linjc16/ctgov huggingface dataset:
Renal Tracer Elimination in Thyroid Cancer Patients Treated With 131-Iodine

Study Overview
=================
Brief Summary
-----------------
Correlation analysis between estimated renal function and biological half life of 131-I during radioiodine treatment of patients with differentiated thyroid cancer.

Detailed Description
-----------------
131-I during radioiodine treatment of patients with differentiated thyroid cancer is mainly renally excreted. It is advised in the clinical guidelines that serum creatinine should be determined before applying 131-I and if necessary the administered dose should be reduced. Nevertheless no guideline gives advice in what extent the dose should be decreased. The adjustment is at the discretion of the attending physician. Aim of this prospective study is to correlate the biological half life of 131-I with the renal function to give objective recommendations concerning the reduction of the applied dose in patients with limited renal function.

Official Title
-----------------
Relationship Between Estimated Glomerular Filtration Rate and Biological Half-life of 131I. Prospective Analysis in Patients With Differentiated Thyroid Carcinoma.

Conditions
-----------------
Thyroid Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with differentiated thyroid carcinoma stationary for treatment or diagnostic with radioiodine state after thyroidectomy written consent of the patient minimum age 18 years Exclusion Criteria: no written consent of the patient patients with large residual thyroid tissue (iodine uptake > 10%) children under 18 years of age inclusion in concurrent interventional studies patients without TSH-stimulation by rhTSH

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 |
| --- | --- | --- |
| Correlation between estimated renal function and biological half life of 131-I | The estimated renal function (estimated GFR) is measured via determination of serum creatinine and Cystatin C. The biological half-life of I-131 is determined via whole-body dosimetry (whole-body probe and whole-body gamma camera) and blood probe measurement. Update 2017/06/07: After analyzing the preliminary results (based on the first 48 patients) probe measurements are not longer needed in a simplified study design. Additionally, measuring the creatinine concentration is no longer needed in comparison to the Cystatin C measurements. | 2 years |
Effects of Physical Activity During Pregnancy on the Newborn's Cognitive Function

Study Overview
=================
Brief Summary
-----------------
Background: It is now generally accepted that an active lifestyle is beneficial for cognition, but can these benefits be transmitted for the active pregnant woman to her unborn child? This has been demonstrated in rats where the pups born of mothers who exercised during pregnancy had increased hippocampal neurogenesis and better memory and learning capabilities. Human studies tend to confirm this by looking at behavioral results, ie. better orientation and state regulation skills in newborns. The aim of the present study is to verify this on the electrophysiological level and to determine the effects of an active lifestyle during pregnancy on the newborn's brain development. Methods: 60 pregnant women will be included in a randomized controlled trial. The exercise group will be asked to exercise a minimum of 20 minutes, 3 times per week, at a minimal intensity of 55% of their maximal aerobic capacity. The control group will not be given exercise counselling. Newborns' brain activity will be recorded using electroencephalography (EEG) 10 days post partum. The primary outcome measure will be the amplitude and latency of the mismatch negativity (MMN), a component of the auditory event-related potential (ERP) that can be used to investigate the auditory sensory memory.

Official Title
-----------------
Effects of Physical Activity During Pregnancy on the Newborn's Cognitive Function, the Healthy Mom, Bright Child Randomized Trial

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First trimester of pregnancy 20 to 35 years of age Pre-pregnancy BMI between 18 and 25 Primipara Without any known health issues Use of folic acid Exclusion Criteria: Use of alcohol, cigarettes or illegal drugs Pregnancy complications Unable or unwilling to breastfeed Excessive or insufficient weight gain

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br> | Behavioral: Exercise<br> <br> |
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mismatch negativity |  |  |
Comprehensive Analysis of Hypoxia in Prostate Cancer: Diagnostic Markers and Prognostic Significance

Study Overview
=================
Brief Summary
-----------------
A single-center cohort study to identify uni- and multivariate associations between marker gene expression and clinico-pathological parameters for the detection of robust and novel prognostic tools in prostate cancer

Detailed Description
-----------------
To perform a large scale assessment of tissue hypoxia by pimonidazole and hypoxia marker gene expression in human prostate cancers To characterize expression and hypoxia/HIF-responsiveness of myoglobin, cytoglobin, α-hemoglobin in prostate tumors and cell lines To identify uni- and multivariate associations between marker gene expression and clinico-pathological parameters for the detection of robust and novel prognostic tools in prostate cancers

Official Title
-----------------
Comprehensive Analysis of Hypoxia in Prostate Cancer: Diagnostic Markers and Prognostic Significance

