linjc16/ctgov huggingface dataset:
Health-promoting Competence, Coping and Quality of Life in Patients With COPD

Study Overview
=================
Brief Summary
-----------------
Chronic obstructive pulmonary disease (COPD) is a major cause of mortality and disability, and by 2020, it is expected to be the third leading cause of mortality worldwide. COPD is a major public health concern and has considerable impact on health and quality of life. For this study an evidence based self-management program is developed, the purpose of the study is to see if this self-management program, in collaboration between specialized health services and municipality health services, improves patients with COPD health-promoting competence, coping and quality of life, and reduces health service costs.The study has a RCT design.

Official Title
-----------------
Health-promoting Competence, Coping and Quality of Life in Patients With COPD

Conditions
-----------------
COPD, Coping, Quality of Life

Intervention / Treatment
-----------------
* Other: Self management program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of COPD, GOLD 2-4 Speak and understand norwegian Adult Exclusion Criteria: -

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: self management program<br>Participation in an 11 week self-management program | Other: Self management program<br> <br> |
| No Intervention: Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health promoting competence, HeiQ |  | Before, after, and 3,6 and 12 months after comlepting the intervention (self-management program) |
Prognostic Factor in the Patients With Benign Prostatic Hyperplasia Who Undergo Holmium Laser Enucleation of the Prostate

Study Overview
=================
Brief Summary
-----------------
Prognostic factor in the patients with benign prostatic hyperplasia (BPH) who undergo holmium laser enucleation of the prostate

Official Title
-----------------
Prognostic Factor in the Patients With Benign Prostatic Hyperplasia Who Undergo Holmium Laser Enucleation of the Prostate

Conditions
-----------------
Benign Prostatic Hyperplasia (BPH)

Intervention / Treatment
-----------------
* Procedure: holmium laser enucleation of the prostate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patient scheduled to undergo prostatectomy using holmium laser Exclusion Criteria: Urethral stricture, large bladder diverticulum, bladder neck contracture
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: holmium laser enucleation of the prostate|undergo holmium laser enucleation of the prostate|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of IPSS(International Prostate Symptom Score) changes | Complete the questionnaire(IPSS) before and after the treatment | pre-operation and post-operation (3month, 6month) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of voided urine volume | Comparison of voided urine volume | pre-operation and post-operation (3month, 6month) | 
| changes of residual urine volume | Comparison of residual urine volume | pre-operation and post-operation (3month, 6month) | 
| Occurrence of adverse event | collection of adverse event | post-operation (3month, 6month) |
Modulation Contrast Microscopy Imaging for Oocyte Quality Assessment

Study Overview
=================
Brief Summary
-----------------
The present study aims to describe novel non-invasive parameters related to the competence of female reproductive cells (oocytes). In a fertility unit, human reproductive cells and embryos are subjected to different imaging technologies. Images can easily be obtained without disturbing the microenvironment during different standard procedures. Turning images into quantifiable data might provide a further understanding on oocyte behavior and performance in the laboratory.

Official Title
-----------------
Efficiency of Modulation Contrast Microscopy Image Analysis as a Predictive Tool for Human Oocyte Quality

Conditions
-----------------
Oocyte Competence

Intervention / Treatment
-----------------
* Other: Image acquisition and analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intracytoplasmic sperm injection Embryo culture with subsequent fresh embryo transfer Exclusion Criteria: - Conventional IVF

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Image acquisition and analysis|Oocyte image obtention and analysis prior to intracytoplasmic sperm injection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation | Number of gestational sacs seen on ultrasound scan | 6 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live Birth | Baby to be born after embryo transfer | 40 weeks gestation | 
| Fertilisation | Appearance of two pronucleii after insemination | 17 ± 1 hours post insemination | 
| Embryo quality clevage | Quality after three days of culture | 68 ± 1 hours post insemination | 
| Embryo quality Blastocyst | Quality at the blastocyst stage | 116 ±2 hours post insemination | 
| Euploidy | Number of chromosomes (if available, after PGT-A) | 2-3 weeks post insemination | 
| Nuclear maturity | Presence of meiotic spindle (if available, PolScope) | 36-41 post hCG | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oocyte, Embryo, Development, Pregnancy, Competence
Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The current study is a prospective phase II study; Eligible patients will receive hypofractionated Irradiation at a total dose of 28.5Gy in 5 once-weekly fractions of 5.7Gy in 5 weeks to the Whole Breast or chest wall with or without peripheral lymphatic irradiation.

Detailed Description
-----------------
Testing the feasibility of a hypofractionated adjuvant radiotherapy regimen after breast surgery on a-once-weekly basis for a total dose of 28.5Gy in 5 fractions over 5 weeks in Kasr EL Aini Hospital.

