linjc16/ctgov huggingface dataset:
Anticoagulation Profile in Pregnant Women Treated With Three Times a Day of Low Molecular Weight Heparin (LMWH)

Study Overview
=================
Brief Summary
-----------------
Pregnancy is associated with a increased risk of developing blood clots. There is nearly a 5 times greater risk of developing a blood clot in pregnancy. Lovenox is a medication that helps to prevent the body from developing clots. It is safe to use in pregnancy. Previous studies have demonstrated that despite recommendation of Lovenox, to prevent blood clots, the majority of patient's (70 to 90%) did not receive adequate levels of Lovenox at times throughout the day, which likely increases the risk of developing clots. The increase in blood volume and increase in kidney function that occurs in pregnancy may contribute to the inadequate levels. Currently the recommendation for pregnant and nonpregnant patients requiring Lovenox, is to calculate the daily dose of Lovenox and split the dose, giving half in the morning and the other half in the evening. This research study proposes that due to changes in the body during pregnancy that the daily Lovenox dosing be split into three times a day to achieve more consistent levels of Lovenox than twice a day in pregnant women.

Official Title
-----------------
Anticoagulation Profile in Pregnant Women Treated With Three Times a Day of Low Molecular Weight Heparin (LMWH)

Conditions
-----------------
Pregnancy, High Risk, Anticoagulants

Intervention / Treatment
-----------------
* Drug: Lovenox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nulliparous or multiparous women with single intrauterine pregnancies who require therapeutic low molecular weight heparin during their pregnancy. Participants must be age 18 or older. Exclusion Criteria: Women with multiples. Women less than age 18 History of Heparin Induced Thrombocytopenia (HIT) Allergy to enoxaparin

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Factor Xa levels in pregnant women with therapeutic Lovenox divided into three times a day dosing<br>Therapeutic Lovenox dosing split into three times a day dosing for 5 day. Xa levels a measured. | Drug: Lovenox<br>* Three times a day dosing and measuring Xa peak and trough levels<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factor Xa levels |  | 4 hours after injection |
Effects of Salvinorin A in Healthy Controls

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effects of Salvinorin A (SA). SA is the active ingredient of the plant Salvia divinorum that is known to have been used by Mexican Indians as part of religious rituals. The purpose of this project is to understand what people experience when they consume Salvinorin A.

Official Title
-----------------
Psychotomimetic Effects of Kappa Opioid Receptor Agonist Salvinorin A in Healthy Controls

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

Intervention / Treatment
-----------------
* Drug: Salvinorin A
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Previous exposure to inhaled Salvinorin A (SA).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Salvinorin A (SA) | Drug: Salvinorin A<br>* Low dose: Active SA 250μg Medium Dose: Active SA 500μg High Dose: Active SA 750μg<br>* Other names: Salvia Divinorim;|
| Placebo Comparator: 2<br>Control or Placebo SA | Drug: Placebo<br>* Control or Placebo SA (30 % ethanolic solution)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Syndrome Scale, Clinician Administered Dissociative Symptoms Scale, Visual Analog Scale, Assessment of Opioid Effects, Cognitive Testing |  | Time Frame: -30, +10, +30, +90, +120. +200 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Salvia, SA, Salvinorin, Psychotomimetic Effects
A Multicenter Evaluation of Methods to Reduce Hyperemia Associated With Bimatoprost Therapy for Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
Evaluate the incidence of hyperemia in patients using bimatoprost and to determine if simple interventions reduce its incidence and to assess the value of detailed instruction in increasing patient compliance and willingness to continue bimatoprost therapy, despite the occurrence of hyperemia.

Official Title
-----------------
A Multicenter Evaluation of Methods to Reduce Hyperemia Associated With Bimatoprost Therapy for Glaucoma or Ocular Hypertension

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Drug: Bimatoprost


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: · Male or female > 18 years of age No prior use of bimatoprost Diagnosis of open-angle glaucoma or ocular hypertension Ability to provide informed consent and likely to complete all study visits Exclusion Criteria: · Known contraindication to bimatoprost Uncontrolled systemic disease Active ocular disease other than glaucoma or ocular hypertension Required use of ocular medications other than the study medications during the study (intermittent use of artificial tear solutions will be permitted) History of intraocular surgery within the last 3 months

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bimatoprost|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparing Electrical Impedance Tomography to Computed Tomographic Angiography

Study Overview
=================
Brief Summary
-----------------
The study aim is to determine whether electrical impedance tomography (EIT) is equivalent in the detection of pulmomary emboli compared to Computed Tomographic Angiography (CTA). EIT is a non-invasive, non-ionizing functional imaging technique that can be performed at bedside. Electrical impedance tomography data will be collected on individuals undergoing a CTA scan of the chest at Medical Center of the Rockies (MCR). The primary outcome measure is to assess whether assessment by CTA corresponds with EIT in detection of pulmonary emboli. The study will include up to 63 participants. EIT data will be collected for up to 20 minutes during tidal breathing and for approximately five to ten seconds during breath-holding.

Official Title
-----------------
Assessing the Effectiveness of Electrical Impedance Tomography Images to Detect Pulmonary Emboli Compared to Computed Tomographic Angiography

Conditions
-----------------
Pulmonary Embolism

Intervention / Treatment
-----------------
* Device: Electrical impedance tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Undergoing a CTA of the chest at MCR Exclusion Criteria: Under 18 years of age Body mass index (BMI) > 30 Individuals with known thoracic metal implants or devices, such as pacemakers (internal and external), staples, or spinal and rib hardware Individuals deemed by the research team as too unstable to safely apply the EIT belt, such as hemodynamic or respiratory instability (e.g., intubated patients), and individuals with unstable spinal injuries Open wounds at the site of electrode belt application

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients receiving CTA<br>Patients who will receive a CTA due to clinical need will be imaged with electrical impedance tomography in addition to the CTA. | Device: Electrical impedance tomography<br>* Non-invasive measure of electrical impedance in the body, with data collected on electrodes on the surface of the body<br>* Other names: EIT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correspondence to CTA | To assess whether assessment by CTA corresponds with EIT in detection of pulmonary emboli (PE). | One year |
ICU Venous Thromboembolism Incidence Study in a Chinese Population

Study Overview
=================
Brief Summary
-----------------
Venous thromboembolism (VTE) is one of the major public health problems in Western country. More than 100,000 Americans die each year from VTE. VTE is also a common complication of critical illness,1-2 and probably related to poor outcome in this patient group. Although there are guidelines about VTE prophylaxis in acutely ill medical patients and patients in medical ICU3, they are overlooked in our daily practice frequently in our country. There are many reasons for our common practice, including inadequate knowledge for the ICU physicians, more patients with bleeding tendency in ICU and low prevalence of VTE in our (eastern) country. However, the true prevalence of VTE in ICU and if thromboprophylaxis still needed in certain high risk patients are not unknown. Besides, if there is a difference in the VTE rate between western and eastern patients, what is the underlying mechanism? The major objective of this application is to answer the first part of the problem, i.e. to delineate the scope of this problem. The specific aims of this application are as follows: prevalence of venous thromboembolism in ICU in Taiwan specific risk in subgroups of ICU patients prevalence and risk factors for silent pulmonary embolism

Official Title
-----------------
Using Inflammatory Markers to Predict the Development and Outcome of Venous Thromboembolism in an Intensive Care Unit

Conditions
-----------------
Venous Thromboembolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted to medical ICU with age over 18 y/o are eligible Exclusion Criteria: Patients who do not sign the informed consent will be excluded from this study

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 |
| --- | --- |
| patinet with deep venous thrombosis<br>patient with deep venous thrombosis by ultrasonography as case; patient with no deep venous thrombosis by ultrasonography as control | |
| patient without deep venous thrombosis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| deep venous thrombosis by ultrasound |  | day 14 after ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| any clinical thromboembolic event |  | day 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patient in critical care
Study of Phosphatidylcholine in a Patient With Methionine Adenosyltransferase Deficiency

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine whether plasma choline and breast milk choline levels are low at fasting in a patient with methionine adenosyltransferase deficiency, and if the choline levels are low, determine whether choline levels respond to dietary supplementation with phosphatidylcholine. II. Determine whether this patient has a fatty liver by magnetic resonance spectroscopy.

Detailed Description
-----------------
PROTOCOL OUTLINE: Blood is drawn for liver function tests and measurement of plasma choline levels and breast milk samples are taken for measurement of breast milk choline levels at fasting and at 1 hour after breakfast on day 1. The patient then undergoes magnetic resonance spectroscopy of the liver to assess liver density and choline compound mass. The patient then receives oral phosphatidylcholine supplement, and plasma and breast milk samples are taken at 3 and 6 hours after the dose. Oral phosphatidylcholine supplements continue for 30 days. The above studies are repeated on day 31.

Conditions
-----------------
Methionine Adenosyltransferase Deficiency, Metabolism, Inborn Errors

Intervention / Treatment
-----------------
* Drug: phosphatidylcholine


Participation Criteria
=================
Eligibility Criteria
-----------------
Patient with methionine adenosyltransferase deficiency who is nursing

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

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: phosphatidylcholine|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
-----------------
genetic diseases and dysmorphic syndromes, inborn errors of metabolism, methionine adenosyltransferase deficiency, rare disease
Intensity Modulated Radiotherapy With Concomitant Boost in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
To assess feasibility of postoperative IMRT with concomitant boost in moderate-high risk breast cancer in terms of late toxicity and local control

Detailed Description
-----------------
Patients treated conservatively with moderate-high risk breast cancer were treated with IMRT plus concomitant boost to surgical bed (up to a dose of 50 Gy to whole breast and 60 Gy to the tumor bed). Aim of the study was to evaluate late toxicity and local control after this treatment compared with a historical control group (CG) of patients treated with 3D-conformal postoperative radiotherapy delivered with conventional fractionation.

Official Title
-----------------
Moderated Accelerated RAdiotherapy (MARA-2) in Moderate-high Risk Breast Cancer: a Phase I-II Study

Conditions
-----------------
Breast Cancer, Radiation Toxicity

Intervention / Treatment
-----------------
* Radiation: IMRT with concomitant boost
* Radiation: 3D-RT with sequential boost


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed invasive breast cancer (pT1-4) with at least one of these characteristics: 3 or more metastatic axillary nodes, pre or peri-menopausal status, close resection margins breast conservative surgery Exclusion Criteria: positive margins distant metastases
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MARA-2: IMRT with concomitant boost<br>A forward planned IMRT technique was used and the prescribed dose to the whole breast was 50 Gy plus a concomitant boost of 10 Gy to the tumor bed | Radiation: IMRT with concomitant boost<br> <br> |
| CG: 3D-RT with sequential boost<br>The whole breast received 50.4 Gy in 28 fractions delivered with 3D-RT, followed by a sequential boost on the tumor bed of 10 Gy in 4 fractions delivered with electrons | Radiation: 3D-RT with sequential boost<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment.related late adverse events | late toxicity (cutaneous and subcutaneous) is evaluated using RTOG/EORTC criteria in both groups of patients | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control | absence of locoregional relapse | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, radiotherapy, cutaneous toxicity, subcutaneous toxicity, local control, IMRT
Selegiline in Outpatient Treatment for Cocaine Dependence - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and clinical safety of selegiline in the treatment of cocaine dependence and to assess neurotoxicity (Magnetic Resonance Imaging, MRI) post-hoc as a possible variable for future stratification in clinical trials.

Official Title
-----------------
Safety and Efficacy of Selegiline in Outpatient Treatment for Cocaine

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Selegiline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M/F ages 21-50. Meets DSM-IV criteria for cocaine. Agreeable to conditions of study and signed informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

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

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

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Selegiline|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine toxicology for cocaine |  |  | 
| Self reports of cocaine and other drug use and craving |  |  | 
| Evidence of change in neurotoxicity based on choreoathetoid movement assessments |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
Cold Polypectomy Site Study

Study Overview
=================
Brief Summary
-----------------
Removal of polyps at colonoscopy reduces colon cancer. Snare polypectomy is the conventional method for removal however the snared area after removal can occasionally appear uneven raising the possibility that complete removal has not occurred. The significance of this irregularity has not be studied. This study aims to separately sample the irregular area and determine the constituents while recording how frequently this occurs during routine colonoscopy and polypectomy. We hypothesize that the irregular areas are submucosal tissue and do not represent polyp tissue left behind.

Official Title
-----------------
Prospective Characterization of the Mucosal Defect After Cold Snare Polypectomy

Conditions
-----------------
Colonic Polyps

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing colonoscopy with at least one polyp identified where polypectomy is planned. Exclusion Criteria: Age < 18 years Patients where polypectomy is not planned to be undertaken (patients scheduled for diagnostic colonoscopy only).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Frequency and constituents of stalk projections in cold snare polypectomy sites | Biopsy of post cold snare polypectomy stalk to determine constituents of stalk. This was reviewed 14 days following the procedure. | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
polyp, colon, polypectomy, snare
Pharmacogenomic Study in Patients of Lung, Colorectal and Head/Neck Cancers Receiving Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at several genes that might determine how the body processes the drugs used to treat lung, colorectal and head and neck cancers. The goal of this examination is to help investigators determine the proper dosage to give future cancer patients or to better predict which future patients will respond to particular drug therapies.

Detailed Description
-----------------
This study is to establish a pilot pharmacogenomic program in identifying genetic variation to predict the safety, toxicity and/or efficacy of drugs. DNA will be extracted from patients' peripheral blood to study SNPs in DPD, TS, MTHFR, UGT1A1, CYP3A4, CYP3A5, GSTM1, GSTT1, GSTP1, HO-1, ERCC1, XPD, XRCC1 and EGFR genes. The results of genetic study will be compared to treatment efficacy and toxicity. The ultimate goal is to use genotype profiles to provide individualized cancer treatment to improve outcome and decrease toxicity.

Official Title
-----------------
Pharmacogenomic Study in Patients of Lung, Colorectal and Head/Neck Cancers Receiving Chemotherapy

Conditions
-----------------
Lung Cancer, Colorectal Cancer, Head and Neck Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lung, Colorectal and Head and Neck Cancer Patients that have received or plan to receive chemotherapy as part of their treatment Exclusion Criteria: Colorectal cancer patients that have never received or will not receive chemotherapy as part of their therapy Head and Neck cancer patients that have never received or will not receive chemotherapy as part of their treatment Patients with cancer types other than colorectal or head and neck Unable to give informed 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 2<br>colorectal cancer patients | |
| 3<br>head and neck cancer patients | |
| 1<br>lung cancer patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |