cyrilzakka/clinical-trials huggingface dataset:
Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections

The purpose of this study is to investigate the frequency of urinary tract infections with symptoms in spinal cord injured patients requiring intermittent catheterization for emptying the bladder. Patients will use either a coated catheter or an uncoated catheter with gel.

Introduction:

Spinal cord injured (SCI) constitutes a large group of patients suffering from neurogenic bladder dysfunction, which is often managed by intermittent catheterization (IC). Intermittent catheterization is accepted as a safe and effective method for maintaining bladder and renal health in individuals with neurogenic bladder dysfunction. However, IC several times a day places an individual at risk for urethral trauma, hematuria, and particularly symptomatic urinary tract infections (UTI).

Attempts to control UTI with prophylactic antibiotics or sterile technique have not been overly successful but more recent advances in catheter technology, such as the hydrophilic-coated catheter, offer potential benefit. The hydrophilic-coated catheter has a slippery, pre-lubricated surface (along the entire length of the catheter) when soaked in water, allowing smooth insertion without the need for additional water soluble lubricant. Two proposed advantages over uncoated catheters are 1) reduced incidence of symptomatic UTI, and 2) reduction of urethral irritation or urethral trauma, and lowered risk of urethral strictures. Currently, while there are trends in favour of hydrophilic-coated catheters with respect to UTI overall evidence remains inadequate for clinical decision-making for choice of catheter type. Randomised trials to date have been limited by short follow up, heterogeneity, attrition, imprecise outcome measures, and varying definitions of UTI5. Conclusions of the Cochrane group in 20076 were echoed in a recent comprehensive re-view of all studies on hydrophilic-coated catheters - there is modest evidence favouring hydrophilic-coated catheter in reduction of UTI, but further robust research is required.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic spinal cord injury within 3 months prior to inclusion
* Neurogenic bladder dysfunction requiring intermittent catheterization at least 3 times daily

Exclusion Criteria:

* Has symptoms of UTI at inclusion
* Treated with prophylactic antibiotics to prevent UTIs
* Has a history of unresolved bladder-ureteral reflux and/or stones in the urinary tract
* Has used intermittent catheterization for more than 10 days prior to inclusion
Study of Platelets Sialylation by Flow Cytometry for the Differential Diagnosis of ICT

Idiopathic thrombocytopenic purpura (ITP) is the most frequent auto-immune cytopenia. There is no specific biological marker and the diagnosis often results from the exclusion of other differential diagnoses, notably inherited thrombocytopenia.

Recent studies have reported an original platelet destruction mechanism in ITP, by antibody-mediated desialylation of membrane proteins. The detection of platelet sialylation can be readily achieved using flow cytometry. This could provide a new biomarker of ITP, useful to ascertain a diagnosis of ITP and guide towards proper patient management.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18yo) with a diagnosis of ITP (primary acute, persisting or chronical)
* Adult patients (\>18yo) with a diagnosis of non immunological thrombocytopenia (constitutive thrombocytopenia, myelodysplastic syndrome, chemotherapy-induced thrombocytopenia)
* Adult patients (\>18 yo) without thrombocytopenia
* Enrolled in a Social Security system
* Having provided informed consent

Exclusion Criteria:

* Minor patients (\<18 yo)
* Enrolled in another clinical study
* Having received corticosteroids or polyvalent immunoglobulins in the past 4
* weeks or anti-platelet therapy or NSAID during the past 7 days
* Having received platelet transfusion in the past fortnight
* With proven iron deficiency
* With drug-induced immune-allergic thrombocytopenia.
* Pregnant and breastfeeding women,
* guardian patients, will be excluded from this population.
68Ga-NOTA-PEG2-RM26 PET/CT, First in Man Study

This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-PEG2-RM26 in prostate cancer patients. A single dose of 2 MBq/kg of 68Ga-NOTA-PEG2-RM26 limited to 100-200 MBq per examination will be given intravenously. Visual and semiquantitative method will be used to assess PET/CT images.

The gastrin-releasing peptide receptor (GRPR), also known as bombesin receptor subtype II (BB2), is a member of the G protein-coupled receptor family of bombesin receptors. GRPR is over-expressed in various types of human tumors. RM26, a GRPR antagonist with high affinity, was discovered by peptide backbone modification of bombesin analogues.

To target gastrin-releasing peptide receptor in human neoplastic cells NOTA-PEG2-RM26 was synthesised and then labeled with 68Ga.

An open-label whole-body PET/ CT study was designed to investigate the safety and dosimetry of 68Ga-NOTA-PEG2-RM26 and to assess its clinical diagnostic value in patients with cancer.

