linjc16/ctgov huggingface dataset:
A Pilot Study to Explore the Role of Gut Flora in Gout

Study Overview
=================
Brief Summary
-----------------
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Detailed Description
-----------------
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to Gout

Official Title
-----------------
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Gout

Conditions
-----------------
Gout

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study i. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent Male or female of all ages. (interest is given to children who present with autism or Crohn's and whose parents wish to analyze their children's gut flora. Also of interest analysis of development of the child's microbiome. In the case of autism, the younger the child, the better to correct the neurological problems if an association is found between autism and the microbiome) Diagnosis of Gout by a physician Exclusion Criteria: Refusal to sign informed consent form History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. Postoperative stoma, ostomy, or ileoanal pouch Participation in any experimental drug protocol within the past 12 weeks Treatment with total parenteral nutrition
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Gout<br>Patients who have been diagnosed with Gout | Other: No intervention<br>* There is no intervention for this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing | Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized with Gout | Three years |
Medication in Early Diabetes (MED) Study

Study Overview
=================
Brief Summary
-----------------
This study compares metformin (current first-line medication) to pioglitazone (a newer diabetic medication currently approved for combination use). Whilst there is good evidence for the benefits of pioglitazone use in other populations, in light of the known weight gain effects of pioglitazone we believe further assessment is required in Indigenous Australians (in whom there is a strong predisposition for central fat deposition). This study will provide evidence regarding the medication appropriate for first line medication in Type 2 diabetes in this high risk population. This study will assist clinicians to make evidenced-based decisions regarding initial medical management of those with Type 2 diabetes (where there is currently a gap in evidence).

Official Title
-----------------
Drug naïve Indigenous Australians With Type 2 Diabetes, Enrolled in a Randomised Controlled Trial of Rosiglitazone Versus Metformin Monotherapy to Assess the Effects on Metabolic and Cardiovascular Parameters

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

Intervention / Treatment
-----------------
* Drug: Pioglitazone
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Drug naïve Indigenous Australians with Type 2 Diabetes Permanent resident of Darwin for at least 1 year immediately before and expected to be for at least 1 year after study commences Participants must be able to give informed voluntary consent Both males and females (females of child bearing potential excluded if not on reliable means of contraception)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Arm A- Metformin | Drug: Metformin<br>* 500 mg of Metformin taken orally twice a day<br>|
| Active Comparator: B<br>Arm B- Pioglitazone | Drug: Pioglitazone<br>* 15mg of Pioglitazone taken orally twice a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c values |  | second monthly | 
| Weight gain |  | monthly | 
| Weight distribution |  | six monthly | 
| Medication side effects |  | monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication compliance |  | monthly | 
| Side effects |  | monthly | 
| Lipids |  | second monthly | 
| Endothelial dysfunction. |  | second monthly |
Capsula Closure vs. Non-Capsula Closure: Hip Arthroscopy in Danish Patients With Femoroacetabular Impingement (FAI)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether patients undergoing surgical treatment (hip arthroscopy) of FAI syndrome will positively benefit from capsular closure, in terms of higher scores in validated patient reported outcome measurements, compared to a Group of patients with FAI syndrome where the capsule is left open at the end of the surgical procedure.

Official Title
-----------------
Capsula Closure Versus Non-Capsula Closure During Hip Arthroscopy in Danish Patients With Femoroacetabular Impingement (FAI)

Conditions
-----------------
Hip Injuries

Intervention / Treatment
-----------------
* Procedure: Capsula Closure
* Procedure: Non-Capsula Closure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Radiological and symptomatic Femoroacetabular Impingement, where surgery is indicated. Preoperatively a minimum of 3 months of relevant physiotherapeutic treatment should have been performed. Exclusion Criteria: Previous hip surgery in either hip Malignant disease Recent hip or pelvic fractures Arthritic disease Hip joint dysplasia Legg-Calvé-Perthes Slipped Capital Femoris Epiphysis Recent (within 6 weeks) medical treatment with corticosteroids Language problems of any kind

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Capsula Closure<br> | Procedure: Capsula Closure<br>* The capsular closure is performed with a minimum of two vicryl # 2 resorbable sutures<br>|
| Other: Non-Capsula Closure<br> | Procedure: Non-Capsula Closure<br>* No capsular closure procedure is performed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient reported outcome scores (Hagos) | Copenhagen Hip and Groin Outcome Score - Questionnaire - Hip-function Score (0-100) | From baseline to 2 year after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient reported outcome scores (Ihot12) | Questionnaire - Hip-function Score (0-100) | From baseline to 2 year after the operation | 
| Change in patient reported outcome scores (NRS) | Questionnaire - Pain-Score (0-10) | From baseline to 2 year after the operation | 
| Change in patient reported outcome scores (EQ5D | Questionnaire - health outcome score. | From baseline to 2 year after the operation | 
| Reoperation | revision hip arthroscopy/THA/other) | Up to 2 years after surgery |
Scribes in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effect of scribes on an academic emergency department.

