linjc16/ctgov huggingface dataset:
Morbimortality in Major Urgent General Surgery in the Geriatric Patient.

Study Overview
=================
Brief Summary
-----------------
Retrospective observational cohort study of geriatric patients operated of urgent major general surgery in our centre during 2018. Our principal goals are: To evaluate the incidence of post operation complications and its severity (defined by the Claiven-Dindo scale) To evaluate the mortality: global mortality and mortality after: 30 days, 6 months and 1 year.

Official Title
-----------------
Morbimortality in Major Urgent General Surgery in the Geriatric Patient. Observational Study of Retrospective Cohort.

Conditions
-----------------
Surgery--Complications, Emergencies

Intervention / Treatment
-----------------
* Procedure: Urgent major general surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgeries on the small and / or large bowel with or without intestinal resection, total colectomies, exploratory laparotomies Exclusion Criteria: Polytraumatic patient, reoperations (for any cause) of scheduled and urgent surgeries

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Urgent major general surgery|All geriatric patients (75 years and over) going under urgent major general surgery during 2018 in our centre|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complications | Evaluate the incidence of post operation complications and its severity (defined by the Claiven-Dindo scale). | 30 days after surgery | 
| Mortality rate | Global mortality and mortality after: 30 days, 6 months and 1 year. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of admission |  | 30 days after surgery | 
| days in ICU/Reanimation |  | 30 days after surgery | 
| NELA Risk Score | National Emergency Laparotomy Audit % of death | pre-surgery | 
| NSQUIP Risk Score | American College of Surgeons National Surgical Quality Improvement Program: % of death | pre-surgery |
OpenGo Sensor Insole in Open Wedge HTO

Study Overview
=================
Brief Summary
-----------------
Weight bearing in 40 patients undergoing open wedge high tibial osteotomy (HTO) will be studied during 12 weeks for their post-operative weight bearing using a pressure insole.

Detailed Description
-----------------
Forty patients who are planned for open wedge HTO with deformity in the proximal tibia will be included in the study. The open wedge HTO will be performed in the well known biplanar technique and the TomoFix plate will be used as fixation plate. To analyze the peak pressure and if the patients are able to reassemble the partial weight bearing/ the full weight bearing the OpenGo Sensor Insole (Moticon) will be used during the first 12 weeks after surgery. In addition, x-rays will be analyze for the alignment and angles and clinical scores will be gathered to investigate patient reported outcomes.

Official Title
-----------------
OpenGo Sensor Insole in Open Wedge HTO

Conditions
-----------------
Tibia; Angulation

Intervention / Treatment
-----------------
* Procedure: High tibial osteotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for high tibial osteotomy Exclusion Criteria: Impairment of the shoulder which has an influence on the ability for partial weight bearing

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

| Intervention/Treatment |
| --- |
|Procedure: High tibial osteotomy|Patients undergoing high tibial osteotomy are investigated by a pressure insole for post-operative weight bearing behavior|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial weight bearing | Differences of the peak pressure (mean of the 13 pressure sensors) recorded by the insole vs. the recommended partial weight bearing of 20 kg and amount of events more than 20 kg partial weight bearing | 2 weeks post-OP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Full weight bearing | Time to full weight bearing after open wedge HTO | 12 weeks post-OP | 
| Weight bearing pre- vs. post-OP | Changes of peak pressure at the sole comparing varus deformity and after open wedge HTO | 12 weeks post-OP | 
| Patient reported outcomes | Depends the clinical outcome on the capability of early full-weight bearing? | 12 weeks post-OP | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high tibial osteotomy
Prospective Registry of Anterior Cruciate Ligament Reconstructions

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate factors that are associated with outcomes of injury to the anterior cruciate ligament (ACL) in the knee among patients who are undergoing surgical reconstruction. This study is a registry of all patients having knee surgery at our institution performed by 4 fellowship-trained orthopaedic surgeons. The surgeon documents patient information on standard data forms including risk factors and surgical findings.

Official Title
-----------------
Prospective Registry of Predictors and Comorbid Injuries Associated With Anterior Cruciate Ligament Reconstructions

Conditions
-----------------
Anterior Cruciate Ligament Tear, Meniscal Tear, Cartilage Injury, Bone Bruising

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing ACL surgery Exclusion Criteria: Previous surgery on the affected knee Posterior cruciate ligament injuries Grade 2 lateral collateral ligament or medial collateral ligament injuries
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 |
| --- | --- | --- |
| additional injury | At the time of ACL surgery, it is determined if the patient has any other injuries to the meniscus or cartilage. | intraoperatively |
Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to evaluate the effectiveness of post-operative pain control without using narcotic pain medications.

