linjc16/ctgov huggingface dataset:
Measuring Cardiovascular Performance and Blood Flow Using Common But Never Compared Methods

Study Overview
=================
Brief Summary
-----------------
The aims of this study are to measure cardiovascular performance and blood flow using common but never compared methods.

Official Title
-----------------
Measuring Cardiovascular Performance and Blood Flow Using Common But Never Compared Methods

Conditions
-----------------
D012039, D001775

Intervention / Treatment
-----------------
* Diagnostic Test: Measuring cardiovascular performance and blood flow


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 50 Patients from New York Heart Association (NYHA) Class 1 (One or more AHA Risk Factors, asymptomatic), ≤75% (36) Male, ≥25% (12) Female At least 50 Patients from NYHA Class 2 (symptomatic), ≤75% (36) Male, ≥25% (12) Female Exclusion Criteria: Subjects on mechanical ventilation. Subjects who require decisions by a medical power of attorney. Subjects unable to safely perform forced expiration. Subjects with known technically difficult (TDS) trans-thoracic echocardiographic windows.

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

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Measuring cardiovascular performance and blood flow<br> | Diagnostic Test: Measuring cardiovascular performance and blood flow<br>* Measuring cardiovascular performance and blood flow<br>* Other names: QuantaFlo Sensor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood flow measurement | A Clinician will use a fingertip sensor and expiration device to measure blood flow in a patient by Volume Plethysmography. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac performance measurement | A Cardiac Echo Technician will measure cardiac performance in a patient using Echocardiography. | through study completion, an average of 10 weeks |
Experimental Word Learning in Children With and Without Language Impairment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the performances of normally developing children and children with Language Impairment (LI) in three different experimental settings designed to promote vocabulary acquisition. This comparison will also provide evidence to support different intervention approaches designed to increase vocabulary abilities, which has been proved to be one of the major deficits of young children with LI.

Official Title
-----------------
Experimental Word Learning in Children With Normal Development and Children With Language Impairment

Conditions
-----------------
Developmental Language Disorders

Intervention / Treatment
-----------------
* Behavioral: Word-learning
* Behavioral: Word-learning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For GP subjects: - diagnosis of Language Impairment enrolled in language therapy age between 3:0 (years:months) and 3:11 For GC subjects: - normal performance in a language screening procedure normal performance in an expressive vocabulary test Exclusion Criteria: For GP subjects: - hearing impairments diagnosed neurological or behavioral conditions major cognitive impairment For GC subjects: - communication complaints from caregivers history of previous enrollment in language therapy

Ages Eligible for Study
-----------------
Minimum Age: 36 Months
Maximum Age: 47 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GP<br>Children with Developmental Language Impairments were enrolled in this group. | Behavioral: Word-learning<br>* Exposure to five nonwords for three sessions of controlled interaction with the experimenter<br>|
| Experimental: GC<br>Children with normal language development were enrolled in this group. | Behavioral: Word-learning<br>* Exposure to five nonwords for three sessions of controlled interaction with the experimenter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance on a post-test administered after every word-learning session. |  | Three weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of correct spontaneous productions of the taught words during the experimental procedure |  | Three weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Child Language, Language Therapy, Vocabulary
Primary Immunodeficiencies in Costa Rican Adults

Study Overview
=================
Brief Summary
-----------------
Primary immunodeficiencies represent a underdiagnosed group of rare diseases which if diagnosed well and in time can be treated in an efficient manner and prevent complications that may affect the quality of patients life in an severe manner. Neither in Costa Rica nor in Central America studies or national registries regarding the prevalence and characterization of primary immunodeficiencies in adult patients exist up to now. This study reflects for the first time the epidemiologic situation of primary immunodeficiencies in a Central American country, characterizing adult patients diagnosed with primary and idiopathic immune disorders treated in two specialized immunodeficiency clinics in Costa Rica.

Official Title
-----------------
CASE SERIES OF PRIMARY IMMUNODEFICIENCIES IN ADULTS DIAGNOSED IN TWO HOSPITALS OF THE TERTIARY LEVEL OF CARE OF THE COSTA RICAN SOCIAL SECURITY Fund, 2017-2018

Conditions
-----------------
Primary Immune Deficiency in Adults

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients from adult primary immunodeficiency clinics will be included. Exclusion Criteria: Patients with HIV Proven secondary immunodeficiencies.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Clinical manifestations of all adult patients diagnosed with primary and idiopathic immune defects | Describe the clinical manifestations of all adult patients diagnosed with primary and idiopathic immune defects attended in the primary immunodeficiency clinics of the Hospitals Mexico and Dr. Rafael Ángel Calderón Guardia during the study period. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| characterization of immunodeficient patients | Characterize immunodeficient patients using sociodemographic and health variables. | 1 year | 
| Concordances between clinical manifestations and literature | •Establish concordances between the clinical manifestations of the group of patients under study with those described in the literature according to the different pathologies. | 1 year | 
| organic complications | Record organic complications secondary to immunodeficiency status. | 1 year | 
| type and degree of immunodeficiency | Differentiate the type and degree of immunodeficiency of each patient. | 1 year | 
| pathonges that cause infectious | Report isolated pathogens that cause infectious manifestations in patients. | 1 year | 
| bacteria present in upper airways | •Report the colonizing bacteria present in the cultures of the upper airways of the patients requested in the initial approach. | 1 year |
Effects of Physical Exercise on Blood Glucose and Pain From the Musculoskeletal System in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the effects og physical exercise on bloodglucose and pain from the musculoskeletal system in patients with type 2 diabetes. The patients will be recruited to 12 weeks of exercise twice weekly. The outomes are long term bloodglucose (HbA1c) and pain reported in questionaires. In data analyses the patients will be stratified to patients with a high or a low degree of complications related to diabetes.

Detailed Description
-----------------
Design: Uncontrolled intervention study Patients: Type 2 diabetes from Nordsjællands Hospital, Denmark Inclusion critera: adults, type 2 diabetes, not participating in an ungoing exercise program, able to conduct exercise training Exclusion criteria: unable to understand Danish, psychiatric disorder, dementia Intervention: two times one hour exercise training for 12 week. The training will be combined aerobic and resistance training supervised by physiotherapists Outcome: bloodglucose, pain (questionaire) Sample size: 80 participants

Official Title
-----------------
Effects of Physical Exercise on Blood Glucose and Pain From the Musculoskeletal System in Patients With Type 2 Diabetes and Diabetes Related Complications

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

Intervention / Treatment
-----------------
* Behavioral: Exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Type 2 diabetes Must be able to perform physical exercise Exclusion Criteria: Participation in structured exercise program within the past three months Dementia Unable to understand Danish language

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise training<br>12 weeks of one hour exercise training twice weekly | Behavioral: Exercise training<br>* Physical activity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of bloodglucose | HbA1c | Participants will be followed for a period of 12 weeks physical exercise | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of musculoskeletal pain | Questionaire | Participants will be followed for a period of 12 weeks physical exercise | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, Physical
Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome

Study Overview
=================
Brief Summary
-----------------
Expanded access to Stiripentol for patients with Dravet Syndrome.

Detailed Description
-----------------
This is a treatment plan, and therefore patients will be monitored according to clinical standard of care.

Official Title
-----------------
Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome

Conditions
-----------------
Dravet Syndrome

Intervention / Treatment
-----------------
* Drug: Stiripentol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6 months and older Diagnosis of Dravet Syndrome with intractable seizures Exclusion Criteria: Hypersensitivity to the active substance or to any of the excipients Past history of psychoses in the form of episodes of delirium Impaired hepatic and/or renal function, defined as creatinine >2 and/or transaminase >4xULN

Ages Eligible for Study
-----------------
Minimum Age: 6 Months

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

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Noninvasive Test for Fetal RHD Genotype

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the performance of Sequenom's noninvasive test for fetal RHD genotype. The test uses MALDI-TOF mass spectrometry to detect DNA. The study is specifically designed to determine whether RHD typing using free fetal DNA in maternal circulation can accurately predict the neonatal RhD phenotype at birth.

Detailed Description
-----------------
In the United States and Canada, routine obstetrical care includes a blood test to determine the blood type of the mother (ABO and RhD). An antibody screen for anti-red cell antibodies in the mother's serum is also performed. Postpartum prophylactic treatment of RhD negative women with anti-D immunoglobulin to prevent RhD Disease, or hemolytic disease of the fetus/newborn, was initiated in the 1960's. In the mid 1980's, the routine administration of antenatal anti-D immunoglobulin became the standard of care as well. Although these treatments have dramatically reduced the incidence of RhD Disease, approximately 40% of all RhD negative pregnancies continue to receive unnecessary injections of antenatal anti-D immunoglobulin. Genotyping platforms such as MALDI-TOF mass spectrometry allow for precise and sensitive detection of fetal-specific (paternally derived) alleles in maternal plasma. In this study, Sequenom's MassARRAY technology will be used to assess a noninvasive test for fetal RHD genotyping in a clinical setting.

Official Title
-----------------
Evaluation Of The Performance Of A Noninvasive Test For Fetal RHD Genotype On The Sequenom MassARRAY System

Conditions
-----------------
Rhesus D Genotype

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female at least 18 years of age RhD negative by serology Pregnant at no more than 11-13 weeks gestation confirmed by ultrasound Willing to provide signed and dated informed consent Able and willing to comply with the protocol Exclusion Criteria: RhD negative women known to be alloimmunized to the RhD antigen

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

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

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 |
| --- | --- | --- |
| To test as to whether advancing gestational age is associated with accuracy of fetal typing for RhD. |  | First, second, and third trimester | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rhesus D, RHD, genotype, phenotype, neonatal, noninvasive, fetal, MassARRAY, DNA
Green Tea, High in Epigallocatechin Gallate (EGCG) and Postprandial Fat Oxidation

Study Overview
=================
Brief Summary
-----------------
The body of evidence regarding the health benefits of green tea has grown considerably during the last decade and includes antioxidant properties, anti- cancer, anti-obesity and anti-diabetes effects. There has been evidence that green tea extract favorably affect body weight and body fat and has positive effects on blood glucose control Aim of this study is to investigate the short term effect (3-day)of TEAVIGO (high in the catechin EGCG) on postprandial fat oxidation during different phases of the postprandial period in overweight subjects. Secondly, in a subset of volunteers changes in lipolysis and glucose metabolism will be studied in skeletal muscle and adipose tissue.

