cyrilzakka/clinical-trials huggingface dataset:
Phase 2a Study to Evaluate the Efficacy and Safety of MEDI9929 in Adults With Atopic Dermatitis

To assess the efficacy and safety of MEDI9929 in adult subjects with Atopic Dermatitis

This is a Phase 2a, randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of MEDI9929 administered subcutaneously to adult subjects with moderate to severe Atopic Dermatitis. Subjects will be randomized in a 1:1 fashion and will be stratified at screening. Approximately 100 subjects are planned to be randomized at approximately 35 sites in 6 countries

Eligibility Criteria:
Inclusion Criteria:

* AD meeting Hanifin and Rajka criteria
* Age 18-75 years inclusive at screening
* Atopic dermatitis that affects greater than/equal to 10% body surface area
* Moderate to severe AD
* Effective birth control in line with protocol details

Exclusion Criteria:

* Active dermatologic conditions which may confuse the diagnosis of Atopic Dermatitis
* Hepatitis B, C or HIV
* Pregnant or breastfeeding
* History of anaphylaxis following any biologic therapy
* History of clinically significant infections within 4 weeks prior to Visit 3
* Diagnosis of helminth parasitic infection within 6 months to screening
* History of Cancer except basal cell
* Receipt of any marketed or investigational biologic agent within 4 months to visit 3
* Any clinically relevant abnormal finding
* Major surgery within 8 weeks prior to Visit 1
Lidocaine: Effect of Lidocaine in Chronic Cough

People cough in order to clear their airways. Most coughs are caused by viruses and settle down by themselves, but some people develop persistent coughing which can be anywhere from 8 weeks to several years. This is called chronic cough. People with chronic cough find the symptom distressing and it can have a major impact on their quality of life. Patients with chronic cough often report a sensation at the back of their throat which makes them feel an urge to cough. There is some evidence that Lidocaine (an anaesthetic used during medical procedures) can suppress a person's cough when given to patients via a nebuliser (a machine that turns liquid into a fine mist).

It is currently unknown whether using a local anaesthetic, such as Lidocaine, in the form of a throat spray would successfully suppress a person's cough. A throat spray would be an easier treatment option in chronic cough patients. Thus, the investigators research aims to compare cough rates, severity and urge to cough scores between Lidocaine throat spray and nebulised Lidocaine.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, age 18 years and over.
* History of cough for more than 8 weeks.
* Normal chest x ray
* Chronic idiopathic cough or chronic cough resistant to treatment of specific triggers.

Exclusion Criteria:

* Smoking status:

  * Current smokers
  * Ex smokers with history of smoking \> 20 pack years or those who have given up \< 6 months ago.
* Prohibited medications:

  * Use of medications likely to suppress / affect cough including codeine, morphine, pregabalin, gabapentin, amitriptylline, angiotensin converting enzyme inhibitors (type 1) and baclofen.
  * Use of any anti-arrhythmic medication.
  * Use of cimetidine, beta blockers, or diuretics.
* Cardiovascular conditions:

  * Sinoatrial disease, bradycardia or all types of heart blocks.
  * History of ischaemic heart disease or heart failure.
  * Clinically significant abnormal electrocardiogram (ECG) at Screening or Baseline.
  * History of cardiac surgery
* Respiratory conditions:

  o Asthma.
* Central nervous system / Peripheral nervous system conditions:

  * Epilepsy.
  * Myasthenia gravis.
* Miscellaneous:

  * History of hepatic or renal dysfunction.
  * Porphyria
  * History of hypersensitivity to Lidocaine or related drugs.
  * Pregnancy or breast feeding.
  * Participation in another trial within the preceding 6 weeks.
  * Trauma or ulceration to oral mucosa.
  * History of chest or upper airway infection within the past 6 weeks.
  * Conditions which may affect cough response such as stroke, diabetes, Parkinson's Disease.
Negative Pressure Dressing After Saphenous Vein Harvest

This study will test the effectiveness of negative pressure wound therapy (using the VAC Prevena device, KCI Canada Inc.) applied to the saphenous vein harvest site after Coronary Artery Bypass Grafting (CABG). When initiated immediately after surgery, this intervention may decrease the incidence of wound infection and non-infectious wound complications. It may decrease wound discomfort and improve mobility and functional recovery of the leg.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for elective or semi-elective isolated first-time CABG surgery with harvesting of the greater saphenous vein.
* Must be 18 years or older.
* Must live with one hour driving distance from Calgary.
* Must provide written consent.

