linjc16/ctgov huggingface dataset:
Observational Study on the Weight Effect of Insulin Detemir (Levemir®) in Type 2 Diabetics

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. Observational study evaluating the body weight progress during the treatment with insulin detemir (Levemir®) in Type 2 patients, previously treated with other basal insulins

Official Title
-----------------
Observational Study Evaluating the Body Weight Progress During the Treatment With Insulin Detemir (Levemir®) in Type 2 Patients, Previously Treated With Other Basal Insulins

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Current treatment with insulin NPH or glargine The selection of the subjects will be at the discretion of the individual physician Exclusion Criteria: Current treatment with insulin detemir Previous enrolment in this study Hypersensitivity to insulin detemir or to any of the excipients. Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months

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 |
| --- | --- |
| All participants<br> | Drug: insulin detemir<br>* Start dose, frequency of dosing, dose titration to be 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 |
| --- | --- | --- |
| Weight effect |  | 12 months prior to and 12 months after detemir treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in FPG levels |  | 12 months prior and 12 months after detemir treatment | 
| Improvement in HbA1c levels |  | 12 months prior and 12 months after detemir treatment |
Transplant Navigator Dissemination

Study Overview
=================
Brief Summary
-----------------
Primary Aim A. To disseminate and determine the impact of streamlined navigation on wait listing and number of transplants. The navigator will provide tailored information and assistance to help dialysis patients complete the tasks required at each step in the transplant process. In the control group, dialysis patients will continue to get usual care from their nephrologists and dialysis facility personnel. Hypothesis: Compared to control patients, intervention patients will be significantly more likely to be wait listed or receive a kidney transplant.

Conditions
-----------------
Kidney Transplant, Renal Failure Chronic Requiring Hemodialysis

Intervention / Treatment
-----------------
* Other: navigator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: between the ages of 18-70 receiving in center hemodialysis Exclusion Criteria: less than 18 years of age older than 70 years of age

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: navigator<br>Kidney transplant recipients will serve as navigators to educate and assist other patients with the transplant process. | Other: navigator<br> <br> |
| No Intervention: usual care<br>usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who are wait listed or receive a kidney transplant. |  | approximately 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Navigators, Kidney Transplant, Hemodialysis
Effect of Intrathecal vs Intraarticular Dexmedetomidine on Postoperative Pain Following Arthroscopy

Study Overview
=================
Brief Summary
-----------------
Comparison between intrathecal Dexmedetomidine versus Intraarticular Dexmedetomidine on postoperative pain after knee arthroscopy.

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Intrathecal Dexmedetomidine
* Drug: Intraarticular Dexmedetomidine
* Drug: Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, ASA I-II, undergoing knee arthroscopy under spinal anesthesia. Exclusion Criteria: Absolute or relative contraindications to spinal anesthesia, allergy to dexmedetomidine or chronic pain treatment.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intrathecal Dexmedetomidine Group<br>30 patients will be given Intrathecal Dexmedetomidine plus Intrathecal Bupivacaine | Drug: Intrathecal Dexmedetomidine<br>* Addition of Intathecal Dexmedetomidine plus Intrathecal Bupivacaine<br>|
| Active Comparator: Intraarticular Dexmedetomidine Group<br>30 patients will be given Intraarticular Dexmedetomidine plus Intrathecal Bupivacaine | Drug: Intraarticular Dexmedetomidine<br>* Addition of Intraarticular Dexmedetomidine plus Intrathecal Bupivacaine<br>|
| Other: control Group<br>30 patients will be given Intrathecal Bupivacaine | Drug: Bupivacaine<br>* Intrathecal Bupivacaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | Assesment is done by Visual Analog Scale | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| c-reactive protein |  | 24 hours |
Regulatory Post Marketing Surveillance Study on Nexavar®

Study Overview
=================
Brief Summary
-----------------
This surveillance are to identify problems/questions regarding adverse events, factors that are considered to affect on safety and efficacy in the clinical practice of using Nexavar

Detailed Description
-----------------
The objectives of this surveillance are to identify problems/questions regarding the followings in the clinical practice of using Nexavar®. Unknown adverse events (in particular, serious adverse events) Identification of adverse events occurred in the real practice. Factors that are considered to affect on safety. Factors that are considered to affect on effectiveness

Official Title
-----------------
Regulatory Post Marketing Surveillance Study on Nexavar®

Conditions
-----------------
Carcinoma, Hepatocellular, Carcinoma, Renal Cell

Intervention / Treatment
-----------------
* Drug: Sorafenib (Nexavar, BAY43-9006)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosis of advanced RCC or HCC and decision taken by the physician to prescribe Nexavar. Exclusion Criteria: Exclusion criteria must be read in conjunction with the local product information but patients who are participating in other interventional studies currently will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 91 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 |
| --- | --- |
| Group 1<br> | Drug: Sorafenib (Nexavar, BAY43-9006)<br>* Daily dose, dosage frequency and duration will be decided by physicians.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events collection |  | From start of treatment to 4 weeks after discontinuation of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of treatment, dosage and indication |  | Whole treatment period | 
| Tumor status |  | Whole treatment period | 
| Performance status |  | Whole treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carcinoma, Hepatocellular, Carcinoma, Renal Cell
Changes in Iron Markers Following Iron Loading in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe alterations of serum ferritin, transferrin saturation, soluble transferrin receptor, % hypochromic erythrocytes, % reticulocytes, reticulocyte hemoglobin content after iron loading in hemodialysis patients.

Official Title
-----------------
Phase IV Study of Iron Indices' Kinetics in Hemodialysis Patients

Conditions
-----------------
Anemia in Chronic Renal Disease

Intervention / Treatment
-----------------
* Drug: iron sucrose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hemodialysis for three months minimum stable epoetin dose for two months minimum serum ferritin concentration < 1000 ng/ml transferrin saturation < 50% parathormone concentration < 800 pg/ml Exclusion Criteria: hemoglobin concentration > 13g/dl serum ferritin concentration < 20 ng/ml vitamin B12 and/or folic deficiency other hematologic disease than anemia cancer hypothyroidism infectious disease

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: iron sucrose|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ferritin alterations after iron loading at six and twelve weeks from the beginning of iron loading. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All iron indices' alterations during twelve weeks from the beginning of iron loading. |  |  |
C-Reactive Protein (CRP) Gene Variants and Coronary Artery Disease in a Chinese Han Population

Study Overview
=================
Brief Summary
-----------------
The recognition of the association between circulating C-reactive protein (CRP) levels and risk of coronary heart disease (CHD) has led to an increased emphasis on CRP genetic effects on CRP level and CHD. However, the causality of CRP variants remains uncertain.The objective of this study is to evaluate the association of CRP gene variants and CRP levels in CHD in Chinese Han population. We conduct case-control study in CRP-Han study participants. The common single-nucleotide polymorphisms (SNPs) in the CRP gene, haplotypes, and plasma CRP levels are detected. A Mendelian randomization analysis will be used to help test the likelihood of causal association of gene-CRP levels, CRP levels-CHD and gene-CHD. The investigators hypothesize that CRP gene variants influence the protein level and may participate in CHD progress.

Detailed Description
-----------------
CHD patients and non-CHD population are recruited. CRP level and CHD severity by coronary angiograph will be examined. Mendelian randomization analysis are taken to analyze statically.

Official Title
-----------------
CRP Gene Variants and Coronary Artery Disease in a Chinese Han Population

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of coronary artery disease Exclusion Criteria: with major organ disfunction or acute inflammatory disease
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<br>patients without coronary artery disease | |
| case<br>patients with coronary artery disease | |

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
-----------------
CRP, coronary artery disease, polymorphisms
Hypnosis for Eye Surgery

Study Overview
=================
Brief Summary
-----------------
Perioperative stress for cataract surgery in the elderly is considerable even in the absence of pain. For these patients with a high comorbidity level, the perioperative situation comprising factors such as uncomfortable positioning, dull ambience, face cover, poor sedation, and anxiety might not only reduce intraoperative compliance but induce cardiac ischemia and hypertensive crises. Hypnosis is supposed to increase patient comfort, to shield the patient from organic stress and to improve intraoperative compliance without side effects even in old and very ill patients. In a controlled study, we, the investigators at the University of Heidelberg, compared phakoemulsification under topical anesthesia as usual (and placebo hypnosis) with either additional hypnosis or hypnoanalgesia without topical anesthesia.

Official Title
-----------------
Correlation of Stress, Patient Comfort and Safety to Bispectral Index in Patients Under Hypnosis for Cataract Surgery

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Procedure: Hypnoanalgesia; Hypnotic shielding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cataract Exclusion Criteria: Uncorrected hearing disability Pharmacological beta-blockade

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 95 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Hypnoanalgesia; Hypnotic shielding|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of perioperative stress |  |  | 
| Improvement of patient comfort and safety |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of hypnotic depth with bispectral index (BIS) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract surgery, Hypnosis, C11.510.245, F04.754.424.771, Suggestion
Evaluation of Potential Vitamin D Effects on Muscle: a Pilot Study

Study Overview
=================
Brief Summary
-----------------
People who do not have adequate amounts of vitamin D develop weakness of leg and arm muscles. This study will determine if vitamin D supplementation benefits muscle functions important for swallowing, bladder and bowel function.

Official Title
-----------------
Evaluation of Potential Vitamin D Effects on Muscle: a Pilot Study

Conditions
-----------------
Dysphagia, Fecal Incontinence, Urinary Incontinence

Intervention / Treatment
-----------------
* Other: Ergocalciferol (vitamin D2)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who present for evaluation to the UW Geriatric clinic including Dr. Pryzbelski's subspecialty, or Osteoporosis clinics Age 70 years or older Cognitively intact, as determined by the attending physicians at above mentioned clinics Exclusion Criteria: History of, on ongoing, renal failure History of liver failure Known malabsorption Known disorders of parathyroid function, hyper/hypocalcemia, or other abnormalities of calcium or phosphate metabolism Known history of vitamin D intoxication or granulomatous disease active seizure disorder Pain associated with temporomandibular joint (TMJ)

Ages Eligible for Study
-----------------
Minimum Age: 70 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>oral placebo 3 times weekly | Other: Ergocalciferol (vitamin D2)<br>* 50,000 IU 3 times weekly for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in lingual strength and perceived swallow function |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in perceived bowel and bladder function |  | 4 weeks |
Percentage Venous Options in Pediatrics & Adults

Study Overview
=================
Brief Summary
-----------------
VeinViewer® Vision will significantly increase the number of peripheral intravenous catheter access targets perceived by clinicians with experience in intravenous cannulation when compared to the number of access targets that these clinicians are able to visualize unaided or to palpate.

Official Title
-----------------
Utilizing a Near Infrared Vein Visualization Device To Increase Peripheral Intravenous Access Targets in Pediatric & Adult Patients (% Venous Options)

Conditions
-----------------
Veins

Participation Criteria
=================
Eligibility Criteria
-----------------
Pediatric arm Inclusion Criteria: Age 17 years of age or younger, Intact skin, without rash,irritation, scarring, open abrasion or other injury in these sites. Parent or guardian is English speaking Pediatric patients 8 years older will be asked to provide assent Participant does not have an acute or critical medical illness or injury requiring immediate evaluation and/or treatment. Exclusion Criteria: 18 years of age or older No intact upper extremities Patient has had current or recent (within 6 months) venous access in the arm that will be evaluated. Acute or critical illness or injury requiring immediate or urgent evaluation and treatment. Adult arm: Inclusion Criteria: Age 18 years or older, At least one intact upper extremity (intact from the base knuckle to the shoulder) Intact skin on the dorsum of the hand, the ventral forearm, and antecubital fossa, without rash, irritation, scarring, open abrasion or other injury in these sites. Participant does not have an acute or critical medical illness or injury requiring immediate evaluation and/or treatment. Exclusion Criteria Younger than 18 years of age No intact upper extremities The participant does not have intact skin on the dorsum of the hand, the ventral forearm, and antecubital fossa, without rash, irritation, scarring, open abrasion or other injury preventing appropriate evaluation of these sites. Non-English speaking participant. Patient has had current or recent (within 6 months) venous access in the arm that will be evaluated. Acute or critical illness or injury requiring immediate or urgent evaluation and treatment.
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 |
| --- | --- | --- |
| Number of Veins Identified with VeinViewer will be greater than those identified by sight or sight & palpation |  | Immediately after assessment-Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Veins, Catheter Segments, Vascular Access, VeinViewer Vision
Long-Term Outcome in Congenital Undescended Testis After Surgical Treatment by Orchidopexy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the long-term outcome in congenital undescended testis after surgical treatment by orchidopexy and to what extent orchidopexy is the treatment for congenital undescended testis.

Official Title
-----------------
Long-Term Outcome in Congenital Undescended Testis After Surgical Treatment by Orchidopexy

Conditions
-----------------
Undescended Testis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The orchidopexy has taken place in the Medical Center Alkmaar between 1986-2004 The indication concerned a congenital undescended testis It concerns a first orchidopexy to the concerning testis Exclusion Criteria: Orchidopexy has taken place on an other reason than congenital undescended testis (for example: torsio testis) It concerns re-orchidopexy

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 25 Years

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

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
-----------------
orchidopexy, long-term outcome, congenital