Official Title
-----------------
Effects of the Green Tea Extract TEAVIGO High in EGCG, on Postprandial Fat Oxidation in Overweight Volunteers

Conditions
-----------------
Obesity, Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Dietary Supplement: Effect of the green tea extract TEAVIGO, high in EGCG, on postprandial fat oxidation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 20 and 50 y BMI 25.0-29.9 kg/m2 Normal fasting glucose <6.1 mmol/L Blood pressure (systolic blood pressure 100-150 mmHg, diastolic blood pressure 60-90 mmHg) Weight stable in last 3 months (±2 kg) Exclusion Criteria: pregnant, lactating or (post)menopausal women regular smokers people with intensive fitness training eg athletes habitual consumption of green or black tea (more than 1 or 2 cups a day, respectively) not more than 300 mg/day caffeine consumption

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EGCG<br>Double blind randomized, placebo-controlled cross-over design with two arms: the green tea extract TEAVIGO, high in EGCG and placebo | Dietary Supplement: Effect of the green tea extract TEAVIGO, high in EGCG, on postprandial fat oxidation<br>* green tea extract TEAVIGO, high in EGCG<br>|
| Placebo Comparator: placebo<br> | Dietary Supplement: Effect of the green tea extract TEAVIGO, high in EGCG, on postprandial fat oxidation<br>* green tea extract TEAVIGO, high in EGCG<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postprandial fat oxidation |  | 8 months |
Urea and Creatinine Level in Vaginal Fluid as a Predicator for Length of Latency Period in Prelabour Membranes Rupture

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the relation between the concentration of urea and creatinine in vaginal fluid and length of latency period in women with PROM between 32 and 35 weeks gestation.

Detailed Description
-----------------
60 pregnant women with PROM with singleton pregnancies with a gestational age between 32- 35 gestational weeks History taking followed by examination All women will be put in dorsal lithotomy position, using a proper light source and sterile gloves; sterile speculum free of gel will be placed into vagina. For every woman a specimen of vaginal fluid will be taken as follows: 5 ml of sterile saline solution will be injected into the posterior vaginal fornix taken after aspiration of 3ml with the same syringe. All samples will be obtained within 6 hours after membranes rupture before vaginal examination and the administration of any drugs. Upon collection, samples were centrifuged at 3000 rpm for 10 minutes and supernatant fluid was separated. Exact concentrations of urea and creatinine will be measured All women will be put under observation for 48 hours and time of onset of delivery will be documented, the onset of labor will be diagnosed by either: Frequent uterine contractions more than 2 contractions in 10 minutes. CTG showing frequent contractions.

Official Title
-----------------
Urea and Creatinine Level in Vaginal Fluid as a Predicator for Length of Latency Period in Prelabour Membranes Rupture

Conditions
-----------------
Rupture of Membranes; Premature

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Maternal age between 20-35 years. 32-35 weeks gestational age. Viable fetus. Exclusion Criteria: Vaginal bleeding either spontaneous or traumatic e.g. placenta previa. Chorioamnionitis. Multiple pregnancy. Presence of uterine contractions. Amniotic fluid disorders e.g. polyhydramnios Meconium stained amniotic fluid prior to active phase of labor. Maternal disease necessitating termination of pregnancy e.g. severe preeclampsia

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 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 |
| --- | --- | --- |
| delivery interval in Premature rupture of membranes | The time needed from the onset of PROM till time of onset of labour | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PROM
Predictive Factors for Cranioplasty Complications - A Decade Experience

Study Overview
=================
Brief Summary
-----------------
This is a single-center, observational retrospective study. This study aims to identify predictive factors of complications for patients submitted to cranioplasty after decompressive craniectomy for all types of etiologies. All patients submitted to cranioplasty since 2008 will be analyzed.

Detailed Description
-----------------
Patients submitted to cranioplasty since 2008 to 2019 will be retrospectively analyzed. Will be considered for analysis all cases treated after decompressive craniectomy. Will be excluded patients with incomplete clinical or imaging records. Main factors determined as a possible influence on complications after cranioplasty will be recorded focusing on patients characteristics, craniectomy characteristics, surgical timing, and cranioplasty materials. Patients' records will be review by two investigators and data will be verified by a third investigator. records will be anonymously recorded.

Official Title
-----------------
Predictive Factors for Cranioplasty Complications - A Decade Experience

Conditions
-----------------
Decompressive Craniectomy and Cranioplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cranioplasty surgery Previous decompressive craniectomy Exclusion Criteria: Incomplete records (Clinical and Imaging) since craniectomy to 6 months after cranioplasty. More than one decompressive craniectomy
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Complications | Complications after cranioplasty - symptomatic hemorrhage, infection, re-intervention. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cranioplasty, Surgery Complications, Decompressive Craniectomy