linjc16/ctgov huggingface dataset:
First-in-Human Exploratory Single Ascending Dose of GLPG0974

Study Overview
=================
Brief Summary
-----------------
The purpose of this exploratory first-in-human study is to evaluate the amount of GLPG0974 present in the blood (pharmacokinetics) after single oral doses of GLPG0974 given to healthy subjects. Furthermore, during the course of the study, safety and tolerability as well as the effects of GLPG0974 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized compared to placebo.

Official Title
-----------------
Exploratory Double-blind Placebo-controlled Study for the Assessment of Pharmacokinetics (PK), Safety, Tolerability, and Pharmacodynamics (PD) of Single Ascending Oral Doses of GLPG0974 in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: GLPG0974
* Drug: GLPG0974


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male, age 18-50 years BMI between 18-30 kg/m2 Exclusion Criteria: Any condition that might interfere with the procedures or tests in this study Drug or alcohol abuse Smoking

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLPG0974 oral solution<br>GLPG0974 oral solution | Drug: GLPG0974<br> <br> |
| Placebo Comparator: Placebo oral solution<br>Placebo oral solution | Drug: GLPG0974<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of GLPG0974 in plasma over time after a single oral dose | To characterize the amount of GLPG0974 in plasma over time - pharmacokinetics (PK) - after a single oral dose in healthy subjects |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | To evaluate the safety and tolerability of GLPG0974 in comparison with placebo after a single oral dose in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments |  | 
| Inhibition of CD11b on neutrophils in blood after a single oral dose of GLPG0974 | To characterize the pharmacodynamics (PD) of GLPG0974 by means of inhibition of expression of CD11b on neutrophils after a single oral dose in healthy subjects |  |
Efficiency of XAL-EASE Device in Glaucoma and/or Ocular Hypertension (OHT) Patients, Treated With Xalatan or Xalacom

Study Overview
=================
Brief Summary
-----------------
Xal-Ease is a novel Pfizer-Pharmacia device aimed to significantly facilitate the Xalatan/Xalacom instillation and to avoid loss of Xalatan/Xalacom eye drops due to incorrect instillation. Patients on Xalatan/Xalacom who have consumed more than one bottle per month within a year according to consumption data drawn from the Clalit Health Services database, will use the Xal-Ease device for a year. The device is expected to reduce consumption of bottles and result in saving money for both patients and medical care providers.

Conditions
-----------------
Glaucoma, Hypertension

Intervention / Treatment
-----------------
* Device: Xal-Ease


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with glaucoma or hypertension treated with Xalatan/Xalacom who have consumed more than one bottle per month within a year prior to initiation of the study. Exclusion Criteria: Patients younger than 18 years, Patients with severe manual disabilities, Patients with impaired cognition and mentality.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Xal-Ease|Xal-Ease device used to facilitate application of Xalatan/Xalacom eye drops.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumption of Xalatan/Xalacom bottles per year per patient. |  | 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating cost of Xalatan/Xalacom eye drops use per year with Xal-Ease |  | 12 months | 
| Characterizing the optimal conditions for proper usage of the Xal-Ease device |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug consumption, The Xal-Ease device, Patient's compliance, Using a novel Pfizer-Pharmacia device to facilitate the Xalatan/Xalacom instillation and to avoid loss of eye drops
Study of the Pharmacokinetics of Mycophenolate Mofetil in Patients Who Have Undergone Orthotopic Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the effects of bile externalization and antibiotic gut sterilization on the pharmacokinetics of mycophenolate mofetil in patients who have undergone orthotopic liver transplantation. II. Correlate serum concentrations of mycophenolic acid with inosine monophosphate dehydrogenase activity in these patients.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients begin a mycophenolate mofetil (MMF)-containing regimen within the first 5 days after transplantation. Patients have blood drawn on postoperative days 7, 21, 42, 70, 98, 126, and 154. Urine is collected on postoperative days 7, 21, and 42. Patients with T-tube bile externalization also have bile collected on postoperative day 7.

Official Title
-----------------
Study of the Pharmacokinetics of Mycophenolate Mofetil in Patients Who Have Undergone Orthotopic Liver Transplantation

Conditions
-----------------
Graft Versus Host Disease

Intervention / Treatment
-----------------
* Drug: mycophenolate mofetil


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Orthotopic liver or kidney transplant recipients who started on a mycophenolate mofetil-containing immunosuppressive regimen within 5 days after transplant Kidney transplant recipients will serve as study controls --Prior/Concurrent Therapy-- No concurrent bile acid sequestrants No mycophenolate mofetil as part of rescue therapy regimen No concurrent albumin replacement therapy --Patient Characteristics-- Renal: Urine output at least 500 mL/day OR Creatinine less than 2.5 mg/dL Other: Not pregnant No mental incompetency No prisoners or parolees HIV negative No active infection defined as: Temperature above 101 F with WBC greater than 12,000/mm3 and left shift OR Two or more positive cultures of a single isolated organism from blood, urine, or sputum

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

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: mycophenolate mofetil|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
-----------------
disease-related problem/condition, graft versus host disease, rare disease
Patient Characteristics in Advanced Renal Cell Carcinoma and Daily Practice Treatment With Nexavar

