linjc16/ctgov huggingface dataset:
Ketamine Versus Dexmedetomidine With Local Anesthetic in TAP Block

Study Overview
=================
Brief Summary
-----------------
Comparing the analgesic effects of ketamine and dexmedetomidine when added to local anesthetic in TAP block for postoperative analgesia after lower abdominal cancer surgery.

Official Title
-----------------
Comparison of the Analgesic Effect of Ketamine Versus Dexmedetomidine Added to Local Anesthetic in TAP Block for Lower Abdominal Cancer Surgery

Conditions
-----------------
Postoperative Analgesia, Lower Abdominal Cancer

Intervention / Treatment
-----------------
* Drug: Ketamine
* Drug: dexmedetomidine
* Drug: control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients ASA I and II to whom abdominal surgery for cancer will be conducted will be included in the study Exclusion Criteria: Coagulopathies ASA III or IV, patient refusal, sensitivity to the used drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group,<br>saline in the same volume will be added to the local anesthetic for TAP block in patients undergoing abdominal cancer surgery | Drug: Ketamine<br>* Ketamine at a dose of 0.5mg/kg will be added to bupivacaine 0.25 (total volume 20ml) in each side using sonar guided TAP block<br>Drug: dexmedetomidine<br>* dexmedetomidine at a dose of 1ug/kg will be added to bupivacaine 0.25 (total volume 20ml) in each side using sonar guided TAP block<br>|
| Active Comparator: ketamine group,<br>ketamine in a dose of 0.5mg/kg will be added to the local anesthetic for TAP block in patients undergoing abdominal cancer surgery | Drug: dexmedetomidine<br>* dexmedetomidine at a dose of 1ug/kg will be added to bupivacaine 0.25 (total volume 20ml) in each side using sonar guided TAP block<br>Drug: control group<br>* 20ml of 0.25% bupivacaine will be injected in each side of the TAP block<br>|
| Active Comparator: dexmedetomidine group<br>dexmedetomidine in a dose of 1ug/kg will be added to the local anesthetic for TAP block in patients undergoing abdominal cancer surgery | Drug: Ketamine<br>* Ketamine at a dose of 0.5mg/kg will be added to bupivacaine 0.25 (total volume 20ml) in each side using sonar guided TAP block<br>Drug: control group<br>* 20ml of 0.25% bupivacaine will be injected in each side of the TAP block<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative rescue morphine consumption | postoperative rescue morphine consumption | 24 hours postoperative |
Isolation of Cells From Biopsy Tissue to Aid in Kidney Repair

Study Overview
=================
Brief Summary
-----------------
Endothelial progenitor cells that reside in renal vasculature may be stimulated to initiate differentiation programs during episodes of injury. It is hypothesized that endothelial progenitor cells resident in the kidney can transition to a post-injury phenotype that promotes endothelial repair.

Detailed Description
-----------------
Endothelial dysfunction is central to the pathophysiology of vascular ischemia, bacterial sepsis, toxin-induced thrombotic microangiopathy, and antibody-mediated kidney transplant rejection and often manifest with renal failure. With each of these diagnoses circulating components of the complement cascade bind to endothelial cells and induce disease progression through anaphylactic cellular messaging, monocyte homing, and direct cell membrane disruption. In response to injury during embryologic development avascular metanephric blastema initiate endothelial differentiation. Although circulating hematopoietic progenitor cells have shown therapeutic promise they incorporate into renal vasculature at very low density.

