linjc16/ctgov huggingface dataset:
Prevalence of Positional Nystagmus in a Population of Healthy Adults

Study Overview
=================
Brief Summary
-----------------
To investigate the prevalence of positional nystagmus in a population of healthy Danish adults.

Detailed Description
-----------------
Open-label, cross-sectional prospective study examining the prevalence of positional nystagmus in healthy adults (adult with no previous or current inner ear disease) using a mechanical repositioning chair (TRV-chair, Interacoustics, Middelfart, Denmark). Patients will undergo traditional testing related to positional nystagmus by means of both the Dix-Hallpike test and Supine Roll Test (SRT) bilaterally. Latency, duration, and slow phase velocities will be registered and examiner as well as order of the positional tests performed with the TRV chair will be block randomized.

Official Title
-----------------
Prevalence of Positional Nystagmus in a Population of Healthy Adults

Conditions
-----------------
Positional Nystagmus, Healthy Volunteers

Intervention / Treatment
-----------------
* Diagnostic Test: Examinations in a TRV chair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: + 18 years Exclusion Criteria: Previous or current BPPV, inner ear disease, other ear conditions or neurological conditions Reduced eye mobility Alcohol consumption within 48 hours Weight > 150 kg. Known cerebral aneurysm Cerebral haemorrhage within 1 month Trouble cooperating during examinations DHI-score > 14

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Examinations in a TRV chair|Positional tests (Dix-Hallpike and SRT) traditionally used to diagnose BPPV uwith a TRV chair.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of positional nystagmus | Number of subjects presenting with positional nystagmus during specific changes of head positions. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of positional nystagmus | Description the characteristics (latency, velocity, duration, direction) of positional nystagmus in healthy subjects. | 2 years |
Pyruvate Kinase Isoform M2 (PKM2) as a Possible Biomarker for Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if pyruvate kinase M2 (PKM2) can be used as a biomarker in cancer. Pyruvate kinase M2 is more elevated in malignant pleural fluid than in plasma, and may be a useful biomarker to distinguish between malignant and non-malignant causes of pleural effusion. In addition, pyruvate kinase M2 has also been found to be elevated in saliva in cancer patients compared to controls. Measuring pyruvate kinase M2 in saliva may be used to diagnose cancer or monitor the treatment progress of cancer.

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: Pyruvate kinase isoform M2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any cancer patient with pleural effusion that is being drained through an indwelling chest-tube in an inpatient ward. Exclusion Criteria: Patient with a pleural effusion who does not have proven cancer or whose pleural effusion is not known to be malignant.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Cancer patient<br> | Other: Pyruvate kinase isoform M2<br> <br> |

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
-----------------
Cancer Patients
Effect of Palifermin on Skin Tumors in Patients Undergoing Bone Marrow Transplantation

Study Overview
=================
Brief Summary
-----------------
We are approaching you to participate in this study because you are taking Palifermin and the purpose of this study is to describe the effect of Palifermin on skin growth found on the body. Palifermin is a new synthetic growth factor (encourages skin cells to grow) specifically designed to protect the areas of the body (mouth and upper digestive tract) that are damaged by chemotherapy. The cells in these areas are rapidly dividing cells and so are killed by chemotherapeutic drugs. Palifermin is a drug that stimulates new cells in these areas to grow and therefore protects patients from some serious side effects of chemotherapy. These include mucositis or inflammation of the lining of the mouth and other organs resulting in difficulty swallowing, speaking and extreme pain in the mouth and upper digestive tract. Skin cells are also known to respond to these types of growth factors like Palifermin, but unfortunately no studies have been done that look specifically at the effect of this drug on pre-existing skin lesions or the development of new skin lesions. We will be asking you if you have noticed any change in moles or other skin lesions that you have, and if you have noticed any new lesions. We will also be doing a full physical examination of the skin at regular intervals during the study to document the appearance of any new lesions or change in pre-existing ones.

Official Title
-----------------
Effect of Palifermin Therapy on Benign and Malignant Skin Tumors in Patients Undergoing High-Dose Chemotherapy With Autologous Stem Cell Transplantation

Conditions
-----------------
Skin Rash

Intervention / Treatment
-----------------
* Other: Palifermin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: receiving bone marrow transplant - Exclusion Criteria: not receiving other growth factors -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Patients receiving palifermin to prevent mucositis from bone marrow transplant. | Other: Palifermin<br>* day -14, -13, -12 before transplant and then day 0,1,2 after transplant<br>* Other names: keratinocyte growth factor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients

Study Overview
=================
Brief Summary
-----------------
This is a pilot study. The purpose of this study is to determine whether adding 4 months of behavioral therapy to primary care physician medication treatment(relative to medication treatment alone) improves outcomes for persistently depressed primary care patients.

Official Title
-----------------
Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients

Conditions
-----------------
Major Depression

Intervention / Treatment
-----------------
* Behavioral: behavior therapy
* Drug: Medication prescribed by PCP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current MDD or MDD within the past year or current dysthymia PHQ-9 > 10 have been prescribed an antidepressant medication (by their PCP) at least 8 weeks before pre-treatment timepoint are able to speak, read, and understand English sufficiently well to complete study procedures are between the ages of 18 and 70 Exclusion Criteria: presence of significant suicidal ideation or risk history of bipolar disorder, schizophrenia, psychotic symptoms, or severe alcohol or drug problems within the past year; history of antisocial personality disorder or borderline personality disorder; currently in psychotherapy or have received counseling more frequently than once per month in the past year.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 2<br>Medication prescribed by PCP | Drug: Medication prescribed by PCP<br>* Can include any antidepressant medication<br>|
| Experimental: 1<br>Medication prescribed by PCP + behavior therapy | Behavioral: behavior therapy<br>* 10 sessions over 4 months<br>Drug: Medication prescribed by PCP<br>* Can include any antidepressant medication<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression symptoms |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychosocial functioning |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major depression, Primary care
Early Antibiotic Therapy and Vaccination

Study Overview
=================
Brief Summary
-----------------
Neonatal Sepsis is one of the most common causes of death in preterm infants. Therefore, up to 80% of very low birth weight infants receive antibiotic therapy in their first week of life. Antibiotic therapy is one of the most important influencing factors for the establishment of the intestinal microbiome, which in turn modulates neonatal immune development. In this pilot study, it will be investigated, if antibiotic therapy in the first week of life influences the vaccination response of preterm infants.

Detailed Description
-----------------
The aim of the study is to compare antibody titers against Hepatitis B, Polio, Pertussis, Haemophilus influenza B, Tetanus, Diphteria and Pneumococcus in very low birth weight infants (VLBWI) infants who received antibiotic therapy in their first week of life and who did not. In this pilot study, 20 VLBWI infants will be included (10 per group). Infants will be matched fo age and gender.

Official Title
-----------------
Impact of Early Antibiotic Therapy on Vaccination Response in Preterm Infants

Conditions
-----------------
Vaccination Reaction

Intervention / Treatment
-----------------
* Drug: ABT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: born at University Hospital Tübingen at least one dose of antibiotics within the first week of life Exclusion Criteria: genetic disorders chronic infections hematological disorders immunoglobulins within the first 60 days of life immunological disorders infants from Hepatitis B positive mothers

Ages Eligible for Study
-----------------
Minimum Age: 24 Weeks
Maximum Age: 28 Weeks

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 |
| --- | --- |
| no antibiotic therapy (ABT) in the first week of life<br>VLBWI with gestational age between 24+0 and 28+6 weeks of gestation without antibiotic treatment in the first week of life | |
| ABT in the first week of life<br>VLBWI with gestational age between 24+0 and 28+6 weeks of gestation with antibiotic treatment in the first week of life | Drug: ABT<br>* any antibiotic therapy in the first week of life<br>* Other names: any antibiotic therapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vaccination reaction | measurement of antibody titers for Hepatitis B, Polio, Pertussis, Haemophilus Influenza B, Tetanus, Diphteria and Pneumococcus 4 months after the first vaccination (at an age of 6 months) | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiome composition | microbiome analyses of stool samples at age 14 days and corrected 4 months | 7 months |
Aortic Cross Clamping Time, and Postoperative Respiratory Function

Study Overview
=================
Brief Summary
-----------------
Does the duration of cardiopulmonary bypass, and aortic cross clamping affects the post operative pulmonary function.

Detailed Description
-----------------
Cardiac surgery usually is done under cardiopulmonary bypass. As the blood contacts with the artificial tubing of the circuit, there is release of mediators which affects pulmonary function. Of no doubt that the duration of cardiopulmonary bypass, and cross clamping time, will affect the spell over of such mediators. Follow up of the pulmonary function, and arterial blood gas is mandatory in such group of patients.

Official Title
-----------------
Implication of Aortic Cross Clamping Time Upon Postoperative Respiratory Function in Adult Patients Undergoing Open Heart Surgery

Conditions
-----------------
Bypass Complication, Respiratory Complication

Intervention / Treatment
-----------------
* Procedure: aortic cross clamping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients elective open heart surgery Exclusion Criteria: Patients with myocardial ischemia or previous infarction low ejection fraction <30% history of AF implanted pacemaker uncontrolled hypertension renal impairment (creatinine >1.8 mg/dl) hepatic dysfunction insulin dependent diabetes chronic pulmonary disease
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group S<br>short time <90 m aortic cross clamping | Procedure: aortic cross clamping<br>* duration of cross clamping, less than 90 minutes, or more than 90 minutes<br>|
| Active Comparator: group L<br>> 90 minutes aortic cross clamping | Procedure: aortic cross clamping<br>* duration of cross clamping, less than 90 minutes, or more than 90 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of oxygenation | PaO2 mmHg | 48 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to extubation | time to extubate in minutes | 24 hours postoperative | 
| ventilation | respiratory rate (breath/minute) | 48 hours postoperative | 
| carbon dioxide | PaCO2 mmhg | 48 hours |
Treatment of Hot Flushes in Asian Women With Ultra-low Dose Estradiol Patch

Study Overview
=================
Brief Summary
-----------------
150 postmenopausal Asian women with vasomotor symptoms, after fulfilling the inclusion and exclusion criteria will be enrolled in the study. The women will be randomly assigned to one of two treatment groups (Menostar® or placebo), after which they will be asked to use a patch once a week for 12 weeks.

Detailed Description
-----------------
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Official Title
-----------------
A Multicenter, Double-blind, Randomized, Placebo Controlled Study on the Effect of Ultra-low Dose Transdermal Estradiol (Menostar®) on the Incidence and Severity of Hot Flushes, Other Menopausal Symptoms and on Well-being in Postmenopausal Asian Women Over 12 Weeks.

Conditions
-----------------
Hot Flashes

Intervention / Treatment
-----------------
* Drug: Menostar (estradiol transdermal delivery system)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Evidence of postmenopausal status Exclusion Criteria: Contraindication to estrogen therapy

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Menostar (estradiol transdermal delivery system)<br>* Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Placebo patch<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative change in frequency of hot flushes |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intensity of hot flushes |  | 12 weeks | 
| Changes in vaginal pH |  | 12 weeks | 
| Changes in vaginal maturation index |  | 12 weeks | 
| Occurrence of urogenital symptoms |  | 12 weeks | 
| Change in MENQOL (menopausal quality of life questionaire) |  | 12 weeks | 
| Bleeding profile |  | 12 weeks | 
| Safety |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menopause
MRI Split Scar Sign as a Predictor to Complete Pathologic Response After Neoadjuvant Chemoradiation in Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
Patients with middle or low rectal cancer who receive neoadjuvant chemoradiation and achieve complete clinical response while their pelvic MRI have split scar sign are included. Patients will have total mesorectal excision and pathologic complete response will be assessed

Detailed Description
-----------------
Patients with middle or low rectal cancer who have T3-4 and/ or N+ will be included. Patients will receive neoadjuvant chemoradiation in the form of pelvic irradiation by 50.4 thousands grays together with radio sensitization by 5-FU or oxaliplatin, 8 months after completion of neoadjuvant chemoradiation patients will be assessed clinically and radiologically. Complete clinical response is diagnosed if clinically no tumor is felt or just small scar and no tumor appears in MRI. Of these patients who achieve complete clinical response we will pick up cases who have split scar sign in the pelvic MRI. Patients will have total mesorectal excision 8-11 weeks after completion of neoadjuvant chemoradiation and pathologic complete response will be assessed. Correlation will be done between preoperative clinical response and postoperative pathologic response

Official Title
-----------------
Complete Clinical Response With MRI Split Scar Sign as a Predictor to Complete Pathologic Response After Neoadjuvant Chemoradiation in Rectal Cancer

Conditions
-----------------
Rectum Cancer

Intervention / Treatment
-----------------
* Procedure: total mesorectal excision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: middle and low rectal cancer Exclusion Criteria: Distant metastasis
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: total mesorectal excision|excision of the rectum with complete excision of the mesorectum|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete pathologic response | disappearance of tumor from resected specimen | after surgical excision with follow up of an average of 1 year |
Nasya in Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate safety and efficacy of Nasya in reducing symptoms of persistent allergic rhinitis when applied before allergen challenge.

Official Title
-----------------
Double-blind, Randomized, Placebo-controlled, Crossover Clinical Investigation to Evaluate Safety and Efficacy of Nasya in Reducing Symptoms of Allergic Rhinitis When Applied Before Allergen Challenge

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

Intervention / Treatment
-----------------
* Device: Nasya
* Device: Saline solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of persistent allergic rhinitis due to house dust mite allergy ≥ 2 years Written informed consent Exclusion Criteria: Clinically significant disease that could interfere with the evaluation of study medication Participation in other studies within the last 4 weeks / during the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Saline solution<br>Nasal spray | Device: Saline solution<br>* Nasal spray, 2 sprays in each nostril<br>|
| Experimental: Nasya<br>Thixotropic nasal spray suspension | Device: Nasya<br>* Thixotropic nasal spray suspension, 2 sprays in each nostril<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Total Nasal Symptom Score |  | 75 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Total Nasal Symptom Score |  | Up to 240 minutes | 
| Difference in Total Ocular Symptom Score |  | Up to 240 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic rhinitis, Allergen, Allergy, Dustmite