linjc16/ctgov huggingface dataset:
Study Of SB-497115 in Healthy Subjects and Subjects With Mild, Moderate or Severe Renal Impairment

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to compare how one 50 mg tablet of SB-497115 is broken down in the body by healthy subjects versus subjects with mild, moderate or severe kidney problems. The study is also being done to 1) check on how well the study drug is tolerated by healthy subjects versus those with liver problems and 2) to check if liver impairment affects how the study drug binds to protein in the blood.

Official Title
-----------------
An Open-Label, Non-Randomized Pharmacokinetic and Safety Study of a Single Oral Dose of 50 mg Eltrombopag in Healthy Subjects and in Subjects With Mild, Moderate, or Severe Renal Impairment

Conditions
-----------------
Purpura, Thrombocytopaenic, Idiopathic

Intervention / Treatment
-----------------
* Drug: eltrombopag


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy or have renal impairment Females (the following requirement applies only if able to have children): agree to doctor approved birth control methods, or partner has had a vasectomy Negative drug, alcohol, and HIV tests. Exclusion Criteria: Taking a medication or therapy not approved by the study doctor Rapidly changing kidney function Drug or alcohol abuse within past 6 months Used an investigational drug in the past 30 days Females who are pregnant or nursing Have active hepatitis B or C

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eltrombopag<br>Eltrombopag 50 mg oral (single dose) | Drug: eltrombopag<br>* eltrombopag 50 mg oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels and protein binding of eltrombopag | plasma levels/protein binding for eltrombopag | at Day 1 to Day 6. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be assessed by: -eye exam | eye exam safety findings | at Screening, Day -1, & followup | 
| adverse assessment | Adverse event review | Day 1 to followup | 
| clinical labs, vital signs, & 12-lead electrocardiograms done | Clinical labs, vital signs and 12 lead electrocardiograms | all days but Day 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal Impairment,, chronic immune thrombocytopenia purpura,, thrombocytopenia,, chemotherapy induced thrombocytopenia
Efficacy of Ultrasound in Evaluating Occult Fractures

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to examine the efficacy and accuracy of Ultrasound in evaluating occult fractures. We want to examine it on children that suffer from suspected fractures of the foot and ankle and the results of the x-ray are either negative or inconclusive.

Official Title
-----------------
The Efficacy of Ultrasound in Evaluating Fractures in the Ankle and Foot in Children When the X-Ray Does Not Demonstrate Fractures.

Conditions
-----------------
Fractures, Occult

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: boys and girls aged <=15 years suspected fracture of the wrist or ankle (no later than one week after the injury) negative or inconclusive x-ray Exclusion Criteria: unwillingness to sign informed consent

Ages Eligible for Study
-----------------
Maximum Age: 15 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
suspected fractures in the ankle and wrist
Myeloid-derived Suppressor Cells in Sepsis

Study Overview
=================
Brief Summary
-----------------
This study is designed for septic patients, to isolate MDSCs and the correlation of prognosis of sepsis. The purpose of this study hopes to explore the phenomenon and possible mechanisms of MDSCs in patients with severe sepsis.

Official Title
-----------------
The Roles of MDSCs (Myeloid-derived Suppressor Cells) in Adult Patients With Sepsis.

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have known origin of infection . Systemic inflammatory response syndrome. Exclusion Criteria: age less than 18 years pregnancy known anaphylactoid reaction to colloid fluids a life expectancy less than 24 hours, inability to provide informed, written consent Patients receiving nephrotoxic drugs, admitted to the hospital following a surgical procedure, sepsis more than 72 hours when screening .

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Intensive care unit (ICU) patients with sepsis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of Intensive care unit (ICU) stay |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In hospital survival |  | 90 days |
Dynamic Imaging of the Subtalar Instability

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe normal dynamic computed tomography anatomy of hind foot in inversion/eversion movement, and to define diagnostic criteria for subtalar instability.

Detailed Description
-----------------
Dynamic CT (Aquilion One Toshiba) of the ankle during inversion and eversion movement will be performed in patients from three groups: healthy volunteers, patients with subtalar arthritis, and patients with suspicion of subtalar instability.

Official Title
-----------------
Evaluation of Dynamic Computed Tomography Anatomy of Ankle in Inversion / Eversion Mouvement in Subtalar Instability.

Conditions
-----------------
Subtalar Arthritis, Subtalar Instability

Intervention / Treatment
-----------------
* Other: Dynamic CT of the ankle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Group Instability: suspicion of subtalar instability Group Arhtritis: subtalar stiffness Group Healthy volunteers: healthy volunteers conscious and cooperating written consent obtained after oral and written clear and intelligible information no pregnancy Exclusion Criteria: pregnancy unable to understand information about this study unable to understand the movement of inversion / eversion of ankle absence of affiliation to social security

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy volunteers<br> | Other: Dynamic CT of the ankle<br>* during inversion and eversion mouvement, with Aquilion One Toshiba scanner<br>|
| Experimental: Arthritis<br> | Other: Dynamic CT of the ankle<br>* during inversion and eversion mouvement, with Aquilion One Toshiba scanner<br>|
| Experimental: Instability<br> | Other: Dynamic CT of the ankle<br>* during inversion and eversion mouvement, with Aquilion One Toshiba scanner<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Talocalcaneal angle |  | baseline | 
| Maximum exposed distance on superolateral surface of calcaneum |  | baseline | 
| Minimum distance between sustentaculum tali and talus posteromedial tubercle |  | baseline | 
| Maximum distance between sustentaculum tali and talus posteromedial tubercle |  | baseline | 
| Maximum anterolateral talocalcaneal distance |  | baseline | 
| Maximum posterolateral talocalcaneal distance |  | baseline | 
| Minimum posterolateral talocalcaneal distance |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subtalar arthritis, Subtalar instability
iStent Inject in OAG Subjects on 2 Pre-op Topical Ocular Hypotensive Medications

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications.

Detailed Description
-----------------
The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications. Outcomes will be evaluated at 12 and 24 months.

Official Title
-----------------
A Prospective Evaluation of the Second Generation iStent Inject in Open-Angle Glaucoma Subjects on Two Preoperative Topical Ocular Hypotensive Medications

Conditions
-----------------
Primary Open Angle Glaucoma (POAG)

Intervention / Treatment
-----------------
* Device: iStent inject surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with primary open angle glaucoma (POAG) Subject on two ocular hypotensive medications Exclusion Criteria: Traumatic, uveitic, neovascular, or angle closure glaucoma Fellow eye already enrolled

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iStent inject surgery<br>Single-arm study. Intervention is micro-invasive glaucoma surgery (MIGS) to implant iStent inject | Device: iStent inject surgery<br>* Micro-invasive glaucoma surgery (MIGS) to implant iStent inject<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP reduction at 12 and 24 months on same number or fewer medications | IOP reduction at 12 and 24 months on same number or fewer medications | 12 months and 24 months |
Institut Paoli Calmettes Chronic Lymphatic Leukemia Database

Study Overview
=================
Brief Summary
-----------------
Database of Institut Paoli-Calmettes patients diagnosed with chronic lymphatic leukemia

Official Title
-----------------
Institut Paoli Calmettes Chronic Lymphatic Leukemia Database

Conditions
-----------------
Leukemia, Lymphocytic, Chronic, B-Cell

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of chronic lymphatic leukemia Exclusion Criteria: Score of Matutes <4

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| Chronic lymphatic leukemia diagnosis<br> | Other: Data collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of patients | Overall survival of all patients who come in the center | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of patients characteristics | Collection of characteristics of patients treated at Institut Paoli Calmettes in order to set up prospective and retrospective studies | 10 years |
Efficacy of Cuminum Cyminum Herbal =Preparation in Inhibition of Plaque and Gingivitis.

Study Overview
=================
Brief Summary
-----------------
Present work was to investigate the possible efficacy of 0.2% cuminum cyminum herbal preparation as an antiplaque and antigingivitis agent when compared with chlorhexidine.

Detailed Description
-----------------
To evaluate and compare the efficacy of 0.2% cuminum cyminum herbal preparation against 0.2% chlorhexidine by various clinical parameters i.e. plaque index, gingival index and sulcus bleeding index.

Official Title
-----------------
Efficacy of Cuminum Cyminum Herbal Preparation in Inhibition of Plaque and Gingivitis

Conditions
-----------------
Chronic Gingivitis

Intervention / Treatment
-----------------
* Drug: Cuminum Cyminum
* Drug: herbal Mouthwash


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: volunteers with minimum 20 natural teeth without restoration. cooperative motivated and committed to participate in the trial period. Exclusion Criteria: Antibiotic or anti-inflammatory therapy in previous month. Any known allergy/ hypersensitivity to any product used in trial.

Ages Eligible for Study
-----------------
Minimum Age: 23 Years
Maximum Age: 30 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
Interventional Model Description: Group phase A Group phase B Group phase C
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cuminum cyminum mouthwash<br>cuminum cyminum mouthwash in chronic gingivitis patients | Drug: Cuminum Cyminum<br>* Cuminum Cyminum mouthwash in chronic gingivitis patients<br>* Other names: Cuminum Cyminum mouthwash;|
| Active Comparator: herbal mouthwash<br>herbal mouthwash in chronic gingivitis patients | Drug: herbal Mouthwash<br>* herbal mouthwash in chronic gingivitis patients<br>* Other names: herbal mouthwash in chronic gingivitis patients;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PLAQUE INDEX | PLAQUE INDEX: Turesky-Gilmore-Glickman Modification of Quigley Hein 1962 | changes from baseline to 8 days | 
| Gingival Index | Gingival Index: Loe H ans Silness 1963 | changes from baseline to 8 days | 
| Bleeding on probing | Bleeding on probing: Muhlemann HR and Son 1971 | changes from baseline to 8 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mouthwash, chlorhexidine, stain
Tamoxifen Pharmacogenetics in Asian Breast Cancer Women

Study Overview
=================
Brief Summary
-----------------
The clinical outcome of tamoxifen treatment in breast cancer patients may be influenced by the activity of cytochrome P450 enzymes involving in tamoxifen biotransformation.

Detailed Description
-----------------
The investigators investigated the prognostic and/or predictive value of genetic polymorphisms of enzymes involved in tamoxifen metabolism for the treatment outcome among Asian breast cancer patients.

Official Title
-----------------
Observational Study: Biomarker Research for Tamoxifen Pharmacogenetics Among Asian Breast Cancer Patients

Conditions
-----------------
Poisoning by, Adverse Effect of and Underdosing of Tamoxifen

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: incident breast cancer patients who underwent surgery Exclusion Criteria: previous cancer history before breast cancer diagnosis

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

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

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 |
| --- | --- | --- |
| Association between genetic polymorphisms of CYP2D6, CYP2C19, and CYP3A5 and disease free survival among tamoxifen treated breast cancer patients | Association between genetic polymorphisms of CYP2D6, CYP2C19, and CYP3A5 and disease free survival among tamoxifen treated breast cancer patients | five years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tamoxifen, Pharmacogenomics, Breast cancer
Recovery Prediction of Motor Function Using Neuroimaging Techniques in Subacute Stroke Patients

Study Overview
=================
Brief Summary
-----------------
Prediction of recovery from stroke can assist in the planning of impairment-focused rehabilitation. To achieve better prediction for clinical purposes, this study investigated a new prediction model with low inter-individual variability and high accuracy using neuroimaging techniques.

Official Title
-----------------
Functional MRI and DTI Study for Brain Network Analysis and Recovery Prediction in Subacute Stroke Patients

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: Conventional therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First-ever stroke patients Unilateral stroke Subacute stage (less than 4 weeks) Exclusion Criteria: Major active neurological disease or psychiatric disease A history of seizure Metallic implants in their brain

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Subacute stroke<br> | Other: Conventional therapy<br>* According to the status of a patient, optimized therapy will be applied.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment score at 3 months after stroke onset | Measurement of motor function of upper and lower extremities | 3 months after stroke onset | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brain connectivity, Magnetic resonance imaging, Recovery prediction
HLH Patients - a Retrospective Study

Study Overview
=================
Brief Summary
-----------------
Monocentric, observational, retrospective, no profit study aimed to analyze factors that are significantly impacting the outcome of patients diagnosed with HLH.

Detailed Description
-----------------
retrospective data collection to study: type of HLH familial vs secondary, sex, age, presence of infectious cause, involvement central nervous system ( SNC), hepatic involvement, presence of hemophagocytosis, presence of splenomegaly, presence of involvement of other organs, the value of neutrophils (PMN), the value of hemoglobin, platelets, albumin, triglycerides, ferritin, LDH, type of therapy and the response to therapy after 2 months

Official Title
-----------------
Retrospective Analysis of the Outcome of Patients Diagnosed With Hemophagocytic Lymphohistiocytosis (HLH) Treated at the S.C.Pediatric Oncohematology of the Regina Margherita Torino Hospital (OIRM)

Conditions
-----------------
Hemophagocytic Lymphohistiocytoses

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have received HLH diagnosis according to HLH 2004 criteria age ⥶18 years. followed at our facility between January 2004 and December 2021 Whose parents have consented to participation and data processing Exclusion Criteria: The study does not foresee specific exclusion criteria other than the non-compliance with the inclusion criteria

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| pediatric patients affected by hemophagocytic lymphohistiocytoses<br>pediatric patients with HLH | Other: Observation<br>* Observation and retrospective data collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physiological parameter that are significantly impacting the outcome of patients diagnosed with HLH | Type of HLH (familial vs secondary); sex (M or F); age (in year); presence of infectious cause; involvement central nervous system (yes or no); hepatic involvement (yes or no); presence of hemophagocytosis (yes or no); presence of splenomegaly (yes or no); involvement of other organs (yes or no); value of neutrophils (PMN, in 10^9/L), hemoglobin (in g/dL), platelets (in 10^9/L), albumin (in g/L), triglycerides (in mg/dL), ferritin (in UI/L) and LDH (in UI/L); | through study completion, an average of 1 year |