linjc16/ctgov huggingface dataset:
Placement of Perineural Catheters in the Popliteal Region

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy of the hydrolocalization technique for placement of popliteal perineural catheters in comparison with the stimulating catheters. A non inferiority trial.

Official Title
-----------------
Comparison of Techniques for Placement of Perineural Catheters in the Popliteal Region

Conditions
-----------------
Foot Surgery

Intervention / Treatment
-----------------
* Procedure: Placement of perineural catheters with Hydrolocalization technique using


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults BMI less than 30 Exclusion Criteria: known allergies to local anesthetics or other drugs used patient refusal any local or systemic contraindication to the use of popliteal block

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hydrolocalization technique group<br>Technique of placement of popliteal perineural catheter using the hydrolocalization technique with ultrasound | Procedure: Placement of perineural catheters with Hydrolocalization technique using<br>* Placement of perineural catheters in the popliteal region comparing two techniques. while the drugs used are the same (ropivacaine 0.6% for initial bolus and 0.2% for continuous technique) we will compare dosage required in each group<br>|
| Active Comparator: Stimulating Catheter technique group<br>A technique for placement of popliteal catheter with the aid of a neurostimulator | Procedure: Placement of perineural catheters with Hydrolocalization technique using<br>* Placement of perineural catheters in the popliteal region comparing two techniques. while the drugs used are the same (ropivacaine 0.6% for initial bolus and 0.2% for continuous technique) we will compare dosage required in each group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| consumption of local anesthetics |  | 36 hours PO | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain scores |  | 36 hours postoperatively |
Study of Talabostat and Rituximab in Advanced Chronic Lymphocytic Leukemia (CLL)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the efficacy and safety of talabostat and rituximab in patients with advanced CLL who failed to respond, or have progressed following a prior response, to a fludarabine regimen.

Detailed Description
-----------------
Completion date provided represents the completion date of the grant per OOPD records

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

Intervention / Treatment
-----------------
* Drug: Talabostat mesylate (PT-100) tablets
* Drug: Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Men or women ≥18 years of age Histopathologically confirmed diagnosis of B-CLL expressing surface CD20 of any detectable intensity Rai Stage III or IV. Rai Stages I and II with massive or progressive lymphadenopathy or hepatosplenomegaly. Primary resistance to a fludarabine regimen (no PR or CR) or progressive disease within 1 year of a prior response ECOG performance status 0, 1, or 2 Written informed consent EXCLUSION CRITERIA: Therapy for CLL within 4 weeks of Study Day 1 (including chemotherapy, radiation, immunotherapy, cytokine or biologic [with the exception of hematopoietic growth factors]). Patients must have recovered from the adverse effects of prior therapy. Known primary or secondary malignancy of the central nervous system Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix Serum creatinine >2.0mg/dL (>176 micromol/L) AST or ALT ≥3 x the upper limit of normal (ULN) Total bilirubin ≥1.5 x ULN (unless secondary to Gilbert's) Positive serology for hepatitis B (HBsAg) or hepatitis C (anti-HCV antibody) Known positivity for HIV Prior organ allograft Concurrent comorbid medical conditions that, in the opinion of the investigator, preclude the safe delivery of the experimental treatment Pregnant or nursing women

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Talabostat mesylate (PT-100) tablets|nan|
|Drug: Rituximab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Prognostic Value of BNP in MCS - a 25 Year Follow up Study

Study Overview
=================
Brief Summary
-----------------
A biobank has been created to investigate the prognostic value of biomarkers (mainly BNP) in patients implanted with durable mechanical assist devices comparing patients with advanced HF supported by MCS with those who are transplanted and those who remain on optimal medical therapy. Patients will be followed up for 25 years after inclusion.

Detailed Description
-----------------
All patients referred for advanced HF treatment at the Dept of Cardiology at Rigshospitalet.

Official Title
-----------------
The Prognostic Value of proBNP in Patients Supported With Durable Mechanical Circulatory Assist Devices - a 25 Year Follow up Study.

Conditions
-----------------
Heart Failure, Left Ventricular Assist Device, Prognosis, Durable Mechanical Support Device

Intervention / Treatment
-----------------
* Other: Observation. No intervention per se.
* Other: 2) Observation and collection and of blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients referred for evaluation for advanced HF treatment at the Rigshospital in Denmark Age>18 years Exclusion Criteria: No consent

