPARZA for the first time for the approved indication Adjuvant treatment for patients with BRCA-mutated HER2 negative high recurrent risk breast cancer Exclusion Criteria: Patients who have no treatment history with LYNPARZA
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 |
| --- | --- | --- |
| Incidence of bone marrow suppression |  | from baseline to 1year |