linjc16/ctgov huggingface dataset:
Does Hormonal Luteal Support After Intra-uterine Insemination (IUI) Increase the Pregnancy Rate?

Study Overview
=================
Brief Summary
-----------------
A randomized study to investigate if hormonal luteal support after intra-uterine insemination (IUI) in ovulation induction cycles with human menopausal gonadotropin increases the pregnancy rate

Official Title
-----------------
Luteal Support With Vaginal Progesterone Capsules Following Ovulation Induction With Human Menopausal Gonadotropins (hMG) for Intra Uterine Insemination: A Comparative Study

Conditions
-----------------
Subfertility

Intervention / Treatment
-----------------
* Drug: progesterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Tubal patency demonstrated ovulation induction with human menopausal gonadotropin Exclusion Criteria: ovulation induction with clomiphene citrate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 43 Years

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

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 |
| --- | --- |
| No Intervention: control<br> | |
| Experimental: utrogestan<br>daily use of vaginal progesterone capsules | Drug: progesterone<br>* vaginal capsules 3X200mg daily<br>* Other names: Utrogestan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate per cycle |  | 12 weeks pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of miscarriages per cycle |  | 12 weeks pregnancy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
subfertility, pregnancy rate, miscarriage
Non-invasive Imaging With [18F]VM4-037

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the toxicity of the hypoxia PET-tracer [18F]-VM4-037 in cancer patients in two dose-steps: Step 1 (3-6 patients): a single dose of maximum 8 mCi (296 MBq) dose of [18F]VM4-037 via a bolus IV injection. Step 2 (3-6 patients): a single dose of maximum 12 mCi (444 MBq) dose of [18F]VM4-037 via a bolus IV injection

Official Title
-----------------
Non Invasive Imaging of [18F]VM4-037 With Positron-Emission-Tomography (PET): A Phase I Trial

Conditions
-----------------
Stage 4 Cancer

Intervention / Treatment
-----------------
* Drug: [18F]VM4-037


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological or cytological confirmed solid tumour, primary or secondary stage IV and/ or tumours with no curative treatment options WHO performance status 0 to 1 Normal white blood cell count and formula Normal platelet count No anaemia requiring blood transfusion or erythropoietin Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution) Calculated Creatinin clearance at least 60 ml/min No administration of Fluor-18 in the previous 24 hours The patient is capable of complying with study procedures 18 years or older Exclusion Criteria: Only visible tumor sites in the upper abdomen (because the uptake of VM4-037 in the liver, stomach and the kidneys would interfere with image quality of the tumor) Known hypersensitivity for sulfonamides Recent (< 3 months) myocardial infarction Uncontrolled infectious disease Less than 18 years old Pregnancy No concurrent anti-cancer agents or radiotherapy allowed

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: [18F]VM4-037|Bolus IV injection of [18F]VM4-037|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity (CTCAE 3.0) |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image Quality |  | 1 week | 
| Correlation with circulating biomarkers of hypoxia |  | 1 week | 
| Correlation with [18F]-FDG on PET scans |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IV cancer with no treatment options, non-curative
Bioactive Glass as Bone Graft Substitute in Operative Treatment of Bone - a 10 Years Follow-up Study

Study Overview
=================
Brief Summary
-----------------
The main aim is to evaluate the long-term safety and bone healing in the operated area and to compare bioactive glass granules with autogenous bone as a filler material.

Official Title
-----------------
Bioactive Glass (S53P4) as Bone Graft Substitute in Operative Treatment of Depressed Lateral Condyle Fractures, Benign Bone Tumour Cavities and in Spinal Fusion - a 10 Years Follow-up and Bone Density Study.

Conditions
-----------------
Depressed Lateral Condyle Fracture, Benign Bone Tumour Cavity, Spinal Fusion

Intervention / Treatment
-----------------
* Device: Bioactive glass and/or autogenous bone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent obtained; Participation of previous clinical investigation with bioactive glass Exclusion Criteria: The subject is unlikely to adhere to study procedures Concurrent disease or condition that in the opinion of the investigator is contraindicating participation Simultaneous participation in another medical device or investigational drug trial
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>DEPRESSED LATERAL CONDYLE FRACTURE | Device: Bioactive glass and/or autogenous bone<br>* No intervention in the current study (10-year follow-up study)<br>|
| B<br>BENIGN BONE TUMOR | Device: Bioactive glass and/or autogenous bone<br>* No intervention in the current study (10-year follow-up study)<br>|
| C<br>SPINAL FUSION | Device: Bioactive glass and/or autogenous bone<br>* No intervention in the current study (10-year follow-up study)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Oral Antibiotic Treatment of Helicobacter Pylori Reduces Intestinal Colonization Rates With Oxalobacter Formigenes

Study Overview
=================
Brief Summary
-----------------
The investigators are finding out if giving antibiotics for Helicobacter pylori will eliminate colonization of the colon by Oxalobacter formigenes.

