linjc16/ctgov huggingface dataset:
Badalona Major Depressive Disorder Database Study

Study Overview
=================
Brief Summary
-----------------
A retrospective study using a data base of anonymized medical records. The purpose of the study is to examine the different therapeutic strategies for the management of patients with major depressive disorder (MDD) and suboptimal response to antidepressant drugs in primary care

Detailed Description
-----------------
Therapeutic strategies for the management of patients with major depressive disorder (MDD) and suboptimal response to antidepressant drugs in primary care: the Badalona database study

Official Title
-----------------
Therapeutic Strategies for the Management of Patients With Major Depressive Disorder (MDD) and Suboptimal Response to Antidepressant Drugs in Primary Care: the Badalona Database Study

Conditions
-----------------
Major Depressive Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An International Classification of Primary Care (ICPC-2) or DSM-IV-TR diagnosis for major depressive disorder (MDD) At least 8 weeks of antidepressant treatment during the identification period of 01 January 2008 - 31 December 2009 18 months of enrollment with medical and pharmacy records after index episode date

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 suboptimal response<br> | |
| Patients with symptomatic remission<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the antidepressant strategies switches | Number and type of treatment changes including combination, switch, or augmentation strategies. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health care resource utilization |  | 18 months | 
| Health care costs |  | 18 months | 
| Hamilton Depression Rating Scale |  | 18 months | 
| Medication possession rate to evaluate adherence |  | 18 months | 
| Referral to psychiatrist office |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major depressive disorder, primary care, real-world evidence, database
Esophageal Motility and Airway Defenses Among Infants

Study Overview
=================
Brief Summary
-----------------
Feeding difficulties and airway related consequences contribute significantly to the infant mortality and morbidity. Some of these problems may be dependent on neural control and muscular function. Prematurity, congenital anomalies and perinatal depression represent three important conditions in infants, that may have feeding and airway difficulties.Development of motility of the foregut and the adaptation during normal and disease in developing infants is unclear.

Detailed Description
-----------------
With the aid of small clinical research funding from the NIDDK, in this proposal, we have developed methods to safely evaluate foregut motility in relation to breathing among high risk infants. We are using simultaneous esophageal motility studies, swallowing and respiratory measurements in this evaluation.

Official Title
-----------------
Esophageal Motility and Airway Defenses Among Infants

Conditions
-----------------
Infant, Premature, Diseases, Congenital Abnormalities, Perinatal Asphyxia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prematurely born infants, Infants with congenital foregut anomalies, Infants with perinatal asphyxia, Ability to maintain vital signs at study, Exclusion Criteria: No contraindication to enteral feeding

Ages Eligible for Study
-----------------
Minimum Age: 2 Weeks
Maximum Age: 6 Months

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 |
| --- | --- |
| A-1,2,3<br>The cohort (A) comprised of high risk infants. There were 3 sub groups studied within this cohort: (1) premature infants, (2) Infants with congenital gut anomalies, and (3) perinatal asphyxia. | |

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
-----------------
Esophageal, Airway
Nasal Pillows vs. Nasal Masks at High CPAP Pressure

Study Overview
=================
Brief Summary
-----------------
The aim of this evaluation is to test: Whether using nasal pillows at high pressures has comparable outcomes to nasal masks Patient mask type preferences at high pressures

Official Title
-----------------
Nasal Pillows at High CPAP Pressure

Conditions
-----------------
OSA

Intervention / Treatment
-----------------
* Device: Nasal mask
* Device: Pillows mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients willing to give written informed consent Patients who can read and comprehend English Patients being treated for OSA for >6 months Patients ≥ 18 years of age Patients using nasal mask systems with fixed pressure ≥ 12 cm H2O Patients who can trial the trial masks up to 14 nights Patients naive to pillows mask systems Exclusion Criteria: Patients using an inappropriate mask system Patients using Bilevel flow generators Patients who are pregnant Patients who have a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury)

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nasal Mask First, then Pillows Mask<br>Nasal mask is used for 7 nights, then followed by Pillows mask for 7 nights. [Nasal mask=Mirage Activa, Micro, FX; Pillows mask=Swift FX] | Device: Nasal mask<br>* Nasal mask (Mirage Activa, Micro, FX)<br>Device: Pillows mask<br>* Nasal pillows mask (Swift FX)<br>|
| Experimental: Pillows Mask, then Nasal Mask<br>Pillows mask for 7 nights, then followed by Nasal mask is used for 7 nights. [Nasal mask=MMirage Activa, Micro, FX; Pillows mask=Swift FX] | Device: Nasal mask<br>* Nasal mask (Mirage Activa, Micro, FX)<br>Device: Pillows mask<br>* Nasal pillows mask (Swift FX)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AHI on Nasal Mask and Pillows Mask | AHI (measure of sleep-disordered breathing severity) on nasal mask and nasal pillows measured as average events/hour | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability | Participant's feedback of performance of the study devices. Likert Scale 0-10 (0=very bad, 10=very good) | After 7 days of use |
Improving Women's and Children's Health Via Biobanking and Electronic Registry

Study Overview
=================
Brief Summary
-----------------
Pregnancy related diseases and exposures in pregnancy are known risk factors for future disease. For example, women with a history of preeclampsia (a hypertensive disorder in pregnancy) and children born to these women are at increased risk of cardiovascular disease later in life. Yet, the mechanisms by which these long term health risks occur are unknown. Clearly, this presents a significant public health hazard as preventative and therapeutic interventions to block these pregnancy related diseases are limited. Current barriers to studying these long-term mechanisms in existing cohorts include 1) lack of paired long-term mother-child data, 2) lack of uniformly collected biosamples and 3) challenges in integrating data from multiple sources and institutions. In particular, data and biosample collection from rural and minority populations present significant challenges. The objective of the iELEVATE proposal is to expand and diversify a current biobank to accelerate long-term translational mechanistic and outcomes research in the vulnerable pregnancy population. We will accomplish this by establishing a widely available biorepository that will collect a first trimester blood and urine sample from pregnant women with a clinical data warehouse and e-registry to support long-term prospective cohort studies.

Official Title
-----------------
Improving Women's and Children's Health Via Biobanking and Electronic Registry

Conditions
-----------------
Pregnancy Related, Maternal-Fetal Relations

Intervention / Treatment
-----------------
* Other: Blood sample
* Other: Urine sample
* Other: Pregnancy, maternal health, and fetal health data


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women in their first trimester (less than 14 weeks) and have the capacity to provide informed consent are eligible to participate Exclusion Criteria: Under 18 years old, known non-viable pregnancy at time of consent,inability to provide informed consent and diagnosis of a known infectious disease.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Pregnant women and their baby | Other: Blood sample<br>* 1st trimester blood sample for bio-bank<br>Other: Urine sample<br>* 1st trimester urine sample for bio-bank<br>Other: Pregnancy, maternal health, and fetal health data<br>* Pregnancy, maternal health, and fetal health data<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1.Number of Participants and Controls Enrolled in Biobank [ Time Frame: 2 years ] | Create bio-bank of maternal blood,urine and data. | 2 years |
Paresthesia-Free Fast-Acting Subperception (FAST) Study

Study Overview
=================
Brief Summary
-----------------
Study to evaluate the effectiveness of FAST-SCS (fast-acting paresthesia-free therapy) and additional SCS therapy options in patients with chronic pain using Boston Scientific WaveWriter SCS Systems.

Official Title
-----------------
Study to Demonstrate the Value of Paresthesia-Free Fast-Acting Subperception (FAST) and Other SCS Therapies Using WaveWriter™ Spinal Cord Stimulator Systems in the Treatment of Chronic Pain

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

Intervention / Treatment
-----------------
* Device: Boston Scientific WaveWriter SCS System


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Chronic pain (predominantly neuropathic) of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain. 22 years of age or older when written informed consent is obtained Able to independently read and complete all questionnaires and assessments provided in English Signed a valid, IRB-approved informed consent form (ICF) provided in English Key Exclusion Criteria: Any pain-related diagnosis or medical/psychological condition or external factors that, in the clinician's best judgment, might confound reporting of study outcomes Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study Breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study

Ages Eligible for Study
-----------------
Minimum Age: 22 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WaveWriter Settings<br> | Device: Boston Scientific WaveWriter SCS System<br>* WaveWriter SCS Programming<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Targeted Pain Responder Rate | Proportion of subjects with 50% or greater reduction from Baseline Visit in average targeted pain intensity at 3 months post-activation | 3 months post-activation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Cord Stimulation
Sublingual Immunotherapy In Alternaria-Induced Rhinitis

Study Overview
=================
Brief Summary
-----------------
Respiratory allergy due to Alternaria is a relevant clinical problem, and specific immunotherapy may represent a viable treatment option. Sublingual immunotherapy (SLIT) is safe and effective, but data for Alternaria are lacking. The study is aimed at assessing the efficacy of a standardized SLIT in patients sensitised to Alternaria, in a randomized, double blind, placebo controlled fashion. Patients with rhinitis with/without intermittent asthma, and ascertained allergy to Alternaria are enrolled. After a baseline season, SLIT or matched placebo are given for 10 months. Symptoms and rescue medication intake are recorded on diary cards from June to October. Skin prick test, specific IgE and IgG4 and precipitins are measured at baseline and at the end of the study. Alternaria spore count is also performed. Primary outcome is the change in symptom score in the active vs placebo group. Secondary outcomes: changes in rescue medication intake, alternaria specific IgE and IgG4, skin prick test reactivity.

Official Title
-----------------
STUDIO IN DOPPIO CIECO DISODIOCROMOGLICATO + PLACEBO vs DISODIOCROMOGLICATO + IMMUNOTERAPIA SPECIFICA SUBLINGUALE PER ALTERNARIA IN PAZIENTI CON RINITE ALLERGICA DOVUTA A SENSIBILIZZAZIONE AD ALTERNARIA

Conditions
-----------------
Allergic Rhinitis (w/w Asthma) Due to Alternaria Alternata

Intervention / Treatment
-----------------
* Biological: sublingual immunotherapy
* Biological: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Allergic rhinitis Symptoms May-October Specific IgE to alternaria (skin test/radioallergosorbent [RAST] test) Age >14 Exclusion Criteria: Sensitization to mites, parietaria, mugwort Pregnancy-lactation Malignancies Chronic systemic steroids Previous immunotherapy to alternaria

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SLIT<br>sublingual immunotherapy biologically standardized | Biological: sublingual immunotherapy<br> <br> |
| Placebo Comparator: placebo<br>same preparation of SLIT without the allergen | Biological: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in symptom score active versus placebo |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in rescue medication intake |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allergic rhinitis, alternaria alternata, symptom score
Levels of High-Sensitivity C-Reactive Protein in Heart Transplant Patients

Study Overview
=================
Brief Summary
-----------------
Objectives: The outcomes of heart transplantation are very favorable but inflammation still plays a critical role in deterioration of chronic transplants. Periodontal diseases are not only limited to supporting structures of the teeth, they also cause systemic inflammation. Based on the importance of inflammation in heart transplant recipients and the association between periodontal disease and systemic inflammation, this study explored whether periodontitis may be a modifier of serum high-sensitivity C-reactive protein (HsCRP) in heart transplant patients.

Official Title
-----------------
Levels of High-Sensitivity C-Reactive Protein in Heart Transplant Patients With and Without Periodontitis

Conditions
-----------------
Heart Transplant Failure, Periodontitis, Crp

Intervention / Treatment
-----------------
* Other: clinical measurements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be clinically stable be at least 1 year post-transplant; no history of antibiotic use during the preceding 4 months have had no periodontal treatment within the previous year. Exclusion Criteria: having other systemic infections

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 65 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 |
| --- | --- |
| periodontitis<br>periodontitis patients which were diagnosed based on clinical parameters | Other: clinical measurements<br>* only clinical parameters were recorded<br>* Other names: no intervention was made;|
| gingivitis/healthy<br>gingivitis healthy patients which were diagnosed based on clinical parameters | Other: clinical measurements<br>* only clinical parameters were recorded<br>* Other names: no intervention was made;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hscrp levels | serum hscrp levels were compared between the groups | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart transplant, periodontitis, hsCRP
Fecal Microbiota Transplantation (FMT) for Clostridium Difficile

Study Overview
=================
Brief Summary
-----------------
Faecal microbiota transplantation (FMT) is used for recurrent Clostridium difficile infection (rCDI) as part of an quality improvement initiative and conducted within the framework of Center for Faecal Microbiota Transplantation at Aarhus University Hospital (CEFTA).

Detailed Description
-----------------
Patients are assessed, treated and monitored at Aarhus University Hospital (AUH) as an Integrated part of the project.

Official Title
-----------------
Fecal Microbiota Transplantation (FMT) for Recurrent Clostridium Difficile Infection - an Observational Cohort Study

Conditions
-----------------
Clostridium Difficile Infection

Intervention / Treatment
-----------------
* Other: Faecal microbiota transplantation (FMT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 or higher documented recurrence of Clostridium difficile Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| rCDI<br>Adult patients with recurrect Clostridium difficile infection | Other: Faecal microbiota transplantation (FMT)<br>* FMT delivered by colonoscopy, nasojejunal tube, glycerol-based capsules, or freeze-dried encapsulated donor faeces<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of Clostridium difficile-Associated disease (CDAD) | Number of patients with resolution of CDAD, , defined by the absense of diarrhea (3 or fewer bowel movements per day) and formed stools (Bristol 5 or lower) or, in the case of abnormal stool frequency or consistency, a negative Clostridium difficile toxin test week 8 | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical effect week 8 | Number of patients with clinical effect, defined by absense of diarrhea (3 or fewer bowel movements per day) and formed stools (Bristol 5 or lower) | 8 weeks | 
| Negative CD test week 8 | Number of patients with negative Clostridium difficile toxin test week 8 | 8 weeks |