linjc16/ctgov huggingface dataset:
Parental Coping With Challenging Behavior in Mucopolysaccharidosis Type I-III

Study Overview
=================
Brief Summary
-----------------
The study quantitates behavioral challenges in mucopolysaccharidosis type I-III and parental coping strategies

Detailed Description
-----------------
This is a prospective, cross-sectional, observational study quantitatively assessing challenging behavior in children with MPS, an orphan, progressive, neurodegenerative metabolic disorder, and parental coping strategies for this challenging behavior. Patients registered at the German Society for Mucopolysacchardoses giving written informed consent are eligible. The study is based on questionnaires. IRB approval was obtained.

Official Title
-----------------
Behavioral Challenges in Children With Mucopolysaccharidosis Type I-III and Parental Coping Strategies

Conditions
-----------------
Coping Behavior, Mucopolysaccharidosis Type I, Mucopolysaccharidosis Type II, Mucopolysaccharidosis Type III, Behavior Disorders

Intervention / Treatment
-----------------
* Other: This is an observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of mucopolysaccharidosis type I, II or III Written informed consent Patient is registered at the German Society for Mucopolysaccharidosis Exclusion Criteria: Patient / Family does not give written informed consent.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: This is an observational study|This is an observational study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coping strategies for challenging behavior and for family burden in mucopolysaccharidosis type I-III | assessed by visual analogue scale | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of behavioral abnormalities in children with mucopolysaccharidosis type I-III | assessed by visual analogue scale | 10 minutes | 
| Intensity of behavioral abnormalities in children with mucopolysaccharidosis type I-III | assessed by visual analogue scale | 10 minutes | 
| Psychosocial burden in families with mucopolysaccharidosis type I-III | assessed by visual analogue scale | 10 minutes | 
| Psychosocial burden in families with mucopolysaccharidosis type I-III | assessed by Likert scale | 10 minutes |
Eficacy of Long-term Suplementation With Docosahexaenoic Acid in Patients With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
Cystic Fibrosis (CF) is a congenital disease secondary to the abnormal function of CFTR. Patients with CF have an alteration of essential fatty acids, Arachidonic Acid (AA) is increased and Docosahexanoic Acid (DHA) is decrease and the ratio ω-6/ ω-3 is elevated, all these alterations stimulated a chronic and bad regulated state of inflammation. For this porpoise, a fase IV trial, multicentric, controlled, double blind, placebo and parallel in patients elder than two months old and randomized to received every day a dietetically supplement with DHA or placebo, will be done during 12 months. The trial has as a principal objective to proved if this long term supplementation could decrease in contrast with placebo.

Official Title
-----------------
Study of the Eficacy of Long-term Suplementation With Docosahexaenoic Acid on Pulmonary, Sistemic and Intestinal Inflammation in Patients With Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Dietary Supplement: Docosahexaenoic acid administration: 50 mg/kg/day during 12 months
* Dietary Supplement: Placebo: 50 mg/kg/day during 12 months


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed of cystic fibrosis over than 2 months age Tolerance clinical supplementation with DHA Clinical situation stable Exclusion Criteria: Changes in the routine treatment in the 2 weeks prior to baseline Admission to hospital or administration of oral or intravenous antibiotics within 2 weeks before inclusion

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 100 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: Docosahexaenoic acid administration<br>50 patients will receive docosahexaenoic acid | Dietary Supplement: Docosahexaenoic acid administration: 50 mg/kg/day during 12 months<br> <br> |
| Placebo Comparator: placebo<br>50 patients will receive placebo | Dietary Supplement: Placebo: 50 mg/kg/day during 12 months<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study whether long-term administration of DHA (12 months), at doses of 50 mg/ kg/day in patients over 2 months age diagnosed of CF decreases inflammation compared with placebo |  | 12 months |
Comparison Between Ultrasound-guided and Landmark-guided Ankle Blocks

Study Overview
=================
Brief Summary
-----------------
The investigators will be comparing ultrasound-guided (USG) ankle block and anatomic landmark-guided (ALG) ankle block to determine which of these procedures is better in surgical anesthesia and in postoperative pain relief.

Conditions
-----------------
Analgesia

Intervention / Treatment
-----------------
* Drug: Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing orthopedic foot operation with osteotomy Exclusion Criteria: Skin infection near block injection site Allergy to local anesthetics Coagulopathy with INR >1.4. Dementia

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 |
| --- | --- |
| I. USG<br>Patients receiving Ultrasound-guided Ankle Block | Drug: Bupivacaine<br> <br> |
| II. ALG<br>Patients receiving Anatomic Landmark-guided Ankle Block | Drug: Bupivacaine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Anesthesia Sufficient | Sufficiency of surgical anesthesia will be determined by the presence of a complete sensory or motor block. If general anesthesia needs to be added to achieve operative analgesia, the surgical block will not be deemed sufficient. | Thirty minutes | 
| Post-operative Pain Relief | Intensity of post-operative pain will be measured by a numerical scale from 0-10 by the patient | Twenty-four hours |
A Pilot Study of Triple NtRTI/NsRTI Therapy in Antiretroviral Naive HIV-1 Infected Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the antiviral effect and durability of antiviral response (HIV-1 RNA PCR) and safety of a triple NtRTI/NsRTI therapy in antiretroviral naive patients. Patients will receive TDF plus FTC plus AZT for at least 48 weeks. Further objectives are to evaluate resistance pathways in failing patients treated with TDF/FTC/AZT and to evaluate a treatment strategy of sparing PIs and NNRTIs for later treatment.

Official Title
-----------------
An Open, Single-Arm, Multi-Center, Phase IV Pilot Study of Treatment of Antiretroviral Naive HIV-1 Infected Patients With Tenofovir Disoproxil Fumarate in Combination With Emtricitabine and Zidovudine

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Drug: Zidovudine (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older HIV-1 positive antiretroviral treatment naive one CD4 count >200/ul within 14d prior to study drug administration one HIV-1 RNA PCR value >5000 and <100.000 cop/ml within 14d prior to study drug administration women of child bearing potential: negative serum pregnancy test within 14d of study ability to understand and provide written informed consent overall stable disease absence of clinical signs of lipodystrophy Exclusion Criteria: alcohol or illicit drug use malabsorption syndrome or other gastrointestinal dysfunction clinically relevant pancreatitis/hepatitis within the last 6 months receiving other investigational drugs abnormal hemoglobin, neutrophil, platelet, AST/ALT, pancreatic amylase, creatinine clearance, total bilirubine levels within 14d prior to study pregnancy/breast-feeding radiation therapy or cytotoxic chemotherapeutic agents within 30d of study prior antiretroviral therapy at any time, investigational antiretrovirals trial at any time, HIV vaccine within 90d prior to study immunomodulating agents serious medical condition (diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction) active diagnosis of AIDS (except for cutaneous Kaposi Sarcoma) foscarnet therapy or other agent with documented activity against HIV-1

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zidovudine (drug)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Cardiovascular Fellow-in-training Feedback on Virtual and Simulator-based Learning Experience in A Low to Middle Income Country

Study Overview
=================
Brief Summary
-----------------
Virtual and simulatorbased learning is not widely available in LMIC. It is imperative to analyze feedback of CV fellow-in-training regarding this mode of learning before large scale implementation.

Detailed Description
-----------------
COVID-19 pandemic has introduced us to a greater need of virtual learning platforms and has resulted in less clinical exposure for fellows-in-training. Virtual and simulatorbased learning is not widely available in LMIC. It is imperative to analyze feedback of CV fellow-in-training regarding this mode of learning before large scale implementation. This was an observational study conducted between July-August 2020. A multicentered survey was conducted. Survey questionnaire was disseminated to FIT via Google Forms. The questionnaire contained total of 24 questions about virtual and simulator-based learning during the pandemic.

Official Title
-----------------
Cardiovascular Fellow-in-training Feedback on Virtual and Simulator-based Learning Experience During Covid-19 Pandemic in A Low to Middle Income Country

Conditions
-----------------
Educational Problems

Intervention / Treatment
-----------------
* Other: None. As this was an observational study.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiovascular fellow-in-training currently under training at the institute. Exclusion Criteria: None.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: None. As this was an observational study.|Observational study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feedback of individual fellow in training on virtual and simulator based learning. | Fellows responded to survey questions. | Survey was conducted from august to july 2020. Subjects had two month period to respond. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiovascular education, virtual education, simulator, LMIC
E-support for Healthcare Processes - ASTHMA

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to establish and clinically evaluate a new approach to treating asthma by using information and communication technologies (ICT). A mobile environment, and organizational interventions to improve the process of an integrated treatment of people with asthma will be identified, developed, introduced and clinically evaluated.

Detailed Description
-----------------
A mobile environment to improve the process of an integrated treatment of people with asthma will be identified, developed, introduced and clinically evaluated. The study will include 120 patients diagnosed with asthma that is poorly managed. The study will use the ACT (Asthma Control Test) questionnaire and an evaluation questionnaire that will cover issues regarding the satisfaction of subjects with asthma care offered. Subjects with a PEF meter, will be able to enter the value of PEF (Peak Expiratory Flow). In addition to this, users can enter values (1) physical activity (type, duration, intensity), and (2) food (type, quantity).