Detailed Description
-----------------
Background and objectives: Oxalobacter formigenes (OF) may play a protective role in preventing calcium oxalate stones. Intestinal colonization by OF is associated with reduced urinary oxalate excretion. Exposure to antibiotics may be an important factor contributing to variable rates of colonization. This is the first prospective study to evaluate the effect of antibiotics on OF colonization. Design, setting, participants, & measurements: The effect of antibiotics on OF colonization was compared in 2 groups: a group receiving antibiotics for gastric infection with Helicobacter pylori (HP) and a group without HP that not receiving antibiotics. OF colonization in stool was detected by oxalate degradation at baseline and after 1 and 6 months.

Official Title
-----------------
Oral Antibiotic Treatment of Helicobacter Pylori Reduces Intestinal Colonization Rates With Oxalobacter Formigenes

Conditions
-----------------
Nephrolithiasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-80 years old undergoing upper endoscopy H. pylori present or absent on gastric histology stool positive for Oxalobacter formigenes Exclusion Criteria: unable to consent stool negative for Oxalobacter formigenes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Antibiotics for H. pylori<br>Patients who underwent upper endoscopy and were found to have H. pylori, and were then to be treated with antibiotics for eradication of H. pylori | |
| Control group, no H. pylori<br>Patients who underwent upper endoscopy and found to not have H. pylori, and then would not receive antibiotics | |

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
-----------------
nephrolithiasis, urolithiasis, hyperoxaluria, Helicobacter pylori
Mucosal Innate Immune Activation in Chronic Intestinal Disorders

Study Overview
=================
Brief Summary
-----------------
Crohn's disease and ulcerative colitis are types of chronic intestinal disorder called inflammatory bowel diseases (IBD) that can affect the small and large bowel causing symptoms of abdominal pain, diarrhea, blood in the stool, and weight loss. Irritable bowel syndrome (IBS) is a milder form of IBD, with symptoms of abdominal pain, bloating, diarrhea or constipation, and blood in the stool. It is not known what causes diseases such as IBD and IBS. This study will look at the events in the gut that leads to leaky gut and inflammation in patients with IBD and IBS. The study will also see if medications such as rifaximin and mesalamine may reduce the amount of leaky gut.

Official Title
-----------------
Mucosal Innate Immune Activation in Chronic Intestinal Disorders

Conditions
-----------------
Irritable Bowel Syndrome, Inflammatory Bowel Diseases

Intervention / Treatment
-----------------
* Procedure: Biopsies from endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women, 18-years old and older Presenting at the University of Arkansas for Medical Sciences (UAMS) Endoscopy center to undergo endoscopy with biopsy for surveillance, screening or diagnosis. Exclusion Criteria: Subjects classified in an anesthesia risk group , American Society of Anesthesiologists Class (ASA) ≥ 4, history of bleeding diathesis or coagulopathy stroke or transient neurological attack within the last 6 months pregnancy currently on blood thinners (excepting aspirin) subject is unable to consent themselves

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Biopsies from endoscopy|1) Patients scheduled for endoscopy (EGD or colonoscopy) for IBD will be consented to allow physicians who are performing endoscopies to take additional biopsies and blood samples for research purposes.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of specimens showing elevated levels of mucosal innate immune activation | Determining the level of mucosal innate immune activation by staining, organoid culture, Western blot analysis, and cytokine expression on biopsy samples in IBD and IBS patient samples. | Up to 2 years |
Pedobarographic Assessments of Clubfoot Treated Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the utility of pedobarographs in evaluating clubfoot post-treatment.

Detailed Description
-----------------
Detailed Description: Using Tekscan's HRMat Pressure assessment system or EMED pedobarography system the distribution of force will be measured across the plantar surface of the subject' foot. The Tekscan system is comprised of a 50 cm square pressure sensor connected to a computer interface. The data collection will be made up of two parts: Part I: Static Profile: The child will be asked to stand on the mat for 6 seconds for five trials. During this time the data collection software will collect force data across the foot 60 times per second. The software will then calculate centre of force as well as changes in pressure during the static trial. The foot will be assessed into the distribution of forces across the hindfoot, midfoot, forefoot, and the big toe. In addition, the centre of gravity will also be determined. Part II: Dynamic Profile: The dynamic test will involve the child walking across the mat for a total of 5 passes per foot. Measurements of force will again be taken at 60 Hz. The EMED-x400 sensor is rectangular and its dimensions are 47.5 cm by 32 cm. Measurements of force will be recorded at up to rates of 400 Hz. Foam pieces (included with the EMED platform) are constructed around the platform to establish a levelled and safe runway for the patient to walk along. The EMED platform is connected to a computer interface which operates on the Novel analysis software. The subject will be asked to walk across the mat independently at their ordinary pace. The foot is required to land in the centre of the mat, at a minimum of three trials per foot10. Plantar pressure recording takes 10-20 minutes for each subject.

