cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX)

The primary objective of the VBX13-05 clinical study is to evaluate the safety and efficacy of VIABAHN BX for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or external iliac arteries.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years old;
* Patient is male, infertile female, or female of childbearing potential practicing an acceptable method of preventing pregnancy;
* Patient or legal representative is willing to give written informed consent;
* Patient is capable of complying with protocol requirements, including all follow-up visits;
* Patient has symptomatic claudication or rest pain without tissue loss (Rutherford Categories 2-4).
* Patient has de novo or restenotic target lesion(s) in the common and/or external iliac artery

Exclusion Criteria:

* Patient has a life expectancy of less than 1 year;
* Patient has a known allergy to stent graft components, including stainless steel or heparin;
* Patient has a known intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would prevent compliance with the protocol;
* Patient has a condition (unrelated to the study) that is expected to require indefinite, or lifelong, anticoagulation
* Patient has had vascular access / catheterization in the lower extremity within 30 days of study enrollment;
* Patient has had a previous or planned coronary intervention within 30 days prior to enrollment in this study or required at time of study procedure; Patient has had a previous or planned bypass surgery in the target leg, or a bypass that occurs at the time of the study procedure;
* Patient is currently participating in this or another investigative clinical study.
* Patient has evidence of angiographically visible thrombus within or adjacent to the target lesion(s);
* Patient has aneurysmal dilation proximal or distal to the target lesion(s) that would interfere with the placement of the device;
* Patient has a target lesion requiring atherectomy or any ablative device to facilitate stent delivery;
* Patient has a target lesion situated in such a way that an implanted device will prevent blood flow or perfusion to the internal iliac artery if patent
Molecular Investigation of Non Alcoholic Fatty Liver Diseases in Obese Patients

Non alcoholic fatty liver diseases (NAFLD) are represented by two main pathological conditions, hepatic steatosis (HS) and non alcoholic steatohepatitis (NASH), which are characterized by the accumulation of fat in the liver. The diagnosis of these two entities is achieved by histology and neither imaging nor biochemical markers are accurate enough to discriminate them. At the contrary of HS, NASH features hepatocyte necrosis, inflammation and fibrosis of variable intensity that could progress and ultimately evolve to cirrhosis. Therefore, it is important to distinguish between HS and NASH in order to treat the patients accordingly. In this study, the investigators aim to understand the molecular mechanisms that govern the transition from benign steatosis to complicated NASH. The investigators will analyze by "Q-RT-PCR" and "DNA microarray" technologies in the liver of obese patients, the expression of genes that are susceptible to be involved in the pathogenesis of NAFLD and identify the potential signaling pathways responsible for the progression of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Group T(n=30): patient without central adiposity, without insulin resistance, operated for cholecystectomy or a benign liver tumor
* Group A (n=30): patient with central adiposity, insulin resistance and hepatic steatosis (histology).
* Group B (n=30): patient with central adiposity, insulin resistance and steatohepatitis ± hepatic fibrosis (histology).

Exclusion Criteria:

* viral or autoimmune hepatitis
* hematochromatosis
* alcohol consumption (\> 20 g/24h women, \>30 g/24h men)
* type 1 diabetes
* inflammation or infection before procedure
* abnormal hemostasis or coagulation- pregnancy
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01

This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 1 or Type 2 diabetes mellitus
* Meet the per protocol criteria of diabetic gastroparesis
* Compliance with diary
* Compliance with the per protocol study treatment dosing instructions

Exclusion Criteria:

* Currently receiving nutrition intravenously, by nasogastric tube, or other feeding tube
* Actively experiencing anorexia nervosa, binge-eating, bulimia, or other eating disorder at the time of Screening (Visit 1)
* Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity
* History of gastrointestinal disorders that may be similar to gastroparesis
* Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus
Phase II Cancer Vaccine Trial for Patients With Follicular Lymphoma

Patients with non-curable disseminated follicular lymphoma receive local radiotherapy targeting single lymph nodes and injection of low-dose rituximab (anti-CD20) and autologous dendritic cells. The therapy is repeated 3 times, targeting different lesion. Aims are to induce tumor immunity and clinical responses.

The clinical protocol is based on the rationale that the immune system has been developed to combat infectious disease. To mimic the environment in infected tissue, selected tumor-affected lymph nodes are treated locally with a single dose of 8 Gy radiotherapy and injected with therapeutic antibody (anti-CD20/Rituximab). Later, dendritic cells (DC) are injected into the damaged tumor tissue together with a stimulatory cytokine (GM-CSF) to initiate an immune response. Patients with untreated or relapsed stage III/IV follicular lymphoma not in need of standard therapy receive intra-tumoral injections of low-dose anti-CD20 antibodies (5 mg) on days 1 and 3 and local radiotherapy on day 2. On days 4 and 5, dendritic cells generated from monocytes isolated from the patients blood are injected into the site together with the stimulatory cytokine GM-CSF administered subcutaneously. Additional lymph nodes are treated similarly after 2 and 4 weeks. The treatment is thus performed three times, targeting different lymphoma nodes. The primary aims are to induce tumor-specific immune responses and clinical responses.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years and older
2. Histologically confirmed (by WHO classification) untreated and relapsed indolent non-Hodgkin's B-cell lymphoma of low-grade follicular, marginal zone, lymphoplasmocytic or small lymphocytic subtypes.
3. Stage III/IV
4. Adequate bone marrow function (leukocyte count\>2,0, neutrophil count\>1.0, platelets\>50)
5. Two or more separate lymph nodes \> 1,5 cm available for biopsy or treatment.
6. Measurable disease present other than biopsy site and injection site(s).
7. Required wash-out period after previous treatment: Chemotherapy - 8 weeks, Radiotherapy - 4 weeks, Rituximab - 12 weeks
8. WHO status 0-1
9. Life expectancy of more than 6 months
10. Written informed consent
11. Able to comply with the treatment protocol -

Exclusion Criteria:

1. Patients with progressive lymphoma in need of systemic therapy or standard dose irradiation.
2. Chronic bacterial, viral or fungal infection
3. Pre-existing autoimmune or antibody mediated disease including: systemic lupus, erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, but excluding controlled thyroid disease, or the presence of autoantibodies without clinical autoimmune disease.
4. Known history of HIV
5. Central nervous system involvement of lymphoma
6. Current anticoagulant therapy which can not safely be paused during treatment injections (ASA \< 325 mg/day allowed)
7. Pregnancy -
Monopolar Dielectric Diathermy by Radiofrequency and Therapeutic Exercise in Patients With Chronic Low Back Pain.

A total of 60 people diagnosed with non-specific chronic low back pain of more than 3 months of evolution and who are not currently undergoing any type of treatment will be recruited, with ages between 30 and 65 years. A random distribution will be made into two treatment groups (diathermy combined with supervised therapeutic exercise versus supervised therapeutic exercise). Participants will receive treatment once a week for a period of four weeks, in the physiotherapy laboratories of the University of Almería, with a follow-up evaluation at three weeks and two months after the start of treatment. At their first visit, participants will be screened for study eligibility according to the study inclusion and exclusion criteria, and will be evaluated by a therapist blinded to the intervention. After this face-to-face evaluation, patients will be randomly assigned to one of the two groups and will receive treatment for low back pain according to their random assignment group by two therapists belonging to the research group and trained in the techniques used.

After randomization, participants will be assigned to the experimental group (8 sessions of monopolar dielectric diathermy by emission of radiofrequency combined with 8 sessions of supervised therapeutic exercise) or to the control group (8 sessions of supervised exercise). The number of participants will be identical between the groups. The randomization sequence will be performed by the principal investigator.

The number of participants for each group will be 30. The results of the random assignment will be sealed in opaque envelopes before being delivered to the participants.

The outcome assessor and study statistician will be blinded throughout the entire process.

A baseline assessment of the primary and secondary outcome measures will be performed before randomization of the participants to the different groups, an immediate post-treatment assessment (1 day after the last intervention) and an assessment two months after the end of the procedure. intervention (follow-up).

Eligibility Criteria:
Inclusion Criteria:

* Low back pain ≥ 3 months.
* Age between 30 and 67 years old.
* Score ≥ 4 points on the Roland Morris Disability Questionnaire.
* Not being receiving physical therapy.

Exclusion Criteria:

(1) patients with sensory and/or coagulation disorders; (2) a history of spinal surgery; (3) heart complications; (4) concurrent severe central or peripheral nervous system disease; (5) epilepsy; (6) needle phobia; (7) serious pathologies that can be the main cause of chronic LBP (for example, presence of lumbar stenosis, spondylolisthesis, tumours, etc.); (8) or patients contraindicated for radiofrequency (diathermy).
Pilot Study on the Effects of Neuromuscular Taping in Parkinson's Disease Patients

Parkinson's disease (PD) is a degenerative disorder characterized by a symptom triad consisting on: tremor, rigidity and bradykinesia . To these symptoms it is often added postural alteration that can stand in two different attitudes, such as the camptocormia and the syndrome of Pisa . Progressing in its evolution, PD becomes increasingly disabling, making it difficult or even impossible daily activities such as washing or dressing.The abnormal posture, with alteration of the limbs, the neck and trunk, is a recurring feature in PD, with a frequency of about 30%. Between 2% and 12.3% are more severe abnormalities such as camptocormia, the syndrome of Pisa and the anterocollis. Several studies disease plug in Neuromuscular Taping technique (NMT) among rehabilitative tools in degenerative neurological syndromes.

To the best of our knowledge, no applications were found in PD. Therefore, the current study was designed to evaluate quantitatively the effects of the NMT intervention on the trunk kinematics during standing position. More specifically, this study aims to compare the trunk kinematic variables of patients with PD who were treated with effective NMT versus those of the subjects who received only the pharmacological treatment.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of idiopathic PD by United Kingdom Brain Bank criteria
* No other significant neurological or orthopedic problems
* Age between 55 and 80 years
* MDS-UPDRS item 3.13 Posture between mild and moderate (definite flexion, scoliosis or leaning to one side)
* Patient able to walk independently or with minimal assistance for 10 meters
* Medical treatment for Parkinson's Disease must be stable for at least two weeks prior to inclusion, and during the study. During the study, the dosage of anti-parkinsonian drug treatment should not change, if it is not deemed necessary by the investigator.

Exclusion criteria:

* Disability to understand instructions required by the study (Informed Consent Test of Comprehension)
* primarily wheelchair bound
* Skin abrasions
* sensitive skin
A Feasibility Study for Elective Cardioversion of Atrial Fibrillation at Home

The goal of this pilot, non-controlled, non-randomised, single centre, prospective intervention feasibility study is to assess the feasibility of a home DC-ECV in the treatment of recurrent symptomatic AF performed by APP in 25 patients.

The main question\[s\] it aims to answer are:

Primary objective:

In this prospective intervention feasibility study, in 25 patients the primary endpoint is completion of cardioversion to sinus rhythm. (% of study patients with a recurrence of AF in whom a home cardioversion is performed, i.e. to whom at least one DC shock was administered while the patient was under sedation).

Feasibility endpoints are ; (a) evaluation of enrolment of participants, (b) evaluation and refinement of data and outcome collection procedures, (c) evaluation of logistics, (d) evaluation of the appropriateness of the intervention and research procedures to manage and implement the intervention, and (e) preliminary evaluation of participant responses to the intervention.

Secondary objectives:

Safety endpoint:

Complications immediately during and one hour after cardioversion (e.g. arrhythmias, changes in the electrocardiogram, hypotension related to sedation and/or vasodilation or skin irritation).

A composite of major adverse cardiovascular and cerebrovascular events (MACCE) occurring within 24 hours MACCE occurring during 6 weeks follow-up; any hospitalisation and all-cause mortality during 6 weeks follow-up; number (%) of patients in sinus rhythm at 1 hour in the post-shock observation period; idem at the end of 6 weeks follow-up; inventory of all interventions in the study related to cost-of-care.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent.
2. Age 18 -75 year subjects, able to understand the provided information and sign an informed consent.
3. Need for direct current electrical cardioversion (DC-ECV) for correction of recurrent symptomatic AF (according to the guidelines of the American College of Cardiology/American Heart Association/European Society of Cardiology (ACC/AHA/ESC)).
4. Weight more than 50 kilograms.
5. Successful hospital DC-ECV for a previous episode of AF performed under propofol sedation.
6. Target range of international normalized ratio (INR) above 2.0, when on vitamin K antagonists, or use of novel oral anticoagulant, stable for 3 weeks.
7. ASA 2.
8. BMI \< 35 kg/m2.
9. Fasting status: at least 6 hours for food, and 2 hours for fluids.

Exclusion Criteria:

* 1. Patients over 75 years old and younger than 18 years. 2. Patients wearing pacemaker or implantable cardioverter-defibrillator. 3. Patients with (cardiovascular): sick sinus syndrome, ventricular pre-excitation, Brugada syndrome or bundle branch block.

severe ischemic or valvular heart disease. known second or third degree atrioventricular block normal sinus rhythm. heart failure NYHA III or IV, known LVEF \< 35%, or cor pulmonale. transient and reversible cause of AF, e.g. in setting of fever and hyperthyroidism.
Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients

This study will compare placebo to 4 different doses of SBR759 to assess the phosphate lowering efficacy in dialysis patients.


Eligibility Criteria:
Inclusion criteria:

1. Men or women of at least 18 years of age
2. Stable maintenance of hemodialysis 3 times per week for 3 months or greater
3. Controlled serum phosphate if under phosphate-binder therapy
4. Patient must either be on a stable phosphate binder dose and are willing to stop their phosphate binder therapy at the beginning of the study, or not have received any phosphate binder therapy for at least 4 weeks prior to screening

Exclusion criteria:

1. Patients who are on peritoneal dialysis
2. Patients who have a transplant or parathyroidectomy scheduled during the study
3. Clinically significant GI disorder
4. Unstable medical condition other than Chronic Kidney Disease
5. Patient is currently being treated with oral iron
6. History of hemachromatosis, or ferritin \> 1000 ng/mL
7. Transferrin saturation \> 60%
8. Uncontrolled hyperparathyroidism (iPTH \> 84.8 pmol/L) Other protocol-defined inclusion/exclusion criteria may apply
Vibratory PEP Device and Hospital Length of Stay for Acute Exacerbation of COPD

This study is evaluating the use of a respiratory device, the Acapella Vibratory Positive Expiratory Pressure (PEP) Therapy device, in patients admitted to the hospital with a chronic obstructive pulmonary disease (COPD) exacerbation.

The investigators hypothesize that the PEP-FV used as adjunctive therapy in patients hospitalized for an acute exacerbation of COPD will result in decreased hospital length of stay and improvement of overall COPD-related health outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Admitted with COPD exacerbation as a primary diagnosis
* Subjectively produces more than 1 tablespoon (15 ml) / day of sputum
* Has the subjective feeling that he/she cannot cough up or clear her secretions
* Physical respiratory system exam by the physician with evidence of course ronchi suggestive of impacted secretions
* \> 10 pack-year smoking history

Exclusion Criteria:

* Cannot use the flutter device or unable to follow commands
* Altered mental status
* Known active malignancy
* Known systolic congestive heart failure (CHF) with ejection fraction (EF) \< 40% or clinically in acute CHF exacerbation as documented by cardiologist or primary diagnosis other than COPD
* Pregnancy
* Patients in severe exacerbation (Intubated, Continuous use of NIPPV, Unable to speak full sentences)
* Intracranial pressure (ICP) \>20 mmHg
* Hemodynamic instability (requiring vasopressor support)
* Recent facial, oral, or skull surgery or trauma.
* Acute sinusitis.
* Epistaxis.
* Esophageal surgery.
* Active Hemoptysis (More than 2 tablespoons of frank blood per day)
* Nausea.
* Severe earache or discharge from ear. (Known or suspected tympanic membrane rupture or other middle ear pathology)
* Untreated pneumothorax.
Cost Effectiveness of Laparoscopic Colorectal Surgery

Hypothesis: The total costs of laparoscopic colorectal surgery are less than those of open surgery.

