cyrilzakka/clinical-trials huggingface dataset:
Dorsal Root Ganglion Stimulation for the Management of Painful Intractable Small Fibre Neuropathy:

A prospective, single-arm, mono-centre pilot study to obtain preliminary information on the ability of Dorsal Root Ganglion Stimulation (DRGS) in alleviating the painful symptoms in patients with small fiber neuropathy (SFN).

This study is a prospective, single-arm, mono-centre pilot study enrolling a maximum of 31 patients with SFN. All enrolled patients will receive a trial neurostimulation (TNS) lasting from 3 to 30 days and only patients with a positive result in terms of pain intensity reduction will be eligible for the implanted neurostimulation (INS) phase. The target number of patients eligible for INS is 10 and this population will be assessed for impact of DRGS on the neuropathic pain caused by SFN. The expected duration of patients participation will be 14 months. The rationale for this open label approach is that this is a novel technique for which pilot data with regard to applicability and efficacy have yet to be established. Data gathered in the study will provide preliminary data required to assess the feasibility of this intervention, to be used for possible future studies with a more rigorous methodological approach (i.e. controlled trial, randomized controlled trial).

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older at inclusion
* Chronic, intractable painful SFN in the peripheral limbs during at least 12 months and a biopsy positive for SFN, with a chronic pain intensity of ≥ 6 on a Numeric Rating Scale (ranging from 0 to 10), for which previous drug therapy was unsuccessful
* Stable medication dosage in the 30 days prior to inclusion
* Stable pattern of neurological symptoms

Exclusion Criteria:

* Known or suspected non-compliance
* Drug or alcohol abuse
* Pain predominantly in upper limbs
* Neuropathy or chronic pain in limbs of other origin than SFN
* Peripheral vascular disease
* Severe foraminal stenosis at the expected target level
* Coagulation disorders
* Known immune-deficiency
* Other significant concomitant diseases and any concomitant malignancies
* Presence of other indwelling devices
Study to Investigate Benefits of Weight Loss in Young Adults and Adolescents

The purpose of this study is to investigate the changes in subcutaneous adipocyte size, number and gene expression after weight loss and to assess whether those changes contribute to decreases in ectopic fat accumulation and insulin resistance in women between ages of 16-32.

There are no studies in young women that have prospectively studied changes in fat cell size, gene expression and insulin sensitivity during the transition from overweight/obese to normal weight. Our preliminary data suggest that the presence of ectopic fat accumulation and insulin resistance in obese children could be considered an "early phase" in the development of T2DM. We hypothesize that a 10% weight loss will restore/improve insulin sensitivity. Furthermore, we speculate that the decrease in subcutaneous fat mass after weight loss is due to a decrease in mean adipocyte cell size, but not cell number.

Eligibility Criteria:
Inclusion Criteria:

* Women ages 16-32

Exclusion Criteria:

* They will not be on any medications that are known to alter glucose or insulin metabolism, such as oral steroids, or certain psychiatric medications, such as Xeleca, Lithium and Paxil. Patients on diuretics will be excluded.
Neutrophil Gelatinase-associated Lipcalin(NGAL): A Novel Blood Marker for Determining the Risk of Developing Contrast-Induced Nephopathy

This is a multi-center clinical study designed to assess the performance of the Triage NGAL test as an aid in the early risk assessment for contrast-induced nephropathy (CIN). Approximately 260 adults at risk for CIN undergoing intra-arterial angiography involving administration of iodinated contrast agent(s) will be enrolled.

EDTA anti-coagulated blood samples will be drawn at eight different time points from within 1 hour prior to first contrast administration through 48 hours. These blood samples will be processed to plasma at the clinical site, frozen and shipped to Biosite for storage and testing of Triage NGAL and serum creatinine. The results of these assessments will be blinded to the medical team during the study and will not impact the medical management of the subject.

Any additional serum creatinine measurements obtained by the medical team as part of routine care as well as need for dialysis, hospitalization, major adverse cardiovascular events and mortality will be recorded through Day 30.

Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 years of age or older;
* Undergoing angiographic procedure involving the intra-arterial administration of iodinated contrast agent(s);
* Chronic kidney disease indiacated by an eGFR \< 75 ml/min/1.73 m2 based on screening labs performed ≤ 3 months prior to procedure.
* Able and willing to provide written informed consent for study participation and to comply with all study procedures.

Exclusion Criteria:

* Renal transplant recipients
* Pre-existing evidence of acute renal failure at the time of enrollment.
* Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at enrollment.
* Coronary artery bypass surgery or PCI within the previous 30 days.
* Participation in an interventional clinical study with an experimental therapy within the previous 30 days.
* Administration of intravasular contrast within the previous 30 days.
* Undergoing renal artery stenting.
Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes

Pulmonary Safety in Diabetics with T/I


Eligibility Criteria:
Inclusion Criteria:

* For All Subjects:

  * Nonsmoking
  * Body mass index \<42 kg/m2
  * FEV1 greater than or equal to 70% of predicted , DLco and TLC greater than or equal to 80% of predicted at screening,
  * No abnormalities in screening pulmonary radiology
* For Subjects with diabetes mellitus:

  * Type 1 or type 2 diabetes for at least 2 years
  * HbA1c greater than or equal to 6.6 % and less than or equal to 12.0 %
* For Subjects without abnormalities in glucose control:

  * No history of diabetes
  * Normal results from a formal glucose tolerance test

Exclusion Criteria:

* History of chronic obstructive pulmonary disease, asthma, or other significant pulmonary disease
* Significant renal, hepatic, or cardiac disease
* Women who are pregnant, lactating, or planning on becoming pregnant
* Subjects who have participated in studies of other investigational drugs within the previous 3 months
* Evidence of severe complications of diabetes
The Effect of Substitution of Out-of-hours Care From General Practitioners to Nurse Practitioners

The aim of this study is to explore the effects of substitution in out-of-hours primary care. In consecutive stages an extra General Practitioner (GP) is substituted by a Nurse Practitioner (NP) aiming at replacing 3 out of 4 GPs by NPs. Effects are measured in terms of feasibility and cost-efficiency.

Out-of-hours care in the Netherlands is under pressure. Workload for GPs during out-of-hours care is high and there are concerns about maintaining the quality of care. Since 80% of the complaints shown in out-of-hours care is neither complex nor urgent not all patients necessarily have to be seen by a GP.

A previous study (ID: 80-82800-98-227) indicated that shifting care from GPs to NPs is possible in terms of safety and quality of care and resulted in cost savings due to less treatment. In that study 4 GPs and 1 NP provided care in the experimental condition and 5 GPs provided care in the control condition. Based on the results it is hypothesized that NPs are competent to diagnose and treat at least 75% of the complaints shown in out-of-hours primary care. Substituting more GPs by NPs in out-of-hours care will probably lead to more cost savings.

In the current study care delivered and direct healthcare costs are compared between different team compositions. In the experimental condition care is provided by a team of NPs and GPs. The intervention starts with a team of 4 professionals in both the experimental (3 GPs and 1 NP) and the control (4 GPs) condition; in consecutive stages an extra GP is substituted by an NP aiming at replacing 3 out of 4 GPs with by NPs.

Control: 4 GPs

Stage 1: experimental: 3 GPs \& 1 NP

Stage 2: experimental: 2 GPs \& 2 NPs

Stage 3: experimental: 1 GP \& 3 NPs

Both feasibility and cost-efficiency will lead to recommendations on the optimal balance in a team between GPs and NPs.

Eligibility Criteria:
Inclusion Criteria:

* Patients (with urgencylevel U2, U3, U4, or U5) requesting an appointment at the primary out-of-hours service during the weekend between 10am and 6pm.

Exclusion Criteria:

* None
CRyo-Ablation to Treat Patients With HOCM.

The purpose of the study is to perform endocardial catheter CRyo-Ablation to relieve the LVOT obstruction in patients with Hypertrophic Obstructive Cardiomyopathy.

The investigators hypothesize that the investigators will be able to reduce \> 50% of the initial LVOT gradient. This will be considered as a successful procedure.


Eligibility Criteria:
Inclusion Criteria:

1. The patient must be ≥18 years of age
2. The patient has left ventricular outflow tract obstruction with hypertrophic obstructive cardiomyopathy
3. The patient is on optimal medication
4. The patient is not eligible for/failed/refused alcohol ablation
5. The patient is not eligible for/failed/refused myectomy
6. The patient is willing to participate in the study and has signed informed consent
7. The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved be the appropriate medical ethics committee.

Exclusion Criteria:

1. Pregnant or nursing patients Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test
2. Patient has history of or known impaired renal function (Serum creatinine \>2.0 mg/dL or 177 µmol/l) or on dialysis
3. Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated
4. Patient has a known hypersensivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel and/or contrast sensitivity/allergy that cannot be adequately pre-medicated
5. Patient has other medical illness not related to the hypertrophic cardiomyopathy (e.g., cancer, known malignancy, or cognitive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with limited life expectancy (i.e., less than 1 year)
6. Subject is enrolled or intended to participate in any concurrent drug and/or device study, which would confound the results of this trial as determined by the investigator, during the course of this clinical study
7. Subjects meets the exclusion criteria required by local low (e.g. age, pregnancy, breast-feeding, etc)
8. Subject is anticipated not being able to complete the study
Effects of Diet Interventions on Monocytes in Metabolic Syndrome

Subjects with hypertriglyceridemia and metabolic syndrome are being recruited and receive diet interventions with either a high-saturated fat diet or a low-fat high protein diet for 4 days (days 1-4) and a breakfast on day 5. Blood samples are collected on day 1 and day 5 to examine lipid levels and circulating monocyte phenotypes.

