linjc16/ctgov huggingface dataset:
Phase 1 Study of Safety and Biological Effects of C326, an Inhibitor of IL-6, in Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether C326, a new inhibitor of IL-6, is safe in patients with Crohn's disease.

Detailed Description
-----------------
Determination of safety is the most important goal of this first study with C326. Other goals of the study are to examine: pharmacokinetics (change in serum concentrations over time), biological activity (change in blood markers relecting activity of Crohn's Disease), effects on symptoms of Crohn's disease. Participants may receive either a single or several intravenous infusions of C326 or matching placebo.

Official Title
-----------------
A Placebo-Controlled, Phase 1, Single and Multiple IV Dose Escalation Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of C326 in Adults With Crohn's Disease

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: C326, IL-6 Inhibitory Avimer protein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 18 - 65 Stable, moderately active Crohn's Disease Otherwise in generally good health Exclusion Criteria: Variety of concurrent medical conditions Various concomitant medications

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: C326, IL-6 Inhibitory Avimer protein|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluations |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  |  | 
| Biomarker changes -- IL-6, CRP and other acute phase reactants |  |  | 
| Crohn's Disease Activity Index (CDAI) |  |  |
Auditory Evoked Potentials and Experimental Pain

Study Overview
=================
Brief Summary
-----------------
Monitoring of auditory evoked potentials (AEP) in patients during general anaesthesia is commonly used to ensure a sufficient hypnotic level during surgery. The amplitude of AEP (AEPa) has in clinical settings been found to correlate to pain. The aim of the study was to test, if AEPa could detect increasing experimental pain stimulations in healthy volunteers. Electric nerve stimulation, cold and heat pain were used as pain models.

Detailed Description
-----------------
During the AEP monitoring, healthy volunteers were exposed to experimental pain. At study day 1: Firstly, single electric nerve stimulation and repetitive electric nerve stimulations causing temporal pain summation. The stimulations were given at 50, 75 and 100% of the thresholds for pain tolerance and temporal pain summation. Secondly, the volunteers were exposed to cold pain by use of two different Cold Pressor Tests (CPT) with water temperatures at 8 and 1 Celsius. All measurements were repeated after an hour to test reproducibility. At study day 2: Brief Thermal Stimulation were used with two different temperatures and duration.

Official Title
-----------------
The Amplitude of Auditory Evoked Potentials and the Intensity of Experimental Pain Stimulation in Healthy Volunteers

Conditions
-----------------
Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Age 20 - 40 years old

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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 |
| --- | --- |
| 1<br> | |
| 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS and amplitude of AEP |  | before, during and after experimental pain | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reproducibility |  | after an hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AEP, experimental pain, healthy volunteers
Margin Status After Pancreaticoduodenectomy for Cancer

Study Overview
=================
Brief Summary
-----------------
This multicentric prospective randomized controlled trial (RCT) compares the Leeds Pathology Protocol (LEEPP) with other conventional pathological protocol of PD specimen for periampullary cancer. Our aims were to evaluate the impact of the protocol and of the clearance on R1 rate and its prognostic value.

Official Title
-----------------
Margin Status After Pancreaticoduodenectomy for Cancer. Results of a Multicentric Prospective Randomized Trial

Conditions
-----------------
Pancreatic Cancer, Cholangiocarcinoma, Ampullary Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Leeds Pathology Protocol (LEEPP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pancreaticoduodenectomy for periampullary cancer Exclusion Criteria: diagnosis of neuroendocrine neoplasm; previous pancreatic surgery; frozen section of each transection margins not performed or presence of positive transection margins without further resection (R1 intraoperative resection); presence of macroscopic residual tumor (R2 resection).

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Leeds Pathology Protocol (LEEPP) | Diagnostic Test: Leeds Pathology Protocol (LEEPP)<br>* LEEPP includes: 1) multicolor inking; 2) axial slicing; 3) circumferential margin; 4) 1-mm clearance<br>|
| No Intervention: Group B<br>Conventional method of pathological evaluation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R1 resection rate | To evaluate difference in terms of R1 resection rates between study groups with 0-mm and 1-mm clearance | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathological data | To evaluate differences in pathological results (T status, N status, number of blocks, number of lymphnodes, etc) between the two study groups | 1 month | 
| oncological results | To evaluate the correlation between R1 resection and oncological results (local recurrence, overall survival) in the two study groups | 60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
periampullary cancer, margin status, R1 resection, clearance margin
Exploratory Study Investigating Urodynamic Parameters During Catheterisation

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to explore and understand how urodynamic parameters are affected when emptying the bladder with an intermittent catheter.

