cyrilzakka/clinical-trials huggingface dataset:
Safety and Tolerability of QVA149 (Indacaterol/Glycopyrrolate) Compared to Placebo and to Indacaterol in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)

An investigational inhalation product (QVA149) for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) is being developed. This 14 day study will investigate the effect on heart rate and cardiovascular effects to ensure the product is safe.


Eligibility Criteria:
Inclusion Criteria:

* Consented male or female adults aged ≥40 years
* Moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines (2006)
* Patients who have smoking history of at least 10 pack years
* Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥30% and \<80% of the predicted normal and post-bronchodilator FEV1/Forced vital capacity (FVC) \<0.70 at Visit 1 and Visit 3

Exclusion Criteria:

* Pregnant or nursing (lactating) women
* Patients requiring long term oxygen therapy (\> 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency room for a COPD exacerbation in the 6 weeks prior to screening (Visit 1) or during the screening period
* Patients who had a respiratory tract infection within 6 weeks of Visit 1 or at screening
* Concomitant pulmonary disease, pulmonary tuberculosis (TB) (unless chest x-ray confirms no longer active) or clinically significant bronchiectasis
* Any history of asthma
* Patients who have clinically relevant lab abnormalities / conditions such as (but not limited to) long term prednisone therapy, unstable ischemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding stable atrial fibrillation \[AF\]), uncontrolled hypertension, narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
* Patients with a history of cardiac failure, life threatening arrhythmias (screening Holter) and acute ischemic changes (screening ECG)
* Patients with a history of long QT syndrome or whose QTc (Fridericia method) interval measured at screening (Visit 1) is prolonged (\>450 ms for males or \>470 for females)
* History of malignancy of any organ system, treated or untreated within the past 5 years
* Uncontrolled Type I / Type II Diabetes or blood glucose outside the normal range or Hemoglobin A1C (HbA1c) \>8.0% of total hemoglobin measured at Visit 1

Other protocol-defined inclusion/exclusion criteria may apply
Wear Measurements of E-Poly in an Uncemented THA With Either 32 or 36 mm Caput of Ceramics.

The aim of the study is to compare polyethylene wear in an uncemented total hip prosthesis with 3rd. generation highly cross-linked polyethylene with a 32 mm ceramic femoral head compared to a 36 mm ceramic head. Using X-ray, RSA and DEXA.

The polyethylene to be used is E-Poly (Biomet).

The H0 hypothesis is that there is no difference with regard to polyethylene wear and bone loss between the two groups.

Uncemented THA, 32 mm or 36 mm caput of ceramics, E-Poly inserts. Measure wear with RSA, X-Ray and bone mineral density with DEXA.

Eligibility Criteria:
Inclusion Criteria:

* 50-65 years old
* Primary or secondary osteoarthritis

Exclusion Criteria:

* Significant anatomical divergence are excluded
* Rheumatoid arthritis
* Fracture sequelae
* Dysplasia
* Immune suppression or grave systemic illness
Impact of Patient Support by the Medical Staff on Adherence to Therapy With PegIntron Plus Rebetol (Study P04413)

The objective of this study is to assess the impact of participant care and support on treatment adherence. PegIntron pen and Rebetol will be administered to participants with Hepatitis C Virus (HCV) in accordance with approved labeling. Sites will be categorized as providing high vs low level of participant management based on information about the level of participant support and management captured on the site questionnaire. Data on each participant will be collected by a physician on an electronic participant case report form (CRF) and by the participant via a questionnaire. Treatment completion rates will be analyzed based on the high vs low level of participant management.

The hypothesis is that Physicians investing more time and effort into participant management achieve higher treatment completion rates among their hepatitis C patients than physicians offering less participant management measures.


Eligibility Criteria:
Inclusion Criteria:

* Participants with chronic hepatitis C.

Those participating in patient assistance programs during therapy for hepatitis C.

Exclusion Criteria:

* Participants who have previously been treatment for hepatitis C (non-naïve)

Other exclusion criteria as described in local Summary of Product Characteristics (SPC).
Does DHEA Enhance the Effects of Exercise in Postmenopausal Women?

Dehydroepiandrostrone (DHEA) and its sulfated ester (DHEAS) are high circulating weak androgens which have been associated with conditions that accompany age-related decline such as sarcopenia, hyperinsulinemia, osteopenia, and cardiovascular disease. The decline in DHEA with age is particularly marked in postmenopausal women. Exercise has always been advocated in women; benefit has been demonstrated inmuscle, bone and lipid physiology, as well as perception of energy and sense of well-being. This study aims to explore the combined effect of both DHEA and exercise in postmenopausal women, age range 55-75 years old. Subjects will receive DHEA (50mg/day) or placebo for a 12-week period. At the beginning and conclusion of the study patients will undergo testing for muscle strength, body composition, VO2 max, insulin sensitivity, muscle biopsy with mitochondria enzyme measurements, and psychological analysis. Blood samples pre and post intervention will also be obtained and the level of selected anabolic markers, lipids, and androgenic and sex steroid levels will be assessed. For the twelve-week period, both placebo and DHEA treated participants will be involved in a resistance and aerobic exercise program coordinated through the GCRC and the Dan Abraham Healthy Living Center. Several correlations have been established with respect to exogenous DHEA administration in postmenopausal women. None have evaluated oral DHEA therapy in the setting resistance and aerobic exercise, key therapies advocated in postmenopausal women. As a plausible anabolic hormone DHEA is hypothesized to accentuate the effects of exercise as has been shown for testosterone. This study, as a randomized double-blind placebo controlled trial, will investigate the effects, if any, of a regimented exercise program and DHEA supplementation in postmenopausal women, specifically for evidence of enhancement of exercise effect by oral supplementation with DHEA in attenuating age-related decline


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be postmenopausal women between the ages of 60 and 75 years old.
* Women with levels of DHEA less than 110 mg will be selected.

Exclusion Criteria:

* Individuals with history or biochemical evidence of liver disease, cardiovascular disease (other than controlled hypertension); polycythemia, cerebrovascular disorders, or disorder of glucose metabolism with fasting hyperglycemia or hypoglycemia will be excluded.
* Use of psycotropic drugs within six months prior to enrollment
* History of severe depression or psychotic disorder
* Professional athletes or BMI greater than 30kg/m2
* Anyone who has been in a regular (greater than twice/weekly) exercise program for more than 2 months prior to the study
* Severe rheumatologic condition with chronic pain not well controlled.
* Use of DHEA, estrogen, progesterone, testosterone, corticosteroid products up to six months prior to study
The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265)

The purpose of this study is to determine the effect of an approved medication on the symptoms of perennial allergic rhinitis (an inflammation of the mucous membrane of the nose similar to that found in hay fever except that symptoms persist throughout the year), in patients who have a history of perennial allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoker with a 2-year documented history of perennial allergic (symptoms that persist throughout the year) rhinitis symptoms and positive allergy testing

Exclusion Criteria:

* Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection
Effectiveness of Phone Calls Intervention on Diabetic Patients After Ambulatory Discharge of a Tertiary Care Center

The study is a randomized clinical trial, controlled, open label that aimed to compare two groups after discharge of a tertiary care: type 2 diabetes patients followed exclusively by primary care (control group) and patients followed by primary care and supported by phone calls (intervention group).

The investigators designed a randomized controlled trial. Patients with stable and controlled type 2 diabetes, and considered to be eligible to discharge from specialized care to primary care will be included. Patients with severe neuropathy, not controlled ischemic heart disease and nephropathy stage IV/V will be excluded. Enrolled patients will be randomized in two groups: follow-up supported by periodic nurse phone calls plus primary care (intervention group) or followed by primary care team (control group). The intervention group will receive regular telephone calls (every 3 months for 1 year) and will have a toll-free number to resolve questions about the disease management. Main outcome is the glycemic control between groups after 1 year of follow-up. Secondary outcomes include: rate of hypoglycaemia, blood pressure control,emergency visits, nephropathy progression and death.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes;
* Patients who met discharges criteria according to endocrinology team;
* Patients with HbA1C \< 8%.

Exclusion Criteria:

* Patients with stage IV or V nephropathy;
* Patients with not controlled Ischemic heart disease;
* Patients with severe autonomous or peripheral neuropathy.
Evaluating the Dose Timing (Morning vs Evening) of Endocrine Therapy and Its Effects on Tolerability and Compliance

Endocrine therapy is an established treatment for hormone receptor-positive breast cancer, but can cause significant side effects with deterioration in quality of life. The side effects of all forms of endocrine therapy are well recognized and can lead to treatment non-persistence or non-compliance. Chronotherapy, also called chronotherapeutics, is defined as the administration of a medication in coordination with circadian rhythm in order to minimize side effects and yield a greater efficacy. The investigators propose to perform a pragmatic, multi-centre, open-label, randomized clinical trial to establish the optimal timing (morning vs. evening) of administering endocrine therapy based on side effects and benefits in early stage breast cancer patients.

