linjc16/ctgov huggingface dataset:
Long-term Paired Associative Stimulation as a Treatment for Incomplete Spinal Cord Injury of Non-traumatic Origin

Study Overview
=================
Brief Summary
-----------------
The investigators have recently shown in incomplete SCI patients that long-term paired associative stimulation is capable of restoring voluntary control over some paralyzed muscles and enhancing motor output in the weak muscles (1). In this study, the investigators will administer long-term paired associative stimulation to patients with incomplete SCI of non-traumatic origin.

Official Title
-----------------
Long-term Paired Associative Stimulation as a Treatment for Incomplete Spinal Cord Injury of Non-traumatic Origin

Conditions
-----------------
Spinal Cord Diseases, Spinal Cord Injuries

Intervention / Treatment
-----------------
* Device: long-term paired associative stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: incomplete SCI of non-traumatic origin Exclusion Criteria: epilepsy metal inclusion in the head area pacemaker hearing device high intracranial pressure

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Long-term PAS<br>The intervention is given to one hand only | Device: long-term paired associative stimulation<br>* Paired associative stimulation (PAS) administered several times per week for 6 weeks to one hand. PAS comprises transcranial magnetic stimulation (eXimia magnetic stimulator, Nexstim Ltd, Helsinki, Finland) and peripheral nerve stimulation (given with Dantec Keypoint® electroneuromyography device (Natus Medical Incorporated, Pleasanton, CA, USA)).<br>|
| No Intervention: No intervention<br>Contralateral hand of the same patient | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daniels and Worthingham's Muscle Testing | each hand muscle is evaluated on 0-5 scale | 2 days after the last stimulation session | 
| Daniels and Worthingham's Muscle Testing | each hand muscle is evaluated on 0-5 scale | 1 month after the last stimulation session |
Minimally Invasive Biomarker for Asthma Disease Severity

Study Overview
=================
Brief Summary
-----------------
Can a clinical test be developed that could help manage asthma symptoms?

Detailed Description
-----------------
Project goals: Develop a point-of-service assay to assess eosinophilic airway inflammation Proposal Specific Aims: To establish the infrastructure and test the feasibility of sputum collection in a clinical setting as a minimally invasive patient sampling process for biomarker testing To transform the laboratory-based eosinophil peroxidase (EPX) ELISA detection assay into a clinic-friendly assessment that does not require sophisticated laboratory equipment

Official Title
-----------------
Feasibility of Using an Eosinophil-Specific Biomarker-(Eosinophil Peroxidase) in Clinical Practice

Conditions
-----------------
Asthma, Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Asthma subjects: Inclusion Provider diagnosed asthma FeNO>50 ppb FEV1 > 1.0 Liter Exclusion COPD by history Bronchiectasis by history Pregnant participants Normal subjects: Inclusion - Age matched to asthma subjects Exclusion Any eosinophil disorder by history Asthma by history Rhinitis or sinusitis by history

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sputum Induction | Primary Outcome measure via EPX levels (at point of care) in the sputum of asthma patients and control subjects as a means of demonstrating the ability to use this biomarker approach in a clinical setting. | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, healthy volunteers, sputum eosinophils
The Influence Body Position and Axial Load on Spinal Stiffness

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to examine the influence of body position and additional axial load on spinal stiffness in young healthy adults.

Detailed Description
-----------------
Spinal stiffness plays an important role in the assessment of the spine in the clinical daily routine. It is often performed as a manual PA-pressure test in the prone position. The spinal stiffness is the result of the resistance from the active, passive and neurological subsystems, like muscles (active), ligaments, joint capsule and the skin (passive). Further research had shown, that the spinal stiffness depends also from other factors. It is increased by axial compression. A better understanding of spinal stiffness leads to novel insights into spinal stabilization mechanisms.

Official Title
-----------------
Assessing Normative Data, Reliability and the Influence of Body Position and Axial Load on Spinal Stiffness by Electromechanical Measurements in Young Healthy Adults

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Diagnostic Test: Spinal stiffness


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy Exclusion Criteria: Acute backpain (thoracal or lumbar) History of significant backpain (thoracal or lumbar) or radiating pain down the leg Contraindications to PA mobilisation/manipulation Spinal fractures Spinal tumors Surgical intervention in the thoracic and lumbar spine Local infections of the spine or the surrounding tissue

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Spinal stiffness|Spinal stiffness will be assessed with a device, which measures tissue compliance according to the concept of impulse-response|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spinal stiffness | posterior-to-anterior spinal will be assesd in prone and upright body position and in upright body position with additional axial. The device measures tissue compliance according to the concept of impulse-response. A force of exact 80 Newton will be applied from the device to the process spinous. The expected impulse-response (result) will be between 40 Newton and 70 Newton. | Day one of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during measuring spinal stiffness | Visual Analogue Pain Rating Scale will be used if the particepants feel any pain during the measurement.The participant will be asked to rate his pain intensity on a straight line (100 millimeter) with two endpoints. | Day one of the study |
Evaluation of Bladder Volumes in Patients Receiving Radiotherapy to the Rectum, Using Kilovoltage Cone-beam Imaging

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to implement and access a newly developed bladder filling protocol for patients receiving radiotherapy for rectal cancer using imaging on the treatment unit.

