linjc16/ctgov huggingface dataset:
Oxycodone-naloxone Prolonged Release Tablets in Relieving Opioid-related Constipation

Study Overview
=================
Brief Summary
-----------------
The primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

Detailed Description
-----------------
Patients with a documented history of moderate to severe non-malignant pain that require around-the-clock opioid therapy will be randomised to an oxycodone or an oxycodone-naloxone treatment arm. The primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

Official Title
-----------------
A Randomsied, Double-blind, Double-dummy, Parallel-group Multicentre Study to Demonstrate Improvement in Symptoms of Constipation in Subjects With Non-malignant Pain Taking Oxycodone Equivalent of 60-80 mg/Day as Oxycodone/Naloxone Prolonged Release Compared to Subjects Taking Oxycodone Prolonged Release Tablets Alone

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Oxycodone naloxone prolonged release tablets (OXN)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects at least 18 years or older with moderate to severe pain that requires around the clock opioid therapy. Subjects must report constipation caused or aggravated by opioids. Exclusion Criteria: Females who are pregnant or lactating. Subjects with evidence of any clinically unstable disease or subjects with evidence of impaired liver/kidney function upon entry into the study. Subjects with evidence of significant structural abnormalities of the gastrointestinal tract.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oxycodone naloxone prolonged release tablets (OXN)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate that subjects with moderate to severe non malignant pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone. |  | 12 weeks with a 6 month open label extension | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
A randomised, double-blind, double-dummy, parallel-group multicentre study to demonstrate improvement in symptoms of constipation, Moderate to severe, chronic non-malignant pain
Anhidrotic Area and Safety of MEDITOXIN in Healthy Male Valunteers

Study Overview
=================
Brief Summary
-----------------
To determine the anhidrotic area and safety of MEDITOXIN

Official Title
-----------------
Open-Label, Active Controlled, Single-Center, Phase 1 Study to Determine the Anhidrotic Area and Safety of MEDITOXIN in Healthy Male Volunteers

Conditions
-----------------
Anhidrotic Area, Hyperhidrosis

Intervention / Treatment
-----------------
* Drug: Meditoxin
* Drug: Botox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male adults aged between 20 and 45 years Exclusion Criteria: Subjects not appropriate for participating in this study according to the investigator's opinion

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: botulinum toxin 1U<br> | Drug: Meditoxin<br>* injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses<br>Drug: Botox<br>* injection of Botox into the intradermal of each contralateral upper back in equal doses<br>|
| Experimental: botulinum toxin 3U(25U/1ml)<br> | Drug: Meditoxin<br>* injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses<br>Drug: Botox<br>* injection of Botox into the intradermal of each contralateral upper back in equal doses<br>|
| Experimental: botulinum toxin 5U<br> | Drug: Meditoxin<br>* injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses<br>Drug: Botox<br>* injection of Botox into the intradermal of each contralateral upper back in equal doses<br>|
| Experimental: botulinum toxin 10U<br> | Drug: Meditoxin<br>* injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses<br>Drug: Botox<br>* injection of Botox into the intradermal of each contralateral upper back in equal doses<br>|
| Experimental: botulinum toxin 3U(50U/1ml)<br> | Drug: Meditoxin<br>* injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses<br>Drug: Botox<br>* injection of Botox into the intradermal of each contralateral upper back in equal doses<br>|
| Experimental: botulinum toxin 3U(12.5U/1ml)<br> | Drug: Meditoxin<br>* injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses<br>Drug: Botox<br>* injection of Botox into the intradermal of each contralateral upper back in equal doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anhidrotic area | After the ninhydrin sweat test, measure the area of the unstained area | week 4 |
Nordic Walking and Chronic Low Back Pain

Study Overview
=================
Brief Summary
-----------------
This is a randimized clinical trial comparing the effect of supervised Nordic walking versus unsupervised Nordic walking versus advice to stay active

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Behavioral: Supervised Nordic Walking
* Behavioral: Unsupervised Nordic Walking
* Behavioral: Advice to stay active


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Finished treatment at secondary sector specialist spinal unit Able to understand and read Danish Exclusion Criteria: Co-morbidity preventing patient from completing Nordic walking program Pain <3 on 11 point box scale Unable to perform Watt Max Cykel Test

Ages Eligible for Study
-----------------
Minimum Age: 8 Weeks
Maximum Age: 8 Weeks

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Supervised Nordic Walking|nan|
|Behavioral: Unsupervised Nordic Walking|nan|
|Behavioral: Advice to stay active|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low back pain, randomized clinical trial, Nordic walking, supervision, Advice to stay active
To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed Conditions.

