linjc16/ctgov huggingface dataset:
Autologous Stem Cell Therapy in Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to study the safety and effect of stem cell therapy on the functional recovery in patients with sub acute/chronic stroke.

Official Title
-----------------
Autologous Bone Marrow Mononuclear Cells Intrathecal Transplantation in Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Biological: Stem cell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age18 years-80 years diagnosed as stroke by clinical and MRI findings Exclusion Criteria: presence of respiratory distress presence of acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/ Hepatitis C Virus malignancies acute medical conditions such as respiratory infection, fever hemoglobin less than 8 bleeding tendency bone marrow disorder left ventricular ejection fraction < 30% pregnancy or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Stem Cell<br>Bone marrow mononuclear cells | Biological: Stem cell<br>* Intrathecal autologous bone marrow mononuclear cell transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Independence Measure | Functional Independence Measure scale assesses the patients ability to carry out activities of daily living. At the follow up of 1 year, every patient in this study will be reevaluated on this scale. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subacute stroke, Chronic Stroke, Autologous Bone Marrow Mononuclear Cell therapy, Stem cell
The Effect of Systane Ultra Lubricant Eye Drops (FID 112903) on Visual Performance

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of 2 different lubricant eye drops on visual function of patients with dry eye

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Other: Systane Ultra Lubricant Eye Drops
* Other: Optive Lubricant Eye Drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of dry eye Must not have worn contact lenses for 12 hours prior to Day 1 Exclusion Criteria: Age related

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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systane Ultra<br>Systane Ultra Lubricant Eye Drops | Other: Systane Ultra Lubricant Eye Drops<br>* Systane Ultra Lubricant Eye Drops 1 drop each eye one time<br>|
| Active Comparator: Optive<br>Optive Lubricant Eye Drops | Other: Optive Lubricant Eye Drops<br>* Optive Lubricant Eye Drops 1 drop each eye one time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time at Best Corrected Visual Acuity | Measuring length of time patient can maintain their best vision while completing a computer task. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Corrected visual acuity means the patient can wear glasses or contacts if needed such that the measure is performed with the patient seeing the best that they can. | 15 minutes, 45 minutes, and 90 minutes post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Blink Rate Time (Time Between Blinks) | Measures time in seconds between normal blinks. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Longer blink rate time correlates with improved visual performance. | 15 minutes, 45 minutes, and 90 minutes post-dose |
Taurolock for Preventing Bacterial Peritonitis During Renal Insufficiency

Study Overview
=================
Brief Summary
-----------------
Dialysis catheters are sites of bacterial proliferation. The purpose of this study is to determine whether or not the use of Taurolock (a catheter lock solution) can prevent bacterial peritonitis in patients undergoing peritoneal dialysis.

Official Title
-----------------
Efficacity of Taurolock in Preventing Primary Bacterial Peritonitis in Patients Undergoing Peritoneal Dialysis for Renal Insufficiency: a Randomized, Multicenter, Double Blind Study With Placebo

Conditions
-----------------
Peritonitis, Catheter-related Infections, Renal Insufficiency

Intervention / Treatment
-----------------
* Device: Taurolock
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Renal insufficiency, stage V (HAS 2007 classification) Requires incident peritoneal dialysis No signs of peritoneal infection on inclusion signed consent affiliated with a social security system Exclusion Criteria: Patient will have a renal transplant in the upcoming year following dialysis Survival prognosis for one year is weak allergy to citrate, (cyclo)-taurolidine, or heparin patient is taking medication with a known contra-indication with citrate or (cyclo)-taurolidine patient has a thrombopenia caused by heparin impossible to inform the patient correctly patient under guardianship patient already included in another biomedical research protocol no signed consent no social security system

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Taurolock<br> | Device: Taurolock<br> <br> |
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Injectable sodium chloride conditioned in exactly the same manner as the experimental product.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of bacterial peritonitis |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dialysis
Breathlessness Assessment in Adult Patients With Myotonic Dystrophy Type 1

Study Overview
=================
Brief Summary
-----------------
Myotonic dystrophy type 1 (DM1) is one of the most common neuromuscular diseases in adults. As respiratory dysfunction is the most common cause of death in patients with DM1, a respiratory disease progression must be monitored combining symptom screening and respiratory function testing, in order to identify the appropriate time to initiate non invasive ventilation (NIV). Dyspnea, one of the main respiratory symptoms, has been little studied in patients with DM1. The main objective of this study is to provide the first multidimensional description of dyspnea in patients with DM1. The secondary objectives are: To compare respiratory symptoms according to the presence or not of criteria from respiratory function testing to initiate NIV To assess associations between dyspnea and respiratory function testing To assess associations between dyspnea and number of Cytosine Thymine Guanine (CTG) repeats To assess associations between dyspnea and muscular strength To assess associations between dyspnea and BMI To assess associations between dyspnea and anxiety or depression To assess associations between dyspnea and cognitive impairment To assess associations between dyspnea and quality of life.