Official Title
-----------------
Evaluation of Bladder Volumes in Patients Receiving Radiotherapy to the Rectum, Using Kilovoltage Cone-beam Imaging

Conditions
-----------------
Rectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving radical radiotherapy to rectal malignancies. Age > 18 years old No previous lower GI radiotherapy Written informed consent according to good clinical practice (GCP) and national / local regulations. Exclusion Criteria: Patients receiving palliative radiotherapy to rectal malignancies. Patients receiving radical short course preoperative radiotherapy for rectal malignancies. Patients unable to give informed consent.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients who are able to achieve a bladder volume within +/- 30% of planning volume, on all treatment CBCT (cone beam computed tomography) scans |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The per-patient standard deviation of bladder volume throughout the course of radiotherapy |  |  | 
| The percentage of patients who are unable to follow the bladder filling protocol at any point during their treatment. |  |  | 
| The correlation between bladder volume and small bowel volume planning target volume |  |  |
Evaluation on the Proper Size of the Nasotracheal Tube and Depth in Nasotracheal Intubation: a Preliminary Study

Study Overview
=================
Brief Summary
-----------------
The nasotracheal intubation is preferred for oral surgery; it provides an easier view of the surgical field. However, nasotracheal tubes are produced by foreign countries. Tubes are often not fitted in anatomy of Korean people because of small nostril. When the size of the tube is chosen by nostril size, the length of nasotracheal tube is not appropriate to the glottis. The aim of this study is to evaluate on the proper size of the nasotracheal tube and depth in nasotracheal intubation in Korean. Forty patients (20 males and 20 females) who are scheduled for nasal intubation for general anesthesia will be enrolled. The primary outcome is the proportion of patients who are in inappropriate insertion of nasotracheal tube; the proximal end of tube's cuff is less than 2 cm below vocal cord. The size of nostril, length from the nare to the carina and vocal cord are measured.

Conditions
-----------------
Nasotracheal Intubation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are scheduled for nasotracheal intubation for general anesthesia Exclusion Criteria: age < 20 years and age > 70 years ASA(American Society of Anesthesiologist) class III or more pregnancy emergency surgery nasal airway disease expected difficult intubation (difficult intubation history, Modified Mallampati score 4, mouth opening <2cm, facial anomaly) unstable teeth

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| Group Nasotracheal Intubation<br>Patients who are scheduled for nasotracheal intubation for general anesthesia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of the inappropriate insertion of nasotracheal tube | the inappropriate insertion of nasotracheal tube; the proximal end of tube's cuff is less than 2 cm below vocal cord | 5 minutes after induction of general anesthesia |
East Asian Breast Cancer Genome Atlas and Recurrence Risk Prediction

Study Overview
=================
Brief Summary
-----------------
This project aims to establish the cancer genome atlas and the platform of recurrence risk prediction specific for East Asian breast cancer patients. The study was planned to collect blood sample, fresh tumor tissue, and paraffin embedded tumor tissue from 2000 patients. Aims to identify unique genetic alterations in Asian tumors, to identify the susceptible genes for breast carcinogenesis in East Asia, and to establish the new platform for accurate prediction of recurrence. The investigator will explore the association of patient outcomes with the genetic alterations from the cancer atlas of East Asian breast tumors.

Official Title
-----------------
The Cancer Genome Atlas and Recurrence Risk Prediction of East Asian Breast Cancer: a Multicenter Collaborative Study

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

Intervention / Treatment
-----------------
* Other: PAM50


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Aged more than 20-year-old at the time of informed consent. 2. An unconfirmed breast tumor, or have histologically confirmed invasive breast cancer. 3. Have radiological or objective evidence of breast tumor size ≥1 cm. 4. Be able to comply with study procedures to collect the clinical medical information, blood sample, fresh tumor tissue, and 12 sections of paraffin embedded tumor tissue. 5. Be able to sign an informed consent. Exclusion Criteria: 1. Have histologically confirmed ductal carcinoma in situ (DCIS). 2. Stage I, II or III breast cancer patients who have received neoadjuvant treatments, including chemotherapy, hormonal therapy, or targeted therapy. 3. Stage IV or metastatic breast cancer patients who have received chemotherapy.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: PAM50|PAM50 results is as one of the references for the physicians and the participants to choose adjuvant treatments.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of unique genetic alterations | To establish the cancer genome atlas and identify the susceptible genes for breast carcinogenesis in East Asia | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate | To establish the new platform for accurate prediction of recurrence | 10 years |
Laparoscopic Versus Open Appendectomy in Pregnancy

Study Overview
=================
Brief Summary
-----------------
The aim of this retrospective trial is to compare surgical and pregnancy outcomes of pregnant patients who underwent laparoscopic or open appendectomy for acute appendicitis.

