linjc16/ctgov huggingface dataset:
Comparison of Techniques for Assessing Cardiac Output and Preload in Critically Ill Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
The ability to measure cardiac output (CO) accurately and reproducibly at frequent intervals remains elusive to the clinician caring for critically ill pediatric patients even though a large proportion of these children are known to have hemodynamic compromise as a result of their illness. Current techniques used in adults to measure CO are not suitable for routine use with pediatric patients. A new ultrasound dilution approach provides an opportunity to measure cardiac output and blood volumes in pediatric patients. The main aim of this study is to compare CO measured by the new method with the clinician's estimate and implied CO from the measurement of the arteriovenous oxygen content difference.

Official Title
-----------------
Comparison of Techniques for Assessing Cardiac Output and Preload in Critically Ill Pediatric Patients

Conditions
-----------------
Cardiac Output

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with in situ central venous and arterial catheters Ability to draw blood from arterial and central venous catheters Presence of parent or guardian to provide consent Exclusion Criteria: Patients over 16 years of age.

Ages Eligible for Study
-----------------
Maximum Age: 16 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 |
| --- | --- | --- |
| Compare CO measured by the new method with clinician's estimate and implied CO from measurement of arteriovenous oxygen content difference. |  | 5-8 minutes minimum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure blood volumes to compare effects of volume infusion and furosemide. |  | 5-8 minutes minimum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Comparison of CO by new method to clinician's estimate and implied CO from the measurement of arteriovenous oxygen content difference.
Assessment of Dental Caries Among a Group of Institutionalized Orphan Children Compared to Parented School Children

Study Overview
=================
Brief Summary
-----------------
Children from two orphanages will be examined for dental caries experience, in comparison to parented school children.

Detailed Description
-----------------
A total of 156 children were included in this study, they were, residing in governmental orphanage, non-governmental orphanage and parented children attending primary school. Written informed consent was obtained prior to the start of the study, form legal guardians or child's parent. Dental examination was carried out on an ordinary chair beside a window on day light. DMF and def indices were used to assess dental caries for primary and permanent teeth. Also, unmet treatment need index, care index and significant caries index were calculated.

Official Title
-----------------
Assessment of Dental Caries Among a Group of Institutionalized Orphan Children Compared to Parented School Children

Conditions
-----------------
Dental Caries in Children

Intervention / Treatment
-----------------
* Diagnostic Test: caries assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: apparently healthy children aged from six to12 years old Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| School children (control group)<br>parented school children (control group) | Diagnostic Test: caries assessment<br>* the child will examined for dental caries, caries prevalence, caries indices (def and DMF, or DMF)<br>|
| Non-Governmental orphanage children (exposed group 1)<br> | Diagnostic Test: caries assessment<br>* the child will examined for dental caries, caries prevalence, caries indices (def and DMF, or DMF)<br>|
| Governmental orphanage children (exposed group 2)<br> | Diagnostic Test: caries assessment<br>* the child will examined for dental caries, caries prevalence, caries indices (def and DMF, or DMF)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| caries experience | measured using DMF/ def index | baseline record |
A Double-blind Study of Controlled Release OROS Hydromorphone Compared to Placebo in Patients With Chronic Osteoarthritis (OA) Pain

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of OROS Hydromorphone in reducing moderate to severe chronic pain in patients with Osteoarthritis (OA) Pain

Official Title
-----------------
A Phase III, Flexible Dose Titration Followed by a Randomized Double-Blind Study of Controlled Release OROS Hydromorphone HCL Compared to Placebo in Patients With OA Pain

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Drug: OROS hydromorphone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Primary clinic diagnosis of osteoarthritis pain of the hip or of the knee for at least 6 months Patients required daily opioid medication to treat their chronic osteoarthritis pain Exclusion Criteria Joint replacement of the hip or of the knee that is the primary source of osteoarthritis Pain History drug or alcohol abuse Fibromyalgia Patients who have major depression or anxiety Women who are pregnant or breast feeding

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OROS Hydromorphone<br>OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg | Drug: OROS hydromorphone<br>* hydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets<br>|
| Placebo Comparator: Placebo<br>Matching placebo tablets orally once daily (number and dosage of tablets to match the number and dosage of the stable dose of OROS hydromorphone obtained in the Conversion and Titration phase). | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity Change From Baseline to Week 12 or Final Visit of the Double-blind Phase | Participants rate their pain intensity on a numeric rating scale (NRS), where 0=no pain and 10=worst possible pain, in a daily diary. At Week 12 (or final visit), all measurements during the preceding week are averaged, and the mean change from the mean score at baseline is calculated. | Baseline, Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OA, Chronic Pain, Osteoarthritis, OA Pain, Osteoarthritis Pain, Pain, Hip Pain, Knee Pain, Joint Pain
The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients

Study Overview
=================
Brief Summary
-----------------
To assess the effects of two doses of synthetic peptide construction 3 ( SPC3 ) on HIV-1 plasma levels (as measured by RNA PCR Amplicor) and on lymphocyte subsets in patients with initial viral load above 10,000 copies/ml. To study the safety of SPC3 and the kinetics of HIV-1 plasma level changes.

Detailed Description
-----------------
The first five patients receive SPC3 daily for 3 weeks. If that dose is tolerated, the dose is increased and given to the next 5 patients for 3 weeks. The remaining ten patients receive a dose of SPC3 based on response to the previous two dose levels. Patients are followed through day 28.

Official Title
-----------------
Study of the Safety and Effects of Two Doses of SPC3, Administered Daily Intravenously in HIV-1 Seropositive Patients

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

Intervention / Treatment
-----------------
* Drug: Peptide Construction 3, Synthetic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Antiretrovirals provided regimen has been stable for at least 6 weeks prior to study screening. Patients must have: HIV seropositivity for at least 6 months. CD4 >= 100 cells/mm3. HIV RNA PCR (Amplicor) > 10,000 copies/ml. No significant active opportunistic infection or tumor at study entry. FDA DISCLAIMER: The FDA encourages the inclusion of females of childbearing potential in study protocols, but the sponsor of this protocol specifically excludes females of childbearing potential from this study and includes only females who are sterile. Any questions about these inclusion/exclusion criteria should be directed to the study's contact person. Prior Medication: Allowed: Prior antiretrovirals. Exclusion Criteria Co-existing Condition: Patients with the following conditions are excluded: Inability to communicate with investigator or deemed likely to be noncompliant on study. Concurrent Medication: Excluded: Any drug that may interact with SPC3 (e.g., suramin). Patients with the following prior condition are excluded: History of relevant drug hypersensitivity. Prior Medication: Excluded: Investigational drug within the past 4 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Peptide Construction 3, Synthetic|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents
A Study to Determine Eligibility for CAH-301 (A Study of Gene Therapy for Classic Congenital Adrenal Hyperplasia (CAH) [NCT04783181])

Study Overview
=================
Brief Summary
-----------------
This pre-screening study is designed to determine potential eligibility of adults with classic CAH due to 21-hydroxylase deficiency (21-OHD) for participation in the CAH-301 [NCT04783181] gene therapy trial with BBP-631.

Detailed Description
-----------------
Adult participants diagnosed with classic CAH due to 21-OHD and who are taking glucocorticoids as treatment for CAH will undergo assessments to determine their potential eligibility for participation in the adult CAH-301 treatment trial with BBP-631.

Official Title
-----------------
Pre-screening Study to Identify Adult Participants With Classic Congenital Adrenal Hyperplasia Due to 21-Hydroxylase Deficiency Who May Be Eligible for Treatment in the CAH-301 Trial With BBP-631, an Adeno-associated Virus (AAV) Serotype 5-Based Recombinant Vector Encoding the Human CYP21A2 Gene

Conditions
-----------------
Congenital Adrenal Hyperplasia

Intervention / Treatment
-----------------
* Other: Pre-Screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male and non-pregnant females with classic CAH (simple virilizing or salt-wasting) due to 21-OHD Screening/baseline 17-OHP levels > 5-10 × ULN Is on a daily regimen of glucocorticoid Naïve to prior gene therapy or AAV-mediated therapy Exclusion Criteria: Positive for anti-AAV5 antibodies History of adrenalectomy and has no significant liver disease

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Overall Study<br>Participants will undergo antibody and genetic screen, initial pre-screening, eligibility monitoring and eligibility confirmation for potential transition to the treatment trial center once a treatment assignment in the study CAH-301 becomes available. Participation in Study CAH-300 is permitted to continue until treatment assignment is available in the treatment trial or unless, during eligibility monitoring or eligibility | Other: Pre-Screening<br>* No intervention given<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Potentially Eligible for CAH-301 Study |  | Up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CAH
Imunomodulation in Acute Pancreatitis

Study Overview
=================
Brief Summary
-----------------
Acute pancreatitis is an acute inflammatory pathology of the pancreas with activation of both innate and adaptive immune system, including T and B lymphocytes and release of inflammatory cytokines. We aim to characterize the circulating profile of T and B cells, its regulatory populations and B cell maturation, as well as inflammatory cytokines, in a prospective way of 50 patients with acute pancreatitis admitted to Hospital da Luz Lisboa. Blood samples will be collected at hospital admission, 48h, one month and 6 months after hospitalization of patients, relating these values to the severity of acute pancreatitis. Patients with acute pancreatitis in the previous 6 months, diabetes mellitus, pregnant women, uncontrolled comorbidity and terminal neoplasms will be excluded. A control group of 30 ambulatory individuals observed at the Hospital da Luz Lisboa will be recruited. Laboratory evaluation will be performed at the Immunology Laboratory of NOVA Medical School.

Official Title
-----------------
Imunomodulation in Acute Pancreatitis- How Can Cytokines, B and T Cells Predict the Outcome of the Disease

Conditions
-----------------
Acute Pancreatitis

Intervention / Treatment
-----------------
* Diagnostic Test: blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hospitalized patients with acute pancreatitis Exclusion Criteria: acute pancreatitis in the last 6 months diabetes mellitus, pregnant women, uncontrolled comorbidity such as organ disease (cardiac, renal, hepatic) and terminal neoplasms

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: blood samples|T cells, B cells and cytokines testing|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the immune profile of patients with acute pancreatitis at admission, 48h after admission and at 1 month and 6 months after discharge. | Blood collection for evaluation of B and T cell subpopulations as well as IL-1, IL6, TNFalpha also in blood collections will be performed in patients with acute pancreatitis in the first 24h of diagnosis, at 48 hours of hospitalization, one month after hospitalization and six months after the first determination. Application of the BISAP (Bedside Index of Severity in Acute Pancreatitis)score at admission Blood collection for RCP (mg/dl) determination in peripheral blood of these patients at hospital admission, 48h after the first determination and at discharge from hospital | 4 years |
The Experiences of People Who Live With Glanzmanns Thrombasthenia.

Study Overview
=================
Brief Summary
-----------------
To understand the lived experiences of people with Glanzmanns Thrombasthenia

Detailed Description
-----------------
A qualitative study of people with Glanzmanns Thrombasthenia including an on-line survey, qualitative in-depth interviews and bleed diary completion.

Official Title
-----------------
Glanzmanns 360. The Lived Experience of People With Glanzmanns.