Official Title
-----------------
Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer: A Single Institution Feasibility Study

Conditions
-----------------
Breast Cancer, Radiotherapy Side Effect

Intervention / Treatment
-----------------
* Radiation: Weekly hypofractionation for early breast cancer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven diagnosis of invasive breast adenocarcinoma. Prior radical surgery (Modified Radical Mastectomy or Breast Conservative Surgery). No macroscopic evidence of distant metastases at diagnosis. Exclusion Criteria: Prior radiation to the thoracic region. Pregnancy. Patients with synchronous or prior malignancy. Positive surgical margins.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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: Hypofractionation<br>Hypofractionated whole breast radiotherapy using a dose of 28.5 Gy over 5 fractions with once weekly fractions. | Radiation: Weekly hypofractionation for early breast cancer<br>* Testing the feasibility of a hypofractionated adjuvant radiotherapy regimen after breast surgery on a-once-weekly basis for a total dose of 28.5Gy in 5 fractions over 5 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cosmetic breast appearance | according to HARVARD cosmesis scale: 1 Excellent, 2Good, 3 Fair and 4 Poor | six months | 
| Acute radiation toxicity assessment | according to the RTOG acute toxicity scale: 0 No visible change, 1 faint/dull erythema, 2tender/ bright +- dry desquamation, 3 patchy moist desquamation, 4 conflueunt moist desquamation, pitting edema, 0 is the best and 4 is the worse. | six months | 
| Patient quality of life assessment. | according to FACT-B | six months | 
| Patient satisfaction. | according to FACIT-TS-PS | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Radiotherapy, Hypofractionation
Efficacy of Systane Ultra in Post Menopausal Women With Dry Eye

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of Systane Ultra in post menopausal women with dry eye.

Conditions
-----------------
Post Menopausal Dry Eye Subjects

Intervention / Treatment
-----------------
* Other: Systane Ultra Lubricant Eye Drops
* Other: Sensitive Eyes Eye Drops (Bausch & Lomb)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post-menopausal (menses ceased more than 12 months prior to the start of the study). Diagnosed for dry eye Exclusion Criteria: History of Sjögren's Syndrome or evidence of chronic dry eye syndrome. Confirmed autoimmune connective tissue diseases such as rheumatoid arthritis, fibromyalgia or scleroderma. Active and severe blepharitis, rosacea and associated ocular sequelae. Has any significant eyelid abnormality affecting lid function.

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systane Ultra<br>Systane Ultra Lubricant Eye Drops | Other: Systane Ultra Lubricant Eye Drops<br>* 1 to 2 drops in each eye 4 times per day for 30 days<br>|
| Active Comparator: Sensitive Eyes<br>Sensitive Eyes Eye Drops (Bausch & Lomb) | Other: Sensitive Eyes Eye Drops (Bausch & Lomb)<br>* 1 to 2 drops in each eye 4 times per day for 30 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in corneal staining |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient acceptability / comfort |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry Eye, Post Menopausal dry eye
Utility of Indwelling Catheter in Orthopaedic Patients Receiving Spinal Anesthesia

Study Overview
=================
Brief Summary
-----------------
A study measuring utility of indwelling bladder catheter placement in orthopaedic surgical patients receiving spinal anesthesia. Study will track clinical outcomes, patient satisfaction and cost efficacy. Absence of indwelling bladder catheter may decrease urinary tract infection (UTI) incidence, increase patient satisfaction, and decrease cost burden without increasing postoperative urinary retention (POUR) incidence.

Conditions
-----------------
Total Joint Arthroplasty

Intervention / Treatment
-----------------
* Device: Foley Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective orthopaedic surgical patients of all ages undergoing lower extremity adult reconstructive surgery with spinal anesthesia will be interviewed. Exclusion Criteria: Patients are excluded from the study preoperatively with a history of prostate or urological surgery, renal failure, previous documented POUR, current indwelling catheter, or acute UTI.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No foley catheter<br> | |
| Active Comparator: Foley Catheter<br> | Device: Foley Catheter<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Chest Tube Drainage of Transudative Pleural Effusions Hastens Liberation From Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether chest tubes to drain transudative pleural effusions helps patients come off mechanical ventilation earlier.

