linjc16/ctgov huggingface dataset:
EFFEKT - Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS

Study Overview
=================
Brief Summary
-----------------
The aim of this international prospective, non-interventional post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer in treatment of patients with haemophilia A under daily-life treatment conditions.

Official Title
-----------------
Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS

Conditions
-----------------
Hemophilia A

Intervention / Treatment
-----------------
* Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosis of haemophilia A, treated with KOGENATE Bayer/FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE Bayer/FS. For pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available; for pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available. Exclusion Criteria: Exclusion criteria must be read in conjunction with the local product information.
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)<br>* Haemophilia A patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy and Safety of Kogenate Bayer/FS |  | After 12 months, after 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Octocog alfa, Haemophilia A
Use of Surgify Safety Burr in Hard Tissue Cutting, Head and Spine Area

Study Overview
=================
Brief Summary
-----------------
Purpose of the study: To evaluate whether the SSB is safe, useful, beneficial and effective in drilling, cutting and removal of bone tissue in neurosurgical and spine procedures.

Detailed Description
-----------------
Sponsored observational clinical pilot study with no control group. Aim is to get a maximum of 20 study subjects, who have disease of the spine or head requiring surgery with bone removal and who are willing to participate into this study.

Official Title
-----------------
Surgify2021. Use of Surgify Safety Burr in Hard Tissue Cutting, Head and Spine Area.

Conditions
-----------------
Spine Surgery, Surgery

Intervention / Treatment
-----------------
* Device: Surgify Safety Burr


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Disease of the spine or head requiring surgery with bone removal Ability to understand the purpose and risks of the study and to give written informed consent Age 18-70 years Exclusion Criteria: Previous surgery on the same area Abnormalities of bone tissue Vulnerable patient (such as prisoner, retarded person, person in nursing home, patient in emergency situation) Allergy or hypersensitivity to medical-grade stainless steel or any of alloying components Problems with blood clotting

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Surgify Safety Burr|Use of Surgify Safety Burr in hard tissue cutting, head and spine area|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate usability of SSB | Using video material from operations, microphone recording of the surgeon commentary during drilling and questionnaires to surgeon. | Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week. | 
| To evaluate safety of SSB | AE reporting | Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate effectiveness of SSB | Using video material from operations, microphone recording of the surgeon commentary during drilling | Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week. | 
| To evaluate beneficiality of SSB | Questionnaires to surgeon | Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week |
Anorexia and Personality Traits in Elderly Individuals

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the relationship between age-related anorexia and personality traits in elderly individuals with comorbidities.

Detailed Description
-----------------
There is no study in the literature investigating the relationship between personality traits and age-related anorexia. The aim of this study is to evaluate the relationship between age-related anorexia and personality traits in elderly individuals with comorbidities.

Official Title
-----------------
Anorexia and Personality Traits in Elderly Individuals

Conditions
-----------------
Anorexia, Personality, Aging, Chronic Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being 65 years or older, Volunteering to participate in the study, Being conscious and not having communication problems, Having a Charlson comorbidity index of 1 or higher and/or a diagnosis of hypertension, Being fed orally. Exclusion Criteria: oropharyngeal dysphagia, Presence of neurological or muscular disease that prevents swallowing, Being fed by nasogastric tube, percutaneous endoscopic gastrostomy or intravenous nutrition, Using drugs that affect appetite (corticosteroid, cancer chemotherapy digoxin, opioids, serotonin reuptake inhibitors, topiramate), Using appetizers (megestrol acetate, dronabinol, mirtazapine, growth hormone analogue), Having an active cancer disease, Major neuro-psychiatric disease (Alzheimer's, dementia, major depression, mania, psychosis, etc.), Presence of acute infection, Not having sufficient communication skills (Mini Mental Test score below 24 points).

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| relationship between anorexia and personality traits | relationship between anorexia and personality traits measured by Simplified Nutritional Appetite Questionnaire (SNAQ) and Five Factor Personality Inventory - Short Form scores | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anorexia, personality, aging, Chronic Disease
Remote-controlled Capsule Endoscopy: a Feasibility Study

Study Overview
=================
Brief Summary
-----------------
The present study is a feasibility study to assess the safety and efficacy of wireless capsule endoscope and compare the data obtained with those obtained by using a conventional esophagogastroduodenoscopy. The product was developed and manufacture in China.(the NaviCam. AKC-1.China)

Official Title
-----------------
Remote-controlled Capsule Endoscopy: a Feasibility Study