Exclusion Criteria:

* Previous CABG surgery or previous lower leg surgical intervention.
* In emergent need for surgery.
* Have severe peripheral vascular disease.
* Do not speak and read the English language.
* Have dialysis-dependent renal failure.
* Require chronic steroids.
* Unable to return to clinic for follow-up due to functional or cognitive impairment.
Personalized Cardiovascular Risk Information to Initiate and Maintain Health Behavior Changes

The investigators propose an evaluation that will assess three important components of risk communication:

1. provide patients with personalized risk communication using the risk calculator developed by FIMDM and health information taken from the Living with Coronary Artery Disease program
2. provide personalized tailored patient feedback to help initiate and maintain specific cardiovascular CVD-related behaviors(e.g., medication adherence, exercise, diet, smoking cessation) to reduce their risks.
3. evaluate how this feedback can be incorporated into clinical care by examining 3 month patient outcome and provider responses to the risk information.

Patients at high risk for CVD events frequently underestimate their risk. Programs to improve CVD outcomes have largely focused on single risk factors and do not contextualize the information with a patient's global risk. An easy, accessible strategy to address global CVD risk based on personalized risk communication feedback with assistance with initiating and maintaining health behaviors has several advantages, but has not formally been tested. A patient's perceived risk of stroke or heart attack is an important factor in understanding motivation for risk reducing behaviors. Lower perceived risk has been associated with poorer adherence to recommended health behaviors. Additionally, a person's beliefs about his or her risk for a disease increased the likelihood of a more informed and activated patient, and figures prominently in models of health behavior (e.g., Health Belief Model). People tend to underestimate their own risk; Therefore providing accurate risk communication has the potential to activate patients to initiate and maintain behavior changes.

Eligibility Criteria:
Inclusion Criteria:

* cardiovascular disease (CVD)
* CVD risk equivalent (peripheral arterial disease, history of ischemic stroke, or diabetes)

Exclusion Criteria:

* metastatic cancer,
* dementia,
* active psychosis
* end-stage renal disease
* no access to computer with Internet
A Study of Lanabecestat (LY3314814) in Healthy Participants When Taken With Rosuvastatin

The purpose of this study is to evaluate the effect of lanabecestat on rosuvastatin. The amount of rosuvastatin in the blood will be compared, when taken alone, and then when taken with lanabecestat. The amount of lanabecestat that gets into the bloodstream will be measured. Information about any side effects that may occur will also be collected.

Participants will be on study for 21 days with a follow-up at least 7 days afterwards.

Screening will be undertaken within 45 days prior to enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Women not of childbearing potential may participate and include those who are:

  * Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis; or
  * Postmenopausal - defined as women over 50 years of age with an intact uterus who have not taken hormones or oral contraceptives within 1 year, who have had either Spontaneous cessation of menses for at least 12 consecutive months, or 6 to 12 months of spontaneous amenorrhea with follicle-stimulating hormone level greater than (\>)40 milli-international units per millilitre (mIU/mL) consistent with menopause
* Caucasian and may be of Hispanic ethnicity
* Body mass index (BMI) of 19 to 32 kilogram per meter square (kg/m²), inclusive, at the time of screening

Exclusion Criteria:

- Have a clinically significant abnormal blood pressure or heart rate (supine) as determined by the investigator
A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy

This randomized controlled study is designed to test the non inferiority of no attachment of posterior mesh compared to fixation of posterior mesh to the vagina in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity and rate of recurrence.


