linjc16/ctgov huggingface dataset:
Clinical Evaluation of Genetron TERT/BRAF PCR Kit in Thyroid Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this trail is to evaluate the performance of Genetron TERT/BRAF PCR Kit in Thyriod Cancer patients using real-time PCR method.

Detailed Description
-----------------
This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron TERT/BRAF PCR Kit and Sanger sequencing method. The results were determined independently according to the cutoff values or interpretation requirements provided by each method. The safety and effectiveness of this kit are confirmed and evaluated.

Official Title
-----------------
Clinical Evaluation of Genetron TERT/BRAF PCR Kit in Thyroid Cancer Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with clinical diagnosis of suspected thyroid cancer who underwent fine-needle aspiration (FNA) The sample should have corresponding basic clinical information, including: the patient's unique traceability number, age, gender, pathological diagnosis results, etc. Subjects who can provide a complete FNA sample Subjects who agree to provide follow-up diagnosis and treatment information Exclusion Criteria: The investigator considers that it is not appropriate to continue the clinical trial, such as the samples that are not prepared according to the required steps. Samples with incomplete information required. The amount of DNA extracted is not enough to complete the samples tested by the assessment reagent or comparative method.
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 |
| --- | --- | --- |
| The main purpose of this study is: by evaluating the Genetron TERT/BRAF PCR Kit to compare the results of the Sanger sequencing method, and to calculate the coincidence rate and consistency of the two methods. |  | 2 months |
Study of Low Dose CT in Sarcoma Patients

Study Overview
=================
Brief Summary
-----------------
The primary outcome of this study is the detection of lung metastases comparing Low dose CT (LDCT) and Minimum dose CT (MnDCT) with CXR. Hypothesis LDCT and MnDCT have similar sensitivity for the detection of lung nodules (metastases). MnDCT of the thorax detects a larger number of nodules (metastases) than CXR.

Detailed Description
-----------------
A 3-year prospective phase II non-randomized study commenced May 2003 enrolling 60 high-risk patients with Intermediate and High Grade STS. Each patient is kept under radiological surveillance for 3 years unless lung metastases are detected. Conventional thoracic imaging for staging and surveillance of STS patients is shown in Figure 1. In the trial, LDCT and MnDCT are added to each imaging visit (Figure 1). A 2-view CXR (CR) is performed (Direct View, Kodak, Rochester) followed by thoracic CT scans performed on a Siemens 16 row MDCT (Sensation 16, Siemens, Erlangen), CT acquisition; 120kVp, 5/2.5/2.5mm. Images are reconstructed with high and low spatial frequency filters and soft copy viewing is performed on a standalone PACS workstation using standard mediastinal (w 350, l 40) and lung (w 1500, l -600) settings. Examinations are performed with varying mAs; SDCT 120 mAs, LDCT 40 mAs and MnDCT 20 mAs. The examinations are evaluated, blinded to the results of the alternative and previous studies, for the presence of nodules (defined as a non-calcified focal opacity ≥3 mm < 3 cm). Surveillance imaging is commenced 3 months post surgery.

Official Title
-----------------
Surveillance Low Dose Computed Tomography of the Thorax in Patients With High Grade Extremity Soft Tissue Sarcoma

Conditions
-----------------
Soft Tissue Sarcoma

Intervention / Treatment
-----------------
* Procedure: low dose CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High Grade Soft tissue sarcoma Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- |
|Procedure: low dose CT|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of metastases |  |  |
GIP Receptor Antagonist Studies in Humans

Study Overview
=================
Brief Summary
-----------------
Antagonizing GIP effects during hyperglycaemia in healthy subjects and measurements of insulin secretion.

Detailed Description
-----------------
Aim: To evaluate the GIP receptor antagonizing effect of peptide-based competitive GIP receptor antagonist GIP-A (vs. saline (placebo)) in 10 healthy subjects during 1 hour hyperglycaemic clamps with and without concomitant iv infusion of GIP[1-42]. The intention is to establish GIP-A as a tool to eliminate glucose-dependent insulinotropic GIP signalling. The study consists of four experimental days (A-D) with assessment of beta cell function during 12 mM-hyperglycaemic clamps with concomitant infusions of A) GIP[1-42], B) GIP-A, C) GIP[1-42] + GIP-A, or D) saline (placebo).

Official Title
-----------------
Involvement of Glucose-dependent Insulinotropic Polypeptide (GIP) in Human Physiology and Pathophysiology - Receptor Antagonist Studies in Humans

Conditions
-----------------
Glucose Metabolism

Intervention / Treatment
-----------------
* Drug: GIP-A
* Drug: GIP(1-42)
* Other: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal kidney function, liver function and hemoglobin levels. Exclusion Criteria: Medication, Diabetes type 1 or 2, BMI > 25, first degree relatives with Type 2 Diabetes

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Infusion of saline | Other: Saline<br>* Placebo<br>|
| Active Comparator: GIP(1-42)<br>Infusion of agonist, GIP(1-42) | Drug: GIP(1-42)<br>* GIP receptor agonist<br>|
| Experimental: GIP-A<br>Infusion of GIP-A alone | Drug: GIP-A<br>* GIP receptor antagonist<br>|
| Experimental: GIP-A + GIP(1-42)<br>Infusion of GIP-A and GIP(1-42) | Drug: GIP-A<br>* GIP receptor antagonist<br>Drug: GIP(1-42)<br>* GIP receptor agonist<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin levels | Serum-insulin AUC (area under the curve for hyperglycemic clamp period) | 65 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GIP, GIP receptor antagonist
Comparison of Outcomes in Mobile and Fixed-bearing Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the clinical and radiological outcomes of mobile-bearing with that of fixed-bearing in total knee arthroplasty.

Detailed Description
-----------------
Double blind, randomized prospective study Mobile or fixed bearing of the same company Mobile bearing group : group M Fixed bearing group : group F Inclusion criteria patients expected primary total knee arthroplasty without severe deformity Clinical outcomes Range of motion Complication Scorings KSS, KSFS, HSS score, WOMAC score, Oxford score, SF-36 Radiological outcomes Alignment angles in knee Positions of femoral and tibial components Position of patella Radiolucency

Official Title
-----------------
Comparison of Outcomes in Mobile and Fixed-bearing Total Knee Arthroplasty

Conditions
-----------------
Osteoarthritis of Knee

Intervention / Treatment
-----------------
* Device: Mobile bearing
* Device: Fixed bearing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary total knee arthroplasty Exclusion Criteria: infection severe deformity in knee revision
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 |
| --- | --- |
| Active Comparator: Mobile bearing<br>Mobile bearing type between polyethylene insert and tibial component MB type will be randomly used in total knee arthroplasty | Device: Mobile bearing<br>* Mobile bearing in total knee arthroplasty<br>* Other names: Zimmer LPS-flex mobile bearing type polyethylene insert;|
| Active Comparator: Fixed bearing<br>Fixed bearing type between polyethylene insert and tibial component FB type will be randomly used in total knee arthroplasty | Device: Fixed bearing<br>* Fixed bearing in total knee arthroplasty<br>* Other names: Zimmer LPS-flex fixed bearing in polyethylene insert;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rotational Angle Between Femur and Tibia |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total knee arthroplasty, Mobile bearing, Fixed bearing, Range of motion, Knee Society Score
The Use of Cervical Length to Reduce Hospital Stay in Women Admitted Because of Preterm Labor.

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to investigate the effect of the use of sonographic cervical length (CL) on the hospital stay in women admitted because of preterm labor.

Detailed Description
-----------------
Eligible women who agreed to participate in the study were randomized by means of a central randomization office into two groups: CONTROL group: cervical length was measured but the result was blinded to the physician in charge and women was managed according to the standard protocol. STUDY group: cervical length was measured and the result was reported to the physician in charge. If cervical length was of 25 mm or more, discharge in 12-24 h was recommended. If cervical length was less than 25 mm, decision on discharge was made following clinical criteria.

Conditions
-----------------
Labor, Premature, Cervical Length

Intervention / Treatment
-----------------
* Procedure: Cervical length ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted because of preterm labor Not delivered after 24-48 h of admission Single pregnancy Intact membranes Gestational age between 24.0 and less tahn 36.0 weeks Bishop score < 6 Exclusion Criteria: Fetal death or malformation Signs of chorioamnionitis Non-reassuring fetal test

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cervical length ultrasound|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  |  | 
| Gestational age at delivery |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of hospital stay below 3 days |  |  | 
| Interval admission-to-delivery < 7 days |  |  | 
| Rate of preterm delivery before 37 weeks |  |  | 
| Rate of preterm delivery before 34 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preterm labor, Cervical ultrasonography, Hospital stay
Clinical Characteristics and Prognosis of STEMI Patients Undergoing Primary Percutaneous Coronary Angioplasty and Angiographic Data

Study Overview
=================
Brief Summary
-----------------
Gensini score (GS) provides valuable information on severity and prognosis of coronary artery disease (CAD). We aim to evaluate the relationship between the severity of CAD determined by the GS and short and long term of ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention.

