linjc16/ctgov huggingface dataset:
Effect of Mobilization on Acute Postoperative Pain and Nociceptive Function

Study Overview
=================
Brief Summary
-----------------
Aim of the present study is twofold. First we want to evaluate the effect of mobilization on acute postoperative pain Second to test weather chances in pain sensitivity are occurring following surgery and mobilization after total knee arthroplasty

Detailed Description
-----------------
Little is known about the effect of mobilization on acute postoperative pain and mobilization induced pain, and if altered pain sensitivity occur under these circumstances. First we want to evaluate the effect of mobilization on acute postoperative pain using the visual analog scale (VAS) Second to test weather chances in pain sensitivity are occurring following surgery and mobilization after total knee arthroplasty, using two simple tools, the Pain Matcher and a Pressure Algometer.

Official Title
-----------------
Effect of Mobilization on Acute Postoperative Pain and Nociceptive Function After Total Knee Arthroplasty: A Prospective, Consecutive, Trial

Conditions
-----------------
Pain, Postoperative, Pain Sensitivity, Postoperative

Intervention / Treatment
-----------------
* Other: Mobilization (walking)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for total unilateral knee arthroplasty Exclusion Criteria: Cognitive dysfunction or peripheral / central neurological dysfunction inconsistent with protocol completing Alcohol and medical abuse (as defined by the National Health Service of Denmark Daily use of opioids or glucocorticoids

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 |
| --- |
|Other: Mobilization (walking)|25 meters twice|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score on the visual analog scale (difference before and after two mobilisation seances) | pain at rest (supine) 5 min after exercise(after the 2nd walk) | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score on the visual analog scale (difference before and after two mobilisation seances) | pain at rest (supine) 20 min after the 2nd walk, pain during passive hip flexion and pain during passive knee flexion 5 and 20 min after the 2nd walk, as well as pain during the 2nd walk after 6 and 25 m | up to 24 hours | 
| Pain sensitivity measured with pressure algometry and with pain matcher (difference before and after two mobilisation seances and difference before and after surgery) | Nociceptive function before and after postoperative exercise | up to 24 hours |
Clinical Usefulness of Therapeutic Drug Monitoring of Colistin in Patients Treated With Colistin.

Study Overview
=================
Brief Summary
-----------------
Clinical usefulness of therapeutic drug monitoring of colistin in patients treated with colistin

Conditions
-----------------
Multidrug-resistant Gram-negative Bacteria Infection

Intervention / Treatment
-----------------
* Other: Therapeutic drug monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 years old. Those who receive colistin therapy for the treatment of multi-drug resistant gram negative bacteria infection. Exclusion Criteria: Those who received colistin therapy less than 48 hours Those who received colistin therapy through the bronchus

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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Group with therapeutic drug monitoring | Other: Therapeutic drug monitoring<br>* Therapeutic drug monitoring for colistin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AKI | Emergence rate of acute kidney injury | Through study completion, an average of 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Death rate | Through study completion, an average of 1 month | 
| Negative conversion rate | Culture-negative conversion rate Treatment success Treatment success | Through study completion, an average of 1 month |
Assessment of Adherence and Efficiency of a Home-based Training Program on Muscular Strength, Endurance and Qol for Colon Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose is to assess the adherence and the efficiency of a home-based training program on muscular strength, endurance and the quality of life, fatigue, physical activity, anxiety and depression for colon cancer patient treated by chemotherapy.

Detailed Description
-----------------
It's a 9-weeks experimentation with 4 moments (every 3 weeks) to do the tests.

Official Title
-----------------
Assessment of Adherence and Efficiency of a Home-based Training Program on the Muscular Strength, the Endurance and the Quality of Life for Colon Cancer Patients Treated by Chemotherapy

Conditions
-----------------
Colon Cancer

Intervention / Treatment
-----------------
* Procedure: Home-based training program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Colon cancer patients treated by chemotherapy adjuvant Exclusion Criteria: Patients who have metastasis Patients hospitalized during the experimentation Patients who have major orthopedic or neurologic problems