Official Title
-----------------
E-support for Healthcare Processes - ASTHMA

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Other: Self management asthma plan indorsment.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ACT points <19 Daily symptoms> = 2 days/week Night symptoms> = 1 night/week Rescue medication > 2days/week At least one asthma exacerbation in the past year, but not in the last month, which was treated with oral glucocorticoid Exclusion Criteria: Worsening of asthma in the last 4 weeks (treated with oral corticosteroids) Age >70 or <18 years Significant co-morbidity Does not own or know how to handle a mobile phone No internet access Not able to perform a PEF measurment Not able to use inhalor

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Asthma - ICT support.<br> | Other: Self management asthma plan indorsment.<br>* Subjects adherence to asthma self management plan will be monitored through web-based support.<br>|
| No Intervention: Asthma, comparator - no ICT support<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of exacerbations. | Number of exacerbations per year. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ACT, Asthma, ICT Support, PEF
Comparing Pvc or Silicone Gastric Calibration Tube During Sleeve Gastrectomy

Study Overview
=================
Brief Summary
-----------------
Time from 40 Fr gastric calibration tube introduction on surgical request till first stapling is measured as introduction time. Problems to advance are noted A note is made If change to other type of gastric tube is needed

Detailed Description
-----------------
when ready to perform sleeve gastrectomy anesthesiologist is asked to introduce 40 Fr gastric calibration tube. A clock is running till first staple is fired as a measure of time to introduce. If problems to position 40 Fr gastric calibration tube correctly, if resistance to advance, change to other type of gastric tube and check again difficulties. Make a note of problems and reason to change.

Official Title
-----------------
Randomized Controlled Trial Comparing Introduction Time of Thin Pvc Versus Thick Silicone Gastric Calibration Tubes for Sleeve Gastrectomy.

Conditions
-----------------
Surgery, Calibration Tube

Intervention / Treatment
-----------------
* Device: thin pvc gastric tube
* Device: thick silicone gastric tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: only primary sleeve gastrectomy - Exclusion Criteria: revision procedure known eosophageal or gastric anatomical abnormalities

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: thin pvc gasrtric calibration tube<br>thin pvc gastric calibration tube is inserted after intubation to release gas from the stomach, then moved in correct position to help surgeon construct a sleeve gastrectomy. | Device: thin pvc gastric tube<br>* a thin pvc gastric tube of 40 Fr for sleeve is used to guide the surgeon<br>|
| Active Comparator: thick silicone gastric calibration tube<br>thick silicone gastrric calibration tube is inserted after intubation to release gas from the stomach, then moved in correct position to help surgeon construct a sleeve gastrectomy | Device: thick silicone gastric tube<br>* a thick silicone gastric tube 40 Fr for sleeve is used to guide the surgeon<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| introduction time | time from introduction until first staple in minutes | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of changing tube | Impossible for correct positioning requiring change to another tube | intraoperative |
Incisional Hernia Repair With Mesh at Waitemata District Health Board - A 15 Year Retrospective Cohort Study'

Study Overview
=================
Brief Summary
-----------------
A retrospective review of all incisional hernia repairs at North Shore Hospital (NSH), Auckland, NZ was performed between January 2004 and July 2019. Patients who had an open or laparoscopic incisional hernia repair with mesh were included in this study. Patients were retrospectively followed up from the date of their operation until the end of the study period.

Official Title
-----------------
Incisional Hernia Repair With Mesh at Waitemata District Health Board - A 15 Year Retrospective Cohort Study'

Conditions
-----------------
Incisional Hernia

Intervention / Treatment
-----------------
* Procedure: Incisional hernia repair with mesh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary surgical procedure was incisional hernia repair with mesh Exclusion Criteria: Suture repair Other hernia repair (not incisional) Operation notes unavailable
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Incisional hernia repair with mesh|open or laparoscopic repairs of incisional hernia with mesh|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative complications | Post operative complications as per Clavien-Dindo classification | 30-days post procedure | 
| Length of Hospital Stay | How long patients stayed admitted to hospital after surgery | 0 days - 38 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of hernia | Did patients experience a recurrence of their hernia, if so after what period of time post operatively. | 0 days - 15 years |
Spironolactone in Covid-19 Induced ARDS

Study Overview
=================
Brief Summary
-----------------
This study intended to evaluate the effects of commonly used diuretic, spironolactone, on oxygenation in covid-19 ARDS patients.

Official Title
-----------------
The Effect of Spironolactone on Oxygenation in Covid-19 ARDS Patients

Conditions
-----------------
Respiratory Distress Syndrome, Adult

Intervention / Treatment
-----------------
* Drug: Spironolactone 100mg
* Drug: Placebo oral tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemodynamically stable Hypoxemia, i.e. p/f <150 Admitted to ICU within 48 hours Not moribund has a life expectancy greater than 24 hours Exclusion Criteria: Age criteria Pregnancy Unwillingness to participate

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 |
| --- | --- |
| Spironolactone<br>2 x 100 mg spironolactone | Drug: Spironolactone 100mg<br>* 2x100 mg spironolactone for 5 consecutive days<br>|
| Placebo<br>2 x 1 placebo | Drug: Placebo oral tablet<br>* 2 x1 placebo tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| p/f ratio | improvement in oxygenation | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SOFA | improvement in SOFA Score | 5 days |