Detailed Description
-----------------
The aim of this retrospective trial is to compare surgical and pregnancy outcomes of pregnant patients who underwent laparoscopic or open appendectomy for acute appendicitis. Patients' medical records from 2010-2020 were extracted using billing information of the national health insurance fund of Estonia and ICD-10 codes (pregnancy, appendicitis). Collected data was stored on RedCap electronic database and analyzed with R Studio. Two group of patients were compared: pregnant patients who had laparoscopic appendectomy and pregnant patients who had open appendectomy.

Official Title
-----------------
Laparoscopic Versus Open Appendectomy in Pregnancy. 10 Year Results of Estonian Population.

Conditions
-----------------
Appendicitis, Pregnancy Loss, Pregnancy Preterm

Intervention / Treatment
-----------------
* Procedure: Appendectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with confirmed pregnancy who underwent appendectomy for acute appendicitis. Exclusion Criteria: Women who were not pregnant when having an appendectomy
Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant patients who underwent laparoscopic appendectomy<br>Pregnant patients who underwent laparoscopic appendectomy | Procedure: Appendectomy<br>* Appendectomy - laparoscopic or open<br>|
| Pregnant patients who underwent open appendectomy<br>Pregnant patients who underwent open appendectomy | Procedure: Appendectomy<br>* Appendectomy - laparoscopic or open<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obstetrical outcomes | Pregnancy loss (fetal demise) - rate of cessation of pregnancy before scheduled delivery | Pregnancy loss within 9 months from appendectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical outcomes | Surgical complications - rate of infectious complications within 30 days after appendectomy | 30 days after appendectomy |
Safety/Efficacy of Combo Therapy With Aliskiren & Hydrochlorothiazide vs Therapy With Hydrochlorothiazide Alone in Patients With Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to evaluate the safety and efficacy of combination therapy of aliskiren/hydrochlorothiazide (HCTZ) 150/25 mg and 300/25 mg compared with HCTZ 25 mg in patients with hypertension who do not show response to HCTZ 25 mg over a 4-week period.

Official Title
-----------------
An Eight-week Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / HCTZ (150/25 mg and 300/25 mg) in Comparison With HCTZ 25 mg in Patients With Essential Hypertension Not Adequately Responsive to HCTZ 25 mg Monotherapy

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Aliskiren/HCTZ


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female outpatients 18 years old or older. Patients with a diagnosis of hypertension defined as follows: Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP >= mmHg and < 110 mmHg at Visit 1. All patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP >= 85 mmHg and < 110 mmHg at Visit 2. All patients must have a msDBP >= 90 mmHg and < 110 mmHg at Visit 5. Patients who are eligible and consent to participate in the study Exclusion Criteria: Severe hypertension (msDBP >= 110 mmHg and/or MSSBP >=180 mmHg). Previous or current diagnosis of heart failure. History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack, myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention. Other protocol-defined inclusion/exclusion criteria may apply

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aliskiren/HCTZ|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean sitting diastolic blood pressure lowering effect at baseline, and week 8. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean sitting systolic blood pressure (msDBP) lowering from baseline to week 8 |  |  | 
| Safety and tolerability |  |  | 
| Proportion of patients achieving a blood pressure control target at week 8 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diastolic, systolic, hypertension, aliskiren, blood pressure, hydrochlorothiazide, HCTZ
Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags

Study Overview
=================
Brief Summary
-----------------
The aim of the current clinical investigation is to evaluate a new filter

Detailed Description
-----------------
The filter has been developed in order to significantly reduce problems with ballooning and other problems related to filter performance in people with a stoma.

Official Title
-----------------
Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags

Conditions
-----------------
Ileostomy - Stoma

Intervention / Treatment
-----------------
* Device: SenSura
* Device: Morfeus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 18 years of age and have full legal capacity. Have given written informed consent. Be able to fill in the Case Report Form. Be ileostomy operated and have had a stoma for at least 6 months. Experience ballooning at least once per week. Be able to manage the bags themselves (application, removal). Be able to use a flat base plate. Have a stoma with a diameter less than 60 mm Exclusion Criteria: Persons who irrigate Currently suffer from peristomal skin problems (i.e. bleeding or broken skin). Currently receiving or have within the past 2 months received radio- and/or chemotherapy. Pregnant or breastfeeding. Participate in other test at the same time.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sensura<br>SenSura is the reference product and the product is already commercially available | Device: SenSura<br>* The ostomy bag filter will be tested for a period of 14 days<br>|
| Experimental: Morfeus<br>The test product is the product with the proposed new filter (Morfeus) | Device: Morfeus<br>* The new ostomy bag filter will be tested for a period of 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period. | Data will not be recorded at specific time points due to individual changing patterns (1-2 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period. | Daily or at every change of bag in a period of a maximum of 28 days |