Conditions
-----------------
Glanzmann Thrombasthenia

Intervention / Treatment
-----------------
* Other: survey and interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of congenital (inherited) Glanzmanns Thrombasthenia Exclusion Criteria: Acquired Glanzmanns Thrombasthenia

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 100 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 |
| --- | --- |
| Qualitative assessment<br>Survey (using validated quality of life assessment questionnaires) and one to one interviews of people and family members living with Glanzmanns Thrombasthenia | Other: survey and interview<br>* qualitative assessment<br>* Other names: diary completion;|
| Bleed diary<br>Daily bleed diary completion over 12 weeks | Other: survey and interview<br>* qualitative assessment<br>* Other names: diary completion;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to understand the impact of GT on quality of life of affected individuals and their families. | Incidence of reported impact of GT on daily life using validated questionnaires EQ5D, MIQ, PHQ9, Rosenbergs self esteem scale. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify levels of acceptability of current treatments and management approaches | Rate of reported satisfaction with current treatments using self efficacy to manage disease assessment tool | one year | 
| Identify areas of unmet need among people with GT | Rate of reported unmet need using ED5D and MIQ | one year |
Office-based Radial Expansion Balloon Dilation of the Esophagus and Trachea

Study Overview
=================
Brief Summary
-----------------
Retrospective chart review of UCDMC patients who have undergone esophageal or tracheal balloon dilation to record data including age, gender, diagnosis pre-and post-procedure eating assessment tool, esophagoscopy findings, tracheobronchoscopy findings, and pre-and post-procedure videofluoroscopic findings.

Detailed Description
-----------------
Dilation of the esophagus is performed for strictures, webs, and rings at all levels of the esophagus. Dilation of the trachea is performed for subglottic and tracheal stenosis. Radial expansion balloons have been developed by Bost Scientific Corporation for the purpose of dilating the esophagus and trachea through flexible esophagoscopies. These sequential controlled radial-expansion balloons can be introduced via a guide wire through the working channel of a 5.1 mm transnasal esophagoscope. Traditionally, otolaryngologists have performed esophageal and tracheal dilation per oral under general anesthesia. This technique allows the procedure to be performed in the office, sparing the patient the risk of anesthetics. The purpose of this study is to review the UCDMC experience with esophageal and tracheal balloon dilation using the transnasal esophagoscope.

Official Title
-----------------
Office-based Radial Expansion Balloon Dilation of the Esophagus and Trachea

Conditions
-----------------
Tracheal Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who have undergone esophageal or tracheal balloon dilation since 1/1/05 patients who underwent an attempted dilation since 1/1/05 Exclusion Criteria: Younger than 18 years of age Those who do not meet the inclusion criteria

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
swallowing problems, tracheal stenosis
Dietry Pattern and Lead Levels in Pregnancy

Study Overview
=================
Brief Summary
-----------------
During pregnancy lead crosses the placenta freely and can have adverse effects on the fetus, with the potential for life-long impact on the child. Identification of dietary patterns and food groups in pregnancy in relation to measures of lead status could provide a more useful alternative to a nutrient-specific advice to minimise fetal exposure to lead during pregnancy. The aim is to evaluate whether dietary patterns and food groups are associated with blood lead concentrations in pregnancy.

Detailed Description
-----------------
Whole blood samples were collected from pregnant women enrolled in the Avon Longitudinal Study of Parents and Children observational birth cohort study and were analysed for lead. Dietary pattern scores were derived from principal components analysis of a food frequency questionnaire. Associations of quartiles of dietary pattern scores, and of food groups categorised by frequency of consumption, with the likelihood of blood lead concentration (B-Pb) ≥5 µg/dl will be identified with adjusted logistic regression (n=2167).

Official Title
-----------------
Dietary Patterns and Variability in Blood Lead Concentrations Among Pregnant British Women

Conditions
-----------------
Dietary Habits, Lead Poisoning, Pregnancy Related

Intervention / Treatment
-----------------
* Other: None - observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrolled in ALSPAC, pregnant - Exclusion Criteria: Not enrolled in ALSPAC, not pregnant -
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women<br>Pregnant women enrolled in ALSPAC | Other: None - observational<br>* None - observational<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lead concentration | Blood lead concentration | During gestation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dietary patterns, Pregnancy, Woman, Diet, Lead, ALSPAC