Eligibility Criteria:
Inclusion Criteria:

-patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence

Exclusion Criteria:

* Age \> 75 years
* Severe cardiovascular or respiratory disease
* Pregnancy
Prospective Anti-Hepatitis C Virus (Anti-HCV) Trial of Peg-Interferon and Ribavirin in Subjects of First Nations, Metis and Caucasian Ethnicity

Background:

According to recent estimates, the prevalence of Chronic Hepatitis C (CHC) in Canada is three times more common in First Nations (FN)and Metis compared to non-FN populations. Moreover, once infected, the progression of CHC to cirrhosis and/or hepatocellular carcinoma is greater in FN patients due to the increased prevalence of alcohol abuse, obesity and diabetes in this segment of the population.

Research Plan:

This research proposal consists of three parts. The objective of Part I is to document the response to anti-viral treatment for CHC among treatment-naïve FN and Metis and Caucasian (hereafter referred to as non-FN) patients residing in three urban Western Canadian centres (Winnipeg, Saskatoon and Regina). Demographic, clinical and response to treatment data in a total of 160 patients (80/group) will be collected at the above centres and transferred to the Section of Hepatology at the University of Manitoba for statistical analyses. In Part II, the applicants will document and compare the immune responses to HCV proteins throughout the course of therapy in FN, Metis and non-FN patients. In the final part, direct economic costs of CHC care in FN, Metis and non-FN patients will be ascertained and future costs predicted.

Hypotheses:

Part I - The rate of sustained virologic response (SVR) to treatment for CHC is higher in FN and Metis compared to non-FN and no Metis patients.

Part II - The immune response to HCV proteins during anti-viral therapy for CHC is enhanced in FN and Metis compared to non-FN and non-Metis patients.

Part III - The direct costs of health care utilization and delivery for CHC are similar among FN and Metis and non-FN and non- Metis patients.

Specific Objectives:

1. To provide detailed information on the demographics and clinical characteristics of treatment-naïve FN and Metis versus non-FN and Non-Metis patients proceeding to treatment for CHC.
2. To document and compare SVR and sustained biochemical response (SBR) rates, adherence to therapy, side effects, dose adjustments and discontinuation of treatment between FN and Metis and non-FN and Non-Metis patients.
3. To determine whether the immunologic features associated with SVR (increased NK cell activity and enhanced interferon gamma production by CD4 cells in response to viral antigens) differ in FN and Metis and non-FN and non-Metis patients.
4. To document and compare the direct costs of health care utilization and delivery for CHC between FN and Metis and non-FN and Non-Metis patients.
5. Develop a model predicting outcome of therapy, using demographic, clinical and viral characteristics, and test the model with race as one of the explanatory variables.
6. To forecast future prevalence, mortality and medical costs of CHC care in Canada.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients of FN and metis and non-FN descent referred for treatment at the three centres will be candidates for this study.
Concomitant Radio-chemotherapy in the Elderly

The purpose of this study is to evaluate the safety of non small cell lung cancer (NSCLC) treatment with cisplatin and oral vinorelbine administered weekly associated with concomitant radiotherapy in elderly patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 70 years
* Independent patients (based on the score of geriatric frailty: IADL = 0, ADL = 0, no geriatric syndrome, low comorbidity (comorbidity index of Charlson to 3 or 4), depression score 0-1)
* Performance Status (ECOG) ≤ 1
* Weight loss \<10% of usual weight in the last 3 months
* Life expectancy greater than 12 weeks
* Hematologic function: neutrophils\> 1.5 x 10\*\*9 / l, hemoglobin\> 9.5 g / dl, platelets \> 100 x 10\*\*9 / l)
* Renal function: creatinine clearance ≥ 50 ml / min calculated by the formula of MDRD
* Normal liver function: bilirubin \< Limit of Normal (ULN), SGOT and / or SGPT \<2.5 x UNL
* Respiratory Function: FEV ≥ 40% predicted, PaO2 ≥ 60 mm Hg, KCO ≥ 60% predicted
* Patient affiliated to a social security regimen or beneficiary of such regimen
* Informed consent signed

The disease

* Pathological anatomy: CBP non-small cell (squamous cell carcinoma, adenocarcinoma, large cell carcinoma, undifferentiated carcinoma) histologically or cytologically proven
* Stage IIIAN2 considered inoperable stage IIIB
* Presence of at least one measurable target
* Delay at least three weeks between surgery and initiation of treatment
* No prior treatment with chemotherapy or radiotherapy for lung cancer

Exclusion Criteria:

* Age \< 70 years
* Performance Status (ECOG) ≥ 2
* Hematologic function: neutrophils \<1.5 x 10\*\*9 / l, hemoglobin \<9.5 g / dl, platelets \<100 x 10\*\*9 / l)
* Renal function: creatinine clearance \<50 ml / min calculated by the formula of MDRD
* Hepatic: bilirubin\> Upper Limit of Normal (ULN), SGOT and / or SGPT\> 2.5 x ULN
* Respiratory Function: FEV \<40% predicted, KCO \<60% predicted, PaO2 \<60 mmHg
* Peripheral neuropathy grade\> 1
* Unstable cardiac pathology requiring treatment (heart failure, angor of effort, arrhythmia) or previous myocardial infarction older than 12 months
* Deafness not paired or deafness requiring major achievement of an audiogram-cons may indicate taking cisplatin
* Neurological or psychiatric disorders prohibiting the understanding of the test
* Previous history of cancer except basal cell cancer, carcinoma in situ of the cervix treated or any other cancer treated with surgery alone or radiotherapy alone extra-thoracic recurrence-free 5 years
* Significant malabsorption syndrome or disease affecting the functioning of the gastrointestinal tract

The disease

* Pathological anatomy: Bronchioloalveolar carcinoma, neuroendocrine carcinoma, small cell carcinoma
* Metastatic disease
* Pleural drain
* Carcinomatous lymphangitis
* Operable Cancer
* Previously treated for lung cancer disease: radiotherapy, chemotherapy, hormonal therapy, endobronchial suctioning older less than eight days
Finnish Tennis Elbow Trial Pilot Study

The study aims to investigate the natural course and the results of operative treatment of chronic tennis elbow (TE). Chronic is defined as symptoms having lasted for more than a year. The investigators will also study the effect of pain catastrophising on the subjective outcome, the patient acceptable symptomatic state and the response shift phenomenon in TE. The study will also ascertain the feasibility of a multi-center randomised, controlled trial (RCT), and test and refine the co-operation and interaction of the planned RCT centers.

Objectives:

1. To study the natural course of tennis elbow/spontaneous recovery of chronic (lasting for over 12 months) tennis elbow and the results of surgery in a pragmatic setting.
2. To investigate the patients' expectations of the treatment, and define the patient acceptable symptomatic state, or PASS, in tennis elbow.
3. To investigate the effect of pain behaviour on treatment results and PASS.
4. To delineate the existence of a potential "response shift" -phenomenon in patients with a tennis elbow.
5. To determine the feasibility of a prospective, placebo-controlled, randomised trial by finding out the actual number of patients in each center and those that may be suitable for the FINITE-RCT. The investigators will also test the functioning and response of the planned outcome measures in this environment and for this purpose.

Study setting The study is carried out as a prospective open-label multi-center cohort study.

The study was originally planned with a follow-up up to 10 years, but the cost-benefit of the long term follow-up was evaluated after the completion of one year data collection, and the decision was made to shorten the follow-up to include two year data, but no further follow-ups.

Eligibility Criteria:
Inclusion Criteria:

1. Clinically diagnosed tennis elbow defined as: Pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and during resisted extension of the wrist or when making a fist with the elbow joint straight.
2. Duration of symptoms over 10 months
3. Age between 35 and 60 years
4. Ability to fill in Finnish questionnaires
5. Written informed consent

Exclusion Criteria:

1. Earlier fracture or dislocation in the elbow joint area
2. Earlier surgical treatment of the same elbow joint
3. Congenital deformity in the elbow
4. Systemic muscle, tendon, nerve or joint disease
5. Other problems causing pain the elbow joint:

   1. Pain in the medial epicondyle of the elbow
   2. Pain in the biceps muscle tendon
   3. Painful snapping or crepitus of elbow joint
   4. Instability of elbow joint (table top, posterolateral drawer test)
6. A passive movement limitation of more than 10 degrees in the elbow joint
7. Abnormal finding in an elbow joint X-ray. An elbow joint X-ray is a routine examination of elbow symptoms.
Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Neonates

The purpose of this study is to further evaluate the immunogenicity and safety of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are healthy full-term infants after birth, Apgar score ≥8;
* Subjects with a birth weight ≥ 2500g;
* Subjects' guardians are able to understand and sign informed consent;
* Subjects who can and will comply with the requirements of the protocol.

