linjc16/ctgov huggingface dataset:
Pharmaco-epidemiological Description of the Population Treated With Aptivus Under Market Conditions, Safety & Efficacy

Study Overview
=================
Brief Summary
-----------------
To obtain information on clinical practices for patients treated by Aptivus in real life

Official Title
-----------------
Pharmaco-epidemiological Description of the Patient Population Treated With Aptivus Under Market Conditions, Safety & Efficacy

Conditions
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HIV Infections

Intervention / Treatment
-----------------
* Drug: tipranavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV positive patients for whom Aptivus treatment is initiated by their physician Aptivus SCP respect Exclusion Criteria: None if the inclusion criteria are respected: observational study

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 |
| --- |
|Drug: tipranavir|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With a Viral Load< 50 Copies/mL and a Gain in CD4 Higher Than 100 Cells/mm3 | The evaluation at month 6 of an immunovirological response defined by a viral load less than 50 copies/mL and a gain in CD4 between day 0 and month 6 higher than 100 cells/mm3 | 6 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Early Virological Response | Number of patients presenting a decrease of viral load (HIV-RNA copies per mL) from day 0 to month 1 higher than 1 log10 | 1 month after inclusion | 
| Viral Load Response at 1 Month | Please note that a reported value of 49 copies/mL for the median or first quartile indicates that the observed statistic for the outcome measure is below the limit of quantification for viral load. The limit of quantification is 50 copies/mL. | 1 month after inclusion | 
| CD4 Count at 1 Month |  | 1 month after inclusion | 
| Evaluation of Intermediate Virological Response, Viral Load < 400 Copies/mL | Number of patients with a viral load < 400 copies/mL after 3 months of treatment | 3 months after inclusion | 
| Evaluation of Intermediate Virological Response, Viral Load < 50 Copies/mL | Number of patients with a viral load < 50 copies/mL after 3 months of treatment | 3 months after inclusion | 
| Viral Load Response at 3 Months | Please note that a reported value of 49 copies/mL for the median or first quartile indicates that the observed statistic for the outcome measure is below the limit of quantification for viral load. The limit of quantification is 50 copies/mL. | 3 months after inclusion | 
| CD4 Count at 3 Months |  | 3 months after inclusion | 
| Patient Self Perception of the New Treatment | Visual analogue scale range from 0 not at all satisfied to 100 extremely satisfied | Day 0, month 3 and month 6 |
Correlation Between Postoperative Central Corneal Thickness and Endothelial Damage After Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
To study correlation between postoperative corneal edema and endothelial cell loss after cataract surgery by microcoaxial phacoemulsification.

Detailed Description
-----------------
Cataract surgery facilitates improved visual acuity through extraction of an opacified lens, followed by intraocular lens implantation. An average adult cornea has 2000 to 2500 cells/mm2, a count that diminishes with age with a rate of attrition of approximately 0.3% to 0.5% per year. Long-term postoperative corneal transparency depends on the morphological stability and functional integrity of the corneal endothelium. It is well established that all surgical interventions that require entry into the anterior chamber result in some damage to the corneal endothelium. Endothelial cell loss results in cell hypertrophy to maintain continuity, resulting in a change in endothelium cell density and morphology. Many studies have assessed the impact of various surgical techniques on endothelial damage and numerous studies have investigated the factors influencing endothelial cell loss after phacoemulsification. The goal of this study is to investigate the correlation of postoperative corneal edema with the reduction of endothelial corneal cell density after phacoemulsification.

Official Title
-----------------
Correlation Between Postoperative Central Corneal Thickness and Endothelial Damage After Cataract Surgery by Phacoemulsification

Conditions
-----------------
Cataract, Phacoemulsification

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The presence of senile cataract with equivalent grades and a history of visual acuity regression Exclusion Criteria: Patient with total white cataract With history of ocular surgery With other eye diseases (corneal pathology, Fuchs dystrophy, uveitis and glaucoma) or systemic diseases (diabetic disorder and dementia)

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 |
| --- | --- | --- |
| Pachymetry | Measurement of the thickness of the eye's cornea with a pachymeter | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial cell density | Endothelial cell density measurements with noncontact specular microscope | Day 1 | 
| Pachymetry after 1 month | Measurement of the thickness of the eye's cornea with a pachymeter | Day 30 | 
| Endothelial cell density after 1 month | Endothelial cell density measurements with noncontact specular microscope | Day 30 |
Multiphoton Laser Scanning Microscopy in Cutaneous Optical Pathology

Study Overview
=================
Brief Summary
-----------------
We use multiphoton laser scanning microscopy to observe cutaneous anatomy and pathology. The study aims to compare surgical specimen by conventional pathology slice with the image by non-invasive multiphoton laser scanning microscopy.

Detailed Description
-----------------
For skin diseases, the most convincing method for diagnosis to date is surgical biopsy. However, a skin biopsy is an invasive procedure which carries the risk of tissue damage, wound infection and scar formation. To solve the inconvenience from surgical biopsy, multiphoton laser scanning microscopy is a developing, non-invasive method for observing the cutaneous anatomy and pathology. Multiphoton laser scanning microscopy is good in tissue penetration and resolution with less tissue damage. The study aims to compare surgical specimen by conventional pathology slice with the image by non-invasive multiphoton laser scanning microscopy. A good correlation in multiphoton image may serve as optical biopsy for cutaneous pathology and spare the invasive procedure of skin biopsy.

