linjc16/ctgov huggingface dataset:
Pharmacokinetics of Tacrolimus in Kidney Transplant Recipients: Once Daily Versus Twice Daily Dosing

Study Overview
=================
Brief Summary
-----------------
Tacrolimus is a medication given to transplant patients to help prevent rejection. The purpose of this study is to see if tacrolimus can be taken once a day instead of twice a day in kidney transplant patients. Transplant patients are required to take several medications to prevent rejection and to treat complications after their transplantation. Because of the complicated dosing schedule, it can be difficult for patients to follow their medication schedule. Taking fewer medications less frequently may help transplant patients to better manage their drug therapy. Tacrolimus is better absorbed in the body if it is taken in the morning than if it is taken in the evening. This suggests that tacrolimus can be taken once every morning instead of twice daily in order to produce appropriate drug exposure to prevent organ rejection without increased side effects.

Official Title
-----------------
Pharmacokinetics of Tacrolimus in Kidney Transplant Recipients: Once Daily Versus Twice Daily Dosing

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) Kidney transplant recipients (18 years or older) at Washington University/Barnes Hospital taking tacrolimus-based immunosuppression; 2) Stable kidney transplant recipients (>6 months post-transplantation, serum creatinine < 2 ml/dL, no history of rejection); 3) Stable immunosuppression (therapeutic tacrolimus concentrations, no change in tacrolimus dose within one month prior to the study); 4) Subjects must agree to abstain from alcohol and caffeine for 48 hours prior to the pharmacokinetics studies. Exclusion Criteria: 1) Pregnant women or nursing mothers; 2) Patients unwilling or unable to comply with the protocol; 3) Significant liver impairment (AST or ALT > 2 x upper limit of normal, or total bilirubin > upper limit of normal); 4) Anemia: Hematocrit < 30%; 5) Use of concomitant P450 3A4/p-glycoprotein inducers or inhibitors; 6) Current smoking; 7) Patients with diabetes mellitus

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
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Citicoline as Neuroprotector in Neonates Exposed to Hypoxia

Study Overview
=================
Brief Summary
-----------------
Citicoline as neuroprotector in neonates exposed to hypoxia: A randomized controlled trial

Detailed Description
-----------------
Efficacy of Citicoline as neuroprotector in neonates exposed to hypoxia: A randomized controlled trial

Official Title
-----------------
Efficacy of Citicoline as Neuroprotector in Neonates Exposed to Hypoxia: A Randomized Controlled Trial

Conditions
-----------------
Neonatal Hypoxia

Intervention / Treatment
-----------------
* Drug: Citicoline
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: neonates with hypoxia. Exclusion Criteria: hypoxic ischemic encephalopathy

Ages Eligible for Study
-----------------
Maximum Age: 1 Month

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 |
| --- | --- |
| Experimental: Citacoline<br>Citacoline as neuroprotector | Drug: Citicoline<br>* Citacoline as neuroprotector<br>* Other names: citacoline;|
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br>* placebo group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of seizures |  | 6 months |
Seminal Fluid's Changes Over 20 Years

Study Overview
=================
Brief Summary
-----------------
This is a cohort study including all the first seminal exams performed at the Fertility Center, Humanitas Research Hospital (Rozzano, Milan) between January 1998 and December 2018.

Detailed Description
-----------------
The objective of this study is to evaluate retrospectively different changes of TPMSC during last 20 years in male population who underwent a seminal exam in our Center

Official Title
-----------------
Seminal Fluid's Changes Over Time: a Single Center 20 Years Experience

Conditions
-----------------
Oligospermia

Intervention / Treatment
-----------------
* Diagnostic Test: sperm count


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male over 18 years old Exclusion Criteria: error in birth or exam date or age under 18, abstinence days < 3 or > 6, volume missing o > 10 ml, spermatozoa number/ ml missing o >220 x106, normal forms missing, progressive motility missing

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| sperm count over time<br>observation | Diagnostic Test: sperm count<br>* total progressive sperm motile count<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mesaurement of changes of sperm count over time | The objective of this study is to evaluate retrospectively different changes of TPMSC during last 20 years in male population who underwent a seminal exam in a tertial fertility care center, regardless of infertility diagnosis. | 20 years |
Prolactin Hormone in Rheumatoid Arthritis Patients With Periodontitis

Study Overview
=================
Brief Summary
-----------------
In this study we will assess the presence of prolactin hormone in the gingival crevicular fluid , and synovial fluid of patient with rheumatoid arthritis and periodontitis

Official Title
-----------------
Synovial and Gingival Crevicular Fluid Levels of Prolactin Hormone in Rheumatoid Arthritis Patients With Periodontitis

Conditions
-----------------
Rheumatoid Arthritis, Periodontitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: for first group patients with active rheumatoid arthritis with periodontitis. second group , patients with periodontitis and otherwise systemically healthy third group, systemically and periodontallly healthy subjects Exclusion Criteria: smokers, pregnant or lactating females patients taking medications the affects levels of prolactin hormone. no periodontal treatment in the past six months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| periodontitis and rheumatoid arthritis<br>group 1: patiernts with periodontitis and rheumatoid arthritis. only | |
| periodontitis<br>group 2: patiernts with periodontitis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prolactin hormone levels in the tested media | changes in prolactin hormone expression in the tested media | 24 hours |
The Epigenetics of Exercise and Physical Activity in COPD

Study Overview
=================
Brief Summary
-----------------
This study seeks to examine genome-wide DNA methylation patterns associated with physical activity and exercise capacity from peripheral blood collected from participants with chronic obstructive pulmonary disease (COPD) before and after participation in a structured 9-week outpatient pulmonary rehabilitation program.

Detailed Description
-----------------
Individuals who are referred to pulmonary rehabilitation IN THE COURSE OF THEIR USUAL CLINICAL CARE will be invited to participate in this observational study. Participants who enroll in the study will undergo two in-person visits, once before initiating pulmonary rehabilitation classes and once at the conclusion of pulmonary rehabilitation classes. Participation in this study will not alter the course of the participants' usual clinical care.

Official Title
-----------------
The Epigenetics of Exercise and Physical Activity in COPD

Conditions
-----------------
Copd

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >40 years Diagnosis of COPD (defined as an FEV1/FVC<0.7 or evidence of emphysema on radiologist's read of a chest CT obtained in the course of patient's usual care) Referral to and participation in the VA Boston Pulmonary Rehabilitation program Exclusion Criteria: Active or unstable cardiac disease Inability to ambulate > 1 block Recent acute exacerbation of COPD (defined as new or increased dose of systemic steroids and/or antibiotics for pulmonary indications)

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| Change in DNA methylation patterns | Baseline patterns and changes over time after participation in exercise training | Baseline and 3-month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6MWD | Change in exercise capacity (assessed as 6 minute walk distance) after exercise training in pulmonary rehabilitation | Baseline and 3-month follow up | 
| Change in average daily step count | Change in pedometer assessed daily step count before and after exercise training in pulmonary rehabilitation | Baseline and 3-month follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DNA methylation, Physical activity, Exercise capacity
Retrospective Study Assessing Molecular Features Predicting Response to Cetuximab

Study Overview
=================
Brief Summary
-----------------
The primary objective is to identify molecular features predicting response or resistance to cetuximab

Detailed Description
-----------------
Secondary objective is to investigate association of genomic status of EGFR and HER-2 genes with clinical outcome, including objective response, time to progression and survival

Official Title
-----------------
Retrospective Study Assessing Molecular Features Predicting Response or Resistance to Cetuximab Therapy in Metastatic Colorectal Cancer Patients

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

Intervention / Treatment
-----------------
* Genetic: Gene mutations analysis and FISH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed diagnosis of colorectal cancer with available tumor tissue and clinical data; presence of at least one measurable lesion. Exclusion Criteria: Less than 3 weeks after completion of previous radiotherapy

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>Colorectal cancer patients | Genetic: Gene mutations analysis and FISH<br>* FISH and mutation analysis of multiple genes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of different biomarkers with Cetuximab sensitivity |  | Assessment every two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of different biomarkers with time to progression and survival |  | At the end of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EGFR, KRAS, BRAF, MET, IGFR1
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy of visilizumab at 5 mcg/kg/day administered intravenously (IV) on Days 1 and 2 to placebo in subjects with IVSR-UC.

Official Title
-----------------
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis

Conditions
-----------------
Intravenous Steroid-Refractory Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: Visilizumab (HuM291; Nuvion®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females, 18 years of age or older. Diagnosis of UC verified by endoscopy within 60 months prior to consent.

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: Visilizumab (HuM291; Nuvion®)|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
-----------------
Ulcerative Colitis, UC, Intravenous Steroid-Refractory Ulcerative Colitis, IVSR-UC
Growth Pattern and Characteristics of Cardiac Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
Congenital heart disease (CHD) is the most common congenital anomaly in the body, affecting about 8 per 1000children. cardiovascular disorders are the most debilitating and one of causes of organic growth disorders in children.Malnutrition is a constant phenomenon among children with CHD. The degree and type of malnutrition may be related to characteristics of the CHD, including presence of cyanosis, congestive heart failure (CHF), or pulmonary hypertension (PHTN).

Detailed Description
-----------------
At birth, the weight and length of children with CHD are close to normal and APGAR scores are generally high. Cyanotic patients are affected in growth, depending on the severity of tissue hypoxemia and on the degree of physiological variation. Mostly acute malnutrition occurs in a cyanotic heart disease but chronic malnutrition occurs in cyanotic lesions. The severity of malnutrition variety from mild under nutrition to failure to thrive. impairing growth and increasing post-operative morbidity and mortality. Early rapid growth retardation detection in early age and improved nutritional status have the potential to reduce cardiac impact on growth and feeding. Insure appropriate nutrition in those patients by the two main methods (enteral and parenteral) help in better outcome

Official Title
-----------------
Growth Pattern and Characteristics of Cardiac Pediatric Patients Attending Assiut University Children Hospital and Sidi Galal Health Insurance Clinic

Conditions
-----------------
Growth Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 0-4 years old Male and female, diagnosed as cardiac diseased children Exclusion Criteria: children more than 4 years old not genetic disorder as down syndrome This is a descriptive study.

Ages Eligible for Study
-----------------
Maximum Age: 4 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 |
| --- | --- | --- |
| Study the pattern of growth in infant and children with heart diseases. | By measurement of : Weight in (Kg)and height in (m) will be combined to report BMI in kg/m^2). Measure mid arm circumference in (cm) & head circumference in(cm) | through study completion, an average of 1 year. |
Anxiety Level of Child and Parents During Preoperative Anesthesia Evaluation

Study Overview
=================
Brief Summary
-----------------
Appreciation of preoperative anxiety in children is important for the anesthesiologist. Several factors defined to effect the anxiety levels preoperatively in children such as , age, previous medical encounters , education level and parental anxiety. 3. This information was tested for Turkish children during the preoperative anesthetic evaluation.

Detailed Description
-----------------
Before the planned surgery all children accompanying parents filled a questionnaire about the demographics, marital status, economical conditions, education level and other diseases and operations in the family. Both the parent and child filled State and Trait Anxiety tests specially prepared for adults Spielberger Anxiety tests and children defined and validation tests had already been proven. Statistical analysis performed for evaluation.

Official Title
-----------------
Anxiety Level of Child and Parents During Preoperative Anesthesia Evaluation

Conditions
-----------------
Anxiety State, Parent, Child

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Legible Exclusion Criteria: Illegible due to lack of education or eye diseases

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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 |
| --- | --- |
| parents and children<br>Anxiety tests | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| children state anxiety | Anxiety scores were filled within 1 hour no further evalution was performed. | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anxiety, preoperative
Diaphragm-sparing Nerve Blocks for Shoulder Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The combination of a modified lateral sagittal infraclavicular block and a suprascapular nerve block has not been studied in a cohort of total arthroplasty patients. Such diaphragm-sparing nerve blocks for shoulder arthroplasty may provide a very good anesthetic alternative in lung diseased patients who are in need for total arthroplasty of the shoulder.

Detailed Description
-----------------
The investigators hypothesized that a combination of suprascapular nerve block and lateral sagittal infraclavicular block of the posterior and lateral cords would provide good postoperative analgesia for patients undergoing shoulder arthroplasty. The primary aims of this study were to document numeric rating scale (NRS, 0-10) and use of morphine equivalents during the first 24 hours after surgery. Secondary aims were to determine the incidence of diaphragm paresis 30 minutes after the block and to quantify postoperative hand grip force at 1 hr.

Official Title
-----------------
Diaphragm-sparing Nerve Blocks for Shoulder Arthroplasty: an Exploratory Feasibility Study

Conditions
-----------------
Shoulder Disease

Intervention / Treatment
-----------------
* Procedure: Peripheral nerve blocks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-78 years old, BMI 20-35 kg.m-2 ASA physical status 1-3 Exclusion Criteria: unable to consent, pregnancy, pre-existing severe respiratory disease, use of anticoagulation drugs other than acetylsalicylic acid or dipyridamol, allergy to local anaesthetics, patients on regular opioids, atrioventricular block, peripheral neuropathy.

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ropivacaine<br>SSNB will be performed with 4 ml ropivacaine 5 mg/ml LSIB will be performed With 15 ml ropivacaine 7.5 mg/ml | Procedure: Peripheral nerve blocks<br>* LSIB + SSNB<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS | Pain on a 0-10 scale where 0=no pain and 10=unbearable pain | Postoperatively at 1 hour | 
| The incidence ipsilateral hemidiaphragmatic paralysis after 30 minutes | Hemidiaphragmatic paralysis was defined as the absence of diaphragmatic motion during normal respiration, coupled with absent or (paradoxical) cranial diaphragmatic movement when the patient forcefully sniffed. | 30 minutes after the blocks |