linjc16/ctgov huggingface dataset:
Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.

Study Overview
=================
Brief Summary
-----------------
This study is designed to determine the efficacy of high nicotine-specific antibody titers in smoking cessation.

Official Title
-----------------
A Double Blind, Placebo-controlled, Multi-centre Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of Repeated s.c Administrations of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.

Conditions
-----------------
Smokers

Intervention / Treatment
-----------------
* Biological: NIC002
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female smoking subjects age 18 to 65 years of age Subjects must be smoking 10 or more cigarettes per day during the past 12 months The exhaled breath carbon monoxide (CO) concentration must be 10 ppm or more at screening. Urine cotinine at screening must be positive. The Fagerström Test for Nicotine Dependence (FTND) score of 5 or above at screening. Exclusion Criteria: Attempted to quit smoking in the three (3) months. Prior use of smoking cessation aid. Other protocol-defined inclusion/exclusion criteria may apply

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Biological: NIC002<br> <br> |
| Placebo Comparator: 2<br> | Biological: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking status |  | 12 weeks | 
| Exhaled carbon monoxide |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking status at various time intervals from target quit date to the end of the study |  | 52 weeks | 
| Safety and tolerability |  | 52 weeks | 
| Immunogenicity (specific anti-nicotine antibodies in serum) |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smokers, smoking cessation, vaccine, antibodies, anti-nicotine
Correlation of Spinopelvic Movement With Lateral Radiographs

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to compare a novel pelvic MetaWear sensor that looks at spine and pelvic movements when taking lateral sit-to-stand radiographs.

Official Title
-----------------
Correlation of Spinopelvic Movement With Lateral Radiographs to Assess Spine Motion Prior to Total Hip Arthroplasty

Conditions
-----------------
Spinopelvic Relationships as They Relate to Total Hip Arthroplasty's

Intervention / Treatment
-----------------
* Device: MetaWear Sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide informed consent. Hip pathology: 20 presenting for total hip arthroplasty, 20 presenting for joint preservation procedures. Exclusion Criteria: - Patients with lumbosacral hardware, contralateral THA, or DJD in the contralateral hip.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will have the MetaWear Sensors used on them
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MetaWear Sensor on radiograph<br>subjects being considered for surgical orthopedic surgery will have a MetaWear sensor added to their standard of care lateral sit to stand radiograph | Device: MetaWear Sensor<br>* Sensor placed on the pelvis to record spinopelvic movement. Lateral sitting and standing lumbar radiographs will be taken<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic Tilt (PT) | PT is a position dependent parameter defined as the angle created by a line running from the sacral endplate midpoint to the center of the bifemoral heads and vertical axis. As recorded by theMetaWear sensor reported in degrees. | Baseline | 
| Sacral Slope (SS) | Sacral slope (SS) is a position-dependent parameter defined as the angle between a line parallel to the sacral end plate and a horizontal line. As recorded by theMetaWear sensor reported in degrees. | Baseline | 
| Pelvic Incidence (PI) | PI is defined as the angle between a line perpendicular to the sacral plate at its midpoint and a line connecting the same point to the center of the bicoxofemoral axis. As recorded by theMetaWear sensor reported in degrees. | Baseline |
Evaluation of Diaphragmatic Function After Bi-pulmonary Transplantation

Study Overview
=================
Brief Summary
-----------------
A current complication after lung transplantation is diaphragmatic dysfunction. These dysfunction result to several factors: duration of mechanical ventilation, chest tube, atelectasis, denutrition, phrenic nerve injury during surgical dissection… Only monocentric and retrospective studies collected diaphragmatic paralysis after lung transplant are published. The incidence of diaphragmatic paralysis in post-operative lung transplantation varies from 3.2% to 16.8%. The main hypothesis of the study is to defined the incidence of diaphragmatic dysfunction in post-operative lung transplantation.

Official Title
-----------------
Evaluation of Diaphragmatic Function After Bi-pulmonary Transplantation

Conditions
-----------------
Lung Transplant, Diaphragmatic Function

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (≥ 18 years old) Admitted for intensive care that can be spontaneously ventilated after bi- pulmonary transplantation Exclusion Criteria: Minor patient Ventilated patients less than 24 hours patients in controlled ventilation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| incidence of diaphragmatic disorders (paralysis, severe and moderate dysfunction) in the post-operative period of bi-pulmonary transplantation | incidence of diaphragmatic disorders (paralysis, severe and moderate dysfunction) in the post-operative period of bi-pulmonary transplantation | 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung transplant, diaphragm evaluation, ultrasound
Non Invasive Brain Stimulation Treatment for CLBP

Study Overview
=================
Brief Summary
-----------------
This trial is designed to preliminary evaluate the efficacy and safety of NIBS system for treatment of chronic low back pain (CLBP) (over 6 months). The trial is of a double blind sham controlled partial crossover design and will involve 2 weekly treatments and evaluations for 6 weeks, with 6 weeks follow-up. The goal of the study is to 1. Asses the CLBP change immediate and long term effect for the trial duration and follow-up. 2. Asses quality of life improvement as measure by sleep quality and questioners. 3. Asses long term neuronal changes or lack thereof in treated and untreated subjects.

Official Title
-----------------
A Novel Non Invasive Brain Stimulation,tDCS Based Treatment for Chronic Low Back Pain (CLBP)-Sourasky Medical Center-Tel Aviv

Conditions
-----------------
Chronic Low Back Pain (CLBP)

Intervention / Treatment
-----------------
* Device: NIBS system for evaluation and treatment utilizing non invasive brain stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 80 CLBP as defined by the European guidelines. low back pain first week average NPRS>4. Exclusion Criteria: Acute low back pain (duration of less than 6 months) first week average NPRS> 4 Neurological illness causing structural brain damage (e.g. Stroke, TIA) Psychiatric disease other than mood disorders Current chronic use of medications with pro-epileptic properties Known alcohol dependency Use of alcohol within the previous 24 hours History of loss of consciousness Epilepsy or epilepsy in a first degree relative Medical implants Pregnancy Illicit drug use or within the previous month

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fully active treatement<br> | Device: NIBS system for evaluation and treatment utilizing non invasive brain stimulation<br> <br> |
| Sham Comparator: partially active<br>first 2.5 weeks will receive sham treatment followed by active | Device: NIBS system for evaluation and treatment utilizing non invasive brain stimulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CLBP on a 0-10 Numerical Pain Rating Scale (NPRS) |  | Baseline to week 6 . | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Sleep Quality (0-10 Numerical Rating Scale Scores) |  | Baseline to 6 weeks | 
| Change CLBP quality of life -Roland-Morris questionnaire |  | Baseline to 6 weeks |
The Impact of Lifestyle Changes on Non-COVID Deaths

Study Overview
=================
Brief Summary
-----------------
The increase of all-cause mortality in the areas with high COVID-19 transmission rate due to COVID-19 deaths and the collateral damage to other healthcare problems is well known. However, the COVID-19 mortality is very low in the regions with low transmission rate and sufficient medical resources. In such regions, strict prevention measures were taken and these would alter the people's lifestyle and hygienic habits and further impact on non-COVID-19 deaths. Yet, there has no thorough investigation in this aspect.

Detailed Description
-----------------
Background The increase of all-cause mortality in the areas with high COVID-19 transmission rate due to COVID-19 deaths and the collateral damage to other healthcare problems is well known. However, the COVID-19 mortality is very low in the regions with low transmission rate and sufficient medical resources. In such regions, strict prevention measures were taken and these would alter the people's lifestyle and hygienic habits and further impact on non-COVID-19 deaths. Yet, there has no thorough investigation in this aspect. Methods The number of registered deaths among 8.8 million permanent residents with specific causes from January 2018 to June 2020 were sourced from the Xuzhou Center for Disease Control and Prevention, Jiangsu Province, China. Death rates were calculated and compared by weeks, months, and years with a focus on the period of COVID-19 pandemic from Jan 24 to March 27, 2020. Numeric values of all-cause death and the death rates of non-COVID diseases were compared in time series at different time scales.

Official Title
-----------------
The Impact of Lifestyle Alteration by Strict Prevention Measures on Non-COVID Deaths in the Region With Low COVID-19 Transmission Rate

Conditions
-----------------
Lifestyle Alteration, Non-COVID Deaths

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All cases of death reported to the Xuzhou CDC during the study period Exclusion Criteria: no
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 |
| --- | --- | --- |
| Numeric values of all-cause death and the death rates of non-COVID diseases |  | from January 2018 to June 2020 |
DNA Analysis of Blood and/or Tissue Samples From Patients With Primary Kidney Cancer Receiving Sorafenib on Clinical Trial MRC-RE05-SORCE

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of blood and/or tissue in the laboratory from patients with kidney cancer receiving sorafenib may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to sorafenib. PURPOSE: This research study is looking at the DNA in blood and/or tissue samples from patients with primary kidney cancer receiving sorafenib on clinical trial MRC-RE05-SORCE.

Detailed Description
-----------------
OBJECTIVES: Examine the relationship between tumor genotype, expression, and patient outcome. Examine the relationship between constitutional genotype and patient outcome. OUTLINE: This is a multicenter study. Patients undergo blood and/or tissue sample collection for laboratory studies. Laboratory studies include generation of tissue microarrays; analysis of protein expression by immunohistochemistry; tumor DNA extraction and whole genome amplification; detection of VHL or other relevant gene mutations by direct sequencing; and constitutional (lymphocyte DNA) genotyping by single nucleotide polymorphism analysis.

