linjc16/ctgov huggingface dataset:
Convalescent Plasma Donor Vaccine Study An Observational Antibody Level Study.

Study Overview
=================
Brief Summary
-----------------
There is a need to understand antibody responses following SARS-COV-2 infection and subsequent vaccination.

Detailed Description
-----------------
This is an observational study to determine changes in antibody levels in individuals who have previously donated COVID-19 convalescent plasma (CCP) and have now received at least one dose of a COVID-19 vaccine. At present these donors could no longer donate CCP as their virus-neutralising antibody levels do not reach the level required (Euroimmun of at least 6 IgG signal/control cutoff). Two blood samples (9 ml total) will be collected at a local NHSBT donor centre to test the levels of the virus-neutralising antibodies in the plasma against different viral strains. The results of this study will: Determine whether NHSBT will collect CCP or plasma for medicines (PFM) from vaccinated members of the public that could have boosted antibody levels following vaccine administration. Understand if antibody levels rebound to a concentration suitable for CCP and PFM. Provide the evidence to support the use of CCP for the early treatment in COVID (currently under consideration as a collaboration with European partners). Assist in development of recording vaccination status on NHSBT databases of donors.

Official Title
-----------------
Convalescent Plasma Donor Vaccine Study: An Observational Antibody Level Study

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals who have had a previous SARS-CoV-2 infection Individuals who have previously donated COVID-19 convalescent plasma (CCP) Received at least one dose of a SARS-CoV-2 vaccine (any type of vaccine) Exclusion Criteria: Not received a SARS-CoV-2 vaccine

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 66 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 |
| --- | --- | --- |
| Increase in antibody levels post-vaccination assessed via Euroimmun assay | Euroimmun assay | at least 28 days following vaccination | 
| Increase in antibody levels post-vaccination assessed via Roche IgG assay | Roche IgG assay | at least 28 days following vaccination | 
| Increase in antibody levels post-vaccination assessed vial live virus neutralization | Live virus neutralization (SARS-CoV-2 wild type (WT), alpha,beta and delta variants) | at least 28 days following vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anti-SARS-CoV-2 antibodies, COVID-19, Convalescent plasma
Efficacy of Azadirachta Indica (Homoeopathic Medicine) in Treatment of Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
Acne is one of the most common skin problems in teenagers and adolescents. There are many lesser known homoeopathic medicines which have been mentioned in the literature for treatment of acne but their potential has not been properly assessed /documented and therefore these medicines don't form a part of many prescriptions. As a part of this study,efficacy of Azadirachta Indica will be studied in the treatment of Acne vulgaris

Official Title
-----------------
Efficacy of Lesser Known Homoeopathic Medicines in Acne Vulgaris - Azadirachta Indica

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: Azadirachta Indica


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females between 12 to 25 years of age Presence of inflammatory and non-inflammatory lesions Able to follow-up according to protocol Patients not taking any medication for treatment of Acne in preceding one month. Exclusion Criteria: Acne Conglobata Pregnant or Breast feeding females or females having intention of becoming pregnant Significant systemic disease Any drug/ alcohol addiction History of chronic diseases treated with medications in the preceding month which might affect acne condition and treatment outcome

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 25 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

| Intervention/Treatment |
| --- |
|Drug: Azadirachta Indica|To start with subjects will be prescribed Azadirachta Indica in 6 potency to be taken in form of pills 4 times a day for seven days. Dosage and frequency will be changed, if required, based on the condition of subject and their response according to homoeopathic principles.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent change in acne lesion counts from the Baseline |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in quality of life of subjects from baseline | Change in Quality of life will be assessed based on Quality of Life Questionnaire to be filled by subjects at the start of Treatment and at the end of time frame. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acne Vulgaris, Homoeopathy, Homeopathy, Azadirachta Indica
Anger and Cardiovascular Risk in Urban Youth

Study Overview
=================
Brief Summary
-----------------
To examine anger and cardiovascular disease risk in urban youth. The project studied patterns of hemodynamic responses to social and nonsocial stressors, ambulatory blood pressure (BP), fasting insulin, fasting glucose, lipid profiles, and central obesity in adolescents from a wide range of socioeconomic status (SES) backgrounds.

Detailed Description
-----------------
BACKGROUND: Urban adolescents at high risk for cardiovascular disease (CVD) exhibit a pattern of hemodynamic responses that: (a) is evoked by social encounters that arouse anger, defensiveness, and distrust; (b) appears related to increased insulin resistance; (c) is more pronounced in males and African Americans; and (d) may constitute a pathway via which chronic exposure to stressful social environments increases CVD risk. DESIGN NARRATIVE: There were four studies. Study 1 in the first two years measured hemodynamics in 200 subjects to test the hypothesis that hostile distrust was associated with increased total peripheral resistance (TPR) response to social challenge, and that adolescents exhibiting this response pattern had elevated levels of ambulatory BP, fasting insulin, glucose, blood lipids, and central obesity. Study 2 followed 200 subjects for four years to determine if defensive hostility and distrust were related to tracking at higher levels of BP (measured every 6 months), and insulin/ glucose/ cholesterol (measured once per year). Study 3 in years 3 and 4 evaluated the influence of race on the cross-situational consistency of hostile distrust/BP by measuring the latter responses in 200 adolescents during structured encounters with a friend of the same race and sex, an unfamiliar same-race peer, and an unfamiliar other-race peer (black or white). Study 4 evaluated video and audiotape recordings from Studies 1 and 3 to test the hypothesis that distrustful individuals expressed more hostile affect in encounters with others, elicited more negative treatment, were perceived as hostile regardless of observer race or gender, and thus experienced chronic, health-damaging interpersonal stress. Study 4 data were used to examine the possibility that hostile distrust is related to exposure to crime, poverty, and racial discrimination. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Obesity, Cardiovascular Diseases, Heart Diseases, Hypertension

Participation Criteria
=================

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Diclofenac Potassium Alone Versus Diclofenac Potassium With Hyoscine-N-butyl Bromide (HBB in Endoscopy

Study Overview
=================
Brief Summary
-----------------
Diclofenac is a proven, commonly prescribed nonsteroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory, and antipyretic properties, and has been shown to be effective in treating a variety of acute and chronic pain and inflammatory conditions.

Detailed Description
-----------------
Diclofenac is a proven, commonly prescribed nonsteroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory, and antipyretic properties, and has been shown to be effective in treating a variety of acute and chronic pain and inflammatory conditions. . As with all NSAIDs, diclofenac exerts its action via inhibition of prostaglandin synthesis by inhibiting cyclooxygenase-1 (COX-1)

Official Title
-----------------
Diclofenac Potassium Alone Versus Diclofenac Potassium With Hyoscine-N-butyl Bromide (HBB in Endoscopy

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Diagnostic Test: Diclofenac + HBB with hysteroscopy
* Diagnostic Test: Diclofenav + placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patients indicated for diagnostic hysteroscopy including infertility, bleeding, suspected intrauterine pathologies (eg polypi , septea) 2. Reproductive age 20 - 40yrs Exclusion Criteria: 1. Menopausal and amenorrhic patients 2. Contraindication to office hysteroscopy such as:- pelvic inflammatory disease, marked cervical stenosis, pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Diclofenac + HBB<br>Women who will receive Diclofenac + HBB | Diagnostic Test: Diclofenac + HBB with hysteroscopy<br>* Giving Diclofenac + HBB with hysteroscopy<br>Diagnostic Test: Diclofenav + placebo<br>* Giving Diclofenac + placebo with hysteroscopy<br>|
| Other: Diclofenav + placebo<br>Women who will receive Diclofenav + placebo | Diagnostic Test: Diclofenac + HBB with hysteroscopy<br>* Giving Diclofenac + HBB with hysteroscopy<br>Diagnostic Test: Diclofenav + placebo<br>* Giving Diclofenac + placebo with hysteroscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of women who will not feel pain | the effect of medications on pain sensation | within half an hour |
Intrapartum Study of Sterile and Clean Gloves

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the use of sterile or clean gloves during labor exams affects the rate of chorioamnionitis. Chorioamnionitis is an infection of the membranes around the baby.

Detailed Description
-----------------
The importance of this study is that intrapartum vaginal exams (while patients are laboring) are performed routinely in modern obstetrical practice, and there is no randomized trial available assessing the relationship between the type of glove used and the rate of chorioamnionitis.

Official Title
-----------------
A Comparison of Sterile and Non-sterile Gloves for the Incidence of Chorioamnionitis During Labor: a Randomized Controlled Trial

Conditions
-----------------
Chorioamnionitis

Intervention / Treatment
-----------------
* Other: Type of glove used for intrapartum vaginal exams


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spontaneous or induced labor Rupture of membranes < 12 hours Nulliparous or multiparous Gestational age greater than or equal to 34 weeks Age greater than or equal to 18 Exclusion Criteria: Contraindications to labor Multiple gestations Rupture of Membranes greater than 12 hours Gestational age less than 34 weeks Non-English speaking patients

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Nonsterile<br>Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams. | Other: Type of glove used for intrapartum vaginal exams<br>* Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams.<br>|
| Other: Sterile<br>Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams. | Other: Type of glove used for intrapartum vaginal exams<br>* Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical chorioamnionitis | Clinical chorioamnionitis with at least two of the four criteria met-maternal fever of 38 degrees Celsius or greater, maternal tachycardia (pulse >100), fetal tachycardia (fetal heart rate >160), and/or fundal tenderness | participants will be followed during their intrapartum hospital stay, an expected average of 48-72hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intrapartum, Glove, Chorioamnionitis
Assessment of Clinical Outcomes in Closure of Deep Neck Space Infection Incisions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if closure of deep neck infection incisions at the time of extraoral drain removal has any impact on rates of reinfection and to determine if this treatment will have any impact on scar formation and qualitative measures of pain or impact on quality of life during the post-operative healing period.

