linjc16/ctgov huggingface dataset:
Epidemiology and Outcome of Pediatric Traumatic Cataract

Study Overview
=================
Brief Summary
-----------------
this study aims to explore the demography of pediatric traumatic cataract in upper Egypt, and report outcomes and complications of traumatic cataract surgery in these children.

Detailed Description
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Ocular trauma is one of the leading causes of acquired unilateral blindness in childhood.1,2 Apart from the permanent disability, ocular trauma has a profound impact on both patients and society at different levels, including, but not limited to, psychological trauma, cosmetic disfigurement, socioeconomic costs, and the need for specialized medical care and vocational rehabilitation. Traumatic cataract is a common complication of pediatric eye injury. In developing countries, ocular trauma was responsible for up to 45% of childhood cataract. Vision loss induced by traumatic cataract is surgically manageable. However, the high risk of postoperative inflammation, posterior capsular opacification (PCO), amblyopia, and the associated ocular tissue damage may negatively impact visual outcome. Several studies reported visual outcome of pediatric traumatic cataract in different populations. With the sacristy of studies on traumatic cataract in Egyptian children, we conducted this retrospective study to report the demographic features, visual outcome, and complications of pediatric traumatic cataract at Assiut University Hospital, the biggest tertiary referral center in Upper Egypt.

Official Title
-----------------
Epidemiology and Outcomes of Pediatric Traumatic Cataract in Upper Egypt: A Tertiary Center Study

Conditions
-----------------
Traumatic Cataract

Intervention / Treatment
-----------------
* Procedure: traumatic cataract extraction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children who have undergone traumatic cataract surgery at Assiut university over 1 year period. Exclusion Criteria: children with posterior segment injury. children who did not complete at least 6 months of postoperative follow-up.

Ages Eligible for Study
-----------------
Maximum Age: 17 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: traumatic cataract extraction|Irrigation/aspiration of traumatic cataract in children with posterior chamber intraocular lens implantation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographics | Age(in years), and gender (male or female) procedure, visual outcome, postoperative complications | 6 months | 
| Mechanism of injury | Blunt or penetrating eye injury | 6 months | 
| Visual outcome | Visual acuity according to Snellen chart and LogMAR | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric ocular trauma, Posterior chamber intraocular lens
Probing the Role of Sodium Channels in Painful Neuropathies

Study Overview
=================
Brief Summary
-----------------
Neuropathic pain is a frequent feature of peripheral neuropathy causing a significant impact on patients' quality of life and health care costs. Not all individuals with neuropathy develop pain and it is not possible to predict who is more or less susceptible among those with similar risk exposure. Current inability to identify high-risk individuals hinders development and application of therapies to counteract neuropathic pain and to address targeted prevention strategies. Recently, the investigators Consortium has identified novel pathogenic mutations in genes encoding for two sodium channels (Nav1.7 and Nav1.8) known to play a critical role in the generation and conduction of action potentials in nociceptors and their terminal axons. This study was undertaken in a carefully selected group of patients with painful neuropathy using a candidate gene approach and directly revealed targets for new therapeutic strategies. This discover widened the spectrum of sodium channel-related pain disorders including conditions more common in the general population than those known so far. PROPANE STUDY, starting from the hypothesis of a common origin of neuropathic pain in a cohort of patients with predominantly small fibre neuropathy, aims to develop this original idea in a larger and well characterized study population, to provide evidence for the reliable stratification of patients at high risk and potential new treatments tailored on patients' clinical features, in order to improve their quality of life.

Official Title
-----------------
Probing the Role of Sodium Channels in Painful Neuropathies: Observational Study

Conditions
-----------------
Painful Peripheral Neuropathy, Painless Peripheral Neuropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of sensory neuropathy, including pure small fibre neuropathy (SFN), based on established clinical, nerve conduction study (NCS) and skin biopsy findings (Tesfaye et al. Diab Care 2010) caused by type 1 or type 2 diabetes (World Health Organization criteria) with stable metabolic control for >6 months (haemoglobin A1C <9%); or idiopathic aetiology after ruling out all known causes of neuropathy including vitamin deficiencies, malignancies, toxic, drugs Exclusion Criteria: any other cause of neuropathy

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 |
| --- | --- | --- |
| Number of patients with novel mutations in the genes encoding for Nav1.7, Nav1.8, Nav1.9, Nav1.6, and Nav1.3 sodium channels |  | 2 years |
Vagifem® Used for the Treatment of Atrophic Vaginitis Due to Oestrogen Deficiency

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this study is to investigate the self-reported impact of Vagifem® (estradiol) treatment on urogenital discomfort in women with atrophic vaginitis due to oestrogen deficiency.

Official Title
-----------------
Vagifem® Used for the Treatment of Atrophic Vaginitis Due to Oestrogen Deficiency

Conditions
-----------------
Menopause, Postmenopausal Vaginal Atrophy

Intervention / Treatment
-----------------
* Drug: estradiol, 25 mcg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Atrophic vaginitis due to estrogen deficiency Post-menopausal
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Local treatment<br> | Drug: estradiol, 25 mcg<br>* Vaginal tablets for 6-12 weeks according to product labelling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects reporting vaginal symptoms occuring 'often' and 'frequently' |  |  | 
| Percentage of subjects reporting 'moderate' and 'severe' vaginal symptoms |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  |
Empowering Patients on Choices for Renal Replacement Therapy (Aim 2)

Study Overview
=================
Brief Summary
-----------------
Empowering Patients On Choices for Renal Replacement Therapy (EPOCH-RRT) study seeks to identify factors that matter the most to patients with kidney disease and study how they are impacted by different types of dialysis. The inclusion of patients, caregivers, and patient advocacy organizations as research partners will assure that the study addresses questions of greatest relevance to patients facing the need for dialysis. Aim two is based on preliminary results of Aim one interviews, and in collaboration with the Patient Advisory Panel, the investigators developed a brief questionnaire to be administered to participants in the Dialysis Outcomes and Practice Patterns Study (DOPPS) and Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS). Two separate versions of the questionnaire were created to reflect unique aspects of in-center hemodialysis (HD) and peritoneal dialysis (PD).

Official Title
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Empowering Patients on Choices for Renal Replacement Therapy (Aim 2)

Conditions
-----------------
Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals 18 years of age or older. Currently consented in the Dialysis Outcomes and Practice Patterns Study - (DOPPS) or the Peritoneal Outcomes and Practice Patterns Study (PDOPPS). Exclusion Criteria: Individuals under 18 years of age. Individuals unable to provide informed consent.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hemodialysis (HD)<br>Patients who have chronic kidney disease (CKD) and are currently on hemodialysis. | |
| Peritoneal Dialysis (PD)<br>Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Quality of Life | % of patients very much or extremely affected by dialysis | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Kidney Disease, Hemodialysis, Peritoneal Dialysis
A Study to Assess the Impact of Pneumococcal Conjugate Vaccination Programme on the Carriage of Pneumococci

Study Overview
=================
Brief Summary
-----------------
A study taking swabs from the back of the nose (nasopharynx) to look at carriage of pneumococci.

Official Title
-----------------
A Study to Assess the Impact of Pneumococcal Conjugate Vaccination Programme on the Carriage of Pneumococci

Conditions
-----------------
Pneumococcal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Born in a cohort eligible for routine or catch up pneumococcal conjugate vaccination (i.e. date of birth since 4th September 2004) or a family member where a child is eligible and has been enrolled Written informed consent given by the subject's parent/ legal guardian as well as assent from the child after the nature of the study has been explained to them or Written informed consent given by the subject after the nature of the study has been explained to them Exclusion Criteria: Moderate to severe disability. Cerebral palsy, syndromes and neurological disorders affecting swallowing. Ear Nose and Throat disorders affecting the anatomy of the ear,i.e.malformed ears. Confirmed or suspected immunodeficiency (congenital or acquired). On immunosuppressive therapy.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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 |
| --- | --- | --- |
| Presence of pneumococci in nasopharyngeal swabs |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumococci, Streptococcus pneumoniae
Epicardial vs. Transvenous ICDs in Children

Study Overview
=================
Brief Summary
-----------------
This observational study included all patients <18-year-old implanted with an Implantable cardioverter defibrillator (ICD) at Necker Hospital, Paris, France, from January 2003 to January 2021. Outcomes (ICD-related complications and reinterventions) were compared between epicardial and transvenous ICDs using Cox proportional hazard models.

Official Title
-----------------
Epicardial Versus Transvenous Implantable Cardioverter Defibrillators in Children

Conditions
-----------------
Implantable Cardioverter Defibrillator Complications, Implantable Defibrillator User

Intervention / Treatment
-----------------
* Device: Implantable cardioverter defibrillator use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICD implantation Age < 18 years Exclusion Criteria: - Absence of patient's consent

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 18 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Implantable cardioverter defibrillator use|Implantation of an implantable cardioverter defibrillator (epicardial or transvenous)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with implantable cardioverter defibrillator system dysfunction (lead dysfunction requiring reintervention) | Number of patients in each group (epicardial and transvenous implantable cardioverter defibrillator) with an implantable cardioverter defibrillator dysfunction (dysfunction of at least one lead requiring reintervention) at the end of the follow-up | up to 15 years |
Study of Prognostic Factors in Adult Lymphoblastic Lymphoma

Study Overview
=================
Brief Summary
-----------------
Retrospective observational study with systematic collection of data on filiation (age at diagnosis and sex), clinical data (IPI, ECOG, early response to chemotherapy, overall response to chemotherapy), biological (strain B or T, infiltration of the nervous system central [CNS], bone marrow [MO], lactate dehydrogenase (LDH) level at the time of diagnosis, as well as genetic patients included in the study, as well as the PETHEMA protocol used in the treatment of same patients The study will review the PETHEMA protocols from 2003 to the present

Detailed Description
-----------------
Retrospective observational study with systematic collection of data on filiation (age at diagnosis and sex), clinical data (IPI, ECOG, early response to chemotherapy, overall response to chemotherapy), biological (strain B or T, infiltration of the nervous system central [CNS], bone marrow [MO], lactate dehydrogenase (LDH) level at the time of diagnosis, as well as genetic patients included in the study, as well as the PETHEMA protocol used in the treatment of same patients The study will review the PETHEMA protocols from 2003 to the present. Analysis of the main clinical-biological variables as independent risk factors in adult patients (> 15 years) diagnosed with ALL

Official Title
-----------------
FPLLA-PETHEMA-001: Study of Prognostic Factors in Adult Lymphoblastic Lymphoma

Conditions
-----------------
Lymphoblastic Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients >15 years old diagnosed with ALL and treated with the PETHEMA protocols for ALL Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
| Description pronostic factors | Study of the main clinical-biological variables as independent risk factors in adult patients (> 15 years) diagnosed with ALL | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | To study if there has been an increase in overall survival (OS), in patients diagnosed with ALL in the different PETHEMA protocols | 1 year | 
| Progression free survival | To study if there has been an increase in progression-free survival (PFS) in patients diagnosed with ALL in the different PETHEMA protocols | 1 year |
Early Access of MK0518 in Combination With an Optimized Background Antiretroviral Therapy (0518-023)

Study Overview
=================
Brief Summary
-----------------
This is a treatment use study to provide early access to MK0518 for the treatment of HIV-1 infection in patients who have limited or no treatment options due to virological failure, resistance, or intolerance to multiple antiretroviral regimens. Enrollment in this study is patient driven. Investigators are not proactively assigned. There is no target sample size and duration of the study is indefinite. For information on how to enroll in the study, see link below.

Official Title
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Early Access of MK0518 in Combination With an Optimized Background Antiretroviral Therapy (OBT) in Highly Treatment Experienced HIV-1 Infected Patients With Limited to No Treatment Options

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: raltegravir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV positive patients who have limited or no treatment options and have documented resistance Exclusion Criteria: Patient has previously been on MK0518 therapy

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: raltegravir|raltegravir 400 mg P.O. bid tablet twice daily for 12 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Food and Microbiome Longitudinal Investigation (FAMiLI)

Study Overview
=================
Brief Summary
-----------------
The NYU Human Microbiome Study Cohort is designed to improve understanding of the role of human microbiome in health and disease. This study will serve as a critical NYU biorepository resource for research on human genetics and the microbiome in health and disease

Official Title
-----------------
Food and Microbiome Longitudinal Investigation (FAMiLI)

Conditions
-----------------
Cancer, Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 40 Exclusion Criteria: Use of long term antibiotics. Pregnant

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

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 |
| --- | --- | --- |
| Demographic | sex, race, education, oral health status, lifestyle, medical history, anthropometry, and medication use will be collected using the baseline questionnaire at enrolment. The collected information will provide risk stratification information for statistical control in studies of colorectal tumors and other major chronic diseases. | 5 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in human microbiota between subjects with colorectal adenoma or colorectal cancer and those without. | Pairwise alignment and clustering of sequences into operational taxonomic units (OTUs) | 5 Years |
Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if it is safe and effective to give Lamisil to HIV-positive patients with thrush (a fungal infection) that has not responded to fluconazole.

Detailed Description
-----------------
This is an open-label, dose-escalating study with up to 2 sequential cohorts. The first 15 patients receive Lamisil for 2 weeks. After 2 weeks, patients considered clinically cured (i.e., absence of removable, white plaques) are removed from treatment; patients not considered clinically cured receive an additional 2 weeks of treatment. At the end of 4 weeks, treatment is discontinued, regardless of clinical cure outcome. If less than 80% of patients are clinically cured after the 4 weeks of treatment, a second cohort of 15 patients receive Lamisil on the same treatment regimen as first cohort (i.e., initial 2-week treatment period, with an additional 2 weeks of treatment for those patients who are not considered clinically cured after 2 weeks of treatment).

Official Title
-----------------
A Four-Week, Open-Label, Non-Randomized, Multicenter, Dose-Finding, Pilot Study to Evaluate the Safety and Efficacy of Two Daily Doses of Lamisil (1500 Mg and 2000 Mg), Administered for a Maximum of 4 Weeks in HIV-Positive Subjects With Oral Mucosal Candidiasis Not Having Responded to a Minimum of 200 Mg Fluconazole Monotherapy

Conditions
-----------------
Candidiasis, Oral, HIV Infections

Intervention / Treatment
-----------------
* Drug: Terbinafine hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria You may be eligible for this study if you: Are at least 18 years old. Have thrush that has not responded to at least 10 days of fluconazole treatment. Are HIV-positive. Are expected to live at least 4 weeks. Are able to take oral medication. Exclusion Criteria You will not be eligible for this study if you: Have liver or kidney disease. Have received certain medications. Have a history of serious diarrhea or digestive problems. Are pregnant or breast-feeding.

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
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Terbinafine hydrochloride|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
-----------------
AIDS-Related Opportunistic Infections, Dose-Response Relationship, Drug, Fluconazole, Antifungal Agents, Candidiasis, Oral, Drug Administration Schedule, terbinafine