Official Title
-----------------
TRANSORCE (A Sub-study of SORCE)

Conditions
-----------------
Kidney Cancer

Intervention / Treatment
-----------------
* Genetic: mutation analysis
* Genetic: polymorphism analysis
* Genetic: protein expression analysis
* Other: immunohistochemistry staining method
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed resected renal cell carcinoma Clear cell or non-clear cell tumor Receiving sorafenib tosylate on clinical trial MRC-RE05-SORCE PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

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 |
| --- |
|Genetic: mutation analysis|nan|
|Genetic: polymorphism analysis|nan|
|Genetic: protein expression analysis|nan|
|Other: immunohistochemistry staining method|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between tumor genotype, expression, and patient outcome |  |  | 
| Relationship between constitutional genotype and patient outcome |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clear cell renal cell carcinoma, stage I renal cell cancer, stage II renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer, papillary renal cell carcinoma
Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the efficacy and safety of ursodeoxycholic acid (UDCA) in the treatment of patients with intrahepatic cholestasis of pregnancy (ICP). In the randomised (double-blind, placebo-controlled) study 20 pregnant women with ICP received (random allocation of) either 450 mg/day UDCA or placebo for 14 days during the third trimester of pregnancy. The severity of pruritus was registered. Itching scores and serum levels of alanine aminotransferase, total bile acids, estradiol, progesterone, prolactin, cholesterol, HDL-cholesterol, triglycerides, activated partial thromboplastin time (APTT), fibrinogen D-dimers (FIDD) and platelet count were assessed before the treatment and weekly thereafter. Data on pregnancy and delivery outcome was recorded and analysed.

Official Title
-----------------
Randomised Placebo-controlled Study of Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy

Conditions
-----------------
Intrahepatic Cholestasis, Pregnancy

Intervention / Treatment
-----------------
* Drug: ursodeoxycholic acid
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women with intrahepatic cholestasis of pregnancy
Sexes Eligible for Study
-----------------
Female

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ursodeoxycholic acid<br>10 pregant women with intrahepatic cholestasis of pregnancy | Drug: ursodeoxycholic acid<br>* 450 mg/day for 14 days<br>|
| Active Comparator: placebo<br>10 pregnant women with intrahepatic cholestasis of pregnancy | Drug: Placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pruritus | visual analogy scale (VAS): 0-10 | an average of 5 weeks | 
| laboratory values | Serum levels of alanine aminotransferases and total bile acids were assessed before the treatment and once a week thereafter at least three times or until delivery. Simultaneously serum levels of estradiol, progesterone, prolactin, cholesterol, HDL-cholesterol and triglyserides were assessed. Platelet count activated partial thromboplastin time and fibrinogen D-dimers were measured as well. | an average 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obstetrical surveillance | Data on pregnancy and delivery outcome was recorded and analysed. | 2-12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ursodeoxycholic acid, intrahepatic cholestasis, pregnancy
3D Camera - Telemedical Foot Ulcer Treatment

Study Overview
=================
Brief Summary
-----------------
Diabetic foot ulcers are deep wounds that occur as a result of nerve damage in the feet (peripheral neuropathy). Amputation is a common consequence of diabetic foot ulcers; approximately 85% of all diabetes-related amputations are caused by foot ulcers. The ulcer treatment is extensive, resource demanding and highly specialized and necessitates involvement of patient, hospital and local in-home care personnel. The 3D photo optic camera project aims at a much more efficient and precise method for diagnosis and treatment of foot ulcers. The Department of Endocrinology and the section for LEAN and Innovation at Odense University Hospital has developed a prototype for a 3D camera that takes pictures and measurements of the ulcer that can provide the basis for correct diagnosis and treatment of the ulcer. The camera was developed in close cooperation with TECCLUSTER A/S, Svendborg Municipality, Team Online and ComMed.

Official Title
-----------------
A Feasibility Study on the Development of 3D Optic Ulcer Camera

Conditions
-----------------
Diabetes Mellitus, Foot Ulcers

Intervention / Treatment
-----------------
* Device: Camera


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diabetic foot ulcers, which has been the diagnosis, stratification (eg ischemia, neuropathy, etc.) and treatment according to current guidelines refer Diabetic Foot Study Group. Age 18-90 years Exclusion Criteria: Superficial wounds (superficial skin defect with loss of substance in 5 x 5 mm)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Telemedicine, Diabetes, foot ulcer<br> | Device: Camera<br>* No real intervention, but a comparison of different methods including the new medical device 3D camera.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of 3D image and normal assessment of wounds |  | outcome measure is assessed in 2013 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of 3D and 2D image assessment of wounds |  | november 2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telemedicine, Diabetes, Foot Ulcers