linjc16/ctgov huggingface dataset:
Treatment of Biliary Obstruction Using Biliary Stent With or Without Antireflux Valve

Study Overview
=================
Brief Summary
-----------------
Biliary obstruction can be relieved by biliary stent. Ascending infection of biliary passage (cholangitis) causes hospitalization and obstruction of stents. Reflux of intestinal fluids through a stent is thought to be one of the causes of cholangitis. Stents with antireflux valves are designed to reduce the reflux from the bowel. The purpose of the study is to investigate prospectively whether it is possible to reduce the amount of infection and thus obstruction of biliary stent by using a stent with an antireflux valve compared to a normal stent without an antireflux valve.

Official Title
-----------------
Treatment of Biliary Obstruction Using Biliary Stent With or Without Antireflux Valve

Conditions
-----------------
Biliary Obstruction, Cholangitis

Intervention / Treatment
-----------------
* Device: Cook´s biliary stent with an antireflux stent, normal biliary stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-89 biliary obstruction in the lower two thirds of the choledochus Exclusion Criteria: allergy to contrast media future pancreaticoduodenectomy refusal from the study previous stent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: biliary stent without an antireflux valve<br>patients with biliary obstruction who need a biliary stent, selected for the stent without an antireflux valve arm | Device: Cook´s biliary stent with an antireflux stent, normal biliary stent<br>* arms are assigned randomly by closed envelope method<br>|
| Active Comparator: biliary stent with an antireflux valve<br>patients with biliary obstruction, who need a biliary stent, selected for the stent with an antireflux valve arm | Device: Cook´s biliary stent with an antireflux stent, normal biliary stent<br>* arms are assigned randomly by closed envelope method<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patency of a biliary stent |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cholangitis |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antireflux valve, biliary obstruction, cholangitis, biliary stent
Morphine Added to Ropivacaine for FICB for Postoperative Analgesia

Study Overview
=================
Brief Summary
-----------------
prospective, randomized double blinded study to investigate the effects of morphine as an adjuvant to ropivacaine on FICB

Official Title
-----------------
Postoperative Analgesic Effect of Morphine Added to Ropivacaine for Fascia Iliaca Compartment Block Following Femoral Fracture Surgeries

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Ropivacaine, Morphine
* Drug: Ropivacaine, Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing elective femur surgery under spinal anaesthesia Age group (18-65 years) ASA physical status I and II Exclusion Criteria: • Not willing to participate in the study Other painful co-morbidities (neuropathies) Allergy or any contraindication to study medication Psychiatric disorder Coagulopathy Infection at the site of the block Use of other modes of anaesthesia or analgesia besides spinal anaesthesia.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Ropivacaine group<br>Ropivacaine 0.375% 20 ml + Normal saline 2 ml via FICB | Drug: Ropivacaine, Saline<br>* Normal saline added to ropivacaine for fascia iliaca compartment block<br>|
| Experimental: Ropivacaine and morphine group<br>Ropivacaine 0.375% 20 ml + Morphine 2 ml via FICB | Drug: Ropivacaine, Morphine<br>* Morphine added to ropivacaine for fascia iliaca compartment block<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Analgesia | The period in minutes when the patient is free of pain | 24 hours |
The Association Between the Distributions MCH and RBC, and Mortality in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
Patients were classified into two groups based on the values of MCH and RBC, patients with MCH ≥30 pg but <35 pg and RBC ≤350×104/μL; and MCH <30 pg and RBC >350×104/μL. Associations between all-cause mortality and the distributions of MCH and RBC were assessed by Kaplan-Meier curves and Cox proportional hazards regression model.

Detailed Description
-----------------
The Hb levels generally provides the value of RBC and iron status because mean corpuscular hemoglobin MCH is derived from the Hb divided by RBC. MCH depends on the size and concentration of erythrocytes. Thus, the value of RBC and MCH depend on dose of ESA and iron, respectively. Guidelines for Renal Anemia in Chronic Kidney Disease of 2015 Japanese Society for Dialysis Therapy recommend administration hemoglobin (Hb) levels ≥10 g/dL but <12 g/dL in dialysis patients.Patients whose Hb levels is maintained at 10 to 12 g/dL, Hb levels is widely distributed when divided into RBC and MCH. Therefore, the investigators examined the prognosis of life in the distribution of MCH and RBC.