Official Title
-----------------
Exploratory Study Investigating Urodynamic Parameters During Catheterisation

Conditions
-----------------
Spinal Cord Injuries, Enlarged Prostate With Lower Urinary Tract Symptoms

Intervention / Treatment
-----------------
* Device: SpeediCath


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have given written informed consent Be at least 18 years of age and have full legal capacity Be male For healthy volunteers: Willing to comply with not using analgesics up to 24 hours prior to study visit For healthy volunteers: Negative urine multistix (leukocytes and nitrite), or if positive, subsequent negative for bacterial growth in urine culture For SCI and BPH patients: Use intermittent catheter daily and have used intermittent catheters for at least 2 months Exclusion Criteria: Symptoms of urinary tract infections (frequent urination, stinging and pain at urination) Participate in other clinical investigations related to urinary tract system during this investigation (Inclusion → termination) For healthy volunteers: Abnormalities, diseases or surgical procedures performed in the lower urinary tract

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Measurement of endpoints<br>In healthy volunteers the endpoint are measured while spontaneous voiding of the bladder and while emptying the bladder using a standard intermittent catheter (SpeediCath). In subjects with spinal cord injury or enlarged prostata the endpoint are measured while emptying the bladder using a standard intermittent catheter. | Device: SpeediCath<br>* SpeediCath is a standard intermittent catheter that is on the market.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discomfort during catheter insertion on a Visual Analogue Scale | Urodynamic examination: On a scale ranging from no discomfort to worst possible discomfort comfort caused by the catheter, set a vertical line indicating how you experienced the insertion of the catheter | 1 hour |
Is Gait Speed and Sarcopenia Prognostic in Chronic Respiratory Disease?

Study Overview
=================
Brief Summary
-----------------
This study aims to assess usual walking speed (4-metre gait speed) and markers of sarcopenia predict mortality in patients with chronic respiratory disease.

Official Title
-----------------
Do Gait Speed and Markers of Sarcopenia Predict Prognosis in Patients With Chronic Respiratory Disease?

Conditions
-----------------
Chronic Obstructive Pulmonary Disease and Allied Conditions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with chronic respiratory disease who are able to complete the assessments. Exclusion Criteria: Significant co-morbidities that would limit walking ability, exercise capacity or make exercise unsafe (e.g. unstable ischaemic heart disease, neuromuscular disease, severe hip/lower limb joint pain, peripheral vascular disease, lower limb amputation). Any patient whom the Chief Investigator feels it is unsafe to exercise (e.g. unstable cardiovascular disease).

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 |
| --- | --- | --- |
| Number of participant deaths |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participant deaths |  | 2 years and 5 years | 
| Number of exacerbations as defined by a worsening of symptoms that warrant a change in medication. |  | 1 and 2 years | 
| Number of hospital admissions |  | 1 and 2 years | 
| Number of patients admitted to a nursing home |  | 2 and 5 years | 
| Number of hospital bed days |  | 1 and 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sarcopenia
Verification of Pulse Oximetry in Neonatal Population

Study Overview
=================
Brief Summary
-----------------
The purpose of this his post-market, observational study titled Verification of Pulse Oximetry in the Neonatal Population is to gather data to further support the accuracy of Nonin's pulse oximeters when used in the neonate population. Neonates who are currently undergoing arterial blood gas (ABG) sampling, as part of their medical care will be recruited to participate in this study for collecting opportunity samples. Nonin's PureLight® noninvasive sensor will be applied to a foot of the neonate; an adhesive wrap secures the sensor to the neonate. The sensor immediately begins obtaining SpO2 and pulse rate measurements which are sent to the oximeter module for display on the Electronic Data Collection System (EDCS). At the time the prescribed ABG is drawn, the EDCS must have a marker captured to identify the end of the ABG for SpO2 comparison. The SpO2 accuracy of pulse oximeter will be measured by comparing SpO2 readings of the pulse oximeter to values of SaO2 (opportunity samples) determined by a CO-oximeter.

Official Title
-----------------
Verification of Pulse Oximetry in Neonatal Population

Conditions
-----------------
Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age: 25 weeks to full term Weight range: No minimum or maximum range Age: up to 1 month (30 DAYS) Gender: Both ABGs as part of their medical care, to be analyzed by co-oximeter Consent signed by at least one legal guardian Exclusion Criteria: Presence of any skin irritation or breakdown on the foot Foot impediments which would preclude proper placement of the sensor Clinical condition precluding the use of adhesive materials Cessation of ABGs during study enrollment

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 30 Days

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oximeter, Arterial blood gas, comparison
Correlation Between ADR of Screening and All Colonoscopies

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare ADR for colonoscopies from various indications and to find correlations between ADR of screening and all examinations.

Detailed Description
-----------------
ADR (adenoma detection rate) is generally accepted quality indicator and it is calculated from screening colonoscopies in patients over 50 years of age. For possible gaming with ADR for screening colonoscopies, monitoring of ADR for all colonoscopies is discussed nowadays.The aim of the study is to compare ADR for colonoscopies from various indications and to find correlations between ADR of screening and all examinations. We want to retrospectively assess the quality indicators of all colonoscopies performed from January 2013 to December 2017. We want to calculate ADR for all colonoscopies in patients over 50 years of age excluding therapeutic, IBD, management of complications and sigmoidoscopies (screening, surveillance, diagnostic) and separately only for screening colonoscopies. Correlation analysis will be performed using Pearson´s correlation coefficient.

Official Title
-----------------
Correlation Between ADR of Screening and All Colonoscopies

Conditions
-----------------
Colon Neoplasm

Intervention / Treatment
-----------------
* Device: Colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: people over 50 years of age coming for colonoscopic examination (screening, surveillance, diagnostic) Exclusion Criteria: age under 50 years indication for colonoscopy: therapeutic, IBD, management of complications and sigmoidoscopies

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Colonoscopy|Endoscopic examination of large bowel|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between ADR of screening and all colonoscopies (screening, surveillance, diagnostic) | Pearson´s correlation coefficient | january 2013 - december 2017 |
Physiological Changes With SPG Stimulation in Migraine Patients

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Stimulation of the SPG at low frequencies (20 Hz)is believed to cause a physiological parasympathetic upregulation which increases VMCA, concentration and cephalic vessel diameter.

Official Title
-----------------
Physiological Changes Induced With SPG Stimulation in Migraine Patients - Amendment to the Pathway M-1 Trial

Conditions
-----------------
Chronic Migraine

Intervention / Treatment
-----------------
* Device: Neurostimulation
* Device: Sham stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic migraine patients Exclusion Criteria: -
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: SPG neurostimulation<br>SPG neurostimulation of frequency 20 Hz | Device: Neurostimulation<br>* Neurostimulation of sphenopalatine ganglion (SPG) of 20 Hz<br>|
| Sham Comparator: Control<br>Sham neurostimulation of amplitude=0 | Device: Sham stimulation<br>* Sham stimulation of sphenopalatine ganglion (SPG) with amplitude=0<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of mean blood velocity of middle cerebral artery (VMCA) using transcranial Doppler upon low frequency SPG stimulation |  | 0-90 min |
Avascular Bone Necrosis in Sickle Cell Disease: a Pediatric Study.

Study Overview
=================
Brief Summary
-----------------
Avascular necrosis (AVN) is a serious complication of sickle cell disease, especially in pediatric patients where the prevalence is between 3% and 8% and are more frequent in patients with multiple vaso-occlusive crisis (VOC). The prevalence of AVN is usually made by a study of the hip through radiography, whereas other possible sites of ischemic infarcts are evaluated only in case of specific symptoms. In addition, bone infarcts may be the trigger for additional VOC. In this study, we want to investigate the presence of possible bone lesions even in asymptomatic or paucisymptomatic children. This is a prospective interventional and monocentric study whose objective is to describe the prevalence of osteonecrosis in children with sickle cell disease in Italy

Official Title
-----------------
Explorative Study on Occult Avascular Osteonecrosis in a Pediatric Patients Cohort With Sickle Cell Disease

Conditions
-----------------
Sickle Cell Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female or male patients diagnosed with sickle cell anemia (HbSS, HbS/β0, HbS/β+, HbSC) with or without known avascular lesions Age ≥ 7 and < 18 years at the moment of signed consent Written informed consent/assent, according to local guidelines, signed by patient and/or guidelines, signed by the patient and/or at least one parent or legal guardian Exclusion Criteria: - Any contraindication to perform Nuclear Magnetic Resonance Magnetic Resonance Imaging (MRI) Inability to obtain informed consent/assent

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 17 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 |
| --- | --- | --- |
| Calculate the prevalence of unknown osteonecrosis | Avascular necrosis of the bones are diagnosed by systematic MRI at sites: total spine, femurs, shoulders, humeri and total hip. These data will be collected in the patient's medical record in patients with sickle cell anemia regardless of the number and intensity of vaso-occlusive crisis | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Avascular necrosis