linjc16/ctgov huggingface dataset:
Efficacy and Safety of Eletriptan for the Treatment of Migraine in Patients Not Satisfied With Rizatriptan Therapy

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy and safety of eletriptan for migraine headaches in subjects who were not satisfied with rizatriptan therapy

Official Title
-----------------
An Open-label Study of Eletriptan for the Acute Treatment of Migraine in Migraine Sufferers Who Are Dissatisfied With Rizatriptan Therapy

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: Eletriptan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of migraine headache according to International Headache Society criteria and migraine headaches for at least 1 year Eletriptan naive Previously treated with rizatriptan and failed to achieve a satisfactory response within the past 12 months Exclusion Criteria: Non-migraine headaches on average more than 6 days per month or have less than 24 hours of freedom from headache between migraine attacks Migraine attacks that are atypical or chronic daily headaches A history of migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migrainous infarction, migraine aura without headache, migraine with acute onset aura

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Eletriptan<br>* 40 mg oral tablet for migraine attack, followed by 40 mg oral tablet if migraine reoccurred >2 hours from first dose and within 24 hours of first dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in headache pain severity |  | 1, 2, 4, and 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional impairment |  | 1, 2, 4, and 24 hours | 
| Work Productivity Questionnaire |  | Week 10 | 
| Time Loss |  | Week 10 | 
| Subject Preference Questionnaire |  | Week 10 | 
| Global Evaluation |  | Week 10 | 
| Subject Satisfaction Scale |  | Week 10 | 
| Associated Symptoms |  | 1, 2, 4, and 24 hours | 
| Use of Rescue Medication |  | Week 10 | 
| Adverse events |  | Week 10 | 
| Vital signs |  | Week 10 | 
| Physical examination |  | Week 10 |
Register Study of the Neoadjuvanten Treatment by Patients With Rectumcarcinoma

Study Overview
=================
Brief Summary
-----------------
goal of this study is to check the effecivity, feasibility and toxicity of the chemoradiotherapy and hyperthermia

Detailed Description
-----------------
Radiation: 5x1,8Gy until 50,4 Gy Hyperthermia: 2x/week Chemotherapy: neoadjuvant= day 1-5 and day 29-33 5FU 1000mg/m2 adjuvant = 4 Cycles 5FU 500mg/m2 all 4 weeks

Official Title
-----------------
Phase II Studie Zur Neoadjuvanten Trimodalen Hyperthermen Radiochemotherapie Des Tief Sitzenden Rektumskarzinoms im Stadium UICC II + III

Conditions
-----------------
Feasibilitystudy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adenocarcinoma until 10 cm until ano UICC II+III 18-80 years old ECOG PS 0-2 Informed Consent Exclusion Criteria: cardiac insufficiency last 6 month heartattack nodal AV pressure III° hip prothesis cardiac pacemaker others contraindikations against the therapie radiation of pelvis chronic gestrointestinal desaese gestation or lactation previous radiotion pelvis previous Chemotherapie second carcinoma beside baslioma infiltation in analarea

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| remission |  | 5 years |
Automated Check-in Data Collection Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine patient acceptability, for providing brief research information, whilst self-completing an automated check-in screen prior to any general practice consultation.

Detailed Description
-----------------
The Automated Check-in Data Collection (AC DC) Study, is a pilot feasibility study, observing patients consulting in general practice and completing an automated check-in screen prior to their booked appointment, to confirm their attendance. Participants will be recruited over three weeks from approximately 11 participating general practices. The primary objective of the study is to assess patient acceptability for answering brief research questions in the general practice waiting room, using an automated check-in screen. This will be measured by observing the percentage of completed automated check-in screens with entered research data. Secondary objectives will assess check-in completion of self-reported pain and willingness to be contacted about future research studies of relevance. Reported severity of bodily pain experienced over the last 4 weeks and the proportion of patients agreeing to be contacted about future research studies of relevance, will be observed.

Official Title
-----------------
Automated Check-in Data Collection Study

Conditions
-----------------
Primary Care

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years of age or over attending participating general practices for a consultation with any healthcare professional. Patients registered with the participating general practice during the specified recruitment period. Patients able to read and respond in English. Exclusion Criteria: • Patients under the age of 18 attending the general practice for a consultation with a healthcare professional.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Self-reported Bodily Pain | To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen. | Through study completion at 1st visit (Day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bodily Pain Response | Proportion of participants answering the bodily pain research question using an automated check-in screen. | Through study completion at 1st visit (Day 1) | 
| Consent to Contact Response | Proportion of participants answering the consent to contact research question using an automated check-in screen. | Through study completion at 1st visit (Day 1) |
Pilot Bleeding Study: Risk and Protective Factors Associated With Bleeding in the Hemodialysis Population

Study Overview
=================
Brief Summary
-----------------
This study is examining the risk and protective factors associated with bleeding in the hemodialysis population.

Official Title
-----------------
Pilot Bleeding Study

Conditions
-----------------
Bleeding, End Stage Renal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is undergoing hemodialysis Exclusion Criteria: This is an observational study. No exclusion criteria required.

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bleeding, end stage renal disease, antiplatelet therapy, anticoagulant therapy, hemodialysis
Epidural Low Dose Morphine in Postoperative Pain After Posterior Lumbar Spinal Surgery

Study Overview
=================
Brief Summary
-----------------
The effect of epidural low-dose morphine-soaked microfibrillar collagen sponge in postoperative pain control after posterior lumbar spinal surgery: a randomized, double-blind, placebo-controlled study

Official Title
-----------------
The Effect of Epidural Low-dose Morphine-soaked Microfibrillar Collagen Sponge in Postoperative Pain Control After Posterior Lumbar Spinal Surgery: a Randomized, Double-blind, Placebo-controlled

Conditions
-----------------
Morphine

Intervention / Treatment
-----------------
* Drug: 1 mg morphine soak in epidural oxidized cellulose
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Yrs Good orientation and communication Exclusion Criteria: opioids or sulfonamides allergy Contraindication for use Epidural morphine Selective COX 2 inhibitor Patient-controlled analgesia (PCA) ASA class > 3 BMI ≥ 35 kg/sq.m. Preoperative use of opioids within 6 Wks Intraoperative bleeding > 1000ml

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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 |
| --- | --- |
| Placebo Comparator: normal saline<br>During posterior lumbar spinal surgery,one group of patient received normal saline soaked collagen sponge. | Drug: normal saline<br>* During posterior lumbar spinal surgery , patients received NSS -soaked in epidural oxidized cellulose.<br>|
| Active Comparator: 1 mg morphine soak in epidural oxidized cellulose<br>During posterior lumbar spinal surgery ,Another group of patients received 1 mg morphine-soaked in epidural oxidized cellulose. | Drug: 1 mg morphine soak in epidural oxidized cellulose<br>* During posterior lumbar spinal surgery , patients received 1 mg morphine-soaked in epidural oxidized cellulose.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS measurement was recorded at twenty-four hour after posterior lumbar spinal surgery then compare VAS between low-dose 1 mg morphine-soaked microfibrillar collagen sponge method with normal saline soked |  | 2 years |
Safety and Efficacy of Multiple EPO Injections in Children With Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
This study is a retrospective review on the safety and efficacy of repetitive erythropoietin injection in children with cerebral palsy

Detailed Description
-----------------
Cerebral palsy is mostly caused by hypoxic-ischemic encephalopathy from preterm birth, involving inflammatory and apoptotic cellular response. Erythropoietin (EPO) has shown neuroprotective effects via activation of anti-inflammatory, angiogenic, and anti-apoptotic pathways. The safety and feasibility of EPO in children were proven in previous clinical trials. In addition, the efficacy of EPO is actively being investigated and some reports have shown potential benefits in cerebral palsy. To confirm the safety and efficacy of multiple injections with expected effect, retrospective review on medical records was performed.

Official Title
-----------------
Safety and Efficacy of Repetitive Erythropoietin Treatment for Cerebral Palsy

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Drug: recombinant human erythropoietin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed clinical diagnosis of cerebral palsy based on neuromotor findings, less than 18 years of age, received recombinant human erythropoietin (rhEPO) more than once. Exclusion Criteria: not responding to phone interview or no functional assessments available.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| recombinant human erythropoietin group<br>cerebral palsy patients who had received erythropoietin from January 2013 to November 2016 | Drug: recombinant human erythropoietin<br>* Subcutaneous rhEPO injection<br>* Other names: rhEPO;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | telephone interview was conducted to collect information of adverse events from all patients. | interview was performed at an average of 1 year after the completion of rhEPO injections | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Gross Motor Function Measure | The change of GMFM score before and after rhEPO injections | The results between the baseline evaluation before rhEPO injection and the last evaluation at an average of 1 year after rhEPO injections were compared | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erythropoeitin
Oxygen Reserve Index: Utility as Early Warning for Desaturation in Morbidly Obese Patients

Study Overview
=================
Brief Summary
-----------------
The Oxygen Reserve Index (ORi) is a reference that could help clinicians with their assessments of normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00. An ORi of 0.00 corresponds to partial pressure of oxygen (PaO2) values of 100 mmHg and below and an ORi of 1.00 corresponds to PaO2 values of 200 mmHg and above. This is clinical study designed to evaluate the clinical utility of the Oxygen Reserve Index (ORI) as an early warning for arterial hemoglobin desaturation during the induction of general anesthesia and tracheal intubation in obese patients undergoing elective surgical procedures.