Official Title
-----------------
The Association Between the Distributions MCH and RBC, and Mortality in a Cohort of Chronic Hemodialysis Patients: a 3-year Retrospective Observational Study

Conditions
-----------------
Renal Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will be controlled with hemoglobin levels between ≥10 g/dL and <12 g/dL and had undergone maintenance HD for >1 year. Exclusion Criteria: Patients will be excluded if they have peritoneal dialysis combined with HD, do not have records of laboratory investigations during this period, or are transferred to another hospital or lost to follow-up.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Survival rate between high or low RBC group (all cause death) | Survival curves for 3-year survival, based on all available follow-up data, will perform with the use of Kaplan-Meier estimates and will be compared between groups with the use of the log-rank test, and used Holm's method as post hoc. | three years (retrospectively) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
red blood cell, mean corpuscular hemoglobin, hemoglobin, Hemodialysis patients
Gait Disorders in Patients With Cognitive Decline

Study Overview
=================
Brief Summary
-----------------
The prevalence of neurodegenerative diseases will increase over the next decades driven by ageing population. It seems important to develop reliable, replicable and accessible diagnostic tools. This is a prospective study whose objective is to study the spatio-temporal parameters of gait in patients with Alzheimer's and Lewy body diseases. 64 patients were included in this study. A comparison of the two pathologies was conducted, followed by an analysis based on four groups (mild, severe Alzheimer's disease, mild, severe Lewy body disease) and a study of the severity of the diseases. To study these parameters, we used the Gaitrite treadmill. The analysis of spatio-temporal parameters of walking in Alzheimer's disease and Lewy body disease enables to identify discriminating variables between the two pathologies. The probability of suffering from an Alzheimer's disease decreases with the pace increase but increases with variations in length of the step, and with the rotation of the foot. While the probability of suffering from Lewy body disease increases with the pace, variations in the step duration, and the duration of double support. These results are interesting but do not allow to establish a diagnostic score for these two diseases. The monitoring of the variations of these parameters at individual level would probably be more relevant and would enable to detect dual pathologies.

Official Title
-----------------
Correlation Between Gait Disorders and Neuropsychological Profile in Patients With Alzheimer's Disease and Lewy Body Disease

Conditions
-----------------
Gait Disorders, Neurologic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 50 Hospitalized patient in day hospital Patient with an etiological diagnosis of his cognitive disorder Patient having a neuropsychological assessment Patient able to walk without technical help Patient having agreed to participate in the study Exclusion Criteria: - Refusal to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- | --- |
| walking test |  | 1 hour after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gait Disorders, Spatio-temporal parameters of walking, Alzheimer's disease, Lewy body disease
Millimeter Wave Therapy (MWT) for Analgesia After Total Knee Replacement

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to test whether the exposure to electromagnetic millimeter waves - Millimeter Wave Therapy (MWT) is effective for relief of acute postoperative pain in patients after elective unilateral total knee arthroplasty (TKA)

Official Title
-----------------
Millimeter Wave Therapy (MWT) Versus Placebo for Analgesia and Wound Healing After Elective Total Knee Arthroplasty - a Randomized Controlled Trial

Conditions
-----------------
Pain, Acute Pain

Intervention / Treatment
-----------------
* Device: Generator of electromagnetic millimeter waves


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with an American Society of Anesthesiologists physical status of II or III scheduled for elective TKA without previous opioid medication patients 35-80 years old able to use PCA pumps and Visual Analogue Scale for pain intensity measurement patients who have signed consent form Exclusion Criteria: pregnant or nursing females recidivist alcoholics extremely obese patients (body mass index > 35) inability to operate PCA-pump. females with the history of unstable angina pectoris (s. Risks for participants) patients who are unable to understand the consent form systemic infection history of psychiatric disease necessity to change postoperative analgesic scheme for particular patient severe intercurrent disease during the course of MWT

Ages Eligible for Study
-----------------
Minimum Age: 35 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Generator of electromagnetic millimeter waves|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of weak opioid drug piritramide delivered via Patient-Controlled-Analgesia pump, registered daily until the 3rd postoperative day |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of ibuprofen; pain intensity measured on VAS-100 twice a day; Insall knee function score; incidence of analgesia side-effects ; inflammation and wound healing parameters; credibility of patients' and research stuff blinding |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative pain, analgesia, total knee arthroplasty
Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in AS Patients(PLANETAS)

Study Overview
=================
Brief Summary
-----------------
This study is the trial to demonstrate how our product is similar to remicade by comparing the results of blood samples in active Ankylosing Spondylitis patients.

Official Title
-----------------
Randomized, Double-blind, Parallel-group, Phase 1 Study

Conditions
-----------------
Ankylosing Spondylitis

Intervention / Treatment
-----------------
* Drug: Infliximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with active ankylosing spondylitis BASDAI score ≥ 4 and visual analogue scale(VAS) score of spinal pain ≥ 4 Exclusion Criteria: have total ankylosing of spine have allergies to infliximab serious infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CT-P13<br>infliximab | Drug: Infliximab<br>* Infliximab 5mg/kg is going to be administered for both arm as a 2-hour infusion per dose.<br>|
| Active Comparator: Remicade<br>infliximab | Drug: Infliximab<br>* Infliximab 5mg/kg is going to be administered for both arm as a 2-hour infusion per dose.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK equivalence to remicade |  | PK sampling at week 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 20% criteria |  | at week 14, 30 and 54 | 
| Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 40 criteria |  | at week 14, 30 and 54 | 
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 14, 30 and 54 compared with Baseline |  | at week 14, 30 and 54 | 
| Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 14, 30 and 54 compared with Baseline |  | at week 14, 30 and 54 | 
| Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 30 and 54 compared with Baseline |  | at weeks 14, 30 and 54 | 
| Chest expansion at Weeks 14, 30 and 54 compared with Baseline |  | at weeks 14, 30 and 54 | 
| Quality of life questionnaire (SF-36) |  | at week 14, 30 and 54 |
Remifentanil And Local Anesthesia Compared With Local Anesthesia For The Insertion Of Central Venous Catheters

