linjc16/ctgov huggingface dataset:
Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Daily Dosing)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine whether paricalcitol is safe and effective compared to placebo in reducing elevated serum PTH levels in patients with chronic kidney disease.

Official Title
-----------------
Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Daily Dosing)

Conditions
-----------------
Renal Insufficiency, Chronic

Intervention / Treatment
-----------------
* Drug: paricalcitol capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Under care of physician at least 2 months (for CKD) Not on active Vitamin D therapy for at least 4 weeks prior If female: Not of childbearing potential, OR, Practicing birth control Not breastfeeding If taking phosphate binders, on a stable regimen at least 4 weeks prior For entry into Pretreatment Phase: iPTH at least 120 pg/mL GFR of 15-60 mL/min and no dialysis expected for at least 6 months For entry into Treatment Phase: Average of 2 consecutive iPTH values of at least 150 pg/mL, taken at least 1 day apart (all values not less than 120 pg/mL_ 2 consecutive corrected serum calcium levels between 8.0-10.0 mg/dL 2 consecutive serum phosphorus levels of not more than 5.2 mg/mL Exclusion Criteria: History of allergic reaction or sensitivity to similar drugs Acute Renal Failure within 12 weeks of study Chronic gastrointestinal disease Spot urine result demonstrating a urine-calcium-to-urine creatinine ratio of greater than 0,2, or a history of renal stones Taken aluminum-containing phosphate binders within last 12 weeks, or requires such medication for more than 3 weeks during study Current malignancy, or clinically significant liver disease Active granulomatous disease (TB, sarcoidosis, etc.) History of drug or alcohol abuse within 6 months prior Evidence of poor compliance with diet or medication Received any investigational drug or participated in any device trial within 30 days prior Taking maintenance calcitonin, bisphosphonates, or drugs that may affect calcium or bone metabolism (other than females on stable estrogen and/or progestin therapy) On glucocorticoids for a period of more than 14 days within the last 6 months HIV positive

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: paricalcitol capsule|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline in iPTH levels |  |  |
Maternal and Infant Cord Blood Monosaccharide Content

Study Overview
=================
Brief Summary
-----------------
Mother's breast milk provides many benefits to babies with regard to development and improved health. We believe the simple sugars which make up these complex sugars in breast milk and are also found in the brain may be critical to normal brain development in term and preterm infants. Babies are exposed to these sugars by placental transport during pregnancy and through mother's breast milk after they are born. For the preterm infant, we do not know if breast milk gives enough of these sugars compared to what the baby gets during pregnancy. A maternal blood sample and blood samples from the baby's umbilical cord will provide us with background information for developing a supplement of special sugars that can be added to infant formulas to provide the amount that the baby usually gets during pregnancy and from breast milk.

Official Title
-----------------
Comparison of Monosaccharide Content of Maternal and Umbilical Venous Cord Blood in Term and Preterm Pregnancies

Conditions
-----------------
Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy mothers with ages ranging from 18 to 35 yrs Delivered infants appropriate weight for gestational age (between 10% and 90%) Exclusion Criteria: Maternal history of smoking, alcohol or drug use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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 |
| --- | --- |
| 30-33 weeks<br>mother infant pairs with gestation of 30-33 weeks | |
| 34-37 weeks<br>mother infant pairs with gestation of 34-37 weeks | |
| 38-42 weeks<br>mother infant pairs with gestation of 38-42 weeks | |

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
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Breastfeeding, Infant, Preterm, Nutrition
Impact of Symbiotic Administration on Intestinal Function of Head and Neck Patients Surgically Treated

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the symbiotic use in patients with head and neck cancer impact on intestinal function after surgical treatment.

Detailed Description
-----------------
The study will be conducted offering the patients symbiotic product twice a day for seven days after the surgical treatment. Patients will be monitored for the number of stools, stools consistency, abdominal pain and gas overproduction.

Official Title
-----------------
Intestinal Function of Patients With Uper Air and Digestive Neoplasia Submitted to Surgical Treatment: Symbiotic Use Impact

Conditions
-----------------
Head and Neck Cancer, Synbiotics, Nutrition Therapy

Intervention / Treatment
-----------------
* Dietary Supplement: Symbiotic
* Dietary Supplement: Maltodextrin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: head and neck cancer with primary surgical treatment, enteral nutrition by enteral tube. Exclusion Criteria: three months antibiotic use earlier the surgery, recently radiotherapy or quimiotherapy, inflammatory bowel 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Symbiotic<br>Patients will receive the symbiotic product LactoFos twice a day during seven days after surgical treatment. The intervention consists of giving twice a day a sachet of 6g of symbiotic diluted in 20mL of water via nasoenteric tube for seven days, totaling the administration of 14 sachets per intervention. | Dietary Supplement: Symbiotic<br>* Intervention will consist of the adminitration of symbiotic product twice a day during seven days after surgical treatment<br>* Other names: LactoFos;|
| Placebo Comparator: Maltodextrin<br>Patients will receive 6g of maltodextrin twice a day during seven days after surgical treatment. | Dietary Supplement: Maltodextrin<br>* Intervention will consist of the adminitration of placebo product twice a day during seven days after surgical treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum DAO Enzyme Concentration | The intestinal permeability using serum DAO enzyme concentration (ng/mL) was determined by sandwich enzyme-linked immunosorbent assay (ELISA) kit (SEA656Hu), according to Cloud-Clone Corporation® (Huston, TX) specifications. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection Rate | According to Dindo et al, 2004 | 7 days |
Comparison of the Management of Post-prandial Hyperglycemia by Multiple Bolus Calculators

Study Overview
=================
Brief Summary
-----------------
This prospective, non-randomized, non-controlled, interventional study will determine whether the Roche automated bolus caclulator (ABC) reduces post-meal hyperglycemia better than the competitor's ABC without causing significant hypoglycemia.

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

Intervention / Treatment
-----------------
* Device: Accu-Chek Combo Kit mg DE/de


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects >/= 18 years at screening Type 1 diabetics currently using an insulin pump for management of their diabetes and have been on a pump for at least at least 6 months prior to the screening visit Subjects have to use a fast acting analog insulin HbA1c = 9% (measured with DCA 2000) Willing to perform periods of intensive blood glucose (BG) monitoring for up to 21 days prior to the study ( 10 tests per day) with skipped meals and testmeals Willing to use the 3 different bolus calculators during the course of the study Willing to undergo planned hyperglycemia Willing to perform high frequency BG monitoring (> 20 / day) during the experiment Exclusion Criteria: Type 2 Diabetes Manifest severe late complications of diabetes (e.g. severe macro- or microangiopathy, severe neuropathy, severe retinopathy and/or severe nephropathy) Current addiction to alcohol or substances of abuse Pregnant or lactating women Any known life-threatening disease

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Device: Accu-Chek Combo Kit mg DE/de<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the difference between the self-monitoring blood glucose (SMBG) value achieved at 6 hours after meals with induced post-prandial hyperglycemia and the mean target value of 110 mg/dL. Target post-prandial range is 80-140 mg/dL. |  | 6 hours after meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the absolute difference between the SMBG value and the target value between the calculators |  | 6 hours after meal | 
| To compare theto compare the relative difference (multiplied by 100) between the SMBG value and the target value between the calculators |  | 6 hours after meal | 
| To compare the absolute relative difference (RAD, multiplied by 100) between the SMBG value and the target value between the calculators |  | 6 hours after meal |
Increase Surveillance for Wellness Decisions, Also to Determine Targeted Risk-reducing and Preventative Strategies

Study Overview
=================
Brief Summary
-----------------
Healthcare Decisions Post-Testing On Risk Reducing, and Preventative Strategies Utilizing Wellness Lab Tests

Detailed Description
-----------------
The general design of this study is collecting data and reviewing the Principal Investigators' Standard Operating Procedures on wellness testing and changes made to their specific SOP.

Official Title
-----------------
Medical Provider Experience and Assessment On Healthcare Decisions Post-Testing On Risk Reducing, and Preventative Strategies Utilizing Wellness Lab Tests

Conditions
-----------------
Overall Wellness

Intervention / Treatment
-----------------
* Other: overall wellness


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be a Medical Practitioner Medical Doctor (MD) Doctor of Osteopathic (DO) Physician Assistant (PA) Advanced Practice Registered Nurse (APRN) Nurse Practitioner (NP) Must have a current standard operating procedure that includes obtaining/reviewing medical history and family medical history. Exclusion Criteria: Government-funded insurance data cannot be included in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: overall wellness|Wellness lab testing|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provider Structures and Processes | Plan of Care Changes due to Wellness testing. Provider based observational survey system on the health and well-being of patients and populations | 36 months |
Dose-escalation Trial of Anti-C5aR Antibody in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to develop a complement system targeted monoclonal antibody (mAb) to be used in treatment of subjects with chronic autoimmune diseases.

Official Title
-----------------
A Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Trial of Anti-C5aR Antibody (NNC 0151-0000-0000) Administered by i.v. Infusion or s.c. Injection in Healthy Subjects.

