linjc16/ctgov huggingface dataset:
Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in oral Cancer patients. Progress-free survival (PFS) will be compared with historical control as defined in the protocol

Detailed Description
-----------------
Radiotherapy improves local control and overall survival for oral cavity cancer patients after surgery. However, limited locoregional control remains a key issue in the management of oral cavity carcinomas. Appropriate target selection is a key issue in the radiotherapy of oral cavity cancer. The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of oral cancer

Official Title
-----------------
Phrase II Single Arm Study of Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral

Conditions
-----------------
Oral Cancer, Radiotherapy; Complications

Intervention / Treatment
-----------------
* Device: PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed oral squamous-cell carcinoma Age > 17 years Signed informed consent ECOG Performance status 0-2 Must be able to start RT within 4 weeks after PET/CT simulation Exclusion Criteria: stage IV disease diagnosed before acquisition of staging PET/CT prior radiotherapy to oral and neck Unable to understand study participation Claustrophobia pregnant or breast feeding mothers

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>PET/CT | Device: PET/CT<br>* pet/ct is used as radiotherapy simulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progress free survival |  | baseline to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET/CT
Hysteroscopy With Fundus Uterus Scratching Incision VS Office Hysteroscopy Before ET With Donor Eggs

Study Overview
=================
Brief Summary
-----------------
A prospective randomised control trial of the impact of the fundus edometrial incision during hysteroscopy in oocyte recipients.

Detailed Description
-----------------
A prospective randomised control trial of the impact of the fundus edometrial incision during hysteroscopy in women without intrauterine pathology which is likely to have an adverse effect on reproductive outcomes. The study populations will be constituted by oocyte recipients. Study group: Hysteroscopy with fundus endometrial incision Control group: Office Hysteroscopy without any endometrial injury

Official Title
-----------------
Oocyte Recipients Before Embryo Transfer Randomization: Hysteroscopy With Fundus Uterus Scratching VS Hysteroscopy Without Fundus Uterus Scratching

Conditions
-----------------
Hysteroscopy, Oocyte Recipients

Intervention / Treatment
-----------------
* Procedure: Uterine fundus endometrial incision during hysteroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: oocyte acceptors age 30-50 embryo transfer with Hormone Replacement Therapy embryo transfer within 6 months of hysteroscopy Exclusion Criteria: previous uterine pathology sperm sample <1mil/ml leiomyoma septate uterus

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Incision Group<br>Women following IVF treatment with donor oocytes who underwent during hysteroscopy fundus endometrial scratching by incision, before embryo transfer. | Procedure: Uterine fundus endometrial incision during hysteroscopy<br>* Uterine fundus endometrial scratching during hysteroscopy by incision<br>|
| No incision Group<br>Women following IVF treatment with donor oocytes who underwent office hysteroscopy without fundus endometrial scratching by incision, before embryo transfer. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation Rate | Implantation rate | 6 weeks to 42 weeks after embryo transfer] | 
| Delivery Rate | Delivery Rate | 6 weeks to 42 weeks after embryo transfer] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hysteroscopy, Fundus Endometrial Incision, Oocyte acceptors, pregnancy outcome, uterine scratching
A Validation Study of Near Infrared Fluorescence Imaging of Lymphatic Vessels in Humans.

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the use of Near Infrared Fluorescence imaging on lymphatic vessels in humans. Different parameters that reflect lymphatic function will be tested for intra and inter individual reproducibility. We use 10 healthy test subjects and examine their lymphatic system. All subjects are healthy men between the ages of 20 and 30. When the fluorescent dye indocyanine green, has been injected into the skin on the patients feet, it will be transported through the lymph vessels, resulting in clear visualization of the vessels, using a laser and a EM-CCD camera. On both legs we examine the frequency of vessel contraction and the velocity of lymph moving in vessels. We furthermore use several methods to quantify the vessel function such as the refill time of a vessel, (manually emptied vessel and refill time of 10 cm of a vessel), and pumping pressure (at what pressure lymph can pass a blood pressure cuff). We investigate the activity of vessels over time, and after several interventions such as exercise, and water baths of the foot at different temperatures. The patients are examined for approximately 4 hours and wil be examined again 14 days later.

Conditions
-----------------
Focus of Study is: Near Infrared Fluorescence Imaging

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Exclusion Criteria: lymphedema, edema or vascular disease.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| Frequency of contraction in lymph vessels. |  | At baseline and after 14 days | 
| Pumping pressure |  | At baseline and after 14 days | 
| refill time |  | At baseline and after 14 days | 
| velocity |  | At baseline and after 14 days |
Minimally Invasive Surgery (MIS) for Spine Metastases

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect information on the effect of minimally invasive spine tumor decompression on treated patients. This treatment option is less invasive that the standard surgical decompression and is expected to result in better wound healing, decreased tissue trauma, and decreased pain after surgery.

