linjc16/ctgov huggingface dataset:
A Study of Lanabecestat in Participants With Severe Kidney Impairment Compared to Healthy Participants

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether lanabecestat can be safely prescribed in participants with kidney impairment without a dose adjustment. Participants will be on study for up to 6 weeks; this includes a 2-week screening and a follow-up about 10 days after final drug administration.

Official Title
-----------------
Pharmacokinetics of Lanabecestat (LY3314814) in Subjects With Impaired Renal Function

Conditions
-----------------
Renal Insufficiency

Intervention / Treatment
-----------------
* Drug: Lanabecestat
* Drug: Iohexol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Have a body mass index (BMI) of 19 to 40 kilograms per meter square (kg/m²) Exclusion Criteria: Have a history of or current significant ophthalmic disease, particularly any eye problem involving the retina Have moderate or severe vitiligo or any other clinically significant disorder of skin or hair pigmentation Have acute unstable neuropsychiatric disease Have active or uncontrolled neurologic disease, or clinically significant head injury

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lanabecestat Control<br>Lanabecestat administered orally to participants with normal renal function | Drug: Lanabecestat<br>* Administered orally<br>* Other names: LY3314814;|
| Experimental: Lanabecestat Severe Renal Impairment<br>Lanabecestat administered orally to participants with severe renal impairment, not on dialysis | Drug: Lanabecestat<br>* Administered orally<br>* Other names: LY3314814;Drug: Iohexol<br>* Administered intravenously. Administration is at investigator's discretion in participants with severe renal impairment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under The Concentration Versus Time Curve From Zero To Infinity (AUC[0-∞]) for Lanabecestat | PK: AUC(0-∞) for Lanabecestat | Baseline through 168 hours after the administration of study drug | 
| PK: Maximum Observed Drug Concentration (Cmax) of Lanabecestat | PK: Cmax of Lanabecestat | Baseline through 168 hours after the administration of study drug |
Assess Vitamin D Levels in Those With & Without Thyroid Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate Vitamin D levels in thyroid cancer patients with active disease compared with thyroid cancer patients in remission and patients with thyroid nodules.

Detailed Description
-----------------
Thyroid cancer is the most common endocrine related malignancy, increasing in incidence in recent years. There are relatively few, well known factors, both genetic and environmental, which predispose to the development of thyroid cancer. Vitamin D deficiency has been associated with other cancers, but the association between vitamin D and thyroid cancer is unknown. We plan to do a case control, pilot study to evaluate the relationship between vitamin D levels and thyroid nodules, thyroid cancer in remission, and active thyroid cancer.

Official Title
-----------------
The Relationship Between Vitamin D and Thyroid Cancer

Conditions
-----------------
Thyroid Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases: History of Papillary, Follicular, Follicular Variant of Papillary, or Hurthle cell thyroid cancer (both active disease and in remission). Controls: Individuals with a thyroid nodule, matched to cases for age, BMI, season of vitamin D measurement. Participating in University of Nebraska Medical Center Thyroid Tumor and Cancer Collaborative Registry database. Exclusion Criteria: Pregnant or breast feeding women Medullary thyroid cancer Anaplastic thyroid cancer

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Thyroid Cancer in Remission Group<br>Thyroid Cancer-Remission Group & use of Vitamin D | |
| Thyroid Cancer with Active Disease Group<br>Thyroid Cancer-Active Group & use of Vitamin D | |
| Thyroid nodule group (no cancer) & Vit D<br>Thyroid nodule group without cancer and use of Vitamin D | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Persons That Are Vitamin D Deficient in the Thyroid Nodule, Thyroid Cancer in Remission, and the Active Thyroid Cancer Groups. | We evaluated serum calcium,creatinine,albumin,and 25-hydroxyvitaminD(25-OH-D)in 42 thyroid nodule, 45 thyroid cancer in remission, & 24 active thyroid cancer patients. We also determined the number and percent of participants in each group that had vitamin D deficiency, defined as 25-OH-D < 30 ng/ml. | Within 12 months of enrollment in thyroid cancer collaborative registry (TCCR) database | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, Thyroid Cancer, Thyroid Nodules
A Pilot Study to Assess the Association Between Human Bioimpedance Measurements and Clinical Urodynamic Procedures

Study Overview
=================
Brief Summary
-----------------
A Pilot Study to Assess the Association between Human Bioimpedance Measurements and Clinical Urodynamic Procedures

Detailed Description
-----------------
The purpose of the study is to assess how well Curbell's Bladder Sensor device measuring bioimpedance correlates to urodynamic studies and the reported sensation subjects feel when reporting bladder fullness and their urge to urinate.

Official Title
-----------------
A Pilot Study to Assess the Association Between Human Bioimpedance Measurements and Clinical Urodynamic Procedures

Conditions
-----------------
Patients Susceptible to Falls

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that have been previously scheduled for a Urodynamic Study Exclusion Criteria: -
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 |
| --- | --- |
| One single trial<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Urge to Urinate to Bioimpedance. Our clinical trial is an attempt to determine the correlation of bioimpedance measurements versus bladder pressure (fullness) taken at the same time during a normally scheduled urodynamic study. | Our primary outcome is determining the correlation strength between the bladder's pressure measurements (acquired during a standard urodynamic study) and bioimpedance measurements. That is, we are trying to find if bladder bioimpedance is correlated to bladder fullness, where pressure is the clinically-accepted measurement of bladder fullness in a urodynamic study. | Bioimpedance measurements are taken in real time simultaneously with urodynamic pressure measurements. Therefore, the time frame is zero. Each measurement characterizes actual bioimpedance at that point in time. |
ICG-NIR Guided Lymph Node Dissection in Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
As the survival rate of patients with gastric cancer has increased, there has been a growing interest in interventions that improve postoperative quality of life. Therefore minimally invasive surgery or endoscopic resection has been performed much more frequently. However, adequate lymph node dissection is important as well. The aim of the study is to identify the feasibility of indocyanine green - near infra-red (ICG-NIR) guided sentinel lymph node dissection for the treatment of gastric cancer.

Official Title
-----------------
Oncologic Safety of Sentinel Lymph Node-guided Lymph Node Dissection Using ICG-NIR Laparoscopy in Gastric Cancer

Conditions
-----------------
Stomach Neoplasm

Intervention / Treatment
-----------------
* Procedure: ICG-NIR guided surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: dignosed gastric adenocarcinoma tumor: size 4cm or smaller depth of invasion: mucosa, submucosa, proper muscle candidates of laparoscopic radical gastrectomy informed consent Exclusion Criteria: metachronous malignancy number of tumors: 2 or more remnant gastric cancer indication for endoscopic resection history of chemotherapy or radiation therapy pregnancy allergy to ICG metastatic gastric cancer

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICG injection<br>ICG 0.5mg/ml x 0.5ml x 4 sites | Procedure: ICG-NIR guided surgery<br>* ICG 0.5mg/ml x 0.5ml x 4 sites injection through intra-operative endoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity and specificity | sensitivity and specificity of ICG-NIR guided lymph node dissection | 1 month |
A Study Evaluating 10 mg and 25 mg Doses of Etanercept in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.

Detailed Description
-----------------
This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.

Official Title
-----------------
A Randomized, Double-Blind, Multicenter, Parallel Study Evaluating the Safety and Efficacy of Etanercept 10 mg Twice Weekly and 25 mg Once Weekly in Japanese Subjects With Active Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: etanercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of >6 swollen joints and >6 tender joints Inadequate response to at least one disease modifying anti-rheumatic drug (DMARD) Have not been treated with a DMARD for at least 4 weeks prior to the baseline visit Exclusion Criteria: Previous treatment with etanercept, antibody to TNFα, or other TNFα inhibitors Received investigational drugs within 6 months of the baseline visit Received intra-articular hyaluronic acid injections within 4 weeks of the baseline visit

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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 |
| --- |
|Drug: etanercept|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary comparison of the study will be the change of DAS28-4ESR scores from baseline (week 0) between the 10 mg BIW group (at week 12) and the 25 mg QW group (at week 12). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR 20, 50, and 70; Number of swollen joints (68 joints); Number of painful joints on pressure or motion (71 joints); Physician global assessment; Patient global assessment; Duration of morning stiffness. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid Arthritis
Comparison of Knotless Barbed Suture and Standard Suture in Knee Replacement Patients

Study Overview
=================
Brief Summary
-----------------
Barbed suture use has been gaining increased acceptance and has been reported to offer potential advantages in wound closure of hip and knee replacement surgeries. The goal of this study is to compare joint replacement patient outcomes who receive a knotless barbed suture versus a traditional suture (randomized into two arms). The traditional suture used at our joint replacement program is defined as: interrupted sutures to close the retinaculum followed by running monocryl sutures for skin closure. Both knotless barbed suture and the traditional sutures have similar suture size. Patient outcomes examined will be patient range of motion (recorded daily) and complications with wound healing (evaluated periodically in-person at post-operative visits). Secondary outcomes examined will include wound drainage on dressings by surface area and weight, as well as the wound cosmesis and perceived presence of subcutaneous surgical knots.

Conditions
-----------------
Knee Osteoarthritis, Hip Osteoarthritis

Intervention / Treatment
-----------------
* Device: barbed suture
* Device: standard suture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary joint replacement Exclusion Criteria: no prior joint surgery no infection
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard suture<br>standard suture used (monocryl) | Device: standard suture<br> <br> |
| Active Comparator: Barbed suture<br>barbed suture used (Quill suture, Surgical Specialties) | Device: barbed suture<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of soft tissue infections | evaluation of wound infection after surgery, number of patients with wound infection based on clinical examination | 12 weeks | 
| use of antibiotics to treat infection, recorded by number | record whether antibiotics used for suspicion or treatment of superficial infection, number of episodes recorded | 12 weeks | 
| measurement of incision drainage, measured in grams and mm surface area | evaluation of incision drainage based on dressing saturation size and weight, measured in grams for weight, and measured by surface area mm | 2 weeks | 
| assessment of quality of incision closure, recorded by time and number | record delayed healing and reported by time, suture rejection based on number of episodes | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Joint Replacement, Knee Replacement, Wound Healing, Hip Replacement
What Are the Effects of Fibrinogen Concentrate Administration on Biological Parameters

Study Overview
=================
Brief Summary
-----------------
the fibrinogen concentrate are given since 50 years with the dose of 2g for a afibrinogenemia. But this dose has been fixed 40 years ago and from now nobody discuss this quantity. Through this retrospective study the investigators tried to explore the evolution of blood test after a prescription of fibrinogen concentrate

Detailed Description
-----------------
the fibrinogen concentrate are given since 50 years with the dose of 2g for a afibrinogenemia. But this dose has been fixed 40 years ago and from now nobody discuss this quantity. Through this retrospective study the investigators tried to explore the evolution of blood test after a prescription of fibrinogen concentrate.

Official Title
-----------------
What Are the Effects of Fibrinogen Concentrate Administration on Biological Parameters

Conditions
-----------------
Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patient who received fibrinogen concentrate Exclusion Criteria: none

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 |
| --- | --- | --- |
| Evolution of fibrinogen | Fibrinogen was measured before and after a fibrinogen factor transfusion. It will be used to calculate the delta (after - before) and mesure the efficiency of a transfusion | one day | 
| Evolution of FIBTEM A5® | FIBTEM A5® was measured before and after a fibrinogen factor transfusion. It will be used to calculate the delta (after - before) and mesure the efficiency of a transfusion | one day |
Behaviours and Emotions in Preschoolers

Study Overview
=================
Brief Summary
-----------------
In this TARGet Kids! Study, we want to find out whether a short questionnaire can be used to help find out about mental health problems in preschool age children.

Detailed Description
-----------------
Research indicates that more than 1 in 10 preschoolers have significant social, emotional and behavioural problems also known as mental health problems. Unfortunately, parents and doctors rarely identify mental health problems in young children in order to begin treatment. We are testing a short five-minute questionnaire completed by parents to see if this may help a doctor notice if a child has social, emotional and behavioural problems. In addition, we also hope to find out if the presence of feelings of stress and depression in on or both parents may be associated with mental health problems in their preschool child. This study is being conducted by researchers at SickKids and St. Michael's Hospital.

Official Title
-----------------
Behaviours and Emotions in Preschoolers - Detecting Mental Health Problems in Preschool Children in a Primary Care Population

Conditions
-----------------
Mental Health Wellness, Emotional Problem, Behavioural Problem, Post Partum Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child is between age 2 to 4 years. Parent is the primary caretaker for the child and is able to speak, read and understand English well enough to complete the forms and the PAPA interview. Either one or both parents (primary caretakers) are available to participate in the study. Exclusion Criteria: Children with associated health conditions affecting growth (e.g. failure to thrive, cystic fibrosis); Children with any acute or chronic conditions except for asthma and high functioning autism; Children with severe developmental delay; Children with a gestational age of less than 32 weeks; Families who are not fluent in English.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 4 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total difficulties score | As measured by the preschool strengths and difficulties questionnaire (P-SDQ) | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mental health, preschool, SDQ, parental depression
Treatment of Bilateral Maxillofacial Post-traumatic Deformities

Study Overview
=================
Brief Summary
-----------------
Combined application of surgery planning software and rapid prototyping technology and preshaped titanium plates can effectively promote the accuracy of the diagnosis and treatment of bilateral maxillofacial post traumatic deformities, reduce operation time and improve surgical effect.

Detailed Description
-----------------
All patients underwent preoperative CT scan. Firstly, SurgiCase were used to analyze CT data and design preliminary surgery plans. Secondly, three-dimensions resin skull models were produced by rapid prototyping technology. Model surgeries were performed to determine the location, reduction direction and shift distance of osteotomy. Based on the surgical simulation, the preliminary surgery plans were validated and optimized. Then, the titanium plates and mesh were preshaped on the models. Finally, according to the final surgery plans the operations were performed. The operation time, therapeutic effects and complications were observed. The follow-up periods were 1-12 months.

Official Title
-----------------
Application of Surgery Planning Software, Rapid Prototyping Model and Preshaped Titanium Plates in Treatment of Bilateral Maxillofacial Post-traumatic Deformities

Conditions
-----------------
Therapeutics of Bilateral Maxillofacial Injuries

Intervention / Treatment
-----------------
* Procedure: rapid prototyping technology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bilateral maxillofacial Post-traumatic Deformities Exclusion Criteria: unilateral maxillofacialPost-traumatic Deformities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 53 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| treat bilateral maxillofacial deformties<br>treatment of bilateral maxillofacial post-traumatic deformities | Procedure: rapid prototyping technology<br>* Rapid prototyping technology was applied in treatment of bilateral maxillofacial post-traumatic deformities<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in mouth openning | The follow-ups showed that the degree of mouth opening of all patients were over 30mm. | from 1 month to 1year |