Detailed Description
-----------------
This study will be a prospective before-after study with washout period of various performance measures before and after the implementation of ED scribes. We will also collect survey data to measure physician satisfaction and patient perception of scribes.

Official Title
-----------------
The Effect of Scribes in the Emergency Department

Conditions
-----------------
Scribes in the Emergency Department

Intervention / Treatment
-----------------
* Other: Scribes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive patients during the study period age > 18 y/o Exclusion Criteria: Patients seen during the washout period

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: Scribes|Scribe|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to attending chart completion |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician productivity | patients / shift | 6 months | 
| Physician Reimbursement | RVU/hr dollars/hr | 6 months | 
| Quality of Documentation |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scribes, Physician Productivity, Electronic Documentation
MCID in 30 STS Test After PR in COPD Patients

Study Overview
=================
Brief Summary
-----------------
The sit-to-stand test (STST) is a feasible alternative for measuring peripheral muscle strength of the lower limbs. Our aim was to evaluate, in Chronic Obstructive Pulmonary Disease (COPD) patients, the minimal clinically important difference (MCID) of 30-second STST (30-STST) after pulmonary rehabilitation (PR). Stable COPD inpatients undergoing 30-STST and 6-minute walk test (6MWT) before and after PR were included. Responsiveness to PR was determined by pre-to-post PR (Δ) evaluation of 30-STST. The MCID was evaluated using an anchor-based method.

Detailed Description
-----------------
The sit-to-stand test (STST) is a feasible alternative for measuring peripheral muscle strength of the lower limbs used as standard test at the beginning and at the end of pulmonary rehabilitation programme. Our aim was to retrospectively evaluate, in Chronic Obstructive Pulmonary Disease (COPD) patients, the minimal clinically important difference (MCID) of 30-second STST (30-STST) after pulmonary rehabilitation (PR). Stable COPD inpatients undergoing 30-STST and 6-minute walk test (6MWT) before and after PR were included. Responsiveness to PR was determined by pre-to-post PR (Δ) evaluation of 30-STST. The MCID was evaluated using an anchor-based method.

Official Title
-----------------
Minimal Clinically Important Difference in 30 Second Sit-to-stand Test After Pulmonary Rehabilitation in Patients With COPD

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Other: Pulmonary rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis for COPD according to the GOLD criteria. no exacerbations over the previous four weeks - Page 3 of 3 - completing PR program smoking history ≥10 pack years regular treatment with inhaled bronchodilators and inhaled steroids Exclusion Criteria: any unstable medical condition Contraindications for participation in the PR program included musculoskeletal disorders, malignant diseases, unstable cardiac condition, and lack of adherence to the program -

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Pulmonary rehabilitation|Stable COPD inpatients undergoing 30-STST and 6-minute walk test (6MWT) before and after PR were included. Responsiveness to PR was determined by pre-to-post PR (Δ) evaluation of 30-STST.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 STS test | Minimally clinically important difference | 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MCID, 30 STS test, Pulmonary rehabilitation
Inspiratory Muscle Training in Chronic Thromboembolic Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
Inspiratory muscle training for 8 weeks in patients with chronic thromboembolic pulmonary hypertension.

Detailed Description
-----------------
32 patients with CTEPH (confirmed by right cardiac catheterization and imaging) will perform: 1) pulmonary function tests; 2) measurement of maximal inspiratory pressure (MIP) and endurance; 3) evaluation of peripheral muscle strength by isokinetic dynamometry; 4) six-minute walk test and 5) incremental and constant load cardiopulmonary exercise test (  75% of maximal work-rate) with non-invasive evaluation of central hemodynamics and peripheral muscle oxygenation. Inspiratory muscle training will consist of twice daily sessions of 30 breaths (  50% PiMAX, 4-5 minutes per session) for 8 weeks. The SHAM group will perform sessions of 30 breaths with no inspiratory load.

Official Title
-----------------
Inspiratory Muscle Training in Patients With Chronic Thromboembolic Pulmonary Hypertension: a Randomized Controlled Trial

Conditions
-----------------
Chronic Thromboembolic Pulmonary Hypertension, Inspiratory Muscle Training, Inspiratory Muscle Weakness

Intervention / Treatment
-----------------
* Other: inspiratory muscle training
* Other: Placebo training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CTEPH confirmed by RHC and imaging NYHA FC II-IV Exclusion Criteria: Limitation to cycling Recent syncope or clinical deterioration

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental: IMT<br>inspiratory muscle training (PowerBREATHE) with  50% of maximum inspiratory pressure | Other: inspiratory muscle training<br>* inspiratory muscle training with 50% of MIP<br>|
| Placebo Comparator: Placebo: SHAM<br>inspiratory muscle training (PowerBREATHE) without inspiratory load | Other: Placebo training<br>* placebo training with PowerBreathe (without inspiratory load)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise capacity¨- cardiopulmonary exercise testing | TLim (seconds) | week 8 | 
| exercise capacity - 6-min walk test | distance (m) | week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventilatory responses | VE/VCO2 | Week 8 | 
| peripheral oxygenation | Near-infrared spectroscopy | Week 8 |
The Efficacy of KIDNET in the Treatment of Traumatized Refugee Children in Germany

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the effectiveness of KIDNET in treating traumatized refugee children in Germany

Official Title
-----------------
The Efficacy of KIDNET in the Treatment of Traumatized Refugee Children in Germany

Conditions
-----------------
PTSD

Intervention / Treatment
-----------------
* Behavioral: KIDNET


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: refugee children age range: 7-16 PTSD-Diagnosis Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 16 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 |
| --- | --- |
| No Intervention: Waitinglist Control<br> | |
| Experimental: KIDNET<br> | Behavioral: KIDNET<br>* Narrative Exposure Therapy for Children<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD-Symptoms according to the UCLA Child PTSD INDEX |  | 1-month, 6-months, 12-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Performance according to SPM, CPM, Rey-Figure-Test, d2; Other mental health disorders according to M.I.N.I.-KID |  | 6-months, 12-months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTSD, Children, trauma-focused Treatment, KIDNET, Narrative Exposure Therapy for Children
Variation in Serum Levels of Metformin in Patients With Reduced Renal Function

Study Overview
=================
Brief Summary
-----------------
Metformin is widely used for treatment of type 2 diabetes mellitus. Side-effects are few and mainly from the gastrointestinal tract. Since metformin is cleared from the blood exclusively via the kidneys reduced renal function is a relative contraindication. We have earlier demonstrated that metformin safely can be used to a lower GFR level of 30 ml/min/1.73. Below that level the risk of lactacidosis, a severe complication, increases. In the present study we plan to analyse serum levels of metformin repeatedly in patients with moderate renal failure (CKD = GFR of 30-60 ml/min/1.73). Blood samples will be taken as trough values in the morning, week 0, 2, 4, and 8 and at four weeks a blood sample will be taken two hours after intake of the morning dose of metformin. Renal function will be estimated with creatinine and cystatin C at each occasion. The intraindividual variation of metformin will be calculated. The study rests on a new method for measuring metformin. The technique uses Liquid Chromatography Tandem Mass Spectometry (LCMSMS). Proteins are removed from serum by adding acetonitrile to the sample. After centrifugation a diluted portion of the supernatant is injected into the LCMSMS-system. The total runtime for a sample is 6 minutes. The study will show if variation in serum levels of metformin measured in the same patient is high or low and thus give us better understanding whether a change i serum level is due to biological variation or to increased retention caused by progressive renal failure.

Official Title
-----------------
Intraindividual Variation of Serum Metformin in a Cohort of Patients With Type 2 DM and Moderately Reduced Renal Function

Conditions
-----------------
Diabetes Mellitus Type 2, Metformin, Pharmacokinetics

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients above the age of 18 years with type 2 diabetes mellitus. Reduced renal function measured as estimated GFR (below 60 ml/min/1.73). Treatment with metformin on going. Exclusion Criteria: Severely reduced GFR (< 30 ml(min/1.73)

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 |
| --- | --- | --- |
G-IVF and Sperm Parameters

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate if adding a fixed volume of a physiological solution to a freshly produced sperm sample will affect sperm characteristics.

Official Title
-----------------
Does Adding Medium to Fresh Semen Samples Increase Motility After Preparation?

Conditions
-----------------
Infertility, Male

Intervention / Treatment
-----------------
* Device: G-IVF PLUS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients producing a pre-clinical semen sample at the clinic Exclusion Criteria: Patients with known azoospermia Patients who have had a vasectomy

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

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

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 |
| --- | --- |
| No Intervention: Control<br>Control | |
| Experimental: G-IVF PLUS<br>G-IVF PLUS | Device: G-IVF PLUS<br>* Experimental<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of progressive motile sperm (%) | Proportion of progressive motile sperm after sample preparation | 10 minutes of assessment will be used to count the motile sperm for each sample. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sperm yield (%) | Percentage of total number of motile sperm after sperm preperation | 10 minutes used to assess motilty (as for primary outcome) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sperm motility, Sperm preparation, Osmolarity