Eligibility Criteria:
Inclusion Criteria:

* Primary/recurrent or metastatic cancer in: prostate cancer, breast cancer, colorectal cancer, gastrointestinal carcinoid, gastric cancer, or lung cancer
* Histopathological diagnosis
* Age 18 years or more and palliative disease OR age above 50 years
* Adequate bone marrow, hepatic and renal function, Eastern Cooperative Oncology Group Performance Status Scale 0 or 1 and a negative pregnancy test

Exclusion Criteria:

* Age less than 18 years
* Less than 6 months since a clinically significant cardiovascular event such as myocardial infarction, unstable angina, angioplasty, bypass surgery, stroke or transient ischemic attack
* Congestive heart failure New York Heart Association class ≥ II
* Pregnant or breast-feeding women
* Patients with reproductive potential not implementing accepted and effective means of contraception
* Participation in any other clinical trial within the previous 4 weeks
* Unable to comply with study procedures (e.g., claustrophobia, low back pain not allowing the patient to lay down in the examination bed)
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes on Anti-Hyperglycemic Medications (IOPE)

The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin glargine as basal insulin therapy in adults with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Have type 2 diabetes mellitus for at least 1 year.
* Are greater than or equal to 18 years old.
* Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1: Metformin- Sulfonylureas-Dipeptidyl peptidase-IV (DPP-IV) inhibitors-Thiazolidinediones (TZDs)
* Have a hemoglobin A1c (HbA1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before Visit 2.
* Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kg/meter squared.

Exclusion Criteria:

* Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
* Have taken any glucose-lowering medications not included in Inclusion Criterion #3; (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before Visit 1.
* Have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
* Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
* Are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
Doxycycline in Treatment of Bleeding With Depot Medroxyprogesterone Acetate (DMPA)

This study aims to test the effect of Doxycycline in treatment of uterine bleeding during the use of injectable contraception that contains one hormone "progesterone only".


Eligibility Criteria:
Inclusion Criteria:

1. Women under DMPA contraception for at least one month.
2. Accept to participate in the trial after receiving adequate information about the trial including information that she is a part of randomization comprising the possibility of receiving new treatment for bleeding or inactive ingredients.
3. Women's ability to keep an accurate menstrual diary for the study.

Exclusion Criteria:

1. Lactating women for the fear of the effect of tetracycline on the breast-fed infant.
2. Patients with already diagnosed local gynecological abnormality.
3. Women receiving treatment for bleeding within the last one month.
A Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated With Ixazomib Plus Lenalidomide and Dexamethasone

The purpose of this study is to investigate the real world effectiveness and safety of ixazomib in combination with lenalidomide and dexamethasone (IRd) in patients with relapsed and/or refractory multiple myeloma (RRMM), under conditions of standard medical care. In addition, an exploratory study of biomarkers will be conducted.

The drug being tested in this study is called Ixazomib. Ixazomib is being tested to treat people who have relapsed and/or refractory multiple myeloma (RRMM) under the conditions of standard medical care. This study is a non-interventional (observational), domestic, multicenter, prospective study in patients with RRMM. This study will look at the effectiveness and safety of ixazomib in combination with lenalidomide and dexamethasone in Japanese patients with RRMM as standard medical care. In addition, an exploratory study of biomarkers will be conducted in this study.

The study will enroll approximately 300 patients. All participants will receive Ixazomib + Lenalidomide + Dexamethasone (IRd) therapy as standard medical care.

This multi-center trial will be conducted in Japan. The overall time of observational period in this study will be 36 months. For each participant, the observation period will be from the start of IRd therapy until either 24 months after the enrollment date of the final patient to enroll, or until death or withdrawal of consent, whichever is earlier.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged 20 years or older at the time of enrollment
2. Patients with RRMM
3. Participants who are scheduled to start IRd therapy
4. Participants who can provide written informed consent of their own free will before the start of study treatment
5. Participants who are judged by the principal investigator or investigator(s) to have the faculty to understand and comply with the requirements of the study

Exclusion Criteria:

1. Female Participants who are nursing or pregnant
2. Participants who have been treated with ixazomib
3. Participants with hypersensitivity to any of the components of IRd therapy, their analogs or excipients
4. Participants with another active malignancy, i.e. synchronous active malignancy or previous malignancy with a disease-free period of less than 5 years, except for participants with carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma judged to be cured by topical treatment
5. Participants who are not registered with, or comply with, the guidelines of the lenalidomide management program
6. Participants who, in the judgement of the principal investigator or investigator(s), are considered to be unsuitable for enrolment into the study
Telemedical Interventional Management in Heart Failure II

Superiority of additional Remote Patient Management (RPM) in patients with chronic heart failure (CHF) in comparison to usual care in terms of, e.g.:

* days lost due to unplanned cardiovascular hospitalization or death
* all-cause mortality
* cardiovascular mortality
* quality of life

The clinical trial assesses 1,500 patients over a period of 12 months each (2013 until 2015). All participants will continue to receive usual care from their general practitioner and specialist. All patients will be examined at the beginning of the study and will undergo a check-up every 3 months. 750 of the patients will be randomly allocated to receive devices for Remote Patient Management (RPM) which will measure various parameters on a daily basis (e.g. weight, blood pressure, heart rate). The devices are mobile and can be used at home or elsewhere.

