linjc16/ctgov huggingface dataset:
Bone Marrow Cells in Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
This study is aimed to assess the effect of bone marrow cells on arrhythmia risk variables in patients with a acute myocardial infarction.

Detailed Description
-----------------
This is a randomized, double-blinded study, where patients treated with thrombolytic therapy for acute myocardial infarction are randomized to receive bone-marrow derived stem cells or sham-infusion at the time percutaneous coronary intervention of the target vessel. The end-points are many arrhythmia risk variables, suchs as heart rate variability, T-wave alternans and many ECG variables as well as systolic and diastolic left ventricular function.

Official Title
-----------------
Effects of Autologous Bone Marrow Celss on Acute ST-Elevation Myocardial Infarction

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Procedure: intracoronary injection of bone marrow cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute ST-elevation myocardial infarction treated with thrombolytic therapy Exclusion Criteria: Indication for rescue PCI, severe clinical heart failure, age <18 years

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: intracoronary injection of bone marrow cells|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arrhythmia risk variables |  |  | 
| left ventricular function |  |  | 
| restenosis assessed by IVUS |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise tolerance |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stem cell, acute myocardial infarction
Early-onset Pneumonia After Out-of-hospital Cardiac Arrest

Study Overview
=================
Brief Summary
-----------------
Early-onset pneumonia after out-of-hospital cardiac arrest is frequent. An association between early-onset pneumonia and an increase in morbidity has been reported in this population. The diagnosis of early-onset pneumonia inpatients with out-of-hospital cardiac arrest may be challenging as diagnosis criteria are unspecific in this setting. On the other hand some studies have reported an association between early antibiotics and better prognosis in patients with out-of-hospital cardiac arrest suggesting that early diagnosis and treatment of pneumonia would benefit to patients. Nonetheless, adminitration of antibiotics to any patients with out-of-hospital cardiac arrest would expose to antibiotic patients without infection and woould participate to increase in antibiotic resistance. Therefore, the PP-ACR study aims to evaluate the impact of a diagnosis algorithm including blinded sampling protected brushes on early-onset pneumonia treatment and patient prognosis after out-of-hospital cardiac arrest.

Detailed Description
-----------------
This study is a single centre observational study with a before - after design.

Official Title
-----------------
Impact of Early Diagnosis Algorithm for Early-onset Pneumonia Diagnosis on Prognosis of Patients With Out-of-hospital Cardiac Arrest

Conditions
-----------------
Out-of-Hospital Cardiac Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients admitted for out-of-hospital cardiac arrest and treated with hypothermia Exclusion Criteria: age less than 18 consent withdrawal

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
| delay between intensive care admission and antibiotic initiation |  | first 5 days | 
| delta respiratory SOFA score between Day 1 and day 3 |  | first 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early onset pneumonia, out-of-hospital cardiac arrest, prognosis, antibiotic
Case-Control Study to Identify Risk Factors for Microscopic Colitis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess among others environmental and hygiene-related risk factors for microscopic colitis (MC), a common diarrheal disease.

Official Title
-----------------
Risk Factors for Microscopic Colitis: A Dutch Case-Control Study

Conditions
-----------------
Microscopic Colitis, Collagenous Colitis, Lymphocytic Colitis

Intervention / Treatment
-----------------
* Other: Whole saliva sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed Diagnosis of MC (CC or LC) between January 1, 2000 and December 31, 2012. Inhabitant of the province of Limburg or the Eindhoven region at the moment of diagnosis Exclusion Criteria: Below 18 years of age at the time of diagnosis Not capable of signing an informed consent Deceased at moment of approximation

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

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 |
| --- | --- |
| Microscopic Colitis<br>Group consists of subjects diagnosed with either collagenous of lymphocytic colitis between January 1, 2000 and December 31, 2012 | Other: Whole saliva sample<br>* Both case and control group will be approached to consider to give permission to sample saliva. This is not obligatory. Collected samples will be stored for future DNA research.<br>|
| Healthy Controls<br>Control group consists of subjects with no history of microscopic colitis. Group is age and sex matched with the case-group | Other: Whole saliva sample<br>* Both case and control group will be approached to consider to give permission to sample saliva. This is not obligatory. Collected samples will be stored for future DNA research.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of environmental and hygiene-related risk factors for microscopic colitis | Information about environmental and hygiene-related risk factors is obtained by a questionnaire, sent to subjects diagnosed with MC between 2000 and 2012 | Retrospective, between 2000 and 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference between the CC and LC subpopulation regarding environmental, hygiene-related, and generally known risk factors | As generally known risk factors are considered: age, gender, medication, comorbidities and smoking. Information about risk factors is obtained by a questionnaire, sent to subjects diagnosed with MC between 2000 and 2012. | Retrospective between 2000 and 2012 |
Effect of Bright Light on Sex Hormones and Ovulation in Humans

Study Overview
=================
Brief Summary
-----------------
The study investigated whether bright artificial light may influence menstrual cycle and ovulation conclusively, and what underlying hormonal changes for this effect are.

Detailed Description
-----------------
Several studies have shown a shortening of the menstrual cycle following light therapy in women with abnormally long menstrual cycles or with winter depression, which suggests that bright light may influence sex hormones and ovulation. The study was designed to investigate this possibility. Twenty-two women with slightly lengthened menstrual cycles and without clinically evident endocrine abnormalities completed a study lasting for two menstrual cycles separated by an off-protocol episode of at least 1 menstrual cycle. Bright light therapy was administered for a week at home during one experimental cycle, and dim light during another cycle (placebo-controlled, crossover, counter-balanced order). Daytime blood sampling and ultrasound scan were performed before and after a week of light therapy, on the  7th and 14th days after menstruation onset. Ultrasound examination was repeated further to document ovulation. Serum was assayed for thyroid-stimulating hormone, prolactin, luteinizing hormone, follicle-stimulating hormone, and estradiol. The preliminary results were reported at the SLTBR meeting in June, 2005.

Conditions
-----------------
Anovulation

Intervention / Treatment
-----------------
* Procedure: Light therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19-40 years Mean menstrual cycle 28-38 days Good general health Generally normal sleep-wake regimen Motivated for free participation Exclusion Criteria: Low cooperation Medications known to interfere with hormone release Clinically evident endocrine abnormalities including the signs of Hyperandrogenism Travel over several time zones during two months prior the study

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Light therapy|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
-----------------
Menstrual Cycle, Light Therapy, Sex Hormones, Ovulation
Molecular Signatures of Relapse in Tissue Samples From Patients With Small Cell Lung Cancer Who Are Receiving Cisplatin and Etoposide

Study Overview
=================
Brief Summary
-----------------
This pilot research trial studies molecular signatures of the return of cancer after a period of improvement (relapse) in tissue samples from patients with small cell lung cancer who are receiving or planning to receive cisplatin and etoposide. Studying samples of tissue from patients with small cell lung cancer in the laboratory may help doctors learn more about the changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer relapse.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To collect and analyze small cell lung cancer (SCLC) tumor DNA and ribonucleic acid (RNA) from 3 human patients before and after relapse to identify the molecular signatures of relapse. OUTLINE: Previously collected tissue samples are analyzed via RNA sequencing and DNA methylation at baseline. Patients also undergo collection of tissue samples for analysis at relapse.

Official Title
-----------------
Pilot Study of the Identification of the Molecular Signatures of Relapse in Small Cell Lung Cancer

Conditions
-----------------
Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Other: cytology specimen collection procedure
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient seen at Norris or County with histologically confirmed SCLC, with tissue in the Norris Cancer Center Tumor Repository Patients must be undergoing or about to start first line treatment with cisplatin and etoposide Patients may not have a second malignancy

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 |
| --- | --- |
| Ancillary-Correlative (molecular profile)<br>Previously collected tissue samples are analyzed via RNA sequencing and DNA methylation at baseline. Patients also undergo collection of tissue samples for analysis at relapse. | Other: cytology specimen collection procedure<br>* Correlative studies<br>* Other names: cytologic sampling;Other: laboratory biomarker analysis<br>* Correlative studies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in tumor tissue molecular profiles | Profiles of pre- and post-relapse tumor tissue will be compared. Data will be compared with mouse data and overlaps determined. | Baseline to up to 1 year |
Post-marketing Safety Surveillance of NovoSeven® in Patients With Haemophilia and Inhibitors by Means of the UK Haemophilia Database

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The purpose of this retrospective study is to collect additional safety information of patients with haemophilia and inhibitors who are treated with rFVIIa.

Detailed Description
-----------------
Non-interventional, retrospective data collection on standard treatments of haemophilia A and B patients with inhibitors in the UK.

Official Title
-----------------
United Kingdom Haemophilia Centre Doctor's Organisation (UKHCDO) - Novo Nordisk Collaboration on NovoSeven® Post Marketing Follow-up Measures

Conditions
-----------------
Congenital Bleeding Disorder, Haemophilia A, Haemophilia B

Intervention / Treatment
-----------------
* Drug: activated recombinant human factor VII


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All haemophilia A or B patients with inhibitors treated with NovoSeven are included Exclusion Criteria: No exclusion criteria beyond the contraindications described in the approved product information text
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: activated recombinant human factor VII<br>* Safety data collection in connection with the use of the drug NovoSeven® in daily clinical practice<br>* Other names: F7;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantify number of thrombotic events in patients treated with the currently recommended dose of 90 microgram/kg compared with higher rFVIIa dose levels up to 270 microgram/kg in relation to number of treatment episodes. |  | Assessments at 6 month intervals |
Fatigue, Sleep Disorders and Endocrine Abnormalities in TBI Patients

Study Overview
=================
Brief Summary
-----------------
This study will test if patients with moderate to severe traumatic brain injuries also have endocrine abnormalities, examine any existing relationships among fatigue, depression and endocrine abnormalities, and the relationship between endocrine abnormalities, quality of life, and community integration.

Official Title
-----------------
The Relationship Between Fatigue, Sleep Disorders and Endocrine Abnormalities Following Traumatic Brain Injury

Conditions
-----------------
Traumatic Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having moderate to severe TBI at least 3 months prior to enrollment. This can be demonstrated by a history of loss of consciousness, amnesia or another neurologic deficit after brain injury Be between the ages of 18 and 70 years Exclusion Criteria: History of prior TBI, stroke, seizures, severe psychiatric disturbances (i.e., those known to influence memory performance, such as schizophrenia, bipolar disorder), or drug abuse will be excluded. Pregnant, nursing, or planning pregnancy during the study period. Dementia Other neurological conditions which are associated with aging and known to cause fatigue (e.g. Parkinson's Disease)

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TBI<br>Patients with moderate to severe TBI | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To further study the incidence of fatigue and endocrine abnormalities in an outpatient TBI population |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the relationship between fatigue and endocrine abnormalities |  | 1 year |
Treatment of Salivary Gland Hypofunction With Neuro- Electrostimulation

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluate with clinical parameters the performance of Saliwell Crown as a neuro-electrostimulator of the submandibular and sublingual salivary glands in hypofunction status due to polypharmacy or Sjögren's Syndrome in patients with symptoms of xerostomia.

Official Title
-----------------
Difference in Salivary Flow in Patients With Salivary Gland Hypofunction of the Following Application of Neuro-electrostimulation

Conditions
-----------------
Xerostomia, Polypharmacy, Sjögren's Syndrome

Intervention / Treatment
-----------------
* Device: Automatic neuro-electrostimulation by Saliwell Crown
* Device: Patient-regulated neuro-electrostimulation by Saliwell Crown


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range between 18 and 75 years of age Clinical symptoms of xerostomia Difference in whole salivary flow between resting and stimulating conditions Patient ASA type I to III Absence of at least one mandibular third molar inferior, but at least partially dentated in the mandible Exclusion Criteria: Patients with antimicrobial treatments in the three previous months Smokers Intake of bisphosphonates Limitation of mandibular opening Interoclusal distance smaller than 10 millimetres Lack of adequate bone availability for implant placement

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient-regulated neuro-electrostimulation by Saliwell Crown<br>Patient regulated (by a remote control) neuro-electrostimulation by Saliwell Crown | Device: Patient-regulated neuro-electrostimulation by Saliwell Crown<br>* On-demand stimulation of the lingual nerveby Saliwell Crown<br>|
| Active Comparator: Automatic neuro-electrostimulation by Saliwell Crown<br>No remote control used | Device: Automatic neuro-electrostimulation by Saliwell Crown<br>* Continuous stimulation of the lingual nerve by Saliwell Crown<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-reported xerostomia |  | 4 weeks |
Group Psychotherapy for People With HIV

Study Overview
=================
Brief Summary
-----------------
This study will examine the effectiveness of supportive-expressive group therapy plus education compared with an educational intervention in improving the quality of life and promoting health-enhancing behavior of men and women living with HIV or AIDS.

Detailed Description
-----------------
The major goal of this project is to examine the effectiveness of supportive-expressive group therapy plus education in comparison to an educationally intervention in improving the quality of life and promoting health-enhancing behavior of men and women living with HIV/AIDS.

Official Title
-----------------
An Evaluation of Group Psychotherapy for People With HIV

Conditions
-----------------
HIV, Depression, Risk-taking, Pain

Intervention / Treatment
-----------------
* Behavioral: Supportive Expressive Group Psychotherapy
* Behavioral: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) a positive HIV diagnosis (either symptomatic or asymptomatic), 2) at least eighteen years of age, 3) English language skill (to complete questionnaires and participate, if assigned, to the group psychotherapy condition) and, 4) geographical proximity to groups in order to attend if assigned. Exclusion Criteria: 1) severe psychiatric disorders (i.e. schizophrenia or other psychotic disorders)who would not be appropriate for participating in the group intervention, 2) active tuberculosis, 3) acute intoxication, 4) participation in an ongoing HIV/AIDS support group or 5) suicidal/homicidal ideation.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Supportive Expressive Group Psychotherapy|nan|
|Behavioral: Education|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |