linjc16/ctgov huggingface dataset:
Effects of Weight on Inflammation and Colon Cancer Risk

Study Overview
=================
Brief Summary
-----------------
An observational study designed to compare colonic cytokine concentrations in lean versus obese individuals

Detailed Description
-----------------
An observational study was performed on 43 individuals undergoing routine screening colonoscopy, some of whom were lean and some who were obese. They had weight, height, and waist-hip ratio measured at the time of colonoscopy and had additional colonic biopsies to measure colonic cytokines.

Official Title
-----------------
Study on the Effects of Weight on Inflammation and Colon Cancer Risk

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

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caucasian undergoing clinically-indicated screening colonoscopy BMI< or = 25, or 30+ Exclusion Criteria: past history of cancer (except non-melanoma skin cancer) a polyposis syndrome any current or chronic inflammatory disease or infection incapable of providing valid informed consent

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 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 |
| --- | --- |
| lean<br>healthy subject undergoing routine screening colonoscopy, BMI< or = 25 | Other: no intervention<br>* there is no intervention in this study<br>|
| mildly obese<br>healthy subject undergoing routine screening colonoscopy, BMI 30-33.9 | Other: no intervention<br>* there is no intervention in this study<br>|
| moderate-to-severe obese<br>healthy subject undergoing routine screening colonoscopy, BMI 34+ | Other: no intervention<br>* there is no intervention in this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| colonic concentration of Tumor Necrosis Factor-alpha |  | time zero: at baseline | 
| colonic concentration of Interleukin-6 |  | time zero: at baseline | 
| colonic concentration of Interleukin-1 beta |  | time zero: at baseline | 
| colonic concentration of Interferon-gamma |  | time zero: at baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, inflammation, cancer risk
Registry of Patients With Chronic Thromboembolic Pulmonary Hypertension in Novosibirsk Region

Study Overview
=================
Brief Summary
-----------------
There will be assessment of patients after acute pulmonary embolism for the development of CTEPH

Detailed Description
-----------------
There will be assessment of patients after acute pulmonary embolism for the development of CTEPH. There will be analysis of case histories of 40 patients with acute pulmonary embolism. All this patients will be clinically assessed by local cardiologist. Also echocardiography, lung VQ scans (perfusion and ventilation) will be performed. Patients with chronic thromboembolic pulmonary hypertension will be assessed by local team experienced in CTEPH treatment.

Official Title
-----------------
Local Registry of Patients With Chronic Thromboembolic Pulmonary Hypertension in Novosibirsk Region

Conditions
-----------------
Chronic Thromboembolic Pulmonary Hypertension

Intervention / Treatment
-----------------
* Diagnostic Test: acute PE survivors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who had episodes of acute pulmonary embolism 3-4 months of anticoagulation treatment after acute pulmonary embolism informed consent Exclusion Criteria: pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: acute PE survivors|Patients from this group will be assessed by cardiologist, echocardiography and VQ scanning|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical presentation of chronic thromboembolic pulmonary hypertension | presence of dyspnea after acute pulmonary embolism will be the sign of clinical symptomatic patients. Dyspnea will be assessed with Borg scale | 3-4 month after acute pulmonary embolism | 
| clinical presentation of chronic thromboembolic pulmonary hypertension | clinical assessment of physical capacity of patient with 6 minute walking distance test and NYHA functional class | 3-4 month after acute pulmonary embolism | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of pulmonary hypertension - mean pulmonary artery pressure > 25 mm Hg according to echocardiography | presence of pulmonary hypertension - mean pulmonary artery pressure > 25 mm Hg according to echocardiography | 3-4 month after acute pulmonary embolism | 
| presence of perfusion deficit in pulmonary artery according to VQ scan | presence of perfusion deficit in pulmonary artery according to VQ scan | 3-4 month after acute pulmonary embolism |
Silicone Arthroplasty vs. Arthrodesis in the Distal Interphalangeal Joint

Study Overview
=================
Brief Summary
-----------------
The operational and favored standard therapy for the treatment of osteoarthritis in the distal interphalangeal joint is the arthrodesis, in which a titanium screw is used. Arthrodesis shows in the most cases the complete reduction of osteoarthritis pain and low loss of function. But restrictions are reported in fine motor skills. The operation with silicone arthroplasty is similar. As an implant, a silicone joint is used, which has been sufficiently tested at the metacarpophalangeal joint and interphalangeal joint. The advantage of arthroplasty is the function obtained in the distal interphalangeal joint and the resulting improved fine motor skills.