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MCS recipients<br>All recipients of durable MCS will be followed up on a yearly basis with collection of blood sample and clinical data for 25 years. | Other: 2) Observation and collection and of blood sample<br>* All patients evaluated for adv HF (HTX/LVAD) will be offered to contribute to this database; Blood samples will be collected from all at baseline. Patients receiving LVAD will contribute on a yearly basis (or until withdrawal of consent). For other patients no further blood will be collected unless they receive an LVAD at a later point.<br>* Other names: Blood sample;|
| Recipient of cardiac transplant<br>All recipients of cardiac transplantation(s) will be followed up on a yearly basis with collection of clinical data for 25 years. | Other: Observation. No intervention per se.<br>* Observation. No intervention (no collection of blood).<br>* Other names: 1) Observation - No intervention;|
| Watchful waiting at Rigshospitalet<br>Patients referred for evaluation for treatment with advanced treatment (LVAD/HTX) but -for whatever reason- these pts will be on watchful waiting at the Rigshospitalet. | Other: Observation. No intervention per se.<br>* Observation. No intervention (no collection of blood).<br>* Other names: 1) Observation - No intervention;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alive |  | 25 years from inclusion | 
| Dead | Dead after inclusion in study | 25 years from inclusion |
Prospective Patient Reported Outcomes (PRO) Registry in Patients With Advanced Renal Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
Evaluation of patient reported outcomes ( PRO) regarding typical ailments in the REAL LIFE Renal Cell Carcinoma population

Detailed Description
-----------------
The PRO Kidney project will recruit a representative cohort of patients with advanced renal cell carcinoma (RCC) treated with systemic antiproliferative therapies such as TKIs, mTOR inhibitors, cytokines, antiVEGF or immune therapy. The aim of this study is to collect data on the effectiveness and patients´quality of life on preference in the real life setting. Patient Reported Outcomes ( PRO) are assessed by a questionnaire consisting Functional Assessment of Cancer Therapy ( FACT) Kidney Syndrome Index 19 (FKSI 19) completed by four questions assessing ailments about changes in skin of hands/feet, taste, color of hair and mouth scores. 13 Questions about Fatigue assessed with the Functional Assessment of Chronic IIlness Disease.

Official Title
-----------------
Open-labeled, Multicenter, Non-interventional, Prospective PRO Registry for Patients With First Line Treatment for Advanced RCC Using a Tablet-technology Based Digital Device

Conditions
-----------------
Renal Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed renal cell carcinoma Start of the first line systemic treatment Ability to read and understand German Written informed consent Exclusion Criteria: None

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 |
| --- | --- | --- |
| Primary Outcome Measure (Patient Reported Outcomes (PRO) regarding typical ailments in the real Life RCC population) | Patient Reported Outcomes (PRO) regarding typical ailments in the real Life RCC population | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcome Measures (Patient Reported Outcomes (PRO) regarding the impact of treatment on daily life) | Patient Reported Outcomes (PRO) regarding the impact of treatment on daily life | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient Reported Outcomes
Role of Exercise for Wound Healing in the Larynx

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore quantitatively the hypothesis that resonant voice, may enhance recovery from acute laryngeal phonotrauma, based on molecular assays from human laryngeal secretions and secondarily, clinical tests.

Detailed Description
-----------------
The objective is to use the following operationalized question: Does a voicing mode shown to correspond to high-amplitude, low impact vocal cord oscillations, resonant voice, improve the amount and time-course of recovery from acute phonotrauma, compared to vocal rest or spontaneous speech, as measured with molecular assays (primarily) and with behavioral and clinical tests (secondarily)?

Official Title
-----------------
Role of Exercise for Wound Healing in the Larynx

Conditions
-----------------
Acute Phonotrauma

Intervention / Treatment
-----------------
* Behavioral: Resonant voice
* Behavioral: Voice rest
* Behavioral: Spontaneous speech


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males and females who have had voice training and feel they are able to produce loud voice safely; ages 18-49; generally healthy; normal hearing bilaterally at 20 dB to 8,000 Hz; and demonstrated ability to produce resonant voice during training as determined by the examiner perceptually. Exclusion Criteria: current chronic voice problems; current medications that are determined to possibly influence voice (e.g. diuretics, decongestants); heightened gag reflex; small nasal passage; deviated septum; and known or suspected allergy to anesthetics.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Voice rest<br> | Behavioral: Voice rest<br>* 4-hr of complete refrain from any voice use<br>|
| Experimental: Resonant voice exercise<br> | Behavioral: Resonant voice<br>* 4-hr of resonant voice exercise<br>|
| Experimental: Spontaneous speech<br> | Behavioral: Spontaneous speech<br> <br> * Other names: 4-hr of conversational (normal) voice use;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers in laryngeal secretions |  | Up to 24-hour post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phonation Threshold Pressure (PTP) |  | Up to 24-hour post baseline | 
| Direct Magnitude Estimations of phonatory effort (DME) |  | Up to 24-hour post baseline | 
| Visual-perceptual ratings of the larynx |  | Up to 24-hour post baseline |
Intraoperative Pleth Variability Index (PVI) Variability

Study Overview
=================
Brief Summary
-----------------
Pleth Variability Index (PVI) is a variable that is derived from photoplethysmography (PPG) signal. It is used as a surrogate for intravascular volume status intraoperatively. PVI can have significant amount of baseline variability which appears to oscillate at a very low frequency (5-10 minute cycles). This study aims to investigate the origin of these baseline oscillations.

Detailed Description
-----------------
PVI is derived from the infrared photoplethysmography signal. Intraoperatively during mechanical ventilation it reflect fluid responsiveness which is a surrogate endpoint of intravascular volume. PVI signal appears to have significant baseline variability which can not be explained by rapid changes in intravascular fluid volume. The baseline PVI changes also appear to oscillate at a very low frequency, much below any previously identified spontaneous vascular oscillations. The aim of this study is to investigate weather the PVI variability originates from changes in the infrared photoplethysmography signal or if they are possibly due to the algorithm calculating PVI.

Official Title
-----------------
Intraoperative Pleth Variability Index (PVI) Variability

Conditions
-----------------
Intraoperative Monitoring

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neurosurgical patients for tumor resection neurointerventional patients general anesthesia with mechanical ventilation communicates in english (consent) over 18 years of age Exclusion Criteria: unable to sign consent less than 18 years of age

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 |
| --- | --- |
| neurosurgical patients<br>Neurosurgical patients undergoing craniotomies for tumor. 25 subjects | |
| Neurointerventional patients<br>Patients undergoing neurointerventional procedures under general anesthesia. 25 subjects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PVI variability | PVI variability will be compare to raw infrared photoplethysmography signal | 1 hour |
Brilinta Clinical Experience Investigation

Study Overview
=================
Brief Summary
-----------------
To confirm the following safety topics in patients to be treated with BRILINTA tablets 60 mg or 90 mg (hereinafter referred to as BRILINTA) in clinical practice in the post-marketing phase. Profile and incidence of ADRs The CEI will be conducted to collect data of the events, especially focusing on bleeding, dyspnoea and bradyarrhythmia so as to investigate onset, outcome, treatment for the event, and risk factors for these events, etc. Profile and incidence of ADRs not expected from Precautions for Use of the ticagrelor JPI Efficacy: Profile and incidence of cardiovascular events (cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke) Factors which may affect safety or efficacy of ticagrelor

Official Title
-----------------
Brilinta Tablets 60mg/90mg Clinical Experience Investigation

Conditions
-----------------
Acute Coronary Syndrome, Old Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with BRILINTA for ACS or OMI, which is the indication of the drug. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 130 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 |
| --- | --- | --- |
| Adverse event incidence |  | from baseline to 4 years | 
| Incidence of ADRs not expected from Precautions for Use of the ticagrelor JPI |  | from baseline to 4 years | 
| Incidence of cardiovascular events |  | from baseline to 4 years | 
| Factors which may affect incidence of bleeding, dyspnoea, bradyarrhythmia, analysed by patient demographic characteristic and by treatment |  | from baseline to 4 years | 
| Factors which may affect incidence of cardiovascular events, analysed by patient demographic characteristic and by treatment |  | from baseline to 4 years |
Effect of Increased Protein Intake on Colonic Metabolism

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to modulate the protein fermentation and to investigate the effect on colon toxicity.

Official Title
-----------------
Influence of a Protein Diet on the Colonic Metabolism and Phosphorus Housekeeping in Healthy Volunteers.

Conditions
-----------------
Protein Fermentation, Toxicity in the Colon

Intervention / Treatment
-----------------
* Dietary Supplement: High protein intake
* Dietary Supplement: Low Protein intake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Regular eating pattern (3 meals/day) Age between 18 and 45 years old BMI between 18,5 and 30 kg/m² Exclusion Criteria: Intake of antibiotics in the last month before the study Abdominal surgeries in the past (accept appendectomy) Consulting a dietician/following a diet Vegetarian Intake of pre- and/or probiotics Exposure to radioactivity in the year proceeding the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Protein intake<br> | Dietary Supplement: High protein intake<br>* 30% of energy intake coming from proteins<br>|
| Experimental: Low Protein intake<br> | Dietary Supplement: Low Protein intake<br>* 9% of energy intake coming from proteins<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal water toxicity |  | Participants were followed for 5 weeks, with measurements on 3 specific time points |
Cognitive Functioning Related to Job Tenure Among Patients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The aim of this research is to explore which cognitive function would affect the job tenure among people with schizophrenia. The investigators plan to recruit 60 people diagnosed with schizophrenia and divide into two groups, employment and unemployment. The investigators will use several cognitive function tests to collect their cognitive functions and PANSS to evaluate their psychotic symptoms. And then the investigators will compare and analysis the data through statistic software. Finally, the investigators will have the answer about if cognitive functions would affect the job tenure among people with schizophrenia. And the investigators hope that we could get the predict factor of cognitive function to predict the successful employment in future.

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: schizophrenia, 18 44y/o Exclusion Criteria: substance abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |