linjc16/ctgov huggingface dataset:
Aspirin Desensitization Registry in Patients With Aspirin Hypersensitivity

Study Overview
=================
Brief Summary
-----------------
Data about aspirin desensitization for patients with coronary artery disease undergoing percutaneous coronary intervention are sparse. This is a prospective, multicenter, observational study including 7 italian centers, to assess safety and feasibility of a standard desensitization protocol in patients with aspirin sensitivity undergoing coronary angiography. Patients with history of aspirin sensitivity undergoing coronary angiography are prospectively enrolled.All patients underwent the desensitization procedure with six sequential doses of aspirin (1, 5, 10, 20, 40, and 100 mg) administered orally at predefined intervals, with the procedure lasting 5.5 hours.All patients are followed for desensitization procedure success, description of reactions due to the desensitization procedure, and in hospital major adverse cardiac events (MACE). All patients are also followed-up for 12 months in order to assess their long-term risk of MACE, compliance with ASA therapy, and late occurrence of side reactions due to ASA sensitivity.

Official Title
-----------------
Aspirin DesensitizAtion in PatienTs With Coronary artEry Disease: Results of a Multi Center Registry: the ADAPTED Registry

Conditions
-----------------
Aspirin Hypersensitivity

Intervention / Treatment
-----------------
* Drug: aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of aspirin hypersensitivity acute coronary syndrome or known/suspected stable coronary artery disease intent to undergo percutaneous coronary intervention Exclusion Criteria: withdrawal of consent

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 |
| --- |
|Drug: aspirin|aspirin desensitization|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with successful desensitization procedure | All patients are followed for desensitization procedure success, description of reactions due to the desensitization procedure. | 12 months | 
| Major adverse cardiac events | Percentage of patients with an adverse cardiac event (cardiac death, myocardial infarction, stent thrombosis, stroke, destabilizing symptoms leading to hospitalization | 12 months |
The Clinical Profile of UK Asthma Patients With Raised Blood Eosinophils

Study Overview
=================
Brief Summary
-----------------
To explore the relationship between blood eosinophil counts, asthma exacerbations and patient asthma control using a large primary care based research database

Detailed Description
-----------------
Sputum eosinophil levels have been shown to predict asthma exacerbation and inhaled corticosteroid (ICS) responsivenesss. Managing asthma based on sputum eosinophils leads to fewer exacerbations than management adhering to Global Initiative for Asthma (GINA) guidelines. However the use of sputum to measure eosinophil levels is expensive and impractical within a clinical setting. This study explores the use of blood-eosinophil levels as a clinical predictor for exacerbations and asthma control within a UK primary care dataset.

Official Title
-----------------
The Clinical Profile of UK Asthma Patients With Raised Blood Eosinophils

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 12-80 at date of last eosinophil count Asthma diagnosis at any time Blood Eosinophil reading in patient record (numeric count expressed in µl) at least one year prior to last data extraction Two years of continuous data Exclusion Criteria: Any other chronic respiratory diseases Eosinophil counts >5000/µl (outliers)

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 80 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 |
| --- | --- |
| Blood eosinophil count ≤ 400/µl<br> | |
| Blood eosinophil count > 400/µl<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exacerbations | Defined as: American Thoracic Society / European Respiratory Society (ATS/ERS) task force definition: Asthma related hospital admissions OR accident and emergency (A&E) room attendance OR Use of acute oral steroids Clinical definition: ATS/ERS definition including any GP consultations for lower respiratory related tract infections (LRTIs) treated with antibiotics | 1 year | 
| Asthma control | Defined as: Risk domain asthma control: No Asthma-related hospital attendance, A&E attendance, out-patient department attendance, no prescriptions for acute oral steroids and no GP consultations for LRTIs treated with antibiotics Overall asthma control: Risk domain asthma control definition, including average daily dose of ≤200mcg salbutamol | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Blood eosinophils, Sputum eosinophils, Clinical predictor, UK primary care, Global Initiative for Asthma (GINA)
Modulation of Painful Perception

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluate in healthy volunteers, the influence of empathy on pain perception. It is widely accepted in the clinical management that the feeling of listening to the patients' pain would have a favorable influence on the pain, and conversely, the lack of listening would be aggravating. In this study, the volunteer will receive painful thermal stimuli in empathetic context (l, empathetic or non-empathetic) Two situations will oppose, one where the examiner neglect or minimize the suffering of the voluntary and the other or the contrary, the subject will receive empathy. The first part of the project is to verify that the pain is influenced by the empathetic context. The second part will be conducted functional MRI, which should isolate the brain regions affected by other people's empathy for pain.

