linjc16/ctgov huggingface dataset:
Blood-based Identification and Monitoring of Patients With ALK-translocated Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Genetic rearrangements in the Anaplastic Lymphoma Kinase (ALK) gene result in the creation of a variety of oncogenic fusion proteins that drive malignancy in a subset of non-small cell lung cancers (NSCLC) patients. Treatment with the ALK small tyrosine kinase inhibitor (TKI) crizotinib has produced remarkable results for ALK-positive patients, however the current diagnostic tests used in the clinic are not sufficiently detailed and require a tumor biopsy. The aim of this study is to use a new diagnostic test to detect ALK rearrangements using next generation sequencing, which will improve the diagnosis and treatment of ALK-positive NSCLC patients. Furthermore, this test will be performed on blood samples, making it minimally invasive for the patients. It is our believe that circulating tumor DNA (ctDNA) in blood can be employed as an easy accessible and comprehensive source of information to diagnose ALK-positive disease, but also as a means of monitoring patient response during treatment. Quantitation of the the amount of ALK rearrangement will give information about which patients benefit from treatment and when treatment is no longer effective. The project will be a multicenter study where blood samples will be collected every 6 weeks from patients treated at four major hospitals in Denmark. This study will benefit future patients with lung cancer, as it will improve both the monitoring and evaluation of their treatment. Monitoring patients during treatment will provide more knowledge of disease progression and the effect of ALK-TKI treatment, contributing to a greater selection of patients, who will respond to treatment. This will potentially allow effective treatment to continue longer than with conventional methods

Official Title
-----------------
Identification of Response to ALK-targeted Treatment in Lung Cancer Patients by Monitoring Tumor DNA in Blood Samples

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-small cell lung cancer diagnosis Biopsy-verified ALK-translocation Exclusion Criteria: Patients were it is not possible to retrieve a biopsy Patients with squamous cell carcinoma

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 |
| --- | --- | --- |
| Progression-free survival |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALK rearrangement, Circulating tumor DNA, Plasma DNA, Non-small cell lung cancer, Tyrosine kinase inhibitors
Analysis of Related Risk Factors of Hypoglycemia Consciousness Disorder

Study Overview
=================
Brief Summary
-----------------
Objective to explore the high risk factors and inducements of consciousness disorder in patients with hypoglycemia, and to conduct a retrospective study.

Official Title
-----------------
Analysis of Related Risk Factors of Hypoglycemia Consciousness Disorder

Conditions
-----------------
Hypoglycemia

Intervention / Treatment
-----------------
* Other: Observation and follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptoms of hypoglycemia such as palpitation, sweating and fatigue were found at the time of treatment. At the same time, the blood glucose of non-diabetic patients was less than 2.8mmol/L, and the blood glucose of diabetic patients was less than 3.9mmol/L Exclusion Criteria: Exclusion criteria: Although there were hypoglycemia symptoms at the time of treatment, the blood glucose of non-diabetic patients was more than 2.8mmol/L, and the blood glucose of diabetic patients was more than 3.9mmol/L.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hypoglycemic disturbance group<br> | Other: Observation and follow-up<br>* Observation and follow-up study<br>|
| Hypoglycemia was not a disorder of consciousness group<br> | Other: Observation and follow-up<br>* Observation and follow-up study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of risk factors of hypoglycemia with disturbance of consciousness | Analysis of risk factors of hypoglycemia with disturbance of consciousness | 2021-2011 |
Safety And Efficacy Study Of Topic Mucopolysaccharide Polysulfate Cream In The Superficial Varicose Veins Treatment

Study Overview
=================
Brief Summary
-----------------
Evaluate the safety, tolerability and effectiveness of mucopolysaccharide polysulfate cream in the treatment of superficial varicose veins

Official Title
-----------------
Phase III of Safety and Efficacy Study of Topic Mucopolysaccharide Polysulfate Cream 5mg/g in the Superficial Varicose Veins Treatment

Conditions
-----------------
VARICOSE VEINS

Intervention / Treatment
-----------------
* Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be able to understand the study procedures, agree to participate, and give written consent. Patients must be able to follow the study medication regimen. Patients with inflammatory process in superficial veins for more than 72 hours. Presence of symmetric lesions to compare one side to the other. Exclusion Criteria: Pregnancy or risk of pregnancy. Lactation. Use of topical or systemic anti-inflammatory, antihistamine or immunosuppressive drugs within the last 48 hours prior to the study Any alteration at other deep veins. History of atopy or allergic diseases. History of allergy to any component of the formulations. Other conditions considered by the investigator as reasonable for non-eligibility

