linjc16/ctgov huggingface dataset:
STEP: Social Support To Empower Parents

Study Overview
=================
Brief Summary
-----------------
This RCT intervention provides parental social support (informational, affirmational, and emotional) using parent mentors (experienced in the management of the chronic illness) for mothers and fathers of young children newly diagnosed with type 1 diabetes. The parent mentors provide both home visits and phone call support over the course of the first year after diagnosis. The hypothesis is that newly diagnosed parents who receive the intervention will perceive less parental concern and worry, less negative impact on the family, more perceived confidence and social support compared to those mothers and fathers not receiving the intervention.

Official Title
-----------------
STEP: Social Support To Empower Parents

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Behavioral: STEP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mothers and fathers of children 12 years and younger with type 1 diabetes

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parent mentor contact<br>Parent mentor provides face-to-face social support | Behavioral: STEP<br>* Experimental: Minutes of parent mentor-parent participant interactions Control: Minutes of parent contact-parent participant interactions<br>* Other names: Control arm: receives phone number of parent contact;|
| Active Comparator: Control Arm<br>Parent is given a phone contact | Behavioral: STEP<br>* Experimental: Minutes of parent mentor-parent participant interactions Control: Minutes of parent contact-parent participant interactions<br>* Other names: Control arm: receives phone number of parent contact;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Confidence Scale | Maternal confidence in managing child with type 1 diabetes . Higher total scores (10 questions, minimum score of 0, maximum score of 50) mean a better outcome (greater maternal confidence) | 12 months | 
| Parent Concern | Parent concern in managing child with type 1 diabetes. Higher total scores (58 questions, minimum score is 58; maximum score is 255) means more worry with managing child's diabetes care. | 12 months | 
| Worry | Parent worry in managing child's care. Higher total scores (11 questions, minimum score is 11, maximum score is 44) indicate more parental worry | 12 months |
Misoprostol for Second Trimester Pregnancy Termination

Study Overview
=================
Brief Summary
-----------------
The majority of second-trimester pregnancy termination performed in the United States are performed surgically by dilation and evacuation. The frequency of induction of abortion increases as gestational age advances. In the late second trimester and early third trimester, induction is the primary method of termination in cases of fetal abnormalities. In many other countries, however, induction is the primary method of abortion throughout the second trimester

Official Title
-----------------
Intra Uterine Extra Amniotic (200 μg ) Versus Vaginal (200 μg) Misoprostol for Second Trimester Pregnancy Termination: Randomized Controlled Trial

Conditions
-----------------
Intra Uterine Fetal Death

Intervention / Treatment
-----------------
* Procedure: termination of second trimester pregnancy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnancy 13-24 weeks. Women with indication for termination of the pregnancy due to intra uterine fetal death Exclusion Criteria:-Pregnancy before 13 weeks. Pregnancy beyond 24 weeks. Women with scared uterus. Known hypersensitivity for misoprostol. Refusal of the woman to participate.
Sexes Eligible for Study
-----------------
Female

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: extra amniotic misoprostol<br>misoprostol dissolved in warm saline , become dissolute misoprostol saline solution(200 microgram every 4 hours) | Procedure: termination of second trimester pregnancy<br>* Intra uterine extra amniotic (200 μg ) versus Vaginal (200 μg) Misoprostol for Second Trimester Pregnancy Termination. Randomized controlled trial<br>|
| Experimental: vaginal misoprostol<br>misoprostol tablet soaked with distilled water and inserted in the posterior fornix of the vagina( 200 microgram every 4 hours) | Procedure: termination of second trimester pregnancy<br>* Intra uterine extra amniotic (200 μg ) versus Vaginal (200 μg) Misoprostol for Second Trimester Pregnancy Termination. Randomized controlled trial<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean duration from the initial misoprostol dose until complete fetal expulsion |  | 24 hours |
Dental Anaesthesia Affects Pain Level

Study Overview
=================
Brief Summary
-----------------
Background: Needles are the most feared tools, making anaesthetic injection a worrying practice. Aim: To compare intraosseous (IOA) and needle-free dental anaesthesia (NFA) methods that painless anaesthesia. Design: Twenty patients aged 8-10 years were included in this cross-over study. To determine the anxiety levels and pain experienced by the patients, visual and behavior scales were used. The pulse rate (PR) and opiorphin levels (OL) determined. The Friedman and Wilcoxon signed-rank tests were used. p<0.05 was considered significant.