Study Overview
=================
Brief Summary
-----------------
Renal cell carcinoma accounts for roughly 3 % of all cancer. It is a rather aggressive cancer type, which means that patients who present with an advanced disease have a rather poor prognosis. When this study has been started the standard therapy for patients has been cytokines, which might be accompanied by significant toxicities or might fail the therapeutic goal. In these cases sorafenib can be a feasible therapeutic option. This non-interventional study has been created and is being conducted to collect clinical data on the patients' therapy with sorafenib in an everyday treatment schedule. The main goal of this study focuses on patient characteristics and tumor status in RCC treated with sorafenib as well as the treatment duration and safety of sorafenib under everyday treatment conditions.

Official Title
-----------------
Patient Characteristics in Advanced Renal Cell Carcinoma and Daily Practice Treatment With Nexavar

Conditions
-----------------
Carcinoma, Renal Cell, Carcinoma, Renal Cell (Advanced)

Intervention / Treatment
-----------------
* Drug: Nexavar (Sorafenib, BAY43-9006)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosis of advanced RCC and decision taken by the investigator to prescribe Sorafenib Exclusion Criteria: Exclusion criteria must be read in conjunction with the local product information

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 |
| --- | --- |
| Group 1<br> | Drug: Nexavar (Sorafenib, BAY43-9006)<br>* Patients with a diagnosis of advanced RCC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor status |  | After about 3, 6, 9 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment duration |  | At end of study after about 12 months | 
| Safety of sorafenib treatment |  | At every documented visit for about 12 months | 
| Progression-free survival |  | Calculation at end of study after about 12 months | 
| Status of Metastases |  | After about 3, 6, 9 and 12 months | 
| Performance status (ECOG) |  | After about 3, 6, 9 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced Renal Cell Carcinoma
Preliminary Study for Identification of Calcium-Binding Proteins in the Serum in Various Metabolic Bone Disorders

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the serum levels of certain calcium-binding proteins may be helpful in the diagnosis and management of metabolic bone diseases.

Detailed Description
-----------------
Osteoporosis is an important and costly health issue. The diagnosis of the disease is based on measurement of bone mineral density or the occurrence of characteristic fractures. Currently it is not possible to predict fractures in individual patients, and the ability to monitor the response to treatment is limited as well. We have synthesized and characterized a novel photoreactive Ca2+-analog reagent, Azido ruthenium (AzRu) that binds covalently to Ca2+-binding sites in proteins. The specificity of AzRu for Ca2+-binding proteins, its photoactivation and its radioactive labeling pave the way for a wide use of AzRu as a powerful tool to assess Ca2+-dependent cellular processes, both in vitro and in vivo. Using radiolabeled AzRu, it will be possible to identify Ca2+-binding proteins in a biological sample such as whole cell, isolated mitochondria, ER or other protein containing fractions. Protein bound [103Ru]AzRu in biological sample can be separated by SDS gel electrophoresis, followed by Coomassie staining and exposure of the dried gel to X-ray film (autoradiography). This allows the identification of the [103Ru] radiolabeled proteins. The labeled protein bands can be cut from the gel and subjected to MALADI-TOF analysis and the identity of the protein can be determined by a sequence homology search. These would allow detection of Ca2+-binding proteins in the serum of various diseases and disorders, potentially leading to identification of novel biomarkers for disease diagnostics. We would like to use blood samples to carry out the procedure described above for identification of Ca2+ binding proteins appearing or their level is increased in disease or under pathogenic conditions. Since Ca2+ binding proteins play an important role in bone metabolism, we chose to test their occurrence in the serum of patients with osteoporosis and other metabolic bone diseases.

Conditions
-----------------
Osteoporosis, Osteitis Deformans, Parathyroid Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of a metabolic bone disorder Exclusion Criteria: none

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 |
| --- | --- | --- |
Prevalence of Internet Addiction Among Adolescent

Study Overview
=================
Brief Summary
-----------------
Internet is now a tool available 24 hours a day, at a lower cost and accessible almost anywhere. Internet addiction could be defined as the inability to control one's Internet use and the continuation of this behavior despite the occurrence of negative consequences. Adolescence is a time of vulnerability to addiction, due to social and neurobiological factors.

Detailed Description
-----------------
The aim of the study is to evaluate prevalence of internet addiction among adolescent attending high school

Official Title
-----------------
Prevalence of Internet Addiction Among Adolescent

Conditions
-----------------
Internet Addiction

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adolescent attending high school agreeing to participate in the study Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 20 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 |
| --- | --- |
| Adolescent<br>adolescent attending high school | Other: Data collection<br>* evaluation of internet addiction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| internet addiction | Internet addiction evaluated using Compulsive Internet Use Scale (CIUS-9). CIUS-9 includes 9 items. Each item is coded from 0 to 4 points. The overall score ranges from 0 to 36 points. The higher the score, the more compulsive the internet behavior. A score greater than or equal to 18 defines an internet addiction. | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adolescent, Internet addiction, Prevalence
Imaging of Soft Tissues

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the potential importance of tissue elasticity in the assessment of soft tissues including muscles, tendons and ligaments and other soft tissue structures. The evaluation of tissue elasticity (easily stretched or moveable) may assist in assessment of various soft tissue structures, such as fatty atrophy of muscles, tendon/ligamentous injury and healing and other soft tissue structures.

