linjc16/ctgov huggingface dataset:
Clinical Presentation, and Treatment Outcomes in Tuberculous Patients in Sohag Governorate

Study Overview
=================
Brief Summary
-----------------
Tuberculosis (TB) is an infectious disease that commonly affects the lung and is caused by a bacterium called Mycobacterium Tuberculosis. The bacterium mostly affects people with impaired immunity TB becomes the second leading cause of morbidity and mortality among infectious diseases, following the emergence of the human immunodeficiency virus (HIV). HIV is the commonest risk factor for developing a life-threatening tuberculosis disease, on the other hand, HIV related immunodeficiency is worsened by TB infection.TB is among the top 10 causes of death worldwide. In2019, among 8.8 million adults who developed TB disease, 36% were women .TB has become the fifth leading cause of death among women.

Official Title
-----------------
Clinical Presentaion, and Treatment Outcomes in Tuberculous Patients in Sohag Governorate

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Diagnostic Test: sputum analysis
* Diagnostic Test: lymph node biobsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age above 18ys. confirmed diagnosis of tuberculosis. Exclusion Criteria: childern. not confirmed diagnosis of tuberculosis.

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 A,<br>group A ( Pulmonary Tuberculosis). | Diagnostic Test: sputum analysis<br>* sputum analysis to diagnose tuberculosis<br>|
| group B<br>group B ( Extra pulmnary Tuberculosis). | Diagnostic Test: lymph node biobsy<br>* to diagnose tuberculous lymphadenitis<br>* Other names: to diagnose tuberculous lymphadenitis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent of cured tuberculous patients | to detect percent of cured patients | 1 year | 
| percent of treatment failure | to detect percent of treatment failure in tuberculous patients | 1 year |
Drug-drug Interactions Between DWC202313 and DWC202314 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This is A two-arm, open-label, single-sequence, multiple oral dosings, crossover study to evaluate the safety and the pharmacokinetic interaction of DWC202313 and DWC202314 in healthy adult volunteers.

Official Title
-----------------
A Two-arm, Open-label, Single-sequence, Multiple Oral Dosings, Crossover Clinical Trial to Evaluate the Safety and the Pharmacokinetic Interaction of DWC202313 and DWC202314 in Healthy Adult Volunteers

Conditions
-----------------
Drug Drug Interaction

Intervention / Treatment
-----------------
* Drug: DWC202313
* Drug: DWC202314


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 19 year old Exclusion Criteria: Galactose intolerance Lapp lactase deficiency

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWC202313<br>DWC202313 | Drug: DWC202313<br>* Experimental Drug 1<br>|
| Experimental: DWC202314<br>DWC202314 | Drug: DWC202314<br>* Experimental Drug 2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax,ss of DWC202313 and DWC202314 |  | Up to 14 days | 
| AUCt,ss of DWC202313 and DWC202314 |  | Up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax,ss of DWC202313 and DWC202314 |  | Up to 14 days | 
| Cmin,ss of DWC202313 and DWC202314 |  | Up to 14 days | 
| t1/2 of DWC202313 and DWC202314 |  | Up to 14 days | 
| CLss/F of DWC202313 and DWC202314 |  | Up to 14 days | 
| Vdss/F of DWC202313 and DWC202314 |  | Up to 14 days | 
| PTF of DWC202313 and DWC202314 |  | Up to 14 days |
Population Pharmacokinetic Study Based on Quantitative Pharmacology in Patients With Lenalidomide

Study Overview
=================
Brief Summary
-----------------
This is a non-intervention, prospective, open-label and observational clinical trial. The researchers plan to recruit at least 50 qualified patients. The main purpose of this study was to establish a population pharmacokinetic(PPK) model of lenalidomide and explore factors associated with the adverse events of lenalidomide from a pharmacokinetic(PK) perspective.

Detailed Description
-----------------
Studies have found that there is significant interpatient variability in the plasma concentration of lenalidomide, and the PK parameters of lenalidomide do not affect its efficacy but may be correlated with its toxicity. Therefore, the investigators plan to conduct a PPK study on lenalidomide to identify factors contributing to interpatient PK differences, thus refining regimens to mitigate its adverse reactions, in the hope of optimizing the clinical application of lenalidomide. At least 50 patients are planned to be included. It should be noted that the study does not interfere with the patients' treatment plans. Except for the discomfort during blood sampling, patients will not be exposed to any risks.

Official Title
-----------------
Population Pharmacokinetic Study Based on Quantitative Pharmacology in Patients With Lenalidomide

Conditions
-----------------
Multiple Myeloma, Myelodysplastic Syndromes, Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are above the age of 18 Patients who receive lenalidomide treatment Exclusion Criteria: Patients have received other investigational systemic drugs The clinical data are deemed insufficient There appear other factors that rendered them ineligible.

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 |
| --- | --- | --- |
| drug blood concentration | Blood samples of patients who took lenalidomide were collected by opportunistic blood collection, which were used for concentration determination by using HPLC/MS. Lenalidomide blood levels in patients were prevalent between 1-1000 ng/ml. | 2 years | 
| genotype | Genotypes of patients needed to be determined include ABCB1 3435 C>T, ABCB1 1236 A>G and ABCB1 2677 A>C/T. | 1 month |
Sleep Quality Among Children And Adolescents With Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Sleep is an important health behavior for children and adolescents due to the impact it has on both mental and physical development. Although sleep is considered a resting period, it is also a period when the brain work to encode and consolidate memories into more stable representations for long term recall . Unfortunately, pediatric sleep disorders affect 25 - 40% of youth and several studies showed that children with chronic illness experience more problems with initiating and maintaining sleep than their non- chronically ill children . Type 1 diabetes mellitus (T1DM) affects the quality of sleep in children and adolescents as well as their caregivers. Sleep disturbances in patients with T1DM may negatively impact their ability to manage their diabetes .

Official Title
-----------------
Sleep Quality Among Children And Adolescents With Type 1 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Other: questionnaire about sleep quality in diabetic children


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children and adolescents aged 6 to 15 years . diagnosed with T1DM for at least 6 months attending the pediatric diabetes outpatient clinic at Sohag University Hospital. Age and sex matched control group for acute non-serious illnesses Exclusion Criteria: Children and adolescents with associated neurological or psychiatric disorders .

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 15 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| diabetes children<br> | Other: questionnaire about sleep quality in diabetic children<br>* Pittsburgh sleep quality index<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of nighttime sleep in hours in night times and weekends | duration of nighttime sleep in hours in night times and weekends | in the past month | 
| sleep problems as frequent awakening during the night | sleep problems as frequent awakening during the night | in the past month |
Treatment of Challenging Macular Holes Using Plasma Rich in Growth Factors

Study Overview
=================
Brief Summary
-----------------
Aim of the Study:To report the structural and visual outcomes of plasma rich in growth factors in closure of challenging macular holes

Detailed Description
-----------------
Challenging full thickness macular holes ( FTMH) include : Recurrent FTMH Persistent (refractory) FTMH Macular holes in eyes with pathological myopia Large macular holes with an inner diameter of more than 650 µm. Plasma rich in growth factors (PRGF) is characterized by a moderate concentration of platelets, in the absence of leukocytes. This absence of leukocytes is based on the fact that they synthesize matrix metalloproteinases, free radicals, and proinflammatory cytokines, which do not contribute and even impair the altered tissue regeneration Aim of the Study:To report the structural and visual outcomes of plasma rich in growth factors in closure of challenging macular holes

Official Title
-----------------
Treatment of Challenging Macular Holes Using Plasma Rich in Growth Factors

Conditions
-----------------
Macular Holes

Intervention / Treatment
-----------------
* Biological: Plasma rich in growth factors ( PRGF )


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Challenging FTMH which include Recurrent macular holes Persistent(refractory) macular holes Macular holes in eyes with pathological myopia Large macular holes with an inner diameter of more than 650 µm Exclusion Criteria: 1-Corneal opacities 2-Glaucomatous patients 3-Co-existing macular pathology ( e.g. diabetic retinopathy, vein occlusion and age related macular degeneration ) 4-History of PPV for any reason other than FTMH

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: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Plasma rich in growth factors ( PRGF )|Plasma rich in growth factors (PRGF) is characterized by a moderate concentration of platelets, in the absence of leukocytes. This absence of leukocytes is based on the fact that they synthesize matrix metalloproteinases, free radicals, and proinflammatory cytokines, which do not contribute and even impair the altered tissue regeneration|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that revealed closure of challenging macular holes | By clinical examination and OCT | 6 months |
Comparison of a Novel Ultrasound System Versus Standard Imaging Modalities

Study Overview
=================
Brief Summary
-----------------
This is an observational study comparing a novel ultrasound-based imaging system (MAUI K3900) to standard-of-care (SoC) imaging systems used to guide and/or manage interventional radiologic procedures such as solid organ biopsies or lesion ablations.

Detailed Description
-----------------
The purpose of this study is to obtain images using the MAUI Imaging Inc.'s K3900 Ultrasound System and compare them to images captured with FDA cleared imaging devices including traditional ultrasound, CT, MRI and Xray, and to study device safety. The information obtained in this study will inform MAUI Imaging as to what specific follow-on studies will be done in support of appropriate FDA clearances and/or claims. No diagnostic or patient management decisions will be made using the MAUI K3900 Ultrasound System in this study.

Official Title
-----------------
Comparison of a Novel Ultrasound System Versus Standard Imaging Modalities in the Context of Interventional Radiologic Procedures

Conditions
-----------------
Image-Guided Biopsies and/or Ablations

Intervention / Treatment
-----------------
* Device: Ultrasound-based imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing standard / routine interventional radiologic procedure Exclusion Criteria: Unwilling or unable to provide informed consent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ultrasound-based imaging|Ultrasound-based imaging|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usefulness relative to standard imaging for image-guided solid organ biopsies and/or ablations | How does imaging with the K3900 compare with imaging currently used to guide solid organ biopsies or ablations, usually standard ultrasound, fluoroscopy, and/or CT? | Up to 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasound Imaging, Interventional Radiology, Image-guided biopsy, Image-guided tumor ablation, Image-guided procedures
Role of MSCT Volumetry in Assessment of Brain Atrophy in Septic Patients

Study Overview
=================
Brief Summary
-----------------
assessment of brain atrophy associated with septic ICU patients by using MSCT Volumetry

Detailed Description
-----------------
Sepsis is the leading cause of admission to ICU , the number of patients who survive and discharge from ICU has also increased due to technological advances in ICU however quality of life of these patients after ICU discharge is lower than that of healthy people of a similar age, in particular Sepsis associated encephalopathy associated with brain dysfunction. We hypothesized that brain damage including brain volume reduction that ocurre in acute phase of Sepsis using CT scan and there finding  relationship to risk factor and outcome. We compared head CT finding at time of admission with those obtained during the course of the treatment

Official Title
-----------------
Role of Semi-automatic MSCT Volumetry in Assessment of Rapidly Progressive Brain Atrophy in Septic ICU Patients.

Conditions
-----------------
Sepsis-Associated Encephalopathy

Intervention / Treatment
-----------------
* Device: MSCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients >16years old with sepsis associated with disturbance in conscious level admitted to ICU Exclusion Criteria: Age< 16y Brain death Hematological disease Malignant disease Hypoxemia Error in automatic tissue classification Motion artifac

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 45 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 |
| --- | --- |
| cohort<br>patients >16y with sepsis associated with disturbance in conscious level, the first braun CT scan will be routinely performed on admission, the second further brain CT Scan will be obtained whenever prolonged disturbance of consciousness will be detected. | Device: MSCT<br>* Using Semi-automatic MSCT Volumetry in assessment of brain atrophy associated with septic ICU patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Correlation between sepsis and brain volume reduction . - Determine the role of the CT scan in assess brain volume in acute phase of sepsis and it,s influences in improvement activities of daily living. | - Determine the role of the CT scan in assess brain volume in acute phase of sepsis and it,s influences in improvement activities of daily living after discharge from ICU. | follow up through 10 days after admission in ICU |
Neurovisual Function in CHARGE Syndrome

Study Overview
=================
Brief Summary
-----------------
The rationale of the study is to analyze visual function and correlate them with adaptive functions in patients with CHARGE syndrome in order to identify a pattern of specific indicators to enable better patient care

Detailed Description
-----------------
CHARGE syndrome is a malformative condition characterized by coloboma in about 70-95% of patients. This anatomical abnormality results in severe visual impairment that strongly affects the characterization of the disability profile. Although the ocular anatomical deficits associated with the syndrome have been extensively described in the literature, coloboma being a major criterion for diagnosis, little is reported about the characteristics of visual function, such as acuity, visual field ocular motility, and other features. Patients with CHARGE syndrome have multiple sensory deficif often accompanied by intellectual disability, which often makes the classical methods used in ophthalmologic evaluation inapplicable. According to the few studies in the literature, visual acuity in patients with CHARGE syndrome is often severely impaired with mean values below 20/60 (McMain et al 2008; Nishina et al 2012; Russell-Eggitt et al. 1990; Stromland et al. 2005; Tellier et al. 1998) However in opposition to the recurrent pessimistic findings resulting from ophthalmologic assessment in clinical practice, such patients present with good visual and adaptive abilities in daily life. The rationale of the study is to analyze visual function and correlate them with adaptive functions in patients with CHARGE syndrome in order to identify a pattern of specific indicators to enable better patient care

Official Title
-----------------
Assessment Study of Neurovisual Function in CHARGE Syndrome

Conditions
-----------------
CHARGE Syndrome

Intervention / Treatment
-----------------
* Behavioral: visual function evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with molecularly confirmed CHARGE syndrome. Exclusion Criteria: Patients with CHARGE syndrome that has not been molecularly confirmed

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: visual function evaluation|visual function evaluation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate the correlation between severity of anatomical impairment and neurovisual ability. | to detect aspects of visual function by studying ocular motility, visual acuity, contrast sensitivity, distance attention, and binocular visual field | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CHARGE syndrome, Visual function
All Children in Focus (ABC) 0-2 Years: A Pilot Study

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to compare parents tools to handle challenges and strengths as parents. The main questions it aims to answer are: Do participating parents feel more confident than non partipating parents? Does the program have positive effects on parenting practices, parents´ well-being, and social support? Is the programme more effective for some groups of parents ( e.g., gender, socioeconomis status) Participating parents will attend four 1-hour, manual based sessions followed by a 30-minutes optional coffe break. In addition parents will be asked to do homework assignments between the sessions. Researchers will compare the intervention group with an equally sized control group that will receive the program later the same year.

Official Title
-----------------
All Children in Focus (ABC) 0-2 Years: A Pilot Study

Conditions
-----------------
Parent-Child Relations, Parenting

Intervention / Treatment
-----------------
* Behavioral: ABC 0-2 years
* Other: waiting list


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents to children aged 0-2 years Exclusion Criteria: Non fluent in Swedish language
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br> | Behavioral: ABC 0-2 years<br>* Four 1 hour meetings and homework<br>|
| Active Comparator: Control group<br> | Other: waiting list<br>* Will be put on hold for four weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parents´self efficacy | Questionnaire | Four weeks | 
| Parenting practices and parent child relationship | Questionnaire | Four weeks | 
| Parents´involvement and warmth | Questionnaire | Four weeks | 
| Parents´ well-being | Questionnaire | Four weeks | 
| Parents´ social network | Questionnaire | Four weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parenting support