Official Title
-----------------
Assessment of Clinical Outcomes in Closure of Deep Neck Space Infection Incisions

Conditions
-----------------
Deep Neck Space Infections

Intervention / Treatment
-----------------
* Procedure: neck incisions closed at bedside at the time of drain removal under local anesthesia
* Procedure: standard treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: deep neck space infection who require a conservative unilateral submandibular neck incision to access affected deep fascial neck spaces Exclusion Criteria: pregnant females cognitively impaired individuals deep neck space infections which require bilateral neck incisions, large neck apron incisions, or placement of negative pressure therapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Arm<br> | Procedure: neck incisions closed at bedside at the time of drain removal under local anesthesia<br>* Participants allocated to the investigational group will have neck incisions closed at bedside at the time of drain removal under local anesthesia<br>|
| Active Comparator: Control Group<br> | Procedure: standard treatment<br>* Participants in the control group will have standard treatment performed as per current practice,their incision will be left to close by secondary intention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with reinfection |  | 1-2 weeks post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants requiring a scar revision surgery |  | 4-6 months post intervention |
Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies

Study Overview
=================
Brief Summary
-----------------
This is a proof of principle study that investigates heart rate variability differences in fetal and neonatal life in a longitudinal study design and compares two subject groups, offspring conceived using in-vitro fertilization and conceived naturally.

Detailed Description
-----------------
This is a proof of principle study that investigates heart rate variability differences in fetal and neonatal life in a longitudinal study design and compares two subject groups, offspring conceived using in-vitro fertilization and conceived naturally.

Official Title
-----------------
Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies

Conditions
-----------------
Neuro Developmental Delay

Intervention / Treatment
-----------------
* Other: Holter monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fetus or newborn Delivery at University of Utah Medical Center, Latter Day Saints Hospital or Intermountain Medical Center Exclusion Criteria: Twins Genetic anomaly Congenital malformation Need for special care

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

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 |
| --- | --- |
| Healthy newborns conceived naturally<br> | Other: Holter monitor<br>* Record heart rate for 2 to 6 hours on day of life 1 or 2.<br>|
| Healthy newborns conceived with IVF<br> | Other: Holter monitor<br>* Record heart rate for 2 to 6 hours on day of life 1 or 2.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies | Holter monitor/2 aims | 2 to 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prediction of neuro developmental delay
Effectiveness of Targeted Educational Interventions at Increasing HPV Vaccine Acceptability and Uptake

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the effectiveness of targeted educational interventions in increasing the acceptability and knowledge of the HPV vaccine among females ages 12 through 26. Subjects will be randomized to one of three study arms (no intervention, viewing an educational video or reading an educational handout) and then a questionnaire will be administered to assess knowledge and acceptability of the HPV vaccine. Subject charts will be reviewed to assess for initiation of the HPV vaccine.

Official Title
-----------------
Effectiveness of Targeted Educational Interventions at Increasing HPV Vaccine Acceptability and Uptake

Conditions
-----------------
HPV-Related Cervical Carcinoma

Intervention / Treatment
-----------------
* Other: Educational video
* Other: Educational handout
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females ages greater than or equal to 12 years and less than or equal to 26 years Presenting to a gynecology clinic for a routine or problem visit Ability to read and write Exclusion Criteria: Women ages less than or greater than 12 years or greater than 26 years Women with known cervical cancer Known pregnancy Prior initiation or completion of the HPV vaccine series

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 26 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>Subject does not receive an educational intervention | Other: Control<br>* Control<br>|
| Other: Educational video<br>Subject watches an educational video | Other: Educational video<br>* Approximately 7 minute video on the HPV vaccine<br>|
| Other: Educational handout<br>Subject reads an educational handout | Other: Educational handout<br>* One page handout on the HPV vaccine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV vaccine acceptability | Subject reported willingness to accept the HPV vaccination, as assessed through agreement or disagreement to the statement I would be willing to accept the HPV vaccine today. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV vaccine knowledge | Subject knowledge of the HPV vaccine and its associated risks and benefits, as assessed through a survey. Subjects are asked to answer 7 questions and total knowledge score is calculated by an unweighted sum of correct answers. | Up to 6 months |