Official Title
-----------------
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Sandoz GmbH and Bristol-Myers Squibb (Cefzil) 500 mg Cefprozil Tablets In Healthy Adults Volunteers Under Fed Conditions.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Cefprozil 500 mg Tablets (Sandoz, GmbH)
* Drug: Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb, USA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cefprozil 500 mg Tablets (Sandoz, GmbH) | Drug: Cefprozil 500 mg Tablets (Sandoz, GmbH)<br> <br> |
| Active Comparator: 2<br>Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb, USA) | Drug: Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb, USA)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibiotics
Physical Activity and Its Correlation to Maximal Oxygen Uptake in an Elderly Population

Study Overview
=================
Brief Summary
-----------------
This is a substudy of the Generation-100 study (NCT01666340). Self reported physical activity versus objectively measured physical activity and its correlation to maximal oxygen uptake in an elderly Norwegian population (observational study).

Detailed Description
-----------------
Data is collected using activity monitors. This data then compared to self reported physical activity obtained through questionnaires. Questionnaires are based on recall. Overall physical activity will then be correlated to maximal oxygen uptake to see whether people with high activity also have high maximal oxygen uptake.

Official Title
-----------------
Self Reported Physical Activity vs Objectively Measured Physical Activity and Its Correlation to Maximal Oxygen Uptake in an Elderly Population: an Observational Study

Conditions
-----------------
Aging

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ability to walk at least 1km, born in 1938,1939,1940,1941 or 1942 Sufficiently good health to be able to take part in the study, as determined by the researchers Exclusion Criteria: Illness or disability that precludes exercise or hinders completion of the study Uncontrolled hypertension Symptomatic valve disease, hyper tropic cardio-myopathy or unstable angina Active cancer Test results indicating that study participation is unsafe Inclusion in other studies conflicting with participation in this one

Ages Eligible for Study
-----------------
Minimum Age: 70 Years
Maximum Age: 77 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 |
| --- | --- |
| 1600 elderly participants<br>Norwegian elderly population | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between maximal oxygen uptake and activity level | maximal oxygen uptake measured using Metamax on a Treadmill. Activity level assessed using triaxial activity monitors. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between self reported recall physical activity and activity monitor measured physical activity | self reported Physical Activity is assessed by having participants fill out a questionnaire (developed by HUNT) outlining their Physical Activity (through recall). Physical activity is objectively measured using triaxial accelerometers. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
physical activity, maximal oxygen uptake
The French EsoGastricTumours Data Base

Study Overview
=================
Brief Summary
-----------------
This retrospective study aims at evaluating the outcomes of gastrointestinal stromal tumor after surgery.

Official Title
-----------------
National Oesophageal and Gastric Carcinomas Data Base Construction: the FREGAT (French EsoGastric Tumours) Data Base

Conditions
-----------------
Esophageal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with esophageal cancer, gastric or gastroesophageal junction diagnosed biopsy , regardless of the subtype of cancer, tumor stage or treatment envisaged. Naive treatment for this cancer, Naive treatment for this cancer , failing that received neoadjuvant treatment , Male or female ≥ 18 years. social protection scheme . sign a free and informed consent for blood sampling , the different questionnaires and the collection of patient information. Exclusion Criteria: Male or female aged ( e) under 18 years. Private person of liberty or under supervision (including guardianship ) . People who do not speak French. Major Nobody unable to consent . Patient FREGAT already included in the base. Patient Refusal .

