linjc16/ctgov huggingface dataset:
RIXUBIS Drug Use-Result Survey (Japan)

Study Overview
=================
Brief Summary
-----------------
The purpose of this survey is to understand the following items observed in the actual clinical use of RIXUBIS. Unexpected adverse drug reactions Occurrence of adverse drug reactions in the actual clinical use Factors that may affect safety and effectiveness Occurrence of Factor IX (FIX) inhibitor development in patients with coagulation FIX deficiency Safety and effectiveness for hemophilia B patients who received routine prophylactic therapy, on-demand therapy and perioperative therapy

Official Title
-----------------
RIXUBIS Drug Use-Result Survey (Japan)

Conditions
-----------------
Hemophilia B

Intervention / Treatment
-----------------
* Biological: RIXUBIS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hemophilia B scheduled to receive treatment with RIXUBIS Exclusion Criteria: Patients not administered RIXUBIS
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Study Participants<br> | Biological: RIXUBIS<br> <br> * Other names: BAX326;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who discontinued the use of Rixubis |  | Throughout the study period, approximately 4 ½ years | 
| Number of participants who developed a Factor IX (FIX) inhibitor |  | Throughout the study period, approximately 4 ½ years | 
| Annual bleed rate (ABR) of participants on a prophylaxis regimen |  | Throughout the study period, approximately 4 ½ years | 
| Number of doses to treat a bleed of participants on an on-demand regimen |  | At bleed resolution throughout the study period of approximately 4 ½ years | 
| Hemostatic effectiveness of Rixubis for participants on an on-demand regimen | Based on a 4-point ordinal scale (none, moderate, good, excellent) | At bleed resolution throughout the study period of approximately 4 ½ years | 
| Hemostatic effectiveness of Rixubis in surgery- perioperative and postoperative | Based on a 4-point ordinal scale (none, moderate, good, excellent) | Assessed at the time of discharge from recovery room; and at 24 to 72 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who experience shock or anaphylaxis |  | Throughout the study period, approximately 4 ½ years | 
| Number of participants who experience a thromboembolism |  | Throughout the study period, approximately 4 ½ years |
Ultrasound Crestal Bone Topography of Edentulous Ridges

Study Overview
=================
Brief Summary
-----------------
A successful implant surgery primarily relies on a prudent evaluation of oral anatomy and meticulous treatment planning. Additionally, of paramount importance that dictates the types of procedures, material selection and ultimately success of implant surgery is the quality and quantity of the edentulous ridge. Ultrasound imaging (US), another cross-sectional imaging modality, has been extensively used in the medical diagnostics field. The ability of ultrasound to image soft tissue-bone interface makes it particularly promising for studying bone ridge width and crestal bone topography. Therefore, this retrospective human study aimed to compare bone width measurements between US and CBCT. This study also investigated the possible correlation between the crestal bone surface quality imaged by US and CBCT.

Official Title
-----------------
Evaluation of Crestal Bone Topography of Edentulous Ridges: A Retrospective Study Comparing Ultrasonography to Cone-Beam Computed Tomography (CBCT)

Conditions
-----------------
Ultrasonography

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient records at the Graduate Periodontal Clinic With both US and CBCT scans taking within 3 months between each other from Jan 2016 to Mar 2020 These images had to include at least one edentulous ridge at the anterior, premolar or molar site. Multiple sites in a given patient may be included.
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 with edentulous ridge<br>This group had edentulous ridge planning to receive a dental implant and had ultrasound and cone-beam computed tomography images of the ridge. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of ultrasound for estimating ridge width | measure the edentulous ridge width at 1, 2 and 3 mm apical to the crest on ultrasound images | up to 3 months after image was taken | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of ultrasound for assessing ridge surface quality | Evaluate the crestal bone surface quality with ultrasound | up to 3 months after image was taken |
Physical Activity in Patients With Gynecological Surgery

Study Overview
=================
Brief Summary
-----------------
Examine whether the measurement and feedback of physical activity increase the physical activity in women who underwent midline incision, gynecological surgery

Conditions
-----------------
Women Who Underwent Midline Incision, Gynecological Surgery

Intervention / Treatment
-----------------
* Behavioral: Physical activity feedback
* Behavioral: Usual care except physical activity measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Midline incision, gynecological surgery Exclusion Criteria: Cannot ambulate Anticipated long term ICU care Cannot wear accelerometer Anticipated discharge before postoperative day 5
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Experimental: Experimental<br>Patients will receive physical activity feedback and be encouraged to achieve the daily goals of physical activity | Behavioral: Physical activity feedback<br> <br> |
| Sham Comparator: Control<br>Physical activity will be measured but not be informed to patients. She will receive usual care. | Behavioral: Usual care except physical activity measurement<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity recovery rate | Baseline physical activity is measured before admission. Specifically, on presurgery day 3 and 4, patients wear accelerometer. The average physical activity of presurgery day 3 and 4 is calculated and be regarded as baseline physical activity. After surgery, the average physical activity of postoperative day 4 and 5 is calculated. The ratio of the average physical activity of postoperative day 4 and 5 versus baseline physical activity is estimated. The ratio is physical activity recovery rate. | Postoperative day 4 and 5 |
A Volumetric Nomogram for Height, Weight, and Intra Abdominal Volume

Study Overview
=================
Brief Summary
-----------------
This is a prospective study to collect a nomogram of intra-abdominal volume correlated with height and weight for O&G patients undergoing minimally invasive surgery.

