linjc16/ctgov huggingface dataset:
Protocol to Examine Methylation of Tumor Suppression Genes in Women at High Risk of Developing Breast Cancer

Study Overview
=================
Brief Summary
-----------------
A study to examine the correlations between methylation of various genes associated with breast cancer and proliferation and cytomorphology in breast epithelial cells acquired by random periareolar fine needle aspiration of women at high risk for development of breast cancer.

Detailed Description
-----------------
A study to examine the correlation between gene promotor methylation and benign breast tissue proliferation and cytomorphology collected via random periareolar fine needle aspiration in postmenopausal women at increased risk for breast cancer.

Official Title
-----------------
QM-MSP, Ki-67, and Cytomorphology of RPFNA Specimens From High Risk Women

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: women at high risk of developing breast cancer determined by family or personal history willing to participate in companion protocol (KUMC HSC#4601) for random periareolar fine needle aspiration (RPFNA) for correlational studies Exclusion criteria: exclude women who have been on raloxifene, tamoxifen, letrozole, anastrozole or exemestane within the six months prior to RPFNA

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Women at high risk for developing breast cancer | |

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
-----------------
Breast Cancer, prevention, tissue sampling, polymorphisms, steroid and carcinogen metabolism
Indirect Calorimetry in Patients at Risk of Malnutrition

Study Overview
=================
Brief Summary
-----------------
Burn patients treated in an outpatient clinic and ICU survivors are at risk of malnutrition. There are no clear guidelines determining the energy target in those two populations. The aim of this observation study is to measure the resting energy expenditure of those patients, using indirect calorimetry.

Official Title
-----------------
Measurement of Resting Energy Expenditure in Burn or Critically Ill Patients at Risk of Malnutrition

Conditions
-----------------
Burns, Critical Illness, Indirect Calorimetry, Resting Energy Expenditure, Nutrition Disorders

Intervention / Treatment
-----------------
* Diagnostic Test: indirect calorimetry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: minor burn treated in an outpatient setting ICU survivor, who was discharged from ICU after a stay of at least 7 days Exclusion Criteria: oxygen supply chest drainage not french speaking confusion, coma cognitive disorder patient refusal

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 |
| --- | --- |
| Burn outpatients<br>Burn patients treated for minor burns in an outpatient setting | Diagnostic Test: indirect calorimetry<br>* measurement of resting energy expenditure using indirect calorimetry<br>|
| ICU survivors<br>Critically ill patients who survived ICU stay and are admitted in a general ward | Diagnostic Test: indirect calorimetry<br>* measurement of resting energy expenditure using indirect calorimetry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resting energy expenditure |  | during the 7 days following injury in burn patients or following ICU discharge in ICU survivors |
A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of DW1809

Study Overview
=================
Brief Summary
-----------------
Randomized, Open-label, Oral, Single-dose, two-Sequence, four-Period, crossover study

Official Title
-----------------
A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DW1809 and DW1809-1 in Healthy Adult Volunteers

Conditions
-----------------
Osteoarthritis, Rheumatoid Arthritis, Back Pain, Acute Upper Respiratory Tract Infection

Intervention / Treatment
-----------------
* Drug: DW1809
* Drug: DW1809-1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteers who are ≥19 years old Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2 and Exclusion Criteria: Clinically significant Medical History In the case of women, pregnant(Urine-HCG positive) or lactating women

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br>cross-over | Drug: DW1809<br>* pelubiprofen 30mg<br>* Other names: Test;Drug: DW1809-1<br>* pelubiprofen 30mg (PELUBI tab.)<br>* Other names: Reference;|
| Experimental: Sequence B<br>cross-over | Drug: DW1809<br>* pelubiprofen 30mg<br>* Other names: Test;Drug: DW1809-1<br>* pelubiprofen 30mg (PELUBI tab.)<br>* Other names: Reference;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) | Pharmacokinetics of Pelubiprofen | up to 8 hour | 
| Area under the plasma concentration versus time curve (AUC) | Pharmacokinetics of Pelubiprofen | up to 8 hour |
VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of VEC-162 compared to placebo to improve sleep parameters in a model of insomnia.

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Efficacy and Safety of VEC-162 and Matching Placebo in Healthy Male and Female Subjects With Induced Transient Insomnia

