cyrilzakka/clinical-trials huggingface dataset:
Feasibility of the Use of Weighted Blankets to Improve Sleep Among Patients with Hematological Malignancies

The goal of this clinical research study is to learn about the effects of weighted blankets on sleep quality in patients with blood cancers. Weighted blankets are heavier blankets that contain inner weight beads. The deep pressure stimulation induced by these blankets can have a calming effect.

Primary Objective:

To determine the feasibility of using weighted blankets to improve Sleep Disturbances (SD) for patients with hematological malignancies in an outpatient setting.

Secondary Objectives:

To explore if weighted blanket use improves sleep as assessed by the ESAS sleep question. A positive response is defined by at least a one-point reduction in ESAS sleep between baseline and day 7 +/-2 days.

To explore if weighted blanket use during a 14-day period improves Insomnia Severity Index (ISI) score.

To explore the response rate in anxiety, where response is defined as a minimum of one-point change in the ESAS anxiety score, between baseline and day 7 +/-2 days after the use of weighted blankets.

To explore if patients are satisfied with the use of weighted blankets as determined by a positive response to at least 2 of the 5 patient satisfaction questions.

To assess safety using NCI CTCAE v5

Eligibility Criteria:
Inclusion Criteria:

1. Outpatient at MD Anderson Cancer Center
2. Adult patients ≥ 18 years
3. Diagnosis of hematological malignancy
4. ESAS Sleep\&amp;gt;/=4
5. Performance status as measured by Eastern Cooperative Oncology Practice group (ECOG) score of 2 or below

Exclusion Criteria:

1. Platelet count of 25 or below
2. History of seizures/intracranial metastasis/ sleep apnea/restless leg syndrome/paralysis
3. Weight less than 150 lbs.
4. Attending physician assessment of prognosis with expected life expectancy of \&amp;lt;1 month
5. Patients who are unable to tolerate their blankets/sheets in the night due to medical conditions such as pain, peripheral neuropathy, night sweats, hot flashes etc.
6. Patients with difficulty breathing, disorders of poor circulation, fragile skin, rash, or open wounds, or by those who are claustrophobic or cleithrophobic.
7. Prior use of weighted blankets within the past 1-year
Surgical Prep in Hand Surgery

The purposes of this study are to identify the common bacterial flora on the hand and evaluate the efficacy of readily available skin-preparation solutions in the elimination of bacterial pathogens from the surgical site following skin preparation. The null hypothesis is that there is no difference in the efficacy of Chloraprep, Duraprep, and betadine in pre-operative skin preparation in clean, elective hand surgery cases.


Eligibility Criteria:
Inclusion Criteria:

* the following procedures (carpal tunnel release, trigger finger release, cyst excision, 1st dorsal compartment release)

Exclusion Criteria:

* prisoners
* pregnant women
Treatment Patterns Among Patients With Prostate Cancer Prior to Diagnosis of a Castration-resistant State

The purpose of the protocol is to describe treatment patterns among patients with prostate cancer prior to diagnosis of castration-resistant state.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients with prostate cancer who had developed a castration resistant state in the last 24 months prior to starting the study
* Patient must give written informed consent before any study related procedure

Exclusion Criteria:

* Patients with medical histories lacking data required to evaluate the study objectives
A Phase I/II, Open Label, Escalating Dose, Pilot Study to Assess Effect, Safety, Tolerability and PK of Multiple SC Doses of Drisapersen in Patients With Duchenne Muscular Dystrophy and to Assess the Potential for IV Dosing as an Alternative Route of Administration

The purpose of the extension phase of this study is to determine whether Drisapersen is effective in the treatment of boys with Duchenne muscular dystrophy resulting from a mutation thought to be corrected by exon 51 skipping.


Eligibility Criteria:
Inclusion Criteria:

* Boys aged between 5 and 16 years inclusive.
* Duchenne muscular dystrophy resulting from a mutation correctable by treatment with PRO051.
* Not ventilator dependent.
* Life expectancy of at least six months.
* No previous treatment with investigational medicinal treatment within six months prior to the study.
* Willing and able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

* Aberrant RNA splicing and/or aberrant response to PRO051, detected by in vitro PRO051 assay during screening.
* Known presence of dystrophin in 5% of fibers in a pre-study diagnostic muscle biopsy.
* Severe muscle abnormalities defined as increased signal intensity in \>50% of the tibialis anterior muscle at MRI.
* FEV1 and/or FVC \<60% of predicted.
* Current or history of liver or renal disease.
* Acute illness within 4 weeks prior to treatment (Day 1) which may interfere with the measurements.
* Severe mental retardation which in the opinion of the investigator prohibits participation in this study.
* Severe cardiac myopathy which in the opinion of the investigator prohibits participation in this study.
* Need for mechanical ventilation.
* Creatinine concentration above 1.5 times the upper limit of normal (age corrected).
* Serum ASAT and/or ALAT concentration(s) which suggest hepatic impairment.
* Use of anticoagulants, antithrombotics or antiplatelet agents.
* Subject has donated blood less than 90 days before the start of the study.
* Current or history of drug and/or alcohol abuse.
* Participation in another trial with an investigational product.
Pharmacists Coordinated Care Oncology Model (PCOM) for Patients Taking Oral Anti-cancer Medications

The objective of this study is to improve medication, symptom, and disease management of patients with hematological malignancies and multiple chronic conditions (2 or more conditions in addition to cancer) through care coordination between pharmacists working in oncology practices and those working in primary care practices (Pharmacists Coordinated care Oncology Model \[PCOM\]).

This is a pilot study in which the investigators will examine the association between outcome measures, but the study design and sample size are insufficient to quantify the impact of OAA initiation or OAA adherence on adherence to chronic medications. This pilot study and data analyses are being done in preparation for a larger, controlled study.


Eligibility Criteria:
Inclusion Criteria:

* Has primary care physician
* Diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), chronic myeloid leukemia (CML), or multiple myeloma (MM)
* Initiating an OAA, either for the first time or a change from previous OAA
* Diagnosis of at least 2 chronic conditions, including at least one of the following: diabetes, hypertension, hyperlipidemia, congestive heart failure, depression/anxiety, gastroesophageal reflux disease, and/or chronic obstructive pulmonary disease
* Patients taking at least two chronic medications, including at least one medication for one of the conditions listed above.
* Willing and able to sign informed consent.

Exclusion Criteria:

* Cannot speak English
* Concurrent diagnosis of type 1 diabetes
* Concurrent diagnosis of human immunodeficiency virus
DyeVert System RCT

The purpose of this study is to evaluate the amount of contrast media (CM) saved using the DyeVert system in diagnostic angiographic procedures compared to a control group.

This is a prospective, randomized, parallel group, single center clinical evaluation of the DyeVert System. Subjects undergoing a diagnostic coronary angiogram procedure with a 5 French catheter are eligible to participate in this study. The treatment group will use the DyeVert System.

The trial will be conducted at one center, located in Germany. A sample size of 96 evaluable subjects will provide a sufficient number of samples to evaluate the primary objectives.

Randomization will occur following confirmation that the subject meets the inclusion/exclusion criteria and has signed an informed consent. Subjects that are anticipated to be a diagnostic only procedure, but end up being an ad-hoc PCI, can still remain enrolled in the trial. If a subject proceeds to a PCI, data will only be collected through the diagnostic portion of the case.

Eligibility Criteria:
Inclusion Criteria:

1. The subject is indicated for a diagnostic coronary angiogram procedure with a 5 French catheter only.
2. The subject is ≥ 18 years of age
3. The subject is willing and able to provide appropriate informed consent.

Exclusion Criteria:

1. Subject is undergoing a STEMI procedure
2. Subject has previously been diagnosed with anomalous coronary anatomy
3. Subject has previously underwent coronary artery bypass grafting
4. Subject has severe peripheral artery disease at access site
5. Subject is having a staged PCI
6. The subject is female and currently pregnant
7. In the investigator's opinion, the subject is not considered to be a suitable candidate
Oxytocin and Social Cognition

The purpose of this study is to determine whether oxytocin influences memory of social stimuli and reaction to social stimuli. Furthermore the investigators explore the effect of oxytocin receptor (OXTR) polymorphism in terms of behavioral and neural responses to social stimuli.

The prevailing view of OXT as a key facilitator of prosocial behaviors has been highly influenced by a plethora of studies in healthy volunteers, which demonstrated increased interpersonal trust, generosity, social learning/empathy and positively biased social stimulus processing as a result of OXT treatment. However, this interpretation is challenged by observations that OXT also promotes envy and schadenfreude (gloating), ethno-centrism (including prejudice, xenophobia, and racial bias), and defensive aggression towards outsiders.We investigate the neural correlates of emotion perception and subsequent memory effects of aversive and neutral stimuli. Tthe oxytocin effect on personal space is questioned. Additionally the effect of OXTR polymorphism regarding behavioral and neural response is explored.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers

Exclusion Criteria:

* Current or past psychiatric disease
* Current or past physical illness
* Psychoactive medication
* Tobacco smokers
* MRI contraindication
Use Quantitative Microradiography to Predict the Periprosthetic Bone Loss in Distal Femur After Total Knee Arthroplasty

The investigators hypothesized that the microarchitecture of bone influence the degree of periprosthetic bone loss after total knee arthroplasty surgery. The investigators collected the bone fragment at the distal femur while performing total knee replacement and take quantitative radiography analysis . Before and after the surgery(6 month ,12 month) , the investigators check the BMD at identical location of the distal femur by using dual energy absorptiometry. The investigators will use linear regression to evaluate the relationship between the microarchitecture and the degree of bone loss.


Eligibility Criteria:
Inclusion Criteria:

* severe knee osteoarthritis
* post menopausal women

Exclusion Criteria:

* immune disease
* end stage of renal disease who receive dialysis
* history of fracture at ipsilateral distal femur
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting

The purpose of this study is to assess Abatacept Intravenous (IV) effectiveness in patients with inadequate response to one or more conventional Disease Modifying Against Rheumatism (DMARDs) including Methotrexate in France, through the estimation of Abatacept retention rate over 2 years and reasons of discontinuation

Observational Model:

Other: ReACTION is a study using secondary data originally collected in ACTION study. In ACTION, data were collected prospectively from October 2010 up to 2015 at each clinical visit. In France, data collection started in June 2011

Eligibility Criteria:
Inclusion Criteria:

- All patients enrolled in ACTION with inadequate response to one or more conventional DMARDs including Methotrexate and treated with Abatacept IV will be included in ReACTION

ACTION inclusion criteria for France were:

* Male or female subjects of more than 18 years old
* Patients with a diagnosis of established moderate to severe active RA
* Patients who at their physician's discretion are treated with Abatacept (initiated or already on treatment within 3 months) according to routine clinical practice
* Patients for whom baseline characteristics are available
* Patients consent for usage of their data in ACTION study
* Patients who were not included in any interventional clinical trial in RA
"EASY EFFECTIVE SMOKELESS" With NICORETTE®

The actually most accepted method of effective smoking cessation is based on structured consultation and medical care in combination with supportive medical treatment. A group of experts developed the concept "EINFACH ERFOLGREICH RAUCHFREI" ("EASY EFFECTIVE SMOKELESS") for general practitioners providing a structured compendium for negotiation.

Physicians who have implemented this concept will conduct this non-interventional study. The implementation of the scheme will be investigated under general practice conditions and the applicability of the concept has to be assessed by the physicians.

In addition further knowledge of smoking cessation in would-be non-smokers which decided to quit, supported by medical treatment with NICORETTE®-products, will be documented for a large patient collective under real practice conditions.

To answer all above mentioned questions for a sufficient number of patients a multicenter, prospective non-interventional study design was used for this trial as only this instrument detects characteristics of the physicians' treatment without any further input or other influences.


Eligibility Criteria:
Inclusion Criteria:

* Routine smokers
* Nicotine replacement therapy with Nicorette® according to physicians treatment decision

Exclusion Criteria:

* Pregnancy
* Contraindication according to Summary of Product Characteristics (SPC)
* Other nicotine replacement therapy during the last month
Myokines Role During Obesity

We showed, for the first time, that Z-score increase during obesity was dependent on sex, severity of obesity and age but also on the bone site. Although the increase in BMD at bearing areas seems to be logically explained by the assumption that mechanical stresses have an osteogenic effect on bone tissue, BMD can in no way respond to the concomitant increase in BMD at non-load bearing areas such as the radius. These results suggest that changes in certain systemic compounds, induced by obesity, may interfere with bone metabolism. Moreover, the fact that the BMD or Z score is positively and only correlated with muscle mass and not with fat mass confirm that mechanical stresses are not the only factors acting on bone tissue.

Our objectives are to determine the relationship between plasma concentration of myokines, adipokines, bone markers and BMD in obese subjects.

We showed, for the first time, that Z-score increase during obesity was dependent on sex, severity of obesity and age but also on the bone site. Although the increase in BMD at bearing areas seems to be logically explained by the assumption that mechanical stresses have an osteogenic effect on bone tissue, BMD can in no way respond to the concomitant increase in BMD at non-load bearing areas such as the radius. (Maïmoun L and Col Bone 2015 Dec 1. S8756-3282 (15) 00421-4). These results suggest that changes in certain systemic compounds, induced by obesity, may interfere with bone metabolism. Moreover, the fact that the BMD or Z score is positively and only correlated with muscle mass and not with fat mass confirm that mechanical stresses are not the only factors acting on bone tissue.

Our objectives are to determine the relationship between plasma concentration of myokines, adipokines, bone markers and BMD in obese subjects.

Our objectives are to determine the relationship between plasma concentration of myokines (myostatin, follistatin), adipokines (leptin, adiponectin) and bone markers (CTX, Trap5, P1NP, ostéocalcin) in a cohort of obese patients, with differents obesity severity, differents ages.