Official Title
-----------------
Characteristics and Prognosis of STEMI Patients Undergoing Primary PCI According to Coronary Occlusion Physiopathogeny and/or Atherosclerotic Burden

Conditions
-----------------
STEMI - ST Elevation Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with STEMI underwent primary PCI within 24 hours after first symptoms Exclusion Criteria: Patients with STEMI 24 hours after first symptoms Pregnant patient <18 years old

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite outcome including all cause death and re myocardial infarction |  | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ST resolution on ECG after primary PCI |  | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
STEMI, Gensini,
Epidermal Cells Delivery and Acute Burns

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare results obtained with epidermal cell spray and classic skin grafting for epidermal replacement in acute burns

Detailed Description
-----------------
Comparing the impact in terms of cicatrisation duration and costs between 2 treatments of deep 2nd and 3rd degree burns. Determine if the costs of the innovating treatment RECELL®, a priori more expensive, are counterbalanced by a shorter cicatrisation duration and an improved evolution versus a conventional strategy. Give an information about efficiency improvement of RECELL® with additional costs

Official Title
-----------------
A Randomized Trial Comparing Recell® Autologous Epidermal Cells Harvesting Kits Versus Classic Skin Grafts for the Treatment of Acute Burn in Adults and Children

Conditions
-----------------
Burn

Intervention / Treatment
-----------------
* Device: autologous epidermal cells harvesting kits
* Procedure: classic skin grafts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thermal burns requiring surgical debridement Area involved < 1260cm² Exclusion Criteria: local or systemic infection conditions that would interfere with wound healing (diabetes, hypertension, inflammatory diseases treated by corticoids) hypersensitivity to trypsin
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Treatment of acute burn in adults and children by epidermal cell spray | Device: autologous epidermal cells harvesting kits<br>* autologous epidermal cells harvesting kits used for the treatment of acute burn<br>* Other names: Recell®;|
| Active Comparator: 2<br>Treatment of acute burn in adults and children by classic skin grafts | Procedure: classic skin grafts<br>* classic skin grafts used for the treatment of acute burn<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 80% epithelialisation (recipient + owner sites) at one week. Percent epithelialisation at 1, 2 and 6 weeks. |  | at 1, 2 and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical costs at complete epithelialisation |  | At 6, 12 and 18 months | 
| Post-operative pain |  | At 6 weeks | 
| Medical assessment of scar quality |  | at 6 weeks and 6, 12, 18 months | 
| Patient self assessment of scar |  | At 6, 12 and 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Keratinocytes, Cell spray, Deep partial thickness burns, Full thickness burns
Phase 4 IOP Signals Associated With ILUVIEN®

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety in patients treated with ILUVIEN, with primary focus on IOP.

Detailed Description
-----------------
The specific objectives include the study of intraocular pressure (IOP) related data in patients who received ILUVIEN and how it relates to the patient's experiences following prior treatment with a course of corticosteroid which did not result in a clinically significant IOP elevation.

Official Title
-----------------
A Phase 4 Safety Study of IOP Signals in Patients Treated With ILUVIEN® (Fluocinolone Acetonide Intravitreal Implant) 0.19 mg

Conditions
-----------------
Diabetic Macular Edema (DME)

Intervention / Treatment
-----------------
* Drug: ILUVIEN 0.19 MG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are eligible for treatment with ILUVIEN based on the Prescribing Information. Exclusion Criteria: Patients who are unable to understand and sign the Informed Consent Form.
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: ILUVIEN 0.19 MG<br>All patients will receive ILUVIEN (Fluocinolone Acetonide Intravitreal Insert) 0.19 mg. | Drug: ILUVIEN 0.19 MG<br> <br> * Other names: Fluocinolone Acetonide Intravitreal Implant 0.19 mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure | Intraocular pressure of the ILUVIEN treated eye | 36 months |
Benefits of Assistive Listening Device for Speech Intelligibility

Study Overview
=================
Brief Summary
-----------------
Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss, using an assistive listening device and hearing aid, and compared to speech intelligibility in noise using hearing aids alone.

Official Title
-----------------
Benefits of an Assistive Listening Device for Speech Intelligibility in Noise

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Device: Roger microphone
* Device: Phonak Audeo hearing aid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults age 18 or older with bilateral moderate to moderate severe sensorineural hearing loss, pure tone average must be between 40 and 69 dB HL (decibel Hearing Level) experienced hearing aid users symmetric hearing loss (no more than 15 dB difference between the ears at three contiguous frequencies) good written and spoken English language skills healthy outer ear as confirmed by otoscopy Exclusion Criteria: contradictions to medical device noted upon otoscopy known hypersensitivity or allergy to materials of investigational device or comparator inability to produce reliable test results known psychological problems self reported symptoms of dizziness or vertigo

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Participants with bilateral moderate to severe sensorineural hearing loss | Device: Roger microphone<br>* Commercially available transmitter microphone which sends distant speech signals to a receiver that is attached/embedded into hearing aids.<br>Device: Phonak Audeo hearing aid<br>* Commercially available receiver-in-canal hearing aid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech Intelligibility in Noise | The percent of correctly repeated words, when a list of 10 sentences is presented in noise. Ten sentences are presented at a certain loudness level while background noise is presented simultaneously at a specific loudness level. The number of words repeated correctly is calculated from the total number of words presented. | Day 1 of a one day study |