Exclusion Criteria:

* Family history of eclampsia, epilepsy and encephalopathy;
* Subjects' birth mother had immune system dysfunction, or history of organ transplantation or blood dialysis;
* Subjects' parents had a medical history of allergic to any ingredient of the vaccine, including supplementary material and formaldehyde;
* Subjects' parents had a medical history of allergic to combined hepatitis A and B vaccine(HAB) or hepatitis B vaccine;
* Subjects had serious acute and chronic diseases;
* with temperature ≧37.1℃;
* Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives.
Serum Immunologic Markers Levels in During the Delivery

This study aim to describe dynamics of immunologic markers C1 inhibitor, C3, C4 during the delivery in order to improve early diagnostics of obstetric emergencies, especially with immune etiology.

Our prospective observational study will explore the differences between dynamics of the complement components C1 inhibitor, C1 inhibitor activity, C3, C4 during the labour in a group of women with physiologic pregnancy and in a group with a risk of complications (pre-eclampsia, HELLP syndrome, placenta praevia, placental abruption, IUGR, previous post partum hypotony).

We will focus on women undergoing the Caesarean delivery. We will also measure D vitamin levels and ACE levels and search for some contexts.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women undergoing the Caesarean delivery
* Signed informed consent

Exclusion Criteria:

* Previous hepatitis or other hepatocyte damage
CT-guided Microwave Ablation in Ground Glass Nodules

In order to conduct a multicenter comparative effectiveness clinical research of phase II to investigate safety and efficacy of applying microwave ablation in patients with Great-glass lung nodules ≤ 3cm, a single center, non-randomized, open label pilot study is conducted to examine the flexibility, safety and efficacy of using Microwave Ablation in Patients with Ground Glass Nodules that are poor candidate of surgery.

Lung cancer is the most common cancer worldwide contributing 13% of the total number of new cases diagnosed. The main treatments of lung cancer are based on surgical resection and adjuvant postoperative chemotherapy. However, the patients who are intolerant of surgery wouldn't be benefit from surgical resection. Microwave ablation provide new choice for lung cancer, which can effectively treat early lung cancer. The diagnosis of early lung cancer can be based on the results of biopsy of ground-glass nodules (GGNs), which is one of the diagnostic criteria for preoperative diagnosis of early lung cancer. The microwave ablation is the good choice for patients who cannot tolerate surgical resection. However, the flexibility, safety and efficacy of using Microwave Ablation in Patients with Ground Glass Nodules are still unclear.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, inclusive of release of medical information.
2. Age ≥ 18 years
3. CT scan indicates presence of Ground Glass Lung Nodules less than 30mm
4. Willing to comply with all protocol required follow-up: 30 days and 90 days post microwave ablation
5. Patients who cannot tolerate surgical resection due to cardiopulmonary dysfunction and advanced age
6. Patients who refuse surgical resection
7. Patients who don't have serious complications

Exclusion Criteria:

1. Unable to give informed consent or potential for noncompliance with the study protocol in the judgement of the investigator
2. Pregnant or breast-feeding at time of screening
3. Active skin infection and ulceration around the percutaneous site
4. Severe pulmonary fibrosis, especially drug-induced pulmonary fibrosis
5. Tendency of severe bleeding, platelets less than 50 × 109 / L and severe blood coagulation disorders. Anticoagulant therapy and/or antiplatelet agents should be discontinued for at least 5d-7d before microwave ablation.
6. Ablation of the ipsilateral malignant pleural effusion is not well controlled
7. Liver, kidney, heart, lung, brain dysfunction, severe anemia, dehydration and serious disorders of nutritional metabolism, cannot be corrected or improved in the short term, severe systemic infection, high fever (\> 38.5 oC)
8. Extensive extrapulmonary metastasis, expected to survive \< 3 months
9. Eastern Cooperative Oncology Group (ECOG) performance status \> 3