Official Title
-----------------
Characters) Dyspnea Assessment in Adult Patients With Myotonic Dystrophy Type 1: a Monocentric Pilot Study

Conditions
-----------------
Myotonic Dystrophy Type 1 (DM1)

Intervention / Treatment
-----------------
* Other: Dyspnea


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with myotonic dystrophy type 1 confirmed by genetic analysis with an age older than 18 years Exclusion Criteria: an ongoing or recent (i.e. within the last 4 weeks prior to study recruitment) medical condition, including pulmonary exacerbations patient already under non-invasive mechanical ventilation

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 |
| --- | --- |
| Myotonic dystrophy type 1<br>adult patients with myotonic dystrophy type 1 | Other: Dyspnea<br>* questionnaires<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea | Borg scale at rest and after 6 minute walking test | Month 6 |
Establishment and Clinical Validation of New Technologies for Accurate Screening of Colorectal Cancer Based on Multi-omics

Study Overview
=================
Brief Summary
-----------------
Background: The current screening techniques for colorectal cancer include colonoscopy, fecal occult blood, and high-risk factor questionnaires. However, the colorectal cancer screening technology that has been widely used at present cannot take into account sensitivity and specificity, and the tumor detection rate is low. The purpose of research: Build a new type of population colorectal cancer precision screening technology program; Improve the detection rate of colorectal cancer in the population by new methods (compared with the existing domestic advanced technology) by ≥20%, and improve the specificity of colorectal cancer screening by ≥15% without significantly reducing the sensitivity.

Official Title
-----------------
Research on New Technologies for Screening and Early Diagnosis of Malignant Tumors - Establishment and Clinical Validation of New Technologies for Accurate Screening of Colorectal Cancer Based on Multi-omics

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 40-74 years old Exclusion Criteria: Combine severe disorders to make it unsuitable for colonoscopy Combine other tumors Mental and behavioral abnormalities do not cooperate with the screener Researchers believe that other reasons are not suitable for enrollment

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 74 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 |
| --- | --- | --- |
| Colorectal cancer detection rate in the population | Colorectal cancer detection rate in the population | through study completion, an average of 3 years | 
| Colorectal cancer screening specificity | Colorectal cancer screening specificity | through study completion, an average of 3 years | 
| Colorectal cancer screening sensitivity | Colorectal cancer screening sensitivity | through study completion, an average of 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal cancer, Cancer Screening, Colonoscopy, APCS, HRFQ
Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) in Invasive Cardiology

Study Overview
=================
Brief Summary
-----------------
Diagnosis of acute kidney injury (AKI) relies on a late marker, namely serum creatinine (SCr). New biomarkers are considered for early and sensitive detection of CIN. In particular, uNGAL has been used for early detection of AKI in the emergency department, after cardiopulmonary bypass or following CM administration. This study will be conducted to assess the possible value of urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) as an early detector of contrast-induced nephropathy (CIN) in a large sized cohort of patients undergoing percutaneous coronary procedures (PCP) and whether or not uNGAL correlates with the volume of contrast medium (CM) used.

Detailed Description
-----------------
Methods. We will enroll all consecutive patients undergoing PCP with iomeprolum during a 3-month period at our institution. CIN will be defined as a ≥25% increase in SCr from baseline when measured 2-4 days after PCP. uNGAL will be measured at its peak with the Abbott ARCHITECT assay.

Official Title
-----------------
Is Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) the Renal Troponin in Invasive Cardiology?

Conditions
-----------------
Renal Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All except patients with exclusion criteria Exclusion Criteria: dialysis-dependent chronic kidney disease lack of written consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| consecutive, PCP patients<br>All patients requiring percutaneous coronary procedures, such as coronary angiography or intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to assess the value of uNGAL measurement 4 to 6 hours after PCP as a possible early detector of CIN | cf title | 4-6 hours after PCP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to study the relationship between the volume of contrast medium used for PCP and the uNGAL levels measured 4 to 6 hours thereafter | cf. title | 4-6 hours after PCP | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal failure, cardiology, contrast-induced nephropathy
Urodynamic Evaluation in Patients With Anorectal Malformation According to Spinal Cord Abnormalities

Study Overview
=================
Brief Summary
-----------------
This study will examine the effects of spinal cord abnormalities on perioperative neurovesical dysfunction in patients with anorectal abnormalities.

Official Title
-----------------
Urodynamic Evaluation in Patients With Anorectal Malformation According to Spinal Cord Abnormalities

Conditions
-----------------
Anorectal Malformation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anorectal malformation patients who underwent preoperative and postoperative urodynamic studies Exclusion Criteria: Severe artifacts in urodynamic result graph when the postoperative urodynamic study was done after spinal surgery

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 11 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients with anorectal malformation
Connect™ CLL: The Chronic Lymphocytic Leukemia Disease Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of the Connect™ Chronic Lymphocytic Leukemia (CLL) Disease Registry is to explore the history and real world management of patients diagnosed with CLL, provide insight into the management of CLL, and evaluate the effectiveness of first, second and subsequent therapeutic strategies employed in both the community and academic settings.