Official Title
-----------------
Determination of the Effect of Two Different Methods of Dental Anaesthesia on Pain Level in Paediatric Patients: A Cross-over, Randomised Trial

Conditions
-----------------
Dental Anxiety, Anesthesia, Local

Intervention / Treatment
-----------------
* Device: DENTAL LOCAL ANESTHESİA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 8-10 years, systemically healthy, had undergone dental treatment (except for extraction) previously but with at least 1 week passed since then were compatible enough to undergo therapy in the clinic in a sitting position, had infection between the roots with a rate over 1/3, had 2/3 root formation, had been indicated for extraction of the maxillary primary molar teeth (55/65 No. teeth), did not have acute and/or subacute infection of the related or other teeth or mouth and surrounding tissues Exclusion Criteria: who scored above 41 in the state anxiety subscale and above 44 in the trait anxiety subscale of the Spielberger State-Trait Anxiety Scale (SSAS-SAAS) not meeting the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 10 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SLEEPERONE<br> | Device: DENTAL LOCAL ANESTHESİA<br>* doing local and topical anesthesia with two different device<br>|
| Experimental: COMFORTIN<br> | Device: DENTAL LOCAL ANESTHESİA<br>* doing local and topical anesthesia with two different device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of scales (wong baker faces pain rating scale) | (0-10) (0= no hurt, 10= hurts worst) | one year | 
| Score of scales (face, legs, activity, cry, consolability) | (0-10) (0= relaxed, 10=severe discomfort) | one year | 
| Score of scales (frankl behavior rating scale) | (1-4) (1= definitely negative, 4=definitely positive) | one year | 
| heart rate (pulse oximeter) |  | one year | 
| level of opiorphin (from saliva samples) |  | one year |
Expanded Access With Trappsol(R) Cyclo (TM) for an Individual Patient With Late Onset Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
To afford urgent access to a potential-disease modifying treatment, Dr. Diana Kerwin, in partnership with CTD Holdings, the manufacturer of Trappsol (R) Cyclo(TM), will administer the product to a patient with Alzheimer's Disease who has no other disease-modifying treatment options.

Detailed Description
-----------------
Trappsol(R) Cyclo(TM) will be administered via intravenous (IV) infusion. The initial dose will be 500 mg/kg (T=Day 0). Subsequent dosing is anticipated to increase over 9 months, with all subsequent doses given monthly at the maximum dose determined by tolerability, lack of toxicity or adverse event, pharmacokinetic analysis and patient preference. So long as the overall risk/benefit profile favors continued dosing, the patient will continue to receive Trappsol (R) Cyclo (TM) for a minimum of 12 months, if not perpetually. Risk/benefit assessments will include: Vital signs, ECG and laboratory parameters (CBC, chemistry panel, hematology, urinalysis, lipids, coagulation) Brain MRI without gadolinium for safety monitoring Amyloid and Tau PET (positron emission tomorgraphy) imaging Adverse Events Mini-mental status score Digital Cognition Technologies (DCT) Clock Changes in blood biomarkers Pharmacokinetic data

Official Title
-----------------
Expanded Access With Trappsol(R) Cyclo(TM) for an Individual Patient With Late Onset Alzheimer's Disease

Conditions
-----------------
Late Onset Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: Trappsol (R) Cyclo (TM)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with Alzheimer's Disease who continued to decline neurologically and had no other treatment options with intent to halt progression available. All other medical conditions stable & well-managed. - Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Trappsol (R) Cyclo (TM)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Obstructive Airways Diseases in Emergency Department (OADED) Study

Study Overview
=================
Brief Summary
-----------------
This is an observational study which aims to evaluate the possibility of using data from a capnography device to assess obstructive airway severity in both Chronic Obstructive Pulmonary Disease (COPD) and Asthma patients.

Detailed Description
-----------------
This is a feasibility observational study which aims to evaluate the possibility of using data from a capnography device to assess obstructive airway severity in both COPD and Asthma patients. The study will include adults asthma and COPD patients (age >18) that arrive at the Emergency Department (ED). Patients will be enrolled on a continuous basis and will be monitored by a capnograph and an oximeter before, during and after lung function assessment and medical treatment.

Official Title
-----------------
Obstructive Airways Diseases in Emergency Department (OADED) Study

Conditions
-----------------
Asthma, Chronic Obstructive Pulmonary Disease (COPD)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 Ability and willingness to participate the study and sign informed consent form Asthma / COPD patients Exclusion Criteria: Pregnant women Asthma or COPD patients with FEV1 > 60% Disability or unwillingness to undergo capnography measurement Cannot be assessed for FEV1 Oxygen supply >5 L/min

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 |
| --- | --- |
| Patients with COPD and Asthma .<br>Patients with COPD and Asthma. Continuous capnography and spirometry measurements of the subjects will be taken form the subjects with at least two minutes recording before the first spirometry assessment. All clinical diagnoses and treatments will be performed according to the department's protocols. This is an observational study with no interventions | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between capnography parameters and severity of asthma | Correlation between the airway obstruction severity calculation based on the capnography parameters and the clinical severity of asthma and COPD as defined by forced expiratory volume in 1 second (FEV1), in severe asthma and COPD patients | 1/2 hour to 48 hours from enrollment of subjects | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, COPD, Capnography
Rajavithi Health Promotion Project (Population Base Cohort)

Study Overview
=================
Brief Summary
-----------------
Metabolic Syndrome (hypertension, diabetes mellitus, obesity, cerebrovascular-cardiovascular disease) In Community Survey was performed in central Bangkok. Prospective Cohort and intensive educated intervention (health promotion program in specific high risk groups) were performed. The aim of the study is to identify high risk patients who can develop serious complications from metabolic syndrome. An analysis of health outcomes in multiple dimensions will be performed.

Official Title
-----------------
The Rajavithi Prospective Cohort Study on Community's Member Health (HPH-cohort Study)

Conditions
-----------------
Hypertension, Diabetes Mellitus, Dyslipidemia, Obesity, Cardiovascular Disease, Coronary Artery Disease

Intervention / Treatment
-----------------
* Behavioral: Intensive Education for Metabolic Syndrome Patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 16 years or more Informed consent Living in selected community (Health Promotion area of Rajavithi Hospital)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Intensive Education for Metabolic Syndrome Patients|Excercise, Intensive diatary program|

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
-----------------
DM, HT, Dyslipidemia, Obesity, Cardiovascular disease, Cerebrovascular disease, Myocardial infarction, stroke, Metabolic syndrome, CVD-CAD
Viral Illness in Pediatric Critical Care: Incidence Timing & Severity of Associated Heart Dysfunction & Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to be able to better describe the incidence, timing and severity of myocardial dysfunction and acute kidney injury (AKI) following a documented respiratory viral illness (RSV, adenovirus, metapneumovirus, parainfluenza, influenza, etc.) in pediatric patients.

Detailed Description
-----------------
This is a single-centre, prospective and retrospective, descriptive data-collection pilot study. Prospective Data Collection: All pediatric patients who are less than 18 years with a confirmed positive respiratory viral swab will be invited to participate. Retrospective Data Collection: The retrospective portion of this study will examine a 5 year period prior to the start of enrollment for the prospective study, with the intention to include all pediatric patients who are less than 18 years with a confirmed positive respiratory viral swab and admitted into the local hospital's PICU.