Subjects with hypertriglyceridemia and metabolic syndrome are being recruited and receive diet interventions with either a high-saturated fat diet or a low-fat high protein diet for 4 days (days 1-4) and a breakfast on day 5. Blood samples are collected on day 1 at fasting state and on day 5 at fasting state and 4 and 6 hours after the breakfast to examine lipid levels and circulating monocyte phenotypes.

Eligibility Criteria:
Inclusion Criteria:

* Obese women and men with metabolic syndrome (MS)
* Fasting triglyceride (TG) equal to or greater than 150 mg/dl

Exclusion Criteria:

* \<21 years of age
* Perimenopausal, pregnant or breastfeeding women
* Current smokers
* Obvious inflammation or other acute illnesses
* Obesity due to endocrinologic disorders including polycystic ovary syndrome
* Partial lipodystrophy
* Diabetes requiring insulin or \>1 oral medication
* Fasting TG ≥650 mg/dl
* A history of pancreatitis
* Myocardial infarction within the past 3 years
* Any hospitalization within the past 2 months
* Takes steroids.
Treatment of Congenital Factor VII Deficiency

This study is conducted globally. The aim of this study is to describe the treatment modalities and outcomes of bleeding episodes, surgery and prophylaxis in patients with factor VII (FVII) deficiency in addition to evaluate the presence (in already treated patients) and/or the appearance of inhibiting antibodies to FVII and/or therapy-related thrombosis.

Due to a Novo Nordisk commitment to the Committee for Medicinal Products for Human Use (CHMP), Novo Nordisk receives data on treatment with activated recombinant human FVII (rFVIIa, NovoSeven®) in patients with FVII deficiency from the Seven Treatment Evaluation Registry (STER, NCT01269138). These patients can also have been treated with other haemostatics for systemic administration.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent by the patient or next of kin or legally acceptable representative to collect data on treatment of a given bleeding episode, surgical event or prophylactic regimen as specified in the protocol. If informed consent is provided by the next of kin or legally acceptable representative, consent must also be obtained from the patient as soon as he/she is able to do so. Informed consent should preferentially be obtained before initiation of treatment or as a minimum before entry of data into the database
* Any patient with a FVII deficiency for whom treatment of bleeding episodes, prevention related to surgery and primary/secondary prophylaxis is considered necessary by the treating physician can be enrolled
* Patients with FVII deficiency without any immediate need for treatment will be entered as stand by registered patients with capture of baseline- and demographic data only. Admission data is entered once an event occurs
Phase 1 Study of SGI-110 in Patients With Acute Myeloid Leukemia

To evaluate the tolerability and pharmacokinetics of SGI-110 when administered subcutaneously to Japanese patients with acute myeloid leukemia (AML).


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with a diagnosis of AML (WHO classification 2008).

  * Patients, 20 years of age or older, who are unresponsive to standard chemotherapy or have relapsed following standard chemotherapy
  * Patients, 65 years of age or older, who are not eligible for standard intensive chemotherapy
* Patients with ECOG performance status (PS) of 0 to 2
* Patients with adequate organ function
* Women of child-bearing potential must not be pregnant or breast feeding (pregnancy test will be performed at Screening). Women of child bearing potential and all men with female partners of child bearing potential must practice two medically acceptable methods of birth control and must not become pregnant or father a child while receiving treatment with SGI-110 and for 3 months following last dosing.
* Patients who have undergone prior allogeneic hematopoietic stem cell transplantation must have no evidence of active graft-versus host disease (GVHD) and must be off immunosuppressive therapy by ≥2 weeks prior to IMP administration.

Exclusion Criteria:

* Patients with acute promyelocytic leukemia accompanied by t(15;17)(q22;q12) or (PML/RARA) karyotype abnormalities (include other variant types of APL)
* Patients with multiple cancers (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for at least 3 years)
* Subjects with life-threatening illnesses other than AML or MDS, uncontrolled medical conditions or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, or put the study outcomes at risk.
* Patients with poorly controlled arrhythmias, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
* Patients with symptomatic central nervous system involvement.
Risk-adapted Strategy Including Magnetic Resonance Imaging and Prostate-specific Antigen Density in Blood for Biopsy Decision in Patients With Lesions Suspicious for Prostate Cancer

Recent guidelines now recommend multi parametric magnetic resonance imaging prior to biopsy for all men as an integral part of improved diagnosis of clinical significant prostate cancer. However, magnetic resonance imaging targeted biopsy is a strategy that focuses on maximizing detection of clinical significant prostate cancer, but this procedure has the disadvantage of leading to higher detection of clinically insignificant prostate cancers. One of the risk-stratifications developed to minimize the existing disadvantages and avoid unnecessary biopsy procedures is a strategy in which multi parametric magnetic resonance imaging and prostate-specific antigen density are used in combination. This is especially important in all patients with PI-RADS (Prostate Imaging Reporting and Data System) 3 lesions which are also interpreted as indeterminate mpMRI findings. Current guidelines suggest that biopsy may be omitted in some patient groups with PI-RADS 3 lesions in the risk-adapted strategy involving prostate-specific antigen density. The aim of this study was to evaluate the role of risk-adapted strategies involving prostate-specific antigen density in biopsy decision to avoid unnecessary biopsy vs the risk of missing clinical significant prostate cancer diagnosis in patients with PI-RADS 3 lesions.


Eligibility Criteria:
Inclusion Criteria:

* Patients who all had undergone multi parametric magnetic resonance imaging at our hospital
* Patients who all had undergone transrectal ultrasonography guided cognitive and fusion targeted biopsies

Exclusion Criteria:

* Magnetic resonance imaging at exterior hospitals
* Insufficient image quality/artifacts
* Previous prostate biopsy and/or prior prostate cancer diagnosis
mMe: Motivational Monitoring to Enhance Smoking Cessation Among Cancer Patients

The objectives of this study are to pilot test a protocol of weekly assessments of motivation to quit and other relevant constructs combined with information about how to enroll in cessation programs, which will allow initial quantification of motivation to quit during cancer treatment and develop hypotheses about the impact of motivation on the decision to enroll in services.


Eligibility Criteria:
Inclusion Criteria:

* An adult (18+)
* Current smoker defined by: Has smoked 100 cigarettes in their lifetime (may be multi-tobacco users as long as they also use combustible cigarettes).
* Any type of cancer (except non-melanoma skin cancer)
* Anticipates receiving any of the following cancer treatments in the 3 months following enrollment: chemotherapy, surgery, immunotherapy, bone marrow or stem cell transplant, hormone therapy, or radiation
* Access to the Internet

Exclusion Criteria:

* Not smoked 100 cigarettes in their lifetime
* \< 18 years in age
* Diagnosed with non-melanoma skin cancer
* Not diagnosed with cancer
* Does not anticipate receiving cancer treatments in the 3 months following enrollment
* Has been previously enrolled in an existing Cancer Center Tobacco Treatment Program (TTP)
* Not comfortable reading and responding to questions in English
* No consistent access to the Internet
Early Lactate Clearance Rate in Sepsis

To assess the Influence of early lactate clearance rate monitoring in patients with sepsis.


Eligibility Criteria:
Inclusion Criteria:

* All patients whose blood lactate level reached or exceeded 2.0 mEq / L

Exclusion Criteria:

* Incomplete clinical data
Gadolinium-Enhanced Extracranial MRA Prior to Mechanical Thrombectomy Is Not Associated With an Improved Procedure Speed

The objective was to assess if performing a pre-intervention gadolinium-enhanced extracranial magnetic resonance angiogram (MRA) in addition to intracranial vascular imaging was associated with improved thrombectomy time metrics.

Consecutive patients (912) treated by mechanical thrombectomy (MT) at a large comprehensive stroke center between January 2012 and December 2017 who were screened using pre-intervention MRI were included. Patient's characteristics and procedural data were collected. Analyses were performed to compare mechanical thrombectomy speed, efficacy, complications, and clinical outcomes between patients with and without pre-intervention gadolinium-enhanced extracranial MRA.


Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke

Exclusion Criteria:
Study of Single and Multiple Doses of ALS-008176 in Healthy Volunteers

This study will assess the safety, tolerability, and pharmacokinetics (PK) of orally administered ALS-008176 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, 18-55 years of age, in good health with screening laboratory values within limits specified by the protocol
* Body mass index 18-30 kg/m2
* Female subjects must be of non-childbearing potential; male subjects must be surgically sterile or practicing birth control

Exclusion Criteria:

* Clinically significant or uncontrolled medical illness
* Use, or anticipated use during conduct of the study, of concomitant medications