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DIsease free survival |  | 5 year disease free survival | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 5 year overall survival | 
| recurrence rate |  | 5 year recurrence rate | 
| Total number of patients with complications |  | from the time between inclusion and occurrence of the event, for the duration of 3 years | 
| Total number of complications |  | from the time between inclusion and occurrence of the event, for the duration of 3 years | 
| Death |  | from the time between inclusion and occurrence of the event, for the duration of 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophagus, Surgery
Kyphosis Evaluation Using SPINESCAN®

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the accuracy of SPINESCAN® with standard lateral x-rays of the spine in patients monitored for kyphosis.

Detailed Description
-----------------
Kyphosis is usually a developmental deformity of the spine in the sagittal plane. Once diagnosed, serial X-rays are used for followup. These are usually required at yearly intervals. SPINESCAN® is a computerized digital inclinometer, design for evaluating angular spine deformities. Patients examined in the spine clinic with recent X-rays will be examined with SPINESCAN® and it's results compared with the classical radiological assessment.

Official Title
-----------------
The Correlation Between Radiological Evaluation of Kyphosis and Evaluation Using SPINESCAN®

Conditions
-----------------
Kyphosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients examined in scoliosis clinic for kyphosis with recent lateral spine X-rays. Age: 7 years old and above. Exclusion Criteria: Less than 7 years old. No informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Main group: patients examined in scoliosis clinic for kyphosis with recent lateral spine X-rays. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kyphosis degree (by SPINESCAN®) |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SPINESCAN®, kyphosis
Post Burn Pruritus Study in Patients Undergoing Wound Healing

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if a drug called ondansetron (Zofran) controls itching from healing burn wounds as well or better than the usual drug used, diphenhydramine (Benadryl).

Detailed Description
-----------------
A clear mechanism or cause for pruritus in patients recovering from burn has not been delineated. While the exact mechanisms/pathways for itching are currently unclear, histamine antagonism appears to be the most popular treatment. Whether histamine antagonism works predominantly via peripheral inhibition or central sedation is uncertain. By treating another intermediary in the pruritus cascade, it may be possible that an alternate treatment could be used while eliminating some of the unwanted side effects of antihistamine at the same time.

Official Title
-----------------
A Pilot Study to Determine the Pruritic Benefits of Ondansetron Versus Diphenhydramine in Burn Patients Undergoing Wound Healing

Conditions
-----------------
Itching

Intervention / Treatment
-----------------
* Drug: Ondansetron (Zofran)
* Drug: Diphenhydramine (Benadryl)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females; 18 years or older. Seen in the United States Army Institute of Surgical Research (USAISR) Burn Clinic with healing burn wounds of any percent (%) of total body surface area (TBSA) causing pruritus Stable medical condition Negative pregnancy test and not nursing Able to indicate status of pruritus on a numeric scale Able to understand and read English Exclusion Criteria: Unstable medical condition as determined by attending burn surgeon Prisoner History of allergic reaction to serotonin inhibitors or diphenhydramine Pregnant or lactating Unable to verbalize pruritus intensity scale Unable to understand or read English

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br> | Drug: Ondansetron (Zofran)<br> <br> Drug: Diphenhydramine (Benadryl)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ondansetron will have a greater ability to control pruritus in burn patients who are undergoing wound healing when compared to the standard of care, diphenhydramine. |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pruritus, burn wound
Management of Bone Defects Around the Elbow

Study Overview
=================
Brief Summary
-----------------
Background: Bone defects of the distal humerus require complex reconstructions, for which standard prostheses may be insufficient. The researchers therefore investigated the clinical and radiological outcome of elbow reconstructions by megaprostheses.

Detailed Description
-----------------
Type of prosthesis: STRYKER Humerus-HMRS

Official Title
-----------------
Modular Prosthetic Reconstruction of Major Bone Defects of the Distal Humerus.

Conditions
-----------------
Tumor, Fracture, Cancer

Intervention / Treatment
-----------------
* Procedure: HMRS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HMRS of the elbow, distal humerus or total humerus Exclusion Criteria: Unwillingness to participate
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with major bone defects around the elbow. | Procedure: HMRS<br>* Modular prosthetic replacement of the humerus and elbow.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Survival |  | 20 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prosthetic Survival |  | 20 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Survival, Function, Infection, Revision, Loosening