linjc16/ctgov huggingface dataset:
Renal Tubular Disorders in Egyptian Children

Study Overview
=================
Brief Summary
-----------------
Renal tubules play an important role in fluid, electrolyte, and acid-base homeostasis. Defect of these functions can give rise to a host of disorders. These disorders can lead to life threatening disturbances in electrolytes and acid-base balance. In Egypt, there is little data about these disorders. Many of these cases are diagnosed late, therefore Early suspicion for diagnosis can improve the overall clinical outcome of these children.

Detailed Description
-----------------
Renal tubules play an important role in fluid, electrolyte, and acid-base homeostasis. Defect of these functions can give rise to a host of disorders. These disorders can lead to life threatening disturbances in electrolytes and acid-base balance. In Egypt, there is little data about these disorders. Many of these cases are diagnosed late, therefore Early suspicion for diagnosis can improve the overall clinical outcome of these children. As a result, starting management early will help those children have a better life. Therefore awareness about these disorders and long-term outcome is really important. The investigators present the clinical characterizations of many tubular disorder and the follow up in our center. The aim of this study is to reveal the different clinical presentations and the main lab features of renal tubular disorders in children to promote early recognition and management.

Official Title
-----------------
Patterns of Renal Tubular Disorders in Egyptian Children: a Single Center Study

Conditions
-----------------
Renal Tubular Disorders in Children

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children aged from one month to 18 years who have renal tubular disorders. Exclusion Criteria: Children who have renal tubular disorders secondary to drugs, intoxication, obstructive uropathy or transient in nature.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum 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 |
| --- | --- | --- |
| weight | in kilograms | 1 years | 
| Glomerular function | The glomerular function was assessed by estimated glomerular filtration rate (eGFR) calculated using Schwartz formula. Chronic kidney disease (CKD) was defined in the presence of a permanent reduction in GFR (e-GFR; <60 ml/min/1.73 m2 Kidney Disease Outcomes Quality Initiative < stage 3). | 1 years | 
| height | in meters | 1 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal tubular disorders, failure to thrive, metabolic acidosis, metabolic alkalosis, hypokalemia
Comparison of Telemedicine Evaluation to Standard Evaluation Methods for Pre-Anesthesia Consultation

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate different methods of pre-anesthesia consultation, with the aim of improving the day of surgery experience for the patient. In this study, we will use a telephone consultation, an in-person consultation, and a telemedicine consultation, which involves television cameras and monitors that allow live two-way communication for the pre-anesthesia consultation. The reason for this study is to evaluate the use of telemedicine for the pre-anesthesia consultation. Patients and anesthesiologists have been highly satisfied in previous studies using pre-anesthesia telemedicine consultation. In this study, we will examine a larger group of patients, as previous studies have studied smaller groups of patients.

Official Title
-----------------
Comparison of Telemedicine Evaluation to Standard Evaluation Methods for Pre-Anesthesia Consultation

Conditions
-----------------
ENT Patients Scheduled for Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between the ages of 18 and 89 who are scheduled for otolaryngologic procedures and pre-anesthesia consultation. Exclusion Criteria: Lack of consent; inability to understand English-

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- |
| telephone group<br>The telephone group must be healthy adults scheduled for an ENT surgery. | |
| telemedicine group<br>This group if qualified will randomly be chosen to be in the telemedicine group. | |
| pre-anesthesia consultation<br>This will be the group that will be randomized to the pre-anesthesia clinic. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison Of Telemedicine Evaluation To Standard Evaluation Methods For Pre-Anesthesia Consultation | Primary outcomes include surgical cancellation rate, delays the day of surgery secondary to inadequate pre-op evaluation, adequacy of the airway, respiratory, and cardiovascular exams, and intra-op and post-op complications. Patient data will include age, gender, ASA Physical Status and type of surgery. The length of the PACE appointment and the number of days prior to surgery the PACE appointment was conducted will be noted. Patient satisfaction with the will be evaluated. | about 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pre anesthesia consultation, telemedicine
Lipoprotein Metabolism in Normal Volunteers and Patients With Abnormal Levels of Lipoproteins

Study Overview
=================
Brief Summary
-----------------
Researchers plan to study the fat-rich particles, called lipoproteins, which circulate in the blood. This study is designed to improve understanding of normal, as well as abnormal, lipoprotein metabolism and the role it plays in the development of hardening of the arteries (atherosclerosis). Patients participating in this study will receive an intravenous (directly into the vein) injection of a small amount of specially prepared amino acids. The amino acids being injected are the same amino acids present in a normal diet. The amount of amino acid given will be less than the amount eaten in a protein-rich meal. The amino acids will be labeled with nonradioactive heavy isotopes which are also present in the environment n low amounts. Patients participating in the study will be required to have blood samples taken, and provide urine samples throughout the course of the study. In addition, patient will be required to follow a specially formulated diet. Patients will be weighed throughout the course of the study.

Detailed Description
-----------------
Apolipoproteins regulate the metabolism of lipids and lipoproteins in plasma of humans. In order to investigate the roles of apolipoproteins in these processes, we plan to quantitate the kinetics of the metabolism of apolipoproteins utilizing nonradioactive isotope labeled amino-acids.

Official Title
-----------------
Lipoprotein Metabolism in Normal Volunteers and Dyslipoproteinemic Patients (Stable Isotopes)

Conditions
-----------------
Healthy, Hyperlipoproteinemia

Participation Criteria
=================
Eligibility Criteria
-----------------
The subjects for these investigations will be either healthy normal volunteer control subjects or patients who have a dyslipoproteinemia. Subjects must be 18-80 years old.
Sexes Eligible for Study
-----------------
All

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

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
-----------------
Nonradioactive Isotopes, Lipoprotein Kinetics, Apolipoproteins, Dyslipoproteinemia, Healthy Volunteers
Observational Study to Evaluate the Safety While Using Levemir®

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin Levemir® under normal clinical practice conditions in Egypt.

Official Title
-----------------
Observational, Safety Study in Subjects Using Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: After the physician decision has been made to use insulin detemir, any subject with Type 1 or Type 2 diabetes mellitus is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before. The selection of the subjects will be at the discretion of the individual physician. Exclusion Criteria: Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit; Subjects currently being treated with insulin detemir; Subjects who previously enrolled in this study Subjects with a hypersensitivity to insulin detemir or to any of the excipients Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures. (Adequate contraceptive measures are an intrauterine device, oral contraceptives and barrier methods)

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 |
| --- | --- |
| A<br> | Drug: insulin detemir<br>* Start dose and frequency to be prescribed by the physician as a result of the actual clinical evaluation<br>* Other names: Levemir®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious ADRs incl. major hypoglycemias |  | after 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serious adverse events |  | after 24 weeks | 
| Number of all adverse events |  | after 24 weeks | 
| Weight changes |  | after 24 weeks | 
| HbA1c |  | after 24 weeks | 
| Subgroup analysis of hypoglycemias |  | after 24 weeks | 
| Number of all hypoglycemic events |  | in the 4 weeks preceding the visits at 12 weeks and 24 weeks. | 
| Variability in fasting Blood Sugar and average plasma glucose levels |  | after 24 weeks |
A Phase II Clinical Study of Lidocain Pertubation as Treatment for Couples With Unexplained Infertility

Study Overview
=================
Brief Summary
-----------------
The study tested the hypothesis that a pertubation with a lidocain solution will enhance pregnancy rate.

Detailed Description
-----------------
In a prospective study, patients were randomized during a clomiphene citrate stimulated cycle to either pertubation with low-dose lidocain or no pertubation before insemination.

Official Title
-----------------
A Randomised, Open, Controlled, Parallel Group, Multi-Centre Phase II Clinical Study of Lidocain Pertubation as Treatment for Couples With Unexplained Infertility

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: Pertubation with Lidocain Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, 20-40 years of age, If presence of peritoneal endometriosis they must be of minimal or mild without adhesions (verified by laparoscopy), Normal menstruation cycle, Male partner 20-70 years of age, Male partner, Normal sperm sample within 5 years (>20x106/mL, total sperm count >30x106, normal morphology 5%), Duration of infertility more than one year, Signed informed consent Exclusion Criteria: Treatment with NSAID, corticosteroids or other drugs, which can cause an increased risk of infection, Clinical signs of PID, Known hypersensitivity to local anesthetics, Non-patent fallopian tubes, Pathological uterine cavity, Pathological PCT, myoma > 2 cm diameter, Any disease or laboratory finding considered of importance by the investigator not to include the patient

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pertubation with Lidocain Solution|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate measured by Serum-HCG day 17 after IUI |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pertubation, tubal flushing, intrauterine insemination.
Drug Interaction With Envarsus XR and Grapefruit Juice