Official Title
-----------------
Functional Outcome in Silicone Arthroplasty Compared to Arthrodesis Screws in Patients With Osteoarthritis in the Distal Interphalangeal Joint

Conditions
-----------------
Finger Joint, Arthroplasty, Replacement

Intervention / Treatment
-----------------
* Procedure: silicone arthroplasty
* Procedure: arthrodesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary osteoarthritis in the distal interphalangeal joint require surgical treatment patient aged 18 years and over signed written informed consent Exclusion Criteria: posttraumatic osteoarthritis rheumatoid disease pregnant woman any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder) legal incompetence no knowledge of German

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: silicone arthroplasty<br>silicone arthroplasty | Procedure: silicone arthroplasty<br>* silicone arthroplasty<br>|
| Active Comparator: arthrodesis<br>arthrodesis | Procedure: arthrodesis<br>* arthrodesis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Michigan Hand Questionnaire (MHQ) | Comparison of silicone arthroplasty and arthrodesis in respect to MHQ | 12 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Michigan Hand Questionnaire Score |  | preoperative, 3mo/6mo/36mo postoperative |
Transpulmonary Pressure in Right Ventricle Protection of ARDS

Study Overview
=================
Brief Summary
-----------------
To compare the effect between mechanical ventilation strategy guided by transpulmonary pressure and tranditional lung protective ventilation strategy in acute respiratory distress syndrome for right ventricle protection.

Official Title
-----------------
Transpulmonary Pressure Guided Mechanical Ventilation Strategy for Right Ventricle Protection in Acute Respiratory Distress Syndrome

Conditions
-----------------
Acute Respiratory Distress Syndrome, Acute Cor Pulmonale

Intervention / Treatment
-----------------
* Procedure: mechanical ventilation strategy guided by transpulmonary pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: duration of invasive mechanical ventilation less than 72 hours; meet the diagnostic criteria of Berlin definition for ARDS; age older than 18 Exclusion Criteria: esophageal surgery or damage; cardiac surgery; severe bronchopleural fistula; serious arrhythmia; pneumothorax; tricuspid stenosis; heparin allergy; chronic pulmonary heart disease

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTP group<br> | Procedure: mechanical ventilation strategy guided by transpulmonary pressure<br>* Mechanical ventilation parameters adjust guided by transpulmonary pressure monitoring. For pressure assist control or volumn assit control mode; inspiratory pressure or volumn setting needs to maintain Ppeak less than 25 cm H2O; PEEP was set at such a level that expiratory Ptp stayed between 0 and 5 cm H2O.<br>|
| No Intervention: Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary vascular resistance (PVR) | PVR will measured by Swan-Ganz catheter | 3 days | 
| Pulmonary vascular compliance | Pulmonary vascular compliance will be calculated using pulmonary artery pressure divided by stroke output measured by Swan-Ganz catheter. | 3 days |
Comparison Between Gamma 3 Nail and ACE Trochanteric Nail

Study Overview
=================
Brief Summary
-----------------
Pertrochanteric and subtrochanteric femur fractures will be treated with a Gamma 3 nail or an ACE Trochanteric nail. Following topics will be assessed: fracture consolidation, mobility, pain, walking power, agility.

Official Title
-----------------
Comparison Between Gamma 3 Nail and ACE Trochanteric Nail

Conditions
-----------------
Pertrochanteric and Subtrochanteric Femur Fractures

Intervention / Treatment
-----------------
* Device: Gamma 3 nail versus ACE trochanteric nail


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pertrochanteric or subtrochanteric femur fracture

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with a Gamma 3 nail.<br> | Device: Gamma 3 nail versus ACE trochanteric nail<br>* Comparing Gamma 3 nail versus ACE trochanteric nail<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consolidation of the fracture |  | From surgery untill healing |
Human Milk Nutrients and Infants' Health Outcomes in South China

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the associations between human milk nutrients and infants' health outcomes in China.

Detailed Description
-----------------
Human milk components are beneficial to the growth and development of infants, such as phospholipids, gangliosides, sialic acids, choline, oligosaccharide and so on. However, studies on the associations between human milk components and infants' outcomes are limited. Therefore, this study is designed to investigate the relationship between Chinese human milk components and the growth and development of infants.

Official Title
-----------------
Human Milk Nutrients and Infants' Health Outcomes in South China

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 3-5 years healthy children breastfeeding at least until 40-45 days of age human milk components in mature milk (40-45days) being determined sign informed consent Exclusion Criteria: children with severe chronic diseases, such as tumor, severe digestive diseases, kidney diseases gestational diabetes, hypertension and other metabolic diseases children with mental system diseases children with congenital and genetic diseases children with infectious diseases, eg, upper respiratory tract infection or diarrhea antibiotic or other drugs influencing intestinal flora being taken within 45 days Withdraw withdraw informed consent serious violation of the scheme no longer meet the research criteria because of health factors or accidents

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 5 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 |
| --- | --- | --- |
| The growth of children | The physical growth and body composition of children will be checked by physical examination. | 18 month | 
| The cognitive development of children | The brain developments of children will be obtained by the Griffith Developmental Assessment Scale. | 18 month | 
| Gut microbiota | Gut microbiota of children will be examined by the analysis of 16S rDNA and metagenomic. | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General demographic materials | The general demographic materials of parents and children will be obtained by questionnaire. | 14 month | 
| Dietary and lifestyle information | Dietary and lifestyle information of children will be obtained by questionnaire. | 3 month | 
| Behavior problems | The behavior problems are collected by Child Behavior Checklist. | 18 month | 
| Allergic assessment | Allergic assessments of children will be conducted by questionnaire. | 18 month | 
| Sleep assessment | Sleep assessment of infants will be conducted by The Children's Sleep Health Questionnaire. | 18 month |
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the safety and tolerability of ONO-6950 across ascending multiple doses in healthy adult male and female subjects. The secondary objectives are to characterize the PK and pharmacodynamic (PD) profiles of ONO-6950 by measuring plasma concentrations of ONO-6950 and pulmonary function.

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects

Conditions
-----------------
Healthy Adult Subjects

Intervention / Treatment
-----------------
* Drug: ONO-6950
* Drug: ONO-6950


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy non-smoking male or female subjects (18-55 inclusive) Body mass index (BMI)of 10-35 kg/m2 (inclusive) For females; postmenopausal, non-lactating, and non-pregnant Exclusion Criteria: History or presence of clinical significant disease

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E<br>ONO-6950 | Drug: ONO-6950<br>* 30 mg, 100 mg, 300 mg at multiple doses<br>|
| Placebo Comparator: P<br>Placebo | Drug: ONO-6950<br>* Placebo to match ONO-6950 tablets dosed in a similar manner to ONO-6950<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of ONO-6950 using vital signs, pulmonary function tests ECGs, laboratory tests and physical examinations |  | At protocol-specified timepoints before and after study drug administration up to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of PK ( Cmax, Tmax, AUC, ty2, etc.) and PD profiles of ONO-6950 using plasma concentration of ONO-6950 in blood and pulmonary function tests |  | At protocol-specified timepoints before and after study drug administration up to 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ONO-6950, Healthy adult subjects
Evaluate the Efficacy of Disopyramide Therapy in Hypertrophic Obstructive Cardiomyopathy Patients

Study Overview
=================
Brief Summary
-----------------
Population study- patients with obstructive hypertrophic cardiomyopathy that are treated with disopyramide. Tow echo examination, few hours apart, that includes strain rate will be done to each patient. The first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide.

Detailed Description
-----------------
Tow echo examination, few hours apart, that includes strain rate will be done to each patient. The first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide.

Official Title
-----------------
Evaluate the Efficacy of Disopyramide Therapy in Hypertrophic Obstructive Cardiomyopathy Patients; Comparison of Two Echocardiography Based Methods: Global Longitudinal Strain vs. Left Ventricle Ejection Fraction

Conditions
-----------------
Cardiomyopathy

Intervention / Treatment
-----------------
* Device: echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hypertrophic cardiomyopathy that treated with disopyramid Exclusion Criteria: pregnancy pacemaker

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: echo<br>Population study- patients with obstructive hypertrophic cardiomyopathy that are treated with disopyramide. Tow echo examination, few hours apart, that includes strain rate will be done to each patient. The first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide. | Device: echocardiography<br>* Tow echo examination, few hours apart, that includes strain rate will be done to each patient. The first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tow echo examination, few hours apart, that includes strain rate will be done to each patient. The first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide |  | 2-3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertrophic cardiomyopathy, disopyramide,
Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization

Study Overview
=================
Brief Summary
-----------------
Twenty four patients with multiple myeloma will be randomized to either AM group (administration of lenograstim at 8 am) or PM group (administration of lenograstim at 6 am ). Apheresis of hematopoietic stem cell will start at 10 am on D5 in AM group and at 8 am on D4 in PM group, respectively. Pharmacokinetic data of lenograstim will be correlated with pharmacodynamic data of CD34+ cell count, absolute neutrophil cell count and hematopoeitic progenitor cell count. In addition, the yield of stem cell collection between two arms will be analyzed.

Official Title
-----------------
Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization in Patients With Multiple Myeloma

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

Intervention / Treatment
-----------------
* Drug: lenograstim 10 microgram/kg/day


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: above 17 years, below 65 years old informed consent ECOG 0-1 autologous stem cell transplant candidate among patients with multiple myeloma Exclusion Criteria: prior history of hematopoetic stem cell transplantation history of failure to mobilize hematopoietic stem cells history of G-CSF administration within 2 weeks before enrollment to this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AM group<br>Lenograstim is administered at 8 am and apheresis is started at 10 am on D4. | Drug: lenograstim 10 microgram/kg/day<br> <br> |
| Experimental: PM group<br>Lenograstim is administered at 6 pm and apheresis is started at 8 am on D5 | Drug: lenograstim 10 microgram/kg/day<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetic data of lenograstim | AUC0-24hr, Cmax, Cmin, Tmax, T1/2 of lenograstim | on day 1 of apheresis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacodynamic data: CD34+ cell count by flow cytometry |  | on day 1 of apheresis | 
| pharmacodynamic data: absolute neutrophil count |  | on day 1 of apheresis | 
| pharmacodynamic data: hematopoietic progenitor cells (HPC) |  | on day 1 of apheresis |