Detailed Description
-----------------
This is a prospective study designed to analyze the impact that minimally invasive spine tumor decompression has upon quality of life, neurological morbidity, pain, and mortality. Prospective findings will be compared with historical controls to determine whether the minimally invasive approach offers better outcomes than traditional treatment methods.

Official Title
-----------------
Minimally Invasive Surgery for Spine Metastases - A Prospective Study

Conditions
-----------------
Spine Metastases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergone minimally invasive surgery over 18 years of age Exclusion Criteria: unable to give 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MIS<br>Those who received minimally invasive surgical procedures | |
| Control<br>Those who received treatments which include surgical resection, chemotherapy, and radiotherapy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival time | Survival time in days | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulation Index | Hauser Ambulation Index to assess mobility by evaluating the time and degree of assistance required to walk 25 feet. Scores range from 0 (asymptomatic and fully active) to 10 (bedridden). | up to 2 years | 
| Cobb Angle | The Cobb angle is used to quantify the magnitude of spinal deformities. | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Minimally invasive surgery
Study of Sutures Versus Staples for Skin Closure After Surgical Procedures of Hip

Study Overview
=================
Brief Summary
-----------------
Skin closure either by sutures or staples is required after any surgical procedure of the hip. The purpose of this study is to compare the amount of drainage between patients who have had either staples or sutures placed for skin closure.

Detailed Description
-----------------
Skin closure either by sutures or staples is required after any surgical procedure of the hip. The purpose of this study is to compare the amount of drainage between patients who have had either staples or sutures placed for skin closure.

Official Title
-----------------
A Comparative Randomized Efficacy Study of Sutures Versus Staples in Hip Surgical Procedures

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Procedure: Surgical wound closure techniques
* Procedure: Surgical wound closure techniques (Comparator)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must be 18 years of age or greater The patient must need an operative procedure of hip Exclusion Criteria: Patients who are unable to undergo surgery. Patients who have a history of clotting or bleeding abnormalities. Patients who have arthroscopic hip surgery. Patients who have infections.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Staples<br> | Procedure: Surgical wound closure techniques<br>* Subjects will be randomized to either receive sutures or staples during the surical procedure to close the incision<br>Procedure: Surgical wound closure techniques (Comparator)<br>* Subjects will be randomized to either receive sutures or staples during the surical procedure to close the incision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of drainage from skin closure site |  | up to 5 days following surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Comparative, Randomized, Suture, Staples, surgical, Skin, Surgical procedures, operative, Orthopedics, Joint, hip, Surgical procedures of Hip, Operative
A Pilot Study of Early Expulsion Rates of the IUB™ SCu380A

Study Overview
=================
Brief Summary
-----------------
The IUB (Intrauterine ball) is a copper releasing intrauterine contraceptive device consisting of copper beads on a flexible NiTinol wire. It was designed to reduce the pain and bleeding caused by traditional T-shaped copper IUDs and to reduce expulsions. In an initial pilot of 15 women, there were no complications during the 12 months. This observational pilot study of 50 women will determine that the early expulsion rate is not greater than 10% and that there is patient and physician acceptance, so that we can plan a larger randomized controlled trial for efficacy and safety.

Official Title
-----------------
A Pilot Study of Early Expulsion Rates of the IUB™ SCu380A Spherical Copper Intrauterine Contraceptive Device.

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Device: IUB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: requesting non-hormonal intrauterine contraception able to return for ultrasound in 6-8 weeks Exclusion Criteria: History of recent pelvic inflammatory disease Known anemia Dysfunctional uterine bleeding Malignancy or suspected malignant disease of female inner or outer genitalia Known intolerance or allergy to copper and/or copper IUDs Any other significant disease or condition that could interfere with the subject's ability to complete the protocol Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: intrauterine contraceptive device IUB
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IUB<br>There is one arm of women who will have IUBs inserted | Device: IUB<br>* intrauterine contraceptive device<br>* Other names: SCu380A IUB™;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expulsion Rate | The device being expelled from the uterus as documented by ultrasound or by seeing the actual device outside the uterus | at 6-8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication | infection, perforation, pregnancy | 12 months | 
| Acceptability | patient-reported acceptability | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intrauterine device, contraception
Study About Effect of Preoperative Bowel Preparation Versus no Bowel Preparation Before Spinal Surgery

Study Overview
=================
Brief Summary
-----------------
This study investigated the effect of preoperative bowel preparations for patients undergoing spinal fusion surgery.

Detailed Description
-----------------
This was a randomised clinical trial with one control group and two treatment groups. Forty-five elective spinal fusion patients were randomised into three groups who received preoperative treatment with either enema of sorbitol and docusat natrium, Bisacodyl suppository or no bowel preparation.

