cyrilzakka/clinical-trials huggingface dataset:
Comparing the Safety and Efficacy of Paclitaxel Controlled Release Balloon Catheter in the Treatment of In-stent Restenosis of Coronary Artery Lesion With Paclitaxel Release Coronary Balloon Catheter

Study purpose The safety and efficacy of paclitaxel controlled release balloon catheter Vasoguard TM in treatment of in-stent restenosis.

Study group Experimental group: paclitaxel controlled release balloon catheter Vasoguard TM Control group: paclitaxel release coronary balloon catheter SeQuent Please


Eligibility Criteria:
Inclusion Criteria:

- Subject need 18 to 80 years of aged male or non-pregnant women; Subject has stable anina pectoris, or unstable anina pectoris, or old myocardial infarction patients, or ischemia with evidence but without symptom; Subject has a life expectancy of more than 2 years; Subject occurred restenosis after vessel lesion in situ receiving the first stent operation; In-stent restenosis type Mehran I, II, III, IV, reference vessel diameter of 1.5-4.0 mm, length of 40 mm or less; Target lesion stenosis must be equal or greater than 70% or 50% and with evidence of ischemia; Single or two coronary small vessel lesions in situ; Other lesion which need interventional treatment must be away from target lesion at least 10 mm; Subject can understand the trail purpose, sign informed consent voluntarily, agree to accept clinical telephone follow-up and angiographic follow-up at 9 months; Target lesion can be pre-expanded successfully (Guide wire can get through lesion, balloon pre-expand the remnant stenosis of vessel lumen is less or equal to 50%, without current limiting interlayer and thrombosis).

Exclusion Criteria:

- Patient that in the opinion of the investigator is not appropriate for this trail; Pregnancy and lactation female patients; Patient has a life expectancy of less than 2 years; Severe congestive heart failure or NYHA IV heart failure; Patient who have bleeding constitution, cannot use anticoagulation and antiplatelet drugs; Patient that happened acute myocardial infarction within a week; Patient who happened stroke within six months; Patient who with severe renal failure (GFR≤30ml/min); Patient who had received heart transplantation; Patient who cannot tolerate aspirin and / or P2Y12 receptor inhibitor drugs; Patient who has allergy to paclitaxel, PLGA or contrast agent; Peptic ulcer or gastrointestinal bleeding within the prior 6 months. Patients who are participating in another drug or device clinical trail, which have not completed the primary endpoint follow- up period.

Angiographic relevant： Three or more coronary artery vessel lesion; Target vessel has extensive thrombosis evidence; Restenosis of vein graft after bypass surgery; Left main coronary artery and ostial lesion within 2mm; Target lesion proximal exist seriously distorted or severe calcified lesion.
Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly

This study will evaluate the efficacy and safety of pasireotide LAR 40 and 60 mg versus octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with written informed consent prior to any study related activity
2. Patients who had inadequately controlled acromegaly as defined by a mean GH concentration of a 5-point profile over a 2-hour period \> 2.5 µg/L and sex- and age-adjusted IGF-1 \> 1.3 x upper limit of normal (ULN)
3. Patients who had been treated with maximum indicated doses of octreotide LAR or lanreotide ATG for at least 6 months prior to visit 1 (screening). The maximum indicated dose for octreotide LAR was 30mg and for lanreotide ATG iwas120 mg
4. Patients who had a diagnosis of pituitary micro- or macro adenoma. Patients could have been previously submitted to surgery
5. Patients who completed the 24-week treatment period in core according to the requirements of the core study protocol or corresponding amendments could enter extension

Exclusion Criteria:

1. Patients who had received pasireotide (SOM 230) prior to enrolment
2. Concomitant treatment with Growth Hormone Receptor (GHR)-antagonist or dopamine agonists unless concomitant treatment was discontinued 8 weeks prior to visit 1 (screening)(8 weeks wash out period). Such patients must have been treated with octreotide LAR 30 mg or lanreotide ATG 120 mg monotherapy continuously for a minimum of 6 months prior to starting combination therapy and they should have been inadequately controlled on monotherapy.
3. Patients who had compression of the optic chiasm causing acute clinically significant visual field defects
4. Patients who required a surgical intervention for relief of any sign or symptom associated with tumor compression
5. Patients who had received pituitary irradiation within 10 years prior to visit 1 (screening).
6. Patients who had undergone major surgery/surgical therapy for any cause within 4 weeks prior to visit 1 (screening).
7. Patients who were hypothyroid and not adequately treated with a stable dose of thyroid hormone replacement therapy
Neuromuscular Electrical Stimulation and Septic Shock

The study will investigate the effects of neuromuscular electrical stimulation (NMES) in patients with septic shock. The objective of this study will be investigate the effects of neuromuscular electrical stimulation (NMES) in patients with septic shock.

The study will investigate the effects of neuromuscular electrical stimulation (NMES) in patients with septic shock.

It will be a randomised crossover clinical trial. Thirty-one patients will enrolled.The study will be divided in two phases, the first will be held in the first 72 hours of septic shock and the second after three days of first assessment. Patients will be selected, randomly, to the intervention Protocol (NMES) and control (positioning). After this procedure the patients will be allocated in Group 1 (NMES and control) or group 2 (control and NMES), with a wash-out period of 4 to 6 hours in between .

The main outcome will be the study of mobilization of endothelial progenitor cells (EPCs). The secondary outcome will be the metabolic and hemodynamic data. Linear mixed model will be used for analysis of dependent variables and estimated values of the mean of the differences of each effect.

The results of this study will allow better understanding of the effects of NMES in patients with septic shock.

Eligibility Criteria:
Inclusion Criteria:The patients admitted to the intensive care unit will be considered eligible if:

* they present in the first 72 hours the diagnosis of septic shock according to the international consensus definition of septic shock, and
* stable hemodynamics through fluid resuscitation, and
* vasoactive drugs and mechanical ventilation.

Exclusion Criteria:The exclusion criteria will be patients aged less than 18 years and greater than 65 years, pregnant women, brain death, neuromuscular diseases, use of pre-existing neuromuscular blocker in the last 24 hours, prior to the study protocol.

* Contraindications for the use of NMES: fractures, burns and skin lesions, systemic vascular impairment diseases such as systemic lupus erythematosus, thromboembolic disease, deep vein thrombosis (which was not therapeutically anticoagulated for a time greater than 36 hours), lower limb amputations, cardiac pacemaker, thrombocytopenia less than 20,000/mm3, BMI greater than 35 kg/m2, important lower extremity oedema, agitation and/or signs of pain during the electrical stimulation.
* Contraindications to begin or continue NMES procedure: Mean arterial blood pressure less than 65 mmHg, use of vasopressor \>50% of the maximum dose (dopamine \>12.5 µg/kg per minute; vasopressin \>0.02U/min and norepinephrine \>1 µg/kg per minute), heart rate \<50 or \>140 bpm, arrhythmias with hemodynamic consequences, myocardial ischemia, temperature \<34 or \>39oC, intracranial pressure \>20 cmH2O, decrease in 10% of SpO2 baseline value or \<88% for more than one minute.
Haploidentical Stem Cell Transplantation in Neuroblastoma

Children with primary resistant or relapsed neuroblastoma who do not achieve remission with conventional chemotherapy have extremely dismal prognosis. A novel treatment strategy combining tumor targeted radioisotope treatment with metaiodobenzylguanidine (MIBG) and immunotherapeutic effect of haploidentical stem cell transplantation (haploSCT) followed by low-dose donor lymphocyte infusions will be piloted. The use of the isotope is aimed to decrease pre-transplant tumour burden. Reduced intensity conditioning containing Fludarabine, Thiotepa and Melfalan will enable sustained engraftment as well as will serve as additional anti-tumor treatment. A prompt natural killer (NK)-cell mediated tumour control may be achieved by haploidentical stem cell transplantation. The investigators hypothesize that tumour cells potentially evading NK-cell mediated immunity may be targeted by infused donor T-cells and eliminated by either MHC-dependent manner or through a bystander effect. The possible graft versus tumor effect will be evaluated in children with therapy resistant neuroblastoma.


Eligibility Criteria:
Inclusion Criteria:

* Refractory neuroblastoma (any chemo/radiosensitive stable disease)
* Relapse incl. autologous HSCT 3 m earlier
* Primary induction failure
* Cardiac output SF ≥25%
* Creatinine clearance ≥40 cc/min/1.73 m2
* Performance score of ≥50% (Lansky or Karnofsky)
* Available haploidentical family donor, aged ≥18 yrs, HIV-neg

Exclusion Criteria:

* Rapidly progressive disease
* Pregnancy
Simulation Training to Improve 911 Dispatcher Identification of Cardiac Arrest

This study is to test the use of simulation training to improve 9-1-1 telecommunicators' call processing and response. Training sessions will expose 9-1-1 telecommunicators to several realistic emergency situations through mock 9-1-1 calls with a trained actor playing the part of a reporting party, followed immediately by feedback on call handling provided by a trained call observer. Investigators hypothesize that simulation followed by trained observer-directed feedback will increase correct triage of medical emergency and delivery of pre-arrival instructions during simulated calls and in actual 9-1-1 calls.


Eligibility Criteria:
Inclusion Criteria: 9-1-1 call-center call receivers. -

Exclusion Criteria:

-
An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus

The aim of this study is to to determine whether atorvastatin 40mg per day is effective in the treatment of SLE.

Background: Statins are lipid-lower agents with pleiotropic effects. Beyond the traditional effect as inhibitors of 3-hydroxy-3methylglytaryl coenzyme A (HMG-CoA) reductase, it has anti-inflammatory and immunomodulatory properties. The administration of atorvastatin to lupus-prone model NZB/W F1 mice results in a significant reduction in serum IgG anti-dsDNA Abs and decreased proteinuria. In a pilot study with three patients with SLE, simvastatin induced rapid and significant reduction in proteinuria levels. However, further randomized double-blinded placebo-controlled study is pending.

Objective: The goal of this study was to evaluate the clinical efficacy and laboratory effect of atorvastatin in SLE.

Methods: Forty patients with SLE will randomize in two groups to receive atorvastatin or not as an adjuvant to immunosuppressive agent therapy. Patients who received atorvastatin for 6 months will stop atorvastatin for 8 weeks as a washout period. We will cross over the placebo and experimental groups, then given atorvastatin for another 6 months. Primary outcome is improvement of lupus disease status measured by SLEDAI and microcirculation improvement via nailfold capillaroscopy.

Eligibility Criteria:
Inclusion Criteria:

1. 16-80 years of age, fulfilling ACR criteria for the classification of SLE (no limit on disease duration)
2. Active disease status including (1) active nephritis with moderate proteinuria (between 1.0gm/day and 2.5gm/day) despite ongoing immunosuppressive therapy or (2) moderate active extra-renal component of the SLEDAI score in the range of 3 to 10. The SLE-DAI score should have been stable for at least two weeks prior to screening.
3. The type and number immunosuppressive agents were not changed in recent one months

Exclusion Criteria:

1. inability to give informed consent;
2. myositis (CK\>3×normal value);
3. dialysis or serum creatinin\>2.5mg/dL;
4. abnormal liver function (ALT\>3×normal value);
5. pregnant or breastfeeding;
6. life-threatening illness that would interfere with ability to complete the study;
7. current drug or alcohol abuse
8. Already under statin therapy
9. Active SLE disease need added new immunosuppressive agent or increased current drug dosage for more than 50%.
The Effect of Education Hemodialysis Patients According to Roy Adaptation Model

The study was conducted in order to evaluate the effect of the training provided to hemodialysis patients according to Roy Adaptation Model on fluid management, symptom control, and quality of life. The study was carried out as a randomized controlled trial with the participation of 107 patients (53 experimental, 54 control) The patients in the experimental group were provided with training based on Roy Adaptation Model, and training booklets were handed out.The control group did not attempt any intervention.

The most difficult domain for hemodialysis patients is fluid-salt restriction. Patients with inadequate fluid compliance/adherence experience many symptoms that negatively affect their life.

The study was carried out as a randomized controlled trial with the participation of 107 patients (53 experimental, 54 control).

The data were collected by using "Patient Information From", "Fluid Control in Hemodialysis Patients Scale" (FCHPS), "Dialysis Symptom Index" (DSI), and "Nottingham Health Profile" (NHP). The forms were filled out by having interviews with the patients in the experimental and control groups in the 0th, 1st, and 3rd months. The patients in the experimental group were provided with training based (face to face individual) on Roy Adaptation Model (0th(onset)and 1st month), and training booklets were handed out. The Training was about 30-45 minutes. control group did not attempt any intervention. Routine maintenance of the control and experimental group and continued. When comparing the experimental and control groups, onset 0th month, 1st month and 3rd month measurements were taken into consideration. All scales were administered to the experimental and control groups at month 0 (onset), 1 and 3 months.

The data were analyzed by using descriptive statistics methods with NCSS (Number Cruncher Statistical System) 2007 software, Student's t-test, Mann-Whitney U Test, Pearson Chi-square test, Fisher-Freeman-Halton Exact test, Repeated Measures test, Bonferroni testi Significance was accepted as p\<0,05.

Eligibility Criteria:
Inclusion Criteria:

Patients with end-stage chronic kidney disease older than 18 years undergoing routine hemodialysis treatment for at least 3 months having 3 hemodialysis sessions literate volunteered to participate in the study

Exclusion Criteria:

Patients with acute renal failure previously diagnosed with liver failure and/or malignancy

,patients with New York Heart Society class 3-4 heart failure a history of kidney transplantation
Hypertension Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension (VENIS)

The purpose of this study is to gain information on safety and efficacy from Korean patients who starting Ventavis treatment by observational method.


Eligibility Criteria:
Inclusion Criteria:

* The treating physician has chosen Ventavis as a suitable treatment for the patient
* Patient with PH and classified as NYHA functional class III or IV and WHO group 1

Exclusion Criteria:

* Any condition that prevents participation in the study, including pregnancy and other contraindications for Ventavis treatment (as listed in the current Ventavis patient package insert).
Evaluation of Ultrasonic Scissors and Diathermy for Axillary Clearance in Breast Cancer Patients

Breast surgery plays an important role in the treatment of breast cancer. This study investigates if the use of Harmonic Focus has advantages than the use of conventional diathermy in axillary clearance due to metastatic breast cancer.

Breast surgery plays an important role in the treatment of breast cancer. Sometimes cancer cells can spread to lymph nodes in the axill. The first lymph node affected in the armpit is called the sentinel node. Surgery to remove this node can answer the question of whether the cancer has spread to the axill. If the node is affected, further surgery is performed to remove most of the lymph nodes in the armpit, a so-called axillary clereance.

The breast unit at Linköping University Hospital performs about 60 axillary clereance per year. Axillary clereance is associated with a number of complications, such as infections, bleeding, pain, loss of sensation and limited mobility in the arm.

Accumulation of wound fluid in the surgical area is common, affecting about a quarter of patients undergoing surgery. Small amounts of wound fluid usually do not require treatment, but larger accumulations usually require drainage. Patients who have symptoms from armpit wound fluid have to make repeated return visits so that a nurse drains the fluid using a needle. This poses several risks to the patient such as infection and/or bleeding. This, in turn, can delay the start of additional treatment and can put a financial burden on both the patient and the healthcare system.