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: GROUP 1<br> | Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G<br>* APLIED 4 TIMES/DAY AT LESION<br>|
| Active Comparator: GROUP 2<br> | Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G<br>* APLIED 4 TIMES/DAY AT LESION<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy - Symptoms reduction | The primary outcome measure will be evaluated for: Lesion area reduction, reduction of symptoms time and edema | Evaluation time: 15 days treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy - patient evaluation | The secondary outcome measure will be measured by subjective opinion (daily register). | Evaluation time: 15 days treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SUPERFICIAL VARICOSE VEINS
The Effects of Vacuum-Compression Therapy on the Healing of Diabetic Foot Ulcers

Study Overview
=================
Brief Summary
-----------------
the objective of this study is to evaluate the impact of vacuum-compression effects of Vasotrain on the diabetic foot ulcers using stereological method based on Cavalieri's principle in diabetic patients.

Detailed Description
-----------------
Diabetic foot ulcers are common and serious complications of chronic diabetes mellitus. The prevalence of foot ulcers among patients with diabetes is 15%. The length of hospital stay is approximately 60% longer among patients with foot ulcers, as compared with those without ulcers. Diabetic foot ulcers accounts for >50% of all nontraumatic lower-leg amputations.Although, current preventive methods and treatment modalities have been effective in healing foot ulcers, statistics show high incidence of foot ulcers and amputations in individuals with diabetes.On the other hand, only a few studies were performed on the effects of Vasotrain in healing diabetic foot ulcers. The use of the machine enhances the delivery of oxygen and nutrients to the area, which in turn, facilitate wound healing

Conditions
-----------------
Diabetic Foot Ulcer

Intervention / Treatment
-----------------
* Device: Vasotrain-447


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diabetic foot ulcer corresponding to grade 2 No history of deep venous thrombosis and no hemorrhage in ulcer Exclusion Criteria: Significant loss of protective sensation Hemorrhage during treatment Vertigo No completion of treatment

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 69 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Vasotrain-447|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot ulcer surface area was estimated stereologically, based on Cavalieri's principle before and after intervention, at pre treatment and post treatment |  | Baseline, 3 Weeks, | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vasotrain, Diabetic Foot Ulcer, Vacuum compression therapy, Stereology, Ulcer Area, Random Controlled Trial.
Pharmacokinetics of Piperacillin and Meropenem in ICU Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to characterize the pharmacokinetics of meropenem and piperacillin in ICU-patients at the time of the first dose administration and to contrast that with the same measurements obtained in the same patient 2-3 days later during the course of ICU treatment.

Official Title
-----------------
First Dose Pharmacokinetics for Piperacillin and Meropenem in ICU Patients

Conditions
-----------------
Antibiotic Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: Piperacillin/tazobactam, Meropenem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patient being treated in one of the participating ICUs and planned to recieve treatment with meropenem or piperacillin. Exclusion Criteria (fullfilling any exlusion criteria means that patient cannot be included in the study): Not possible to retrospectively ask the patient or next of kin for consent to take part in the study or patient or next-of-kin not providing consent. Not posisble to obtain and process blood samples as specified by protocol. Ongoing renal replacement therapy. Patient having received the same antibiotic within the previous 96 h.

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 |
| --- | --- |
| Study Kohort<br>As specified by study population, inclusion and exclusion criteria | Drug: Piperacillin/tazobactam, Meropenem<br>* This is an observational study exploring the antibiotic plasma concentration profiles in ICU paitents after the first drug administration.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of distribution | Apparent volume of distribution calculated from repeated plasma concentrations measurements and pharmacokinetic modelling. | For the first antibiotic administration and if possible for a second administration 48-72 hour later. | 
| Plasma clearance | Plasma clearance calculated from repeated plasma concentrations measurements and pharmacokinetic modelling. | For the first antibiotic administration and if possible for a second administration 48-72 hour later. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma antibiotic concentrations at mid and end of dosing interval | Plasma antibiotic concentrations at mid and end of dosing interval | For the first antibiotic administration and if possible for a second administration 48-72 hour later. |
Post-Operative Pain Scores and Analgesic Requirements After Elective Inguinal Herniorrhaphy

Study Overview
=================
Brief Summary
-----------------
The study will investigate the effects of single dose pre-operative oral dose of gabapentin (1200) on post -operative pain scores and oral analgesic requirements.

Detailed Description
-----------------
The study will benefit patients in reducing post-operative pain scores as well as reduction in oral analgesic consumption. Gabapentin has been shown to reduce post operative pain pain scores in breast surgery, hysterectomy , spinal surgery, orthopedic and thyroid surgery

Official Title
-----------------
An Investigation of Post-Operative Pain Scores and Analgesic Requirements After Ambulatory Inguinal Herniorrhaphy With Pre-Operative Gabapentin Therapy

Conditions
-----------------
Pain, Analgesia, Hernia, Inguinal

Intervention / Treatment
-----------------
* Drug: Gabapentin
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects having elective surgery with open unilateral Inguinal herniorraphy Exclusion Criteria: Non elective surgery Patients currently on gabapentin therapy Patient hypersensitive to gabapentin surgery History of alcohol or drug abuse Patients who are pregnant or who are nursing

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single pre-op dose of Gabapentine<br>Active treatment with the study drug | Drug: Gabapentin<br>* 1200 mg single dose gabapentin<br>* Other names: Neurtonin;|
| Placebo Comparator: Placebo<br>Placebo arm for blinding the medication | Other: placebo<br>* Injection of placebo/sham<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain is reduced when single pre-operative oral dose of Gabapentine is given to the patient before the Inguinal Herniorrhaphy | Post operative pain is reduced when single pre-operative oral dose of | 1yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The post operative analgesia requirement is also reduced | The post operative analgesia requirement is also reduced | 1yrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
analgesia requirement and post operative pain
The PaTHS Descriptive Correlational Longitudinal Study

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to measure parent's post-traumatic stress before and after their infant's second palliative heart surgery for single ventricle congenital heart disease. The investigators will use the posttraumatic stress disorder checklist for the DSM-V (PCL-5) to measure levels 2-4 weeks before and after the infant's second heart surgery. The investigators aim to describe the levels at the two-time points, compare the scores, and identify demographic information that correlates with the scores.

Official Title
-----------------
Parents Post-traumatic Stress Before and After Their Infant's Second Palliative Heart Surgery: The PaTHS Descriptive Correlational Longitudinal Study

Conditions
-----------------
Single-ventricle, Posttraumatic Stress Disorder, Psychosocial Impairment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parent who is 18 years or older of an infant with SVCHD Following with CHAMP through Children's Mercy Hospital. Any person personally identifying as a parent of the child, who lives in the same household as the infant, and who will provide primary care after discharge from the hospital is eligible to participate. Exclusion Criteria: Parents of an SVCHD infant who is undergoing end-of-life care, determined by the primary care team.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parents of infants with single ventricle heart disease<br>All participants | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the level of parental post-traumatic stress two to four weeks before their infant's second palliative heart surgery | Measure level using the posttraumatic stress disorder checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition. The scores range 0-80 with scores greater than or equal to 31 suggest provisional Posttraumatic stress disorder diagnosis. | on average at 4-6 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the level of parental post-traumatic stress two to four weeks after discharge following their infant's second palliative heart surgery. | Measure level using the posttraumatic stress disorder checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition. The scores range 0-80 with scores greater than or equal to 31 suggest provisional Posttraumatic stress disorder diagnosis. | On average 5-6 months of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
remote monitoring, nursing, parents, transition
Effectiveness of a Real Time Data Safety Study Tool

Study Overview
=================
Brief Summary
-----------------
Study RTD-01 is a non-interventional, pilot study designed to determine if a specific coded SMS text message study tool is effective in collecting daily real time safety data in subjects participating in clinical trials.

Detailed Description
-----------------
This study is to determine if a daily SMS text message study tool will improve adverse event and concomitant medication reporting. Patient reported adverse events and changes in concomitant medications are essential in clinical trials to determine drug-related symptoms and side effects. This study will help identify the benefits and challenges of real time daily reported outcome measures that can later be implemented in future clinical trials to enhance trial outcomes. In addition, data collected from this study will support a more sophisticated safety study tool for future study participants.

Official Title
-----------------
Determining the Effectiveness of a Real Time Data Safety Study Tool for Clinical Research Subjects

Conditions
-----------------
Study Subjects Currently Enrolled in a Clinical Research Trial

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-85 age inclusive Male or Female Currently enrolled in an ongoing clinical trial Capable of providing informed consent and complying with daily study procedures Must be able to receive and respond to text messages through phone provider Exclusion Criteria: Subjects not currently involved in a clinical trial Subjects who cannot receive text messages Unable to comply to the study protocol and study visits

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| active group<br>Every study participant will actively receive daily text messages asking about their change in health and concomitant medication. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To improve AE and concomitant medication reporting | Data collected daily through secure text messaging | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease recall bias | Daily reporting of AEs and concomitant medication changes | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
text messaging, safety, real time data