Official Title
-----------------
Preoperative Bowel Preparation Versus no Preparation Before Spinal Surgery: a Randomised Clinical Trial

Conditions
-----------------
Constipation, Ileus, Surgery

Intervention / Treatment
-----------------
* Drug: Docusate natrium and sorbitol
* Drug: Bisacodyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing spinal fusion surgery Age 15 years or older The patients had to understand oral and written Norwegian. Postoperative pain management via epidural catheter should have been planned. Exclusion Criteria: Constipation Regularly use of enema

Ages Eligible for Study
-----------------
Minimum Age: 15 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enema<br>Docusate natrium and sorbitol, 240 ml enema, the evening before surgery | Drug: Docusate natrium and sorbitol<br> <br> * Other names: Klyx;|
| Active Comparator: Suppository<br>Bisacodyl, suppository 10 mg, the evening before surgery. | Drug: Bisacodyl<br> <br> * Other names: Dulcolax;|
| No Intervention: Control grup<br>No intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defecation within 72 hours postoperatively |  | The study's outcome measures were recorded every evening between 17.00 and 21.00 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative constipation |  | The study's outcome measures were recorded every evening between 17.00 and 21.00 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal surgery, Bowel preparation, Ileus, Constipation, Well-being
Inspiratory Muscle Training in Pulmonary Arterial Hypertension

Study Overview
=================
Brief Summary
-----------------
Pulmonary arterial hypertension is a rare condition characterised by high blood pressure in the lungs and results in breathlessness and reduced exercise capacity for patients. Previous research has shown weakness in respiratory muscles in these patients that may contribute towards their symptoms. Despite advances in medical therapy, the condition still results in a significant symptom burden. Inspiratory muscle training is a non-invasive intervention involving a device that provides resistance to the muscles of inspiration and increases their strength. This study will investigate the benefit of inspiratory muscle training in patients with pulmonary arterial hypertension who are stable on medical therapy for three months. This will be performed as an outpatient and they will then be reviewed following this with assessment of exercise capacity, breathing capacity (spirometry), quality of life, and assessment of neural respiratory drive (the signals from the brain to the muscles controlling breathing). The study will be based at the Golden Jubilee National Hospital and patients will be recruited from outpatients who are already under the care of the Scottish Pulmonary Vascular Unit.

Official Title
-----------------
Inspiratory Muscle Training in Pulmonary Arterial Hypertension

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Device: Inspiratory muscle training device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed by pulmonary hypertension specialist with precapillary pulmonary hypertension able to give consent stable on medical therapy for at least 3 months Exclusion Criteria: significant contribution to pulmonary hypertension from lung disease pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Inspiratory muscle training device|Inspiratory muscle training, 6 cycles of 30 breaths for 12 weeks.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six minute walking distance |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life: emPHasis 10 score | emPHasis 10 score | 3 months | 
| Peak VO2 | Assessed by cardiopulmonary exercise test | 3 months | 
| VE/VCO2 slope | Assessed by cardiopulmonary exercise test | 3 months |
Minimal Invasive TLIF Arthrodesis Using Augmented Reality Navigation for Percutaneous Pedicle Aiming

Study Overview
=================
Brief Summary
-----------------
Surgery for degenerative spondylolisthesis requires decompression of the narrow lumbar canal and fixation by osteosynthesis-arthrodesis. Conventional surgery is done through the open route. For 10-15 years, minimally invasive techniques have been established, allowing faster postoperative recovery for the patient. The downside to these techniques is the use of intraoperative fluoroscopy. This is why surgical navigation systems have been developed, allowing safe positioning of implants (pedicle screws). A new process (augmented reality navigation) has been tested in vitro and applied in open surgery. The HUS were the first establishment to apply this new method in minimally invasive surgery in a hybrid room of surgery and interventional radiology.

Official Title
-----------------
Minimal Invasive TLIF Arthrodesis Using Augmented Reality Navigation for Percutaneous Pedicle Aiming

Conditions
-----------------
Arthrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject (≥18 years old) Subject operated at the HUS between March and December 2019 Subject with a surgical indication for arthrodesis and decompression of the lumbar canal for degenerative spondylolisthesis L3-L4 or L4-L5 Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research. Exclusion criteria: Subject having expressed opposition to participating in the study Subject under guardianship or guardianship Subject under safeguard of justice

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Retrospective description of minimally invasive surgery using augmented reality navigation |  | Files analysed retrospectively from March 01, 2019 to December 31, 2019 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fluoroscopy., Arthrodesis, Arthrosis, Spondylolisthesis, Degenerative spondylolisthesis, Osteosynthesis-arthrodesis, Pedicle screws