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>They will have to do all the tests and to follow the home-based training program during 9 weeks. | Procedure: Home-based training program<br>* A home-based training program of 8 exercises to do 5 times a week during 9 weeks<br>|
| No Intervention: control group<br>They will have to do all the tests but not to follow the home-based training program. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscular strength measured by Microfet |  | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life measured by questionnaire |  | 3 minutes | 
| Fatigue measured by questionnaire |  | 3 minutes | 
| Physical activity measured by questionnaire |  | 3 minutes | 
| Anxiety measured by questionnaire |  | 3 minutes | 
| Exercise tolerance measured by Six minute walking test |  | 6 minutes | 
| Depression measured by questionnaire |  | 3 minutes |
Diabetes Education and A1c Study

Study Overview
=================
Brief Summary
-----------------
Sleep problems are associated with poor blood glucose control, but current diabetes self-management programs do not include sleep education. This study will randomize participants into two groups: one that receives sleep education and one that does not. The researchers expect both groups to experience reductions in blood glucose. The researchers hypothesize that individuals who receive sleep education as part of their diabetes self-management training will experience greater improvements in blood glucose control, as measured by hemoglobin A1c, compared to the control group.

Official Title
-----------------
Diabetes Education and A1c Study

Conditions
-----------------
Diabetes Mellitus, Type 2, Sleep

Intervention / Treatment
-----------------
* Behavioral: Sleep education
* Behavioral: Diet only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with a diagnosis of type 2 diabetes who are patients at the Michigan State University (MSU) Endocrinology clinic, a diagnosis of overweight or obesity (Body Mass Index greater than or equal to 25.0 kg/m2), the most recent hemoglobin A1c value greater than or equal to 7.5%, and the ability to attend online program sessions. Exclusion Criteria: significant psychiatric disorders, advanced medical conditions that require alterations to the MNT for DM2, e.g., advanced chronic kidney disease, and an inability to follow recommendations due to cognitive deficits.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Diet therapy plus sleep education | Behavioral: Sleep education<br>* Medical nutrition therapy plus behavior-based sleep education intervention<br>|
| Other: Control<br>Diet therapy | Behavioral: Diet only<br>* No sleep education<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | Lab value | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index | Calculated from height and weight | 12 weeks | 
| Sleep duration | FitBit outcomes data | 12 weeks | 
| Sleep quality | Pittsburgh Sleep Quality Index | 12 weeks | 
| Diabetes self-care | Diabetes Self-Management Questionnaire | 12 weeks | 
| Epworth Sleepiness Scale | Validated survey measuring excessive daytime sleepiness | 12 weeks | 
| Insomnia Severity Index | Validated survey measuring insomnia symptoms | 12 weeks |
Study of Zinc for Wilson Disease

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Establish the safety and efficacy of extended maintenance zinc therapy in 200 patients with Wilson disease. II. Establish further the role of zinc in the prophylactic treatment of presymptomatic patients by increasing the current cohort from 80 to at least 100 patients. III. Establish further the role of zinc therapy in pregnant patients with Wilson disease. IV. Establish further the role of zinc therapy in children with Wilson disease.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients receive copper regulation therapy with zinc acetate: an existing cohort on maintenance therapy will be followed for long-term data collection; presymptomatic patients are treated prophylactically; and pregnant patients are evaluated for fetal outcome. All patients are evaluated for copper balance, clinical control, and toxicity.

Conditions
-----------------
Wilson Disease

Intervention / Treatment
-----------------
* Drug: zinc acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Wilson disease Presymptomatic, pregnant, and children 16 years or younger patients eligible Patient age: Any age, including children

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: zinc acetate|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
-----------------
Wilson disease, inborn errors of metabolism, rare disease
Evaluation of Symbicort® Turbuhaler® (Budesonide/Formoterol) in Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
This non-interventional study is to analyse the therapeutic effectiveness in patients with severe COPD following a generally accepted 12-week treatment period with Symbicort Turbuhaler, which could anyhow be shortened or extended at physician's discretion.

Official Title
-----------------
An Open-label Non-interventional Evaluation of Efficacy of Symbicort® Forte Turbuhaler 320/9 µg (Budesonide / Formoterol) and Symbicort® Turbuhaler® 160/4,5 µg (Budesonide / Formoterol)in Functional Status Improvement of Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non pregnant female COPD with persistent symptoms in spite of regular bronchodilator therapy Naive or fixed combination treated patients including patients already on Symbicort Turbuhaler Exclusion Criteria: Hypersensitivity to budesonide, formoterol or inhaled lactose

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Reduction in overall Clinical COPD Questionnaire (CCQ) score |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction |  | 12 weeks | 
| Physicians' global clinical impression of the treatment |  | 12 weeks | 
| Evaluation of smoking habits |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic obstructive pulmonary disease, COPD, Symbicort Turbuhaler
Neurobiology of Opioid Dependence: 3 - 3

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the effects of cycloserine on naloxone-precipitated opiate withdrawal.

Official Title
-----------------
Neurobiology of Opioid Dependence: 3

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Cycloserine


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
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral, subjective, measures of naloxone-preci |  |  | 
| Phsyiological, neuroendocrine measures of naloxone |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
opioid disorders
Long--term Outcome Analysis of Fracture--related Infections

Study Overview
=================
Brief Summary
-----------------
This retrospective analysis of medical records is to identify risk factors for treatment failures in fracture-associated infections (FAI) at the University Hospital Basel.

Official Title
-----------------
Long--term Outcome Analysis of Fracture--related Infections (Re_FRI)

Conditions
-----------------
Fracture-associated Infection (FAI)

Intervention / Treatment
-----------------
* Other: data collection from patients with FAI (occuring January 2000 until December 2019)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with FAI Exclusion Criteria: documented denial of consent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: data collection from patients with FAI (occuring January 2000 until December 2019)|data collection from patient files (data regarding surgery, adverse events, infections, demographic data)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of flap failures at discharge from hospital | number of flap failures at discharge from hospital | at baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prosthesis infection
Detection of PCOS by Sensors Array

Study Overview
=================
Brief Summary
-----------------
Detection of metabolic state of women with polycystic ovary using NA-Nose.

Detailed Description
-----------------
Breath of women undergoing fertility treatment including PCOS and ovulatory women will be collected and transferred for our labs for further analysis in define the metabolic state. The detection will be made using sensors arrays and GCMS.

Official Title
-----------------
Detection of PCOS and Ovulation Timing by NA-Nose

Conditions
-----------------
Metabolic State, Breath Analysis, NA-Nose

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:women undergoing follow up for ovulation detection. - Exclusion Criteria:Pregnancy -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: ovulatory women will be compared to women who do not ovulate regularly (PCOS)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ovulatory<br>Comparison in metabolic state between ovulatory and PCOS women by collecting breath test from participant. | Diagnostic Test: Breath test<br>* Collecting breath test from participants<br>|
| Active Comparator: PCOS<br>Comparison in metabolic state between ovulatory and PCOS women by collecting breath test from participant | Diagnostic Test: Breath test<br>* Collecting breath test from participants<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of different metabolic state between groups. | Finding that there special markers in the breath test that indicate a different metabolic state in PCOS. | two years |
Inflammatory Regulation Effect of NAC on COVID-19 Treatment

Study Overview
=================
Brief Summary
-----------------
Study times to evaluate the efficacy of N-Acetylcysteine therapy in the management of adult admitted patients with COVID-19.

Official Title
-----------------
Pilot Double Blinded Randomized Placebo Controlled Multi Central Clinical Trial on Inflammatory Regulation Effect of NAC on COVID-19

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Drug: N-Acetyl cysteine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult above 18 years of age Admitted to the hospital With confirmed COVID-19 by RT-PCR test On oxygen supplement Exclusion Criteria: Active use of NAC Known NAC allergy In the opinion of the treating team, progression of death is imminent and inevitable within the next 24 hour, irrespective of provision treatment All patients enrolled in any other investigational drug studies in COVID-19.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br> | Drug: N-Acetyl cysteine<br>* 150 mg/kg every 12 hours for 14 days (oral/IV) Diluted in 200 ml diluent (D5%, NS)<br>* Other names: NAC;|
| Placebo Comparator: Control group<br> | Drug: Placebo<br>* Matching placebo administered in the same schedule and volume as NAC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Recovery | Day of recovery is defined as the first day on which of the following three categories from The Ordinal Scale on Covid-19 Clinical Improvement Not-Hospitalized, No limitation on activity. Not Hospitalized, with limitation on activity. Hospitalized, Not requiring supplemental Oxygen | 28 days | 

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