linjc16/ctgov huggingface dataset:
A Study to Evaluate the Interaction Between Vicodin® CR and Ethanol in Healthy Male and Female Moderate Alcohol Drinkers

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to determine if varying strengths of ethanol affect the drug level and safety profile of Vicodin® CR.

Official Title
-----------------
A Single-Centre, Double-Blind, Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the Interaction Between Vicodin® CR and Ethanol in Healthy Male and Female Moderate Alcohol Drinkers

Conditions
-----------------
Drug Interactions

Intervention / Treatment
-----------------
* Drug: Vicodin® CR (extended-release hydrocodone/acetaminophen)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females ages 19 to 55 If female, must be of non-child bearing potential or practicing birth control Current alcohol users who are classified as moderate drinkers (defined as 7-21 drinks per week) Exclusion Criteria: Intolerance towards ethanol Is allergic to or has a serious reaction to hydrocodone, other opioids, or acetaminophen Significant GI narrowing or abnormality with a potential to inhibit GI motility or tablet transport History of seizures or convulsions, head injury or other intracranial lesions, or a pre-existing increase in intracranial pressure Has any clinically significant abnormalities on physical examination, ECG, or laboratory values Treatment with any investigational drug within 30 days of administration of study drug in the Treatment Phase

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vicodin® CR (extended-release hydrocodone/acetaminophen)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard pharmacokinetic assessments |  |  | 
| statistical, clinical and laboratory procedures |  |  |
Biomarkers in Samples From Young Patients With Neuroblastoma

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of tissue and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study studies biomarkers in samples from young patients with neuroblastoma.

Detailed Description
-----------------
OBJECTIVES: Primary To analyze the expression of ROR1 on the surface of primary neuroblastoma cells. To investigate the therapeutic potential of anti-ROR1 monoclonal antibodies (mAbs), bispecific antibodies, and immunotoxins in in vitro and in vivo models of neuroblastoma. OUTLINE: Archived bone marrow and tumor tissue samples are analyzed for ROR1 expression by flow cytometry, western blotting, qPCR, and IHC.

Official Title
-----------------
ROR1 as a Novel Target for Neuroblastoma

Conditions
-----------------
Neuroblastoma

Intervention / Treatment
-----------------
* Genetic: polymerase chain reaction
* Genetic: protein expression analysis
* Genetic: western blotting
* Other: flow cytometry
* Other: immunohistochemistry staining method
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosed with neuroblastoma With or without N-myc amplification Primary tumor samples as frozen tissue in liquid nitrogen or -80 degrees C Bone marrow samples from high-risk patients as peripheral blood mononuclear cells (PBMC) that have been cryopreserved with DMSO as viable cells to be used for flow cytometry or slides of bone marrow that can be used for immunohistochemistry PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: polymerase chain reaction|nan|
|Genetic: protein expression analysis|nan|
|Genetic: western blotting|nan|
|Other: flow cytometry|nan|
|Other: immunohistochemistry staining method|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ROR1 is expressed on the surface of neuroblastoma cells and constitutes a suitable target for mAb therapy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
localized resectable neuroblastoma, recurrent neuroblastoma, regional neuroblastoma, stage 4S neuroblastoma, localized unresectable neuroblastoma
Nursing Care Management of External Fixation in Hospitalization: Pin Site Infection Incidence

Study Overview
=================
Brief Summary
-----------------
The incidence of pin site infection is related to the nursing management of external fixation.

Conditions
-----------------
Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 year old patients Exclusion Criteria: Immune Depression Patients who are treated with immunosupressive drugs or steroids

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Pin Site Infection Incidence |  | 6 MONTH | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PIN SITE INFECTION AFTER EXTERNAL FIXATION
Using CGM for Evaluating Effects of Food on Glucose Regulation in Healthy Humans

Study Overview
=================
Brief Summary
-----------------
The specific goal of this pilot study is to evaluate if it is possible to detect a statistical difference in postprandial glycemia after meals served with and without a drink previously shown to reduce postprandial glycemia by about 25%. A third drink, with a new recipe, is also included for comparisons. Six participants will carry continuous blood glucose monitors for 10 days and follow a specific meal schedule. The data from this study will form the basis for forming hypothesis of future studies as well as make appropriate calculations of statistical power.

