linjc16/ctgov huggingface dataset:
Telephone Care Management to Address Sleep Problems in Young Children With Autism

Study Overview
=================
Brief Summary
-----------------
The investigators will conduct a randomized controlled trial comparing a telephone based intervention (TCM) to usual care (UC). TCM will feature a registered nurse providing a series of phone calls to assist caregivers in learning and modifying behavioral strategies that may help young children with autism to sleep better. Objective (activity monitors) and subjective (rating scales) data will be collected by an independent research assistant at the end of the project. The investigators hypothesize that TCM improves sleep duration and decreases sleep problems relative to a usual care control condition (UC).

Detailed Description
-----------------
Please see brief summary.

Official Title
-----------------
Telephone Care Management to Address Sleep Problems in Young Children With Autism

Conditions
-----------------
Autism Spectrum Disorders, Insomnia

Intervention / Treatment
-----------------
* Behavioral: Telephone Care Management
* Behavioral: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Insomnia Autism Spectrum Disorder Regular telephone service for caregiver Stable dose of medication Exclusion Criteria: Signs of obstructive sleep apnea (e.g., turning blue or stop breathing at night, recurrent snoring) Receptive language skills under 18 months

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 6 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telephone Care Management<br>calls from a registered nurse to educate caregivers about behavioral sleep strategies | Behavioral: Telephone Care Management<br>* series of phone calls from registered nurse to discuss behavioral suggestions for pediatric insomnia<br>* Other names: TCM;|
| Placebo Comparator: Usual Care<br>It's a placebo comparator because individuals in this group will receive an educational handout on behavioral sleep strategies. This handout approximates standard of care. | Behavioral: Usual Care<br>* educational handouts on pediatric insomnia<br>* Other names: UC;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Sleep Habits Questionnaire |  | 2 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actigraphy (Activity Monitoring) |  | 2 month follow up |
Dermatologists' Educational Demonstration for Epiduo Application

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and tolerability of this combination gel compared with BPO monotherapy in Korean patients, and test clinical practicability of dermatologists' educational demonstration for how to apply this gel in reducing uncomfortable irritations.

Conditions
-----------------
Facial Acne, Local Adverse Effects

Intervention / Treatment
-----------------
* Drug: Epiduo once daily with detailed instruction for how to apply it
* Drug: Epiduo- once daily, simple instruction for application
* Drug: BPO once daily


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild to moderate acne were evaluated by Leeds revised acne grade from 2 to 6 age: 18-40 Exclusion Criteria: pregnancy mental illness intake of oral isotretinoin within 6 months application of the other oral or topical acne medications chemical peeling or light based treatments within 6 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epiduo- dermatologist's detailed instruction<br>After randomly assigned to side of epiduo application, half of total patients were also re-assigned into detailed instruction for application of epiduo from dermatologist | Drug: Epiduo once daily with detailed instruction for how to apply it<br> <br> |
| Experimental: Epiduo- drug insert only gruop<br>After randomly assigned to side of epiduo application, half of total patients were also re-assigned into drug insert only group | Drug: Epiduo- once daily, simple instruction for application<br> <br> |
| Placebo Comparator: BPO group<br>After randomly assigned to side of BPO application, patients apply BPO during 12 week | Drug: BPO once daily<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentile reduction of non-inflammatory & inflammatory acne lesions | Measurement of decreases in both non-inflammatory & inflammatory acne lesions | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of local irriation effect counts (erythema, scaling, dryness, itching) | Calcuation of total number of local irriation effect counts (erythema, scaling, dryness, itching) | 12 week |
A Phase III Study to Evaluate the Safety and Efficacy of Ganciclovir (Dihydroxypropoxymethyl Guanine [DHPG]) Treatment of Symptomatic Central Nervous System (CNS) Congenital Cytomegalovirus (CMV) Infections.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the benefits and safety of the antiviral drug ganciclovir (DHPG) given intravenously to treat newborn infants who are born infected with cytomegalovirus (CMV). CMV is a herpes virus that can infect most organs of the body, resulting in death in 10-30% of babies with symptoms of CMV. It can cause severe brain damage in a large percentage of surviving babies. Children in this study have a CMV infection of the central nervous system (CNS).

Detailed Description
-----------------
The study will enroll 130 newborn infants 1 month of age or younger with CMV involving the CNS. Patients will be assigned randomly (like tossing a coin) to receive either DHPG or no study drug treatment. All babies in the study will receive standard of care treatment and clinical, diagnostic, laboratory, safety, and follow-up evaluations. Follow-up evaluations, including hearing and eye exams and developmental assessments, will be done periodically until the child reaches 5 years of age. The degree of improved hearing among surviving patients will be a primary measure of drug effectiveness.

Official Title
-----------------
A Phase III Study to Evaluate the Safety and Efficacy of Ganciclovir (Dihydroxypropoxymethyl Guanine [DHPG]) Treatment of Symptomatic Central Nervous System (CNS) Congenital Cytomegalovirus (CMV) Infections.

Conditions
-----------------
Cytomegalovirus Infections

Intervention / Treatment
-----------------
* Drug: ganciclovir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants may be eligible for this study if they: Were full term infants (at least 32 weeks gestation). Are 1 month of age or younger (preferably less than 2 weeks). Weighed at least 1,200 grams (2.5 lbs) at birth. Have confirmed cytomegalovirus. Have evidence of CMV infection of the CNS with or without evidence of other organ involvement. Exclusion Criteria: Infants will not be eligible for this study if they: Have concurrent bacterial infection. Have HIV infection. Have mild symptoms or no symptoms of CMV infection at birth. Have an abnormal brain development (hydranencephaly) or any devastating brain involvement.

Ages Eligible for Study
-----------------
Maximum Age: 1 Month

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Influence of Inguinal Hernia Repair on Sperm Autoimmunity

Study Overview
=================
Brief Summary
-----------------
Influence of inguinal hernia repair on sperm autoimmunity using MAR test

Detailed Description
-----------------
All infertile male patients, visited between February 2000 and September 2020 and which were tested with MAR (Mixed Autoglobulin Reaction) test, were included in this retrospective study. Sperm quality (number of spermatozoa, motility, vitality and normal forms) were also studied in this patients. The aim of the study is to evaluate if there is a higher incidence of positive MAR test among patients undergoing inguinal hernioplasty compared to the general population

Official Title
-----------------
Influence of Inguinal Hernia Repair on Sperm Autoimmunity Using MAR Test

Conditions
-----------------
Male Infertility Due to Antisperm Antibody

Intervention / Treatment
-----------------
* Diagnostic Test: Mar test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergone to correction of inguinal hernia Exclusion Criteria: No specific exclusion criteria were set.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| General population<br> | Diagnostic Test: Mar test<br>* Study of antisperm antibodies<br>|
| Pazients undergone inguinal hernia correction<br> | Diagnostic Test: Mar test<br>* Study of antisperm antibodies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate if there is a higher incidence of positive MAR test among patients undergoing inguinal hernioplasty |  | 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate if there is a modification of seminal parameters among patients undergoing inguinal hernioplasty |  | 20 years |
Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesis is that a carbohydrate-free diet, ingested for 3 days, results in a change in blood glucose that is similar to the change observed after 3 days of fasting.

Detailed Description
-----------------
In addition to plasma glucose concentrations, other hormones and metabolites known to be affected by fasting will be measured. These include insulin and glucagon, which are hormones that have an important role in regulating fuel use in the body.

Official Title
-----------------
Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Other: 3 day fast
* Other: 3 day CHO-free diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes C-peptide > 1.5 ng/ml Exclusion Criteria: Body mass index > 40 hematological abnormalities liver disease kidney disease congestive heart failure life threatening malignancies

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 3 day fast<br>After receiving a standard diet on day 1, subject will fast on days 2, 3, and 4. Water and calorie-fee beverages will be allowed during this 72 hour period. | Other: 3 day fast<br>* Subjects will fast for 72 hours<br>* Other names: 3-Day Fast;|
| Active Comparator: CHO-free diet<br>After receiving a standard diet on day 1, a carbohydrate-free diet will be provided on days 2, 3, and 4. | Other: 3 day CHO-free diet<br>* Subjects will receive a carbohydrate-free diet for 72 hours<br>* Other names: Carbohydrate-free diet;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma glucose concentration |  | 24 hour profile:before and after meals, or traditional meal times | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum insulin concentrations |  | 24 hour profiles: before and after meals or traditional meal times | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes
STI Combined to Valsalva Maneuver for the Diagnosis of Left Ventricular Dysfunction in COPD Exacerbations

Study Overview
=================
Brief Summary
-----------------
The aim of this investigation was to assess the value of Systolic Time Intervals (STIs) as a method of detecting Left Ventricular Dysfunction (LVD) in patients admitted to the emergency department for cute exacerbations of chronic obstructive pulmonary disease (AECOPD) and whether STIs measured under Valsalva manoeuver (VM) could improve the distinction between patients with LVD and those without LVD.

Detailed Description
-----------------
We included patients admitted to the ED for AECOPD. Measurement of STIs included electromechanical activation time (EMAT), left ventricular ejection time and EMAT/LVET ratio. These were performed at baseline and during the first strain phase of the VM using a computerized phono and electrocardiographic method. The diagnosis of LVD was determined on the basis of clinical examination, echocardiography and brain natriuretic peptide. The values of STIs were compared between patients with and without LVD ; their diagnostic performance was assessed using the area under receiver operating characteristic curve (AUC of ROC).