Eligibility Criteria:
Inclusion Criteria:

* chronic heart failure New York Heart Association (NYHA) class II or III
* echocardiographically determined left ventricular ejection fraction (LVEF) ≤45% or \>45% + minimum 1 diuretic in permanent medicinal therapy
* hospitalization due to decompensated HF within the last 12months before randomization
* informed consent
* Depression score PHQ-9: \<10

Exclusion Criteria:

* hospitalization within the last 7 days before randomization
* implanted cardiac assist system
* acute coronary syndrome within the last 7 days before randomization
* high urgent listed for heart transplantation (HTx)
* planned revascularization, Transcatheter Aortic Valve Implantation (TAVI), MitraClip and/or Cardiac Resynchronization Therapy (CRT)-implantation within the last 3 months before randomization
* revascularization and/or CRT-implantation within 28 days before randomization
* known alcohol or drug abuse
* terminal renal insufficiency with hemodialysis
* impairment or unwillingness to use the telemonitoring equipment (e.g. dementia, impaired self-determination, lacking ability to communicate)
* existence of any disease reducing life expectancy to less than 1 year
* age \<18 years
* pregnancy
* participation in other treatment studies or remote patient management programmes (register studies possible)
Swedish PAP in Osteoarthritis - a RCT Study

The purpose of this study is to determine whether an intervention with Physical activity on prescription (PAP) to individuals in primary care with knee or hip osteoarthritis would result in effects on physical activity level, physical capacity and quality on life.

The hypothesis is that patients with osteoarthritis in hip or knee will increase their level of physical activity significantly more with a PAP intervention compared to patients who only get general advice about physical activity.

According to guidelines the recommended first-line management for people with osteoarthritis consist of exercise, information about osteoarthritis and if necessary, weight reduction. It is well documented that exercise has a positive effect on pain and physical function in these patients. Therefore, it is important to have methods to increase physical activity levels in these patients. It is not explored whether an intervention with PAP may lead to increased physical activity in patients with knee or hip osteoarthritis. The study will be a prospective, randomized, single-blind intervention study including 140 patients (70 patients/group). Patients will in a parallel design be randomized to intervention or control group. Both groups receive oral and written information about osteoarthritis and if necessary, advice on weight loss. The intervention group receives Swedish Physical activity on prescription. It is a patient-centered counselling about physical activity related to the disease. The counselling results in an individualized written prescription on physical activity including specific modes on physical activity. After three weeks, three months and six months they are offered a follow up which could be by telephone or personal meeting. During the follow up they discuss who the physical activity works out and plan new goals. The control group will receive an intervention with general advice about being active three times a week and do strength training functional during the day. Patients in the control group see the physiotherapist once.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with clinically verified osteoarthritis in knee or hip
2. Sedentary (physical activity level, less than 150 minutes of moderate-intensity or less than 75 minutes of vigorous-intensity a week) includes

Exclusion Criteria:

1. Severe pain in hip or knee when walking
2. Other serious disorders causing problems when walking
3. Back injury causing pain in the leg
4. Cruciate ligament injury in the knee which causes severe dysfunction
5. Severe menisci injury
6. Total joint replacement in hip or knee
7. Unable to understand Swedish and follow verbal visual instructions

Study population: Patients who contact primary care center because of their hip or knee osteoarthritis and which is referred to the physical therapist. Seven health centers in Gävle include patients.
Ketoprofen Gel vs Placebo in Low Back Pain

This study aimed to analyse the analgesic effect of ketoprofen gel in patients presented with mechanical low-back pain to the emergency department.

Mechanical low-back pain which warrants immediate pain relief is not an infrequent symptom for emergency department physicians to deal with. Parenteral analgesic is the most common drugs for the these patients in emergency department. However, pain killers in gel forms have not been studied sufficiently for ceasing the pain of these patients. This study aimed to analyse the analgesic effect of ketoprofen gel in patients presented with mechanical low-back pain to the emergency department.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 and lower 65 years old
* Patients presented with mechanical low-back pain

Exclusion Criteria:

* Pain more than 24 hours
* Pain lower than with a pain score of 40 mm
* Allergy to ketoprofen
* Drug or alcohol addiction
* pregnancy and breast feeding
Suitability of an Infant Formula With L-5-Methyltetrahydrofolate for the Particular Nutritional Use in Infants

