linjc16/ctgov huggingface dataset:
Remote Assessment of Outpatient With Severe Acute Respiratory Syndrome (SARS-CoV-2)

Study Overview
=================
Brief Summary
-----------------
Outpatient management of patients with a milder form of COVID may be associated to an unfavorable initial or deferred course in relation to the pathology.. Outpatients represent the bulk of patients with COVID-19. To know their evolution, their secondary complications and identifying a profile of at risk patients is essential for the prevention and care of future non-hospitalized patients, in an epidemic context still active. This study could make it possible to redefine the follow-up of outpatients. The study consists of a simple questionnaire and possibly a teleconsultation.

Official Title
-----------------
Remote Assessment of Outpatient With SARS-CoV-2

Conditions
-----------------
SARS-CoV2 Infection

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a PCR (polymerase chain reaction assay ) positive for Sars-COV-2 between the start of the pandemic and May 11, 2020 Outpatient care Inclusion 24 months from the date of diagnosis of Sars-COV-2 (± 6 months) Exclusion Criteria: Patients in EHPAD (accommodation facilities for dependent elderly people), home, retirement home, center for disabled people Patients under protective measure, curators or guardianship Patients with a pathology or condition that does not allow them to express their wishes Patients hospitalized when performing PCR or within 10 days with Sars-COV-2

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

| Intervention/Treatment |
| --- |
|Other: Questionnaire|Patients diagnosed positive for COVID on an outpatient basis will respond to a questionnaire by mail, at 24 month of diagnosis. This questionnaire will make it possible in particular to collect intercurrent events (hospitalization, emergencies, etc.).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical procedures | number of medical procedures | At month 24 |
Epidemiology of ST131 in Besançon University Hospital

Study Overview
=================
Brief Summary
-----------------
The sequence type 131 (ST131) is a predominant lineage among extraintestinal pathogenic Escherichia coli. It plays a major role in the worldwide dissemination of E. coli that produce extended-spectrum beta-lactamase (ESBL). The aim of this study was to describe the epidemiology of ESBL producing ST131clonal group in our university hospital. All patients with an infection due to ESBL E. coli will be prospectively included for a 2-year period. ST131 isolates will be identified and risk factors associated to ST131 will be determined in comparison to non-ST131 ESBL E. coli.

Official Title
-----------------
Epidemiology of ST131 in Besançon University Hospital

Conditions
-----------------
Escherichia Coli Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients infected with ESBL producing E. coli Exclusion Criteria: Patients known to be carrier or infected in the previous year, patients only colonised with ESBL producing E. coli.
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 |
| --- | --- | --- |
| Risk factors associated to ESBL ST 131 infections | Time of hospitalization | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
E. coli, extended-spectrum beta-lactamase, molecular epidemiology, risk factors
Chronic Pain in Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
This trial tests the effectiveness of the drug amitriptyline vs placebo to relieve chronic pain in adults that have had a spinal cord injury.

Detailed Description
-----------------
This double masked placebo-controlled trial will randomize patients (n=100) with a greater than 6 month history spinal cord injury and a greater than 3 month history of associated pain to a daily dose of amitriptyline or placebo for 6 weeks. Patients will be examined before randomization by a study physician or nurse masked to their treatment assignment. They will be assessed by telephone interview before, during treatment, at the end of treatment and 4 months later to assess pain, pain interference with activities, physical and mental health, and number of health care visits for pain.

Official Title
-----------------
Management of Chronic Pain in Rehabilitation Project I - Management of Chronic Pain in Persons With Spinal Cord Injury

Conditions
-----------------
Spinal Cord Injuries, Pain

Intervention / Treatment
-----------------
* Drug: Amitriptyline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spinal Cord Injury six months ago or longer Pain for 3 months or longer Exclusion Criteria: History of cardiovascular disease, seizures, or glaucoma Currently taking antidepressant medications Currently hyperthyroid or taking thyroid medicine Currently pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Amitriptyline|nan|

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
-----------------
Spinal Cord injury (SCI), Chronic Pain, Amitriptyline
Effects of Teriparatide in Postmenopausal Women With Osteoporosis

Study Overview
=================
Brief Summary
-----------------
Effects of Teriparatide in Postmenopausal Women Previously Treated with Alendronate or Raloxifene.

Official Title
-----------------
Effects of Teriparatide in Postmenopausal Women With Osteoporosis Previously Treated With Alendronate or Raloxifene

Conditions
-----------------
Postmenopausal Osteoporosis

Intervention / Treatment
-----------------
* Drug: teriparatide
* Drug: aldrenodate
* Drug: raloxifene


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women aged at least 50 years A previous clinical diagnosis of osteoporosis At high risk for fracture Current therapy for at least 18 months prior to study entry with either raloxifene HCl or alendronate Na Exclusion Criteria: History of metabolic bone disease other than osteoporosis History of malignant neoplasm within the last 5 years except for superficial basal cell carcinoma or squamous cell carcinoma

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

| Intervention/Treatment |
| --- |
|Drug: teriparatide|nan|
|Drug: aldrenodate|nan|
|Drug: raloxifene|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in calcium values after beginning teriparatide |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of hypercalcemia, various calcium assessments, change in bone mineral density and tests of bone formation and resorption |  |  |
GI Biorepository of Tissue and Bodily Fluids

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish the working protocols for a general biorepository with the specific aim of procuring tissues and bodily fluids from the human gastrointestinal tract from a diverse range of clinical patients at the UC Davis Medical Center. The establishment of a GI-specific biorepository will support future translational endeavors within the UC Davis campus by providing laboratories with readily available GI tissue and bodily fluid samples to test newly developed hypotheses with relative ease.

Detailed Description
-----------------
UC Davis is currently lacking a general use biorepository for GI tissues and bodily fluids. As with any translational research study, the procurement of human tissue samples can be a difficult and time- consuming process. The establishment of this biorepository will help streamline GI biospecimen collection and centralize these samples in a conveniently located space to facilitate the implementation of future unspecified translational studies.

Official Title
-----------------
GI Biorepository of Tissue and Bodily Fluids

Conditions
-----------------
Gastrointestinal Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all consenting adults aged 18 years or older with an appointment with a healthcare professional in the Division of Gastroenterology or the Department of Surgery Exclusion Criteria: minors, pregnant women, prisoners, and all other vulnerable populations who are unable to consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| To build a model biorepository to streamline the biobanking process and provide centralized specimens and associated health information for translational research. | To have biospecimens available for the UC Davis IRB approved studies. | 4 years |
Timing of Indomethacin Administration for the Prevention of Post-ERCP Pancreatitis (PEP)

Study Overview
=================
Brief Summary
-----------------
To determine if the timing of administration of indomethacin affects the primary outcome of post-ERCP pancreatitis (PEP). Patients undergoing ERCP will be randomly assigned to receive pre or post-procedure rectal indomethacin to prevent the occurrence of PEP.

Official Title
-----------------
Timing of Indomethacin Administration for the Prevention of Post-ERCP Pancreatitis (PEP)

Conditions
-----------------
Acute Pancreatitis

Intervention / Treatment
-----------------
* Drug: Rectal indomethacin 100mg one time before or after ERCP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients referred for ERCP at the University of Alberta Age greater than 18 years Ability to provide written informed consent Exclusion Criteria: Acute pancreatitis Active peptic ulcer disease Rectal disease Aspirin-induced asthma Nonsteroidal anti-inflammatory drug (NSAIDs) induced hypersensitivity Pregnancy Breast feeding Creatinine clearance < 30 ml/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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rectal Indomethacin pre-ERCP<br>Patients will receive rectal indomethacin 100mg 30 minutes before procedure (ERCP). | Drug: Rectal indomethacin 100mg one time before or after ERCP<br>* Patients will receive rectal indomethacin suppository 30 minutes before or immediately after ERCP for prevention of post-procedure pancreatitis. Patients will be randomized to the timing of administration.<br>* Other names: Indocid 100mg;|
| Active Comparator: Rectal Indomethacin post-ERCP<br>Patients will receive rectal indomethacin 100mg immediately after procedure (ERCP) | Drug: Rectal indomethacin 100mg one time before or after ERCP<br>* Patients will receive rectal indomethacin suppository 30 minutes before or immediately after ERCP for prevention of post-procedure pancreatitis. Patients will be randomized to the timing of administration.<br>* Other names: Indocid 100mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Post-ERCP pancreatitis |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Post-ERCP pancreatitis | To evaluate the severity of post-ERCP pancreatitis between the 2 groups studied | 30 days |
Physiological Phenotyping of Respiratory Outcomes in Infants Born Premature

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine if infants are more likely to suffer from respiratory complications during their first year of life due to being born premature.

Detailed Description
-----------------
The overall objective of this study is to determine if infant respiratory morbidities after preterm birth are highly variable due to differential impairment of airway, parenchymal and vascular development that can be characterized as distinct physiologic phenotypes. If the nature and severity of these specific impairments of lung function are strongly associated with increased respiratory morbidities during infancy and that proteomic biomarkers can enhance the physiologic characterization of phenotype and prediction of late respiratory outcomes.

Official Title
-----------------
Physiological Phenotyping of Respiratory Outcomes in Infants Born Premature

Conditions
-----------------
Premature Lungs

Intervention / Treatment
-----------------
* Other: Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants born to mothers who are between the gestational ages of 24+0 and 36+6 weeks. Exclusion Criteria: Cardiopulmonary defects Chromosomal defects Structural abnormalities of the upper airway, chest wall, or lungs Neurological/Neuromuscular disorders Infant not considered viable Family unlikely to be available for long term follow up Mothers under the age of 18. Non English speaking

Ages Eligible for Study
-----------------
Minimum Age: 24 Weeks
Maximum Age: 36 Weeks

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Premature Infants<br>Premature infants born between 24+0 and 36+6 weeks of gestation. | Other: Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)<br>* Infant lung function testing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant lung development measured by diffusion lung capacity (DLCO). | To characterize respiratory phenotypes through specific physiologic measures that quantify and identify predominant small airways, parenchymal and vascular dysfunction at 4 months CA and determine whether these phenotypes define risks for late respiratory morbidity during infancy. | By 5 months CGA. |
Strep A FIA Field Study, Sofia

Study Overview
=================
Brief Summary
-----------------
To demonstrate the clinical performance of the Strep A FIA and Sofia, using throat swabs collected from symptomatic subjects.

