linjc16/ctgov huggingface dataset:
Clinicopathologic and Ancillary Testing of Primary Clear Cell Carcinoma of the Cervix

Study Overview
=================
Brief Summary
-----------------
This study aims to provide a comprehensive report on clinicopathologic features, immunohistochemical/biomarker testing and molecular profile of cervical clear cell carcinoma. This study may help researchers learn more about the molecular profile of cervical clear cell carcinoma.

Detailed Description
-----------------
PRIMARY OBJECTIVE: I. To perform a retrospective clinicopathologic study on patients diagnosed and treated for clear cell carcinoma of the cervix at M D Anderson Cancer Center (MDACC) and to delineate the immunohistochemical and molecular profile of these cases. OUTLINE: Patients' medical records are reviewed retrospectively, and archival tumor tissue analyzed by immunohistochemistry and next generation sequencing.

Official Title
-----------------
Clinicopathologic and Ancillary Testing of Primary Clear Cell Carcinoma of the Cervix - a Rare Tumor

Conditions
-----------------
Human Papillomavirus-Independent Cervical Adenocarcinoma, Clear Cell-Type

Intervention / Treatment
-----------------
* Other: Electronic Health Record Review
* Other: Laboratory Biomarker Analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with clear cell carcinoma of the cervix at MDACC
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (medical record review)<br>Patients' medical records are reviewed retrospectively, and archival tumor tissue analyzed by immunohistochemistry and next generation sequencing. | Other: Electronic Health Record Review<br>* Medical records reviewed<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinicopathologic study on patients diagnosed and treated for clear cell carcinoma of the cervix |  | through study completion, an average of 1 year |
Cereals and Intestinal Function

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to determine the effect of dietary fiber on intestinal function in healthy subjects.

Detailed Description
-----------------
In the intervention study normal weight participants will receive defined amounts of different cereal flakes for several days. Before and after intervention parameters of intestinal function will be assessed.

Official Title
-----------------
Cereals and Intestinal Function: Investigations in Healthy Participants

Conditions
-----------------
Endotoxemia, Diet, Healthy

Intervention / Treatment
-----------------
* Other: Dietary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI <25 kg/m2 daily alcohol consumption <20g (men) or <10g (women) Exclusion Criteria: food allergies or intolerances instable body weight BMI <18,5 kg/m2 or >25 kg/m2 bariatric surgery within the last 5 years intake of antibiotics within the last month or during the study daily alcohol consumption >20g (men) or >10g (women) pregnancy and/or lactation period viral or bacterial infection during the last three weeks increased inflammatory markers of unknown reason chronic or acute disease of gastrointestinal tract

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary fiber 1<br>Participants receive cereal flakes 1 to include it in their normal diet. | Other: Dietary intervention<br>* Dietary intervention: Participants receive dietary fibers for a defined number of days.<br>|
| Experimental: Dietary fiber 2<br>Participants receive cereal flakes 2 to include it in their normal diet. | Other: Dietary intervention<br>* Dietary intervention: Participants receive dietary fibers for a defined number of days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in parameters of intestinal barrier function | Changes in endotoxin plasma levels | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blood lipid levels | Changes in triglyceride levels (mg/dl), changes in cholesterol levels (mg/dl) | 1 week |
Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Cyclosporine Microemulsion and Steroids in Pediatric de Novo Renal Transplant Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this pilot study is to evaluate efficacy and tolerability of EC-MPS b.i.d, with Cyclosporine microemulsion and steroids in pediatric de novo renal transplant patients. Safety and doses variations are also evaluated.

Official Title
-----------------
A Multicenter, Open, Single Arm, Pilot Study to Evaluate Efficacy, Tolerability and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion and Steroids in Pediatric de Novo Renal Transplant Patients

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recipients of a primary renal transplantation Recipients of a renal transplantation only Exclusion Criteria: Recipients of a multi-organ transplantation Unable to take an oral medication Requiring an induction therapy with polyclonal, monoclonal antibodies (OKT3, ATG, ALG). Other protocol-defined inclusion / exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 16 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of biopsy-proven-acute-rejection and treatment failure (defined by graft loss and/or biopsy-proven-acute-rejection and/or death and/or lost to follow-up and/or study discontinuation) within the 6 and 12 months post transplantation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Within the 6 and 12 months post transplantation |  |  | 
| Incidence of acute rejection resistant to steroids |  |  | 
| Incidence of graft loss and death |  |  | 
| Renal function by creatinine and creatinine clearance (Schwartz formula) |  |  | 
| Incidence of premature study drug discontinuation due to safety reason |  |  | 
| Pharmacokinetic profile of Myfortic. |  |  | 
| Frequency of adverse events, incidence of clinically notable laboratory abnormalities, and change on vital signs. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Enteric-coated mycophenolate sodium,, de novo,, renal transplantation,, pediatric, De novo pediatric renal transplantation
A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®

Study Overview
=================
Brief Summary
-----------------
This is a 48-week extension study to CMA-0631-PR-0010 Core Study. Patients who have a positive culture for P. aeruginosa at visit 4 of the first 8-week core study period and/or if deemed appropriate by the Investigators will be able to be included in the 48-week follow-on period (Extension Study) to continue the treatment only with Bramitob® (tobramycin nebuliser solution, 300 mg twice daily in 4 mL unit dose vials).

Official Title
-----------------
A Single Arm 48-Week Follow-on Safety Study to the Core Study (A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas Aeruginosa)

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: tobramycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Successful completion of Core Study At least 6 years of age Males and females

Ages Eligible for Study
-----------------
Minimum Age: 6 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

| Intervention/Treatment |
| --- |
|Drug: tobramycin|300mg/4ml solution, via a nebuliser, over a 48-week period in a twice-daily regimen, with 6 on cycles of 4 weeks duration during the 48-week period.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to assess safety profile in terms of incidence of adverse events/adverse drug reactions, frequency of cystic fibrosis exacerbations, audiometric test, laboratory parameters (hematology and blood chemistry), vitals signs (hr and bp), physical examination. |  | up to 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to assess whether prolonged use of aerosolized tobramycin is required to sustain FEV1 increase (FEV1 expressed in liters and % predicted) |  | up to 48 weeks | 
| Categorical results of microbiological tests referred to P. aeruginosa (negativisation, persistence, superinfection, re-infection); susceptibility testing of isolated P. aeruginosa strains (MIC90 and MIC50) |  | up to 48 weeks | 
| Changes in body weight and BMI |  | up to 48 weeks | 
| to assess health related quality of life |  | Initial visit, Week 20, Week 44 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cystic fibrosis, P. aeruginosa, tobramycin
Association of Bone Quality and Quantity With Vascular Calcification

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if there is a link between calcium build up in the veins or arteries (including the veins/arteries of the heart) and deterioration of the bone. This will help understand if there is a connection between heart disease and bone disease.

Official Title
-----------------
Association of Bone Quality and Quantity With Vascular Calcification.

Conditions
-----------------
Vascular Calcification, Atherosclerosis, Bone Density

Intervention / Treatment
-----------------
* Procedure: CT of the bones


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female 30 years of age or older Must already be scheduled to have a CT examination of the arteries of the heart Exclusion Criteria: Diagnosed with bone cancer Previous diagnosis of cancer that's spread to the bone History of cancer that involves bone marrow Any bone disease other than osteoporosis Any disease which leads to serious osteoporosis or vascular calcification such as: kidney disease thyroid and adrenal disease anorexia nervosa secondary osteoporosis

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Bone Density Scanning<br>To acquire high resolution images of the bones and aid in determining bone density. | Procedure: CT of the bones<br>* A CT scan will be performed on one arm and one leg for the purpose of acquiring images for this research study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if there is a connection between heart disease and bone disease through correlation of bone density with the calcium deposited in the coronary arteries. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
calcification, osteoporosis
Dealing With Anxiety: A Cognitive Behavioural Program for Diabetes

Study Overview
=================
Brief Summary
-----------------
This study was designed to assess whether a cognitive behavior therapy (CBT) program for diabetes clinic patients was acceptable, improved quality of life and produced measurable change in levels of depression, anxiety and stress.

Detailed Description
-----------------
Having co-morbid anxiety or depression makes it difficult to carry out the activities for diabetes selfcare. Psychological interventions have been shown to result in improvements in HbA1C and depression. Reports on psychosocial outcomes are conflicting and there are no studies of quality of life. Our diabetes outpatient population has a higher prevalence of anxiety and depression compared to the general public and this led to the development of a group CBT intervention designed to reduce anxiety as a co-morbidity of diabetes.

Official Title
-----------------
Dealing With Anxiety: A Pilot Cognitive Behavioural Program for Diabetic Clinic Outpatient Attendees

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

Intervention / Treatment
-----------------
* Behavioral: Immediate Cognitive behavioural therapy (CBT)
* Behavioral: Delayed CBT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consenting attendees of the Hunter Area Diabetes Services RNH Diabetes Outpatient Clinic Exclusion Criteria: Accessibility problems including: limited English developmental disability physical immobility geographical distance extreme age/frailty
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: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Behavioral: Immediate Cognitive behavioural therapy (CBT)<br>* The Dealing with Anxiety CBT Group Program comprises 7 group sessions: an initial five hour session followed by 6 three hour sessions over a three month period<br>|
| Active Comparator: 2<br> | Behavioral: Delayed CBT<br>* Commencement of the CBT Group Program is delayed 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1C (HbA1C) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression Anxiety Stress Scale (DASS) |  | 6 months | 
| Diabetes Quality of Life (ADDQoL) |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, cognitive behavioural therapy
Development and Exploration of the Feasibility of Using Locally Synthesized Small Molecule Inhibitors to Treat Human Acute Leukemia Cells

Study Overview
=================
Brief Summary
-----------------
Acute leukemias are commonly seen in elderly and have no effective therapy. In recent years, small molecule inhibitors have shown a tremendous promise in cancer treatment such as chronic myeloid leukemia and lung cancer. Thus, in this proposal, we intend to use our novel patented indole compound to conjugated with hydroxamic acid in histone deacetylases inhibitor, suberoylanilide hydroxamic acid and further modify its structure to generate novel small-molecule anticancer compounds. By screening acute leukemic cell lines, we will look for compounds that have shown potential for future drug development. In our preliminary studies, we have identified a novel compound, MPT0E001, to have marked growth inhibitory activity, induce apoptosis and downregulate c-Myc protein level. We intend to use MPT0E001 as a basis to develop novel compounds and test them in multiple leukemic cell lines and primary leukemia samples (Specific aim 1) and identify the mechanisms for downregulation of c-Myc and other pathways such as NF-kappaB and Akt (Specific aim 2). Once we have identified the lead compounds, we will use murine model to assess the acute toxicity profiles in different dose ranges and examine the effects of blood counts and vital organs. After toxicity study, we will test the lead compounds using in vivo xenogenic murine model using both cell lines and primary leukemia. Using this approach, we hope to develop novel compounds that are able to be used in future leukemic therapy.

Official Title
-----------------
Development and Exploration of the Feasibility of Using Locally Synthesized Small Molecule Inhibitors to Treat Human Acute Leukemia Cells

Conditions
-----------------
Acute Myeloid Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute Myeloid Leukemia Exclusion Criteria: Hematologic malignancies other than AML
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
-----------------
AML
Mapping Multidimensional Illness Trajectories of Patients With End-stage Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Patients with end-stage kidney disease (ESKD) must manage not only the demands of dialysis and comorbid conditions but also associated symptoms and acute life-threatening events that contribute to functional limitations and increased risk of mortality. Yet little is known about the trajectories of quality of life dimensions in patients with ESKD when they experience acute life-threatening episodes, to guide palliative care for this population. In this prospective, descriptive study, we will identify trajectories of symptoms, physical functioning, psychosocial needs, and emotional and spiritual well-being in 200 patients with ESKD who are at a high risk of experiencing acute life-threatening events and mortality within 12 months.

Official Title
-----------------
Mapping Multidimensional Illness Trajectories of Patients With ESKD

Conditions
-----------------
End Stage Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18 years or older; receiving either Hemodialysis or Peritoneal dialysis on dialysis either < 3 months or ≥ 6 months with a Charlson Comorbidity Index (CCI) score ≥ 5 Exclusion Criteria: Patients who are enrolled in hospice or too sick to participate in questionnaire completion will not be eligible. Kidney transplant candidates will be excluded because their illness trajectories after transplant are likely to differ.

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 |
| --- | --- | --- |
| Symptoms, physical functioning, psychosocial needs, spiritual well-being, cognitive functioning |  | 12 months |
Post-operative Drainage After Pancreaticoduodenectomy

Study Overview
=================
Brief Summary
-----------------
The study compares regular use of surgical drains and no use of surgical drains in patients subjected to pancreaticoduodenectomy with expected low to intermediate risk for post operative pancreatic fistula.

Official Title
-----------------
Post-operative Drainage After Pancreaticoduodenectomy: A Randomized Controlled Trial of Patients With Intermediate and Low Risk for Pancreatic Fistula

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Procedure: Drain
* Procedure: No drain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing pancreaticoduodenectomy of both sexes Patients with predicted risk score of 10 or less of pancreatic fistula Written informed consent Expected survival time > 6 months Exclusion Criteria: Patients with predicted high risk of fistula with a risk score above 10 Patients with intraabdominal abscess or infection ASA score > 3 Pregnancy Expected lack of compliance

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: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drain<br>Surgical drains used as routine | Procedure: Drain<br>* Surgical drains are placed as a standard of care (control arm) or not (experimental arm)<br>|
| Experimental: No drain<br>No surgical drain used | Procedure: No drain<br>* Surgical drains are placed as a standard of care (control arm) or not (experimental arm)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall morbidity rate | Post operative morbidity | 90 days post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate (in-hospital, 30 and 90 days) |  | 90 days post operatively | 
| Severe morbidity rate as classified by Clavien-Dindo >3 |  | 90 days post operatively | 
| Fistula rate according to ISGPF |  | 90 days post operatively | 
| Intraabdominal abscess rate |  | 90 days post operatively | 
| Wound infection rate |  | 90 days post operatively | 
| Delayed gastric emptying according to ISGPF |  | 90 days post operatively | 
| Postpancreatectomy bleeding according to ISGPF |  | 90 days post operatively | 
| Need of interventional radiology |  | 90 days post operatively | 
| Need for reoperation |  | 90 days post operatively | 
| Hospital stay |  | 90 days post operatively | 
| Readmission rate |  | 90 days post operatively |