linjc16/ctgov huggingface dataset:
Hemodynamic Parameters in Euthyroid Patients With Thyroid Nodules

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the relationship of hemodynamic parameters with the level of thyroid hormones and the histological structure of thyroid nodules in euthyroid patients.

Detailed Description
-----------------
As opposed to widely investigated condition of cardiovascular system in patients with functional disorders of thyroid gland, the relationship between thyroid hormones and hemodynamic parameters in euthyroid patients remains not enough clear. We detect the parameters of blood pressure and thyroid hormones in euthyroid patients with thyroid nodules directly before planned operation on the thyroid gland. As the study is carries out directly before operation, that assumes presence of preoperative stress in patients, activity of the sympatho - adrenal system is estimated in addition. On the one hand, the design of our research will allow to estimate relationship of thyroid hormones with the parameters of blood pressure in conditions of euthyroidism, on the other hand - to investigate features of blood pressure in patients with thyroid nodules. The research of the patients in the preoperative period will enable to select the group of patients without pathology of cardiovascular system whose increased blood pressure is connected with preoperative stress, that in turn will allow to exclude influence of the pathology of the cardiovascular system on studied correlation.

Conditions
-----------------
Thyroid Nodules

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Euthyroid patients with thyroid nodules before operation on the thyroid gland Exclusion Criteria: Hyperthyroidism Hypothyroidism
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Cohort: Patients with normal blood pressure scheduled to have thyroid nodules surgically removed | |
| A1<br>Patients from group A not receiving any drugs and who lack other pathology, gender and age matched group B1 | |
| B<br>Cohort: Patients with increased blood pressure scheduled to have thyroid nodules surgically removed | |
| B1<br>Patients from group B not receiving any drugs and who lack other pathology, gender and age matched group A1 | |

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
-----------------
thyroid nodules, blood pressure, thyroid hormones
Gene Expression Profiling in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
One of the goals of the Kansas City Diabetes Consortium is to identify and characterize genes and their products that are associated with T1DM. Characterization of such genes and their products can aid in developing new tools for risk assessment, development of new prevention strategies and monitoring progression of disease. Study design: Descriptive, basic science pilot study. The results of this pilot study will be used to help design a much larger study to address the importance of viral response and autoimmune diabetes.

Detailed Description
-----------------
The hypothesis is that viral responsive genes are up-regulated prior to the onset of symptoms of Type 1 Diabetes (T1DM) and may correlate with increased expression of interferon alpha. Both genetic and environmental factors contribute to risk of development of T1DM. There are a number of conflicting reports associating viral infections and T1DM in genetically susceptible individuals and causality has not been proven. Viruses may not have a large role in the initiation of islet cell autoimmunity but more of a role in acceleration of the disease leading to overt symptoms. There are no studies describing viral responsive gene expression in these individuals.

Official Title
-----------------
Gene Expression Profiling in Type 1 Diabetes

Conditions
-----------------
Type 1 Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects 7-14 years of age New onset T1DM Five years post onset of T1DM Participant in the TrialNet initiative and either antibody positive or antibody negative sibling control Body weight sufficient to tolerate an additional 15ml (1 tbsp) blood loss Exclusion Criteria: Subjects who do not meet the criteria above Subjects who have received steroids or other immunosuppressive therapy within the 6 months prior to enrollment into the study

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 14 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
-----------------
viral response genes
Spinal Cord Neuromodulation for Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
This study is designed to assess the strategy of using spinal cord stimulation to improve the ability to move in spinal cord injured humans.

Detailed Description
-----------------
An epidural stimulation device will be tested to determine if motor function can be improved.

Official Title
-----------------
Enabling Forelimb Function With Agonist Drug and Epidural Stimulation in SCI

Conditions
-----------------
Cervical Spinal Cord Injury, Tetraparesis, Tetraplegia

Intervention / Treatment
-----------------
* Device: Epidural Stimulation
* Drug: Buspirone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate hand/arm movement No severe cardiopulmonary diseases such as severe bradycardia, severe autonomic dysreflexia, and/or Chronic Obstructive Pulmonary Disease. No painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or infection that might interfere with upper extremity training No clinically significant depression or ongoing drug abuse No current anti-spasticity medication regimen Non-progressive SCI above C5 Must not have received botox injections in the prior six months Be unable to grip or move independently Be at least one-year post injury Must be at least 18 years of age Segmental reflexes remain functional below the lesion Female subjects of child-bearing potential must not be pregnant and must be using a medically acceptable method of contraception No current implant(s) of neurostimulators, cardiac pacemakers, defibrillators, shunts, stents, or aneurysm clips, and must have no future exposure to diathermy following implantation No coagulopathy, cardiac risk factors, or other significant medical risk factors for surgery Must not be involved in another clinical trial Must not have disorders or conditions that would require MRI monitoring Exclusion Criteria: None as long as inclusion criteria are met.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stimulation<br>Determine if epidural stimulation can improve motor function. | Device: Epidural Stimulation<br>* Determine if epidural stimulation can improve motor function<br>Drug: Buspirone<br>* Determine if the pharmacological agent in combination with the stimulator can improve motor function.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of arm/hand function | Formal motor testing | 24 months |
Clinical Validation of a Predictive Model for the Presence of Cervical Lymph Node Metastasis in Papillary Thyroid Cancer