Official Title
-----------------
Sofia Strep A FIA Field Study

Conditions
-----------------
Group A Streptococcus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female, 3 years of age or older Must currently be exhibiting one or more of the symptoms characteristic of pharyngitis to be eligible for inclusion in this study. For example: Acute onset of sore throat Redness of the posterior pharyngeal wall Difficulty/pain on swallowing Fever, > 37.8º C (100ºF) at presentation or within past 24 hours Pharyngeal exudate Tender cervical lymphadenopathy Absence of cough, runny nose or other upper respiratory symptoms.* Other, symptoms specific to Strep A not listed above. Must include at least one additional symptom from a-f and cannot be the only criteria used to meet inclusion for enrollment in the study. Exclusion Criteria: Subjects currently under treatment with antibiotics are not to be included in this study. At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.

Ages Eligible for Study
-----------------
Minimum Age: 3 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 |
| --- | --- |
| Symptomatic population for GAS<br>This study is a diagnostic study to aid in the detection of Strep throat. No intervention or medication is a part of this study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of Group A Streptococcus | A throat swab specimen will be obtained and tested for the presence of Group A Streptococcus via the Sofia Analyzer | Within 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Strep throat
The Impact of Udenafil on Exercise Capacity in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Overview
=================
Brief Summary
-----------------
Pulmonary hypertension (PH) is a serious complication of COPD which is associated with shorter survival, more frequent exacerbation, and increased use of health resources. There is no effective pharmacological treatment for COPD-associated PH. Therefore, the investigators wanted to evaluate the effect of udenafil, a phosphodiesterase- 5 (PDE-5) inhibitor, on exercise capacity of severe COPD patients.

Detailed Description
-----------------
Study design prospective, single arm, open-label study Udenafil 50mg qd po for 8 weeks

Official Title
-----------------
The Impact of Udenafil on Exercise Capacity in Severe COPD Patients

Conditions
-----------------
Dyspnea, Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension

Intervention / Treatment
-----------------
* Drug: Udenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe COPD who showed post-bronchodilator forced expiratory volume in 1 second (FEV1) less than 50% of predicted value Exclusion Criteria: Acute exacerbation within 4 weeks of the study entry Coronary heart disease History of adverse event on PDE-5 inhibitors

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Udenafil<br>Udenafil 50mg qd po | Drug: Udenafil<br>* Udenafil 50mg qd po<br>* Other names: Zydena;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of 6-minute walk distance |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of mean pulmonary artery pressure | change of lung function, SGRQ score, Borg index, oxygen saturation, mean pulmonary artery pressure | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dyspnea, Udenafil, Chronic obstructive pulmonary disease, pulmonary hypertension, Phosphodiesterase 5 inhibitors, Exercise
HP Improves Sleep and Overall Survival Rate in Maintenance Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
Sleep disturbance has been long-standing torments in most of patients with maintenance hemodialysis (HD). In this study, we attempted to explore whether long-term hemoperfusion (HP) could improve sleep disorder and increase overall survival rate in HD patients.

Official Title
-----------------
Hemoperfusion in Combination With Hemodialysis for Improvement of Self-reported Sleep Disturbance and Overall Survival Rate in Maintenance Hemodialysis Patients

Conditions
-----------------
Hemoperfusion

Intervention / Treatment
-----------------
* Device: hemoperfusion(HP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: duration of maintenance HD should be equal or more than 3 months, patient's age should be equal or more than 18 years Exclusion Criteria: - i) he/she diagnosed with malignant tumors, an active rheumatism, infectious diseases, or a severe heart failure ii) he/she would disagree with the study he/she has received a short-term poor prognosis he/she would be more than 80 years old

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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: HD(hemodialysis) group<br>HD group as conventional control arm | |
| Active Comparator: HD+HP(hemodialysis+hemoperfusion) group<br>HD+HP as active interventional group.HP was performed 1-2 times/per 2 weeks, and each session lasted for two hours. | Device: hemoperfusion(HP)<br>* These patients were computer-matched into two groups, involving 100 patients with absolute HD vs. 100 cases with HD+HP.HP was performed 1-2 times/per 2 weeks, and each session lasted for two hours.Self-reported sleep disturbance was evaluated before and after observational time (two-year period), which lasted at least 7 hours based on the recommendations presented by National Institute of Health (NIH). Sleep efficiency (%) was calculated as the ratio of sleep duration to total time in bed, and was multiplied by 100.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of self-reported sleep disturbance | Analysis of the sleep disturbance by using Pittsburgh Sleep Quality Index (PSQI) questionnaire | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival | increase overall survival rate | 2 years |