Official Title
-----------------
Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures

Conditions
-----------------
Hip Arthroscopy

Intervention / Treatment
-----------------
* Drug: Oxycodone
* Drug: Ibuprofen
* Drug: Gabapentin
* Drug: Acetaminophen
* Drug: Methocarbamol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Scheduled for a primary Hip Arthroscopy at Mayo Clinic (Rochester, MN) Exclusion Criteria: medical history of known allergies or intolerance to allergies or intolerance to Motrin, Gabapentin, Tylenol, dexamethasone, tramadol, or Robaxin. Substantial alcohol or drug abuse. History of narcotics within 6 months of surgery. Pregnancy. Renal impairment. Peptic ulcer disease. GI bleeding.

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Standard of Care Group<br>Subjects will receive standard of care pain medication Oxycodone for pain control following hip arthroscopy procedure | Drug: Oxycodone<br>* 5 mg tablets every 4 hours postoperatively as needed for pain control<br>|
| Experimental: Non-Opiate Pain Control Group<br>Subjects will receive a non-opiate pain control regime using Ibuprofen, Gabapentin, Acetaminophen, Methocarbamol for pain control following hip arthroscopy procedure. | Drug: Ibuprofen<br>* 800 mg three times a day for 2 weeks postoperatively for pain control; not to exceed 3200 mg/day<br>Drug: Gabapentin<br>* 300 mg three times a day for 5 days then wean off by day 10 postoperatively<br>Drug: Acetaminophen<br>* 1000 mg three times a day for up to 4 weeks postoperatively for pain control; not to exceed 4 grams per day<br>Drug: Methocarbamol<br>* 500 mg three times a week for 2 weeks postoperatively<br>* Other names: Robaxin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain score | Measure using a visual analog scale (VAS) to rate pain on a scale 0-10; 0=no pain to 10=worst possible pain | Baseline, 14 days post-operatively |
Elbow Arthroscopy Data Analysis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate preoperative objective measurements and operative objective measurements to determine if there is any effect to postoperative outcomes. Patients who were 13 years old or greater at the time of arthroscopic osteocapsular release were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.

Official Title
-----------------
Retrospective Chart Analysis of Elbow Arthroscopy for the Treatment of Osteoarthritis, Radiocapitellar Plica, Lateral Epicondylitis or Osteochondritis Dissecans

Conditions
-----------------
Osteoarthritis Elbow Left, Osteoarthritis Elbow Right, Lateral Epicondylitis, Left Elbow, Lateral Epicondylitis, Right Elbow, Plica Syndromes, Osteochondritis Dissecans

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking >13 years of age Patients treated with elbow arthroscopy for elbow arthritis, radiocapitellar plica, osteochondritis dissecans or lateral epicondylitis. Exclusion Criteria: Non-English speaking <13 years of age

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Outcomes | The Quick Disabilities of the Arm, Shoulder and Hand Score. Scale of 0-100, 100 being the best possible score | preoperative to up to 8 years postoperative | 
| Patient Satisfaction: one question assessment | one question assessment of the patients overall long term satisfaction with the outcome of the treatment. | 2 years to 8 years postoperative | 
| Patient Outcomes | Visual Analogue pain Scale. Scale is 0-10, 0 is no pain, 10 is the most pain | preoperative to up to 8 years postoperative |
Morphometric, Clinical and Histological Study on One Stage Bone Augmentation Using BoneCeramic (BCP) and Collagen Membranes

Study Overview
=================
Brief Summary
-----------------
Prospective randomized assessment of alveolar ridge alterations after augmenting dehisced areas by applying principles of guided bone regeneration (GBR) subsequently to implant installation. Ossix as cross-linked and BioGide as non cross-linked degradable collagen membranes, both used in combination with biphasic Calcium-Phosphate (BoneCeramic) as bone substitute. Clinical measurements and impressions from the sites of interest are to be taken at the stage of augmentation and 6 months after. At six months re-entry non-standardized biopsies from augmented sites will be taken to determine newly grown tissue in quality and quantity. Due to different degradation characteristics of the two collagen membranes used as barrier, amount of newly formed mineralized tissue is suspected to vary in tests and controls, respectively.

Official Title
-----------------
Prospective Clinical, Morphometric and Histological Study on Augmentation Using BoneCeramic as Bone Substitute in Combination With Either Cross-Linked or Non Cross-Linked Collagen Membrane in Dehiscent Type of Defects .

Conditions
-----------------
Dehiscent Type of Alveolar Bone Defect, One Stage Bone Augmentation

Intervention / Treatment
-----------------
* Device: Ossix
* Device: Biogide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: alveolar ridge deficiences after tooth loss Exclusion Criteria: systemic disorders (diabetes mellitus, morbus crown, etc.) pregnancy or lactating period

Ages Eligible for Study
-----------------
Minimum Age: 22 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ossix|Test group|
|Device: Biogide|controls|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alteration in width of alveolar bone at implant location after augmentation in mm |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histomorphometry in regard to areas occupied by bone to soft tissue to grafting material |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lateral augmentation, GBR, BoneCeramic, collagen membrane, histomorphometry, morphometry, reentry, biopsy
Genetic Mosaicism in Hirschsprung's Disease

Study Overview
=================
Brief Summary
-----------------
Hirschsprung's disease is a complex genetic disorder. The etiology of this disease is not completely understood. It is characterized by the absence of ganglia (nerve cells) in de distal colon. This impairs bowel relaxation which can lead to bowel disfunction, toxic megacolon, ileus and enterocolitis. So far, several genes have been identified that play a role in Hirschsprung's disease. The precise mechanisms however, remain unclear. This study wants to identify new mutations and hopefully clarify more about the etiology of the disease.