Study Overview
=================
Brief Summary
-----------------
At present, there is no reference protocol for Central Venous Catheter (CVC) insertion assuring analgesia, anxiolysis and safety. Medical teams use various levels of analgesia and anesthesia to realize this gesture, from single local anesthesia to general anesthesia. Remifentanil has been shown to decrease pain scores for insertion and removal of long-term central venous access. Remifentanil is also often employed for pediatric or labor analgesia for short acts as procedural sedation.

Official Title
-----------------
REMIFENTANIL AND LOCAL ANESTHESIA COMPARED WITH LOCAL ANESTHESIA FOR THE INSERTION OF CENTRAL VENOUS CATHETERS IN AWAKE PATIENTS

Conditions
-----------------
Local Anesthesia

Intervention / Treatment
-----------------
* Drug: Remifentanil
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more than 18 years old eligible for CVC insertion Exclusion Criteria: pregnancy patients who can't give their consent contra-indications to remifentanil infusion

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remifentanil<br>Patients who undergone a Central Venous Catheter (CVC) insertion under remifentanil infusion | Drug: Remifentanil<br>* Pain's evaluation for Remifentanil Group<br>|
| Placebo Comparator: Placebo<br>Patients who undergone a Central Venous Catheter (CVC) insertion under placebo infusion | Drug: Placebo<br>* CVC pain's evaluation after local anesthesia + placebo infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal pain score on numeric rating scale (NRS) will be assessed after the insertion |  | up to 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of patient's anxiety by the Face Anxiety Scale |  | up to 60 minutes | 
| Patient and physician's satisfaction by a 10-points numeric rating scale |  | up to 60 minutes | 
| Number of adverse events |  | up to 60 minutes | 
| Number of realized punctions |  | up to 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Central Venous Catheter, Remifentanil, local anesthesia, pain
Myeloid Mutations Register in R/R CML

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to know the percentage of ABL mutations in patients with chronic myeloid leukemia that relapsed or are refractory to tyrosine-kinase inhibitors measured with a myeloid mutations panel by NGS.

Official Title
-----------------
ABL Mutation Register in Patients With ITK Relapsed or Refractory Chronic Myeloid Leukemia

Conditions
-----------------
Chronic Myeloid Leukaemia Recurrent, Chronic Myeloid Leukemia, in Relapse

Intervention / Treatment
-----------------
* Diagnostic Test: Myeloid mutations measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CML diagnosis by the WHO 2016 criteria Failure to reach cytogenetic response of Ph chromosome of 36 to 95% at 3 months or BCR/ABL <10% at 6 months of treatment with TKI Progression or relapse of the disease after previous response to treatment with TKI Validation of adherence to treatment Inform consent Exclusion Criteria: Lack of information to complete the register Failure to response achievement due lack of adherence to treatment

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mutation Register<br>Measure of myeloid mutations after detection of relapse or refractoriness to ITK treatment | Diagnostic Test: Myeloid mutations measurement<br>* Measure of myeloid mutations by NGS when detection of refractory or relapsed CML is done<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of myeloid mutations by Next Generation Sequence | Detection of positive myeloid mutations at detection of relapse or refractoriness to ITK treatment | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic myeloid leukemia
Collect Breast Cancer Patients' Digital Mammography Images With Corresponding Reports for the Development of Software

Study Overview
=================
Brief Summary
-----------------
The purpose of this case collection effort is software design by R2 Technologies, Inc., The information received from Women's Imaging will be provided to the Case Collection, Data Management and Algorithm/software design and development teams who are responsible for the receipt of patient data and management of such data; and creation, testing and validation of R2 Technologies, Inc., for Computer Aided Detection (CAD) and new digital image archiving software design.

Detailed Description
-----------------
The information is necessary for Sponsor development efforts and will be utilized as a viewing tool with supporting written documentation of the findings on each image itself. The information will be used to develop algorithms that will foster development of CAD software. The information in each image and/or accompanying written clinical case documentation will not be analyzed in any way for clinical events

Official Title
-----------------
R2 Case Collection

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects with known breast cancer ages 18 and over case images originating from Women's imaging or one of the affiliated screening centers. Raw images must be available for each image source documents or mammographic interpretation must be available Exclusion Criteria: 17 or younger

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 |
| --- | --- |
| FFDM<br>a sum of at least 200 cancer cases, mammographically visible, on at least one image view (including masses and calcifications) | |

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
-----------------
Breast Cancer, Digital archiver software