Study Overview
=================
Brief Summary
-----------------
This research study is performed to compare the accuracy of two methods of lymph node evaluation: research method versus standard method. Standard method is what is usually performed as standard of care where the radiologist evaluates the images overall and decides whether each node seen should or should not be biopsied. In the research method, a second radiologist will evaluate the ultrasound images of the lymph nodes separately, and use a small specific checklist of ultrasound appearance to determine whether each node should or should not be biopsied. Results of both the standard and research method will be used to decide which node(s), if any should be biopsied. Neck ultrasound examination, lymph node evaluation by standard method and subsequent lymph node biopsy are part of the standard clinical care. It is less likely but possible that the research method may identify additional lymph nodes for biopsy to check if that lymph node contains thyroid cancer.

Official Title
-----------------
Clinical Validation of a Predictive Model for the Presence of Cervical Lymph Node Metastasis in Papillary Thyroid Cancer

Conditions
-----------------
Papillary Thyroid Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of PTC and at least one sonographic examination of the cervical lymph nodes. Patients can only be included in the study once. Thus, if they have two sonographic examinations, only one can be included in the study results. All patients who fit the study criteria after the start of the study will be included, using the first sonographic exam as the study exam. Exclusion Criteria: Lymph node with oval shape, hypoechoic cortex, smooth border, hyperechoic hilum and hilar Doppler flow by ultrasound are considered to be normal and be excluded from FNAB per standard clinical practice. Lymph node less than 5 mm in short axis on ultrasound.

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 |
| --- | --- | --- |
| Detection of lymph node metastasis in a patient with Papillary Thyroid Cancer by neck ultrasound by radiologist's standard assessment method (Ir test). |  | 6 months | 
| Detection of lymph node metastasis in a patient with Papillary Thyroid Cancer by neck ultrasound by predictive model method (Im test). |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmation of the lymph node metastasis by fine needle aspiration biopsy prior to the surgery. |  | 6 months | 
| Measure true positive and false positive results of Ir test and Im test for comparison. |  | 6 months |
Brief Intervention to Prevent Alcohol Socialization (BIPAS Alcohol)

Study Overview
=================
Brief Summary
-----------------
Early alcohol socialization occurs within the family. This multi-level, high-reach, low-intensity intervention to prevent early alcohol use capitalizes on the influence of providers, immunization timing, and pediatric guidelines that advise healthcare providers to give anticipatory guidance about early alcohol use. In conjunction, the intervention capitalizes on the power of technology to reinforce and expand upon pediatrician messages. The study seeks to understand the feasibility and effectiveness of a pilot intervention designed to prevent alcohol socialization through education of parents of rising 6th grade students.

Official Title
-----------------
Brief Intervention to Prevent Alcohol Socialization / Better Informed Parents Keeping Adolescents Safe From Alcohol (BIPAS Alcohol)

Conditions
-----------------
Alcohol Drinking, Adolescent, Drinking Behavior, Drinking, Alcohol, Adolescent Behavior

Intervention / Treatment
-----------------
* Behavioral: BIPAS Alcohol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older; Parent or guardian of an enrolled child at a study clinic; Cohabitate part time (2 days/week) or more with enrolled child; Be able to complete study activities in English; Be able to give informed consent; Own a phone with text message capabilities and access to internet. Exclusion Criteria: Families in which the 10-to-12-year old child is actively receiving treatment for alcohol use disorder.

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

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

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 |
| --- | --- |
| Experimental: Intervention arm<br>Families receive text messages for three months. | Behavioral: BIPAS Alcohol<br>* Weekly text messages for three months.<br>|
| No Intervention: Waitlist-control arm<br>Families are randomized into a control group for three months and begin receiving text messages for three months. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Parental Pro-sipping Beliefs Score | Parental Alcohol Socialization Beliefs, Attitudes, and Practices scale (eight items). A four-point scale ranging from strongly disagree (lowest value=1) to strongly agree (highest value=4) will be used, with higher values on the scale indicating a more pro-sipping belief system. The scores will have a range from 8-32. Higher values are associated with worse outcomes. | Baseline, three months |
HCV (Hepatitis C Virus) Viral and Host Genotyping (IL28B, Interleukin 28B) in China

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to estimate the distributions of HCV viral/human genotypes (including IL28B and inosine triphosphatase, ITPA), and HCV RNA level among ITPA gene among 1000 Han ethnic Chinese patients with HCV who are antiviral treatment naive at the time the study is conducted.