Official Title
-----------------
Modulation of Painful Perception

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: thermal stimulation delivered by a thermode.
* Other: functional MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Right handed Exclusion Criteria: Pregnant or lactating women, Against-indications to MRI Drug intake of less than 12 hours, Neurological history or deficits, psychiatric, auditory or visual. Decline to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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: healthy volunteers<br> | Device: thermal stimulation delivered by a thermode.<br>* Empathetic context (neutral, empathetic, non-empathetic) when thermal stimulation<br>Other: functional MRI<br>* MRI realised with thermal stimulations and empathetic context (neutral, empathetic, non-empathetic) when thermal stimulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of the perceived pain assessed by the volunteer by a analog scale (VAS) at each thermal stimulation. |  | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood-oxygen-level dependent (MRI) |  | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy volunteers
Clinical Trial of the Optimal Endpoint of Early Sepsis Resuscitation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if there is equivalence between two different methods of treating patients with severe bloodstream infection called sepsis. We will randomly assign patients to one of two treatment methods. One of the treatment methods is the current standard of care and uses an infrared sensor on the end of a catheter to determine the adequacy of treatment. The second treatment method is identical to the first but instead of the infrared sensor a blood test that is performed as a part of standard care (with blood drawn from the catheter) will be used to determine the adequacy of treatment. This study will attempt to determine an easier method of guiding treatment.

Official Title
-----------------
Lactate Assessment in the Treatment of Early Sepsis: The LactATES Trial

Conditions
-----------------
Severe Sepsis, Septic Shock

Intervention / Treatment
-----------------
* Procedure: Modified EGDT
* Procedure: Standard EGDT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected infection Any two of four criteria of systemic inflammatory response SBP < 90 mm Hg after 20cc/kg crystalloid (septic shock) or either a whole blood lactate > 4 mmol/L (severe sepsis). Exclusion Criteria: Age < 18 years Pregnancy Established Do Not Resuscitate orders prior to enrollment Primary diagnosis other than sepsis Requirement for immediate surgery in < 6 hours from admission Any absolute contraindication to central venous catheterization

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: 1<br> | Procedure: Standard EGDT<br>* Early goal directed therapy<br>|
| Experimental: 2<br> | Procedure: Modified EGDT<br>* Early goal directed therapy with lactate clearance<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | In-hospital | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, shock, emergency department, resuscitation
Mass-balance Study of [14C]-APD421 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Open-label, non-randomised, single dose study in 6 healthy male subjects to assess the mass balance recovery, metabolite profile, metabolite identification and pharmacokinetics of 14C-labelled APD421

Official Title
-----------------
An Open Label, Single Dose, Single Period Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C] APD421 Administered Via the Intravenous Route to Healthy Male Subjects

Conditions
-----------------
Post-operative Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: 14C-APD421


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males Age 18 to 65 years of age at time of signing informed consent Body mass index (BMI) of 18 to 30 kg/m2 or, if outside the range, considered not clinically significant by the investigator Must be willing and able to communicate and participate in the whole study Must provide written informed consent Must agree to use an adequate method of contraception (as defined in Section 8.4) Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day) Exclusion Criteria: Prior participation in another study with a radiation burden of > 0.1 mSv and ≤ 1 mSv in the period of 1 year prior to screening; a radiation burden of > 1 mSv and ≤ 2 mSv in the period of 2 years prior to screening; a radiation burden of > 2 mSv and ≤ 3 mSv in the period of 3 years prior to screening, etc (add 1 year per 1 mSv)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

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

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: 14C-APD421<br> | Drug: 14C-APD421<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass Balance | Mean recovery of radioactivity in excreta after a single intravenous (IV) dose of carbon-14-labelled APD421 | 168 hours |
The Impact of Intraoperative Systemic Lidocaine Infusion on Chronic Postoperative Pain After Video-assisted Thoracic Surgery (VATS)

Study Overview
=================
Brief Summary
-----------------
Systemic lidocaine infusion may improve the patients' chronic post surgical pain after video-assisted thoracic surgery

Conditions
-----------------
Lung Cancer(Primary, Metastatic), Benign Lung Mass Requiring Operation

Intervention / Treatment
-----------------
* Drug: Systemic intravenous lidocaine infusion
* Drug: Normal saline infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 20 and 65 years ASA class 1 and 2 Patients who are scheduled for video-assisted thoracic surgery Exclusion Criteria: Allergy to local anesthetics or contraindication to use of lidocaine Pregnancy Severe cardiovascular disease Renal failure Liver failure Neurologic and psychologic disease Chronic treatment with analgesics or chronic pain patients Previous history of thoracic surgery (open or video-assisted) Patients' refusal

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group L<br>Intravenous lidocaine infusion group | Drug: Systemic intravenous lidocaine infusion<br>* In group L, intravenous lidocaine infusion(0.1mg/kg) for 10minutes after induction of anesthesia. After 10 minutes, lidocaine infusion continued at rate of 3mg/kg/hr during operation, and discontinued before move the patients to PACU.<br>|
| Active Comparator: Group C<br>Intravenous normal saline infusion - control group | Drug: Normal saline infusion<br>* In group C, the patients receive same volume of normal saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing pain score after operation | Assessing pain score by Short-form McGill pain questionnaire at 2 months after operation | 2 months after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Systemic lidocaine, postoperative pain, Video-assisted thoracic surgery, VATS
The Role of Consolidative Autologous Stem Cell Transplantation After First-line Therapy in Peripheral T Cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
The role of autologous stem cell transplantation (ASCT) in the first remission (CR1 & PR1) of peripheral T-cell lymphomas (PTCLs) is not well defined. This study analyzed the impact of ASCT on the clinical outcomes of patients with newly diagnosed PTCL in CR1 and PR1.

