linjc16/ctgov huggingface dataset:
Correlation Study Between Clinical Phenotype and Pathology of Type 2 Diabetic Nephropathy

Study Overview
=================
Brief Summary
-----------------
With the rapid increase of diabetic nephropathy worldwide, type 2 diabetes mellitus(DM) is the leading cause of end-stage renal disease(ESRD). Pathological types of diabetic kidney disease(DKD) could be mainly divided into diabetic nephropathy（DN）and non-diabetic renal diseases（NDRD）. There are no accurate renal biopsy indications and standardized operation procedures for type 2 diabetic nephropathy. The clinical stages of type 2 diabetic nephropathy still referred to the Mogensen stage of type 1 diabetic nephropathy. Thus, our study aim to clarify the differences in clinical phenotype between type 2 DN and type 2 NDRD, analysis the correlation between clinical and pathological features, and offer the criteria for clinical staging and prognosis.

Official Title
-----------------
Correlation Study Between Clinical Phenotype and Pathology of Type 2 Diabetic Nephropathy

Conditions
-----------------
Diabetic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age≥18, male or female Clinical diagnosed as type 2 diabetes mellitus The presence of renal impairment including: microalbuminuria or overt proteinuria or renal insufficiency The renal biopsy was performed with complete renal pathological diagnosis Obtaining the signed informed consent from patients Exclusion Criteria: The history of the disease was not complete Clinical diagnosed as other secondary renal diseases Patients with hereditary kidney disease Autoimmune diseases Patients with malignant tumor were expected to survive less than 6 months Pregnancy and lactation

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 |
| --- | --- |
| Type 2 diabetic nephropathy<br>The cohort will be followed for at least 10 years. The cohort will be divided into 2 groups according the pathological results of patients,and at least 3 groups according to clinical features such as renal function and proteinuria. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in eGFR and urine protein from baseline | eGFR is calculated using the CKD-EPI formula, involving gender, age, and serum creatinine. | 24months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic kidney disease (DKD), Diabetic nephropathy（DN), non-diabetic renal diseases（ NDRD), Clinical-pathological correlations, differential diagnosis
Investigation of Clofarabine in Acute Leukemias

Study Overview
=================
Brief Summary
-----------------
The goals and objectives of this project are to evaluate the antileukemic activity of the investigational agent clofarabine in patients with acute myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), and chronic myelogenous leukemia (CML) in accelerated and blastic phases.

Detailed Description
-----------------
The specific aims of the project are (1) conduct the phase II study of clofarabine and evaluate the antileukemic efficacy in AML, ALL, and CML-accelerated and blastic phases in terms of complete response (CR) rate, response duration, and survival; and (2) analyze the relationship between cellular uptake and retention of clofarabine triphosphate (the active metabolite), inhibition of DNA synthesis, and clinical outcome. Completion date provided represents the completion date of the grant per OOPD records

Official Title
-----------------
Phase II Clinical and Pharmacodynamic Investigation of Clofarabine in Acute Leukemias

Conditions
-----------------
Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia

Intervention / Treatment
-----------------
* Drug: clofarabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Patient is diagnosed with AML, ALL, myelodysplastic syndrome (MDS), and CML in transformation (includes CML-blastic phase and CML-accelerated phase). No prior chemo-, immuno-, or radio-therapy for 2 weeks before entering the study, unless progressive life-threatening leukemia as judged by the treated physician. Adequate liver function (bilirubin </= 2 mg%) and renal function (creatinine </= 2 mg%). Pregnant and lactating females not eligible. Zubrod performance status 0-2 Adequate cardiac status No life-threatening conditions (e.g. infections) which may cause death within 3 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 12 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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clinical, pharmacodynamics, investigational drug clofarabine, AML, ALL, CML-accelerated phase, CML-blastic phase, Chronic Myelogenous Leukemia - accelerated phase, Chronic Myelogenous Leukemia - blastic phase
Targeted Forceps Biopsy for Colorectal Tumors

Study Overview
=================
Brief Summary
-----------------
This study evaluates whether targeted forceps biopsy with careful tumor surface evaluation can improve diagnostic accuracy of colorectal tumors larger than 2 cm during colonoscopy.

Official Title
-----------------
Concordance Rate of Pathology Between Targeted Forceps Biopsy and Resected Specimen for Large Colorectal Tumors

Conditions
-----------------
Colorectal Neoplasms

Intervention / Treatment
-----------------
* Diagnostic Test: Targeted group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with colorectal neoplasms of the size larger than 2 cm Exclusion Criteria: Patients who deny the participation in the study

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Targeted forceps biopsy<br>In this group, an endoscopist takes a forceps biopsy at depressed mucosa or large nodular area of large colorectal tumors after meticulous surface evaluation. | Diagnostic Test: Targeted group<br>* Forceps biopsy is taken after surface evaluation of the large colorectal tumors.<br>|
| No Intervention: Conventional forceps biopsy<br>In this group, an endoscopist takes a forceps biopsy at the most convenient area of large colorectal tumors. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathologic diagnosis | The pathologic diagnosis of forceps biopsy is compared with the pathologic diagnosis of resected specimen of the colorectal tumor. | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
forceps biopsy, colorectal tumors
Glycemic Holter Study (Continuous Glucose Monitoring) -

Study Overview
=================
Brief Summary
-----------------
The study will assess glycemic variability and optimized glycemic control in T2DM patients treated with a DPP-4 inhibitor as add-on therapy to metformin.

Official Title
-----------------
Prospective, Randomized, Open-label Study With Blinded Endpoint (PROBE Design) to Compare the 72 hr Glycemic Profiles Obtained by Continuous Subcutaneous Glucose Monitoring (CSGM) in Type 2 Diabetic Patients at Baseline With Metformin Monotherapy and After an 8-week Period With the Addition of Either Vildagliptin or Sitagliptin in Patients Insufficiently Controlled by Metformin After at Least 3 Months of Monotherapy

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Vildagliptin
* Drug: Sitagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes Mellitus (DM) willing to perform SMBG at least 6 times daily to use the MiniMed CGMS for up to 3 consecutive days on 2 occasions. HbA1c: 6.5 to 9% with metformin monotherapy for a least 3 months Exclusion Criteria: Age >= 80 years BMI <= 22 and >=40 kg/m2 Secondary T2 DM Hepatic failure, ASAT/ALAT>3 ULN, and moderate/severe renal failure (CI < 50 ml/min) CHF III & IV Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin<br> | Drug: Vildagliptin<br> <br> |
| Active Comparator: Sitagliptin<br> | Drug: Sitagliptin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic variability assessed by MAGE (Mean Amplitude of Glycemic Excursion) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control assessed through CSGM |  | 8 weeks | 
| Glycemic control assessed by A1C, FPG, PPG and the mean of 6 points self-monitoring of blood glucose (SMBG) at baseline and after 8 weeks |  | 8 weeks | 
| Unrecognized hypoglycemic periods recorded by CSGM, frequency and duration |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes mellitus, vildagliptin, continuous glucose monitoring
Changes in Incretins Response and Glycemic Control After Gastric Bypass Surgery in Type 2 Diabetic Patients Versus Healthy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the early changes in gut hormonal, and other metabolites with known relations to the glycemic homeostasis. The study mainly focus on these responses to food in the diabetic patient, compared to the non-diabetic, after gastric bypass surgery. Also aiming for recording changes in the earliest postoperative phase.

Official Title
-----------------
Study of Incretins Response and Glycemic Control: Pre Diet, After Conventional Weight Loss and in the Early Postoperative Phase After Gastric Bypass in T2D-patients.

Conditions
-----------------
Type 2 Diabetes, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of type 2 diabetes obesity BMI >35 Exclusion Criteria: prior bariatric surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in incretines in the bariatric patient | standardized meals prior to pre op diet, day before surgery, first day after surgery and 6 weeks after surgery. | 2 months prior to surgery - 6 weeks post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes control | resolution of t2D as early as first day after surgery | 6 weeks post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, Bariatric surgery, incretines, GLP-1, GIP, gastric bypass, foregut, hindgut
Development of Clinical Method to Triclosan Retention in Plaque Following Brushing

Study Overview
=================
Brief Summary
-----------------
The objective is to develop a method to determine active ingredient uptake in oral care products.

Official Title
-----------------
Development of Clinical Method to Triclosan Retention in Plaque Following Brushing

Conditions
-----------------
Dental Plaque

Intervention / Treatment
-----------------
* Drug: Fluoride
* Drug: Fluoride and triclosan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female volunteer 18 - 65 years of age (inclusive). Good general health with a minimum of twenty (20) natural, uncrowned teeth (excluding third molars) Able and willing to sign the informed consent form. Plaque score of at least 1.5 on the modified Quigley-Hein plaque index. No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study Exclusion Criteria: Medical condition which requires pre-medication prior to dental procedures/visits Medical condition which precludes not eating/drinking for 2 hours Advanced periodontal disease (gum disease) 5 or more decayed, untreated dental sites (cavities) Diseases of the soft or hard oral tissues Orthodontic appliances Abnormal salivary function Use of drugs that can affect salivary flow Use of antibiotics one (1) month prior to or during this study Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen, naproxyn, etc) Pregnant or breastfeeding. Participation in another clinical study in the month preceding this study Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br>fluoride toothpaste from Thailand | Drug: Fluoride<br>* Brush half mouth once with assigned study treatment<br>|
| Active Comparator: B<br>fluoride/triclosan/copolymer toothpaste | Drug: Fluoride and triclosan<br>* Brush half mouth once with assigned study treatment<br>* Other names: Colgate Total toothpaste;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triclosan Concentration in Dental Plaque | Triclosan is analyzed by gas chromatography (GC) with Atomic Emission Detection (480 nm) and quantitated by determining the ration of the peak height of triclosan to the peak height of an internal standard and relating the result to corresponding ratios of calibration standards. | 12 hours |
Stroke Unit in the Philippines: Is it Effective