Official Title
-----------------
Oxygen Reserve Index: Utility as Early Warning for Desaturation in Morbidly Obese Patients

Conditions
-----------------
Morbid Obesity, Surgery

Intervention / Treatment
-----------------
* Device: Rainbow sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 18 years BMI>30, <40 m/kg2 Control group only: BMI >18.5 m/kg2, <25 m/kg2 Scheduled for an elective surgical procedure requiring general anesthesia and endotracheal intubation Exclusion Criteria Age less than 18 years Adults unable to give primary consent Pregnancy Prisoners

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rainbow sensor<br> | Device: Rainbow sensor<br>* Masimo Radical-7 and Root System with ORi parameter in all subjects are enrolled in the test group and receive an Rainbow sensor during their elective surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utility of ORi Providing Added Warning Time | Evaluate the clinical utility of the change in the oxygen reserve index as an early warning of impending arterial oxygen desaturation in Obese patients (30 < BMI < 40 kg m-2) and Normal BMI patients (19 < BMI < 25 kg m-2). | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oxygen, desaturation, obesity
Why Are Patients With Absence Seizures Absent? A Brain Imaging Study

Study Overview
=================
Brief Summary
-----------------
Our study examines which different brain regions are involved in child absence seizures and how they are related to attention and cognition.

Detailed Description
-----------------
The fundamental mechanisms of altered brain function and impaired attention in childhood absence epilepsy (CAE) are not known. Absence seizures consist of brief 5-10 seconds episodes of unresponsiveness, associated with a 3-4 Hz spike-wave discharge on electroencephalogram (EEG). CAE affects 10-15% of children with epilepsy. In addition to the deficit during seizures, many children also suffer from milder attention impairment between absence episodes, which may not be due entirely to medications. Impaired attention during and between absence seizures has a major negative impact on patient quality of life due to deficits in school performance, potential for injuries, and social stigma. Recent studies suggest that impaired cognition in so-called generalized absence seizures may, in fact, depend on dysfunction in specific brain networks. Our central hypothesis is: abnormal function in focal brain regions, such as the anterior cingulate/medial prefrontal cortex and medial thalamus, causes impaired attention both during and between seizures in CAE. If confirmed, this may lead to innovative regional therapies targeted at improving impaired attention in CAE. Specifically, we hope to determine which specific cortical and sub-cortical networks are selectively involved when patients show impaired attention. Using simultaneous EEG and functional magnetic resonance imaging (fMRI), we will determine which brain regions are involved in absence seizures while using a continuous performance task (CPT) to test attention vigilance in the same patients. A few neuropsychology tests will then follow. Patients will be reimbursed $100 as well as all travel and parking expenses. For more information, please visit www.yalecae.com

Official Title
-----------------
Functional Neuroimaging in Childhood Absence Epilepsy

Conditions
-----------------
Childhood Absence Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of childhood absence epilepsy or juvenile absence epilepsy No other serious health problems or neurological problems 6 years or older Exclusion Criteria: No history of myoclonic or tonic-clonic seizures

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Absence, Epilepsy, Seizure, Brain
Headache Inducing Effect of NN414 in Migraine Patients

Study Overview
=================
Brief Summary
-----------------
To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.

Official Title
-----------------
NN414's Effect in Cerebral Hemodynamics and Headache Induction in Migraine Patients

Conditions
-----------------
Headache, Migraine

Intervention / Treatment
-----------------
* Drug: NN414
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Criteria Inclusion Criteria: Migraine patients of both sexes. 18-60 years. 50-100 kg. Women of childbearing potential must use adequate contraception. Exclusion Criteria: Headache less than 48 hours before the tests start Daily consumption of drugs of any kind other than oral contraceptives Pregnant or nursing women. Cardiovascular disease of any kind, including cerebrovascular diseases. Diabetes mellitus and other endocrinologic disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NN414<br>To investigate the role of NN414 compared with placebo in migraine patients. | Drug: NN414<br>* To investigate the role of NN414 on cerebral hemodynamic in migraine patients<br>* Other names: 6-Chloro-3-[[1-methylcyclopropyl]amino]-4H-thieno[3,2-e]-1,2,4-thiadiazine 1,1-dioxide;|
| Placebo Comparator: Saline<br>To investigate the role of NN414 compared with placebo in migraine patients. | Drug: Saline<br>* To investigate the role of NN414 compared with saline cerebral hemodynamic in migraine patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence and change of migraine attack | Occurrence of migraine according to international criteria | Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cerebral hemodynamic | Change on velocity of media cerebri artery. | Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline | 
| Occurrence and change of headache | Occurrence of headache measured by numerical rating scale (NRS) | Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline | 
| Change of diameter of the artery | Change of diameter of superficial temporal artery and radial artery. The diameter will be measured by millimeter (mm). | Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline |