cyrilzakka/clinical-trials huggingface dataset:
Immune Status SARS-CoV-2 in a Sample of a Tertiary Eye Health Centre

A sequential combination of different antibodies test against SARS-CoV-2 is evaluated. The protocol included a rapid test and several ELISA tests within a defined cohort of healthcare workers.

In the current pandemic, the assessment of actual COVID-19 infections plays an important role in the assessment of the risk and progress of the epidemic. Shortly, more and more rapid tests will be available, the aim of which is to be able to obtain a good overview of the immune status of corresponding samples in a timely manner.

Employees in the health sector are faced with additional challenges, not only due to the tightened hygiene regulations. The concern about infecting other people and/or exposing oneself to a relevant health risk is of great importance. A moderate to high transmission risk can be assumed for ophthalmology. In view of older patients and sometimes unavoidable proximity, targeted and reliable diagnostics can offer the potential to reduce the risk potential for the current situation by determining antibodies.

A rapid diagnosis is not yet available outside of clinical studies, especially since deficits in specificity (contact with other coronaviruses) are to be expected. Studies on the serological reaction are not yet available for longer observation periods, but it can be assumed that positive direct detection of IgG (Anti Sars-CV-2-ELISA; Euroimmun) is available at the latest 3 weeks after the onset of symptoms. Without larger and representative analyses, it is currently unclear whether seroconversion is associated with permanent immunity or a lack of it leads to a possible susceptibility to reinfection. A combined test procedure is therefore to be offered to employees within the framework of a random sample.

The query of anamnestic parameters allows the assignment to different groups (CC: past COVID infection, PC: possible infection, N: asymptomatic). The primary goal of the planned study is to provide a first preliminary evaluation of the tests used in the current context.

Eligibility Criteria:
Inclusion Criteria:

* Employees of the health facility described
* voluntary request for testing

Exclusion Criteria:

- None
Mindfulness: a Novel Approach for the Management of Diabetes-related Distress

The purpose of this study is to evaluate the impact of stress reduction on physiological and psychological variables in adults with Type 2 diabetes (T2DM) who have moderate to severe levels of diabetes-related emotional distress. Subjects will be randomized to one of two interventions. We will evaluate the impact of the interventions on glucose metabolism, blood pressure, diabetes-related distress and quality of life. Additionally, we will investigate the role of neuroendocrine dysfunction, systemic inflammation and diabetes self-care practices as mediators in the relationship between increased stress, adverse glucose metabolism and elevated blood pressure in those subjects with T2DM.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 30 years
2. Male or female
3. Duration of diabetes 1-15 years from time of initial diagnosis
4. Diagnosis of T2DM made/confirmed by physician
5. Completed diabetes education in the past
6. Most recent HgA1c \>7%; measurement must be within the past 6 months either in physicians office or at the Thriving with Diabetes Boot Camp Class
7. Treatment for diabetes must include any or all of the following modalities:

   diet, exercise, oral medications, insulin or other injectable diabetic medication
8. Score \> 30 on the Problem Area in Diabetes (PAID) Questionnaire
9. Able to use a glucometer for self-monitoring of blood glucose values
10. Most recent clinic blood pressure less than 180/95

Exclusion Criteria:

1. History of ketoacidosis
2. Age at diagnosis of T2DM \< 30 years
3. Score \>15 on the PHQ-9
4. Previous training in relaxation or meditation techniques
5. Current practice of yoga, tai chi or any other mind-body movement for \> 60 minutes per week
6. Current use of a psychoactive drug for less than 3 months or not yet on a stable dose
7. Inability to participate fully or behave appropriately in the group treatment setting, as observed by baseline acknowledgement of substance abuse, psychotic episode(s), psychiatric hospitalization or history of self- harm within the past 2 years, or current suicidal or homicidal ideation
8. Inability to complete standardized instruments because of a cognitive deficit or language barrier
9. Current use or use within the past 3 months of oral glucocorticoids, excluding intraocular, topical or inhaled preparations
10. History of inflammatory diseases including rheumatoid arthritis and inflammatory bowel disease
11. Use of immune modulating agents
12. Night shift work or other type of schedule in which sleep wake cycle is disrupted
13. Women who consume \> 7 alcoholic drinks per week and men who consume \> 14 drinks per week
14. Current use or history of daily tobacco use within the past 1 year
15. End stage renal failure on dialysis
16. Pregnancy or post partum \<3 months
17. Subjects with known secondary causes of hypertension including renal artery stenosis, pheochromocytoma, coarctation of aorta, hyperaldosteronemia
18. Non-dominant arm circumference \> 46cm
19. Unwilling to accept randomization
Molecular Characterization of Blastocystis Isolates From Human by Restriction Fragment Length Polymorphism (RFLP) Analysis

Blastocystis is an anaerobic unicellular protozoal parasite infecting the gastrointestinal tract of humans and a wide range of animals. It is one of the most common enteric microorganisms with higher prevalence rates in developing than in developed countries. Feco-oral is the main route of transmission where low socioeconomic conditions, poor hygienic practices, close contact with animals, and drinking contaminated water act as major risk factors. Infection with Blastocystis was demonstrated in both symptomatic and asymptomatic people. For a long period, Blastocystis was considered a commensal organism with no pathogenic role, but recently, many studies linked it to different gastrointestinal symptoms such as nausea, diarrhea, and abdominal pain. Association with irritable bowel syndrome and colorectal cancer was also reported.

This study aims to:

- Identify subtypes of human Blastocystis isolates in Sohag by using RFLP-PCR and provide additional information on the molecular epidemiology of this parasite in our locality.


Eligibility Criteria:
Inclusion Criteria:

* Patients from outpatient clinics, Sohag hospitals.

Exclusion Criteria:

* Patients received antiparasitic drugs in the last two weeks
Brain Markers of Treatment Response in Post-Traumatic Stress Disorder (PTSD)

The purpose of this study is to examine if treatment of post-traumatic stress disorder in combat veterans with paroxetine changes brain responses as measured by functional magnetic resonance imaging and if brain responses can predict who will get better with treatment.


Eligibility Criteria:
Inclusion Criteria:

* Veterans with clinical diagnosis of post-traumatic stress disorder from combat related to deployment to Afghanistan/Iraq (Operation Enduring Freedom/Operation Iraqi Freedom)

Exclusion Criteria:

* Intolerance or sensitivity to paroxetine
* Major medical or neurologic illness
* Current psychotropic medication or active psychotherapy treatment
* Other major psychiatric illness
A Study to Evaluate ABP 938 and Aflibercept (Eylea®) in Participants With Chorioretinal Vascular Disease (CVD)

The primary objective of this study is to is to assess the ability of retina specialists to successfully administer, via an intravitreal (IVT) injection, a 2 mg dose of ABP 938, using the ABP 938 aflibercept prefilled syringe (PFS), compared to a 2 mg dose of aflibercept using the aflibercept PFS.


Eligibility Criteria:
Inclusion Criteria

* Must sign an IRB approved informed consent form before any study-specific procedures are initiated.
* Men or women ≥18 years old.
* Treatment-naïve or previously treated neovascular age-related macular degeneration, diabetic macular edema, macular edema following retinal vein occlusion, or diabetic retinopathy in the study eye.

Exclusion Criteria

* Active intraocular or periocular infection or active intraocular inflammation in either eye.
* Uncontrolled intraocular pressure greater than (\>) 25 mmHg in the study eye.
* Deemed legally blind in one or both eyes.
* History of or any current indication of excessive bleeding or recurrent hemorrhages, including any prior excessive intraocular bleeding or hemorrhages after IVT injection or intraocular procedures in either eye.
* Current systemic infectious disease or on a therapy for active infectious disease.
* History of any medical, ocular or non-ocular conditions that, in the opinion of the investigator, may interfere with the injection procedure or pose a safety concern.
* History of stroke or transient ischemic attacks or myocardial infarction within the last 6 months.
* Treatment with anti-VEGF IVT injection in the study eye within 28 days.
* Any use of intraocular corticosteroids in the study eye within 3 months.
* Receipt of any systemic anti-VEGF within the last 6 months.
* Any invasive intraocular surgery, prior long-acting therapeutic agent, or ocular drug release device implantation in the study eye within the past 3 months.
* For women: pregnant or breast feeding, or planning to become pregnant while enrolled in the study and for 3 months after IP administration.
* Sexually active participants and their partners who are of childbearing potential who refuse to use adequate contraception while on-study and for 3 months after IP administration. Male participants must agree not to donate sperm during study and for 3 months following dose of IP.
* Allergy or hypersensitivity to the IP, to any of the excipients of ABP 938 or aflibercept, or to other study-related procedures/medications.
* Previously enrolled in this study.
* Participation in any interventional clinical study within 3 months prior to screening.
Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus

Pemphigus is a severe autoimmune blistering disease mediated by circulating antibodies against certain proteins important for maintaining skin integrity. Protein A immunoadsorption is a dialysis-like technique selectively removing the antibodies from patient's blood. Rituximab is a synthetic antibody capable of destroying B cells. B cells are responsible for production of antibodies in the patients blood that, in turn, lead to clinical signs of pemphigus. Dexamethasone pulse therapy is a high-dose short-term corticosteroid therapy that may be used to suppress autoantibody production in pemphigus. While each of these three therapies had been used to treat pemphigus, none was shown effective in all cases. The hypothesis of this study is that a combination of protein A immunoadsorption, rituximab and dexamethasone is more effective that either of these treatments alone in achieving a rapid and durable improvement or cure in patients with pemphigus.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pemphigus confirmed by immunofluorescence and desmoglein ELISA.
* Severe disease or past treatment(s) not effective or past treatment(s) not tolerated.

Exclusion Criteria:

* General condition too poor to tolerate immunoadsorption treatment.
* Severe dementia or psychiatric disease.
Prioritising Prevention of COVID-19 in Persons With Cancer in the French West Indies

The public health council (Haut Conseil de Santé Publique) published a statement on 14 March 2020 relating to the management of patients with severe forms of COVID-19, stipulating specific recommendations for patients with cancer.

The statement notes that patients with cancer at much higher risk (four to five times higher) of several respiratory complications, which develop very rapidly, especially if they had recently undergone surgery or chemotherapy in the previous few weeks, and that this risk could be life-threatening, on top of the cancer-related risk. In addition, the statement noted that:

* COVID-19 appears to be more frequent in patients with cancer than among the general population (1% vs 0.29%)
* Among those infected, the risk of severe respiratory complications requiring admission to the intensive care unit (ICU) is higher in patients with cancer than among those without (39% vs 8%, P=0.0003).
* A history of chemotherapy or surgery in the previous months is an important prognostic factor for the development of severe respiratory complications (odds ratio (OR) = 5.34, P= 0.0026).
* Deterioration of respiratory function occurs more quickly in patients with cancer (13 vs 43 days, hazard ratio (HR) 3.56, 95% confidence interval (CI) \[1.65-7.69\]).

In addition, COVID-19 may lead to a change in the diagnostic and therapeutic management of patients with cancer, with potential consequences such as use of oral treatments at home, discontinuation of anticancer therapy depending on the context, or prioritization of management according to curative/palliative treatment type, age, and line of therapy.

International studies previously reported the psychological repercussions of major epidemics on the emotional state. The impact of COVID-19 on patients with cancer therefore warrants evaluation, among cancer patients in the French West Indies, in the current situation of nationwide lockdown.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older living in the French West Indies
* Patient with prevalent cancer of the prostate, breast, lung, colon or rectum
* Patients who receive the information leaflet and do not express any opposition to the use of their personal medical data

Exclusion Criteria:

* Patients who are unable to answer the study questionnaires
* Patients who do not speak fluent French
* Persons under legal protection
Evaluation of the Trabecular Metal™ Revision Hip Cup Using Bone Mineral Density (DEXA)

In 1997, the FDA approved the use of Trabecular Metal™ (Zimmer, Trabecular Metal Technology, Inc., Parsippany, NJ) for acetabular cups, a porous tantalum structural biomaterial that was developed to address the limitations of other implant materials, with the potential to improve implant fixation.

Porous tantalum (80% porosity) offers potentially greater ingrowth and bone graft incorporation, believed to be restricted by the low porosity of other commonly used implants (30%). Additionally, the low modulus of elasticity property (3 MPa) of porous tantalum provides more normal physiological loading conditions which theoretically reduce stress shielding and resultant bone loss surrounding the implant. These properties are much desired advantages for implants used in cementless THA.

Various porous tantalum implants have shown favorable clinical results. Unger et al. reported excellent bone graft incorporation of the acetabular component based on serial radiograph data at a minimum 1-year follow-up.

Dual-energy X-ray absorptiometry (DEXA) is a well-established method for detecting periprosthetic bone mass changes around the femoral and acetabular THA components.

The primary objective of this study is to quantify and compare periprosthetic bone mineral density (BMD) changes in THA revision patients receiving Trabecular Metal™ and metal-backed acetabular components, measured using DEXA scanning techniques. Additionally, this study will analyze and compare clinical outcomes of these patients, based on SF-12v2 and HOOS.

none provided.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 - 85 years
* Sex: Both male and female will be included. The male-to-female ratio will depend upon the patient population.
* Stable Health: At the time of surgery based on physical examination and medical history.
* Patient is a revision total hip recipient, which requires a metal-backed hemispherical cup.
* Patient or patient's legal representative has signed the Informed Consent form. The patient is capable of making informed decisions regarding his/her healthcare.

Exclusion Criteria:

* Patients undergoing bilateral surgery or had prior hip arthroplasty on contralateral side less than 6 months from date of surgery.
* Patients who do not plan to return to a Cleveland Clinic surgeon for follow-up visits (i.e. out of state/country patients who may choose to follow-up with a different surgeon).
* Patients with history of radiation therapy.
* Patients with known diagnosis of Brooker grade 3 or 4 HO (heterotopic ossification) in the hip joint region.
* Patients with known diagnosis of renal disease.
* Patients with known diagnosis of osteoporosis.
* Patients with history of steroid use in the hip joint region.
* Patients that have had a previous lumbar fusion.
* Patients whose surgical reconstruction required a pelvic cage or plate.
* Patient was a poor compliance risk - treated for ethanol or drug abuse, physical or mental handicap, etc.
* Any female of childbearing potential who is pregnant or is planning on becoming pregnant during the study period (\~2 years postoperative).
Safety and Efficacy of Insulin Aspart in Type 2 Diabetes

This trial is conducted in Japan. The aim of this trial is to investigate the safety and efficacy of NovoRapid® (insulin aspart) as meal time insulin in subjects with type 2 diabetes treated on a basal-bolus regimen with Neutral Protamine Hagedorn (NPH) human insulin.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Treated with insulin for at least 12 months and currently on a basal-bolus regimen for at least 12 weeks
* HbA1c below or equal to 11.0%
* BMI (body mass index) below 30 kg/m\^2
Cost Free Pharmacotherapy for Smoking Cessation in Stroke Patients

This pilot study examined the effect of providing a 4 weeks of cost free quit smoking medications to smokers identified in a stroke prevention clinic who were interested in quitting smoking compared to providing a prescription for the medication only.

DESIGN: Randomized controlled trial. METHODS: All patients seen at the Ottawa Hospital Stroke Prevention Clinic were screened for smoking status, advised to quit smoking and treated using a standardized protocol including counselling and pharmacotherapy. Eligible smokers were randomly assigned to either a prescription only usual care group, or, the experimental group who received a 4-week supply of cost-free quit smoking medications and prescription for medication renewal. All patients received follow-up counselling 7-days prior to and 5, 14, 30, 60, 90, 180 days following their quit attempt. Levels of eligibility, consent, adherence and retention were used as indicators of study feasibility. The primary outcome was bio-chemically validated quit rates at 26-weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients were eligible to participate in the study if they reported smoking an average of 5 or more cigarettes per day in past 3 months; were 18 years of age or older; were willing to set a quit date in the next 30 days; and were willing to use a quit smoking medication.