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Device: Pimonidazol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with biopsy-proven adenocarcinoma of the prostate who are to be treated with radical prostatectomy at the Department of Urology, University Hospital of Zurich Written informed consent Exclusion criteria: Metastatic prostate cancer Contraindications to the class of investigational product under study, e.g. known hypersensitivity or allergy to the investigational product Severe heart or lung disease Severe liver or kidney dysfunction Severe stridor Distant metastases Concurrent treatment for other malignant disease Prior hormonal therapy or radiotherapy
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Pimonidazol|0.5gm/m2 Pimonidazol i.v. 16-24 hours before prostatectomy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
ENTact™ Septal Stapler Shelf Life Extension

Study Overview
=================
Brief Summary
-----------------
This study is a prospective, limited-use evaluation of the ENTact™ Septal Stapler for tissue approximation utilizing staples with extended shelf life. The ENTact™ Septal Stapler will be used to approximate the mucoperichondrial flaps in all patients. Each treatment group will be implanted with product that has been aged for a specified amount of time.

Official Title
-----------------
A Prospective, Limited-Use Evaluation of the ENTact™ Septal Stapler for Tissue Approximation Utilizing Staples With Extended Shelf Life

Conditions
-----------------
Deviated Nasal Septum

Intervention / Treatment
-----------------
* Device: ENTact™ Septal Stapler
* Device: ENTact™ Septal Stapler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, between the ages of 18 and 65 years, with a clinically significant deviation of the nasal septum. Patient is able to provide a signed informed consent form. Patient will agree to comply with all study related procedures. Subject is not pregnant at this time by confirmation of one of the following: subject is male, subject not of child bearing age, subject is surgically sterile, subject is not pregnant per negative hCG test. Subject does not plan on becoming pregnant and is not breast feeding during the course of the study. Exclusion Criteria: Patients who have had previous septoplasty Patients with uncontrolled diabetes Presence of infection at the study site Subject is a: smoker, severe drug abuser, severe alcohol abuser. Patient with autoimmune disease deemed clinically significant by the Principal Investigator.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One year aged staples<br>Subjects implanted with sterile staples aged to approximately one year. | Device: ENTact™ Septal Stapler<br>* 1 year aged septal staples<br>|
| Experimental: 18 month aged staples<br>Subjects implanted with sterile staples aged to approximately 18 months. | Device: ENTact™ Septal Stapler<br>* 18 Month Aged Staples<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance of aged ENTact™ Septal Staples |  | One week post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evaluation of gross tissue appearance at implantation site(s) |  | One week post op | 
| ENTact™ Septal Staple functionality based on maintained coaptation |  | One week post op |
Safety of Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in North America. The aim of this trial is to evaluate the safety of insulin detemir for the treatment of diabetes.

Official Title
-----------------
A Multicentre, Open Label, Nonrandomised, Safety Study in Subjects Using Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with type 1 or type 2 diabetes Using a basal/bolus insulin regimen Exclusion Criteria: Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit Subjects who previously enrolled in this study Subjects with a hypersensitivity to insulin detemir or to any of the excipients

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin detemir<br> | Drug: insulin detemir<br>* Administered subcutaneously (s.c., under the skin). Dose individually adjusted.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemic events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events (all and serious) |  |  | 
| Number of all hypoglycaemic events |  |  | 
| Change in weight |  |  | 
| HbA1c (glycosylated haemoglobin) |  |  | 
| Treatment satisfaction as assessed by Insulin Treatment Satisfaction Questionnaire (ITSQ-22) |  |  |
Requirement of Analgesics After Two Remifentanil Dosing Regimen in Cardiac Surgery.

Study Overview
=================
Brief Summary
-----------------
Prospective double blind study comparing two remifentanil dosing protocols (0.1 and 0.3 mcg/kg/min) during cardiac surgery. Main outcome measures are postoperative opioid requirements (PCA oxycodone) and postoperative pain (VAS, verbal rating scale).

Official Title
-----------------
Requirement of Analgesics After Two Remifentanil Dosing Regimen in Cardiac Surgery.

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

Intervention / Treatment
-----------------
* Drug: remifentanil
* Drug: remifentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Coronary artery bypass grafting patients Exclusion Criteria: Psychiatric disorders, sleep apnea, cardiac insufficiency

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>remifentanil o.1 mcg/kg/min | Drug: remifentanil<br>* remifentanil infusion<br>|
| Active Comparator: 2<br>remifentanil 0.3 mcg/kg/min | Drug: remifentanil<br>* remifentanil infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative opioid (oxycodone) consumption |  | Postoperatively 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, postoperative, opioid, PCA, cardiac surgery
Evaluating the Impact of the Intervention of a Pharmacist in the Operating Room on the Appropriate Use of Sterile Medical deviceS

Study Overview
=================
Brief Summary
-----------------
assess the impact of the intervention of a clinical pharmacist expert in sterile medical devices

Official Title
-----------------
Pilot Study Evaluating the Impact of the Intervention of a Pharmacist in the Operating Room on the Appropriate Use of Sterile Medical Devices and the Economic Repercussions

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Other: impact of the intervention of a clinical pharmacist with expertise in sterile medical devices on non-compliances related to the use of sterile medical devices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - The patient must be a member or beneficiary of a health insurance plan. The patient is managed for scheduled surgery (full hospitalization or outpatient) in the UDG (Urology Digestive Gynecology) operating room. Exclusion Criteria: - The subject is in a period of exclusion determined by a previous study. The subject is under judicial protection. The subject (or his/her legal representative) has expressed his/her opposition to participate in the study. The patient is undergoing emergency surgery in the UDG (Urology Digestive Gynecology) operating room. It is not possible to give informed information about the subject. Translated with www.DeepL.com/Translator (free version)

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: impact of the intervention of a clinical pharmacist with expertise in sterile medical devices on non-compliances related to the use of sterile medical devices|- Failure to trace, Lack of product information, absence of product in the operating room|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| identify compliance with the appropriate use of sterile medical devices |  | 1 day |
Reliability of an Objective Measurement to Assess Lumbar Spine Motion in Healthy Controls and in Low Back Pain Patients

Study Overview
=================
Brief Summary
-----------------
Main of the study is to assess the reliability of a new objective tool to measure lumbar spine motion. The data will be collected from healthy subjects and subjects with frequent or daily low back pain in the last three months. In addition we compare the results of the motion measurements with disability and pain questionnaires such as the Roland Morris, Oswestry Disability Index and the Brief Pain Inventory.

Official Title
-----------------
Reliability of an Objective Measurement to Assess Lumbar Spine Motion in Healthy Controls and in Low Back Pain Patients

Conditions
-----------------
Reliability, Validity of Measurement to Assess Lumbar Spine Motion, Comparison of Healthy Subjects and Low Back Pain Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18 years, informed consent, sufficient German skills <30 days low back pain in the last 90 days (control group) >31days of low back pain in the last 90 days (low back pain group) Exclusion Criteria: neurological disorder (including multiple sclerosis, Stroke, Parkinson´s disease), Current pain >= 4 (NSR)/intake of analgesic in the last 24h/ previous low back surgery (control group), inability to perform choreography (LBP group)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Control group 1<br>Never low back pain in the last 3 months | |
| Control group 2<br>occasionally (1-30days) low back pain in the last 3 months | |
| Low back pain group 3<br>frequently (31-60days) low back pain in the last 3 months | |
| Low back pain group 4<br>daily (61-90days) low back pain in the last 3 months | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reliability of measurement tool | reliability of measurement tool | February 2012-February 2013 |
A Single Patient Compassionate Use of MBM-02 (Tempol) for the Treatment of Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
A single patient compassionate use clinical trial for the use of MBM-02 (TEMPOL) for the treatment of prostate cancer. The single patient will be exposed to orally administered TEMPOL for up to 12 months at a maximum total daily dose of 800mg.

Detailed Description
-----------------
Localized therapy for prostate cancer is often curative; however, 20% to 30% of patients experience a recurrence. Biochemical recurrence (BCR) occurs in an estimated 50,000 men/year in the U.S and is marked by a rising prostate specific antigen (PSA) after definitive radical prostatectomy and/or radiation therapy for localized disease. Continuous androgen deprivation therapy (ADT), in which serum testosterone is decreased to a castrate level (less than 50 ng/dL) is a standard treatment in BCR. ADT is associated with significant short term and long term toxicities, including declining quality of life on treatment and increased risk of osteoporosis, diabetes, and cardiovascular disease. MBM-02 is being tested as a novel non-hormonal agent with improved biologic activity and better tolerability for use in biochemically recurrent prostate cancer.

Official Title
-----------------
A Single Patient Compassionate Use of MBM-02 (Tempol) for the Treatment of Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: MBM-02 (Tempol)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biochemical Recurrent Prostate Cancer Exclusion Criteria: -

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MBM-02 (Tempol)|Study drug will be administered orally using the capsule formulation (200 mg). The study drug will be administered 7 days a week for the entire treatment period.|

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

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