Study Overview
=================
Brief Summary
-----------------
Transplant patients must take lifelong immunosuppression in order to prevent rejection of their organ. Tacrolimus is the most widely used immnosuppressive agent. Part of the routine education given to patients regarding tacrolimus is that they must avoid many drugs and substances that can interact with tacrolimus so that they don't experience side effects or lack of effect. Patients are told they must avoid readily available substances such as grapefruit juice and St. John's wort. A new once daily formulation of tacrolimus, Envarsus XR, may bypass the place in the gut in which many of these drug interactions occur. We will give kidney transplant patients Envarsus with and without grapefruit juice and measure the effect on blood levels throughout the day. Results from this study will also give us information about the likelihood of other drugs interacting with Envarsus XR.

Official Title
-----------------
Assessment of the Intestinal CYP3A Contribution to Drug Interactions With Envarsus XR Using Grapefruit Juice

Conditions
-----------------
Kidney Transplant; Complications, Drug Interaction Food

Intervention / Treatment
-----------------
* Dietary Supplement: Grapefruit Juice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary Kidney Transplant Age > 18 years At least 3 months post-transplantation Taking a stable dose of tacrolimus extended release with a target trough of 8-10 ng/mL BMI between 18-32 Exclusion Criteria: Multi-organ transplant Concomitant use of mTOR inhibitor Concomitant use of belatacept Concomitant use of medication affecting CYP3A or P-gp History of rejection Hypersensitivity to midazolam Hypersensitivity to Envarsus Active diarrhea or constipation BMI < 18 or > 32

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group A<br>Tacrolimus Extended Release + Midazolam | |
| Active Comparator: Group B<br>Tacrolimus Extended Release + Midazolam + Grapefruit Juice | Dietary Supplement: Grapefruit Juice<br>* Single 8 ounce administration of oral grapefruit juice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tacrolimus AUC before and after Grapefruit Juice |  | 2-4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tacrolimus AUC compared to Midazolam AUC |  | 2-4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tacrolimus, Grapefruit Juice, CYP3A4, Midazolam, Kidney Transplant
Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney transplant.

Official Title
-----------------
Two-year Extension of a One-year, Multicenter, Randomized, Partially-blinded Study of the Safety and Efficacy of FTY720 Combined With Corticosteroids and Full or Reduced-dose Cyclosporine, USP [Modified] (Novartis Brand) in de Novo Adult Renal Transplant Recipients

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Drug: FTY720


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria - Completion of Core study Exclusion Criteria Other protocol-defined exclusion criteria may apply.

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: FTY720|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IA, IB, IIA, IIB or III diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant |  |  | 
| Permanent resumption of dialysis within 36 months post transplant |  |  | 
| Surgical removal of graft within 36 months post transplant |  |  | 
| Death within 36 months post transplant |  |  | 
| Discontinuation within 36 months post transplant |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 , FVC, DLCO within 36 months post transplant |  |  | 
| Serum creatinine and estimated creatinine clearance within 36 months post transplant |  |  | 
| Absolute lymphocyte count within 36 months post transplant |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transplantation, kidney, and organ transplantation
Immunohistochemical Expression Patterns of microRNA Processing Enzyme Dicer in Cutaneous Malignant Melanoma, Benign and Dysplastic Melanocytic Naevi

Study Overview
=================
Brief Summary
-----------------
MicroRNAs (miRNAs) are very small endogenous RNA molecules about 22-25 nucleotides in length, capable of post-transcriptional gene regulation. miRNAs bind to their target messenger RNAs (mRNAs), leading to cleavage or suppression of target mRNA translation based on the degree of complementarity. miRNAs have recently been shown to play pivotal roles in diverse developmental and cellular processes and linked to a variety of skin diseases and cancers. In the present study the researchers investigate the immunohistochemical distribution of Dicer in benign and dysplastic melanocytic naevi as well as in cutaneous malignant melanoma compared to intraindividual healthy control.

Conditions
-----------------
Naevi, Malignant Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with benign melanocytic naevi, dysplastic melanocytic naevi and cutaneous malignant melanoma. Exclusion Criteria: Patients under 18 years of age Patients with other forms of cancer in previous medical history Pregnancy

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 |
| --- | --- |
| 1<br>benign melanocytic naevi | |
| 2<br>dysplastic melanocytic naevi | |
| 3<br>cutaneous malignant melanoma | |

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
-----------------
Skin, MicroRNA, miRNA, Dicer, Malignant Melanoma