Secondary hypothesis: Patients quality of life is higher following laparoscopic surgery, as compared to open colorectal surgery.

Research objectives:

1. To estimate the cost implications and clinical benefits of incorporating laparoscopic colorectal surgery into routine clinical practice.
2. To examine whether the increased operative costs of laparoscopic surgery are compensated for by a faster recovery, shorter duration of hospital stay, and a reduction in late complications, as compared to open surgery.
3. To investigate whether there are differences in quality of life following laparoscopic colorectal surgery as compared to open surgery.

Lay summary:

Patients needing an operation for a bowel problem have traditionally had an open operation with an incision on the abdomen, and this is the type of operation that is currently performed in the majority of cases in the United Kingdom today (over 90%). Laparoscopic (or keyhole) surgery has been introduced into bowel surgery, but is currently not widely performed. This is because thus far there have been no clear-cut benefits demonstrated with this technique and the perceived costs are higher than an open operation. The investigators aim to evaluate both of these issues.


Eligibility Criteria:
Inclusion Criteria:

* All patients having a colorectal resection, including benign and malignant tumours, inflammatory bowel disease, diverticular disease, and endometriosis

Exclusion Criteria:

* Children
* Emergency procedures
* Patients unable to consent, unable to complete a quality of life diary
Behavioral Counseling Intervention Trial to Reduce Alcohol-related Sexual Risk Behavior Among HIV-negative Men in Namibia

The overall purpose of this study is to evaluate an intervention that aims to reduce alcohol-related HIV sexual risk behaviors among HIV-negative men in Namibia. The objectives of the study are to determine the effectiveness of an individual counseling intervention in reducing alcohol-related HIV sexual risk behaviors among men, and in reducing harmful and hazardous alcohol use among men.

This study involves a randomized controlled trial of 550 HIV-negative adult men recruited from a single Voluntary Counseling and Testing (VCT) center for HIV in Windhoek, Namibia who report harmful or hazardous alcohol consumption and more than one sex partner in the previous three months.

After receiving standard counseling at the VCT center, all men who test HIV-negative will be invited to be screened for eligibility for the study, and if eligible, to consent to enroll. Personnel hired for the study will then administer a baseline survey via Personal Digital Assistant to all enrolled men. Enrolled participants will then be randomized to either an intervention arm, and receive an additional one-hour counseling session and take-home materials plus general alcohol information materials or to a control arm, and receive general alcohol information materials alone. All men enrolled in the study will receive the general alcohol information materials, consisting of a booklet with alcohol health information and a brochure detailing alcohol abuse support services in the local community. Men in the intervention arm will also receive two cellphone text messages one month and four months following enrollment to boost the risk reduction counseling. Follow-up surveys of all participants will be conducted three months and six months after enrollment

Outcomes measured include self-reported data at baseline, three months and six months post-enrollment regarding: 1) Number, proportion of sex acts preceded by alcohol use; 2) Number, proportion of sex acts protected by condoms; 3) Number of sex partners; and 4) Quantity and frequency of alcohol use; 5) Condom use demonstration scores.

Eligibility Criteria:
Inclusion Criteria:

* Self reported HIV negative status after testing at the Council of Churches Namibia (CCN) NewStart VCT center
* More than 1 sexual partner in the past 6 months
* AUDIT screen score 8 to 19
* Able to provide informed consent
* Access to a cell phone to retrieve private text messages and calls
* Plans to stay in the local area for 6 months
* Able to verbally communicate in English, Oshiwambo, or Afrikaans

Exclusion Criteria:

* Self reported HIV positive status after testing at the CCN NewStart VCT center
* Less than 1 sexual partner in the past 6 months
* AUDIT screen score less than 8 or greater than 20
* Unable to provide informed consent to participate to enroll in the study
* Unable to retrieve private cell phone text messages and calls
* Unable to verbally communicate in English, Oshiwambo, or Afrikaans