linjc16/ctgov huggingface dataset:
Comparing Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec and Insulin Glargine 300 U/mL at Steady-state Conditions in Subjects With Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to compare pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (the exposure of the trial drug in the body) properties of insulin degludec and insulin glargine 300 U/mL at steady-state conditions in subjects with type 1 diabetes mellitus.

Official Title
-----------------
A Randomised, Single-centre, Double-blind, Two-period Cross-over, Multiple Dose Trial Comparing Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec and Insulin Glargine 300 U/mL at Steady-state Conditions in Subjects With Type 1 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: insulin degludec
* Drug: insulin glargine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18-64 years (both inclusive) at the time of signing informed consent Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening Body mass index 18.5-29.0 kg/m^2 (both inclusive) Exclusion Criteria: Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the in-patient period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDeg<br> | Drug: insulin degludec<br>* Dose levels will be 0.4 U/kg body weight. The trial products will be administered subcutaneously (s.c., under the skin) once daily.<br>|
| Active Comparator: IGlar U300<br> | Drug: insulin glargine<br>* Dose levels will be 0.4 U/kg body weight. The trial products will be administered subcutaneously (s.c., under the skin) once daily.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the glucose infusion rate curve |  | During one dosing interval (0-24h) at steady-state. At day 6, 9 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the glucose infusion rate curve |  | During one dosing interval at steady state.At day 6, 9 and 12 |
Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV Infections

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate whether thalidomide modulates toxic host inflammatory responses in patients receiving antitubercular therapy. II. Evaluate whether thalidomide modifies tumor necrosis factor-mediated toxic symptoms of HIV and mycobacterial infections, and limits progression of HIV immunodeficiency. III. Evaluate whether thalidomide stimulates immunity in patients with HIV and/or mycobacterial infections.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are stratified by type of infection. Patients are randomly assigned to oral thalidomide or placebo. Therapy is administered daily for up to 8 weeks, beginning the night before antitubercular treatment is initiated.

Conditions
-----------------
HIV Infections, Mycobacterium Infections, Tuberculosis

Intervention / Treatment
-----------------
* Drug: thalidomide


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Human immunodeficiency virus (HIV) or mycobacterial infection that requires at least 10 days of inpatient antitubercular treatment Mycobacterial infection confirmed by positive acid-fast bacilli smear or culture for Mycobacterium tuberculosis At least 1 of the following signs and symptoms required: Temperature over 38 degrees C on at least 2 occasions within 1 week prior to treatment Weight loss greater than 5 kg Pulmonary involvement in at least 1 lobe on x-ray Night sweats on at least 2 occasions within 1 week prior to treatment --Prior/Concurrent Therapy-- Concurrent rifampicin, isoniazid, pyrazinamide, and ethambutol for tuberculosis allowed --Patient Characteristics-- No neuropathy and not at risk for neuropathy Not pregnant Negative pregnancy test Fertile patients must use effective contraception during and for 4 weeks after study

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: thalidomide|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
-----------------
bacterial infection, human immunodeficiency virus infection, immunologic disorders and infectious disorders, mycobacterium infection, mycobacterium tuberculosis infection, rare disease, viral infection
Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen

Study Overview
=================
Brief Summary
-----------------
Standard administration of capecitabine use a 14 days administration. Routine practice in several intitution leads to use a 5 out of 7 days regimen, with less toxicity. Purpose : to compare the pharmacokinetics of capecitabine, administered 5 days out of 7, as compared to the standard administration (14 days out of 21). The second end point is to compare toxicity with either regimen. Method : Randomized study with two groups : one with standard administration , the second with 5/7 days regimen

Official Title
-----------------
Phase I/II Study of Tolerance and Pharmacokinetics With Capecitabine Given 5 Days Out of 7 in Metastatic Breast Cancer

Conditions
-----------------
Breast Neoplasms, Chemotherapy

Intervention / Treatment
-----------------
* Drug: capecitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven breast adenocarcinoma Evaluable or measurable metastases HER-2 status 0 or 1 in immnohistochimy or negative in FISH/CISH Previously treated with anthracyclines and taxanes Age > = 18 y No more than two previous chemotherapy regimens for metastases No nervous central system involvement Hormonal therapy must have been stopped two weeks before enrollment Adequate biologic function Performance status OMS < = 2 Signed informed consent Exclusion Criteria: History of other malignancies, except basocellular cancer, in situ cervix carcinoma Gastro intestinal disease that might affect absorption of capecitabine Cardiac failure or angina pectoris uncontrolled Hypersensitivity for capecitabine, fluorouracil, or one of their excipient Known dihydropyrimidine dehydrogenase (DPD) deficiency Concomitant anticancer therapy (included hormonotherapy) Concomitant radiotherapy Treatment with sorivudine and analogs Pregnant or breast feeding patients. Contraception methods excluding hormonal treatment is required. Inclusion in an experimental protocol within 30 days

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: capecitabine|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
-----------------
fluoropyrimidines, metastases, pharmacokinetics, phase 1-2 study
Antibiotic Misuse During COVID-19 Pandemic

Study Overview
=================
Brief Summary
-----------------
Evaluating the important role of the community pharmacists in pandemics like covid-19 and to find whether there was a misuse of antibiotics during the pandemic or not and to define the reasons behind this misuse if any present.

Detailed Description
-----------------
Community pharmacy in Egypt is considered as the frontline health care system that is easily and freely accessible by the patients, in this pandemic and due to the current circumstances from closing most general hospitals in front of the public, and with the government applying curfew long hours, community pharmacists were the only healthcare providers available for most patients. Their role will not be restricted to delivering medication but expands to monitoring patient conditions especially those with chronic diseases and patient counseling and education clarifying any misunderstanding concerning covid1-19 medication. The present study includes a questionnaire (with detailed questions including how/when/which/for how long antibiotics are prescribed) that is addressed for community pharmacists who dealt with covid-19 patients during the pandemic.

Official Title
-----------------
Assessment of Community Pharmacies Related Antibiotic Misuse and Application of Infection Control Measures During COVID-19 Pandemic

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Other: online questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All community pharmacists worked during the pandemic and dealt with covid-19 patients inside their pharmacies are welcomed to participate Exclusion Criteria: Clinical and hospital pharmacists- other medical staff- pharmacist assistant

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| community pharmacists<br> | Other: online questionnaires<br>* questionnaire (with detailed questions including how/when/which/for how long antibiotics are prescribed)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antibiotic misuse | using a questionnaire and direct interviews to evaluate the important role of community pharmacist in pandemics like covid-19 and to assess antibiotic misuse during the pandemic or not and to define the reasons behind this misuse if any present | 15-20 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronavirus, observational survey, antibiotics, Egypt
Pilot Study for the Urinary Incontinence Treatment

Study Overview
=================
Brief Summary
-----------------
Non invasive study to improve the urinary incontinence, through pelvic floor muscles exercises

Detailed Description
-----------------
A non invasive study to improve the urinary incontinence performed in 36 women from two groups: 18 menopausal women and 18 fertile women. The participants have to do pelvic floor muscles exercises with a restorative pelvic floor device every day for two months using the Magic Kegel app download in their mobile devices

Official Title
-----------------
Pilot Study for the Urinary Incontinence Treatment by Using a Pelvic Floor Muscles Restorative Device (E-NNA®)

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Device: Magic Kegel app


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Urinary incontinence diagnosis Exclusion Criteria: No urinary infection No surgery for urinary incontinence

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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 |
| --- | --- |
| Other: Unique arm<br>Magic Kegel app | Device: Magic Kegel app<br>* Pelvic floor muscles recover exercises with a specific device and Magic Kegel App<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in values registered in Magic Kegel App |  | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in ICIQ-SF questionnaire at month 2 respect to baseline |  | 60 days | 
| Changes in FSFI questionnaire at month 2 respect to baseline |  | 60 days | 
| Changes in Sandvick questionnaire at month 2 respect to baseline |  | 60 days | 
| Changes in PISQ-12 questionnaire at month 2 respect to baseline |  | 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urinary Incontinence, Pelvic Floor
Dose-response Enteral Citrulline for Normal Healthy Volunteers and Surgery Patients

Study Overview
=================
Brief Summary
-----------------
To determine the level of citrulline to produce a given amount of arginine in healthy volunteers and surgical patients. Arginine-related amino acids are expected to increase as a result of increased substrate provided by citrulline.

Official Title
-----------------
Clinical Trial of Enteral Citrulline in Volunteers With Surgical Repair of Ventral Hernias

Conditions
-----------------
Nutritional Deficiency

Intervention / Treatment
-----------------
* Other: citrulline
* Other: Lemonade


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults, male & female, non-pregnant BMI 18.5-29.9 Exclusion Criteria: cancer HIV positive

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Citrulline<br> | Other: citrulline<br>* TID for 5 days<br>|
| Placebo Comparator: lemonade<br>Equal volume and flavor to citrulline. | Other: Lemonade<br>* TID for 5 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma amino acid levels |  | 8 hours |
Demographic, Clinical, Laboratory and Genetical Characteristics of Patients With Beta Thalassemia Intermedia

Study Overview
=================
Brief Summary
-----------------
The definition of Thalassemia Intermedia is not generally accepted and the specific clinical and laboratory characteristics varies between patients. Some patients are blood transfusion dependent and others are occasionally transfused. Also the mutations in the beta globin gene are diverse. Another mutations including mutations in the alfa globin gene and in the xmn1 gene can affect the clinical course of this disease. The purpose of this study is to summarize the characteristics of patients with Thalassemia Intermedia treated at the Pediatric Hematology Unit at the HaEmek Medical Center in Israel

Detailed Description
-----------------
The characteristics that will be recorded from the medical files include: demographic data, included gender and ethnic origin, family history, age at diagnosis, number and frequency of blood transfusions including age of first transfusion and physical examination findings. The laboratory data included iron metabolism parameters, mutation in the alfa and beta gene and the presence of the xmn1 polymorphism.

Official Title
-----------------
Demographic, Clinical, Laboratory and Genetical Characteristics of Patients With Beta Thalassemia Intermedia

Conditions
-----------------
Thalassemia

Intervention / Treatment
-----------------
* Genetic: Laboratory analysis.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -All patients treated at the Pediatric Hematology Unit Exclusion Criteria: Not enough medical records. Patients who refuse to give consent to perform genetic studies will be included in the study but only the retrospective clinical data will be recorded.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 40 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 |
| --- | --- |
| Thalassemia Intermedia Patients<br>Patients with Beta Thalassemia Intermedia treated at the Pediatric Hematology Unit. The characterization of Thalassemia Intermedia was based on age at diagnosis (Older than 2 ys) and / or clinical characteristics that are milder than Thalassemia Major in patients homozygous for beta globin genes. | Genetic: Laboratory analysis.<br>* The blood transfusions given to the patients are in accord to physician decision and not related to the study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The characteristics of patients with thalassemia intermedia | Observational study that analyzed the characteristics of thalassemia intermedia patients | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Beta globin gene, Alfa globin gene, xmn1 polymorphism
Analysis of Screen-detected Lung Cancers' Genomic Traits

Study Overview
=================
Brief Summary
-----------------
Prospective, observational cohort study of patients undergoing surgical resection for low dose CT (LDCT) screen-detected lung cancer (detected through the SUMMIT study- ClinicalTrials.gov Identifier: NCT03934866/ lung screening programmes), in which translational research is a fundamental aspect.

Detailed Description
-----------------
The ASCENT study seeks to examine the genomic signatures of screen-detected cancers, in order to categorise the biological behaviour of such lesions and correlate this against non-invasive biological and radiological parameters. From these data, the plan is to explore strategies to characterise LDCT-detected cancers through non-invasive means, which the researchers believe may prove key in mitigating potential screening-associated harms.

Official Title
-----------------
Analysis of Screen-detected Lung Cancers' Genomic Traits

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with confirmed lung cancer or probable lung cancer via LDCT screening. Planned for, or completed primary surgical resection either for histologically confirmed lung cancer, or strongly suspected lung cancer. Able to provide written informed consent (or verbal informed consent for participants consenting to retrospective diagnostic samples and data collection only). Exclusion Criteria: Treatment with neoadjuvant therapy for current lung malignancy as per local MDT treatment decision. Known Active Human Immunodeficiency Virus (HIV), Hepatitis B virus, Hepatitis C Virus or Syphilis.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 77 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 |
| --- | --- | --- |
| Genomic exploratory research | Measuring the differences in chromosomal instability between fast- and slow-growing screen detected cancers, quantified by weighted genome integrity index (WGII) derived from whole exome sequencing (WES) data | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Genomic signatures, Screen-detected cancer, Non-invasive biological and radiological parameters