Exclusion Criteria:

* Patients who were unable to read and understand English or French or who had contraindications to all approved smoking cessation medications (nicotine replacement therapy, bupropion, and varenicline) were excluded from the study.
Comparison of Upper and Lower Body Air Warming in Patients Undergoing Thoracic Surgery

This study is conducted to evaluate the effectiveness of forced air warming using upper and lower body blankets by measuring core body temperature in patients undergoing video-assisted thoracic surgery in the lateral decubitus position over 2 hours of general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing video-assisted thoracic surgery over 2 hours
* ASA I, II and III
* age over 18 years

Exclusion Criteria:

* refuse to enroll
* patients with fever or hypothermia before surgery
* patients who required changes of position during surgery
Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI

Combination therapy of rosuvastatin 5mg and ezetimibe 10 mg showed similar achievement rate in decreasing LDL cholesterol level by 50% as single use of rosuvastatin 20 mg.

This trial aims to prove non-inferiority of concomitant usage of low dose rosuvastatin and ezetimibe among patients with acute myocardial infarction who went through percutaneous coronary intervention at decreasing major adverse cardiac events compared to the efficacy of single use of high dose rosuvastatin.

IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) study showed that even when statin is not used as a treatment the rate of decrease of LDL cholesterol is correlated to the risk of heart disease. Yet whether concomitant use of ezetimibe and statin will have similar degree of clinical efficacy as single use of high dose statin in decreasing LDL cholesterol level needs further examination.

Eligibility Criteria:
Inclusion Criteria:

1. Adults Aged 19 and up
2. Patients diagnosed with myocardial infarction (both ST segment elevation and non-ST segment elevation) who were treated with percutaneous coronary intervention (Myocardial infarction defined as in the 4th Universal Definition of Myocardial Infarction)
3. For female patients who are of childbearing age, subjects that agreed on taking mandatory pregnancy test
4. Patients who agreed and signed on the informed consent form

Exclusion Criteria:

1. Patients with life expectancy of a year or less due to malignancy
2. Patients with chronic liver disease
3. Patients with sensitivity to active ingredient of the research drugs (ezetimibe and/or rosuvastatin) or patients who are prohibited to take ezetimibe and/or rosuvastatin.
4. Pregnant and/or breastfeeding
5. Female patients who are unable to use any means of contraception
6. Patients receiving hemodialysis, peritoneal dialysis patients and/or kidney transplant patients, due to end stage renal disease
7. Patients who participated in other clinical trial(s) within 3 months from the screening (except non-interventional observational study)
8. Patients considered inappropriate for the study for any other reason(s) by the inspector(s)
Long-term Efficacy and Safety Study of GV-971

Sodium Oligomannate Capsules (GV-971) has been approved for treatment of mild to moderate Alzheimer's disease and improving the cognitive function of patients. This study plans to observe, in the clinical patients, the long-term efficacy and safety of GV-971, as well as the changes in blood and gut microbiota biomarkers after treatment, to validate the mechanism of action of GV-971, in order to better guide the rational use of drug in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 50 to 85 years (inclusive), with no restriction on gender;
2. Patients who met criteria for "probable AD" by National Institute on Aging and Alzheimer's Association (NIA-AA) diagnostic criteria;
3. Patients with mild to moderate AD as characterized by Mini-Mental State Examination (MMSE) scores between 11 and 26, inclusive;
4. Patients who have received at least primary education and have capacity to complete the measurement of cognition and other tests as specified in the protocol;
5. Patients receiving GV-971 treatment prescribed by clinicians;
6. Sign the informed consent form.

Exclusion Criteria:

1. Patients who have received GV-971 treatment within 6 months prior to screening;
2. Patients who may be allergic to Sodium Oligomannate Capsules as judged by the investigator;
3. Female participants who are pregnant or lactating;
4. Patients who cannot cooperate to complete the follow-up inquiries;
5. Any other diseases or conditions that are inappropriate to participate in this clinical trial in the opinion of the investigator.