Official Title
-----------------
Chest Tube Drainage of Transudative Pleural Effusions Hastens Liberation From Mechanical Ventilation

Conditions
-----------------
Liberation From Mechanical Ventilation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with transudative pleural effusion and requiring mechanical ventilation Exclusion Criteria: Patients with coagulopathy

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 |
| --- | --- |
| Standard care<br>Treatment of pleural effusion with diuresis | |
| Chest tube<br>Treatment of pleural effusion with diuresis and chest tube | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Days of Mechanical Ventilatory Support |  | days |
Investigation of the Contents and Prognostic Values of Glucose Metabolism Molecules in Patients With Lung Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
Detect the contents of glucose metabolism molecules in the tumor and adjacent normal samples of about 100 patients with lung adenocarcinoma using mass spectroscopy. Analyze the correlation between the contents and the clinicopathological characteristics and survival.

Official Title
-----------------
Investigation of the Contents and Prognostic Values of Glucose Metabolism Molecules in Patients With Lung Adenocarcinoma

Conditions
-----------------
Diagnosis, Lung Cancer, Glycolysis, Survival

Intervention / Treatment
-----------------
* Diagnostic Test: Diagnostic test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary lung adenocarcinoma Exclusion Criteria: Other tumor histories, received radiotherapy or chemotherapy before surgery, tumor or adjacent normal tissues can't be obtained, patient rejected.

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 |
| --- | --- |
| lung adenocarcinoma<br>patients with lung adenocarcinoma | Diagnostic Test: Diagnostic test<br>* detect the contents of glucose metabolism molecules using mass spectrum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival | disease-free survival | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | overall survival | 1 month |
Perioperative Lactate Kinetics in Patient Undergoing Major Liver Surgery

Study Overview
=================
Brief Summary
-----------------
Major liver surgery is associated with increased incidence of perioperative complications and increased mortality if these are not addressed quickly in a high dependency intensive care unit. Of these, posthepatectomy liver failure (PHLF) represents one of the most important cause of postoperative unfavourable outcome. The present study investigates the correlation between lactate levels and PHLF. Lactate levels were collected at six specific timepoints: preoperative, pre-dissection phase, post-dissection phase, end of surgery and 24-hours and 48-hours in the postoperative period.

Official Title
-----------------
Evaluation of Lactate Levels in as a Risk Factor for Posthepatectomy Liver Failure

Conditions
-----------------
Liver Failure, Acute

Intervention / Treatment
-----------------
* Diagnostic Test: serum lactate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing major liver surgery for primary or secondary tumours Exclusion Criteria: unsigned patient consent death within 24 hours need for perioperative renal replacement therapy underlying liver disease (e.g. liver cirrhosis) other causes of raised lactate levels (e.g. shock)

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 |
| --- | --- |
| major liver surgery<br>Patients undergoing major liver surgery | Diagnostic Test: serum lactate<br>* perioperative measurement of lactate levels<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lactate levels (mmol/L) in patients with PHLF | correlation of lactate levels with the diagnosis of PHLF | early postoperative period (48 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | in hospital mortality | 30 days mortality |
Temporal Artery Temperature Measurement in Neonates

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the temporal artery thermometer by comparing temporal artery and axillary thermometer temperature measurements with rectal thermometer temperature measurements in neonatal patients. The investigators measured temporal artery, axillary, and rectal temperatures of 49 infants. Temporal artery temperature was measured using an infrared temporal artery thermometer, and the results with this device were compared with axillary temperature (clinical standard) and rectal temperature (gold standard). The difference between rectal and temporal artery temperatures was compared with the difference between rectal and axillary temperatures for each infant, and the data were analyzed based on weight, postmenstrual age and bed type - open crib or incubator.

Official Title
-----------------
Comparing Temporal Artery and Axillary Temperatures With Rectal Temperature in Neonates

Conditions
-----------------
Newborn Infant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in hospital well-baby nursery or neonatal intensive care unit Exclusion Criteria: Birth weight <500 grams Anal atresia Central nervous system malformation Hypoxic-ischemic encephalopathy Clinical concerns for necrotizing enterocolitis or other bowel injury or discontinuity

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

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 |
| --- | --- | --- |
| Temporal Artery Temperature | With commercial infrared temporal artery thermometer | Mean of 2 measurements within 2 minutes of each other and within 2 minutes of axillary and rectal temperature measurements | 
| Axillary Temperature | With commercial digital thermometer | Single measurement within 2 minutes of temporal artery and rectal temperature measurements | 
| Rectal Temperature | With thermistor probe and telethermometer | Single measurement within 2 minutes of temporal artery and axillary temperature measurements | 
| Difference Between Temporal Artery and Rectal Temperatures | Rectal temperature minus temporal artery temperature | Within 2 minutes of each other | 
| Difference Between Rectal and Axillary Temperatures | Rectal temperature minus axillary temperature | Within 2 minutes of each other |