Eligibility Criteria:
Inclusion Criteria:

* obese patients age above 18 years old

Exclusion Criteria:

* non agreement of inclusion
Anti-cancer Neoantigen Polypeptide Vaccine to Treat Solid Tumors

The WES and RAN-seq will be performed to identify and verify neoantigens and appropriate polypeptide sequences will be verified, manufactured and protected for vaccine production by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the polypeptide vaccine for immunotherapy of human cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the polypeptide vaccine immunotherapy on human cancers will firstly be evaluated.

1. Choose appropriate patients with advanced solid cancers, with written consent for this study;
2. Perform biopsy to get fresh sample for DNA/RNA-seqencings and bioinformatics analysis;
3. Produce appropriate polypeptide vaccine for human use and deliver the vaccine into selected patients via local injections, and follow up closely to collect related results as required;
4. To enhance the killing capability, cotreatment the patients with PD1/PDL1/CTLA4 antibodies may be applied;
5. Evaluate the clinical results as needed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with advanced cancer; 2. Life expectancy \>12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available high quality vaccine for human use; 5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.

-

Exclusion Criteria:

1. Had accepted gene therapy before;
2. Severe virus infection such as HBV, HCV, HIV, et al;
3. Known HIV positivity;
4. Active infectious disease related to bacteria, virus,fungi,et al;
5. Other severe diseases that the investigators consider not appropriate;
6. Pregnant or lactating women;
7. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);
8. Other conditions that the investigators consider not appropriate.
BIOLUX P-I First in Man Study

A prospective, multi-centre, randomized controlled, First in Man study to assess the safety and performance of the coated Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter vs. an uncoated balloon catheter in patients with stenosis and occlusion of the femoropopliteal arteries.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 50 years,
2. Informed consent signed by patient prior to randomization
3. Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the femoropopliteal arteries ≥ 30 mm and ≤ 200 mm long
4. Rutherford Class 2 - 5 in the target limb
5. Reference Vessel Diameter (RVD) 3 - 7 mm, based on visual estimation
6. Inflow free from flow-limiting lesion (\< 50% stenosis) confirmed by angiography. Patients with flow-limiting inflow lesions (\> 50% stenosis) can be included if lesion has been treated successfully before the index procedure
7. At least one non-occluded crural vessel (eg without significant stenosis) with angiographically documented run-off to the foot
8. Successful wire crossing of the lesion
9. Willingness to comply with all specified follow-up evaluations
10. Male or negative pregnancy test of women in childbearing age

Exclusion Criteria:

1. Co-morbid conditions limiting life expectancy ≤ 1 year
2. Patient currently participating in another clinical trial
3. Lesions which are untreatable with PTA or other interventional techniques
4. The target stenosis is located distal to a stenosis ≥ 50% that cannot be pre-treated because the drug coating could get lost during crossing the proximal lesion
5. Thrombus in the target vessel, documented by angiography
6. Target lesion is severely calcified, documented by angiography
7. Prior bypass surgery of target vessel
8. Previously implanted stent in the target lesion
9. Treatment of bifurcation required
10. Planned amputation of the target limb
11. Flow-limiting (\> 50% DS) Inflow lesion proximal to target lesion, left untreated
12. Failure to obtain \<30% residual stenosis in a pre-existing haemodynamically significant (\>50% DS) inflow lesion in the ipsilateral iliac or proximal SFA. (DEB or DES not allowed for the treatment of inflow lesion)
13. Additional hemodynamically relevant proximal and distal lesions with stenosis ≥ 50 %, except iliac arteries, are excluded. Iliac artery lesion treatments have to be successful with a residual stenosis ≤ 30 %
14. Haemorrhagic diathesis or another disorder such as gastrointestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anticoagulation therapy
15. Phenprocoumon intake
16. Impaired renal function (creatinine ≥ 2.0 - 2.5 mg/dl), according to investigator assessment
17. Known allergy to contrast media that cannot be adequately controlled with pre-medication
18. Allergy, intolerance or hypersensitivity to Paclitaxel structurally or related compounds and/or to the delivery matrix n-Butyryl tri-nhexyl citrate (BTHC)
Comparison Between RTX (Biphasic Cuirass Ventilator) and Physiotherapy in Cystic Fibrosis Patients

The purpose of this study is to compare the effectiveness of different mucous clearance techniques in cystic fibrosis patients

Cystic fibrosis (CF) is associated with chronic progressive lung disease that may lead to respiratory failure.Bi-Phasic Cuirass Ventilation (BPCV) is a form of non-invasive respiratory support, which can provide negative pressure ventilation as well as high frequency chest wall oscillations and cough mode.The standard therapy for CF patients to release mucous is treatment by a physiotherapist. In this study we will compare the effect of BPCV with regular physiotherapy by full pulmonary function testing prior and post treatment.

Eligibility Criteria:
Inclusion Criteria:

* CF patients over 7 years old

Exclusion Criteria:

* Hemoptysis
* Pregnancy