The study is designed to show equivalence of an infant formula containing L-5- Methyltetrahydrofolate (MTHF) compared to a standard infant formula containing folic acid in respect to weight gain of healthy term infants receiving these infant formulae exclusively during the first 4 months of life. Healthy non breast fed infants will be randomized to receive either a standard infant formula with folic acid or a corresponding formula with MTHF instead of folic acid. Besides weight and length further anthropometric measures will be taken monthly from the age of 4 weeks to the age of 16 weeks and at the age 4 and 16 weeks blood samples will be taken for the determination of folate status and genotyping. As a reference the same measures will be taken in a group of breast fed infants, whose mothers' folate status will be determined as well.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent (by parents, caregiver)
* Healthy male or female infants \<28 days of life
* Gestational age at delivery ≥37 and ≤42 weeks
* Birth weight between 2500 - 4500g
* Parents / Caregivers are able to speak Serbian language

Exclusion Criteria:

* Serious acquired or congenital diseases that is expected to interfere with normal feeding or growth
* Feeding of more than 10% of energy (1 bottle/day) from sources other than the formula (or breast milk in the reference group) at inclusion
* Participation in another clinical study
* Mothers with diabetes mellitus (including gestational diabetes)
* Reason to presume that the parents are unable to meet the study plan requirements
* Diseases of the mother which have an effect on the child's gastro-intestinal tract/ability to be fed
* Major abnormalities in hematological parameters
* Major abnormalities in hepatic, renal or metabolic functions
* Use of medication and vitamin supplements except vitamin K or D supplementation or vaccination
* Mother follows a vegan diet
Evaluating Monitoring Techniques for Postoperative Spinal Cord Ischemia

During open surgery of a thoraco-abdominal aortic aneurysma (TAAA), diminished blood flow to the myelum can result in hypoxia, compromising proper function of the spinal cord.

Intraoperatively, motor evoked potentials (MEP) are elicited to measure the functional integrity of the spinal cord. MEPs have proven to be a reliable marker of spinal cord ischemia. Moreover, these potentials react within minutes, which facilitates interventions to restore the blood flow. Monitoring intraoperatively with this ancillary test has reduced the rate of paraparesis to \< 5%. Unfortunately, in the early postoperative period, spinal cord vulnerability is high. Therefore, some patients develop paraparesis, not during the surgical procedure, but after the surgical procedure. Postoperatively, suboptimal blood flow may lead to critical loss of function. This inadequate perfusion results in "delayed paraparesis". In the postoperative patient, it is not possible to measure MEPs when sedation is decreased, due to the high intensity of the electrical stimulus, which is unacceptably painful in the unanesthetized or partially anesthetized patient. Therefore ancillary tests are needed which can detect spinal cord ischemia postoperatively early, thus preceding the phase with clinically overt paraparesis. The test should be reliable and easy to perform for an extended period of time (up to several days).

The purpose of this study is to explore the usefulness of various neurophysiological tests regarding accuracy and feasibility for the detection of spinal cord ischemia. In particular, to find a diagnostic test which is acceptable for the unanesthetized or partially anesthetized patient and therefore can also be performed postoperatively. These tests will be examined in fully sedated as well as partially sedated patients.

The following candidate tests will be examined:

1. Long loop reflexes (LLR) consisting of F-waves.
2. Oxygenation measurements of the paraspinal muscles using Near-infrared spectroscopy (NIRS).


Eligibility Criteria:
Inclusion Criteria:

* Thoraco-abdominal aneurysm (TAA) of the descending aorta: Crawford type I,II, III, IV or V
* Repair using open surgical or endovascular procedure.
* Undergoing monitoring by motor evoked potentials (MEP) as part of the standard surgical procedure.

Exclusion Criteria:

* Aneurysm only in ascending part of the aorta
* Standard contraindications for motor evoked potential (MEP) monitoring.
* Standard contraindications for electrode placement (skin wounds, etc.)
* No informed consent can be obtained prior to the procedure
MuLtibranchEd Graft for OPen RepAir of ThoRacoabdominal Aneurysms

The objective of the study is the evaluation of the technical success and clinical outcomes of the surgical treatment of thoraco-abdominal aortic aneurysms treated by Jotec "TAAA spinal loop graft" "custom made "CE equivalent" branched prosthesis, compared with the patient cohort already treated with standard and / or bench-top prostheses Gelweave ™ Coselli Thoracoabdominal Grafts.


Eligibility Criteria:
Inclusion Criteria:

* patients aged ≥ 18 years;
* patients candidates for surgical treatment of thoraco-abdominal aorta of the II and III type sec. Crawford using "TAAA spinal loop graft" "custom made CE equivalent" prosthesis

Exclusion Criteria:

• patients aged ≤ 18 years