Official Title
-----------------
Viral Illness in the Pediatric Critical Care Setting: the Incidence, Timing and Severity of Associated Myocardial Dysfunction and Acute Kidney Injury.

Conditions
-----------------
Heart Failure, Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The parent or legal guardian of the pediatric subject must sign the Consent Form for participants in the prospective portion of the study. The subject must be no greater than 18 years of age, at the time of consent. The subject must be admitted to the local hospital. The subject must have a confirmed positive respiratory viral swab. Exclusion Criteria: The parent or legal guardian of the pediatric subject is unavailable or unwilling to sign the Consent Form for participants in the prospective portion of the study. The subject has had previous kidney injury or myocardial dysfunction prior to positive respiratory viral swab. The subject has any previous problems (prior to positive respiratory viral swab) with their heart or kidneys that could compromise the results, in the opinion of the Investigator.

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| Myocardial dysfunction, as defined by a low ejection fraction on an Echocardiogram. |  | up to 7 days | 
| Acute Kidney Injury (AKI) as defined by the meeting of the pediatric RIFLE criteria. |  | up to 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, Acute Kidney Injury, Myocardial Dysfunction, Pediatric Critical Care, Pediatric Intensive Care Units, Respiratory Virus
The Effects of Bimanual Laryngoscopy on Post-Operative Sore Throat in Adults

Study Overview
=================
Brief Summary
-----------------
Post-operative sore throat, cough, and hoarseness of voice are common, uncomfortable, distressing sequelae after tracheal intubation. It was postulated that these effects are because of irritation and inflammation of the airway. Bimanual laryngoscopy is known to improve visual field during intubation. This procedure might reduce laryngeal trauma during intubation and therefore reduce the incidence or degree of post-operative sore throat. This is the first prospective, double-blinded, controlled study, which is focused on the effects of bimanual laryngoscopy on first 24-houred post-operative sore throat (POST).

Conditions
-----------------
Postoperative Sorethroat, Bimanual Laryngoscopy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I or II 20-70 y/o GAET for A. Breast op B. GYN op C. Upper/lower extremities op D. Ophthalmology op E. GU op F. minor surgery Exclusion Criteria: emergency surgery head and neck surgery recent URI symptom in last one weeks with medication post op PCA use on NG/OG perioperative bucking

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| post, bimanual laryngoscopy, POGO score<br>one control, one study group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Tolerability/PoP Study in Allergic Rhinitis After Intranasal Administration of AZD8848

Study Overview
=================
Brief Summary
-----------------
The primary purpose is to investigate tolerability/safety of repeated weekly doses of AZD8848 administered intranasally to seasonal allergic rhinitis patients.

Official Title
-----------------
A Double-blind, Placebo Controlled, Randomized, Parallel Group Study to Investigate the Tolerability, Safety, Pharmacodynamics and Pharmacokinetics of Repeated Weekly Doses of AZD8848 Administered Intranasally to Seasonal Allergic Rhinitis Patients

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: AZD8848
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a history of birch and/ or timothy grass pollen induced seasonal allergic rhinitis for at least the previous 2 years (verified by a positive skin prick test) Patients with need of treatment for their nasal symptoms during the pollen season Exclusion Criteria: Clinical relevant disease or abnormality (past or present) - other than allergic rhinitis Symptomatic perennial allergic or non-allergic rhinitis A history of asthma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD8848<br>* nasal spray solution; 30 or 60 µg administered intranasally once weekly for one month<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* nasal spray solution. Once weekly intranasal administrations for one month.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence/nature of adverse events,pulse, BP, body temperature, ECG parameters, lab assessments |  | During the study | 
| Nasal symptoms, peak nasal inspiratory flow |  | During the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reflective Total Nasal Symptom Score, Peak Nasal Inspiratory Flow |  | During the study | 
| Blood biomarkers and nasal lavage biomarkers |  | During the study | 
| Pharmacokinetics |  | During the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients, allergic rhinitis, tolerability, safety, nasal symptoms