Official Title
-----------------
Development of Methodology for Use of Continuous Blood Glucose Measurements When Evaluating Meal Effects on Glucose Regulation - a Pilot Trial

Conditions
-----------------
Glycemic Control, Diet, Food and Nutrition

Intervention / Treatment
-----------------
* Dietary Supplement: Drinks containing 5AA+CrPic and Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 25-29.9 kg/m^2 HOMA-IR < 2.5 Fasting glucose < 6.1 mmol/L Stable weight since 3 months Access to iPhone with Bluetooth 4.0 and iOS 13 or later Exclusion Criteria: Diabetes Pharmacological treatment known to interfer with metabolism Antibiotics treatment the latest 3 months Vegetarian/Vegan diet Use of tobacco Pregnancy or breast-feeding

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Drink intervention<br>Placebo and two drinks containing a blend of five amino acids and chromium picolinate, are included with every main meal and served in a standardized, non-randomised order. | Dietary Supplement: Drinks containing 5AA+CrPic and Placebo<br>* Same diet will be repeated for 3 days in a row and the beverage switched every day. 3 periods of 3 days are included in the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glucose response | Incremental area under the blood glucose curve after each meal | From start of meal (0 min) to 120 min postprandially | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic variability | Variation in blood glucose levels | 24 hour cycles |
Measuring Blood Pressure in Pregnancy Using Mercury and Automated Device

Study Overview
=================
Brief Summary
-----------------
The aim of the PRAM study was to determine whether women diagnosed with hypertension in pregnancy, using the traditional mercury device, have the same pregnancy outcomes when blood pressure is measured by either an automated device or a mercury device throughout the pregnancy.

Official Title
-----------------
A Prospective Randomised Study of Automated Versus Mercury Blood Pressure Recordings in Pregnancy

Conditions
-----------------
Hypertension, Pregnancy, Pre Eclampsia

Intervention / Treatment
-----------------
* Device: Automated blood pressure recording device Omron HEM 705CP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with a diagnosis of hypertension in pregnancy Exclusion Criteria: non-pregnant and normotensive pregnancy women

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Mercury<br>All subsequent blood pressure recording done using mercury sphygmomanometry | Device: Automated blood pressure recording device Omron HEM 705CP<br>* All subsequent blood pressure recordings done using the automated device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary maternal outcome measure was the number of women having any episode of severe hypertension (BP ³ 170/110mmHg). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary end points included gestation at birth, caesarean section and induction of labour rates. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy, hypertension, mercury sphygmomanometry, blood pressure, automated blood pressure, pre eclampsia, Hypertension in pregnancy
Glaucoma After Congenital And Infantile Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
Pediatric patients who have undergone surgery for congenital or infantile cataracts have a risk of developing suspected glaucoma and glaucoma, but the current evidence does not address our understanding of the incidence and associated risk factors of suspected glaucoma/glaucoma for application in clinical standard care. Therefore, this study investigated the incidence of and risk factors for suspected glaucoma/glaucoma in patients who have undergone surgery for congenital/infantile cataracts.

Detailed Description
-----------------
A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital/infantile cataracts between January 2011 and December 2021 was performed.

Official Title
-----------------
Suspected Glaucoma and Glaucoma After Congenital and Infantile Cataract Surgery: A Longitudinal Study in China

Conditions
-----------------
Glaucoma, Congenital Cataract

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a diagnosis of congenital/infantile cataracts without any surgical intervention; age younger than 10 years; cataract surgery performed at the Zhongshan Ophthalmic Center after enrollment Exclusion Criteria: a preoperative IOP above 21 mm Hg; the presence of any preoperative sign of glaucoma, such as corneal enlargement, corneal clouding, excessive optic nerve cupping, or a family history of glaucoma; the presence of ocular trauma or other abnormalities, such as microcornea, microphthalmia, persistent hyperplastic primary vitreous, Peters anomaly, congenital aniridia, Marfan syndrome, lens dislocation, retinitis pigmentosa, high myopia, fundus lesions, rubella, and Lowe syndrome.

Ages Eligible for Study
-----------------
Maximum Age: 10 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 |
| --- | --- | --- |
| the incidence of suspected glaucoma/glaucoma after congenital cataracts | A Kaplan-Meier analysis was used. | 3 years | 
| Risk Factors of suspected glaucoma/glaucoma after congenital cataracts | Cox regression analysis was assessed | 3 years |
Retroperitoneoscopic Donor Nephrectomy

Study Overview
=================
Brief Summary
-----------------
to compare the results of right and left-sided retroperitoneoscopic donor nephrectomy (RDN).

Detailed Description
-----------------
This was a retrospective study evaluating demographics, intraoperative and postoperative data of 158 kidney donors who underwent RDN from January 2010 to August 2018. Two groups were created according to the side of the surgery including Right RDN (group 1) and left RDN (group 2). The results of the recipients' were also evaluated.

Official Title
-----------------
Retroperitoneoscopic Donor Nephrectomy: a Retrospective Single-center Study

Conditions
-----------------
Transplant; Complication, Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult donors Kidney donors undergoing retroperitoneoscopic donor nephrectomy Recipients of the kidneys Donors with the consent form Recipients with consent form Exclusion Criteria: open donor nephrectomies donors without the consent form Recipients without the consent form

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 57 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | time from onset to complete of surgery | at the end of the surgery | 
| Blood loss | amount of bleeding during surgery (mililiter) | at the end of the surgery | 
| warm ishemia time | time from renal artery and vein dissection of the kidney to the initiation of perfusion on the bench table. | at the end of the surgery | 
| İntraoperative complications | abnormal problems that may be seen during surgery and require additional intervention. | at the end of the surgery | 
| incisional hernia | abdominal incision or trocar site defects of donors | up to 2 years | 
| postoperative complication | abnormal problems that may be seen after surgery and require additional intervention or follow-up (grade I-V) | up to 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Living donor nephrectomy, Kindey transplantation, Retroperitoneoscopic donor nephrectomy, Hernia
Comparison of Diagnostic Performance of an Algorithm and a High Definition Classical Iterative Algorithm Positron Emission Tomography (PET) to 18Fluoro-deoxy-glucose (18FDG) in the Evaluation of Axillary Lymph Node Invasion of Breast Tumors

Study Overview
=================
Brief Summary
-----------------
The primary endpoint of this study is to show that this algorithm in high definition is superior to the classical algorithm in the diagnosis of lymph node metastases.

Official Title
-----------------
Comparison of Diagnostic Performance of an Algorithm and a High Definition Classical Iterative Algorithm Positron Emission Tomography (PET) to 18Fluoro-deoxy-glucose (18FDG) in the Evaluation of Axillary Lymph Node Invasion of Breast Tumors

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent and signed by the patient Age ≥ 18 years Breast tumor for which the therapeutic indication for surgery has from the outset: breast surgery (conservative or radical) associated with a conventional axillary dissection Proof of infiltrating ductal carcinoma histology No known metastasis No cons-indication to anesthesia. Exclusion criteria: History of neoadjuvant therapy Patients with invasive lobular carcinoma Indication of the use of sentinel node (if invasive carcinoma uni-centric, ≤ 2 cm in diameter, without palpable lymphadenopathy (N0)) Diabetes is not controlled by conventional treatment (blood glucose> 1.8 g / l) Inability to capital Patients who are pregnant or nursing or of childbearing potential and not using adequate contraception Persons deprived of their liberty Major subject of a measure of legal protection or unable to consent Refusal to participate

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

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

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 |
| --- | --- | --- |
| Performance of FDG-PET for the evaluation of nodal status | Show that the algorithm of high-definition positron emission tomography (PET) to 18Fluoro-deoxy-glucose (18FDG) is greater than a classical algorithm in the diagnosis of lymph node metastases. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Information on lymph node status in patients with breast cancer. | Show that scintigraphy performed on a FDG positron camera equipped with a reconstruction algorithm for high-definition can provide reliable information on lymph node status in patients with breast cancer and determine the minimum size of lymph node metastatic lesions. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Breast, 18FDG, Axillary, Positron Emission Tomography
Identification the Expression of Sox2 in Colorectal Cancer Tissues

Study Overview
=================
Brief Summary
-----------------
Sox2 has been studied in several types of human solid tumors. The investigators found that Sox2 had higher expression level in colorectal cancer and metastatic tissues than normal tissues. So the investigators assumed that whether Sox2 plays an important role in the progression and migration of colon cancer.

Detailed Description
-----------------
In our study, we examined Sox2 expression in archived human colon cancer tissues and found that its Sox2 expression correlates with reduced patient survival, increased tumor grade and metastasis probability.

Official Title
-----------------
The Role of Sox2 in Tumor Genesis and Migration in Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of colorectal cancer Exclusion Criteria: Clinical diagnosis characteristics not exactly described in the patients information

Ages Eligible for Study
-----------------
Minimum Age: 24 Years
Maximum Age: 79 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colorectal cancer, invasion, metastasis, IHC
The Importance of Glucagon-Like Peptide-2 (GLP-2)in Mesenteric Bloodflow in Humans

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the effect of GLP-2 on mesenteric bloodflow in healthy adults by the use of ultrasound., it is the hypothesis that GLP-2 vil increase the bloodflow.

Detailed Description
-----------------
The investigation will include 10 testpersons. It will be a 2 fase study over 2 days. day 1: The testperson will meet fasting, and take in a standard liquid meal, after this the bloodflow in a mesenteric artery will be measured by use of ultrasonic technique. Bloodsamples will be taken regular in a total wolumne of 200 ml. day 2:The testperson will meet fasting, there wil be administered intraveneous GLP-2 in 3 increasing doses over 3 x 45 min.and one subcutaneous dose. During this the bloodflow in a mesenteric artery will be measured by use of ultrasonic technique. Bloodsamples will be taken regular in a total wolumne of 200 ml.

Official Title
-----------------
The Importance of Glucagon-Like Peptide-2 (GLP-2)in Mesenteric Bloodflow in Humans

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

Intervention / Treatment
-----------------
* Drug: GLP-2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy Exclusion Criteria: use of drugs

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GLP-2|nan|

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

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