Today, the investigators use a device with a weak electric current (diathermy) to remove lymph nodes from the armpit. Harmonic Focus ® is a pair of scissors that instead uses ultrasound waves to divide the tissue. There are scientific studies showing that the use of ultrasonic scissors reduces the risk of fluid accumulation and thus the risk of complications after surgery\[1, 2\]. The investigators want to conduct a prospective study, an economic analysis comparing the costs of using diathermy versus Harmonic Focus®.

In addition, patients will complete a quality of life questionnaire before surgery, approximately 4-6 weeks after and one year after surgery. The results of the questionnaires will be compared between the Harmonic Focus® and the diathermy group.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* All patients who will undergo axillary evacuation
* Informed consent

Exclusion Criteria:

* Patients who have previously undergone axillary evacuation.
Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma

The intent of the study is to assess the antitumor activity of PHA-848125AC as second-line treatment in patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy.

The Simon's optimal 2 stage design is adopted for this single-arm, open-label, multicenter phase II clinical trial of PHA-848125AC administered to patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy (only one prior systemic therapy allowed). The intent of the study is to assess the antitumor activity of PHA-848125AC and ultimately to improve the outcome of patients with thymic carcinoma who have already exploited one chemotherapy option. The primary end point for this study is a progression free survival rate of 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven diagnosis of unresectable B3 thymoma or thymic carcinoma recurrent or progressing after prior chemotherapy (only one prior systemic therapy allowed)
* Presence of measurable disease
* Age \>=18 years
* ECOG performance status 0-1
* Negative pregnancy test (if female in reproductive years)
* Use of effective contraceptive methods if men and women of child producing potential
* Adequate liver function Total Serum Bilirubin \<=1.5 x upper limit of normal (ULN) Transaminases (AST/ALT) \<=2.5ULN (if liver metastases are present, then \<=5ULN is allowed) ALP \<=2.5ULN (if liver and/or bone metastases are present, then \<=5ULN is allowed)
* Adequate renal function Serum Creatinine \<=ULN or Creatinine Clearance calculated by Cockcroft and Gault's formula \> 60 mL/min.
* Adequate hematologic status ANC \>=1,500cells/mm3 Platelet Count \>=100,000cells/mm3 Hemoglobin \>=9.0g/dL
* Two weeks must have elapsed since completion of prior chemotherapy, minor surgery, radiotherapy (provided that no more than 25% of bone marrow reserve has been irradiated)
* Resolution of all acute toxic effects of any prior treatments to NCI CTC (Version 3.0) grade \<=1

Exclusion Criteria:

* Any of the following in the past 6 months: myocardial infarction, uncontrolled cardiac arrhythmia, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis
* Grade \>1 retinopathy
* Known brain metastases
* Known active infections
* Pregnant or breast feeding women
* Diabetes mellitus uncontrolled
* Gastrointestinal disease that would impact on drug absorption
* Patients under treatment with anticoagulants or with coagulation disorders or with signs of hemorrhage at baseline
* Patients with previous history or current presence of neurological disorders, including epilepsy (although controlled by anticonvulsant therapy), Parkinson's disease and extra-pyramidal syndromes
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that make the patient inappropriate for entry into this study
Effect of Different Protein Diets on Glucose and Insulin Metabolism and Substrate Partitioning

The purpose of this study is to determine whether different protein diets affects glucose and insulin metabolism and substrate partitioning.


Eligibility Criteria:
Inclusion Criteria:

* BMI: 18.5-25 kg/m2 (lean)
* Gender: Male
* Age: \<35 years
* Caucasian

Exclusion Criteria:

* Elevated fasting blood glucose level
* Lactose intolerant
* Diabetes Mellitus
* Hypertension (systolic/diastolic blood pressure)
* Hypotension (systolic/diastolic blood pressure)
* Cardiovascular diseases
* Asthma and other obstructive pulmonary diseases