linjc16/ctgov huggingface dataset:
Sleep Disturbances as a Non-Traditional Risk Factor in Chronic Kidney Disease- University of Illinois

Study Overview
=================
Brief Summary
-----------------
This study will help determine the relationship between impaired sleep and chronic kidney disease, specifically to determine if sleep disturbances are a risk factor for worsening kidney function.

Official Title
-----------------
Sleep Disturbances as a Non-Traditional Risk Factor in Chronic Kidney Disease

Conditions
-----------------
Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CKD subjects will be participants in a larger study, CRIC, at the University of Illinois, Chicago 30 Healthy controls age and gender matched to 30 CKD subjects, regular bedtimes of at least 6h/night, sedentary lifestyle Exclusion Criteria: Diabetes Current or previous dialysis for more than 1 month Uncontrolled hypertension Heart failure Liver disease HIV Hemoglobin < 10.5 g/dl Treatment with EProcrit, Epogen, or Aranesp Bone or organ transplant, Use of immunosuppressive drugs within past 6 months Current oral contraceptive use Current pregnancy Chemotherapy for malignancy within past 2 years

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 74 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 |
| --- | --- |
| 1<br>Subjects with mild to moderate kidney disease | |
| 2<br>Healthy Control Subjects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Quality |  | Sleep Quality was determined after PSG on all subjects were completed | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep, CKD, kidney, PSG, polysomnography, Decreased sleep time, Decreased sleep quality
Post-traumatic Stress, Signs of Depression and Burnout Syndrome Among Nursing Home Staff in Occitanie During the COVID-19 Pandemic

Study Overview
=================
Brief Summary
-----------------
Nursing home staff face multiple stresses during the Covid-19 pandemic including personal risk of infection, risk of transmission of the virus to residents and relatives, and risk of witnessing end-of-life scenarios under difficult contexts (absence of families). The hypothesis of this study is that the Covid-19 period is associated with an incidence of more than 30% of post-traumatic stress in nursing home staff.

Official Title
-----------------
Stress Post Traumatique, Signes de dépression et Syndrome d'épuisement Professionnel Chez le Personnel Des EHPAD en Occitanie Pendant la pandémie COVID-19 : étude Prospective

Conditions
-----------------
Covid19, Post Traumatic Stress Disorder, Anxiety, Depressive Disorder, Substance Use Disorders

Intervention / Treatment
-----------------
* Other: Cognitive tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Professional working in a nursing home in Occitanie Professional agreeing to participate Professional in a nursing home for at least 3 months Professional able to read French Profession with an internet connection Exclusion Criteria: The subject is in a period of exclusion determined by a previous study The subject refuses to participate The subject has already been included into the study It is impossible to give the subject informed information The subject is under safeguard of justice or state guardianship The subject is unable to express consent

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 |
| --- | --- |
| Staff working in a nursing home in Occitanie<br> | Other: Cognitive tests<br>* Optional tests: Corsi block-tapping task, Stroop test and Iowa gambling task<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the prevalence of post-traumatic stress disorder (PTSD) in the context of the COVID-19 health crisis | Posttraumatic Stress Disorder Checklist Scale (PCL-5) scale, where the recommended cut-off threshold for screening is 44 | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of depression in the context of the COVID-19 health crisis | Hospital Anxiety and Depression Scale (HADS) scale, using a cut-off above 7 | Day 0 | 
| Prevalence of burn out in the context of the COVID-19 health crisis | Masslach Burn out Inventory (MBI) questionnaire where high scores for the professional burnout and depersonalization sections and a low score for the personal accomplishments section will signal burn out | Day 0 |
Study on the Efficacy of LAS41005 in the Treatment of Actinic Keratosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy of LAS41005 in comparison to placebo and to LAS106521 in actinic keratosis (AK).

Detailed Description
-----------------
To investigate as primary objective: Superiority to placebo and non-inferiority to LAS106521 measured by histological clearance of one predefined target lesion; To investigate as secondary objective: Superiority to LAS106521 Improvement of treated lesions (lesion response) Assessment of tolerability and safety by physicians global assessment score (PGA, PGT) Patient's assessment of tolerability and efficacy and patient's compliance

Official Title
-----------------
Study on the Efficacy of LAS41005 Compared to Placebo and to LAS106521 in the Treatment of Actinic Keratosis Grade I to II

Conditions
-----------------
Actinic Keratosis

Intervention / Treatment
-----------------
* Drug: Placebo Gel
* Drug: LAS41005
* Drug: LAS106521


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Have at least 4 but not more than 10 clinically confirmed AK target lesions of mild to moderate intensity within the face/forehead or bald scalp (excluding eyelids, lips, and mucosa), i.e. actinic keratosis grade I and II according to Olsen EA et al. 1991 Woman of childbearing potential are allowed to participate in this study only if they use a highly effective method of contraception Main Exclusion Criteria: Have received effective treatment of AK in the three months preceding this clinical trial Have known hypersensitivity to LAS41005 or LAS106521 Have currently other malignant or benign tumors of the skin within the treatment area (e.g. malignant melanoma, basal cell carcinoma, squamous cell carcinoma) Patient's taking phenytoin Show cornu cutaneum like alterations of the skin in the face or the bald scalp (target area)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LAS41005<br> | Drug: LAS41005<br>* Topical<br>|
| Active Comparator: LAS106521<br> | Drug: LAS106521<br>* Topical<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo Gel<br>* Topical<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological status of AK target lesion |  | Day 140 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Actinic Keratosis, AK, NMSC, Combination
Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia

Study Overview
=================
Brief Summary
-----------------
This is a diagnostic efficacy study to evaluate a set of biomarkers in human breath indicative of an acute malaria infection. The investigators plan to enroll 75 malaria patients and 175 febrile non-malaria patients in Ethiopia. Upon enrollment, blood for malaria RDT, microscopy and PCR will be collected as well as a breath sample to assess the presence of biomarkers at a reference center. Malaria patients identified by microscopy are revisited at day 2 and 7 to collect a further samples. G6PD testing will be performed concurrently to identify prevalent G6PD variants.

Conditions
-----------------
Malaria

Participation Criteria
=================
Eligibility Criteria
-----------------
Malaria cohort Age ≥5 years of age Malaria microscopy and / or Malaria RDT confirmed malaria infection Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours Written informed consent Febrile controls Age ≥5 years of age Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours Absence of a malaria episode confirmed by malaria microscopy Written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 5 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 |
| --- | --- |
| Malaria patients<br> | |
| Febrile controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of the VOC breathalyser | Sensitivity and specificity of the VOC breathalyser compared to microscopy, rapid diagnostic tests (RDTs) and PCR for the diagnosis of clinical malaria. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of malaria parasite density with VOC concentrations | The correlation of malaria parasite density with VOC concentrations in patients with clinical and subpatent malaria and the recovery profile of VOC following acute malaria. | 7 days | 
| G6PD variants | G6PD variants within the local population | 1 day | 
| G6PD activity in U/gHb | The distribution of G6PD enzyme activity in the local population measured in U/gHb. | 1 day | 
| Performance characteristics of qualitative and quantitative G6PD test formats. | Sensitivity and specificity of other G6PD diagnostic assays compared to the gold standard spectrophotometry | 1 day |
Clinical Cardiovascular Outcomes of African-Americans

Study Overview
=================
Brief Summary
-----------------
To examine clinical cardiovascular outcomes of African Americans.

Detailed Description
-----------------
BACKGROUND: It has been well recognized for years that the survival rates among African-Americans with chronic diseases are reduced compared to their white counterparts. Recently attention has focussed on racial disparities in survival with chronic cardiovascular diseases. Prior to the widespread availability of coronary arteriography, African-Americans were thought to have a very low incidence of coronary artery disease. These findings appear to be inconsistent with the now generally accepted view that the coronary artery disease mortality rate is nearly equal in United States Black and white men and is increased in Black women as compared to white women. Howard University and Howard University Hospital provided a unique environment for studying the clinical cardiovascular outcomes of African-Americans, in light of its history. That is, due to the influx of blacks into the District of Columbia in 1862, Freedmen's Hospital (which is now known as Howard University Hospital) was established for their care. Howard University Hospital has had an admissions profile with greater than 95 percent African-Americans for the past century DESIGN NARRATIVE: The study used previously collected data to: 1) examine the trends in mortality rates at Howard University Hospital, based on discharge status, between 1986 - 1992, for selected cardiovascular diseases; 2) compare cardiovascular mortality rate trends between Howard University Hospital and the National Hospital Discharge data; 3) examine cardiovascular co- morbidity experiences using a severity of illness index at Howard University Hospital compared to National data by race/ethnicity, geographic location and hospital bed size; and 4) identify a cohort of cardiovascular patients retrospectively based on repeated discharge data at Howard University Hospital, to analyze survival data. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Post-operative Efficacy and Safety Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to compare the analgesic efficacy of 5 mg oxymorphone IR with placebo in patients with mild to moderate pain following outpatient knee arthroscopy.

Official Title
-----------------
A Randomized, Double-blind Evaluation of the Analgesic Efficacy and Safety of a Low Dose Oxymorphone Immediate Release in Patients Following Ambulatory Arthroscopic Knee Surgery

Conditions
-----------------
Post-operative Pain

Intervention / Treatment
-----------------
* Drug: Oxymorphone IR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females, 18 years of age or older, who have completed outpatient knee arthroscopy Have an initial pain intensity score of between 30mm and 70mm on a 100mm Visual Analogue Scale(VAS) and a categorical pain rating scale of none, mild, moderate, or severe, Have been informed of the nature of the study and provided written informed consent Exclusion Criteria: Have a positive pregnancy test Have received any of the following medications within 24 hours prior to dosing: COX2 inhibitors, Minor Tranquilizers, Muscle relaxants, Antihistamines Long-acting oral and parenteral analgesics are prohibited for at least 12 hours prior to receiving study medication. Have received any of the following medication within 48 hours prior to dosing: Chronic use of analgesics (opioid or non-opioid including aspirin [>325 mg/day], acetaminophen, and NSAIDs) Have received MAOI drugs within 2 weeks prior to dosing Not stabilized on the following medications for at least 4 weeks prior to dosing: Tricyclic antidepressant drugs, Serotonin reuptake inhibitors, Amphetamines used for ADHD

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxymorphone<br> | Drug: Oxymorphone IR<br>* 5 mg<br>|
| Placebo Comparator: Placebo<br> | Drug: Oxymorphone IR<br>* 5 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sum of Pain Intensity (SPID) Visual Analog Scale (VAS) |  | 2 months |
Sequencing to Identify Gene Variants in Familial Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The project will use exome sequencing to search for genetic predispositions for familial colorectal cancer (CRC). Except for certain syndromes there is today no good method for identifying individuals with a hereditary high risk for CRC (about 25% of the cases). There is currently no routine screening of the population in Norway for CRC today. Coloscopy, which is the most reliable method, is demanding with respect to resources, it can be painful, and may have complications. This project will attempt to find genetic determinants for identification of individuals with increased risk for familial CRC. Such methods will reduce unnecessary medical examination of unaffected family members, and will make it easier to focus health services on individuals with increased risk. This will represent a significant contribution towards improved health reduced death rate caused by CRC. The project includes research on the ethical aspects, in particular challenges related to how feedback to donors is handled.

Detailed Description
-----------------
Participants will be from a specific family, and will be selected by invitation to volunteer.

Official Title
-----------------
Exom-sekvensering for å Identifisere høyrisiko Genvarianter i en Familie Predisponert for Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Genetic: gene sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Member of a specific family with increased risk of CRC, including individuals both with and without CRC Exclusion Criteria: Young age

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| CRC high risk<br>Participants belong to a family with increased risk for CRC, will be analyzed with gene sequencing | Genetic: gene sequencing<br>* Gene sequencing by exome capture and high throughput sequencing for identification of rare variants<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data on association between sequence variants in exons and CRC risk | For each participant the genome will be analyzed by exome capture and high throughput sequencing. The exome data will be compared between participants and to reference data for identification of unique variants that can be associated with disease risk. | Data available within 18 months after recruitment completed | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gene sequencing, familial, risk factors
Single Center Food Allergy Oral Immunotherapy Study

Study Overview
=================
Brief Summary
-----------------
The Primary Objective of the study is to develop a customized regimen for oral immunotherapy that reflects what the subject is allergic in a clinically significant way (i.e., the offending food allergen is defined as a food allergen with a positive skin test or positive specific IgE and a positive DBPCFC). Therefore, the investigators prefer that both single and multiple food allergy subjects are included in the study.

Official Title
-----------------
Single Center, Phase I Food Allergy Oral Immunotherapy Study

Conditions
-----------------
Immune System Diseases

Intervention / Treatment
-----------------
* Drug: Food proteins


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe peanut and/or egg and/or milk and/or tree nut and/or seed allergic subjects between the ages of 4 to 55 years old. Sensitivity to food allergen will be documented by a positive skin prick test result (see Appendix for details) or allergen specific ImmunoCAP IgE level with 7 kU/L as a lower limit of eligibility. Exclusion Criteria: No absolute contraindications are known. However, the risk of serious systemic anaphylactic reactions to food allergens suggests a number of preexisting conditions that should be considered relative contraindications. Among those conditions are acute infections, autoimmune disease, severe cardiac disease, and treatment with beta-adrenergic antagonistic drugs (beta-blockers). Subjects having a history of severe anaphylaxis to food allergens that will be desensitized in this study requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 55 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: One<br> | Drug: Food proteins<br>* Oral ingestion of Food proteins<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events in the treatment population |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects who reach 2g or more of food flour |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple food allergies