Official Title
-----------------
Connect™ CLL: The Chronic Lymphocytic Leukemia Disease Registry

Conditions
-----------------
Chronic Lymphocytic Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis with CLL Clinical decision made to initiate first-line therapy, second-line therapy or subsequent line of therapy prior to enrollment into the ConnectTM CLL registry, but within 2 months of enrollment Age≥18 years Willing and able to provide signed informed consent Willing and able to complete patient assessment questionnaires either alone or with minimal assistance from caregivers and/or trained site personnel Exclusion Criteria: Participation in a clinical study in which study treatment is blinded Patient condition is considered terminal (i.e.<6 months to live)

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 |
| --- | --- | --- |
| Identify and summarize patterns in therapeutic regimens and patient outcomes | The primary objective is to 1) describe practice patterns of first line therapy regimens and subsequent therapeutic strategies in patients initiated on therapy for CLL, as well as initiated on second line and subsequent therapies, in the community and academic setting (2) Provide insight into therapeutic regimens and therapy sequence in clinical practice as they relate to clinical outcomes in patients initiated on first-line, second-line or subsequent therapies for CLL. | up to 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summarize Effectiveness of Treatment Regimens | Describe any differences in effectiveness associated with treatment regimens, including first-line regimens and subsequent therapeutic strategies in patients actively treated for CLL | up to 8 years | 
| Health Related Quality of Life Measures Related to Therapeutic Regimens | Describe the health-related quality of life of patients actively treated for CLL, and to explore the association of HRQoL with therapeutic regimens, sequences and clinical outcomes. | up to 8 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLL, Chronic Lymphocytic Leukemia, disease registry, Connect™
Clinical Sequencing Project for Metastatic Cancer Patients for Personalized Cancer Clinic.

Study Overview
=================
Brief Summary
-----------------
The next generation of personalized medical treatment according to the type of personal genetic information are evolving rapidly. The genome analysis needs systematic infra and database based on personal genetic information. Therefore, a big data of genome-clinical information is important. To determine the feasibility of the use of tumor's molecular profiling and targeted therapies in the treatment of advanced cancer and to determine the clinical outcome(Response rate,PFS, duration of response and overall survival )of patients with advanced cancer, the investigators are going to take a tumor tissue of patients and process molecular profiling and receive molecular profile directed treatments.

Official Title
-----------------
Clinical Sequencing Project for Metastatic Cancer Patients for Personalized Cancer Clinic.

Conditions
-----------------
Metastatic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is at least 19 years of age. Subject has a histologically or cytologically confirmed diagnosis of hepatocellular carcinoma/rare cancer, melanoma, neuroendocrine tumor, sarcoma etc. Prior treatment with anti-PDL1 antibody or immune check point inhibitor or ramucirumab therapy in the First-line or maintenance setting is allowed They must have refractory or progressive disease for which there is no further curative therapy available. Be willing to provide fresh tissue for biomarker analysis, and, based on the adequacy of the tissue sample quality for assessment of biomarker status. Must have a life expectancy of 3 months or more Written and voluntary informed consent understood, signed and dated. Exclusion Criteria: 1. Patients who do not have enough tissue for acquisition

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Biomarker group<br>Advanced cancer undergoing genomic profiling | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | 1 year | 
| Duration of response |  | 1 year | 
| Overall survival |  | 1 year |
Randomized Study on the Effects of Moderate Anaemia in Free Microvascular Tissue Transfer

Study Overview
=================
Brief Summary
-----------------
The evaluation of Perfusion of free flaps in patients with moderate anaemia and possible reduction of the transfusion threshold. Trial with surgical intervention

Detailed Description
-----------------
In study group 1 patients will be kept at a hematocrit level below 28% and only receive transfusions if symptomatic or the fall below 25%. Patients in group 2 will receive transfusions to reach a hematocrit always above 30%. Tissue perfusion in free flaps will be measured with indocyanine green fluorescence angiography, confocal microscopy and oxygen partial pressure measurement probes.

Official Title
-----------------
Randomized Study on the Effects of Moderate Anaemia in Free Microvascular Tissue Transfer

Conditions
-----------------
Tumor, Open Fracture of Foot

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: planned defect reconstruction with free flap and preoperative hematocrit of 28% or below Exclusion criteria: coagulation disorder Jehovah's witness iodine allergy renal or hepatic insufficiency

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 |
| --- | --- |
| anaemia group<br>no blood transfusions will be given until hct falls under 25% | |
| normal hct group<br>patients in group 2 will receive transfusions as is currently standard protocol outside the study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Blood transfusions peri- and postoperative |  | 10 days |