Conditions
-----------------
Inflammation, Systemic Lupus Erythematosus, Rheumatoid Arthritis, Healthy

Intervention / Treatment
-----------------
* Drug: NNC 0151-0000-0000
* Drug: NNC 0151-0000-0000
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent obtained before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject) Body weight (BW) below or equal to 110.0 kg Body Mass Index (BMI) 20.0 - 27.0 kg/m^2, both inclusive Good state of health: evidenced by medical history, physical examination and results of laboratory examinations Exclusion Criteria: History of known or suspected cardiovascular diseases including: supine systolic blood pressure (BP) above or equal to 140 mmHg or below 90 mm Hg, diastolic BP above oe equal to 90 mm Hg or below 40 mm Hg, heart rate (HR) in supine position above 100 beats/minute or below 45 beats/minute Hepatic insufficiency: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above Upper Limit of Normal (ULN) (retesting is permitted within one week if first test is elevated but below 1.5 fold ULN) Renal insufficiency: Serum creatinine above ULN Positive for humane immunodeficiency virus (HIV) (by test) Positive for hepatitis B (HBV) or hepatitis C (HCV) (by test)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

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: NNC 0151-0000-0000 i.v.<br>Dose escalation trial | Drug: NNC 0151-0000-0000<br>* A single dose (SD), administrated i.v. (intravenous) at 8 dose levels.<br>|
| Experimental: NNC 0151-0000-0000 s.c.<br>Dose escalation trial | Drug: NNC 0151-0000-0000<br>* A single dose (SD), administrated s.c. (subcutaneously) at 7 dose levels<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* A single dose (SD), administrated i.v. (intravenous) or s.c. (subcutaneously).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs) |  | Week 0-10 |
Fimasartan on Hypertensive Cardiac Disease With Left Ventricular Hypertrophy Estimated by ECG

Study Overview
=================
Brief Summary
-----------------
Assess the efficacy of fimasartan on left ventricular hypertrophy in hypertensive patients

Detailed Description
-----------------
Patients who were diagnosed with left ventricular hypertrophy (LVH) by ECG at the start of the study are followed up at 3-month intervals for 1 year. Increase Fimasartan if blood pressure is not controlled.

Official Title
-----------------
Angiotensin Blocking Effect of Fimasartan on Hypertensive Cardiac Disease With Left Ventricular Hypertrophy Estimated by ECG: a Prospective, Multicenter, Observational Registry

Conditions
-----------------
Left Ventricular Hypertrophy, Hypertension

Intervention / Treatment
-----------------
* Drug: Fimasartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have been treated or not treated with hypertension from 20 to 80 years of age Patients with electrocardiographic left ventricular hypertrophy (In this study, we define left ventricular hypertrophy if one of the following two criteria is met) RaVL+SV3 > 20mm(M). 16mm(F) SV1+RV5 or RV6 > 35mm. Patients who are taking or expecting Fimasartan Exclusion Criteria: Patients with unstable angina or myocardial infarction within 3 months Patients with clinically significant severe valve disease, congenital heart disease, peripheral vascular disease, cerebrovascular disease Clinically significant severe congestive heart failure patients Patients with renal dialysis Clinically significant renal disease patients Patients with clinically significant hepatic impairment Patients with a history of alcohol or substance abuse Patients with hypersensitivity to angiotensin-receptor blocker Patients needing angiotensin-receptor blocker drugs other than fimasartan For women, pregnancy, Patients who are breastfeeding or planning to become pregnant A person who is determined to be inappropriate by the Investigator Patients participating in other clinical trials

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- |
|Drug: Fimasartan|Fimasartan is a non-peptide angiotensin II receptor antagonist (ARB) used for the treatment of hypertension and heart failure.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in systolic and diastolic blood pressure, left ventricular hypertrophy in ECG (composite). | Measurements of changes in baseline at 12 months (change in systolic and diastolic blood pressure, left ventricular hypertrophy in ECG) | 1 year |
A Pilot Study to Explore the Role of Gut Flora in Lupus

Study Overview
=================
Brief Summary
-----------------
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Detailed Description
-----------------
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to Lupus.

Official Title
-----------------
A Pilot Study to Explore the Role of Gut Flora in Lupus

Conditions
-----------------
Lupus Erythematosus, Lupus Erythematosus, Systemic

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent Male or female of all ages. (interest is given to children who present with autism or Crohn's and whose parents wish to analyze their children's gut flora. Also of interest analysis of development of the child's microbiome. In the case of autism, the younger the child, the better to correct the neurological problems if an association is found between autism and the microbiome) Diagnosis of Lupus by a physician Exclusion Criteria: Refusal to sign informed consent form History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. Postoperative stoma, ostomy, or ileoanal pouch Participation in any experimental drug protocol within the past 12 weeks Treatment with total parenteral nutrition
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Lupus<br>Patients who have been diagnosed with Lupus | Other: No Intervention<br>* There is no intervention for this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing | Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized with Lupus | Three years |