Conditions
-----------------
Gastric Ulcer, Gastric Polyp

Intervention / Treatment
-----------------
* Device: magnetic-controlled capsule endoscopy(Navicam)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: upper abdominal symptoms (≥1 year ) surveillance gastroscopy for known gastric ulcer or polyps history of gastric ulcer or polyps （≤1w）at Nanfang Hospital were enrolled. Exclusion Criteria: dysphagia suspected or documented digestive tract malformation ,obstruction, strictures or fistula acute upper GI bleeding, acute enteritis, acute ischemia disease history of abdominal operations impaired renal function, congestive heart failure patients with critical condition or mental illness patients with, known allergy to polymer material or antifoam agent patients with cardiac pacemakers or other implanted electromedical devices，magnetic resonance imaging ( mri) examination in 7 days pregnancy

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: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esophagogastroduodenoscopy（ECG）<br>n=15 | Device: magnetic-controlled capsule endoscopy(Navicam)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of complete visualization of anatomic landmarks | the percentage of patients in whom there was complete visualization of the gastric surface in the antrum, body, and fundus and identification of the cardia and pylorus | 2 year | 
| examination time and the percentage of abnormal finding | examination time and the percentage of abnormal findings seen on gastroscopy that were reproducible by capsule endoscopy | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse effect | any discomfort like chest pain, nausea will be documented. capsule retention（defined as not extrusion in 14 days）will be documented. | 2 year | 
| Acceptability | Acceptability to patients was assessed by means of a questionnaire, with ratings on a scale of 0 to 10 and examination chosen for next time. completed in the recovery room immediately after capsule examination. | 2 year |
Methamphetamine Abuse Treatment in Patients With AIDS - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of desipramine, sertraline, and placebo on methamphetamine dependent gay men with AIDS.

Official Title
-----------------
Methamphetamine Abuse Pharmacology in Patients With AIDS

Conditions
-----------------
Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: Desipramine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.
Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Desipramine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving |  |  | 
| Retention |  |  | 
| Depression |  |  | 
| Methamphetamine use |  |  | 
| Anxiety and Depression |  |  | 
| ASI Scales (7) |  |  | 
| AIDS medical care engagement |  |  | 
| High risk sexual behaviors |  |  | 
| Mood indicators |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
methamphetamine dependence
The Application of Performance Improvement Principles to the Patient Throughput Process in an Adult Outpatient Pain Treatment Clinic

Study Overview
=================
Brief Summary
-----------------
This study is undertaken to assess and improve the existing patient flow, or so-called throughput process, in an adult outpatient pain treatment clinic.

Official Title
-----------------
The Application of Performance Improvement Principles to the Patient Throughput Process in an Adult Outpatient Pain Treatment Clinic

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Other: Performance Improvement Measures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19-100 years of age. patient presenting to the UAB Highlands Pain Treatment Clinic for initial evaluation and treatment or subsequent follow-up evaluation and treatment. Exclusion Criteria: <19 or >100 years of age a current prisoner

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Medical Management<br>Patient satisfaction under current operational conditions | |
| Interventional Management<br>Patient satisfaction under the PSDA (Plan, do, study, act) performance improvement measures | Other: Performance Improvement Measures<br>* PDSA (Plan, Do, Study, Act) performance improvement measures<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the total time patients spend to receive chronic pain treatment |  | prospective | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total time health care providers must devote to delivering chronic pain treatment |  | prospective | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Pain
BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM

Study Overview
=================
Brief Summary
-----------------
Prospective, multi-center, registry designed to enrol up to 2,000 patients in up to 35 International centers. All patients will receive a BioMatrix AlphaTM stent as per clinical practice and will be followed for 2 years for data collection. Major adverse cardiac events (MACE) results at 9 months will be compared to the results obtained from the BioMatrix FlexTM arm of the LEADERS trial.

Official Title
-----------------
A Post-market Registry of the BioMatrix Alpha TM (Cobalt Chromium Biolimus A9TM (BA9TM) Drug-eluting Stent)

Conditions
-----------------
Coronary Artery Disease, Stable Angina, Ischemia, Acute Coronary Syndrome, NSTEMI, STEMI

