linjc16/ctgov huggingface dataset:
Serum Parameter Prior and After EUS-guided Fine Needle Aspiration of the Pancreas

Study Overview
=================
Brief Summary
-----------------
Endoscopic ultrasonography (EUS ) -guided fine needle aspiration (EUS -FNA ) of focal pancreatic lesions is an essential diagnostic procedure with high therapeutic effect in clinical routine. The aim of this study is to determine the levels of serum lipase, serum amylase and the tumor marker CA 19-9 prior and after EUS-FNA. In animal experiments on dogs, an increase of all three parameters was observed after surgery on the pancreas. For humans, these clinically important data are not yet available . It is assumed that the probability of pancreatitis with increased activity of lipase and amylase will rise with the number of puncture procedures as well as the size of the puncture needle. In addition, the post-interventional assessment of the tumor marker CA 19-9 could result in a false positive assumption of malignant neoplastic pancreatic lesion.

Official Title
-----------------
Serum Lipase, Amylase and CA 19-9 Prior and After EUS-guided Fine Needle Aspiration of the Pancreas

Conditions
-----------------
Pancreatitis

Intervention / Treatment
-----------------
* Procedure: blood collection
* Procedure: fine needle aspiration
* Procedure: blood collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: independent indication for pancreatic EUS-FNA age ≥ 18 years patient able to give informed consent Exclusion Criteria: Contraindications for EUS-FNA pregnancy no informed consent available known stenosis of esophagus or duodenum relevant coagulation disorders

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FNA, blood collection<br>blood collection prior to fine needle aspiration Endoscopic ultrasonography-guided fine needle aspiration of the pancreas blood collection after to fine needle aspiration | Procedure: blood collection<br>* blood will be taken for assessment of serum lipase, serum amylase and CA 19-9 prior to EUS-FNA<br>Procedure: fine needle aspiration<br>* During endoscopic ultrasonography, fine needle aspiration will be performed for cytological analysis of the pancreas<br>Procedure: blood collection<br>* blood will be taken 4h after EUS-FNA for assessment of serum lipase, serum amylase and CA 19-9<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum lipase |  | up to 24h prior to EUS-FNA and 4 hours after EUS-FNA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum amylase |  | up to 24 hours prior to EUS-FNA | 
| Serum amylase |  | 4 hours after EUS-FNA | 
| CA 19-9 |  | up to 24 hours prior to EUS-FNA | 
| CA 19-9 |  | 4 hours after EUS-FNA |
An Interaction Study of LY3200882 in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to evaluate the effect of itraconazole on the amount of LY3200882 in the blood stream and how long the body takes to get rid of LY3200882. The safety and tolerability of LY3200882 when given with itraconazole will be evaluated. The study is expected to last up to 19 days from the first dose to follow-up (inclusive). Screening will occur up to 28 days prior to enrollment.

Official Title
-----------------
Effects of CYP3A4 Inhibition by Itraconazole on the Pharmacokinetics of LY3200882 in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: LY3200882
* Drug: Itraconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males or postmenopausal females, as determined by medical history and physical examination Exclusion Criteria: Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data Have used or intend to use over-the-counter or prescription medication including herbal medications within 14 days prior to dosing and during the study (with the exception of vitamins and occasional acetaminophen or ibuprofen, which will be permitted at the discretion of the investigator). Drugs that are known substrates, inducers, or inhibitors of CYP3A4 are specifically excluded within 30 days of dosing and throughout the study

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

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

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: LY3200882<br>LY3200882 administered orally. | Drug: LY3200882<br>* Administered orally.<br>|
| Experimental: Itraconazole + LY3200882<br>Itraconazole + LY3200882 administered orally. | Drug: LY3200882<br>* Administered orally.<br>Drug: Itraconazole<br>* Administered orally.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3200882 | PK: Cmax of LY3200882 | Baseline through 72 hours post-dose | 
| PK: Area Under the Concentration Curve (AUC) of LY3200882 | PK: AUC of LY3200882 | Baseline through 72 hours post-dose |
Let's be Well Red: Efficacy of Gudness Bars in Improving the Hemoglobin and Hematocrit Levels of Anemic Subjects

Study Overview
=================
Brief Summary
-----------------
To test the efficacy of Gudness Bars in improving the hemoglobin and hematocrit levels of anemic subjects longitudinally. To quantify the demographics of subjects attending anemia testing camps through LBWR and to explore correlations with the demographics data.

Official Title
-----------------
Let's Be Well Red (LBWR)

Conditions
-----------------
Treatment and Prevention of Anemia After Administration of Gudness Nutrition Bar

Intervention / Treatment
-----------------
* Dietary Supplement: Education plus Gudness Nutritional Bar
* Other: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Ages 18-35 years age Exclusion Criteria: Known allergy towards nuts.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Education plus Gudness Nutritional Bar<br>Subjects will receive education about anemia and will consume Gudness Nutrition bars for 3 months | Dietary Supplement: Education plus Gudness Nutritional Bar<br> <br> |
| Placebo Comparator: Education with no nutrition bar<br>Subjects will receive education about anemia but will not receive nutrition bar | Other: Education<br> <br> * Other names: Education about Anemia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin level | Measure hemoglobin levels before and after administration of Gudness nutrition bar. | 3 months | 
| Hematocrit level | Measure Hematocrit levels before and after administration of Gudness nutrition bar. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anemia
Assessment of Bortezomib (Alvocade ®) Efficacy and Safety in Newly Diagnosed Multiple Myeloma Patients

Study Overview
=================
Brief Summary
-----------------
Bortezomib considered the standard of care for treating multiple myeloma patients, the aim was to assess the safety and efficacy of newly approved drug (Alvocade ®) in Iraq, in newly diagnosed patients.

Official Title
-----------------
Assessment of Bortezomib (Alvocade ®) Efficacy and Safety in Newly Diagnosed Multiple Myeloma Patients

Conditions
-----------------
Newly Diagnosed Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Bortezomib 3.5 MG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosis Multiple myeloma with CRAB (C: hypercalcemia, R: renal impairment, A: anemia, and B: bone lesions) Age above 18 years old Exclusion Criteria: Age below 18 years Smoldering MM

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Induction Therapy<br>Bortezomib will be administered as part of VCD or VRD protocols | Drug: Bortezomib 3.5 MG<br>* VCD protocol V, Alvocade®: Day 1, 4, 8, 11 (1.3 mg/m2 SC) C, Cyclophosphamide: 300 mg/m2 IV over 30 min (day 1, 8, 15) D, Dexamethasone oral: 40mg (days 1 to 4) VRD protocol: V, Alvocade®: Day 1, 4, 8, 11 (1.3 mg/m2 SC) R, Lenalid® cap 25 mg po (day 1 to 21) D, Dexamethasone oral: 40mg (days 1 to 4)<br>* Other names: lenalidomide;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment the safety of Alvocade® therapy | Monitoring the rate of any adverse effect/event that will occur during the induction therapy | During 6 months | 
| Assessment the effecacy of Alvocade® therapy | Assessment of overall response rate (ORR) of treatment after completion of induction protocol | At end of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First assessment response | Assessment of response rate after 2 cycle from starting treatment protocol | At end of 2 months | 
| Second assessment response | Assessment of response rate after 4 cycle from starting treatment protocol | At end of 4 months | 
| Third assessment response | Third assessment response after 6th cycle protocol (if there is no response or get less than VGPR after 4th cycle) | At end of 6 months |
ALIMTA Plus Carboplatin as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase 2 Clinical Trial.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects (good and bad) of LY231514 (ALIMTA) and Carboplatin on you and your non-small cell lung cancer.

Official Title
-----------------
ALIMTA Plus Carboplatin as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase 2 Clinical Trial.

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

Intervention / Treatment
-----------------
* Drug: ALIMTA
* Drug: Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: You have a diagnosis of non-small cell lung cancer. You have received no prior chemotherapy. You have at least one measurable lesion. You have an adequate performance status. You are at least 18 years of age. Exclusion Criteria: You have previously received chemotherapy for your lung cancer. You have received radiation within the last 30 days. You have active infection or other serious condition. You have brain metastasis. You have recently lost a significant amount of weight.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ALIMTA|nan|
|Drug: Carboplatin|nan|

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
-----------------
Non-Small Cell Lung Cancer, Lung Cancer, NSCLC, Advanced Non-Small Cell Lung Cancer
The Effect of SCIM on Neonatal Resuscitation

Study Overview
=================
Brief Summary
-----------------
In this randomized controlled trial 48 students were randomly allocated in three groups SCIM, Video training (VT) and control group(no training). They had a workshops based on NRP and lasted 6 hours for each group. Before and after the workshops and one month later all students participated in a 7 station OSCE..

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Other: SCIM
* Other: video


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, without any history of severe stress in the past 6 months prior to the study. Accepts Healthy Volunteers Exclusion Criteria:severe stress -

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 32 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCIM<br>after lecture students had rotation in 6 groups through 6 stations, trained and practiced under supervision of 6 instructors about Initial Steps, Positive Pressure Ventilation(PPV), Intubation, Chest Compressions, Medications and management of advanced resuscitation | Other: SCIM<br>* after lecture students had rotation in 6 groups through 6 stations, trained and practiced under supervision of 6 instructors about Initial Steps, Positive Pressure Ventilation(PPV), Intubation, Chest Compressions, Medications and management of advanced resuscitation<br>|
| Experimental: video<br>video about neonatal resuscitation presented then students repeated the video. Workshops was based on NRP and lasted 6 hours for each group the contentof the video was based on the educational content of the course. | Other: video<br>* video about neonatal resuscitation presented then students repeated the video. Workshops was based on NRP and lasted 6 hours for each group the contentof the video was based on the educational content of the course<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| education | after educational course for each group (SCIM and Video), students' competency in neonatal resuscitation would be evaluated through an OSCE in each group. the competency between group (before and after education) and in each group would be comapared before and after education. | 3 months |
Assessment of Onset, Safety & Toleration of UK-369,003 in Male Erectile Dysfunction

Study Overview
=================
Brief Summary
-----------------
To determine the onset of action, safety and toleration of different formulations and doses of UK-369,003 in patients with erectile dysfunction. Patients should have been previously treated with PDE5 inhibitors and have been responders to the drugs. Duration of treatment is 4 weeks.

Official Title
-----------------
A Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Assess the Time to Onset, Safety, and Toleration of Differing Doses and Combinations of Immediate Release and Modified Release Formulations of UK369,003 in Adult Male Subject With Erectile Dysfunction

Conditions
-----------------
Impotence

Intervention / Treatment
-----------------
* Drug: UK-369,003


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Erectile dysfunction as defined by DSM-IV. Patients should have been PDE5 inhibitor respondents Exclusion Criteria: Alpha blockers and Nitrates of any preparation

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

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

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: UK-369,003|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time needed to obtain an erection hard enough to attempt sexual intercourse. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of responders based on successful erections Based on erections hard enough for sexual intercourse 15, 45 and 60 minutes post dose Proportion of good responders based on successful erections International Index of Erectile Function |  |  |
How do Older Adults and Caregivers Feel About Their Medications?

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to study patients' and caregivers' perspectives towards deprescribing using the Revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire.

Official Title
-----------------
Patients' and Caregivers' Attitudes Towards Deprescribing in the Asian Community Setting

Conditions
-----------------
Deprescribing

Intervention / Treatment
-----------------
* Other: rPATD Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older adults' inclusion criteria: age at least 65 years; taking one or more long-term prescription medication; have not participated in this anonymous questionnaire previously Caregivers' inclusion criteria: currently an informal caregiver for an older adult (defined as having any role in a family member or friend's management of health and/or medications); care recipient must be at least 65 years of age and taking one or more long-term prescription medication; have not participated in this anonymous questionnaire previously Exclusion Criteria: Older adults' exclusion criteria: inability to complete a questionnaire in English. Caregivers' exclusion criteria: caregiver's age less than 21 years; caregiver's inability to complete a questionnaire in English.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Older adults<br> | Other: rPATD Questionnaire<br>* A 5-point Likert scale questionnaire consisting of 22 questions for older adults, and 19 questions of caregivers.<br>|
| Caregivers<br> | Other: rPATD Questionnaire<br>* A 5-point Likert scale questionnaire consisting of 22 questions for older adults, and 19 questions of caregivers.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rPATD questionnaire scorings |  | up to 9 months |
(VIII): The Eight Study and Immunologic Response Sub-study

Study Overview
=================
Brief Summary
-----------------
The study's objective is to test the hypothesis that immune system activation and subsequent systemic inflammation can be detected through continuously tracking multiple bio signals including physiologic variables (ECG, skin temperature and their derivatives) and behavioral variables (activity and sleep from accelerometers) collected during routine activities of daily living using wearable biosensors. In the sub-study, the objective is to explore the association between these objectively measured physiologic changes and vaccine-induced humoral and T-cell responses.

Official Title
-----------------
Monitoring of Physiologic Changes Associated With Immune System Activation Associated With Vaccination Against the SARS-CoV-2 Virus: Vaccine-Induced Inflammation Identification

Conditions
-----------------
Vaccine Reaction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is 18 years of age or older. Is able to speak and read English. Plan to receive either the Moderna or Pfizer vaccine (mRNA vaccine). No known prior COVID-19 infection. Exclusion Criteria: Known allergy to the adhesive used on the VitalPatch.
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 |
| --- | --- |
| Physiology Monitoring<br>The study's objective is to test the hypothesis that immune system activation and subsequent systemic inflammation can be detected through continuously tracking multiple bio signals including physiologic variables (ECG, skin temperature and their derivatives) and behavioral variables (activity and sleep from accelerometers) collected during routine activities of daily living using wearable biosensors. | |
| Physiology & Immune Monitoring<br>A limited sub-study including 30 individuals enrolled in the primary study (not retrospective group) will incorporate serial blood draws relative to the vaccine doses. The purpose of the serologies and immunoassays is to explore the correlation an individual's development of a vaccine-induced immune response with changes in the continuous physiologic data surrounding the immunization process. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect bio signal data before and after vaccination in  100 individuals using one or more wearable biosensors. |  | December, 2022 | 
| Evaluate the relationship between the MCI and individual bio signals parameters and the subjective symptoms experienced by participants. |  | December, 2022 | 
| Explore the association between these objectively measured physiologic changes and vaccine-induced humoral and T-cell responses. |  | December, 2022 |