Official Title
-----------------
Isolation of Cells From Biopsy Tissue to Aid in Kidney Repair

Conditions
-----------------
Kidney Diseases, Endothelial Dysfunction

Intervention / Treatment
-----------------
* Diagnostic Test: Cell isolation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only patients who have a clinical indication for kidney biopsy will be considered. All subjects will be at least 18 years of age and may be of any gender. Patients undergoing a native or kidney transplant biopsy will be considered. Exclusion Criteria: Patients not undergoing a kidney biopsy will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Consecutive patients will be consented to obtain kidney biopsy material.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients will have kidney biopsy designated for cell isolation and culture. | Diagnostic Test: Cell isolation<br>* Tissue from kidney biopsy will be used to isolate Cluster Differentiation 34+ cells.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cell growth | Tissue will be isolated and cell viability will be documented by rate of colony growth over one week per patient enrolled. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney disease progression | Isolated cell growth will be compared to serum creatinine of patients | 3 years |
Targeted BEACOPP Variants in Patients With Newly Diagnosed Advanced Classical Hodgkin Lymphoma

Study Overview
=================
Brief Summary
-----------------
The Purpose of this trial is: to determine complete response rate (CRR) after six cycles of chemotherapy to determine complete remission rate (CR/CRr) as final treatment outcome after completion of treatment

Conditions
-----------------
Hodgkin Lymphoma

Intervention / Treatment
-----------------
* Drug: Etoposide
* Drug: Cyclophosphamide
* Drug: Doxorubicin
* Drug: Prednisone
* Drug: Procarbazine
* Drug: Dexamethasone
* Drug: Dacarbazine
* Drug: Brentuximab Vedotin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven classical Hodgkin lymphoma First diagnosis, no previous treatment, age: 18-60 years Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV disease Exclusion Criteria: Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL) Previous malignancy Prior chemotherapy or radiation

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BrECAPP<br>modified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin | Drug: Etoposide<br> <br> Drug: Cyclophosphamide<br> <br> Drug: Doxorubicin<br> <br> Drug: Prednisone<br> <br> Drug: Procarbazine<br> <br> Drug: Brentuximab Vedotin<br> <br> |
| Active Comparator: BrECADD<br>modified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone | Drug: Etoposide<br> <br> Drug: Cyclophosphamide<br> <br> Drug: Doxorubicin<br> <br> Drug: Dexamethasone<br> <br> Drug: Dacarbazine<br> <br> Drug: Brentuximab Vedotin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate (RR) after six cycles of chemotherapy |  | 18 weeks | 
| Complete remission rate (CR/CRr) as final treatment outcome after completion of treatment |  | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) |  | 2 years | 
| Overall survival (OS) |  | 2 years | 
| Adverse event rate |  | 2 years | 
| Dose reduction rate |  | 18 weeks | 
| Relative dose intensity |  | 18 weeks |
Omega-3 Fatty Acids Enriched Food and Microvascular Reactivity

Study Overview
=================
Brief Summary
-----------------
Previous studies have shown that omega-3 fatty acid pills intake have beneficial effect on vascular health in overweight and/or hypertensive patients. However, there is a lack of studies showing the effect of everyday consumption of omega-3 fatty acids enriched food (not pills) on lipid profile and microvascular reactivity in healthy population. This study aimed to determine the effect of omega-3 enriched chicken eggs consumption on microvascular reactivity and lipid profile in young healthy subjects.

Official Title
-----------------
Effect of Omega-3 Fatty Acids Enriched Chicken Eggs Consumption on Microvascular Reactivity and Lipid Profile in Young Healthy Subjects

Conditions
-----------------
Omega-3 Polyunsaturated Fatty Acids

Intervention / Treatment
-----------------
* Dietary Supplement: Omega-3 chicken eggs
* Dietary Supplement: Regular chicken eggs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - healthy volunteers Exclusion Criteria: oral contraceptives drugs that could affect endothelium hypertension coronary artery disease diabetes hyperlipidaemia renal impairment cerebrovascular and peripheral artery disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega-3<br>Intake of 3 omega-3 fatty acids enriched chicken eggs per day for three weeks. | Dietary Supplement: Omega-3 chicken eggs<br>* Intake of 3 omega-3 fatty acids enriched chicken eggs per day for three weeks.<br>|
| Experimental: Regular<br>Intake of 3 regular chicken eggs per day for three weeks. | Dietary Supplement: Regular chicken eggs<br>* Intake of 3 regular chicken eggs per day for three weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microvascular reactivity | Cutaneous microvascular blood flow will be measured by Laser Doppler Flowmetry in response to vascular occlusion (post occlusive reactive hyperaemia - PORH) and in response to iontophoresis of acetylcholine (ACh) (endothelium dependent vasodilation). | Three weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid profile | Measurement of plasma cholesterol, HDL cholesterol, LDL cholesterol and triglycerides level. | Three weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
omega-3 fatty acids, microcirculation, laser Doppler flowmetry, lipid profile
Controlled Ventilation CT in CF Infants

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to implement a new method of performing chest CT imaging in young children with cystic fibrosis at Packard Children's Hospital. This technique will be used to evaluate early lung disease comparing quantitative chest CT air trapping and airway measurements with lung function measurements in infants, toddlers, and young children with chronic lung disease.

Official Title
-----------------
Differentiating Outcome Measures in Infants/Young Children With Cystic Fibrosis Utilizing Controlled Ventilation Infant/Young Child Chest CT Scanning and Lung Function Testing

Conditions
-----------------
Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants and young children (age   2/3 months to < 5 years) Diagnosed with cystic fibrosis with either 2 identified CFTR gene mutations, or a positive sweat chloride Informed consent by parent or legal guardian. Ability to comply with study visit procedures as judged by the investigator. Exclusion Criteria: Acute wheezing and/or respiratory distress at either study visit. Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset in 1 week preceding Study visit. Oxygen saturation < 90% on room air at study visit. Any medical condition that in the opinion of the investigator precludes subject participation.

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 5 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 |
| --- | --- | --- |
| Quantitative Air Trapping, A2 & A3 | Quantitative Chest CT Air Trapping by CT post-processing for Measure A2 & Measure A3 (% of segmented total lung) | Baseline & F/U | 
| Quantitative CT Airway Measurements (AWT/TAD, LD/TAD, Wall Area %, Lumen Area % | Quantitative Chest CT airway measurements by CT Post-Processing. AWT/TAD = Airway Wall Thickness/Total Airway Diameter LD/TAD = Lumen Diameter/Total Airway Diameter Wall Area % = Wall Area/Total Airway Area (%) | Baseline & F/U | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV 0.5 sec | FEV 0.5sec = % predicted | Baseline & F/U | 
| FEF 85% | FEF 85% (% predicted) | Baseline & F/U | 
| FEF25-75% | FEF25-75% (% predicted) | Baseline & F/U |
The Evaluation of a Novel Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F&P trial nasal pillows mask amongst Obstructive Sleep Apnea (OSA) participants.

Detailed Description
-----------------
Visit 1 will involve the participants consented in to the trial. Participants will be fitted with the F&P trial nasal pillows mask for use in-lab. The participant will then return the mask and have a interview, this ensures the maximum time participants will be exposed to the trial mask in lab will be in 1 night. The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all participants within 1 week of the beginning of the study.

Official Title
-----------------
The Evaluation of a Novel Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Nasal Pillows CPAP mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (18+ years of age) Able to give consent Apnea hypopnea Index (AHI)≥ 5 on diagnostic night Prescribed PAP for OSA Existing nasal pillows mask user Exclusion Criteria: Inability to give consent Patients who are in a coma or a decreased level of consciousness Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure) Commercial drivers who are investigated by New Zealand Transport Agency Current diagnosis of carbon dioxide (CO2) retention Pregnant or may think they are pregnant

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: Trial Continuous Positive Airway Pressure (CPAP) mask<br>Trial nasal pillows CPAP mask | Device: Nasal Pillows CPAP mask<br>* Investigative Nasal pillows Mask to be used for OSA therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of use | Subjective Questionnaire | 1 night | 
| Acceptability | Subjective Questionnaire | 1 night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Leak Data | Data obtained from participant's device - Objective | 1 night |
A Randomized Trial of Cerclage Versus 17 α-Hydroxyprogesterone Caproate for Treatment of a Short Cervix

Study Overview
=================
Brief Summary
-----------------
We hypothesized that weekly intramuscular injections of 17 hydroxyprogesterone caproate(17P) will reduce the number spontaneous preterm births prior to 35 weeks gestation when compared to cerclage therapy. The purpose of this study was to compare medical therapy with 17P to surgical therapy with transvaginal cerclage in patients with an ultrasound diagnosed short cervix and funnel in the mid-trimester.

