linjc16/ctgov huggingface dataset:
The Expression Heparanase in Term and Preterm Placentas

Study Overview
=================
Brief Summary
-----------------
Heparanase is an endo-β-glucuronidase that cleaves heparin-sulfate (HS) side chains of heparan sulfate proteoglycans, an integral constituent of the extra cellular matrix (ECM). This study aims to investigate the association between heparanase expression in the human placenta and preterm birth (PTB) . The investigators hypothesize that an abnormal placentation causes relative placental ischemia that induces higher rates of heparanase expression.

Official Title
-----------------
The Expression Heparanase in Term and Preterm Placentas

Conditions
-----------------
Preterm Birth

Intervention / Treatment
-----------------
* Other: Placental analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnancy Exclusion Criteria: High-risk patients Multiple pregnancy Significant maternal illness Significant fetal anomaly

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Elective term cesarean<br>Low-risk women undergoing elective term cesarean section | Other: Placental analysis<br>* Analysis of placenta to determine expression of heparanase<br>|
| Term vaginal delivery<br>Low-risk women undergoing term vaginal delivery | Other: Placental analysis<br>* Analysis of placenta to determine expression of heparanase<br>|
| Preterm vaginal delivery<br>Women undergoing preterm vaginal delivery | Other: Placental analysis<br>* Analysis of placenta to determine expression of heparanase<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heparanase expression | Heparanase expression in the human placenta following delivery will be evaluated by western blot analysis in the three groups and will be compared to determine differences in the levels. | Six months |
The Effect of Vitamin K2 on Bone Turnover

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of menatetrenone on bone turnover in postmenopausal patients with osteoporosis. One month of menatetrenone therapy enhanced the secretion and gamma-carboxylation of osteocalcin. Moderate increases of bone resorption and formation markers were observed after 6 months. These changes may contribute to fracture prevention in patients with osteoporosis.

Official Title
-----------------
Short-Term Menatetrenone Therapy Increases Gamma-Carboxylation Of Osteocalcin With A Moderate Increase Of Bone Turnover In Postmenopausal Osteoporosis: A Randomized Prospective Study

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Menatetrenone (Vitamin K2)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: A diagnosis of osteoporosis was made according to the Year 2000 version of the Diagnostic Criteria for Osteoporosis proposed by the Japanese Society for Bone and Mineral Research. These criteria state that patients with a lumbar bone mineral density (BMD)<70% of the young adult mean or patients with pre-existing osteoporotic fractures and a lumbar BMD<80% of the young adult mean can be diagnosed as having osteoporosis. Exclusion criteria: Patients with secondary osteoporosis (e.g., due to major gastrointestinal surgery, steroid therapy, rheumatoid arthritis, premenopausal bilateral oophorectomy, renal dysfunction, and thyroid dysfunction ). Patients taking medications that could affect bone turnover (such as bisphosphonates, estrogen, calcitonin, SERM, active vitamin D3, or Warfarin) were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 49 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Menatetrenone (Vitamin K2)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gamma-carboxylation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone turnover marker |  |  |
Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH)

Study Overview
=================
Brief Summary
-----------------
Postdural puncture headaches (PDPH) are a consequence of spinal and epidural anesthesia in approximately 1% of cases when performed in obstetric patients. The gold standard treatment for a PDPH is currently an epidural blood patch (EBP), which involves placing a needle back into the epidural space of the neuraxium and then injecting 20 ml of the patient's own blood through the needle and into the epidural space to form a clot over the insult in the tissue layer that causes the headaches. The investigators want to test the efficacy of using a less invasive procedure, called a sphenopalatine block (SPGB), for treatment of PDPH. SPGB has been used for many years in the treatment of migraines and cluster headaches, and there are several case reports of its use to successfully treat PDPH as well. SPGB simply involves applying a local anesthetic to the mucosa in the back of each nostril to numb the nerves that cause the headache. The investigators hope that the SPGB will reduce the number of PDPH patients that require and EBP.

