linjc16/ctgov huggingface dataset:
Stem Cell Therapy in Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the effect of stem cell therapy on common symptoms in patients with spinal cord injury.

Detailed Description
-----------------
Autologous bone marrow mononuclear cells are administered intrathecally by a standard procedure followed by vigorous rehabilitation therapy.

Official Title
-----------------
Open Label Study of Autologous Bone Marrow Mononuclear Cells in Spinal Cord Injury

Conditions
-----------------
Spinal Cord Injury

Intervention / Treatment
-----------------
* Biological: Autologous bone marrow mononuclear cell transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed cases of any type of spinal cord injury age above 12 months. Exclusion Criteria: presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/Hepatitis C Virus malignancies bleeding tendencies pneumonia renal failure severe liver dysfunction severe anemia [Hemoglobin < 8] any bone marrow disorder space occupying lesion in brain other acute medical conditions such as respiratory infection and pyrexia.

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem cell<br>autologous bone marrow mononuclear cell transplantation | Biological: Autologous bone marrow mononuclear cell transplantation<br>* Bone marrow is aspirated by a standard procedure. Mononuclear cells are separated by density gradient method and then injected intrathecally by a standard lumbar puncture procedure<br>|
| No Intervention: Control<br>Stem cell therapy is not done for this group of spinal cord injury patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinical symptoms of spinal cord injury after 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional independence measure (FIM) | It is a standard objective scale used for functional evaluation of the spinal cord injury patients. Its reliability and validity has been well established. It will be marked by a certified occupational therapy expert before the intervention and 6 months after the intervention. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spinal cord injury, stem cell therapy, bone marrow, mononuclear cells, autologous
Serum Alpha-fetoprotein Levels and Response to Direct Antiviral Therapy in Patients With Chronic Hepatitis C

Study Overview
=================
Brief Summary
-----------------
Alpha-fetoprotein Levels on the Response to direct Antiviral Therapy in Patients with Chronic Hepatitis C

Detailed Description
-----------------
Impact of Serum Alpha-fetoprotein Levels on the Response to direct Antiviral Therapy in Egyptian Patients with Chronic Hepatitis C

Official Title
-----------------
Impact of Serum Alpha-fetoprotein Levels on the Response to Direct Antiviral Therapy in Egyptian Patients With Chronic Hepatitis C

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HCV patients who will undergo treatment by direct acting antiviral agents. Exclusion Criteria: Patients with decompensated liver disease

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal Alfafetoprotein<br>Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir | Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir<br>* Response to DAAD's and developing HCC<br>* Other names: Sofaldy, Harvony;|
| Experimental: Mild elevation of alfafetoprotein<br>Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir | Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir<br>* Response to DAAD's and developing HCC<br>* Other names: Sofaldy, Harvony;|
| Experimental: High elevation of alfafetoprotein<br>Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir | Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir<br>* Response to DAAD's and developing HCC<br>* Other names: Sofaldy, Harvony;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with sustained virologic response | The total number of patients with SVR in each group | 6 months |
Depth of Anaesthesia and Cognitive Dysfunction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate if there is an association between the depth of anaesthesia and the presence of cognitive deterioration after surgery.

Official Title
-----------------
Depth of Anaesthesia and Presence of Postoperative Cognitive Dysfunction

Conditions
-----------------
Cognitive Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 60 Surgery in general anesthesia surgery > 1 hour ASA: 1-3 Exclusion Criteria: Dementia Excessive Use of alcohol or anxiolytics Unable to understand danish MMSE score < 24

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- | --- |
| mean Cerebral state index in relation to postoperative cognitive dysfunction |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative, Cognitive, Dysfunction
Ambient Air Pollution, Preeclampsia, and Preterm Delivery

Study Overview
=================
Brief Summary
-----------------
An epidemiologic study of pregnant women in western Washington to measure the relationships between exposure to air pollutants and risks of preeclampsia and preterm delivery.

Detailed Description
-----------------
We will design models that use local traffic, weather, and population characteristics to predict monthly ambient concentrations of fine particulate matter (PM2.5) and carbon monoxide (CO). These models will be used to estimate study participants' PM2.5 and CO exposures during and before pregnancy. We will test whether these air pollutant exposures are associated with subsequent risk of preeclampsia and preterm delivery. Additionally, we will test biological markers of maternal lipid peroxidation (thiobarbituric acid reactive substances) and inflammation (high sensitivity C-reactive protein) in maternal blood samples drawn during early pregnancy. We will also examine carboxyhemoglobin measured in early-pregnancy maternal blood samples as a marker of CO exposure.