Intervention / Treatment
-----------------
* Device: BioMatrix AlphaTM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with the BioMatrix AlphaTM stent per clinical indication and physician's choice; Patients who agree to comply with the follow up requirements; Patients with a life expectancy of > 1 year at time of consent; Patients eligible to receive dual anti platelet therapy (DAPT) according to guidelines; Hemodynamically stable patients. Exclusion Criteria: Inability to provide informed consent; Currently participating in another trial before reaching primary endpoint; Planned surgery within 6 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the perisurgical period; Patient has received an additional stent different from a BioMatrix AlphaTM stent during the index procedure.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: BioMatrix AlphaTM|Cobalt Chromium BA9 TM drug-eluting stent|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or clinically driven target vessel revascularization (TVR). |  | 9 months |
WB-DW-MRI vs CHOLINE-PET/CT for Selecting Treatments in Recurrent Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of whole-body diffusion-weighted magnetic resonance imaging (WB-DW- MRI) in detecting metastases by comparing the results with those from choline-positron emission tomography-computed tomography (choline-PET/CT) in patients with metastatic/oligometastatic prostate cancer. Patients with this disease profile who could benefit from treatment with stereotactic body radiation therapy (SBRT) were selected and their responses to these techniques were rated.

Detailed Description
-----------------
This was a prospective, controlled, unicentric study, involving 46 consecutive patients from our centre who presented biochemical relapse after adjuvant, salvage or radical treatment with external beam radiotherapy, or brachytherapy. After initial tests ( bone scintigraphy, CT, pelvic MRI) 35 patients with oligometastases or without them were selected. 11 patients with multiple metastases were excluded from the study. WB-DW- MRI and choline-PET/CT was then performed on each patient within one week. The results were interpreted by specialists in nuclear medicine and MRI. If they were candidates for treatment with ablative SBRT (SABR) they were then evaluated every three months with both tests.

Official Title
-----------------
WHOLE-BODY DIFFUSION-WEIGHTED MAGNETIC RESONANCE IMAGING (WB-DW-MRI) VS CHOLINE-POSITRON EMISSION TOMOGRAPHY-COMPUTED TOMOGRAPHY (CHOLINE- PET/CT) for Selecting Treatments in Recurrent Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Other: IMAGING STUDY


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prostate cancer histologic diagnostic after one treatment 5 o less lessions Asimptomatic lessions Informed Consent Form signed Exclusion Criteria: Not capability to perform NMR os CT/PET scans

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: IMAGING STUDY|Choline-PET/CT versus NMRscan comparative study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effectiveness of whole-body diffusion-weighted magnetic resonance imaging (WB-DW- MRI) in detecting metastases |  | 2 years |
Vaginal Elasticity Assessment Before and After Surgical Repair for Urinary Stress Incontinence.

Study Overview
=================
Brief Summary
-----------------
Female patients with USI will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after surgery for the repair of the USI. Surgical repair will be performed by a single surgeon who will perform a tension free vaginal tape obturator (TVT-O) repair.

Detailed Description
-----------------
Patients will be recruited and sign a consent form. The patients included are patients with USI that are candidates for a TVT-O repair. Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different points: The day of surgery before surgery. The day after surgery. 3 months post-operational. Every patient will serve as her own control. Demographic, gynecologic and obstetric history will be obtained from patients' electronic files.

Official Title
-----------------
Vaginal Elasticity Assessment Before and After the Affect of Surgical Repair for Urinary Stress Incontinence (USI) on Vaginal Elasticity as Measured by Vaginal Tactile Imaging.

Conditions
-----------------
Stress Incontinence, Female

Intervention / Treatment
-----------------
* Device: Vaginal tactile imager


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any woman undergoing USI repair. Exclusion Criteria: Women with high grade pelvic floor prolapse.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients undergoing USI repair<br> | Device: Vaginal tactile imager<br>* Patients will undergo elasticity assessment with vaginal tactile imaging the be once before surgical repair and twice after during a 3 month interval.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal elasticity assessment | Vaginal elasticity as measured by the vaginal tactile imager | up to 3 months from enrollment |
Effect of Intraoperative Fluid Management on Morbidity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether intraoperative fluid and sodium restriction decreases postoperative morbidity

Official Title
-----------------
Effect of Intraoperative Fluid Management on Morbidity in Patients Undergoing Colorectal Surgery

Conditions
-----------------
Epidural Anesthesia

Intervention / Treatment
-----------------
* Procedure: fluid management
* Procedure: fluid management
* Procedure: fluid management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: epidural anesthesia ASA I-III Exclusion Criteria: metastasized cancer pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>volume and sodium restriction | Procedure: fluid management<br>* volume and sodium restriction<br>|
| Active Comparator: 2<br>volume restriction | Procedure: fluid management<br>* volume restriction<br>|
| Active Comparator: 3<br>liberal fluid management | Procedure: fluid management<br>* liberal fluid management<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause Morbidity |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastral and intestinal function |  | within the first 30 days after surgery | 
| all cause Mortality |  | one year | 
| Gastral and intestinal function |  | one year after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fluid therapy