linjc16/ctgov huggingface dataset:
A Study of Acute Kidney Injury in Children at Sohag University Hospital

Study Overview
=================
Brief Summary
-----------------
Acute kidney injury (AKI) has been traditionally defined as an abrupt loss of kidney function leading to a rapid decline in the glomerular filtration rate (GFR), accumulation of waste products such as blood urea nitrogen (BUN) and creatinine, and dysregulation of extracellular volume and electrolyte homeostasis . Acute kidney injury (AKI) is a very common condition, especially among hospitalized patients. this work aims to study the demographics, etiology, clinical characteristics, and outcome of acute kidney injury in children in Sohag University Hospital - Pediatrics Department.

Official Title
-----------------
A Study of Acute Kidney Injury in Children at Sohag University Hospital

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Diagnostic Test: serum creatinine and Other investigations will be done according to the case


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children with acute kidney injury with an age range from 1 month to 16 years old Exclusion Criteria: patients with chronic kidney disease (CKD) Patients with irregular follow up Patients with incomplete data Patients whose medical guardians refuse participation in the study

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 16 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: serum creatinine and Other investigations will be done according to the case|following up AKI patients with serum creatinine,Urine out put, CBC,Serum electrolytes,renal functin test,Liver function test,urine analysisand specific investigations according to case|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinine level | follow up AKI patients with serum creatinine level | one year |
IPI-145 Single Ascending, Multiple Ascending, Food Effect and Drug-Drug-Interaction Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-145 after single and repeat oral administration, and to evaluate the effects of food and ketoconazole on the plasma pharmacokinetics of IPI-145.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Food and Ketoconazole on the Pharmacokinetics of IPI-145 When Administered to Healthy Adult Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: IPI-145
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gender : male or female Age : 18-55 years, inclusive Body Mass Index (BMI) : 18.0-30.0 kg/m2 Medical history without major pathology For males only: Willingness to use adequate contraception from the time of dosing and not donate sperm until 3 months after the follow-up visit Females who have a negative pregnancy test at screening and on each admission, and are of non-childbearing potential. Females of non-childbearing potential are defined as women who are surgically sterile or post-menopausal (defined as at least 1 year post cessation of menses and follicular stimulating hormone (FSH) >23.0 mIU/mL) Willing and able to sign the written Informed Consent Form (ICF) Exclusion Criteria: Previous participation in the current study Evidence of clinically relevant pathology History of relevant drug and/or food allergies Part 4 only: Known or suspected adverse reaction or contraindication to the imidazole class of drugs

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPI-145<br> | Drug: IPI-145<br>* Single ascending dose up to 6 cohorts; multiple ascending dose up to 4 cohorts; food effect arm; ketoconazole drug interaction study<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Single ascending dose up to 6 cohorts; multiple ascending dose up to 4 cohorts; food effect arm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability assessments consisting of adverse events, vital signs, 12-lead ECG, clinical laboratory tests and physical examinations will be performed following IPI-145 single and repeat oral administration in healthy subjects |  | 8 months | 
| Plasma concentrations of IPI-145 and metabolites |  | 8 months |
Safety and Efficacy Study of INGN 241 Gene Therapy in Patients With In Transit Melanoma

Study Overview
=================
Brief Summary
-----------------
This is a research study to look at the ways in which a treatment called INGN241 can kill melanoma cells or help the patient's immune system kill melanoma cells.

Detailed Description
-----------------
INGN 241 is an adenoviral vector carrying the MDA-7 cDNA. MDA-7 is a novel tumor suppressor molecule with cytokine properties, recently designated as IL-24. Over expression of MDA-7 in melanoma cells in vitro has been shown to inhibit cellular proliferation and induce apoptosis. Loss of MDA-7 expression in human melanomas has been shown to correlate with invasion and metastasis. The INGN 241 gene transfer construct has been previously used in human subjects in an ongoing open label Phase I study using intratumoral administration, and has been well tolerated to date. The primary objectives of the present study are to determine if INGN 241, injected into a melanoma in transit lesion, can induce apoptosis in regional uninjected lesions and initiate systemic immune activation. Secondary objectives include examination of specific immunity and of clinical response and toxicity.

Official Title
-----------------
Phase II Study Examining the Biological Efficacy of Intratumoral INGN 241 (Ad-mda7) Administration in Patients With In Transit Melanoma

Conditions
-----------------
Malignant Melanoma, Neoplasm Metastasis

Intervention / Treatment
-----------------
* Genetic: investigational drug INGN 241


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven melanoma, must have 3 regional metastatic lesions that are in transit Exclusion Criteria: Central nervous system involvement by melanoma

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: investigational drug INGN 241|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anti-tumor effects and systemic immune activation at 28 days |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor response |  |  | 
| toxicity and safety |  |  | 
| the induction of antigen-specific T-lymphocytes after multiple cycles of treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gene therapy, melanoma, adenovirus, in-transit melanoma, metastatic melanoma
The Influence of Significant Weight Lost on the Quality of Voice

Study Overview
=================
Brief Summary
-----------------
The rate of obesity and bariatric surgery is rising steadily. Though Bariatric Surgery Influences on aspects such as endocrin analysis, finance, etc are well tested, quantitative and quality voice impacts have not been evaluated. The aim of the study is to recruit 50 patients who underwent bariatric surgery and compare voice quality in each of these patients before and after surgery.

Official Title
-----------------
The Influence of Significant Weight Lost on the Quality of Voice

Conditions
-----------------
Obesity, Morbid, Voice Alteration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Morbid obese Candidates for bariatric Surgery Exclusion Criteria: History of benign \ malignant disease of the larynx. History of head and neck tumors History of radiation therapy of the neck BMI under 30 pre-surgery

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 |
| --- | --- | --- |
| Stroboscopic evaluation of the larynx | A visual examination of the larynx | 2/16-2/20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysphagia handicap Index | Validitated questioners for dysphagia which result in a score | 2/16-2/20 | 
| EAT 10 | Validitated questioners for dysphagia which result in a score | 2/16-2/20 | 
| Voice Handicap Index | Validitated questioners for dysphagia which result in a score | 2/16-2/20 | 
| Average Fundamental frequency | part of voice assessment, in Hertz | 2/16-2/20 | 
| Mean Fundamental frequency | part of voice assessment, in Hertz | 2/16-2/20 | 
| Highest Fundamental frequency | part of voice assessment, in Hertz | 2/16-2/20 | 
| Lowest Fundamental frequency | part of voice assessment, in Hertz | 2/16-2/20 | 
| Standard deviation of Fundamental frequency | part of voice assessment, in numbers | 2/16-2/20 | 
| Noise to harmonic ratio | part of voice assessment, a descripitive measure of voice quality | 2/16-2/20 | 
| Voice turbulence Index | part of voice assessment | 2/16-2/20 | 
| Absolute gitter | Variability of frequency | 2/16-2/20 | 
| Jitter percent | assessment of voice variability | 2/16-2/20 | 
| Shimmer percent | assessment of voice variability | 2/16-2/20 | 
| Shimmer in dB | variability of voice volume | 2/16-2/20 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, voice
Impact of a Training-action About Projects Leading for the Improvement of Care Quality in Managing Practice of Health Executive

Study Overview
=================
Brief Summary
-----------------
The present study focuses on the quality of care and how the health executives can bring it to a central place in their management. A training-action has been set-up at the Health Executive training institute (University Hospital Grenoble) to improve care quality. Reports prepared by students (tutored projects) related to operational diagnosis and action plans about care quality improvement are given to health executives. The objective is to evaluate how the health executive will use the tutored project to improve care quality and set-up actions.The hypothesis is that the health executive will use the tutored project to improve project management.

Detailed Description
-----------------
Every year, 9 voluntary health executives will be included and followed during 1 year. The experience will be done 3 times (3 years). It is a qualitative study using 3 forms to recover data: group focus, individual interviews, project monographs. Speeches coding will enable to test the hypothesis from 2 analysis points: place of health executive and place of tutored project. The study will be resulting in recommendations to health executives for their management methods and taken into account to define training.

Official Title
-----------------
Impact of a Training-action About Projects Leading for the Improvement of Care Quality in Managing Practice of Health Executive

Conditions
-----------------
Health Care Quality Management (no Condition).

Intervention / Treatment
-----------------
* Other: Health care quality management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The volunteers are health executives with diploma Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Health care quality management|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the managerial practices of health executives about health care quality management after tutored projects. | The subjects are not patients but health executive managers. The study foccuses on their management pratices and changes after tutored projects. There are 2 analysis criteria: place of health executive and place of tutored project. | 1 year for each volunteer. |
Evaluation of Dexterity in Prevalent Peritoneal Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to measure the manual dexterity of patients treated by peritoneal dialysis - transversal study

Detailed Description
-----------------
All peritoneal dialysis patients from Peritoneal Dialysis unit will, after information and consent, have to realise four tests, one time each, to quantify their manual dexterity. The tests are already used to measure dexterity: Purdue Pegboard, Jebsen test, JAMAR, Pinch test. These tests will be performed during an in-hospital visit.

Official Title
-----------------
Evaluation of Manual Dexterity in a Monocentric Cohort of Peritoneal Dialysis Patients

Conditions
-----------------
Peritoneal Dialysis

Intervention / Treatment
-----------------
* Other: dexterity measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients treated by peritoneal dialysis in Caen University Hospital Exclusion Criteria: refusal to participate

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: dexterity measurement|4 non-invasive tests will be performed|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success of dexterity measurement in peritoneal dialysis patients evaluated by the Purdue Pegboard | number of completed tests (Purdue Pegboard - number inserted in 30 second) | baseline | 
| success of dexterity measurement in peritoneal dialysis patients evaluated by the Jebsen test | number of completed tests (Jebsen test - time in second) | baseline | 
| success of dexterity measurement in peritoneal dialysis patients evaluated by the JAMAR | number of completed tests (JAMAR - in kilogramms) | baseline | 
| success of dexterity measurement in peritoneal dialysis patients evaluated by the Pinch test | number of completed tests (Pinch testin - kilogramms) | baseline |
Platelet Rich Plasma Testis Treatment for Infertile Men

Study Overview
=================
Brief Summary
-----------------
Investigate the effect of intratesticular injection of autologous platelet rich plasma (PRP) on sperm retrieval rates and IVF outcomes in infertile men who already underwent a negative sperm retrieval. Currently, there is no alternative treatment after failed TESE. Prior series suggest that intratesticular PRP injections may improve TESE outcomes. We hope to determine whether PRP is an effective treatment for this patient population.

Official Title
-----------------
Platelet Rich Plasma Testis

Conditions
-----------------
Male Infertility, Nonobstructive Azoospermia, Azoospermia

Intervention / Treatment
-----------------
* Biological: Platelet rich plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men over the age of 18 diagnosed with NOA and at least one failed TESE, negative mapping or negative biopsy Exclusion Criteria: -

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

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

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

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: Platelet rich plasma treatment arm<br>After consent in obtained, the patient will undergo a blood draw (12 tsp) to prepare the PRP infusion. The use of a centrifuge and an Arteriocyte Magellan kit are necessary for the PRP preparation. After injection of local anesthesia, PRP will be injected into each testicle. | Biological: Platelet rich plasma<br>* Patients will undergo a blood draw (12 tsp) to prepare the PRP infusion. The use of a centrifuge and an Arteriocyte Magellan kit are necessary for the PRP preparation. After injection of local anesthesia, PRP will be injected into each testicle. On the third month after the testicular PRP procedure, a TESE will be performed If the procedure is successful a new IVF cycle using the sperm procured from the procedure will be done.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sperm present | A TESE procedure will be performed to determine if sperm are present | 3 months after PRP injection |
Subclinical Delirium and Clinical Outcome

Study Overview
=================
Brief Summary
-----------------
Delirium has been associated with clinical outcomes in critical care setting. However, its subclinical form has not been investigated. The investigators aimed to establish the association of subclinical delirium with outcome.

Detailed Description
-----------------
Delirium has been associated with clinical outcome in critical care setting. This syndrome has been associated with longer length of stay in ICU and hospital, longer duration of mechanical ventilation and higher mortality rate. however, its subclinical form has not been investigated. The subclinical syndrome is defined by CAM-ICU, in which several features of delirium are fulfilled but the diagnostic criteria are not fulfilled. The investigators aimed to establish the association of subclinical delirium with outcome.

Official Title
-----------------
Delirium and Clinical Outcome

Conditions
-----------------
Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients enter ICU GCS > 10 RASS > -2 Exclusion Criteria: unable to cooperate coma

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| delirium group<br>patients with delirium during ICU stay | |
| non-delirium group<br>patients without delirium during ICU stay | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | 60 days after enrollment | during hospital stay(60 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of mechanical ventilation |  | 60 days | 
| length of stay in ICU and hospital |  | 60 days after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
delirium, outcome
Natural History Study of Incidence of Otorrhea Following Tympanostomy Tube Insertion in Children 6 Months to 12 Years

Study Overview
=================
Brief Summary
-----------------
This study was conducted to describe the time to first incidence of otorrhea post tympanostomy tube insertion.

Conditions
-----------------
Otorrhea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be at least 6 months old and no more than 13 years of age at the time of enrollment scheduled for unilateral or bilateral myringotomy and tympanostomy tube insertion. Patients and/or child must read/sign informed consent and comply with requirement of the study. Exclusion Criteria: There are no exclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 12 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 |
| --- | --- | --- |
| Incidence of, time to, and relationship of risk factors associated with otorrhea post tympanostomy tube insertion. |  | Up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ear tubes, ear drainage, ear infection, ear drops, tympanostomy tubes, Pediatric patients