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Drug: 20 mg VEC-162
* Drug: 50 mg VEC-162
* Drug: 100 mg VEC-162
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects with no medical, psychiatric or current sleep disorders. Subject must sign a written consent form. Exclusion Criteria: Recent history of night shift work or jet lag. Prior experience sleeping in a sleep lab environment. History of sleep disorders.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Take orally 30 minutes prior to bedtime. | Drug: Placebo<br>* Placebo<br>|
| Experimental: 20 mg VEC-162<br>20 mg taken orally 30 minutes prior to bedtime. | Drug: 20 mg VEC-162<br>* 20 mg VEC-162<br>|
| Experimental: 50 mg VEC-162<br>50 mg taken orally 30 minutes prior to bedtime. | Drug: 50 mg VEC-162<br>* 50 mg VEC-162<br>|
| Experimental: 100 mg VEC-162<br>100 mg taken orally 30 minutes prior to bedtime. | Drug: 100 mg VEC-162<br>* 100 mg VEC-162<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Improvement of Latency to Persistent Sleep (LPS) | The average improvement in Latency to persistent sleep (the number of minutes between Lights Off and the onset of at least 10 minutes of persistent sleep, as measured by polysomnography) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects. | Night 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Improvement of Wake After Sleep Onset (WASO) | The average improvement of wake after sleep onset (time spent awake between onset of sleep and lights on, determined by PSG) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects. | Night 1 |
Immunophenotyping of Plasma Cells and Immune Effector Cells in Peripheral Whole Blood and Bone Marrow Samples From Multiple Myeloma (MM) Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the immune profile of plasma cells and immune effector cells in paired peripheral whole blood and bone marrow samples from MM patients by standardized flow cytometry. The quantitative and/or qualitative variation of these immune effectors according to the different status of myeloma pathology (diagnosis, relapse or refractory). It is interesting to assess the extent to which a particular immune profile is associated with a better therapeutic response for a given treatment. In addition, the study will validate the stability of the samples between T0 (< 4 hours after sampling) and T0 + 72 hours.

Detailed Description
-----------------
Study the biomarkers recorded on plasma cells and normal leukocytes including T lymphocytes (naïve, effectors and memories), B lymphocytes, Treg, NK, monocytes as well as their activation markers (CD25, PD-1) in paired bone marrow and blood samples. Validate the pre-analytical stability of the samples between T0 (< 4 hours after sampling) and T0 + 72 hours. Secondary objectives: Validate the strategy of quantification of receptors on plasma cells by direct labeling in flow cytometry. Validate a new method for measuring receptor occupancy by a drug. Validate the pre-analytical stability of the absolute quantitative expression of the receptors and the specific marker CD138 on samples between T0 (< 4 hours after sampling) and T0 + 72 hours. The study will be enrolling 20 patients.

Official Title
-----------------
Immunophenotyping of Plasma Cells and Immune Effector Cells in Peripheral Whole Blood and Bone Marrow Samples From Multiple Myeloma (MM) Patients

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Other: Biological sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Multiple myeloma without treatment Exclusion Criteria: -

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 |
| --- |
|Other: Biological sampling|3ml of blood|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunophenotyped cells | change in % of immunophenotyped cells during time | day 0; day0+24hour; day 0+ 48hours; day0+72hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immune response, Plasma cells, Multiple myeloma, Drugs targeting plasma cells
Cytokine Profiles in Children With Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the cytokine profile of tonsillar and peripheral blood mononuclear cells in patients with obstructive sleep apnea (OSA) and to compare the blood mononuclear cell cytokine secretion profile between patients with obstructive sleep apnea and controls without apnea.

Detailed Description
-----------------
We will recruit subjects with OSA about to undergo adenotonsillectomy and collect a blood sample and portion of their tonsils after the induction of general anesthesia. The mononuclear cells will be isolated from both these tissues and stimulated with different markers and cytokines assayed and compared. We will also recruit patients with no symptoms of OSA undergoing unrelated elective surgery and ascertain the absence of OSA by having the parents fill out a sleep questionnaire. We will then collect blood samples from these patients after the induction of anesthesia and examine the cytokine secretion profile and compare it to that of the children with OSA.

Official Title
-----------------
Local and Systemic Cytokine Profiles in Children With Obstructive Sleep Apnea and Controls

Conditions
-----------------
Obstructive Sleep Apnea Syndrome

Intervention / Treatment
-----------------
* Procedure: tonsillectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OSA documented by polysomnography and clinical symptoms. Patients with no symptoms of OSA and negative sleep questionnaire. Exclusion Criteria: Significant systemic disease except mild asthma

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 12 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: tonsillectomy|medically indicated tonsillectomy in subjects with and without OAS|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| levels of cytokines released from PBMCs of OAS subjects and controls |  | just prior to surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cytokine level comparison between PBMCs and tonsillar lymphocytes within OAS groups |  | at time of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric Obstructive sleep apnea syndrome
Early Fluid Resuscitation With Balanced HES 130/0.4 [6%] in Severe Burn Injury

Study Overview
=================
Brief Summary
-----------------
RCT colloids versus cristalloids only in severe burn victims. Trial with medicinal product

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Drug: Fluid resuscitation
* Drug: HES 130/0.4 (6%), Voluven balanced vs. Lactated Ringer's solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Deep burn injury more than 15% of total body surface area (2nd and 3rd degree burns) Informed consent (via deferred consent, if necessary, according to Swiss HMG § 55 and 56). Patients or relatives can understand the study information and the provided information in German language Exclusion criteria: Patients expected to succumb within the next 24 to 36 hours, i.e. whole body burn trauma, palliative care situation Pregnancy No informed consent Known allergic reaction to HES Patients or patient's relatives, who do not understand the German language and therefore the study information, can not be provided in a legally correct manner. Patients with contraindications for balanced 6% HES 130/0.4, i.e. heart failure, pulmonary edema, intracerebral bleeding, acute renal failure, severe hypernatraemia and other severe electrolyte imbalances, severe von-Willebrand Syndrome and acute liver failure (see Arzneimittelkompendium der Schweiz® - Documed)

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fluid resuscitation|Volume resuscitation|
|Drug: HES 130/0.4 (6%), Voluven balanced vs. Lactated Ringer's solution|Volume Resuscitation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced amount of fluids given |  | 3 days |
hOKT3gamma1 (Ala-Ala) for the Prevention of Human Islet Allograft Failure

Study Overview
=================
Brief Summary
-----------------
The broad, long-term goal of this proposal is to improve the results and applicability of islet allotransplantation early in the course of type 1 diabetes through the administration of selective and short-term immunotherapy. More specifically, the objectives of these studies is to conduct an open-labeled, one-year follow-up Phase I/II study in patients with surgical and type 1 diabetes to determine the safety, tolerability, immune activity, and pharmacokinetics of hOKT3gamma1 (Ala-ala) administration for the prevention of autoimmune destruction and rejection of allogeneic islet transplants.

Detailed Description
-----------------
Adverse events will be monitored and recorded throughout the first year post-transplant. The proportion of surgical and type 1 diabetic subjects receiving an islet allotransplant who achieve and maintain full or partial islet graft function during the first year post-transplant will be determined to assess the efficacy of hOKT3gamma1 (Ala-ala) administration. Successful completion of the proposed clinical trial will increase our understanding of the safety, efficacy and underlying mechanisms of selective immunotherapy with the anti-CD3 monoclonal antibody hOKT3gamma1 (Ala-ala) for the maximization of engraftment and functional survival of allogeneic human islets in surgical and type 1 diabetic recipients.

Official Title
-----------------
hOKT3gamma1 (Ala-Ala) for the Prevention of Human Islet Allograft Failure

Conditions
-----------------
Diabetes Mellitus, Insulin-Dependent, Diabetes Mellitus, Experimental, Transplantation, Homologous, Islets of Langerhans Transplantation

Intervention / Treatment
-----------------
* Drug: hOKT3gamma1 (Ala-ala)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Primary islet allotransplant surgical or type 1 diabetes mellitus, complicated by signs and symptoms that persist despite intensive efforts made in close cooperation with their diabetes care team Age 18 or older must give written informed consent

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: hOKT3gamma1 (Ala-ala)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Early Diagnosis of Pulmonary Nodules

Study Overview
=================
Brief Summary
-----------------
This study is intended to determine the positive predictive value (PPV) and negative predictive value (NPV) of the multiprotein classifier based on the observed study prevalence of Non-Small Cell Lung Cancer (NSCLC) in the study participants.

Detailed Description
-----------------
Patients must present with previously non-diagnosed lung nodules as found on CT. There is no change to the typical standard of care that any of the investigating physicians and/or centers provide the patients enrolled in this study. The data from this study will not be used to diagnose cancer nor be used to influence treatment decisions for the study participants.

Official Title
-----------------
Early Diagnosis of Pulmonary Nodules Using A Plasma Proteomic Classifier, Protocol Number 1001-12

Conditions
-----------------
Precancerous Conditions, Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 40 years Smoking history: Never, Former, Current Subject undergoing diagnostic evaluation for a lung nodule Subject undergoing evaluation for a lung nodule by a pulmonologist, and/or by a thoracic surgeon Baseline CT scan identifying lung nodule performed within 60 days of subject enrollment Nodule(s) identified by CT scan previously not followed Subject willing to provide informed consent for the collection of blood specimens Exclusion Criteria: Nodule work-up at the time of enrollment eligibility indicates any prior attempted or completed diagnostic biopsy procedure, such as transthoracic needle aspiration, bronchoscopic biopsy or surgery A prior CT scan is available that previously identifies the same lung nodule under consideration for study inclusion on the most current CT scan; AND the prior CT scan was performed more than 60 days before the current CT scan, irrespective of the candidate nodule's radiographic characterization such as size, density or appearance Current diagnosis of any cancer Prior diagnosis of any cancer within 2 years of lung nodule detection, except for non-melanoma skin cancer Administration of blood products, e.g. packed red blood cells, fresh frozen plasma, or platelets, within 30 days of subject enrollment History of human immunodeficiency virus (HIV) or Hepatitis C

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| Incidence rate of adult patients diagnosed with Non-Small Cell Lung Cancer | Incidence rate of Non-Small Cell Lung Cancer as determined by histologic or cytologic diagnosis and/or radiographically stability at 2 years post enrollment. | 2 years post enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Precancerous conditions, Carcinoma