Detailed Description
-----------------
This is a prospective study that will recruit males and females 18 years of age and older who present to the department for a clinically indicated ultrasound of a superficial soft tissue abnormality with prior or following MRI / CT assessment ordered for clinical purposes. The elasticity properties of tissues depend on their molecular building blocks and on the organization of these blocks. Injuries, disease etc are known to be associated with changes in tissue elasticity. Little research has been done on the potential of sonoelastographic (elasticity ultrasound imaging) assessment of normal, injured or healing muscles, tendons or ligaments. Elasticity changes in muscle, ligaments and tendons following injury may have implication on the choice of treatment and help in determine how the length of time needed to heal from an injury. Stiffness/elasticity of the tissue can be assessed by mechanical excitation with measurement of resultant tissue motion. Reconstruction of the elastic deformability (strain imaging) in real time ultrasound is known as sonoelastography. Elasticity ultrasound imaging will be performed on the area being evaluated clinically.

Official Title
-----------------
Elasticity Imaging of Soft Tissues

Conditions
-----------------
Soft Tissue Injury

Intervention / Treatment
-----------------
* Other: Ultrasound examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who present for a clinically ordered ultrasound for evaluation of a soft tissue abnormality. Exclusion Criteria: Women who are pregnant

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 |
| --- | --- |
| Evaluation of tissue elasticity<br>Evaluate the potential importance of tissue elasticity in the assessment soft tissue structures. | Other: Ultrasound examination<br>* Sonoelastrography is an ultrasound examination that can determine the elasticity of soft tissue. This examination takes approximately 10 minutes to complete.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the potential importance of Sonoelastography in evaluating tissue injury or abnormalities of soft tissues. |  | hours |
RCT of Evening Primrose Oil for the Treatment of Breastfeeding Pain

Study Overview
=================
Brief Summary
-----------------
Breastfeeding related mastalgia is a common post-partum complaint. We propose a double-blind, randomized, placebo-controlled trial that investigates the use of Evening Primrose Oil in the treatment of breastfeeding related mastalgia.

Official Title
-----------------
Evening Primrose Oil for the Treatment of Breastfeeding Related Mastalgia: A Randomized, Double Blinded, Placebo-Controlled Clinical Trial.

Conditions
-----------------
Breast Feeding

Intervention / Treatment
-----------------
* Dietary Supplement: Evening Primrose Oil
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: currently breastfeeding recent delivery within the trailing 60 days Exclusion Criteria: history of seizure disorder

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind, randomized, placebo-controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Evening Primrose Oil<br> | Dietary Supplement: Evening Primrose Oil<br>* botanical oil derivative from the seeds of Evening Primrose (Oenothera biennis),1,300 milligrams t.i.d.<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Pill<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding Related Mastalgia | Visual Pain Score | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Epistaxis, Change in perceived lochia flow. | 7 days |
Accuracy of a Blood Pressure Measuring Mobile Device in Volunteers

Study Overview
=================
Brief Summary
-----------------
The accuracy and safety of blood pressure module of new mobile device (M- HEALTHCARE device) is evaluated according to Korean FDA guidelines in 100 healthy volunteers.

Official Title
-----------------
M- HEALTHCARE Confirmatory Clinical Trials Used for Measurement of the ABP for the Accuracy and Safety Assessment of the Module Measuring Blood Pressure

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Device: blood pressure check


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants whose systolic blood pressure <=110 should be at least 10% of whole cohort Participants whose systolic blood pressure >=160 should be at least 10% of whole cohort Participants whose diastolic blood pressure >=100 should be at least 10% of whole cohort Participants whose diastolic blood pressure <=70 should be at least 10% of whole cohort Participants whose arm circumference are between 20cm and 30cm should be 25 - 50% of whole cohort Participants whose arm circumference are between 30cm and 40cm should be 50 - 75% of whole cohort Exclusion Criteria: heart disease with abnormal rhythm peripheral vascular anomaly or disease inadequate to be applied blood pressure cuff (e.g. trauma on arm) pregnant or lactating women

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXPERIMENTAL<br>Blood pressure check using mobile device and control device | Device: blood pressure check<br>* Check blood pressure using new device and conventional device alternatively. Compare blood pressure measured with new device and conventional device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean difference of systolic blood pressure | mean difference of blood pressure between new and control device | 1 day at visit 2 | 
| mean difference of diastolic blood pressure | mean difference of diastolic blood pressure between new and control device | 1 day at visit 2 | 
| standard deviation of the difference of systolic blood pressure | standard deviation of the difference of systolic blood pressure between new and control device | 1 day at visit 2 | 
| standard deviation of the difference of diastolic blood pressure | standard deviation of the difference of diastolic blood pressure between new and control device | 1 day at visit 2 |