cyrilzakka/clinical-trials huggingface dataset:
Combined Anabolic Therapy

In this research study the study investigators want to learn more about the effect of two different FDA-approved medication regimens in the treatment of postmenopausal osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* women aged 45+
* postmenopausal
* osteoporotic with high risk of fracture

Exclusion Criteria:

* no significant previous use of bone health modifying treatments
* known congenital or acquired bone disease other than osteoporosis
* significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease
* abnormal calcium or parathyroid hormone level
* serum vitamin D \<20 ng/dL
* anemia (hematocrit \<32%)
* history of malignancy (except non-melanoma skin carcinoma)
* excessive alcohol use or substance abuse
* known contraindications to romosozumab or teriparatide
Study of Blood and Urine Samples in Patients With Newly Diagnosed Localized Prostate Cancer Treated With Hormone Therapy and Radiation Therapy. ICORG 06-15

RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This clinical trial is studying blood and urine samples in patients with newly diagnosed localized prostate cancer treated with hormone therapy and radiation therapy.

OBJECTIVES:

* Detect changes in serum and urine proteomic profiles that predict outcome in patients with newly diagnosed localized prostate cancer treated with hormonal therapy and radiotherapy.
* Identify prognostic and biochemical markers of early disease progression in patients treated with this regimen.
* Identify unique protein expression and temporal alterations, in these profiles, that facilitate understanding of the factors predicting relapse or toxicity.
* Identify molecular signatures that allow identification of targets for therapeutic intervention.

OUTLINE: This is a multicenter study.

Patients receive induction hormones\* (bicalutimide and releasing-hormone agonist) for approximately 4 months prior to starting radiotherapy (per standard treatment). Patients then receive radiotherapy consisting of 74 Gy up to a maximum of 81 Gy to the prostate gland per standard treatment.NOTE: \* Patients receiving short-term hormonal treatment for 4-8 months are eligible to participate in the trial.

Blood and urine samples are collected at baseline, and periodically during and after induction therapy for proteomic analysis.

After completion of study therapy, patients are followed up periodically for 5 years and yearly thereafter for the duration of the trial.

Eligibility Criteria:
Inclusion criteria:

1. Age 18 years or over.
2. Histologically confirmed invasive adenocarcinoma of the prostate (by TURP or TRUS).
3. Localised prostate cancer with a Gleason score 7
4. Short term hormonal treatment 4-8 months
5. Performance status of KPS ≥ 60 / WHO 0-2
6. Absence of distant metastases

Exclusion criteria:

1. The patient has previously received treatment for prostate cancer other than TURP/ TRUS
2. The patient has had a bilateral orchidectomy
3. The patient has previously received hormonal treatment for prostate cancer
4. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial. In the opinion of the investigator, any evidence of severe or uncontrolled systematic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease
5. The patient has or had other co-existing malignancies within the past 5 years other than non- melanoma skin cancer
6. Treatment with non-approved or investigational drug within 30 days before day one of the trial
Non-invasive Brain Stimulation to Improve Quadriceps Muscle Function After Anterior Cruciate Ligament Reconstruction