Official Title
-----------------
A Prospective Study of Consolidative Autologous Stem Cell Transplantation After First-line Therapy in Peripheral T Cell Lymphoma

Conditions
-----------------
Peripheral T Cell Lymphoma

Intervention / Treatment
-----------------
* Drug: Transplant, Autologous


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with confirmed pathological diagnosis of aggressive PTCL Age 18-65 years old Achieving CR or PR after first-line therapy Exclusion Criteria: Subtypes with a more indolent course, including precursor T/natural killer neoplasms, T-cell large granular lymphocytic leukemia, mycosis fungoides other than transformed mycosis fungoides, Sézary syndrome, and primary cutaneous CD30-positive disorders.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ASCT group<br>patients who achieved CR or PR after 6-8 cycles first-line therapy receive ASCT as consolidation therapy | Drug: Transplant, Autologous<br>* high dose chemotherapy followed by autologous stem cell transplantation<br>|
| Observation group<br>patients who achieved CR or PR after 6-8 cycles first-line therapy finish their therapy and go into follow-up | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS |  | 2-year PFS | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autologous Stem Cell Transplantation
Validity of Neck Extensor Muscles Endurance Test in Non-specific Chronic Neck Pain and Asymptomatic Subjects

Study Overview
=================
Brief Summary
-----------------
Neck pain (NP) is one of the most common and costly musculoskeletal complaints in today's societies. Cervical muscles endurance has been commonly associated with the development of NP. Real-time ultrasound imaging is a reliable and valid technique recently used by physical therapists to evaluate muscle structure, function and activation patterns. The aim of this study is if change in muscle thickness can correlate with the results of the endurance testing.

Conditions
-----------------
Neck Pain

Intervention / Treatment
-----------------
* Other: Assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with neck pain: experiencing pain for at least 3 months in the last year, having pain score of 3 or more on visual analogue scale. Healthy subjects: no history of neck pain Exclusion Criteria: History of cervical discopathy Any surgery on neck Traumatic neck injury Any congenital disorders

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| Chronic non specific neck pain<br>Experiencing neck pain for at least 3 months in the last year | Other: Assessment<br> <br> |
| Without neck pain (asymptomatic)<br>No history of neck pain | Other: Assessment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flexor and Extensor cervical muscles holding time (second) |  | 6 months | 
| Anteroposterior diameter of the flexor and extensor cervical muscles (mm) |  | 6 months | 
| Mediolateral diameter of the flexor and extensor cervical muscles (mm) |  | 6 months | 
| Cross section area of the flexor and extensor cervical muscles (cm2) |  | 6 months | 
| Neck disability questionnaire score |  | 6 months | 
| Visual analogue scale score |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pearson correlation coefficient of the cervical muscles holding time with Anteroposterior and border and cross section area of the flexor and extensor cervical muscles |  | 6 months |
OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer

Study Overview
=================
Brief Summary
-----------------
It is to be achieved that in postmenopausal women through the combination of Hysteroscopy and intraoperative rapid section a positive predictive value (PPV) regarding the objective illness like endometrial cancer or adenomatous hyperplasia of 100% so as a negative predictive value (NPV) of 99%.

Detailed Description
-----------------
If a patient fulfills the inclusion criteria, the surgeon decides intraoperatively due to the aspect in the hysteroscopy if it is a clearly benign result or if it looks suspicious or malign. In case of a hysteroscopical benign result the patient will be informed about the result after the operation. In case of a hysteroscopal suspicious or malignant aspect, the curettement will be sent for a rapid section. If the hysteroscopic result confirms the hysteroscopic suspicion the patient will be informed after the operation and the further treatment can be planned right away.

Official Title
-----------------
Pilot-study of OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer

Conditions
-----------------
Endometrial Cancer, Atypical Hyperplasia

Intervention / Treatment
-----------------
* Procedure: hysteroscopy/curettage in case of suspicious aspect will be done a rapid section


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal status (more than 1 year of last menopausal bleeding) Postmenopausal vaginal bleeding Asymptomatic postmenopausal endometrial hyperplasia Understanding of the german language Signature and consent of the patient Exclusion Criteria: Not able to understand and participate in the study Premenopausal status no informed consent

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: hysteroscopy/curettage in case of suspicious aspect will be done a rapid section|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A negative predictive value of 99 % | To get in combination of hysteroscopy and rapid section of the endometrial curettement a negative predictive value of 99% as well as a positive predictive value of 100%. | Intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postmenopausal bleeding, postmenopausal hyperplasia, endometrial cancer, atypical hyperplasia, curettage, intraoperative rapid section