Official Title
-----------------
Ambient Air Pollution, Preeclampsia, and Preterm Delivery

Conditions
-----------------
Preeclampsia, Preterm Delivery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking enrolled in parent study pregnant at <20 weeks gestation and attending prenatal care clinics affiliated with Swedish Medical Center and Tacoma General Hospital Exclusion Criteria: -

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


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
-----------------
preeclampsia, preterm delivery, lipid peroxidation, inflammation
Does Liposomal Bupivacaine Provide Improved Pain Management for ORIF of Midshaft Clavicle Fractures?

Study Overview
=================
Brief Summary
-----------------
To determine whether liposomal bupivacaine wound infiltration decreases pain scores and narcotic use when compared to bupivacaine alone after open reduction internal fixation of midshaft clavicle fractures.

Official Title
-----------------
Does Liposomal Bupivacaine Provide Improved Pain Management for ORIF of Midshaft Clavicle Fractures?

Conditions
-----------------
Clavicle Fracture

Intervention / Treatment
-----------------
* Drug: Liposomal Bupivacaine
* Drug: Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mid-shaft Clavicle Fracture treated with ORIF Exclusion Criteria: Unable to be contacted for 72 hours post surgery Other concurrent surgical procedures Chronic narcotic user

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liposomal Bupivacaine<br>Time release Bupivacaine | Drug: Liposomal Bupivacaine<br>* Liposomal Bupivacaine<br>|
| Placebo Comparator: Bupivacaine<br>Immediate Acting Bupivacaine | Drug: Bupivacaine<br>* Bupivacaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Pain Scale Averages between the two treatments | Scale is based on 1-10 with 1 being the lowest pain and 10 being the highest pain. | 72 hours post surgery |
Home Sleep and Circadian Phase: Mediators of Diabetes Risk

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if deficient sleep and/or disruption with the body's internal clock (circadian rhythms) are associated with diabetes risk. This study is being done to look at the possible relationships between sleep and risk of diabetes by examining sleep in the home and diabetes risk in the laboratory.

Official Title
-----------------
Home Sleep and Circadian Phase: Mediators of Diabetes Risk

Conditions
-----------------
Diabetes, Sleep Deprivation, Circadian Dysregulation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 21-50 years BMI <40 kg/m2. No major illness. No history of psychiatric, endocrine, cardiac or sleep disorders, Premenopausal, non-pregnant women. Those with dyslipidemia and hypertension will be included if these conditions are controlled by a stable treatment, such as lipid-lowering or antihypertensive medications (except beta blockers). Exclusion criteria include: Persons with diabetes. Persons with diagnosed sleep disorders or apnea-hypopnea index>15. History of cardiovascular event or disease (excluding controlled hypertension). Major psychiatric disorder or other major illness. Persons taking medications, including but not limited to antidepressants and hypnotics (but excluding lipid-lowering drugs and anti-hypertensive medications as mentioned above). Persons regularly taking medication that affects melatonin such as beta blockers and exogenous melatonin. Anyone who tests positive for common drugs of abuse. People with color blindness. People who have had Lasik eye surgery. People who work night shifts. Participants who travel across multiple time zones will be studied only after they have remained in the Central Time Zone (or Indiana) for one month prior to the study.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 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 |
| --- | --- | --- |
| Oral Disposition Index | The oral disposition index is based on the glucose and insulin levels during the first 30 minutes of a frequently sampled 5-hour oral glucose tolerance test. It reflects the combination of insulin sensitivity and insulin release in response to the glucose challenge. Higher values suggest a greater response. | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, sleep
Artificial Intelligence - SARS-CoV-2 Risk Evaluation

Study Overview
=================
Brief Summary
-----------------
The management of COVID-19 patients in overwhelmed hospital facing the pandemic is a clinical challenge. The improvement of decision making may allow a better allocation of available resources and a better treatment of patients at higher risk. Chest CT has been widely adopted for COVID-19 pneumonia diagnosis. Several experiences documented the capability of Artificial Intelligence to improve and fasten COVID-19 pneumonia detection, mainly using chest X-ray. Aim of the present study was to develop and validate an Artificial Intelligence approach integrating clinical and imaging data (automatically extracted through the adoption of dedicated neural networks) for the creation of a cloud platform capable of performing automatic patients risk stratification. Such an approach could be used for triage of COVID-19 patients in the emergency department, with the aim to improve healthcare personnel decision-making and allocation of resources during health emergencies.

Official Title
-----------------
Artificial Intelligence - SARS-CoV-2 Risk Evaluation

Conditions
-----------------
Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed SARS-CoV-2 infection with RT-PCR non contrast chest CT scan performed within 72 hours after admission to the emergency department Exclusion Criteria: age < 18 ys

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| COVID-19 first wave patients<br>1700 patients retrospectively enrolled in 15 Italian hospitals from 16/2/2020 to 29/4/2020. | |
| COVID-19 second wave patients<br>300 patients prospectively enrolled in IRCCS San Raffaele Hospital from 19/10/2020 to 31/12/2020. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Training, testing and validation of an AI platform for predicting Italian first wave Covid-19 patients prognosis. |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of the developed AI platform on italian second wave of Covid-19 patients |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Artificial Intelligence, Covid19, Chest CT
Value of Multiple Modalities Using the Spectra WaveWriter Spinal Cord Stimulator System

Study Overview
=================
Brief Summary
-----------------
To demonstrate the value of multiple modalities and sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Spectra WaveWriter Spinal Cord Stimulator (SCS) System.

Official Title
-----------------
VERITAS - A Study to Demonstrate the Value of Multiple Modalities Using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain

Conditions
-----------------
Chronic Pain, Back Pain

Intervention / Treatment
-----------------
* Device: Spectra WaveWriter SCS System


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Chronic pain of the trunk and/or limbs 22 years of age or older at time of enrollment Willing and able to comply with all protocol-required procedures and assessments/evaluations provided in English Willing and capable of giving informed consent Key Exclusion Criteria: Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study Current systemic infection, or local infection in close proximity to the anticipated surgical field Breast-feeding, pregnant or planning to get pregnant during the course of the study or not using adequate contraception Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator) Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study

Ages Eligible for Study
-----------------
Minimum Age: 22 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: Spinal Cord Stimulation<br>Spectra WaveWriter SCS System | Device: Spectra WaveWriter SCS System<br>* Multiple modalities of stimulation therapy<br>* Other names: Spectra WaveWriter Spinal Cord Stimulation System;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline |  | 3 months post activation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Cord Stimulator, Chronic Pain, Back Pain, Leg Pain, Pain, Stimulation, Implantable Pulse Generator
Evaluation of Tolerability of Adjuvant Cisplatin/Docetaxel in Completely Resected Stage IB/II Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the tolerability (in terms of drug delivery and toxicity) of four cycles of adjuvant docetaxel plus cisplatin in patients with completely resected stage IB-II Non-Small Cell Lung Cancer. To avoid a selection bias, eligible patients will be randomised to receive cisplatin/docetaxel or cisplatin/vinorelbine.

Official Title
-----------------
Randomized Phase II Study Evaluating The Tolerability Of Adjuvant Docetaxel-based Chemotherapy For Completely Resected Stage IB-II Non-Small Cell Lung Cancer (NSCLC): Toledo Trial

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: cisplatin/docetaxel
* Drug: cisplatin/vinorelbine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: completely resected pathological stage IB or II NSCLC adequate haematological, renal and liver function and condition Exclusion Criteria: previous chemo or radiotherapy for NSCLC bronchoalveolar cell subtype second active primary malignancy or serious concomitant medical disease difficulties with adequate follow-up

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin/docetaxel|nan|
|Drug: cisplatin/vinorelbine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of delivery treatment; data collected during chemotherapy treatment |  |  | 
| Toxicity (occurrence of any grade 4 toxicity); data collected at the end of each cycle |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall toxicity |  |  | 
| Progression free survival and overall survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-Small Cell Lung Cancer, NSCLC, Adjuvant chemotherapy for completely resected NSCLC
Ill-health Related Job Loss

Study Overview
=================
Brief Summary
-----------------
The current study aimed to estimate the one-year incidence of unfitness for the job in an occupational health service, and to describe their aetiology and the characteristics of the unfit employees

Official Title
-----------------
Ill-health Related Jobloss

Conditions
-----------------
Job Loss Noticed by the Occupational Physicians

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - to be followed-up in the occupational health center Exclusion criteria: - civil servants

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of job loss | number of job loss related to poor health | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| highlight trades or sectors associated with increased risk of medical incapacity | identify occupations or sectors associated with an increased risk of medical incapacity, regardless of the socio-demographic characteristics (including age and sex) of employees in the occupation | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
job loss, unfit for a job