linjc16/ctgov huggingface dataset:
Evaluation of the HSV 1 & 2 Assay in Specimens From Symptomatic Subjects

Study Overview
=================
Brief Summary
-----------------
This clinical performance study is being conducted to evaluate the performance of the Aptima Herpes Simplex Viruses 1 & 2 assay for detection of herpes simplex virus (HSV) type 1 (HSV-1) and HSV type 2 (HSV-2) in swab samples prospectively collected from suspected HSV lesions. Specimens collected using swabs from viral transport medium (VTM)collection kits and Aptima swab collection kits will be evaluated.

Official Title
-----------------
Clinical Evaluation of the Aptima® Herpes Simplex Viruses 1 & 2 Assay on the Panther® System in Swab Specimens From Symptomatic Subjects Presenting With a Suspected Herpes Lesion(s)

Conditions
-----------------
Herpes Simplex Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject has at least 1 active lesion (lesion with exudates and cellular material; eg, vesicle, ulcer) that is suspected to be caused by HSV (as determined by the clinician) The subject and/or legally authorized representative is willing and able to provide consent prior to study participation (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an institutional review board-approved waiver for parental consent for minors) Exclusion Criteria: The subject has only HSV lesions without exudates and cellular material The subject used a topical or oral antiviral medication used to treat HSV within 21 days of enrollment Subject already participated in this study Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the study Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled in the study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with suspected HSV Lesions<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of sensitivity and specificity of the Aptima HSV 1 & 2 Assay on Panther | Sensitivity and specificity of the Aptima HSV 1 & 2 assay will be determined by comparing assay results to results from a reference method representing the true infected status of the subjects. Sensitivity will be reported as the percentage of subjects with an HSV infection who test positive by the Aptima HSV 1 & 2 assay. Specificity will be reported as the percentage of subjects without an HSV infection who test negative by the Aptima HSV 1 & 2 assay. | 1 day |
A Retrospective Study of COVID-19 Treatments

Study Overview
=================
Brief Summary
-----------------
Surveys administered to subjects who have recovered from COVID-19 to assess how effective their treatment was.

Detailed Description
-----------------
Subjects who have recovered from COVID-19 will answer questions regarding the severity of their illness, symptoms experienced, what treatment they received, and how long they were ill.

Official Title
-----------------
A Retrospective Study to Analyze Efficacy of COVID-19 Treatments

Conditions
-----------------
Covid19, COVID-19 Pneumonia, COVID-19 Respiratory Infection, COVID-19 Acute Bronchitis, COVID-19 Acute Respiratory Distress Syndrome, COVID-19 Lower Respiratory Infection, SARS-CoV2 Infection, SARS-CoV-2 Acute Respiratory Disease

Intervention / Treatment
-----------------
* Other: No Intervention Used


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study Male or female of 18 years of age or older Diagnosis of COVID-19 infection by RT- PCR Recovery from COVID-19 Exclusion Criteria:

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 Patients<br>Subjects who have recovered from COVID-19 | Other: No Intervention Used<br>* There is no intervention in this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survey Response | Answers given by subjects on their recovery from COVID-19 | One hour |
A Study to Determine the Effect of Food on the Pharmacokinetics of Oral AZD8931 Tablets

Study Overview
=================
Brief Summary
-----------------
Phase I, randomised, open label, 3-period crossover study in healthy male subjects to investigate the effect of food on the pharmacokinetics of AZD8931 and to investigate the safety and tolerability of AZD8931.

