cyrilzakka/clinical-trials huggingface dataset:
The Effect of Azithromycin in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Productive Cough

The purpose of this study is to demonstrate the efficacy of azithromycin to produce a significant change in the cough-related health status, measured with the Dutch version of the Leicester Cough Questionnaire in patiënts with COPD gold classification 2-4 and chronic productive coughing.

This study is a prospective double-centre, double blind randomised trial. Patients \> 40 years of age, referred to our outpatient clinic with chronic cough and sputum production due to COPD will be recruited after informed consent is obtained.

Consenting patients will be randomises to a 12-week treatment with 250 mg azithromycin three times a week or placebo.

Before randomisation all patients have to fill in the SF 36 , SGRQ and the Dutch version of the Leicester Cough Questionnaire (LCQ) for assessment of the baseline quality of life and the disease specific quality of life.

The LCQ questionnaires will be performed at the beginning and every 3 weeks afterwards until 18 weeks, except the second LCQ which will be filled in after 2 weeks. Scores from this questionnaire will be used to calculate the 2-week repeatability. The SF 36 and SGRQ will be performed at the start of the study and after 12 weeks. Adverse events will be recorded during the whole treatment period. After 2 and 12 weeks a Global Rating of Change will be performed. This questionnaire will be used to validate the LCQ in COPD patients.

Randomisation will take place using a computer allocation program (BAMI-computer)

Azithromycin and placebo will be provided by Teva Pharmaceuticals. Placebo and azithromycin will be identical in appearance and packaging.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 40 years of age, in our outpatient clinic with chronic cough and COPD (gold2-4)
* Chronic cough is defined as a cough \> 12 weeks duration, at least 12 weeks a year in 2 subsequent years.
* Analysed for bronchiectasis prior to participation by CT-thorax.

Exclusion Criteria:

* Prior history of asthma
* Use of i.v. or oral corticosteroids and or antibiotics for an exacerbation 3 weeks before inclusion
* Patients suffering from other relevant lung diseases.
* Clinically relevant abnormal laboratory values suggesting an unknown disease requiring further clinical evaluation.
* Liver disease, (ALAT and/or ASAT levels two or more times the upper limit of normal).
* Pregnancy or lactation.
* Use of macrolides the last 6 weeks prior to inclusion.
* Allergy or intolerance to macrolides.
* Other research medication started 2 months prior to inclusion.
* Prior randomisation in this study.
Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success With Protease Inhibitor-Containing HAART Regimen(s)

This study will compare 2 treatments in the way they affect cholesterol levels and the amount of HIV in the blood.

The study is designed to determine the metabolic changes, antiviral activity, safety, and tolerability of atazanavir as compared to LPV/RTV, each in combination with 2 nucleosides, over the initial 24 weeks, with a final analysis at 48 weeks.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are receiving a PI-containing highly active antiretroviral therapy (HAART) for at least 12 weeks.
* Have a viral load of 1,000 or more copies/ml within 4 weeks of screening and within 4 weeks prior to randomization.
* Have 2 CD4 cell counts of 50 or more cells/mm3 at least 96 hours apart and within 4 weeks before randomization.
* Are at least 16 years old.
* Have a documented virologic response to at least 1 HAART regimen.
* Have phenotypic sensitivity to at least 2 of the following: ddl, d4T, ZDV, 3TC, ABC.
* Have phenotypic sensitivity to atazanavir and LPV/RTV.
* Use effective barrier methods of birth control.
* Will be available for 48 weeks.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have taken 2 or more PIs and had virologic failure.
* Have taken atazanavir or LPV/RTV.
* Have an HIV-related infection (within 30 days) or any medical condition requiring treatment at the time of enrollment.
* Have had acute hepatitis in the 30 days prior to study entry.
* Have received certain drugs within 3 months of study start or expect to need them at time of enrollment.
* Abuse alcohol or drugs in a way that would interfere with the study.
* Have very bad diarrhea within 30 days prior to study entry.
* Are pregnant or breast-feeding.
* Have a history of hemophilia.
* Use lipid-lowering drugs (within the previous 30 days).
* Have cardiomyopathy or symptoms of other heart disease.
* Cannot take medicine by mouth.
* Have any other condition that would interfere with the study.
* Have pancreatitis, if choosing ddI as part of NRTI pair.
* Have bilateral peripheral neuropathy at time of screening, if choosing ddI or or d4T as part of the NRTI pair.
Comparative Effects of Chronic Treatment With Olanzapine and Risperidone on Glucose and Lipid Metabolism

The primary objective of the study is to assess whether chronic treatment with olanzapine over a five-month period produces a significant increase in abnormalities in glucose levels. The main secondary objective is to evaluate whether the increase in glucose levels and rate of glucose abnormalities differs between Olanzapine and Risperidone during this treatment period. Additional secondary objectives of the study are to investigate similar questions with respect to glycohemoglobin, triglycerides and other measures of glucose and lipid metabolism.

We hypothesize that Olanzapine will not be inferior to Risperidone in extent of increase in the primary outcome measure of serum glucose, and secondary measures of glycohemoglobin, insulin and lipids.

In the on-going study in progress we use an extensive battery of assessments to investigate a)fasting levels of glucose and lipids at baseline and monthly during 5 months of treatment, b) glucose tolerance tests to investigate glucose and insulin abnormalities after a glucose load at baseline and during study treatment, and c)the effects of treatment with olanzapine and risperidone of post prandial glucose metabolism after a fatty meal (as detailed in the body of the proposal). Recent studies have shown that increased postprandial lipidemia is an important feature of many patients with type 2 diabetes and atherosclerosis. In addition to the biochemical measures, we will also assess clinical effects (PANSS and CGI ratings) and other side-effects (weight gain, appetite, somnolence, and EPS and TD). The specific plan calls for inpatients in a tertiary care hospital to be randomly assigned to olanzapine or risperidone, using a stratified random assignment procedure, and treated for five months with either olanzapine or risperidone. We estimate that we will have to enroll a sample of approximately 50-55 patients to obtain 46 acceptable complete cases(as specified in proposal below). On the basis of preliminary results from our prior and ongoing studies we predict no significant increase in glucose abnormalities from baseline during chronic treatment with olanzapine and no significant differences in development of glucose abnormalities in patients in patient treated with olanzapine and risperidone.

Additional measures being investigated include: comparison of olanzapine and risperidone in glucose and lipid responses to a fatty meal, ghrelin changes in response to a fatty mean, and CRP and IL-6, and thyroid and prolactin response to five months of treatment with the two drugs.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis
* Schizophrenia or schizoaffective psychosis
* 18-65 years of age

Exclusion Criteria:

* Currently being treated with oral antidiabetics or insulin
Trial of Either Surgery or Stereotactic Radiotherapy for Early Stage (IA) Lung Cancer

The standard treatment for an early stage I lung cancer is surgery. However, surgery can be associated with complications and long-term impairment of the quality of life of patients. Stereotactic radiotherapy (SRT) is a outpatient technique which allows for local control rates that are comparable to those achieved using surgery. In this study, patients with stage IA non-small cell lung cancer will be randomized to either surgery or SRT in order to study the local and regional tumor control, quality of life and treatment costs at 2- and 5-years.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a cytological or histological diagnosis of stage IA non-cell lung cancer diagnosed in accordance with Dutch CBO guidelines \[2004\]. When no pathological diagnosis is available, a patient with a new or growing pulmonary lesion with radiological features consistent with malignancy AND a lesion showing uptake on a FDG-PET scan will be eligible \[Herder 2005\].
* No evidence of regional or distant metastases on a standardized FDG-PET scan within 6 weeks of any protocol treatment .
* The medial extension of tumors should be least 2 cm away from main and lobar bronchi, and also minimum of 1.5 cm from large peripheral blood vessels such as the aorta and main pulmonary artery. Lesions of at least 2 cm from the mediastinal pleura will be eligible if the responsible radiation oncologist judges that the specified normal tissue tolerance doses specified in the protocol will not be exceeded.
* Patients who are judged by a multi-disciplinary team to have 2 primary lung tumors (on the basis of clinical, radiological, FDG-PET and/or cyto-pathology findings) are eligible for randomization provided that both surgery and SRT can be performed in accordance with protocol requirements.
* Patient should be fit to undergo a complete surgical resection of the lesion in accordance with Dutch CBO guidelines \[2004\]
* Performance score of ECOG ≤ 2 before any treatment.
* Able to comply with post-treatment follow-up
* Patients must sign and date a written Independent Ethics Committee approved informed consent form.

Exclusion Criteria:

* Prior chemotherapy or radiotherapy for the present diagnosis of NSCLC.
* History of any active malignancy (other than NSCLC) unless treated more than 3 years with curative intent and no recurrence, with the exception of non-melanoma skin cancers or in-situ cervical cancers.
* Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, severe cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease).
* Concomitant treatment with any other experimental drug under investigation.
* Pregnancy
* Men and women of child-bearing potential not using effective means of contraception for 6 months after treatment has been completed.
Airtraq Versus Conventional Laryngoscopy in Children

The investigators aim to compare the new paediatric Airtraq indirect optical laryngoscope with conventional direct laryngoscopy for tracheal intubation in a randomised crossover study during routine anaesthesia. The investigators hypothesise that the Airtraq is as good as conventional laryngoscopy for tracheal intubation of infants and children. This will be an equivalence rather than a non-inferiority study.


Eligibility Criteria:
Inclusion Criteria:

* All children less than 6 years of age, in whom a size 2.5 - 5.5 tracheal tube would be considered suitable.
* Classified by the American Society of Anesthesiology (ASA) as grade 1-3.
* Scheduled for surgery under general anaesthesia, and in whom tracheal intubation and neuromuscular blocking drugs are planned to be used.

Exclusion Criteria:

* inability of patient or parents to understand the study or consent process
* known or suspected difficult airway
* ASA 4 and above
Effects of Exercise Poles on Older Adults During Exercise Walking

This study uses a patented type of exercise poles, developed to assist runners rehabilitating from lower body injuries. These poles may offer older adults improved stability, reduced fear of falling, and lessened lower body pain when exercise walking.

Phase 1 (being concluded as of Feb 2002) used 18 older adults to investigate prototype versions of the running poles. Preliminary results, after 3 months of testing, indicate the poles are safe and effective. Phase 2 will use improved versions of the poles, which are currently in development, with a group of around 125-150 subjects over a longer length of time (12 months). Changes in walking gait quality, balance, strength, body composition, exercise adherence, and subjective perceptions of wellness will be assessed before, during, and after the 12 month exercise session.

Eligibility Criteria:
Inclusion Criteria:

* Age 65-80
* Normal gait

Exclusion Criteria:

* Inability to walk continuously for 5 minutes
* Contraindication from a personal physician
* Height over 6'2" or weight over 200 lbs (due to limitations of existing pole design)
* Mild to severe cognitive impairment
Telephone-Based Lifestyle Intervention to Reduce Blood Pressure in Prehypertensive Patients

Individuals with prehypertension are at risk for developing cardiovascular disease and sustained hypertension. Modifying lifestyle behaviors (diet, weight loss, sodium intake, physical activity, alcohol intake) has been shown to reduce blood pressure in hypertensives. Participants in this study will be enrolled in one of two groups. Participants in the first group will receive usual care, and participants in the second group will receive a 4 session telephone-based lifestyle intervention. The goal of the study is to determine whether this intervention is effective in promoting behavior change and reducing blood pressure among prehypertensives.

Individuals with prehypertension are at increased cardiovascular risk compared with normotension, as well as increased risk of progression to sustained hypertension. The recommended treatment for prehypertension is lifestyle modification, including weight loss, adoption of the Dietary Approaches to Stop Hypertension (DASH) diet, reduction of dietary sodium, physical activity, and moderation of alcohol intake. The proposed pilot study will test the effect of a 4 session telephone-based lifestyle intervention on blood pressure change in 125 prehypertensive participants. The intervention includes education and behavioral counseling strategies that have been shown to be effective in promoting behavior change and reducing blood pressure among hypertensives.

Following baseline assessment, participants will be randomized to the intervention or usual care, and will complete follow-up assessments at 6 weeks and 3 months post-randomization. The primary aim of the study is to examine the effect of the intervention on blood pressure at 3 months. Secondary aims include examining intervention effects on lifestyle behavior changes at 6 weeks and 3 months. This study will provide pilot and feasibility data for a future application to study effects of the intervention on risk factor modification, blood pressure reduction, and cardiovascular morbidity and mortality. If successful, this brief, cost-effective intervention could easily be incorporated into routine care, and could have a significant impact on the management of prehypertension.

Eligibility Criteria:
Inclusion Criteria:

1. Screening BP in prehypertensive range (SBP of 120-139 mmHg or DBP of 80-89 mmHg). If SBP or DBP is below these ranges, the patient is eligible. However, if either SBP or DBP is above the upper cutoffs (i.e., patient meets criteria for HTN), the patient will not be eligible.
2. Able to read and communicate in English or Spanish.
3. Must have access to a telephone at home or at work.
4. Age 18 years or older

Exclusion Criteria:

1. Patients who are currently taking anti-hypertensive medication will be excluded.
2. Patients with diabetes or kidney disease will be excluded, because pharmacologic treatment may be initiated to achieve the JNC 7 recommended BP goal of 130/80 mmHg in patients with these compelling indications.
3. Patients who are currently participating in another HTN-related clinical trial will be excluded.
Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder

The investigators hypothesize that implementation of a shared decision making care plan for prophylactic treatment will help therapeutic adherence of bipolar patients. They also anticipate that patients treated according to a shared decision making plan will have an elevated satisfaction of their care, quality of life and functionment, as well as a lower number of relapses


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient must be available for the 12 months of follow-up
* The patient is at least 18 years old
* Patients is suffering from bipolar disorder (I or II) according to DSM-5 criteria
* Following resolution of a mood episode (manic or depressive according to DSM-5 criteria) according to the criteria of l'International Society for Bipolar Disorder (Recovery, clinical remission of at least 4 weeks)
* Followed by at least one of the practitioner belonging to one of the participating centers
* Without comprehension problems of fluent French

Exclusion Criteria:

* The subject is participating in an interventional study, or has participated in another interventional study within the previous 3 months
* The subject is in a period of exclusion determined by a previous study
* The patient is under safeguard of justice or state guardianship
* It is impossible to give the subject informed information, or the subject refuses to sign the consent
* The subject has already participated in this study
* The patient has troubles linked to the usage of severe intensive substances (such as those defined by the DMS-5)
* The patient has a revision of the initial diagnosis of bipolar disorder
Lifestyle Intervention's Impact on Health Care Costs

The ICAN Pilot project aims to evaluate the differences in economic, clinical and quality of life outcomes of a nutrition intervention involving lifestyle case management and medical nutrition therapy by a registered dietitian compared to usual medical care in obese persons with type 2 diabetes. The intervention is aimed at moderate weight loss (\> 5-10%), improvement in diet quality and an increase in physical activity.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 30 kg/m2, calculated from measured weight and height.
* Type 2 diabetics on medication for their diabetes.
* Age 20 -60 years of age.
* Have phone.
* Fluency in reading, writing and comprehension of English
* Have Qualchoice as their primary health insurer.

Exclusion Criteria:

* Depression, BDI score \> 20
* Pregnancy
Effects of Pericapsular Nerve Group Block on Postoperative Recovery for Total Hip Arthroplasty

The hypothesis of this study is that patients who undergo PENG block in before Total Hip Artroplasthy (THA) surgery with spinal anesthesia will have reduced postoperative pain scores, less need for opioid analgesics and earlier mobilisation.

This prospective randomised controlled study included a total of 60 patients aged 40-85 years who underwent THA surgery under spinal anaesthesia. Patients were divided into two groups as PENG block (n:30) and non-PENG block (n:30). PENG block was placed in the fascial plane between the pseudotendon and pubic ramus with USG in-plane technique, 20 ml of 0.5% bupivacaine was administered and surgery was initiated. The primary outcome of the study was to investigate the effect of preoperative PENG block application on postoperative pain, opioid requirement, mobilisation time, hip joint patency and length of hospital stay in patients undergoing THA surgery. The secondary outcome was to investigate the effect of PENG block on perioperative haemodynamics and postoperative side effects.

For multimodal analgesia, 10 ml 0.5% bupivacaine + 10 ml 2% lidocaine is infiltrated into the surgical wound incision line by the surgical team at the end of surgery. After tramadol 50 mg loading with PCA device, a basal rate of 5-10 mg/hour (20 mg bolus dose + 30 minutes lock time) is given with paracetamol 10 mg/kg iv (8 hours interval).

Eligibility Criteria:
Inclusion Criteria:

* THA performed by posterior approach
* 40-85 age range
* ASA 1-3

Exclusion Criteria:

Under 40 years of age, over 85 years of age,

* ASA 4 and above,
* Cognitive impairment (Alzheimer's disease, dementia, delirium etc.),
* Hip fracture,
* Application site infection,
* Allergy to local anaesthetic agents,
* Patients are non-consenting patients.
SierraSil Joint Formula 14 as an Ergogenic Aid to Performance in Athletes

The purpose of this study is to examine whether supplementation with SierraSil can improve anaerobic power and reduce muscle fatigue in a group of well-trained athletes.

A secondary purpose is to examine the effect of SierraSil on the severity of delayed onset muscle soreness.

This is a double blind, crossover, pilot study that will examine the effect of SierraSil supplementation on the determinants of human performance. Anaerobic capacity, muscle fatigue, the severity of delayed onset muscle soreness (DOMS) and markers of inflammation will be measured before and after 3 weeks of supplementation with SierraSil or placebo. There will be a 3 week washout period prior to the crossover to ensure SierraSil supplementation has no residual effect.

Eligibility Criteria:
Inclusion Criteria:

* no contraindications to strenuous exercise

Exclusion Criteria:

* muscle or joint injury
* taking any form of anti-inflammatory or pain medication
* females due to the variability that might be introduced due to the phases of the menstrual cycle