Endocrine therapy is an established treatment for hormone receptor-positive breast cancer, but can cause significant side effects with deterioration in quality of life. The side effects of all forms of endocrine therapy are well recognized and can lead to treatment non-persistence or non-compliance. Compliance is defined as the degree or extent of conformity to the recommended administration by the provider, whereas persistence refers to the act of continuing treatment for a certain prescribed duration. Treatment adherence is especially important in breast cancer, as early cessation or reduced compliance to hormonal therapy are associated with reduced disease-free survival and increased mortality. Chronotherapy, also called chronotherapeutics, is defined as the administration of a medication in coordination with circadian rhythm in order to minimize side effects and yield a greater efficacy. The investigators propose to perform a pragmatic, multi-centre, open-label, randomized clinical trial to establish the optimal timing (morning vs. evening) of administering endocrine therapy based on side effects and benefits in early stage breast cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an early stage or locally advanced hormonal receptor positive breast cancer
* Plan to receive endocrine therapy
* 18 years of age or older
* Able to provide oral consent
* Willing and able to complete questionnaires as per study protocol

Exclusion Criteria:

* Metastatic cancer
* Previous endocrine therapy for breast cancer
Group a Streptococcus Saliva Study

This study is being done to evaluate whether saliva can be used to diagnose GAS infection and also to compare different testing methods in the microbiology lab. The saliva sample testing will be compared to the throat swab testing to see if saliva testing works as well. The lab will also try different testing methods to see if a faster type of testing (e.g. molecular testing) works as well as the regular method, which takes 48 hours to get results.

This is important because throat swabs can be challenging to collect in some children, and saliva is often much easier and more acceptable by children to collect. This could improve our ability to accurately diagnose and treat GAS infections.


Eligibility Criteria:
Inclusion Criteria:

* \< 19 years of age
* Have provided a sample for GAS testing (bacterial throat swab or POCT rapid antigen test) at the discretion of the clinical team
* Able to provide a saliva sample

Exclusion Criteria:

* Parent/guardian and/or patient unable to consent or assent
* Unable to provide a saliva sample
Stress Reduction in Middle Eastern Refugees

This interventional, randomized controlled study tests the effects of a a brief psychological intervention (Narrative Exposure Therapy) against a wait list control group among refugees who have experienced trauma and have some symptoms of PTSD.


Eligibility Criteria:
Inclusion Criteria:

* Refugees from the Middle East, and possible from Africa, who have experienced conflict-related trauma, have symptoms of PTSD, and speak either Arabic or English

Exclusion Criteria:

* Currently received exposure therapy for PTSD
* Planning to leave area in next 4 months
Passive Transmission of COVID-19 Antibody From Mother to Infant

At present, there is no relevant research focusing on children's acquisition of novel coronavirus antibodies through maternal passive transmission. Therefore, this study assessed the changes of maternal passive transmission of COVID-19 antibodies by monitoring the specific antibodies of COVID-19 in young children; This will lay a foundation for further exploring the risk of COVID-19 infection in children and formulating immune prevention strategies.


Eligibility Criteria:
Inclusion Criteria:

1. Children aged 0-2;
2. No history of blood transfusion, chemotherapy, or related immunosuppressive therapy; No immune system related diseases;

Exclusion Criteria:

Not willing to participate
Effect of Bevel Position of the Artery Needle on Puncture Pain and Post-puncture Bleeding Time

A patient with an arteriovenous fistula (AVF) receiving chronic hemodialysis (HD) treatment is cannulated 312 times a year on average. The patients cannot comply with dialysis treatment and the quality of life is decreased by pain when the fistula cannot be accessed with a single attempt. Sharp pain depends on the tear in the skin, the tissue where the sensitive nerve ends receptive to pain are located, and it is particularly important during AVF puncture. Also, punctures are accompanied by haemorrhages and frequent loss of blood.