Official Title
-----------------
Pedobarographic Assessments of Clubfoot Treated Patients

Conditions
-----------------
Clubfoot

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria - all clubfoot patients seen at BC Children's Hospital who have commenced walking and compliant to the study protocol. As the goal of the study is to evaluate the utility of pedobarographs in evaluating clubfoot treatment, we will be following subjects with all presentations of clubfoot (this includes idiopathic clubfoot and clubfoot that is secondary to another global disorder). Exclusion Criteria:

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Evaluation of an outcome tool, clubfoot, foot pressure profiles, pedobarographs
Coronary CT Angiography to Predict Vascular Events In Noncardiac Surgery patIents cOhort evaluatioN (CTA -VISION) Study

Study Overview
=================
Brief Summary
-----------------
Worldwide 200 million adults annually undergo major noncardiac surgery and 5 million of these patients will suffer a major vascular complication. Despite the magnitude of this problem our capacity to predict these events is limited. Although perioperative myocardial infarction (MI) is the most common major perioperative cardiac complication, little is known about its pathophysiology. Coronary computed tomography angiography (CTA) is a potential non-invasive method for the detection of coronary artery disease and cardiac risk stratification in the non-operative setting; however, the value of this test to enhance risk prediction among patients scheduled for noncardiac surgery is unknown. This study is an international prospective cohort study to determine among patients with, or at risk of, atherosclerotic disease who are undergoing noncardiac surgery: 1) if preoperative coronary CTA has additional predictive value for the occurrence of major perioperative cardiac events and 2) the underlying coronary anatomy associated with perioperative MIs.

Official Title
-----------------
Coronary CT Angiography to Predict Vascular Events In Noncardiac Surgery patIents cOhort evaluatioN (CTA -VISION) Study

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Other: Coronary CT Angiogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >=45 years undergoing non cardiac surgery requiring an overnight stay and general or regional anaesthetic at least one of: Coronary Artery Disease (CAD) Peripheral Vascular Disease (PVD) History of Stroke History of Congestive Heart Failure (CHF) Combination of at least 3 of: age >= 70 years history of treatment for hypertension history of treatment for dyslipidemia smoking in last 2 years diabetic and currently taking insulin or oral diabetic drugs history of Transient Ischemic Attack (TIA) Exclusion Criteria: contraindications to CTA

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- |
| Non-cardiac surgical patients<br>>= 45 years old, undergoing non-cardiac surgery requiring regional or general anaesthetic and an overnight stay with cardiac risk factors | Other: Coronary CT Angiogram<br>* pre-operative coronary CTA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative MI |  | 30-days post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative Cardiovascular Event |  | 30-days post-operative |
Observational Study of Patients Using NovoMix® 30 or Levemir® for Treatment of Type 1 or Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this observational study is to evaluate the glycaemic control in patients with type 1 or 2 diabetes using NovoMix® 30 or Levemir® under normal clinical practice conditions.

Official Title
-----------------
A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 1 or Type 2 Diabetes Mellitus in Macedonia

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 30
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Levemir® above 6 yrs NovoMix® 30 above 18 yrs Patients with Type 1 or Type 2 diabetes, including newly diagnosed Exclusion Criteria: Current treatment with NovoMix® 30 or Levemir®
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: biphasic insulin aspart 30<br>* Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation<br>* Other names: BIASP;|
| B<br> | Drug: insulin detemir<br>* Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | at 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FPG, PG profile, weight, % of subjects on target |  | at 24 weeks |
Autologous Blood Transfusion After Local Infiltration

Study Overview
=================
Brief Summary
-----------------
Total knee and hip arthroplasty for osteoarthritis is performed on still broader indications even in elderly patients with previous or current medical conditions. Especially comorbidity like cardiovascular diseases and conditions with increased risk of bleeding or previous thrombo-embolic events are major challenges. To facilitate safe use of ropivacaine as an analgesic, information on the concentrations levels after autologous blood transfusion following local infiltration analgesia is very crucial. However, very limited data are available. To verify the safety of autologous blood transfusion, ropivacaine concentrations were studied in 52 patients undergoing either total knee arthroplasty or total hip arthroplasty.

Official Title
-----------------
Autologous Blood Transfusion After Local Infiltration Analgesia With Ropivacaine in Total Knee and Hip Arthroplasty

Conditions
-----------------
Total Hip Arthroplasty, Total Knee Arthroplasty

Intervention / Treatment
-----------------
* Drug: Autologous blood transfusion with ropivacaine
* Drug: Autologous blood transfusion with ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis for hip arthroplasty Clinical diagnosis for knee arthroplasty Exclusion Criteria: Patients < 18 years Lack of informed consent Inability to read/understand Danish Bilateral diagnosis Cancer diagnosis

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Total knee arthroplasty<br>25 consecutive patients diagnosed for total knee arthroplasty. | Drug: Autologous blood transfusion with ropivacaine<br>* Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg<br>* Other names: No other names.;|
| Total hip arthroplasty<br>27 patients diagnosed for total hip arthroplasty. | Drug: Autologous blood transfusion with ropivacaine<br>* Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg.<br>* Other names: No other names.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of ropivacaine in serum | Concentrations of ropivacaine in serum before and after autologous blood transfusion will be analyzed. | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of ECG and pulse rate | ECG, pulse rate and blood pressure will be analyzed in proportion to concentrations of serum before and after autologous blood transfusion | 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anaesthesia, Infiltration, Blood transfusion, Autologous, Arthroplasty, Replacement, Ropivacaine