Official Title
-----------------
Genetics of Hirschsprung's Disease - Can Genetic Mosaicism Due to Early Somatic Mutations, Explain Disease Development?

Conditions
-----------------
Hirschsprung Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children with Hirschsprung's disease that will receive a corrective pull through procedure Exclusion Criteria: None

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New somatic mutation | Primary outcome measure of this study is to identify new (previously unknown) somatic mutations as a cause for the development of Hirschsprung's disease. Tissue to find these mutations will be gathered during surgery for all patients (see protocol). When sufficient samples are collected (est 25 samples) a first comparative analysis for new somatic mutations will be performed. After the end of the study a final analysis for new somatic mutation will be performed. | During surgery (coolection); after inclusion of approx. 25 patients (preliminairy analysis); final analysis after end of the study (approx. 3 years from first inclusion) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation disease type | Secondary outcome measure is to assess if any of the found mutations can be correlated with the type of Hirschsprung's disease (i.e. long-segment, short segment). This will be done after all patients DNA is analysed for somatic mutations after closure of the study. | At the end of the study (approximately 3 years after inclusion of first patient) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hereditary Diseases, Colon
Efficacy of Tranexamic Acid in Preventing Post Operative Blood Loss in Bone Sarcoma Patient

Study Overview
=================
Brief Summary
-----------------
investigator will see the efficacy of tranexamic acid in limb salvage surgery patients which will prevent blood loss and help in conservation of blood products.

Official Title
-----------------
Efficacy of Tranexamic Acid in Preventing Post Operative Blood Loss and Associated Complications in Bone Sarcoma Patients Treated With Limb Salvage Surgery: A Randomized Controlled Trial

Conditions
-----------------
Blood Loss, Surgical

Intervention / Treatment
-----------------
* Drug: Tranexamic acid injection
* Other: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Limb sarcoma of upper and lower limb Limb salvage Exclusion Criteria: liver insufficiency renal insufficiency allergic to drug history of thromboembolic condition pregnancy metastatic disease
Sexes Eligible for Study
-----------------
All

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>will injection 10 ml of normal saline to ensure binding | Other: normal saline<br>* normal saline will be injected to ensure placebo<br>|
| Active Comparator: tranexamic acid(TXA)<br>will inject tranexamic acid according to body weight | Drug: Tranexamic acid injection<br>* will inject tranexamic acid in limb salvage surgery of sarcoma patient to check its efficacy in preventing blood loss<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss | measure by hemoglobin direct method | 72 hour post operatively | 
| no of blood transfused | measured by number of transfusion | 72 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of hospital stay | Total days of hospital admission 2 months after surgery | total hospital stay post operatively for 02 month | 
| volume of drain out put | to measure blood collected in drain bottle | measure till drain out in 72 hour | 
| thromboembolic events | look for limb swelling for deep vein thrombosis and chest symptoms for any embolic event confirmed by CT chest | observed for 6 week determine on out patient visits |
Repeat Insult Patch Test APPENDIX I to HRL Standard Protocol #100

Study Overview
=================
Brief Summary
-----------------
Patch Testing for device cream on human subjects

Official Title
-----------------
Repeat Insult Patch Testing (RIPT) APPENDIX I to HRL Standard Protocol #100

Conditions
-----------------
Allergic Sensitization

Intervention / Treatment
-----------------
* Device: Light Therapy Mask Cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female 18+ years Good health Signed and datad Informed Consent Signed and dated HIPAA Exclusion Criteria: On test at any other research lab or clinic Known allergy or sensitivity to cosmetics or toiletries Pre-existing other medical conditions Treatment with antibiotics, antihistamines, or corticosteroids within 2 weeks of the test Chronic medication which could affect the outcome of the study Known pregnant or nursing women Cancer diagnosis within the past 5 years

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Panel<br>Light Therapy Mask Cream | Device: Light Therapy Mask Cream<br>* test panel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation | Clinically Significant Dermal Irritation refers to an overall outcome measure in which, after 6 weeks of the test (patching the skin (3 weeks) & then challenging the skin (at week 6)), the test product caused a clinically significant dermal reaction (scores of 2 or greater). Participant scores less than 2 are not considered to be Clinically significant. Scoring System: 0 = No visible reaction ± = Faint, minimal erythema = Erythema = Intense erythema = Intense erythema, induration, vesicles = Severe reaction with erythema, induration, vesicles, pustules (may be weeping) E = Edema DR = Dryness P = Peeling S = Staining = Hyperpigmentation / Hypopigmentation C = Change of test site N9R = No 9th reading = No patch application and / or reading TR = Tape Reaction | approximately 6 weeks |