Official Title
-----------------
a New and Non Invasive Method to Calculate STI ( Systolic Time Intervals) Combined to Valsalva Maneuver in Patient With Acute Exacerbation of COPD

Conditions
-----------------
Obstructive Chronic Bronchitis With Acute Exacerbation

Intervention / Treatment
-----------------
* Device: STI measurements at baseline and under Valsalva maneuver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Oxygen Saturation (SPO2) <90%, Respiratory Rate >25c/min, PaCO2 > 6 kPa et pH< 7.35. Exclusion Criteria: Neurological distress and hemodynamic instability Confusion, agitation pneumothorax Non cooperative patients Refusal of consent

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 |
| --- |
|Device: STI measurements at baseline and under Valsalva maneuver|STI measurements at baseline and under Valsalva maneuver|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnosis of left ventricular dysfunction | Systolic time intervals measured at baseline and under Valsalva maneuver | during the first day admission in emergency department | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AECOPD, left ventricular dysfunction, valsalva maneuver, systolic time intervals
Children's Health Study Diet and Air Pollution

Study Overview
=================
Brief Summary
-----------------
This study is built upon the existing data in the Children's Health Study to examine the longitudinal association between childhood exposure to air pollutants and changes in diet among adolescents.

Official Title
-----------------
Regional and Traffic-related Air Pollutants Are Associated With Consumption of a High Fat Diet Among Adolescents

Conditions
-----------------
Diet Habit, Pollution; Exposure, Child Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children of 4th and 7th grades were enrolled from 12 Southern California communities Exclusion Criteria: extreme mean caloric intake (>5000 or < 500 kcal/day) or no demographic information

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 18 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 |
| --- | --- | --- |
| Dietary behavior | self-reported food frequency questionnaire data | one year before visit date |
Retrospective Study Collecting Neurological Follow-up of Hereditary Transthyretin Amyloidosis (ATTRv) Patients Included in B3461028 and B3461045.

Study Overview
=================
Brief Summary
-----------------
A study of patients with hereditary transthyretin amyloidosis (ATTRv) and wild-type transthyretin amyloidosis (ATTRwt) that have been enrolled in B3461028 and B3461045 studies in Spain - exposed to tafamidis 61mg for ≥12 months with polyneuropathy (PN) have kept going to their multisystemic follow-ups (neuro/ophtalmo/gastrointestinal) ≥12 months.

Official Title
-----------------
Tafamidis 61mg, Resultados en Amiloidosis ATTR Con afectación neurológica y Multisistémica - TRAMA

Conditions
-----------------
Hereditary Transthyretin Amyloidosis (ATTRv), Polyneuropathy

Intervention / Treatment
-----------------
* Drug: Tafamidis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment with tafamidis 61 mg ≥ 12 months Neurological follow up ≥ 12 months Diagnosis of transthyretin amyloidosis with polyneuropayhy (ATTR-PN) based on one of the following: Amplitude reduction in, at least, 2 nerves under normal value, excluding median nerve OR 50% amplitude reduction in, at least, 2 nerves on the basal value of the patient, excluding median nerve OR 2 abnormal tests detecting thin fibers alterations (through Sudoscan, RR Interval análisis, etc..) Exclusion Criteria: Treatment with tafamidis 61 mg < 12 months Neurological follow up < 12 months Other diagnosis for polyneuropathy

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 |
| --- | --- |
| Retrospective cohort ATTRv and ATTRwt patients enrolled in B3461028 and B3461045 studies in Spain<br> | Drug: Tafamidis<br>* 61 milligrams (mg) as received in studies B3461028 and B3461045<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Neurological Impairment score (NIS) |  | Baseline, Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe extra-cardiac clinical features and clinical management of the Spanish ATTRv and ATTRwt patients with mixed phenotype treated with tafamidis 61 mg. |  | Baseline through month 36 | 
| Change From Baseline in Neuropathy Impairment Score - Lower Limbs [NIS (LL) |  | Baseline through Month 36 | 
| Change from Baseline in Norfolk Quality of Life- Diabetic Neuropathy (Norfolk QOL-DN) |  | Baseline through month 36 | 
| Change From Baseline in composite autonomic symptom scale 31 (Compass-31) |  | Baseline through month 36 | 
| Change from Baseline in Modified Body Mass Index (mBMI) |  | Baseline through month 36 | 
| Change from Baseline in Sudomotor Response |  | Baseline through month 36 |
Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse

Study Overview
=================
Brief Summary
-----------------
Pelvic floor prolapse is a general term used to describe various clinical conditions that are associated with pelvic floor (muscles that support the vagina) relaxation in female patients.Pelvic floor prolapse is thought to result from a stretching, weakening or tearing of the soft tissue structures that support the pelvic organs. These tissues become compromised because of a weakened or damaged.The purpose of the study will be to demonstrate the usability of Polypropylene Mesh for prolapse repair, using the TVM technique.

Official Title
-----------------
Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse

Conditions
-----------------
Vaginal Prolapse

Intervention / Treatment
-----------------
* Device: Polypropylene Mesh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female candidate for surgical pelvic floor repair (at least ICS stage II symptomatic prolapse). Patient who is at leat 21 years of age. Patient whose family is complete. Patient may not have uncontrolled diabetes. Exclusion Criteria: Patients may not have coagulation disorders.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Polypropylene Mesh|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the TVM treatment in curing vaginal prolapse as indicated by recurrence rate. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative complication |  |  | 
| Patient tolerance of the synthetic mesh placed |  |  | 
| Postoperative complications |  |  | 
| Quality of life |  |  |