linjc16/ctgov huggingface dataset:
Ofatumumab and Bendamustine for Previously Treated Chronic Lymphocytic Leukemia (CLL)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of the combination of bendamustine and ofatumumab in subjects with relapsed/refractory chronic lymphocytic leukemia and small cell lymphoma. All subjects enrolled on this study will receive both drugs by intravenous (IV) infusion.

Official Title
-----------------
Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia/ Small Lymphocytic Leukemia

Conditions
-----------------
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Intervention / Treatment
-----------------
* Drug: Ofatumumab and Bendamustine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically confirmed CLL or SLL requiring therapy Age 18 years of age or older ECOG performance status 0, 1, or 2 Normal organ and bone marrow function Resolution of toxic effects from prior therapies Ability to adhere to the study schedule and give written informed consent Exclusion Criteria: Any serious medical, psychiatric illness or laboratory abnormality Chemotherapy or radiotherapy within 4 weeks of entering the study Currently receiving other treatment for CLL/SLL or other malignancies Active other malignancies History of allergic reactions to bendamustine or ofatumumab Ongoing corticosteroid use Pregnant or lactating HIV positive Active hepatitis B Allogeneic transplant within 6 months of entering study or graft-versus-host disease.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ofatumumab and Bendamustine<br>Ofatumumab and Bendamustine | Drug: Ofatumumab and Bendamustine<br>* Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles<br>* Other names: Ofatumumab;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | 40% per the National Cancer Institute Working Group Response Criteria for Chronic Lymphocytic Leukemia | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Response Rate | NCI IWG response criteria | 6 months | 
| Median PFS | Kaplan Meyer PFS | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLL, SLL, Bendamustine, Ofatumumab
Vitamin D Status and Immune Function

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the relationship between Vitamin D status and immunity.

Detailed Description
-----------------
Vitamin D is mainly obtained from the sun and follows a seasonal pattern, with Vitamin D levels peaking in summer and reaching a trough during winter. Vitamin D deficiency is associated with impaired immunity. However, knowledge of Vitamin D deficiency with in vivo immunity is limited. This observational study aims to investigate the relationship between Vitamin D status and the in vivo immunity.

Official Title
-----------------
Vitamin D Status and in Vivo Immune Function

Conditions
-----------------
Vitamin D Deficiency

Intervention / Treatment
-----------------
* Other: In vivo immunity model


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Passed medical assessment by medical doctor Passed audio test (this is part of medical assessment) Met physical fitness requirements Exclusion Criteria: • Medically deferred by medical doctor

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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 |
| --- | --- |
| Army recruits<br>Army recruits at the start of basic training will complete an in vivo immunity model | Other: In vivo immunity model<br>* A measure of in vivo immune function.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D measured by liquid chromatography tandem mass spectroscopy | Circulating 25-hydroxy-vitamin D | Up to 20 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune function measured by analytic biochemistry assay | In vivo immune measure | Up to 20 months |
Noninvasive Biomarkers for Monitoring Cardiometabolic Risk in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify salivary biomarkers for monitoring cardiometabolic risk in children. The study hypothesis is that a combination of salivary biomarkers will predict the presence of risk factors including impaired fasting glucose, hypertension and dyslipidemia and will reflect changes in these risk factors over time.

Official Title
-----------------
Noninvasive Biomarkers for Monitoring Cardiometabolic Risk in Children

Conditions
-----------------
Obesity, Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participating in the CARDIAC Boot Camp Program Between the ages of 4 and 17 Parental permission Ability to provide assent Exclusion Criteria: Inability to comply with saliva collection procedures Renal insufficiency or juvenile gout

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 17 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 |
| --- | --- | --- |
| Correlation (R values) of salivary biomarkers with blood pressure percentile and serum glucose, HDL, total cholesterol, triglyceride and insulin levels in children |  | Baseline | 
| Predictive utility (C-statistic) of salivary biomarkers for development of metabolic syndrome during childhood and adolescence |  | final assessment at age 18 (up to 14 years depending on age of enrollment) |
Assessment Of Sildenafil On Erectile Function And Intercourse Satisfaction And To Validate A New Subject Questionnaire

Study Overview
=================
Brief Summary
-----------------
To evaluate the effectiveness of sildenafil on erectile function and intercourse satisfaction in men with ED as well as to validate the new Sexual Experience Questionnaire which incorporates functional and emotional elements of a man's sexual experience into one comprehensive questionnaire.

Official Title
-----------------
A Multi-Center, Double-Blind Placebo Controlled, Flexible-Dose Study With An Open-Label Phase To Assess The Efficacy Of Sildenafil Citrate On Erectile Function And Intercourse Satisfaction As Well As To Validate The Sexual Experience Questionnaire And Its Treatment Responsiveness In Men With Erectile Dysfunction

Conditions
-----------------
Impotence

Intervention / Treatment
-----------------
* Drug: sildenafil citrate
* Drug: placebo for sildenafil citrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented clinical diagnosis of erectile dysfunction, defined by a score of less than or equal to 25 on the Erectile Dysfunction domain of the International Index of Erectile Function Exclusion Criteria: Subjects who have been treated with more than 6 doses of sildenafil or any other phosphodiesterase type 5 inhibitor

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

Sexes Eligible for Study
-----------------
Male

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 |
| --- |
|Drug: sildenafil citrate|nan|
|Drug: placebo for sildenafil citrate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoints are: The changes from baseline to Visit 5 (Week 10) of the Erectile Function (Questions 1-5, 15) Intercourse Satisfaction domains (Questions 6-8) of the International Index of Erectile Function (IIEF). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline to Visit 4 (Week 6), Visit 5 (Week 10) and Visit 7 (Week 16) in the domains and total score as well as the individual questions of the Sexual Experience Questionnaire (SEX-Q) |  |  |
Evaluation of Parameters Collected From Routine Data for the Diagnosis of Sepsis and Septic Shock and Their Influence on Time to Diagnosis and Patient Outcome

Study Overview
=================
Brief Summary
-----------------
Retrospective observational study to develop a Machine Learning Algorithm to evaluate parameters collected from routine data for the diagnosis of sepsis and septic shock and their influence on time to diagnosis and patient outcome.

Detailed Description
-----------------
Retrospective routine data from the medical records of the department of anesthesiology and operative intensive care from 01. 01. 2007 to 31. 12. 2021 are analyzed in digital form. The first step is the development of a machine learning algorithm (MLA). This MLA will be validated and analyzed for his predictive value with regard to early diagnosis of sepsis/septic shock depending on the conceptual value of detection variables (Sepsis-3 vs. SIRS). Further analysis will focus on improvement of accuracy for the MLA and the effect of these detection variables on quality of treatment processes and also on economic consequences like cost and revenue. Timeline: Conception and development of the ML Algorithm (6 months) Identification and diagnostic validation of sepsis patients (6 months) Secondary analyses (36 months)

Official Title
-----------------
Evaluation of Parameters Collected From Routine Data for the Diagnosis of Sepsis and Septic Shock and Their Influence on Time to Diagnosis and Patient Outcome (QUICK-SEPSIS)

Conditions
-----------------
Sepsis, Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >= 18 years ICU stay of > 24 hours Exclusion Criteria: none

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 |
| --- | --- | --- |
| Sepsis/septic shock | Development of a machine learning algorithm (MLA) for the prediction of sepsis/septic shock from hospital routine data. | 01.01.2007 -31.12.2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive accuracy | Evaluation of the predictive accuracy (= predictive value) of the respective sepsis diagnostic algorithm (i.e. comparison of the concepts SIRS and Sepsis-3) | 01.01.2007 -31.12.2021 | 
| Diagnostic accuracy | Identification of additional variables for diagnostic accuracy (laboratory values, clinical parameters and vital-sign monitor parameters and other relevant health data | 01.01.2007 -31.12.2021 | 
| Performance indicators | Evaluation of performance indicators of clinical routine processes (Intensive care quality indicators) | 01.01.2007 -31.12.2021 | 
| Case costs | Case costs related to hospitalization | 01.01.2007 -31.12.2021 | 
| Revenues | Revenues related to hospitalization | 01.01.2007 -31.12.2021 |
Effects of a Supplement Containing Fucoidan on Basal Body Temperature

Study Overview
=================
Brief Summary
-----------------
We aim to determine whether a supplement containing fucoidan isolated from Mekabu (sporophyll of Undaria pinnatifida), EPA, and DHA has effects of elevating basal body temperature in subjects with low basal body temperature.

Official Title
-----------------
Effects of a Supplement Containing Fucoidan as a Major Component on Basal Body Temperature: a Placebo Controlled, Cross-over Study

Conditions
-----------------
Low Basal Body Temperature

Intervention / Treatment
-----------------
* Dietary Supplement: Supplement containing fucoidan, EPA, and DHA
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women with basal body temperature < 36.0 ºC Healthy as based on medical history and physical examination Willing not to donate blood during the study Informed consent signed Exclusion Criteria: Renal or hepatic dysfunction Heart disease Participation in any clinical trial within 90 days of the commencement of the trial Subjects who are taking medicines or functional food that may affect basal body temperature

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fucoidan supplement<br> | Dietary Supplement: Supplement containing fucoidan, EPA, and DHA<br>* 75 mg fucoidan per day, for 8 weeks<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basal body temperature |  | up to 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in serum lipid levels (total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride) |  | Weeks 0, 8, 12, and 20 |
Number of Multiple Breath Washout Tests in Adults With Pulmonary Disease and Healthy Controls

Study Overview
=================
Brief Summary
-----------------
The investigators aim to determine the optimal number of measurements required for multiple-breath-washout derived lung function parameters in adults with pulmonary disease as well as in healthy controls

Official Title
-----------------
Determination of the Optimal Number of Multiple Breath Washout Tests in Adults With Pulmonary Disease and Healthy Controls

Conditions
-----------------
Healthy Controls, Chronic Obstructive Pulmonary Disease, Bronchial Asthma, Sarcoidosis

Intervention / Treatment
-----------------
* Diagnostic Test: multiple breath washout


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - informed consent Exclusion Criteria: inability to perform multiple breath washout testing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| healthy controls<br>no history of pulmonary disease absence of symptoms, smoking history < 10 pack years normal lung function testing | Diagnostic Test: multiple breath washout<br>* determination of lung clearance index using SF6 multiple breath washout<br>|
| chronic obstructive pulmonary disease<br>clinical history and/or specialist diagnosis of COPD and risk factor(s) persistent bronchial obstruction and/or hyperinflation and/or radiological sign of emphysema, each without alternative explanation dyspnea, cough and/or sputum production | Diagnostic Test: multiple breath washout<br>* determination of lung clearance index using SF6 multiple breath washout<br>|
| bronchial asthma<br>clinical history and/or specialist diagnosis of bronchial asthma respiratory symptoms compatible with asthma varying over time variable and/or reversible obstructive ventilation disorder and/or airway hyperresponsiveness exclusion of alternative explanation | Diagnostic Test: multiple breath washout<br>* determination of lung clearance index using SF6 multiple breath washout<br>|
| sarcoidosis<br>clinical history and/or specialist diagnosis of sarcoidosis lymphocytic alveolitis and CD4/CD8 > 3.5 in bronchoalveolar lavage and/or noncaseating epithelioid granuloma exclusion of alternative explanation | Diagnostic Test: multiple breath washout<br>* determination of lung clearance index using SF6 multiple breath washout<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of lung clearance index (LCI) as determined by multiple breath washout | comparing the repeatability of duplicate vs. triplicate LCI measurements | 60 minutes |
Clinical Evaluation of Two Daily Disposable Lenses in Neophytes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the performance of two daily disposable contact lenses in a population of neophytes (new wearers).

Official Title
-----------------
Clinical Evaluation of Two Daily Disposable Lenses in Neophytes

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: nelfilcon A contact lens
* Device: narafilcon A contact lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No previous contact lens experience or attempts to try contact lenses (neophytes). Currently wearing spectacles or needing vision correction in both eyes. No older than 45 years of age. Able to achieve visual acuity of at least 20/40 in each eye with study lenses in the available parameters. Interested in wearing contact lenses. Willing to wear study lenses for at least 8 hours/day, at least 5 days/week. Other protocol-defined inclusion/exclusion criteria may apply. Exclusion Criteria: Eye injury or surgery within twelve weeks prior to enrollment. Pre-existing ocular irritation that would preclude contact lens fitting. Previous corneal or refractive surgery. Currently enrolled in any Clinical Trial. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Maximum Age: 45 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: nelfilcon A<br>Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week. | Device: nelfilcon A contact lens<br>* Commercially marketed, hydrogel, single-vision contact lens for daily wear, daily disposable use.<br>|
| Active Comparator: narafilcon A<br>Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week. | Device: narafilcon A contact lens<br>* Commercially marketed, silicone hydrogel, single-vision contact lens for daily wear, daily disposable use.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Lens Satisfaction | Overall Lens Satisfaction, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being Poor and 10 being Excellent | 1 week |
Changes in Eye Pressure and Anterior Chamber Depth With Oral Endothelin Antagonist Therapy

Study Overview
=================
Brief Summary
-----------------
There is growing evidence that a cause of glaucoma is linked to circulatory problems and poor auto-regulation of blood flow to the optic nerve. Pulmonary hypertension (PH)is a disease characterized by low oxygen levels in the blood and altered blood circulation. The decrease in oxygen delivery to the optic nerve could lead to the loss of nerve fiber layer(NFL)in the retina and the resulting visual field compromise. This situation is characteristic of glaucoma. The ability to identify NFL thinning early could lead to earlier diagnosis of glaucoma and more effective treatment to limit dysfunction from visual field loss. We hypothesize that the rate of structural damage to the NFL, a feature of glaucoma, is higher in patients with PH than expected in healthy populations lacking this disease.

Official Title
-----------------
The Effect of a Systemic Non-selective Endothelin Antagonist on Intraocular Pressure and Anterior Depth in Pulmonary Hypertension Patients.

Conditions
-----------------
Glaucoma, Pulmonary Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with pulmonary hypertension between the ages of 18 and 80 years ability to undergo the various ocular exams. Exclusion Criteria: patients with other diseases that could affect the nerve fiber layer special populations; ie children, pregnancy, lactating females, prisoners

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of nerve fiber layer abnormalities |  | Single Exam | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optic Nerve Head Structure |  | Single Exam |