Official Title
-----------------
Multiphoton Laser Scanning Microscopy in Cutaneous Optical Pathology

Conditions
-----------------
Optical Biopsy, Cutaneous Pathology, Dermatopathology

Intervention / Treatment
-----------------
* Behavioral: Multiphoton laser image in cutaneous pathology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving cosmetic surgeries such as removal of moles Exclusion Criteria: No special exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Multiphoton laser image in cutaneous pathology|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
An Open-Label Study of DCCR Tablet in Patients With PWS

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to monitor the long-term safety of DCCR in PWS patients.

Official Title
-----------------
An Open-Label Study of Diazoxide Choline Controlled-Release Tablet in Patients With Prader-Willi Syndrome

Conditions
-----------------
Prader-Willi Syndrome

Intervention / Treatment
-----------------
* Drug: DCCR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Successful completion of clinical study C602, Visit 15 Provide voluntary, written informed consent (parent(s) / legal guardian(s) of subject); provide voluntary, written assent (subject, as appropriate) Primary caregiver must be able to communicate with Investigator and study site personnel as well as read and complete the study-required questionnaires. Exclusion Criteria: Positive urine pregnancy test (in females of childbearing potential) Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 90 days after study participation Any new disease, condition, or circumstance, which may significantly impact subject safety

Ages Eligible for Study
-----------------
Minimum Age: 4 Years

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

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: DCCR<br>25 - 450 mg DCCR | Drug: DCCR<br>* Once daily oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (Safety) | Assess the safety of DCCR by evaluating the incidence and severity of adverse events reported. | Baseline to Week 106 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PWS, Prader-Willi Syndrome
Gardner Packard Healthy Lifestyles Program

Study Overview
=================
Brief Summary
-----------------
Gardner GOALS is a 6 month program for treatment of childhood obesity that consists of twice monthly telehealth meetings with a health educator. Potential participants enter the study using a randomly ordered list of eligible patients based on BMI, age and number of clinic visits in 2020.

Detailed Description
-----------------
The Gardner GOALS curriculum focuses on healthy eating and activity. The study participants are kids 6 to 14 years old with BMI ≥95th percentile who are patients at the Gardner Packard Children's Health Center, a federally qualified health center. Lessons contain educational materials and behavioral change strategies to promote healthy eating and physical activity and reduce screen time. Patients are encouraged to continue routine clinic visits with their primary care physicians during the course of the study.

Official Title
-----------------
Gardner GOALS for Treatment of Obesity

Conditions
-----------------
Childhood Obesity

Intervention / Treatment
-----------------
* Behavioral: Gardner GOALS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI ≥ 95th percentile Two clinic visits in 2020 Exclusion Criteria: Signs of an eating disorder Moved out of town and not planning to return to Gardner Packard Children's Health Center

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 14 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gardner GOALS<br>Healthy lifestyle intervention by telehealth plus regular clinic visits | Behavioral: Gardner GOALS<br>* 12 lesson curriculum focusing on healthy eating, increased physical activity and decreased screen time<br>|
| No Intervention: Control<br>Regular clinic visits | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index | Change in trajectory of body mass index from the year prior to the intervention compared to the year after starting the intervention | Baseline, year 1 |
The Effect of Light Deprivation on Visual Functions in Adult Amblyopes

Study Overview
=================
Brief Summary
-----------------
Amblyopia is a significant health problem, affecting up to 4% of the population in the United States. Amblyopia, commonly known as lazy eye, is a developmental visual disorder in which one or both eyes suffer from poor vision as a result of being disadvantaged in early life. Strabismus, or eye misalignment, such as crossed eyes (esotropia) or wandering eyes (exotropia), and anisometropia, or a power difference between the eyes, are the most common causes of amblyopia. If conventional treatment, such as patching the better seeing eye, is not initiated during the critical period of visual development, lasting visual impairment may persist throughout life. This critical period of visual development has been thought to end around age 10. However, recent research has demonstrated that the critical period of visual development can be extended into adulthood. Complete light deprivation in animal models has restored plasticity in the visual cortex and has demonstrated drastic recovery of vision in amblyopic eyes. The objective of this pilot study is to evaluate the impact of complete light deprivation on visual function in a cohort of human adults with severe amblyopia from anisometropia.

Official Title
-----------------
The Effect of Light Deprivation on Visual Functions in Adult Amblyopes

Conditions
-----------------
Amblyopia, Anisometropia, Visual Impairment

Intervention / Treatment
-----------------
* Device: Blindfold


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Amblyopia, defined as decreased vision, less than or equal to 20/100, in one eye secondary to anisometropia Age 18-50 years Exclusion Criteria: Strabismus Eye pathology, such as cataract, corneal disorder, maculopathy, glaucoma, Mental health diagnosis, such as depression, schizophrenia, bipolar disorder or anxiety disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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: Light deprived study subjects<br>Study subjects who are blindfolded for 48 hours | Device: Blindfold<br>* Study subjects will be blindfolded to create an environment of complete light deprivation which will be worn for 48 hours.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Logmar visual acuity |  | Measured at 60 minutes after blindfold is removed | 
| Logmar visual acuity |  | Measured at one week after blindfold is removed |
Monitoring of Lung Sounds of Patients With Pneumonia

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate if any correlation between lung sounds of pneumonia patients and the clinical development or therapy of the pneumonia exists.

Official Title
-----------------
Monitoring of Lung Sounds of Patients With Pneumonia

Conditions
-----------------
Pneumonia

Intervention / Treatment
-----------------
* Device: Lung sound analyzer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ambulant aquired pneumonia with typically radiological signs hospitalisation at medical clinic I, university hospital Aachen age at least > 18 years CRB-65 score > 1 CRP> 60mg/l fever lung sounds audible by stethoscope legal capacity and being able to understand and to follow the instructions of the study staff being able to consent and being able to understand the importance and the consequence of the study not being accomondated in an institution Exclusion Criteria: pneumonia acquired in a hospital artificial respiration or other means for supporting respiration allergic reaction because of skin contact with polymers pregnancy or breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Lung Sound Analyzer<br>Patient with pneumonia admitted to hospital will receive additional auscultation with lung sound analyzing stethoscope | Device: Lung sound analyzer<br>* Patients will be aucultated with lung sound analyzer. The auscultation will be done three times daily during the duration of the complete hospital stay.<br>* Other names: Littmann 3M;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sound of lungs | 3 times a day for longest 5 days | 5 days |
Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning

Study Overview
=================
Brief Summary
-----------------
Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning.

Detailed Description
-----------------
The study aims to investigate the Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning: A Randomized Controlled Clinical Trial

Official Title
-----------------
Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning: A Randomized Controlled Clinical Trial

Conditions
-----------------
Toxicity, Drug

Intervention / Treatment
-----------------
* Device: Paraffin oil gastric lavage
* Device: Gastric lavage with saline and sodium bicarbonate 8.4%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Patients with symptomatic acute aluminum phosphide poisoning Exclusion Criteria: • Pregnant and lactating women Asymptomatic patients with history of acute aluminum phosphide exposure. Patients with ingestion or exposure to other substances in addition to aluminum phosphide. Patients with other major medical conditions (e.g. cardiovascular disease, renal or hepatic failure). Patients with previous medical intervention (had gastric lavage in any medical center before admission). Patients with disturbed consciousness level Patients with post cardiac arrest cases
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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paraffin oil gastric lavafe<br>Gastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution | Device: Paraffin oil gastric lavage<br>* Gastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution<br>* Other names: Paraffin oil;|
| Active Comparator: Saline gastric lavage<br>Gastric lavage with saline and sodium bicarbonate | Device: Gastric lavage with saline and sodium bicarbonate 8.4%<br>* Gastric lavage with saline and sodium bicarbonate 8.4%<br>* Other names: Saline gastric lavage;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of deaths | The number of deaths | 6 months |
Stereotactic Directional Vacuum-Assisted Breast Biopsy

Study Overview
=================
Brief Summary
-----------------
Stereotactic directional vacuum-assisted breast biopsy (ST DVAB) is a standard biopsy procedure for suspicious findings on mammograms in Western countries for more than 10 years [1-3], it has replaced the needle localization (NLOC) excisional biopsy for the lesions alike and was reported to feature a high sensitivity, very low delayed false-negative rate (less than 2%)[4,5]. Moreover, it causes less scarring, less psychologic stress to patients and less morbidity compared with needle localization excisional biopsy [6,7]. However, its sensitivity, accuracy has seldom been reported in Asian countries [8] , since most Asian women have different breast parenchyma pattern, different breast cancer prevalence. Therefore, we retrospectively reviewed outcomes of the two groups of patients receiving either ST DVAB or NLOC excisional biopsy, trying to investigate if ST DVAB can be an effective alternative to NLOC excisional biopsy in our country.

Official Title
-----------------
The Diagnostic Accuracy of Stereotactic Directional Vacuum-Assisted Breast Biopsy

Conditions
-----------------
Breast Cancer, Stereotactic Directional Vacuum-assisted Breast Biopsy, Female, Adult Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The indication for ST DVAB was lesions with suspicious nature for malignancy seen on mammograms which biopsy is necessitated for tissue proof, or probably benign or benign appearing lesions seen on mammograms but patients or clinicians requested biopsy Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

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

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 |
| --- | --- | --- |
| The sensitivity of stereotactic vacuum assisted breast biopsy for breast cancer diagnosis | the aforementioned outcome measure-sensitivity- is the probability of the stereotactic vaccum assisted breast biopsy can correctly diagnose the breast cancer. And according to statistical definition, it is defined as- for those breast cancer cases, how many of them can be correctly diagnosed by stereotactic breast biopsy. | up to 5 years ( July 2008 to June 2013) |