Detailed Description
-----------------
A sample of 1000 Han ethnic Chinese male or female who are ≥ 18 years old with a recent confirmation of anti-HCV-antibody positive and HCV RNA positive but antiviral treatment naive from 28 university affiliated hospital in China. The primary objective of this study is to estimate the distributions of HCV Viral genotyping(ie, genotype 1 through 6 and their known subtypes), and host genotypes, both inosine triphosphatase (ITPA) gene, and IL28B. This study also collects other data including patients' demographic and clinical characteristics. There is no active antiviral treatments and no follow-up in this study.

Official Title
-----------------
HCV Viral Genotyping Distribution and Genetic Variation in IL28B Distributions Among the Han Ethnic Chinese in China

Conditions
-----------------
Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female Han ethnic ≥ 18 years old recent confirmation of anti-HCV-antibody positive and HCV RNA positive 30 days prior to the recruitment antiviral or interferon treatment naive Exclusion Criteria: < 18 years old not Han ethnic treated by antiviral before 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 |
| --- | --- |
| HCV Patients who are treatment naive<br>Han ethnic Chinese male or female ≥ 18 years old with recent a confirmation of anti-HCV-antibody positive and HCV RNA positive but antiviral or interferon treatment naive at the time this study starts from 28 university affiliated hospital throughout China. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatitis C viral and host genotypes | To describe the distributions of both HCV viral and host genotypes (IL28B and ITPA) among antiviral treatment naive HCV patients | Confirmation of an HCV infection 30 days prior to the recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatitis C RNA levels | To describe the distribution of HCV RNA levels in antiviral treatment-naive HCV patients | Confirmation of an HCV infection 30 days prior to the recruitment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCV viral genotypes, host genotypes, IL28B, ITPA, RNA, China
Gastric Decompression After Sub-total Gastrectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the utility of the nasogastric tube, which is used to decompress and as guardian of gastro-jejunal anastomosis, in patients undergoing distal subtotal gastrectomy for gastric cancer with reconstruction according to Billroth II or according Roux.

Detailed Description
-----------------
A silastic naso-gastric tube (Rusch® distributed by Teleflex Medical Srl) is used in the naso-gastric/jejunal tube group

Official Title
-----------------
Naso-gastric/Jejunal Tube Placement After Sub-total Gastrectomy. A Multicenter Prospective Randomized Trial

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Device: Naso-Gastric/Jejunal Tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All people subjected to subtotal gastrectomy for distal gastric adenocarcinoma. Exclusion Criteria: People undergoing enteral nutrition through naso-jejunal tube
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Place Naso-Gastric/Jejunal Tube Group<br>In this group a silastic naso-gastric/jejunal tube is placed (Rusch® distributed by Teleflex Medical Srl) | Device: Naso-Gastric/Jejunal Tube<br>* Silastic Naso-Gastric/Jejunal Tube (Rusch® distributed by Teleflex Medical Srl)<br>* Other names: Rusch® distributed by Teleflex Medical Srl;|
| No Naso-Gastric/Jejunal Tube Group<br>In this group a silastic naso-gastric/jejunal tube is not placed | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of Naso-Gastric/Jejunal Tube on Postoperative complications |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of Naso-Gastric/Jejunal Tube on Postoperative Patient's Comfort |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Naso-Gastric/Jejunal Tube, Sub-total Gastrectomy, Gastric Cancer, Decompression, Discomfort, Complications
Faslodex Post Marketing Surveillance

Study Overview
=================
Brief Summary
-----------------
This PMS aims to assess the efficacy, the safety and tolerability profile of Faslodex in everyday practice. Secondary objective of this PMS is to identify the frequency of serious adverse events or any unknown adverse events of Faslodex.

Official Title
-----------------
Faslodex Post Marketing Surveillance

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women Patients who have failed 2 or more prior hormone therapies (The prior hormone therapies should contain both antiestrogen and non-steroidal Aromatase inhibitor) Patients who were intolerant to prior hormone therapy and have no endocrine therapeutic options (The prior hormone therapies should contain both antiestrogen and non-steroidal Aromatase inhibitor) Exclusion Criteria: The patients who received Faslodex treatment before
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>Postmenopausal women with locally advanced or metastatic breast cancer who have failed 2 or more prior hormone therapies, or were intolerant to prior hormone therapy and have no endocrine therapeutic options. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events are confirmed by investigator through asking to patients or patients' voluntary reporting. |  | 5 years | 
| Efficacy of Faslodex is assessed by proper method among CT scan, MRI, Ultrasound, etc. The RECIST criteria for target and non-target lesions will be used to evaluate efficacy. |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Efficacy profile, Safety profile, Faslodex