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the effectiveness of Stroke Unit in the Philippines by comparing the functional outcome between those patient admitted in the general neurology wards and stroke units using modified Rankin Scale

Detailed Description
-----------------
This study aims to look into functionality of patient admitted in the stroke unit in the Philippines

Official Title
-----------------
Stroke Unit in the Philippines: Is it Effective?

Conditions
-----------------
Acute Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive patients admitted in participating SUs starting June 2016 during acute stroke (within 7 days from onset), either hemorrhagic or ischemic stroke confirmed by CT-Scan or MRI, will be included Exclusion Criteria: Patient who had previous of stroke and secondary cause of intracerebral hemorrhage such as trauma, arteriovenous malformation and aneurysm are not included in the study. Those who transferred from other institutions will be excluded. And also, patients who are below 18 years old are excluded in the 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality Rate |  | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome in modified rankin scale |  | 3 and 6 months |
Correlation Between ΔPP/HR and ΔSV During Fluid Challenge.

Study Overview
=================
Brief Summary
-----------------
In high perioperative risk patients, guidelines suggest intraoperative haemodynamic optimization by measurement of stroke volume (SV) to guide fluid resucitation.This strategy requires an invasive monitoring and learning. Some studies tried to find SV surrogates based on haemodynamic usual parameters. In an experimental hemorrhagic shock, SV was correlated to the pulse pressure (PP) / heart rate (HR) ratio. The investigators hypothesized that SV variations (ΔSV) would be correlated to the PP/HR ratio variations (ΔPP / HR) during fluid challenge, and ΔPP / HR would be able to detect a ΔSV greater than 10%.

Official Title
-----------------
Correlation Between the Pulse Pressure / Heart Rate Ratio Variations and Stroke Volume Variations During Fluid Challenge.

Conditions
-----------------
Hypovolemia

Intervention / Treatment
-----------------
* Drug: fluid challenge of saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a suspected hypovolemia, based on clinical or paraclinical parameters. a fluid challenge decision at the discretion of the anaesthesiologist physician in charge of the patient. Exclusion Criteria: Minor or major patient under guardianship, oesophageal Diseases

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

| Intervention/Treatment |
| --- |
|Drug: fluid challenge of saline|250 ml of saline|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation by linear regression between variations of the ratio PP/HR ( in percentage) and variations of SV ( in percentage) during fluid challenge |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the receiver operating characteristic curve (AUC roc) of the ability of variations of the ratio PP/HR ( in percentage)during fluid challenge to predict an increase of SV greater than 10% |  | 18 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke volume, haemodynamic, fluid resucitation
Double-blind, Placebocontrolled A Randomized Trial on the Efficacy of Herbal Galactogogues

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effectiveness of a commercially available product containing a combination of Silybum marianum and Galega officinalis to support continuation or augmentation of breast milk production.

Official Title
-----------------
Efficacy of Herbal Galactogogues: a Double-blinded, Placebo-controlled Randomized Trial.

Conditions
-----------------
Breastfeeding

Intervention / Treatment
-----------------
* Dietary Supplement: Herbal galactagogue
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton, term delivery >2.5 kg newborn weight lactation-deficiency Exclusion Criteria: Neonatal Intensive Care Unit admission use of galactagogue drugs allergy

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>a placebo identical in appearance to the galactagogue product | Dietary Supplement: Placebo<br> <br> |
| No Intervention: No treatment<br>Usual care and breastfeeding support | |
| Experimental: Herbal galactagogue<br>A commercially available product containing a combination of Silybum marianum 400 mg and Galega officinalis 150 mg, once a day for 6 weeks | Dietary Supplement: Herbal galactagogue<br> <br> * Other names: Piùlatte® Plus (MILTE ITALIA SpA);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of mothers who exclusively breastfeed their child |  | At 6 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of breastfeeding (either exclusively or as a supplement to formula feeding ) |  | at 6 weeks and 3 months | 
| Volume (mL) and frequency (times a day) of formula |  | 6 weeks postpartum | 
| weight gain experienced by the newborns |  | 6 weeks postpartum | 
| serum prolactin level |  | at baseline and 6 weeks after treatment | 
| Rate of maternal allergic reactions and gastrointestinal side effects |  | 6 weeks postpartum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
herbs, galactagogues, breastfeeding, supplements, Silybum marianum, Galega officinalis