Official Title
-----------------
A Prospective Randomized Double-Blind Placebo Controlled Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH)

Conditions
-----------------
Postdural Puncture Headache

Intervention / Treatment
-----------------
* Drug: 0.5% bupivacaine
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Active postdural puncture headache within 7 days after neuraxial analgesia/anesthesia Age ≥ 18 years. ASA physical status ≤ 3 Exclusion Criteria Known coagulopathy Known nasal septal deviation or abnormalities Medical conditions contraindicated to bupivacaine or the nasal applicator (according to the product labeling)

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acitve<br>This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360® | Drug: 0.5% bupivacaine<br>* This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360®<br>|
| Placebo Comparator: Placebo<br>This group will receive 0.3 ml of normal saline per nare, applied with the Tx360® | Drug: normal saline<br>* This group will receive 0.3 ml of normal saline per nare, applied with the Tx360®<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache verbal pain score |  | 1 hour |
The Detection and Factors of Brown Adipose Tissue in Different Locations of Adults

Study Overview
=================
Brief Summary
-----------------
Retrospective studies have combined positron-emission tomography and computed tomography (PET-CT) to identify adipose tissue with a high rate of uptake of 18F-fluorodeoxyglucose(18F-FDG) as active brown adipose tissue(BAT). In addition, biopsy specimens and immunohistochemical staining with a UCP1-specific antiserum were used to indicate that normal adults were able to have BAT. However,these studies only chose few subjects and limited to the neck tissue. Therefore, the investigators intend to test BAT in different parts of adults and analyse the clinical factors.

Detailed Description
-----------------
The investigators will promote the cross-sectional study from 2010 to 2013 in Shanghai. Data on demographic statistics, medical history,physical examination and fasting blood sample will be collected for all patients. Adipose tissue of adults will be collected from different regions, such as cervical, perirenal, along the large blood vessels and trachea, because they are included in the range of surgical therapy and are the major locations of BAT. Adipose tissue samples will be used to immunohistochemical stain, to detect the expression of BAT related genes.

Official Title
-----------------
Cross Sectional Study on the Detection and Factors of Brown Adipose Tissue in Different Locations of Adults

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who underwent surgical therapy and the operation scope includes BAT sample sites. Exclusion Criteria: Pregnant women With implantable medical electronic instrument Younger than 18 years

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brown adipose tissue, Different regions, Chinese adults
Metabolic Derangements in Acute Heart Failure Syndrome

Study Overview
=================
Brief Summary
-----------------
To determine the association of both neurohormonal and hemodynamic alterations associated with metabolic abnormalities in acute heart failure syndrome.

Official Title
-----------------
Metabolic Derangements in Acute Heart Failure Syndrome

Conditions
-----------------
Congestive Heart Failure

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (age > 18 yrs) patients admitted to the Heart Failure Intensive Care Unit (H22) with Acute Heart Failure Syndrome (AHFS) requiring placement of a Pulmonary Artery catheter for hemodynamically guided therapy. Exclusion Criteria: History of Congenital Heart Disease. Acute HF in the setting of acute myocardial infarction. Severe Anemia Patients listed for cardiac transplantation. Terminal Malignancy, AIDS or CNS disease. Concomitant sepsis, ARDS, trauma, aortic dissection, or pericardial tamponade

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 |
| --- | --- |
| Observation<br>Adult (age > 18 yrs) patients admitted to the Heart Failure Intensive Care Unit with Acute Heart Failure Syndrome requiring placement of a Pulmonary Artery catheter for hemodynamically guided therapy. | Other: Observational<br>* Pulmonary Artery pressure (PA), pulmonary capillary wedge pressure (PCWP), cardiac output (CO), and cardiac index (CI). This data will be collected after 24 ± 2 and 48 ± 2 hours of standard heart failure therapy<br>|

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
-----------------
Congestive Heart Failure
Sublingual Administration of PPI

Study Overview
=================
Brief Summary
-----------------
Compare 24-hour intragastric pH and therapeutic effectiveness of proton pump inhibitor (PPI) among different administration methods: per oral (PO), intravenous (IV), and sublingual (SL).

Detailed Description
-----------------
Intragastric pH and therapeutic effectiveness of PPI was compared among patients given PPI with different administration methods. 24 hour intragastric pH catheter was inserted in stomach of patients with peptic ulcer an hour prior to PPI administration in order to observe the initial change in pH. Three groups of patients were given PPI through per oral, intravenous, and sublingual administration methods. The hypothesis of this study is that sublingual administration will be faster than oral or IV administration in PPI dosing with respect to intragastric pH change and re-bleeding rate.

Official Title
-----------------
Sublingual Administration is More Fast Than Oral or IV Administration in PPI Dosing With Respect to Intragastric pH and Therapeutic Effectiveness: a Prospective, Randomized, Controlled Trial

Conditions
-----------------
Gastric or Duodenal Ulcer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with peptic ulcer disease Age: 20-75 years old Patients who submitted informed consent Exclusion Criteria: Peptic ulcer disease with spurting and oozing Shock, hypotension, pregnancy Gastrointestinal malignancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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 |
| --- | --- |
| PO<br>administrated by per oral | |
| IV<br>Administrated by intravenous | |
| SL<br>administrated by sublingual | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure 24-hour intragastric pH |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric ulcer, duodenal ulcer, re-bleeding rate, intragastric pH, proton pump inhibitor
Acute Postthoracotomy Pain - Impact of Gender

Study Overview
=================
Brief Summary
-----------------
Adequate analgesia in thoracic surgery is essential to prevent severe postoperative complications, especially respiratory problems. Current knowledge about gender-related differences in pain states generally more frequent and intense pain and more demand for analgesics in women. Results about postsurgical pain in particular are very inconclusive. The investigators tried to find out if gender has an influence on postthoracotomy pain and analgesics requirement.

Official Title
-----------------
No Impact of Gender on Acute Postthoracotomy Pain - a Retrospective Analysis

Conditions
-----------------
Gender, Postoperative Pain, Thoracotomy, Analgesia

Intervention / Treatment
-----------------
* Other: Thoracotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: open lung surgery between July 2010 and December 2014 Exclusion Criteria: redo-thoracotomy chest wall or rib resection other approach than lateral thoracotomy additional incision at other site (e.g. laparotomy) chest trauma mesothelioma hemofiltration or haemodialysis longer than one day stay at intensive care unit pre-existent chronic pain and/or chronic opioid intake short stay in hospital

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Female<br> | Other: Thoracotomy<br> <br> |
| Male<br> | Other: Thoracotomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scores |  | first 5 postoperative days | 
| Analgesics requirement |  | first 5 postoperative days |
Study of Daclatasvir-based Therapy in Chinese Participants With Chronic Hepatitis C (CHC)

Study Overview
=================
Brief Summary
-----------------
Study is a non-interventional, prospective, multicenter post marketing surveillance study to determine the safety of daclatasvir based therapy

Official Title
-----------------
Daclatasvir-Based Therapy Safety Surveillance in Chinese Patients With Chronic Hepatitis C

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants 18 years of age and older Participants with Chronic Hepatitis C virus (CHC) who are eligible for treatment with branded DCV-based therapy as indicated in the locally approved label Exclusion Criteria: Participants under the age of 18 Other protocol defined inclusion/exclusion criteria could apply

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 participant population in China<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events (AEs) |  | Approximately 72 weeks | 
| Number of serious adverse events (SAEs) |  | Approximately 72 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who discontinue therapy due to an AE |  | Approximately 72 weeks | 
| Effectiveness of daclatasvir DCV-based therapy | As measured by Sustained virologic response 12 weeks after the end of treatment (SVR12) Achieved SVR12: Hepatitis C virus (HCV) RNA below the lower limit of quantification (LLOQ) | Approximately 72 weeks |
Helping Young Children Improve Eating

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the impact of different types of educational materials on parent and child feeding behaviors. Specifically, the investigators will test the feasibility, acceptability, and effectiveness of an investigator-developed series of parent training videos designed to teach behavioral strategies to promote feeding in young children with feeding difficulties.

Official Title
-----------------
Helping Young Children Improve Eating

Conditions
-----------------
Feeding and Eating Disorders of Childhood

Intervention / Treatment
-----------------
* Behavioral: Parent Education Videos
* Behavioral: Educational Handout


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents of patients ages 18 months through 6 years currently on the waitlist (for an estimated time of at least 4-6 weeks) for outpatient feeding therapy, or with feeding concerns identified in a primary care visit; English-speaking parents; parent has the technology to access the videos and REDCap survey. Exclusion Criteria: Parents of patients not currently eating by mouth; parents of patients currently being treated by a psychologist, occupational therapist, or speech therapist to address feeding, eating, or swallowing skills; parents of patients who have aspirated on their most recent videofluoroscopic swallow study or who currently have a tracheostomy.
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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Educational handout<br> | Behavioral: Educational Handout<br>* Participants will receive educational handouts describing behavioral techniques to improve parent and child eating behavior.<br>|
| Experimental: Video plus educational handout<br> | Behavioral: Parent Education Videos<br>* Participants will receive educational videos describing behavioral techniques to improve parent and child eating behavior.<br>Behavioral: Educational Handout<br>* Participants will receive educational handouts describing behavioral techniques to improve parent and child eating behavior.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral Pediatrics Feeding Assessment | Parent questionnaire that measures parent and child feeding behaviors and attitudes. A higher score indicates more difficulties. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food Frequency Questionnaire | Parent questionnaire that measures the amount of different foods children ate over a specific time period (e.g. one month). A higher score indicates more different foods were consumed by the child. | 4 weeks |