The repeated puncture of the AVF leads to a considerable degree of pain, due to the calibre and length of the bevel of fistula needles. When the fistula needle is removed, the small punctures that occur in the entrance area are closed with a thrombus. As a result, scar tissue forms in the entrance area and the surrounding skin, which can lead to the development of stenosis and aneurysm. For this reason, the needle conical tip direction is important in terms of delaying the loss of tissue elasticity and prolonging the use of the intervention area. There are very few studies investigating the effect of the conical tip being up or down on the pain that develops during cannulation in the patient.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* On maintenance hemodialysis three times per week for four hours per session
* Receiving hemodialysis therapy for a least six moths at the time of the study
* Pain level of one or more measured by the Visual Analogue Scale during cannulation
* Able to communicate in Turkish
* Willing to participate to the study

Exclusion Criteria:

* Known to be difficult to enter the fistula (with more than one cannulation)
* History of hematoma or stenosis in fistula
* Having an infection in the fistula area
* Taking painkillers 3 hours before treatment
Superficial Cervical Plexus Block and Quality of Recovery After Thyroidectomy

The goal of this clinical trial is to learn whether a superficial cervical plexus block improves quality of recovery after thyroid surgery. Investigators will compare a superficial cervical plexus block with bupivacaine compared to an identical procedure performed saline placebo to see if there is a difference in quality of recovery on the first postoperative day.

The main question to answer is:

• Does a superficial cervical plexus block with bupivacaine compared to placebo improve quality of recovery in patients having thyroid surgery.

Participants will:

* Fill out an initial preoperative survey
* Be randomized to receive a superficial cervical plexus block with bupivacaine or saline placebo while under anesthesia before the surgery starts
* Fill out a survey about recovery on the first day after surgery

Thyroid surgery is associated with mild to moderate post-operative pain, with most patients requiring opioid pain medicine postoperatively. Nerve blocks, such as the superficial cervical plexus block, are an important component of pain control plans. Superficial cervical plexus blocks have been proven to decrease pain and reduce the need for opioid medications in thyroid surgery. However, previous studies were performed before it became common practice to administer a combination of acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and steroids for thyroid surgery which also help with pain. Whether the superficial cervical plexus block improves pain control and quality of recovery in this context is unknown. This study aims to determine whether the superficial cervical plexus block has an impact on quality of recovery as measured by a survey called the Quality of Recovery-40 (QoR-40).

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* American Society of Anesthesiologists Physical Status classification I-III
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Scheduled for thyroid surgery
* Access to smartphone device or computer with internet connection and has an email address

Exclusion Criteria:

* Non-English speaking
* American Society of Anesthesiologists Physical Status classification \> III
* Have an intolerance or contraindication to the medications involved in the study
* Undergoing repeat thyroid surgery
* Undergoing surgery with planned neck dissection
* Plan for admission post-operatively
* Positive pregnancy test on day of surgery (for participants with child-bearing potential)
* Refusal to participate
Prospective Study of Personalized Approach to Inpatient Patients With Hyperglycemia

The purpose of this study is to compare the outcomes between hospitalized cancer patients with high blood sugar receiving the current standard of care of administering insulin, and hospitalized cancer patients receiving a new, individualized method of insulin administration.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Provide race and ethnicity information
* Male or female, aged 18 years or greater
* Diagnosed with cancer
* Hospitalized at MCC in the medical, hematologic, or bone marrow transplant units
* Having in-hospital hyperglycemia with or without a pre-existing diagnosis of DM, with 2 measurements of BG \> 180 mg/dL and/or 1 measurement of BG \> 350mg/dL within the first 72 hours of admission, detected by bedside point-of-care testing and/or basic metabolic panel laboratory data.
* Participants enrolled in other clinical trials are admissible to this trial.

Exclusion Criteria:

* An individual who meets any of the following criteria will be excluded from participation in this study:
* Participants \< 18 years of age
* Participants at the end of life and/or with limited life expectancies (\< 6 months)
* Participants without cancer diagnoses
* Surgical patients and patients admitted directly to the intensive care unit, other than those in the Bone Marrow Transplant Unit, who are included
* Participants treated and discharged in outpatient settings (ie, direct referral center, infusion center, or clinical research unit) or those admitted for observation only (hospitalized less than 24 hours)
* Participants on total parenteral nutrition
* Participants on insulin pumps
* Participants admitted with diabetic ketoacidosis and hyperglycemic hyperosmolar syndrome
* Pregnant Participants based on medical history
* Participants being followed by endocrinology for hyperglycemia or hypoglycemia