linjc16/ctgov huggingface dataset:
Maternal Loss of Control Eating

Study Overview
=================
Brief Summary
-----------------
This study focused on investigating the effects of maternal disordered eating on maternal and child outcomes as part of a secondary data analysis of the Avon Longitudinal Study of Parents and Children (ALSPAC).

Detailed Description
-----------------
Deidentified and anonymised data already collected as part of the ALSPAC study will be analysed to investigate the effects of maternal eating on maternal and child outcomes (diet, eating, weight, metabolic). The Avon Longitudinal Study of Parents and Children (ALSPAC) is a longitudinal, prospective study designed to examine the effects of environment, genetics and other factors on health and development.All pregnant women living in the geographical area of Avon, UK, who were expected to deliver their baby between 1st April 1991 and 31st December 1992, were recruited. 14,541 women were enrolled. Amongst these pregnancies, there were a total of 14,676 fetuses, resulting in 14,062 live births and 13,798 children who were alive at 1 year of age and were singletons. The ALSPAC study website contains details of all the data that is available through a fully searchable data Dictionary (http://www.bris.ac.uk/alspac/researchers/data-access/data-dictionary/). Missingness will be assessed and standard data analytical techniques such as MI will be used.Crude and adjusted logistic, linear, and multinomial regression models will be employed.

Official Title
-----------------
Maternal Loss of Control Eating: a Longitudinal Study of Maternal and Child Outcomes

Conditions
-----------------
Eating Disorder, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: multiple pregnancies no questionnaire data at 32 weeks. eligibility criteria : enrolled in the ALSPAC study; inclusion: all women part of the ALSPAC study;

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 43 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 |
| --- | --- | --- |
| birth weight | weight at birth | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | body mass index | average 21 years | 
| Food Frequency Questionnaire (FFQ) | adult dietary patterns - software specific to the FFQ will be used to analyze data. | average 9 months | 
| Food Frequency Questionnaire | child dietary patterns- software specific to the FFQ will be used to analyze data. | average 21 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALSPAC, longitudinal
Familial Pancreatic Cancer PROPHilation Program in Italy

Study Overview
=================
Brief Summary
-----------------
The goal of the PROPH-ITA Study is to perform genetic testing in family members of pancreatic cancer patients who may have a genetic predisposition. The subjects belong to the Italian Registry of Families At Risk of Pancreatic Cancer (IRFARPC, #NCT04095195). This investigational study will assess the genetic background of subjects with familiarity with pancreatic cancer only. Participants may accept to undergo genetic testing as part of the IRFARPC registry, through a saliva-swab-based 41-gene panel test. Up to 3,000 participants will be enrolled in this study.

Official Title
-----------------
Standardised Genetic Profiling of Subjects Belonging to the Italian Multicenter Registry of Prospective Surveillance of Subjects at Genetic Risk of Pancreatic Cancer

Conditions
-----------------
Candidates for Hereditary Pancreatic Cancer Testing

Intervention / Treatment
-----------------
* Genetic: Saliva swab testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being enrolled on the IRFARPC registry Having familiarity for pancreatic cancer (according to the IRFARPC criteria, Capurso et al. Dig Liv Dis, 2020) Willingness to participate in saliva-swab-based genetic testing Exclusion Criteria: - Already known genetic mutation

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Saliva testing swab<br>Subjects with familiarity with pancreatic cancer enrolled into the IRFARPC registry (NCT04095195) will be submitted to buccal swab for saliva-based genetic testing | Genetic: Saliva swab testing<br>* 41 pancreatic cancer predisposition genes will be tested through a saliva-based swab<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence - absence of predisposing mutations | Prevalence of genetic mutations over the total tested | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of genetic mutations with personal oncological history | Correlation between presence of predisposing mutation and prevalence of cancers | 5 years | 
| Correlation of genetic mutations with familial oncological history | Correlation between presence of predisposing mutation and prevalence of cancers in the family | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreatic Cancer, Pancreatic Cancer familiarity, Genetic profiling, Genetic predisposition, Pancreatic Cancer surveillance
A Pharmacokinetic Study of Actinomycin-D and Vincristine in Children With Cancer

Study Overview
=================
Brief Summary
-----------------
To obtain a preliminary characterization of the plasma PK and metabolites of actinomycin-D in children with cancer.

Detailed Description
-----------------
There is a fundamental lack of knowledge regarding optimal dosing of anti-cancer agents for young children with cancer, with resultant increased risk of morbidity, mortality and inferior outcome. Of the anti-cancer agents used frequently in infants and young children, the drug with the least amount of knowledge is actinomycin-D. Actinomycin-D, has been used for the treatment of several childhood cancers since the 1960s. Despite its longstanding and widespread use in pediatric oncology, there is virtually no pharmacokinetic information from which safe and appropriate age-based pediatric dosing can be derived. Actinomycin-D is an integral component of rhabdomyosarcoma and Wilms tumor therapy, and pediatric oncologists will continue to administer the durg despite the gap in knowledge.

Official Title
-----------------
A Pharmacokinetic Study of Actinomycin-D and Vincristine in Children With Cancer

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: Actinomycin-D
* Drug: Vincristine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6 months - 18 years Due to receive actinomycin-D as a component of cancer treatment Central venous catheter (e.g. Port-a Cath, Broviac) Informed consent of parent or legal guardian and patient assent when appropriate Exclusion Criteria: Serious illness other than the primary diagnosis of cancer Weight < 5 kilograms Previous participation in CHP-810

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

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

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: Actinomycin-D|nan|
|Drug: Vincristine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of Plasma Pharmacokinetics to examine the optimal dosing, metabolites and inter-patient variability of actinomycin-D in children with cancer during any sample of chemotherapy. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Actinomycin, Vincristine
Six Minute Walking Test and Breath-holding

Study Overview
=================
Brief Summary
-----------------
To compare the relationship between breath-hold time and the distance in a Six Minute Walking Test in chronic obstructive pulmonary disease population.

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Other: breath-holding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable chronic obstructive pulmonary disease Exclusion Criteria: contra-indication for six minutes walking test difficulty to walk musculoskeletal disorder

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

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

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

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

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 6 minutes walking test<br> | Other: breath-holding<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| six minute walking test |  | day 1 |
Treatment of Medically Unexplained Physical Ailments (Somatization Disorder)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare cognitive behavior therapy (CBT) to medical care-as-usual for the treatment of patients with high levels of medically unexplained physical symptoms (Somatization Disorder). A second goal is to examine the effectiveness of CBT in Latinos, since Latinos suffer a relatively high prevalence of Somatization Disorder.

Detailed Description
-----------------
Patients with Somatization Disorder suffer from medically unexplained physical ailments and experience significant distress and disability. This disorder is an important problem for the primary health care system because patients with Somatization Disorder use health care resources extensively but receive little benefit. To date, no medical or psychiatric intervention has been demonstrated in controlled trials to produce clinically significant and lasting symptom relief or improved functional status in Somatization Disorder patients. Patients in primary care settings with multiple unexplained symptoms are treated with 10 weekly sessions of CBT or treatment as usual. Physical symptoms, comorbid psychiatric symptoms, disability, and health care utilization are measured and assessed through a combination of structured interviews and self-reports. Assessments are performed at study start, mid-treatment, end of treatment, and at a 6-month follow-up.

Official Title
-----------------
Treatment of Somatization in Primary Care

Conditions
-----------------
Somatoform Disorders

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavioral Therapy
* Behavioral: CBT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Somatization disorder Exclusion Criteria: Bipolar disorder Schizophrenia or other psychosis Major Depression

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: 1<br>10 Session modified CBT (including a relaxation component) administered by trained mental health clinicians at the primary care setting | Behavioral: Cognitive Behavioral Therapy<br>* Ten Weekly Sessions of Manualized CBT<br>Behavioral: CBT<br>* Cognitive Behavioral Therapy<br>|
| No Intervention: 2<br>Treatment as Usual, defined as the use of a consultation letter and traditional primary care management. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI Improvement |  | Post Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression |  | Post Treatment |
Autism Registry for French Guiana

Study Overview
=================
Brief Summary
-----------------
The objective of the autism registry is to estimate the prevalence of autism in French Guiana in the cohort of children aged 8 years. Secondary objectives are to determine the prevalence of comorbidities, and to determine the theoretical and actual orientation of these children regarding care and education in a territory with significant structural deficits relative to mainland France. The outcomes of this registry will be to guide decision makers in their funding priorities to improve, screening, diagnosis, care and education for children on the autistic spectrum

Official Title
-----------------
Autism Registry for French Guiana

Conditions
-----------------
Autism Spectrum Disorder

Intervention / Treatment
-----------------
* Other: observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children aged 8 years with a diagnosis of autism spectrum disorder Exclusion Criteria: refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 8 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: observational|registry|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| autism spectrum disorder | the number of 8 year old children with a diagnosis of autism spectrum disorder in a given year relative to the total population of children aged 8 years old in that given year | 1 year (the year at age 8) |
Vaginal Heat Wash-out (HWO) in 4 Groups of Women (Pre- and Postmenopausal With and Without Female Sexual Arousal Disorder (FSAD)).

Study Overview
=================
Brief Summary
-----------------
The Pfizer developed Heat Wash-Out (HWO) system is a software controlled electromechanical system designed to measure vaginal wall blood flow. A small vaginal probe is attached to a control unit. Output data are collected on a PC. By measuring the clearance of heat from the heated probe, a direct measure of absolute blood flow can be obtained. The study will assess the technique's ability to differentiate between pre- and post-menopausal women; with and without Female Sexual Arousal Disorder (FSAD).

Detailed Description
-----------------
Medical Device Development

Official Title
-----------------
A 2-Way Repeatability Study To Investigate Vaginal Blood Flow Before, During And After Visual Sexual Stimulation In Pre- And Post-Menopausal Women With And Without Female Sexual Arousal Disorder, Using The Heat Wash-Out Technique.

Conditions
-----------------
Sexual Dysfunction, Physiological

Intervention / Treatment
-----------------
* Device: Vaginal Heat Wash-Out Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-menopausal women aged 18-40 (with and without FSAD) or Post-menopausal women aged 50-65 (with and without FSAD. FSAD must have been present for at least 6 months. Exclusion Criteria: Pregnant or lactating women (pre-menopausal population) Systemic Hormone Replacement Therapy (HRT) or Selective Estrogen Receptor Modulator (SERM) (postmenopausal population) Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic disease or other major psychological or sexual disorder.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal Heat Wash-Out Device<br> | Device: Vaginal Heat Wash-Out Device<br>* No drug administered. Device tested twice with each subject.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and toleration of the heat washout device. |  | 2 weeks | 
| To investigate differences in vaginal blood flow following visual sexual stimulation in pre-menopausal women with and without FSAD. |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate changes in subjective acute sexual arousal following visual sexual stimulation in women with and without FSAD. |  | 2 weeks |
Comparison of Three Methods of Hemoglobin Monitoring

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the hemoglobin results obtained with 1) the HemoCue™, 2) the Masimo SpHb™, and 3) the UCSF Clinical Laboratory. The goal is to determine if these three values differ from each other during various levels of blood loss in the clinical care of patients for spine revision and hip revision surgery.

Detailed Description
-----------------
See above

Official Title
-----------------
Comparison of Three Methods of Hemoglobin Monitoring in Patients Undergoing Spine Revision or Hip Revision Surgery.

Conditions
-----------------
Blood Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or non-pregnant female 18 y/o or older American Society of Anesthesiology Classification 1, 2 or 3 Scheduled to undergo spine or hip revision surgery Exclusion Criteria: Pregnant or nursing Patients who in the study investigators clinical judgement would not be suitable for research.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| spine or hip surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| See description below | Primary outcome is based on the difference between SpHb (Masimo SpHb™ continuous hemoglobin reading ) - tHb (laboratory hemoglobin determination). | A minimum of three differences recorded during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| See description below | Secondary outcome is based on the difference between a HemoCue™ derived hemoglobin determination - laboratory hemoglobin determination. | A minimum of three differences recorded during surgery |
Clinical Evaluation of i-STAT Analyzer Glucose, Hematocrit and Sodium for Capillary Samples

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to compare the performance of two i-STAT Analyzers in a Point-of-Care (POC) setting. The evaluation will be performed using a cartridge to test glucose, hematocrit and sodium on capillary specimens.

Detailed Description
-----------------
The clinical performance for glucose, hematocrit and sodium assays for capillary samples was evaluated for the investigational i-STAT 500 (Alinity) analyzer based on results of method comparison testing against the i-STAT 1W analyzer.

Official Title
-----------------
Clinical Evaluation of i-STAT Analyzer for Glucose, Hematocrit and Sodium

Conditions
-----------------
Analytical Performance of Sodium, Glucose and Hematocrit Assays by the i-STAT 500 (Alinity) Analyzer

Intervention / Treatment
-----------------
* Diagnostic Test: In-vitro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is ≥ 18 years of age Subjects (or their legal representative) who are willing to voluntarily consent to the study Exclusion Criteria: There are no exclusion criteria

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: In-vitro|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose (mg/dL) levels | Data analysis | Patient's blood is tested within 3 minutes of blood collection | 
| Hematocrit (%PCV) levels | Data analysis | Patient's blood is tested within 3 minutes of blood collection | 
| Sodium (mmol/L) levels | Data analysis | Patient's blood is tested within 3 minutes of blood collection |