linjc16/ctgov huggingface dataset:
A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to investigate the safety and efficacy of aripiprazole orally administered over long term in subjects who complete a short-term treatment study of pediatric Autistic Disorder (031-11-002 study).

Official Title
-----------------
A Long-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder

Conditions
-----------------
Autistic Disorder

Intervention / Treatment
-----------------
* Drug: Aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient meets Autistic disorder diagnostic criteria defined in DSM-IV-TR. The patient has completed the 031-11-002 study (the patient has visited the hospital during week8) Inpatient or outpatient status Exclusion Criteria: The patient is currently diagnosed with another disorder on the autism spectrum in DSM-IV-TR, including Asperger's, Rett's Disorder, PDD-NOS, Childhood Disintegrative Disorder, or Fragile-X Syndrome. Patients who fall under a contraindication listed in the ABILIFY package insert Others

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 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: Aripiprazole<br>administered orally once daily | Drug: Aripiprazole<br>* Flexibly dose administered orally once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score | The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Individual scores were summed, therefore, the overall score range was between 0-45. Higher scores represent worse condition. | Baseline, the final administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autistic Disorder, children and adolescents, aripiprazole, Long-term safety study, children and adolescents
Incidence of Dyschromatopsia in Glaucoma

Study Overview
=================
Brief Summary
-----------------
Incidence of dyschromatopsia

Detailed Description
-----------------
Incidence of dyschromatopsia should be elevated in glaucoma compared to a healthy control population. However, the actual incidence rate is not investigated.

Official Title
-----------------
Incidence of Dyschromatopsia in Glaucoma

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Procedure: Color Vision Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of glaucoma age between 18 and 99 years old best corrected visual acuity(BCVA) > 0.2 (decimal Snellen) Exclusion Criteria: age < 18 yo BCVA < 0.2 known dyschromatopsia known corneal disease St.p. corneal surgeries macula disease history of medication use that can influence color vision (e.g. hydroxychloroquine)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Glaucoma<br>Patients with a diagnosis of glaucoma will undergo color vision test | Procedure: Color Vision Test<br>* Farnsworth Panel D15/Hue test plus Ishihara charts<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dyschromatopsia | Incidence of dyschromatopsia should be elevated in glaucoma compared to a healthy control population. However, the actual incidence rate is not investigated. | first and only study visit (day 1 of the study) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Dychromatopsia
Orthostatic Hypotension in Elderly Nursing Home Residents

Study Overview
=================
Brief Summary
-----------------
In this study the investigators aimed to investigate the prevalence of orthostatic hypotension in elderly nursing home residents. to investigate whether the presence of orthostatic hypotension influences the chance of successful rehabilitation.

Conditions
-----------------
Orthostatic Hypotension

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nursing home resident Exclusion Criteria: patients at the palliative department life expectancy < 4 weeks patients only temporarily admitted to the nursing home
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nursing home residents<br>In this study, patients from both the somatic and the psychogeriatric department are included. For the primary endpoint 'successful rehabilitation' only the patients from the somatic departments are included. | Other: No intervention<br>* This study is an observational cohort study > no interventions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Orthostatic hypotension | Orthostatic hypotension is defined by consensus as a fall in blood pressure of at least 20 mmHg systolic or 10 mmHg diastolic within 3 minutes in the upright position | Baseline | 
| Successful rehabilitation | Successful rehabilitation is defined as whether the patient is able to return to his/her home or another location (but not a nursing home) after discharge from the nursing home. Unsuccessful rehabilitations implies that the patients becomes a long-stay nursing home resident. | After 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause and Cardiovascular mortality |  | Date of death | 
| Quality of life | Quality of life is measured using the RAND-36 questionnaire. | Measured at baseline and after 1 year | 
| Fall incidents |  | After 5 years |
SARS-CoV-2 Infection Among Healthcare Workers

Study Overview
=================
Brief Summary
-----------------
At present, COVID-19 vaccine is considered as the safest, economic and effective measure to prevent and control COVID-19. Adaptive immunity, including humoral immunity and cellular immunity, plays a role in anti-viral responses. Cellular immunity includes virus specific B cells and T cells, which can provide long-term memory immunity. For acute viral infection, neutralizing antibody is of great significance in preventing infection, while memory cell immunity can maintain a good broad-spectrum and persistence in controlling mutant strains, which is a key factor in controlling viral replication after infection and reducing severe disease and death. However, there is no systematic study on the specific immune response and infection risk of novel coronavirus, and there is no definite conclusion on which specific protective immune response induced by vaccine can reduce the risk of infection. Therefore, this study aims to establish a prospective real-world cohort, analyze the correlation between multiple baseline immune protection indicators and infection risk, follow up the population with breakthrough infection, and monitor the dynamic specific immune response to COVID-19 in peripheral blood and respiratory mucosa. This study will provide an important scientific basis for us to scientifically assess the risk of individual infection with COVID-19.

Official Title
-----------------
The Risk of SARS-CoV-2 Infection and Severity of COVID-19 Among Healthcare Workers With or Without Previous COVID-19 Vaccines

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Biological: inactivated COVID-19 vaccines; orally aerosolized Ad5-nCoV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years SARS-CoV-2 nucleic acid testing showed negative within 72 hours Exclusion Criteria: 1.Do not consent to enroll in this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: inactivated COVID-19 vaccines; orally aerosolized Ad5-nCoV|the protection of COVID-19 vaccines on breakthrough infection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 infection | SARS-CoV-2 infection confirmed by either by nucleic acid testing or antigen testing | from Dec 2022 to April 2023 | 
| The severity of COVID-19 | the severity of COVID-19 symptoms including the period from SARS-CoV-2 positive to negative, fever days, etc. | from Dec 2022 to April 2023 |
Seroprevalence of SARS CoV 2 Antibodies in Previously Undiagnosed Healthcare Workers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify healthcare workers with SARS CoV 2 antibodies who have not been previously diagnosed and are presumed COVID-19 negative, then determine the level of immunity in this population which could inform further decisions about widespread antibody testing in a healthcare worker population.

Detailed Description
-----------------
Enrolled participants will complete a survey gauging their level of confidence they will be antibody positive. Participants will then complete serologic testing for SARS CoV 2 IgG antibodies. The study will characterize the prevalence of antibody positivity in this population and assess whether there is a correlation between a pre-test confidence level using a Likert scale and actual antibody positivity.

Official Title
-----------------
Seroprevalence of SARS CoV 2 Antibodies in Previously Undiagnosed Healthcare Workers

Conditions
-----------------
SARS-CoV 2, COVID-19

Intervention / Treatment
-----------------
* Other: Serologic testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old. Mayo Clinic employee in procedural and surgical area. Suspected COVID-19 exposure. Completed PCR test twice with negative results. Exclusion Criteria: - Refusal to participate in this study.

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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Serologic Arm<br>Enrolled participants will have COVID19 IgG antibody testing performed. | Other: Serologic testing<br>* COVID19 IgG antibody testing to be performed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With COVID-19 Antibodies | Presence of IgG antibodies detected | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to Predict Immune Status/Antibody Positivity | Survey of participants to gauge their confidence they will be antibody positive | Single point in time prior to COVID-19 Antibody testing |
Gait Pattern Between a Cemented and Non-cemented Femur Stem

Study Overview
=================
Brief Summary
-----------------
Acute cervical femoral neck fracture patients randomized to either cemented or non-cemented stem. The investigators used gait analysis to evaluate if patients operated with a cemented stem showed more favourable hip kinematics and kinetics when compared with a group of patients operated with a non-cemented stem.

Detailed Description
-----------------
45 patients randomized to receive either a cemented or a non-cemented stem were studied . 2 years after the operation gait analysis was performed with a 16-camera motion capture system together with 2 force-plates. Hip kinematics and kinetics were analysed and 70 subjects served as controls.

Official Title
-----------------
No Difference in Gait Pattern Between a Cemented and Non-cemented Femur Stem. 45 Prospective Randomized Total Hip Arthroplasty Patients After Acute Cervical Femur Fracture Evaluated After 2 Years

Conditions
-----------------
Gait Analysis, Hip Fractures, Hip Arthroplasty, Randomized

Intervention / Treatment
-----------------
* Other: Gait analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute collum femoris fracture Exclusion Criteria: -
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
Intervention Model: Parallel Assignment
Interventional Model Description: Gait of cemented femur stem of acute cervical collum femoris stem. Gait of non-cemented femur stem of acute cervical collum femoris stem.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gait analysis of cemented total hip<br>Gait analysis of acute collum femoris fracture patient randomized to cemented stem | Other: Gait analysis<br>* Kinematic and kinetic analysis<br>|
| Experimental: Gait analysis of non-cemented total hip<br>Gait analysis of acute collum femoris fracture patient randomized to non-cemented stem | Other: Gait analysis<br>* Kinematic and kinetic analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Analysis with focus on hip kinematics 2 year after total hip arthroplasty | Optical tracking system focusing on reflective markers according a model used in gait analysis in order to record degrees of hip angels in 3 planes | 2 year postop | 
| Gait Analysis with focus on hip kinetics 2 year after total hip arthroplasty | Optical tracking system focusing on reflective markers according a model used in gait analysis together with force plates record hip moments (Nm/kg) in 3 planes | 2 year postop |
Dermacyd Infantile (Lactic Acid)- Compatibility.

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergic potential (sensibilization) of the product Dermacyd Infantile.

Official Title
-----------------
Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermic Irritability, Dermic Sensitivity) of Dermacyd Infantile (Lactic Acid).

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: LACTIC ACID(ND)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Photo type Skin I,II, III e IV Integral skin test in the region Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion. Exclusion criteria: Lactation or gestation Use of Anti-inflammatory 30 days and/or immunosuppressant drugs during 3 months before the selection Diseases which can cause immunity decrease, such as HIV, diabetes Previous atopy History of sensitivity or irritation for topic products Active cutaneous diseases which can interfere in the study results Use of new drugs and/ or cosmetics during the study Cutaneous reactivity Previous participation in studies, which had used the product Volunteers who have immunodeficiency congenital or acquired Relevant clinical history or present evidence of alcohol abuse or others drugs Non tolerance to some component of the study product. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermacyd Infantile (Lactic Acid)<br>six weeks treatment | Drug: LACTIC ACID(ND)<br>* Dermacyd Infantile (Lactic Acid)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absence of primary and accumulated dermic irritability and dermic sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. |  | During 6 weeks (i.e. treatment period) |
Uterine Rupture After Hysteroscopic Septum Resection

Study Overview
=================
Brief Summary
-----------------
To date, several studies have already confirmed a positive effect of hysteroscopic metroplasty on reproductive outcomes in primary infertile women affected by uterine septum, the most common uterine malformation. Nevertheless, very few data are available about the risk of uterine rupture in subsequent pregnancies after hysteroscopic septum resection (HSR). In order to shed about this element, we will retrospectively review the cases of uterine rupture in our setting in the last twenty years, identify which of them had previously undergone HSR, and evaluate the main clinical characteristics for each case.

Official Title
-----------------
Uterine Rupture in Pregnancy After Hysteroscopic Septum Resection: a Twenty-year Retrospective Analysis

Conditions
-----------------
Septum; Uterus, Rupture, Uterine

Intervention / Treatment
-----------------
* Procedure: Hysteroscopic septum resection.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous hysteroscopic septum resection; Pregnancy; Uterine rupture. Exclusion Criteria: Previous myomectomy (regardless of the surgical technique) or cesarean section.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 48 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Uterine rupture<br>Women who had uterine rupture during pregnancy. | Procedure: Hysteroscopic septum resection.<br>* Resection of a uterine septum by hysteroscopic surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine rupture | Rupture of muscular wall of the uterus tears during pregnancy or childbirth. | Retrospective analysis over the last twenty years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hysteroscopy, Uterine septum, Complications, Uterine perforation, Pregnancy, Uterine rupture
Evaluation of the Index of Sexual Life Questionnaire

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the sensibility of the ISL questionnaire.

Official Title
-----------------
An Open Label, Multicenter Study to Measure Treatment Responsiveness of Quality of Sexual Life Questionnaire in the Female Partner of Men With Erectile Dysfunction Treated With Viagra (Sildenafil Citrate)

Conditions
-----------------
Impotence

Intervention / Treatment
-----------------
* Drug: sildenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ED patient must: Be male, 18 years of age with no upper age limit; Have a documented clinical diagnosis of erectile dysfunction confirmed by an Erectile Function (IIEF) score 25. Erectile dysfunction is defined as the inability to achieve and/or maintain an erection of the penis sufficient to permit satisfactory sexual performance (Impotence-NIH Consensus Conference, JAMA 1993, 270: 83-90); Have a stable female partner for at least 6 months prior to screening. Exclusion Criteria: Have a known hypersensitivity to sildenafil or any component of the study medication; medical history of treatment-related intolerable side effects to sildenafil Be currently prescribed, taking and/or likely to be treated with nitrates or nitric oxide donors in any form on either a regular or intermittent basis.

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment responsiveness of a new quality of sexual life questionnaire for female partners of men with erectile dysfunction. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation between ED patients' partner quality of sexual life changes and patient's efficacy measures and these changes and patient reported outcomes of self-esteem |  |  |