Official Title
-----------------
A Randomised, Open-label, Phase I Study to Determine the Effect of Food on the Pharmacokinetics of Oral AZD8931 Tablets in Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: AZD8931


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of written informed consent Body mass index (BMI) between 19 and 30 kg/m2 Exclusion Criteria: Use of any prescribed or non-prescribed medication (including analgesics, herbal remedies, vitamins and minerals) during the two weeks prior to the first administration of investigational product Administration of another investigational medicinal product in the 3 months before the start of dosing in this study Definite or suspected clinically relevant personal history of adverse drug reactions, or drug hypersensitivity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>160mg oral dose of AZD8931 | Drug: AZD8931<br>* 160mg oral single dose (4 x 40mg tablets)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the effect of food on the pharmacokinetics of AZD8931 160mg oral dose |  | Multiple blood PK samples taken between predose to up to 5 days post last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety profile by assessment of adverse events, physical examination, pulse, blood pressure, clinical chemistry, haematology, urinalysis & ECG |  | Maximus of 7 weeks (From time of consent to last visit including any follow-up) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteers, ADME, Healthy male volunteers
Long Term Results of STARR With Contour Transtar

Study Overview
=================
Brief Summary
-----------------
Obstructed defecation syndrome (ODS) is a widespread and disabling syndrome. With this study the investigators want to evaluate the long term results of Stapled Transanal Rectal Resection (STARR) performed with Contour Transtar device in the treatment of ODS. A re-evaluation of 113 patients subjected to STARR from June 2007 to January 2010 was conducted.

Official Title
-----------------
STARR With Contour Transtar for Obstructed Defecation Syndrome: Long Term Results

Conditions
-----------------
Rectal Prolapse, Rectocele, Intussusception of Rectum

Intervention / Treatment
-----------------
* Procedure: Stapled Transanal Rectal Resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ODS presence of a rectocele that did not empty and/or a recto-rectal or recto-anal intussusception. Exclusion Criteria: anal sphincter contractile deficiency previous rectal resection

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 |
| --- | --- |
| Treatment Group<br>Patients candidated to STARR after the failure of medical and dietary therapy and after a complete radiological and functional study. | Procedure: Stapled Transanal Rectal Resection<br>* The prolapsed tissue is pulled out through the CAD using e gauze pad and Allis forceps; this allows us to identify the extent of the prolapse to be resected. Four to five parachute stitches are then apposed circumferentially, like parachute cords, at the apex of the prolapse, in order to control the tissue during resection. The prolapse is then opened longitudinally at 3 o'clock with the electric scalpel between two Kocher clamps. Two traction stitches are applied at the deep vertex of the prolapse, one for each Kocher apex. The longitudinal opening then allows the surgeon to begin circumferential resection of the rectum by pulling on the parachute stitches. This maneuver is performed counterclockwise using an average of 4-6 recharges, with care to always place the stapler at the base of the prolapse. The resected specimen was always inspected before the end of the procedure.<br>* Other names: STARR;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of constipation | Cleveland Clinic Constipation Score | 6 months | 
| degree of constipation | Cleveland Clinic Constipation Score | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Complications | intraoperative and postoperative surgical complications | 0-6 months |
Oxidative Stress Markers in COPD

Study Overview
=================
Brief Summary
-----------------
Background:Striking feature of Chronic obstructive pulmonary disease (COPD) is its inability to resolve after cigarette smoke exposure has ended, which has contributed to the possibility that the disease could also be driven by other endogenous causes, such as autoimmunity or chronic infection . Many of the pathogenetic pathways involved in COPD and its development tend to be driven by oxidative stress.

Official Title
-----------------
Chronic Obstructive Pulmonary Disease in Non Smokers:Role of Oxidative Stress

Conditions
-----------------
Role of Oxidative Stress in COPD

Intervention / Treatment
-----------------
* Other: oxidative stess markers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1-Forty subjects of COPD who are non-smokers or stopped smoking for more than 6 months Based on the Global Initiative for Chronic Obstructive Lung Disease guidelines, COPD was diagnosed.9 2- Thirty subjects of non smokers healthy control Exclusion Criteria: Patients of: Acute exacerbation, at the time of the study, of COPD. Any obvious abnormal lung parenchymal lesions. Lung cancer. Congestive heart failure. current smokers Drugs e.g anti-inflammatory , steroids ,analgesics, insulin , antineoplastic, antipsychotic drugs in the previous 2 weeks before the study.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| nonsmokers copd cases ,<br>Fourty subjects of COPD who are non-smokers or stopped smoking for more than 6 months | Other: oxidative stess markers<br>* markers of oxidative stress , Superoxide Dismutase (SOD) and Malondialdehyde (MDA) by ( ELISA Kit SinoGeneClon Biotech Co.,Ltd Catalog No : SG- 10188) .<br>* Other names: Superoxide Dismutase (SOD) and Malondialdehyde (MDA);|
| non smokers healthy control<br>Thirty subjects of non smokers healthy control | Other: oxidative stess markers<br>* markers of oxidative stress , Superoxide Dismutase (SOD) and Malondialdehyde (MDA) by ( ELISA Kit SinoGeneClon Biotech Co.,Ltd Catalog No : SG- 10188) .<br>* Other names: Superoxide Dismutase (SOD) and Malondialdehyde (MDA);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxidative stress markers in non smokers COPD compared to healthy control | markers of oxidative stress , Superoxide Dismutase (SOD) and Malondialdehyde (MDA) by ( ELISA Kit SinoGeneClon Biotech Co.,Ltd Catalog No : SG- 10188) . | 1month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD , oxidative stress, Superoxide Dismutase
Does Islet Transplantation Eliminate Hypoglycemia?

Study Overview
=================
Brief Summary
-----------------
Low blood sugar (hypoglycemia) is a recurrent problem for many people with diabetes. Successful transplantation of clusters (islets) of normal cells, that include those which produce the sugar-lowering hormone insulin, from the pancreas of a person who did not have diabetes into a person with diabetes should eliminate high blood sugar levels. We wish to determine if it will also eliminate low blood sugar. To do so we will give insulin to lower the blood sugar, measure the levels of the hormones that normally raise blood sugar levels (e.g., glucagon and epinephrine) and then stop the insulin and see if blood sugar levels return to normal. Because we anticipate that the transplanted islets will produce insulin, but not glucagon, this study may also tell us if regulated insulin production alone can prevent hypoglycemia in humans.

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Procedure: Pancreatic Islet Transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically stable, insulin dependent islet transplant recipients and matched nondiabetic healthy controls

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: Non-Randomized
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Pancreatic Islet Transplantation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Impact of Lung Cancer-derived Fibroblasts on Mast Cells Activation

Study Overview
=================
Brief Summary
-----------------
In addition to their role in allergic inflammation, mast cells are often found at the site of tumors. They have been attributed both to pro- and anti-tumorigenic roles depending on the tumor type. Secretion of mast cell mediators such as histamine, tryptase, fibroblast growth factor (b-FGF), vascular endothelial growth factor (VEGF) and interleukin-8 (IL-8) can enhance tumor growth and angiogenesis while TNF-a and heparin act as tumor suppressors. The non-small cell lung cancer constitutes the majority of cases of lung cancer. In lung cancer, mast cell numbers correlate with tumor angiogenesis and poor prognosis. In this work, we are interested to determine the factors in lung cancer microenvironment that attribute to mast cell activation. Beside the tumor cells themselves, the cancer microenvironment includes other cells such as fibroblasts. The fibroblasts arising from tumor stroma, called cancer-associated fibroblasts (CAFs), undergo activation, and have different feature compared to normal fibroblasts (NFs). In this work we are interested to determine whether CAF cells derived from lung tumors, together with the lung cancer cells, or microvesicles-derived from these cells, are able to stimulate mast cells to degranulate and/ or to release various cytokines and chemokines. For this propose, during surgery of patients with lung cancer, we will take unnecessary sample from the cancer and from normal area for purification of CAF or normal fibroblast cells. Those cells will be co-cultured with both lung cancer cell line (A-549) or microvesicles-derived from these cells, and human mast cell line (LAD2). Supernatants will be collected for determine degranulation and cytokine release from these mast cells.

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with non small cell lung carcinoma Exclusion Criteria: none
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 |
| --- | --- | --- |
| Measuring the levels of b-hexosaminidase (marker for mast cells degranulation ) and the cytokines levels |  | 1-2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mast cells, lung cancer, cancer associated fibroblasts (CAF)
Early Follicular Supplementation of Ganirelix in IVF 2004

Study Overview
=================
Brief Summary
-----------------
Our goal was to investigate whether early follicular supplementation of the GnRH antagonist to the flexible GnRH antagonist protocol, has a potential to improve IVF-ET clinical results

Detailed Description
-----------------
GnRH antagonist offers many advantages when used in IVF-ET treatment, however, it is suspected to yield lower pregnancy rate when compared with the long GnRH agonist protocol. Our goal was to investigate whether early follicular supplementation of the GnRH antagonist to the flexible GnRH antagonist protocol, has a potential to improve IVF-ET clinical results. Consecutive patients are prospectively enrolled and randomly assigned to the study and control groups. Patients with low ovarian reserve or with uterine distortion are excluded from the study. Both groups are treated with recombinant FSH and the flexible GnRH antagonist protocol. Women in the study group are also treated with additional GnRH antagonist 0.25 mg/day on day 1, 2 and 3 of the menstrual cycle.

Official Title
-----------------
Early Follicular GnRH Antagonist Supplementation Improves Fertilization and Embryo Cleavage Rates in IVF-ET GnRH Antagonist Cycles

Conditions
-----------------
Infertility, IVF Treatment

Intervention / Treatment
-----------------
* Drug: Ganirelix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infertility IVF candidate failure of previous IVF attempt Exclusion Criteria: low ovarian reserve untreated distortion of uterine cavity medical contraindication for IVF treatment
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Standard Flexible antagonist protocol Addition of Ganirelix at first 3 days of the cycle | Drug: Ganirelix<br>* sc injection of Ganirelix 0.25 mg per day<br>|
| No Intervention: 2<br>Standard Flexible antagonist protocol | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rates |  | one cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| differences in hormonal levels |  | one cycle | 
| differences in the basic treatment doses |  | one cycle | 
| oocyte counts |  | one cycle | 
| fertilization rate |  | one cycle | 
| cleavage rate |  | one cycle | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IVF, GnRH antagonist
Prodigy, a Level 2 Sleep Study Device, Validation Study

Study Overview
=================
Brief Summary
-----------------
The Prodigy system, developed by Cerebra Medical Ltd, allows for the generation of the same information in the home that is currently only obtained in in-laboratory studies. The objective of the current study is to demonstrate that the signals obtained by this comprehensive, portable system are comparable to those obtained in in-laboratory studies.

Detailed Description
-----------------
This study consists of obtaining standard polysomnography signals concurrently by the Prodigy 2 and by the standard commercial systems used in the Sleep Disorders Clinic (Alice G3) in Hamilton, ON and the St. Charles Sleep Disorders Center (Nihon Kohden) in Port Jefferson, NY. 42 patients will be recruited from each of the two sites, for a total of 84 patients. Questionnaires on demographics and mental health, including the Depression Anxiety Stress Scale-21, questionnaires on sleep and fatigue including Pittsburgh Sleep Quality Index, Insomnia Severity Index, and Epworth Sleepiness Scale and questionnaires on quality of life including the Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) and the Euroquol 5D-5L will be completed online using a survey platform (Qualtrics or RedCap).

Official Title
-----------------
Validation of a Level 2 Sleep Study Device

Conditions
-----------------
Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing a diagnostic sleep test Exclusion Criteria: in-hospital patients subjects who self-report a previous diagnosis of neuromuscular disorders, obesity hypoventilation, or severe lung disease subjects who are not fluent in English, or who have special communication needs subjects who have dementia/Alzheimer's disease subjects with comorbid violent parasomnias subjects requiring additional assistance or who have limited ability follow commands.

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sleep Time | To compare Level 1 and Level 2 sleep tests on TST | Concurrent measurement for one night | 
| Apnea-Hypopnea Index | To compare Level 1 and Level 2 sleep tests on AHI | Concurrent measurement for one night | 
| Periodic Limb Movement Index | To visually compare Level 1 and Level 2 sleep tests on PLM | Concurrent measurement for one night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signal Quality | To compare signal quality between Level 1 and Level 2 sleep tests | Concurrent measurement for one night | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prodigy