Official Title
-----------------
Histologic Evaluation of the Cervix at Risk for Preterm Birth Trial:Medical Versus Surgical Therapy

Conditions
-----------------
Mid Trimester Cervical Shortening

Intervention / Treatment
-----------------
* Procedure: McDonald cerclage placement
* Drug: 17 hydroxyprogesterone caproate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ultrasonographic evidence of premature dilatation of the internal os Prolapse of the chorio-amniotic membranes into the endocervical canal Functional cervical length less than 25mm Exacerbation of these ultrasound findings with transfundal and/or suprapubic pressure Exclusion Criteria: Any fetal chromosomal or structural anomaly Multiple gestation Known allergy to progesterone Ruptured membranes Vaginal bleeding Intra-amniotic infection (diagnosed clinically or by amniocentesis) Prolapse of endocervical membranes beyond the external cervical os Persistent uterine activity accompanied by cervical change Obstetrically indicated delivery.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>McDonald cerclage | Procedure: McDonald cerclage placement<br>* Transcervical McDonald cerclage placement<br>|
| Active Comparator: 2<br>17 hydroxyprogesterone caproate | Drug: 17 hydroxyprogesterone caproate<br>* Weekly 250mg intramuscular injections<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome was spontaneous preterm birth prior to 35 weeks gestation |  | 11/2003 - 12/2006 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obstetrical complications |  | 11/2003 - 12/2006 | 
| Neonatal morbidity & mortality |  | 11/2003 --12/2006 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
short cervix, cervical funneling, spontaneous preterm birth, cerclage, progesterone
Comparison of Function and Fit of Standard and Gender-Specific CR High-Flex Total Knee Prostheses

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective, randomized study was to compare functional outcome, radiographic results, range of motion, patients satisfaction, and fit of the femoral component in patients receiving either a standard posterior cruciate-retaining high-flexion (CR-flex) and gender-specific CR-flex total knee prostheses.

Detailed Description
-----------------
The design features of the gender-specific knee prostheses have been claimed to improve fit and function of total knee arthroplasty in women. The purpose of this prospective, randomized study was to compare functional outcome, radiographic results, range of motion, patients satisfaction, and fit of the femoral component in patients receiving either a standard posterior cruciate-retaining high-flexion (CR-flex) and gender-specific CR-flex total knee prostheses.

Official Title
-----------------
Comparison of Function and Fit of Standard Posterior Cruciate-Retaining High-Flexion and Gender-Specific Posterior Cruciate-Retaining High-Flexion Total Knee Prostheses A Prospective, Randomized Study

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Device: Standard CR-Flex total knee
* Device: Gender specific CR-Flex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: End stage osteoarthritis of the knee joint who require total knee arthroplasty with bilateral lesions. Exclusion Criteria: Inflammatory arthritis Osteoarthritis effecting hip joint Traumatic arthritis Neurologic disorders affecting motor function of lower extremity foot and ankle disorders limiting ambulation of the patient
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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard CR-Flex<br> | Device: Standard CR-Flex total knee<br>* total knee implant used for joint replacement surgery of the knee<br>* Other names: Zimmer, Nexgen CR-flex;|
| Experimental: Gender specific CR-Flex<br> | Device: Gender specific CR-Flex<br>* TKA by Gender specific Nexgen CR-Flex<br>* Other names: Gender Specific Nexgen CR-Flex implant;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Knee Score |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant or bone overhang |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gender specific, cruciate retaining, total knee arthroplasty, Bilateral Osteoarthritis of the knee joint