Quadriceps muscle dysfunction persists for years after anterior cruciate ligament reconstruction (ACLR) and is related to poor self-reported outcomes, altered movement patterns and joint loading associated with post-traumatic knee osteoarthritis (OA), and higher risk of reinjury. Emerging evidence indicates that central drive (pathway from the brain to the muscle of interest, i.e corticospinal excitability) to the quadriceps muscle is reduced as early as 2 weeks after surgery and can persist for years after ACLR, meaning that current rehabilitation strategies may not be addressing potential maladaptive changes in central drive. Anodal tDCS is a neurostimulation technology that increases brain excitability (i.e. central drive) and has the potential to address alterations in central drive and quadriceps muscle performance. The purpose of this study is twofold: 1) to determine the effects of anodal tDCS on central drive and quadriceps muscle performance in patients after ACLR, and 2) determine the relationship between central drive and quadriceps muscle performance in patients after ACLR. Central drive will be defined by two measures: 1) active motor thresholds, and 2) slope of a stimulus response curve. Quadriceps muscle performance will be defined by two measures: 1) isometric quadriceps strength, and 2) rate of torque development (RTD). For purpose 1 the investigators hypothesize that measures of central drive and quadriceps muscle performance will increase with administration of active anodal tDCS compared to no change with sham tDCS. For purpose 2 the investigators hypothesize that both measures of central drive will be associated with both measures of quadriceps performance, with a stronger association between central drive and RTD. Following a cross-over design patients 3-6 months from ACLR will receive active and sham anodal tDCS at different sessions separated by 7-10 days while they ride a stationary bike for 20 minutes. Bike position and intensity will be standardized for all patients to maximize quadriceps activity. Findings from this study will expand our basic science knowledge on how tDCS effects different aspects of corticospinal excitability and quadriceps strength, and lead to subsequent studies to determine the effects of multiple sessions of tDCS on corticospinal excitability and quadriceps muscle performance in patients recovering from ACLR.


Eligibility Criteria:
Inclusion Criteria:

-Underwent primary ACL reconstruction within 3-6 months

Exclusion Criteria include:

* multiple ligament reconstruction
* osteo-chondral procedures
* any previous lower extremity surgery
* previous ACL injury
* Metal or implants in the head or neck
* history of neurological disease, seizures, severe migraines, and concussion within the last 6 months
Correlation Analysis of Lens Nucleus Density and Surgical Parameters Based on Ss-oct and Scheimpflug Technology

To study the correlation between three different lens nuclear opacity classification methods and intraoperative phacoemulsification parameters .

Slit-lamp lens images, Pentacam and IOL-Master 700 images were collected in patients with dilated pupil before cataract surgery, and phacoemulsification parameters on the Centurion phacoemulsification machine (Alcon) screen were recorded. Spearman correlation analysis was used to analyze the correlation between lens nuclear density and phacoemulsification parameters based on SS-OCT and Scheimpflug techniques.

Eligibility Criteria:
Inclusion Criteria:

1. Age-related cataracts performed by the same surgeon in our hospital;
2. Pupil diameter can be enlarged more than 6 millimetre.

Exclusion Criteria:

1. The pupil diameter cannot be dilated greater than 6mm;
2. previously ocular surgery or laser treatment;
3. history of ocular trauma;
4. other ocular diseases such as keratoconus, glaucoma and retinal detachment;
5. corneal opacities caused by leucoma, pterygium and other diseases;
6. lens dislocation or complicated cataract surgery (any complications during/after the operations);
7. poor fixation leading to low image quality or inability to cooperate with examinations.
Comparing SMS and E-mail Reminders in an Online Smoking Cessation Intervention

The primary purpose of the current study is to compare the effect of SMS-textmessage vs e-mail reminders on user engagement and proportion of reported quit attempts in an online smoking cessation intervention.

Web- and mobile phone health behavior change interventions, including smoking cessation programs, offer great promise, but little is known about how such interventions should be designed to increase user engagement. The primary purpose of the current study is to compare the effect of SMS-textmessage vs e-mail reminders on user engagement and proportion of reported quit attempts in an online smoking cessation intervention.

The investigators propose a 2-arm RCT with 700 adult study participants that all receive a best practices web-based smoking cessation program designed for use on smart phones (web-app). The intervention includes a ten day preparation phase, in which participants continue smoking. On the eleventh day (and onward) the user will receive a session in which (s)he is asked whether (s)he has quit smoking or not. If not, the user will receive additional treatment sessions until (s)he reports having quit (or dropped out of the study). Each day (for up to 14 days) a new unique session is assigned to the user. However, if the user does not log on to the web-intervention and starts using the session by noon on the second day after assignment, the user will receive a reminder to do so. When a user is to be sent a reminder for the first time, (s)he will be randomized to either receive such reminders by SMS or by e-mail.

The primary outcome is reporting a quit attempt or not. Secondary outcomes include number web-sessions started and completed and time spent navigating sessions after the first reminder is received.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* current smoker
* determined to or considering to quit smoking
* provide valid e-mail address
* provide valid norwegian cell phone number
* complete a baseline questionnaire
* start using the intervention (pushing the next page button one time or more on the first session provided)
* has not logged on to any of the online session within noon on the second day after that particular session was made available

Exclusion Criteria:

* Not starting the first treatment session
* Taking every treatment session on time (no need for reminders, and thus not randomized)
Effect of Folic Acid in Levodopa Treated Parkinson's Disease Patients

This is a prospective single center, randomized, double-blind, 2 arm placebo-controlled study in subjects with Parkinson's disease receiving levodopa .The patients will be randomized to receive tablet Folic Acid 10 mg per day or placebo for 8 weeks. The safety and efficacy outcome measures will be assessed at baseline and 8 weeks.

Parkinson's disease is a progressive neurodegenerative disorder that is caused by degeneration of dopaminergic neuron in the substantia nigra. Most commonly used drug, levodopa can improve the dopamine level in brain but levodapa causes hyperhomocysteinmia as a result increse neurotoxicity,oxidative stress and motor fluctuations and dyskinesia in many patients. Folic acid has been reduced homocystein level in levodopa treated Parkinson's disease on animal model and also reduced Levodopa induced dyskinesia without compromising the motor benefits of Levodopa. Therefore, the present study is to attempt to improve the sign symptoms of Parkinson's disease by giving folic acid along with Levodopa.

This study is a Randomized, Double-Blind, Placebo-Controlled Trial and conducting at Department of Pharmacology, BSMMU in collaboration with Department of Neurology, BSMMU. A total of 60 patients suffering from Parkinson's disease is selected according to inclusion and exclusion criteria. The diagnosis of the patients suffering from Parkinson's disease will be performed by a neurologist at movement disorder clinic of department of Neurology, BSMMU. Patients will undergo MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) to assess the severity of the disease. The patients will be randomly allocated into two arms: control and intervention. Patients in intervention arm consisted of 30 patients who will receive levodopa plus folic acid orally for 8 weeks. On the other hand, control arm consisted of 30 patients who will receive levodopa plus placebo for 8 weeks. The severity of Parkinson's disease will be assessed 8 weeks follow up.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed PD patients taking levodopa for at least 6months.
* Mild to moderate Parkinson's disease patient according to Hoehn and Yahr staging, stage -I, II, III
* Homocysteine level ≥ 13 µmol/L

Exclusion Criteria:

* Secondary causes of parkinsonism
* Prior stereotactic surgery for PD
* Suffering from active malignancy
* Known hypersensitivity to folic acid
* Multivitamin supplementation within 30 days of enrollment
* Patients taking anticonvulsant, oral contraceptive pill, disease modifying anti-rheumatic drugs
* Pregnancy or lactating mother
* Has any clinically significant medical condition that could interfere with the subject's ability to safely participate in the study or to be followed
Randomized Evaluation and Verification of Ventricular Enhancement

A prospective, multi-center, dual-arm randomized controlled study comparing treatment of ischemic cardiomyopathy induced heart failure with the Revivent TC System plus Guideline Directed Medical Therapy (GDMT) compared to GDMT alone.

The purpose of the study is to demonstrate that treatment with the BioVentrix Revivent TC System is more effective than guideline directed medical therapy for the treatment of ischemic heart failure. This is a prospective, multi-center, dual-arm randomized controlled study comparing treatment of ischemic cardiomyopathy induced heart failure with the Revivent TC System plus Guideline Directed Medical Therapy (GDMT) compared to GDMT alone. This study will include 180 patients of which 120 patients will be treated with the investigational device and 60 patients will be maintained on GDMT.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from heart failure symptoms with cardiac dysfunction caused by a previous myocardial infarction resulting in increased LV systolic volume and in a discrete, contiguous, acontractile, (akinetic and/or dyskinetic) scar located in the antero-septal, apical (may extend laterally) region of the left ventricle.

Exclusion Criteria:

* Calcified ventricular wall in the area of intended scar exclusion as verified by one or more appropriate imaging modalities;
* Inadequate myocardial viability in regions remote from the scar.
* Thrombus or intra-ventricular mass in the left atrium or ventricle as verified by echocardiography or equivalent that has not been adequately treated with weeks of anticoagulant at therapeutic levels;
* Cardiac Resynchronization Therapy (CRT) consisting of Bi-ventricular pacemaker device (i.e., not ICD only) placement ≤ 60 days prior to treatment;
* Patient intolerance or unwillingness to take anti-coagulation medication;
* Functioning pacemaker leads in antero-apical RV, which, in the opinion of the investigator, would interfere with anchor placement;
* Pulmonary Arterial Pressure \> 60 mm Hg shown by right heart catheterization to be precapillary or unresponsive to vasodilator therapy;
* Myocardial Infarction within 90 days prior to the procedure;
* Previous right neck surgery, previous pericardiotomy, previous left chest surgery that precludes device placement;
* Chronic renal failure with a serum creatinine \>2 mg/dL;
* Inoperable coronary disease with significant ischemia or pulmonary disease that would preclude transient single lung ventilation.
* Baseline 6-minute walk distance of \>450m
Assessment of Updated Educational Materials for Instanyl®

The purpose of the Instanyl study is to learn how much doctors know and understand about Instanyl® before and after they receive updated educational information, including the risks of its unapproved use. In this study, the doctors will complete two surveys: one three months before they receive the updated educational information, and one about six months after they receive this information. They will answer questions about their prescribing behavior plus their knowledge of Instanyl® including any risks.

This is a non-interventional, observational, cross-sectional study of prescribers of Instanyl®.

This study will assess the prescribers' awareness of the updated EMs and changes in prescribers' knowledge and understanding of the key information contained in the updated EMs. The study will enroll approximately 259 prescribers. The first survey (pre-EM survey) will be conducted three months before the distribution of updated EMs, second survey (post-EM survey) will be conducted six months following the distribution of updated EMs.

The data will be collected, through a self-administered web-based questionnaire. All participants will be enrolled in a single observational group:

• Prescriber of Instanyl®

This multi-center study will be conducted in France, the Netherlands, and Poland. The overall duration of the study will be approximately 22 months.

Eligibility Criteria:
Inclusion Criteria:

1. Specialists of any of those medical specialties targeted for the EMs as agreed with each national competent authority. The foreseen specialties include the following (subject to changes after the EM distribution plan is completed and agreed with national competent authorities):

   * Oncologists and oncoradiologists
   * Anaesthesiologists
   * Pain management prescribers
   * Palliative care prescribers
   * Internal medicine prescribers
   * General practitioner (GPs)
   * Other specialties may be locally included such as hematology. Current and potential prescribers may vary between country; thus, some countries may have modified lists of target specialties.
2. Physicians who have prescribed Instanyl® in the past 12 months (pre-EM survey) or since the updated EMs (post-EM survey) and who intend to prescribe Instanyl® in the following months after each survey.

Exclusion Criteria:

1. Physicians who may have a conflict of interest (that is, prescribers employed by regulatory bodies, pharmaceutical industries).
2. Inactive or retired prescribers.
3. Physicians who did not prescribe Instanyl® in the past 12 months (pre-EM survey) or since the updated EMs are distributed (post-EM survey) and do not foresee treating a participants with Instanyl® in the following 12 months, regardless of whether they have prescribed Instanyl® before.
In-Home Weight Loss Program for Adults With Type 2 Diabetes Delivered by Interactive Cable Television Technology

The majority of patients with Type 2 Diabetes are obese and weight loss is known to improve diabetes outcomes and reduce the need for anti-diabetic medical. This 8-week Telehealth study will compare the effects of standard weight loss advice given in a clinic setting to weight loss advice delivered in the home using an interactive cable television technology called Healthium.

The majority of patients with Type 2 Diabetes are obese and weight loss is known to improve diabetes outcomes and reduce the need for anti-diabetic medical. The overall goal of this study is to explore the human engineering issues of a home (non-clinical) telehealth system, Healthium, utilizing an interactive television system over a broadband connection.

The study seeks to demonstrate a convenient, intuitive and inexpensive way to conduct large-scale interventions related to obesity and nutrition. This could lead to a viable public health care initiative for prevention of chronic diseases such as diabetes. The specific aims to be addressed are Aim #1: To transfer a successful internet-based weight loss program onto the Healthium interactive platform and further develop the intervention for use in patients with Type 2 diabetes. Aim #2: To conduct focus groups to determine consumer acceptability of the convenience and intuitiveness of the Healthium interface. Aim #3: To perform a pilot study in patients with Type 2 diabetes to determine whether the Healthium interface improves weight loss and diabetes outcomes relative to standard clinic-based treatment over a period of 8 weeks.

Eligibility Criteria:
Inclusion Criteria: Clinical Diagnosis of TYpe 2 Diabetes, Body Mass Index 25-35; Ability to read at 8th grade level, have a working television set in the household, be willing to complete daily exercise and diet logs for the 8-233k study; be willing to attend at least 3 clinic visits; Under care of physician for diabetes -

Exclusion Criteria: Evidence of cardiac, renal, or other endocrine diseases; clinical evidence of a substance abuse or mental illness; pregnancy or anticipated pregnancy; breastfeeding; excessive alcohol consumption; anticipated major lifestyle changes

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Effectiveness of PRECEDE Model for Health Education on Changes and Level of Control in Patients With Type 2 Diabetes Mellitus

BACKGROUND: Individual health education is considered to be essential in the overall care of patients with type 2 diabetes (DM2), although there is some uncertainty regarding its metabolic control benefits. There have been very few randomized studies on the effects of individual education on normal care in DM2 patients with a control group, and none of these have assessed the long-term results. Therefore, this study aims to use this design to assess the effectiveness of the PRECEDE (Predisposing, Reinforcing, Enabling, Causes in Educational Diagnosis, and Evaluation) education model in the metabolic control and the reduction of cardiovascular risk factors, in patients with type 2 diabetes.

METHODS: An open community randomized clinical trial will be carried out in 8 urban community health centers in the Northeastern Madrid (Spain). Six hundred patients with DM2 will be randomized in two groups: PRECEDE or conventional model for health promotion education. The main outcome measures is glycated hemoglobin A1C, body mass index (BMI), blood pressure, lipids and control criteria during the 2-year follow-up period.

Assignment to the Health Promotion Education (HPE) will be random, three centers will use conventional HPE (the control group) and the remaining five will use PRECEDE-type HPE. Eligible patients are selected from a list of DM2 patients by each professional using random sampling, until the predetermined sample size is attained.

Conventional HPE is defined according to the recommendations of the Spanish Ministry of Health National Conference on Diabetes Mellitus, and was complemented by the criteria for good care of the Madrid Primary Healthcare Service for the promotion of healthy lifestyles among adults for 2004-2007

Eligibility Criteria:
Inclusion Criteria:

* Older than 30 years of age, with previously diagnosed DM2 (cardinal clinical, plus random blood glucose \> 200 mg/dl or oral glucose of \> 200 mg/dl at 2 h, twice, or plasma fasting glucose of \> 126 mg/dl on two occasions or being diagnosed previously, received specific treatment for DM2)

Exclusion Criteria:

* Gestational diabetes
* Patients involved in clinical trials
* Patients with life expectancy less than 1 year (according to clinical judgment)
* Patients who refused to participate
* Homebound patients Patients meeting criteria for inclusion and not meeting any exclusion criteria were invited to participate, and were included after accepting and signing an informed consent form.