Detailed Description
-----------------
This is a prospective study from the date of approval of the study for a period of 24 months. The potential participants are from O&G department who will be undergoing laparoscopy The participant's height, weight, and total volume of carbon dioxide gas infused into the abdomen are collected from CPSS to create a standard operative pneumoperitoneum of 18mmHg for all patients undergoing laparoscopic procedures. Patients with an abdomino-pelvic mass, or pelvic masses larger than 12 weeks size, or assessed to have an abdominal mass are excluded. Pregnant and/or breast feeding women are also excluded. Specific patient identifiers will not be collected into the data collection and are not necessary to the study or to achieving to the objective of the study. Therefore data will not contain any identifiers.

Official Title
-----------------
A Volumetric Nomogram for Height, Weight, and Intra Abdominal Volume

Conditions
-----------------
Laparoscopy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: O&G patients that are undergoing laparoscopic surgery. Exclusion Criteria: Patients with an abdomino-pelvic mass Patients with pelvic masses larger than 12 weeks size Patients assessed to have an abdominal mass Pregnant and/or breast feeding women

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing laparoscopy<br>The participants are patients that have undergone the laparoscopic surgery. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creation of a nomogram | The study aims to generate a nomogram. | 2 years | 
| Recording height | in cm | 2 years | 
| Recording weight | In kg | 2 years | 
| Recording intra-abdominal volume during surgery | In ml | 2 years |
Using QPOP to Predict Treatment for Sarcomas and Melanomas

Study Overview
=================
Brief Summary
-----------------
This is a multi-cohort proof of concept study involving patients with sarcomas or melanomas. Patient models, both two- and three-dimensional, will be derived from tumour samples. These will then be used to evaluate drug sensitivities ex vivo. Enrolled patients will undergo resections or biopsies as part of standard-of-care, which will be used to generate patient models. Patients will receive standard-of-care systemic treatment. Patient models will also be subjected up to a 14-drug screening panel. The majority of drugs in the respective drug panels has been shown to have activity in the respective cancers and would be used in the standard-of-care setting by treating physicians.

Detailed Description
-----------------
Hypothesis: Ex vivo drug testing on patient-derived models using QPOP can identify drug sensitivities and combinations which may have clinical efficacy against sarcomas and melanomas. Specific aim 1: To derive patient models, both two- and three-dimensional, of sarcomas and melanomas Specific aim 2: To perform ex vivo drug testing on patient models of sarcoma and melanoma using QPOP Specific aim 3: To assess the efficacy of phenotype directed therapy using QPOP to assign treatment after progression on standard-of-care treatment in sarcoma and melanoma

Official Title
-----------------
Q-SAM (Using QPOP to Predict Treatment for Sarcomas and Melanomas)

Conditions
-----------------
Sarcoma, Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of sarcoma or melanoma At least 1 tumour lesion amenable to fresh biopsy or resection Signed informed consent from patient or legal representative Able to comply with study-related procedures Exclusion Criteria: There are no specific exclusion criteria if patients meet the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| Percentage of patients with successful model generation for each tumour subtype. | Patients enrolled on study will undergo resection or biopsy of fresh tumour tissue to obtain cells for the generation of models. | 8 years. | 
| Rates of radiological response from QPOP-directed treatment regimens. | Complete and partial clinical response and stable disease. | 8 years. | 
| Survival outcomes from QPOP-directed treatment regimens. | Overall survival, progression-free survival. | 8 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Organoids, Tumour-derived models, Ex vivo drug testing, Personalised therapy, QPOP
Monovision vs Multifocal Lens Insertion in Cataract Patients

Study Overview
=================
Brief Summary
-----------------
The investigators would like to assess whether monovision correction of multifocal lens insertion provides more satisfaction to cataract patients following an uncomplicated phacoemulsification surgery.

Official Title
-----------------
Monovision Correction Versus Multifocal Lens Insertion Following Emulsification Cataract Surgery

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Procedure: Phacoemulsification surgery
* Procedure: Phacoemulsification surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bilateral senile cataract Exclusion Criteria: Glaucoma Corneal pathology Fundus pathology Severe neurological/mental diseases that interfere with visual acuity Former intraocular operation

Ages Eligible for Study
-----------------
Minimum Age: 60 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Monovision Group<br>Phacoemulsification surgery with intraocular lens implantation (monovision correction) | Procedure: Phacoemulsification surgery<br>* Phacoemulsification surgery with intraocular lens implantation and monovision correction<br>* Other names: Alcon Intraocular lens SN60WF;|
| Active Comparator: Multifocal Group<br>Phacoemulsification surgery with intraocular lens implantation (multifocal lens insertion) | Procedure: Phacoemulsification surgery<br>* Phacoemulsification surgery with multifocal intraocular lens implantation<br>* Other names: Hoya Intraocular lens PY-60MV;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VF14 score |  | 6 months following operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distant Visual Acuity |  | 6 months following surgery | 
| Near Vision visual acuity |  | 6 months following surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract, phacoemulsification, monovision, multifocal lens
HDAC Activity in Peripheral Skeletal Muscle in COPD

Study Overview
=================
Brief Summary
-----------------
We wish to study the effect of Chronic Obstructive Pulmonary Disease on the activity of the nuclear transcription pathway in peripheral skeletal muscle to determine whether altered activity of this pathway may be responsible for the muscle dysfunction observed in these patients.

Detailed Description
-----------------
Peripheral muscle dysfunction is well recognised in COPD. We wish to study patients who we have found to have weak quadriceps muscles and study the molecular mechanisms underlying this problem. Patients will be well characterised with regard to their physiologic parameters and quadriceps muscle biopsies will be taken. These biopsy samples will be analysed with respect to NFkappaB activity and HDAC activity by nuclear extraction and for muscle inflammatory cytokines. We know that in the lung tissue of COPD patients there is evidence of a reduction in HDAC activity which might be responsible for the higher levels of pronflammatory cytokines in the lung. We will also study a healthy control group and a small selection of patients who are in respiratory failure due to idiopathic scoliosis in the same way.

Official Title
-----------------
The Investigation of HDAC and NF Kappa B Activity in Peripheral Skeletal Muscle in COPD

Conditions
-----------------
COPD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD - Exclusion Criteria: Aspirin therapy Bleeding diasthesis Neuromuscular disease

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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 |
| --- | --- | --- |
Passive Leg Raise Induced Stroke Volume Changes in Elderly Prior to Elective Surgery Measured by LiDCOplusTM

Study Overview
=================
Brief Summary
-----------------
This is a pilot study to investigate whether patients at advanced age are fluid responders via a reversible fluid challenge, the passive leg raise test. This will be measured with a non-invasive cardiac output monitor, the LiDCO (LiDCO Hemodynamic monitoring) .

Detailed Description
-----------------
The intervention is as simple as a passive leg raise with measurement of effect on Stroke volume.

Official Title
-----------------
Passive Leg Raise Induced Stroke Volume Changes in Elderly Prior to Elective Surgery Measured by LiDCOplusTM to Guide Fluid Therapy

Conditions
-----------------
Stroke Volume, Cardiovascular System, Fluid Therapy

Intervention / Treatment
-----------------
* Other: Passive leg raise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients ≥80 years of age, undergoing elective urologic surgical procedure Exclusion Criteria: age <80 years, severe aortic insufficiency, first case of the day on the operation program, unavailability of research personnel and contraindication to Lithium.

Ages Eligible for Study
-----------------
Minimum Age: 80 Years

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

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

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 |
| --- | --- |
| Other: Passive Leg Raise (PLR)<br>The patient is placed in a 45 degree recumbent position. Stroke volume is measured in ml. Intervention:The patient is placed horizontal and the legs are passively raised to 45 degrees. Measurement:The effect of the PLR on Stroke Volume is measured. Thereafter the patient is repositioned to the initial position and Stroke Volume is measured again. | Other: Passive leg raise<br>* By tilting the patient's bed from sitting 45 degrees to supine with legs tilted up 45 degrees we recruit the blood volume in the legs and can measure a reversible fluid challenge on stroke volume.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess passive leg raise responsiveness in spontaneously breathing aged patients. | Stroke volume changes in ml and as per cent change compared to baseline | Within 1 minute of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate whether there is an association between a positive response to passive leg raise on stroke volume and post spinal anesthesia. | Post spinal bloodpressure per cent change or 30 mmHg decrease | 30 minutes |
Respiratory Muscle Endurance Training in Obese Patients

Study Overview
=================
Brief Summary
-----------------
Obese patients are known to have increased work of breathing inducing dyspnea, exercise intolerance and impaired quality of life. Respiratory muscle training is known to increase respiratory muscle capacity, reduce dyspnoea and improve exercise performance in healthy subjects and respiratory patients. The investigators hypothesized that Respiratory muscle training would reduce dyspnoea, increase exercise tolerance and quality of life in obese patients.

Official Title
-----------------
Respiratory Muscle Endurance Training in Obese Patients

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Respiratory muscle training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese patients (BMI > 30 kg/m2), without respiratory pathology (VEMS > 80% predicted, VEMS/CV > 80%) men or women age between 18 and 60 years old Exclusion Criteria: Respiratory, cardiovascular, musculoskeletal diseases Alcoholism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Respiratory muscle traininig<br>Low caloric diet and physical activities + Respiratory muscle endurance training by means of isocapnic voluntary hyperpnoea | Other: Respiratory muscle training<br>* Respiratory muscle endurance training by means of isocapnic voluntary hyperpnoea<br>|
| Active Comparator: Control<br>Low caloric diet and physical activities | Other: Respiratory muscle training<br>* Respiratory muscle endurance training by means of isocapnic voluntary hyperpnoea<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea at rest and during exercise |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise performance (6-min walking distance) Quality of life (SF36 questionnaire) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obese patients (BMI > 30 kg / m²)