cyrilzakka/clinical-trials huggingface dataset:
Zilver® PTX™ Global Registry

The Zilver PTX Registry Study is a prospective, non-randomized, open-label, multicenter single-arm study enrolling patients in Europe, Asia, and North America with de novo or restenotic (including in-stent restenosis) lesions of the above-the-knee femoropopliteal artery (SFA). The primary endpoint of the study is event-free survival (EFS) at 6 months.


Eligibility Criteria:
Inclusion Criteria:

* stenosis of the above-the-knee femoropopliteal artery
* appropriate size and location of the lesion

Exclusion Criteria:

* pregnant or breast feeding
* failure or inability to give informed consent
* simultaneously participating in another drug or device study
123 I-FP-CIT SPECT Prescriptions for Parkinsonian Syndromes

123I-FP-CIT SPECT (DaTSCAN®) allows to detect presynaptic dopamine neuronal denervation. It is recommended to differentiate neurodegenerative parkinsonism from secondary parkinsonian syndromes or from essential tremor, and to distinguish patients with suspected dementia with Lewy bodies and those with other subtypes of dementia. The aim of this retrospective study was to evaluate the relevance of 123I-FP-CIT SPECT prescriptions, the profile of prescribers and the evolution of the prescription rate over a ten-year period.

the investigators included 723 patients in this retrospective study between February 2009 and May 2019, in the nuclear medicine Department of Avicenne University Hospital. No patients were excluded. Demographic, clinical, brain imaging, and 123I-FP-CIT SPECT data were collected from medical records. The study was conducted in accordance with the Declaration of Helsinki, and approved by the Institutional Ethics Committee (CLEA-2019-75).

Regarding the relevance of the indications, the investigators have defined three groups: " inappropriate ", "uncertain " and " relevant ", also respectively named (a), (b) and (c) groups.

In the "inappropriate" group (a), the investigators placed prescriptions with no indication, 123I-FP-CIT SPECT requested to confirm a PS clinically evident, and those prescribed for isolated cognitive-behavioral disturbances with no PS or differential diagnosis mentioned.

In the "uncertain" group (b), the investigators did not have sufficient data to determine with certainty whether this was an inappropriate or relevant indication.

In the "relevant" group (c), the prescriptions concerned the differential diagnosis between neurodegenerative parkinsonism and secondary parkinsonian syndromes (for instance post-neuroleptics) or other doubtful disorders (Alzheimer's disease, essential tremor), clinically uncertain PS (such as an isolated asymmetric resting tremor without akinesia or lead-pipe rigidity) and PD of atypical evolution.

Data were presented as mean (standard deviation) for numeric variables and as count (percentage) for categorical variables. To compare demographic, clinical and paraclinical data, and the distribution of prescribers between the three groups (i.e. inappropriate (a), uncertain (b) and relevant (c)), one-factor analysis of variance (ANOVA) was used for numerical variables and Fisher's exact test for categorical variables. To identify which groups differed from each other, post hoc comparisons were made using the Tukey test for numeric variables and the Fisher pairwise exact test followed by the Benjamini-Hochberg correction to account for multiple testing, for categorical variables. For all tests, the significance level was set at p \< 0.05. All data were analyzed using R software (version 3.6.1, R Core Team).

Eligibility Criteria:
Inclusion Criteria:

* Parkinsonian patients who benefited from a 123I-FP-CIT SPECT

Exclusion criteria:
Long-Term Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder (AD/HD)

The study is long-term extension study to evaluate long-term safety and efficacy of Atomoxetine in Japanese pediatric patients with Attention-Deficit/Hyperactivity Disorder (AD/HD).


Eligibility Criteria:
Inclusion Criteria:

* Patients who met all of the disease diagnostic and study criteria at Visit 2 of previous placebo-controlled study, completed the study
* Patients wish to enter into this study

Exclusion Criteria:

* Patients whose families anticipate a move outside the geographic range of the investigative site, or who plan extended travel inconsistent with the recommended visit interval
LATINO Study: A Study of Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.

This single arm study will assess the efficacy and safety of Mircera when administered once monthly, subcutaneously or intravenously, for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa will receive monthly injections of Mircera with a starting dose (120, 200 or 360 micrograms) derived from the dose of epoetin alfa they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic renal anemia;
* hemodialysis or peritoneal dialysis, with same mode of dialysis for \>=3 months before and throughout screening period;
* stable maintenance epoetin alfa therapy for past 2 months.

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months;
* poorly controlled hypertension requiring interruption of epoetin alfa in past 6 months;
* acute or chronic bleeding during previous 2 months.
177Lu-PSMA As a Systemic Adjuvant Treatment in Patients with High and Very High Risk Prostate Cancer

Single-center, non-commercial phase 2 clinical trial to evaluate 177Lu-PSMA as a systemic adjuvant treatment in patients with high and very high risk prostate cancer after radical treatment using locoregional teleradiotherapy and hormone therapy

The intervention will consist of a single administration of 177Lu-PSMA in the research arm. Both the study and control groups will receive standard hormone therapy.

The study population includes 200 adult men with high-risk or very high-risk prostate cancer, with no signs of cancer dissemination in radiological examinations after completion of radiotherapy and continued hormone therapy

Participation time in the Study:

intervention phase - 1 day; observation phase - 5 years

Eligibility Criteria:
Inclusion Criteria:

* Giving a written informed consent
* Histopathologically confirmed high or very high risk prostate cancer
* Completion of radical locoregional treatment
* Completion of locoregional treatment within 3 months before inclusion to the study
* ECOG performance status 0 to 2
* Age over 18 years
* Within 28 days before entering the study, there were no signs of cancer dissemination documented in radiological tests
* Castrate testosterone level (testosteron \< 50 ng/dL lub 1,7 nmol/L)
* Patients with adequate function of main organs:

  * bone marrow:

    * neutrophils \> 1500x10\^9/L;
    * thrombocytes \> 100,000x10\^9/L;
    * hemoglobin \> 9 g/dL
  * liver:

    * bilirubin \< 2xULN (upper limit of normal) in patients with Gilbert's syndrome \< 5xULN;
    * aminotransferase \< 3xULN
  * kidneys:

    * eGFR \> 50 ml/min
    * albumin \>2.5 mg/ml
* For men of reproductive age: the need to use double barrier contraception

Exclusion Criteria:

* The presence of distant metastases confirmed by radiological examination
* Absence of approval to use effective contraception method
* Absence of Patient's consent to participate in the Study
* Urinary tract obstruction or/and hydronephrosis.
* Concurrent anticancer treatment.
The Effects of Covid-19 Pandemic on The Patients With Fibromyalgia

The investigators planned to analyze the effect of Covid-19 fear and anxiety on the daily life, sleep quality and depression-anxiety levels of fibromyalgia patients.

Fibromyalgia; as a chronic syndrome of unknown cause with widespread body pain, fatigue, sleep disorder, cognitive impairment and anxiety. Many studies have shown a relationship between pain levels and anxiety levels in patients with fibromyalgia. Covid-19 started from Wuhan, China in December 2019 and spread worldwide. The rapid spread of this unexpected pandemic all over the world brought with it many conditions such as anxiety and stress disorders. It has been reported by experts that individuals with a predisposition to conditions such as anxiety and stress disorder in premorbidity require special attention.To evaluate the psychological effects of the Covid-19 pandemic, the Covid-19 anxiety scale was developed from Lee et al. and the Covid-19 fear scale was developed from Ahoursou et al. The investigators planned to analyzed the effect on Covid-19 fear and anxiety level on fibromyalgia patients' daily life with revised Fibromyalgia Impact questionnaire, sleep quality with Pittsburgh Sleep Quality Index, and anxiety-depression level with The Hospital Anxiety and Depression scale. This study was planned as a cross-sectional case control study.

Eligibility Criteria:
Inclusion Criteria (Fibromyalgia group):

* Patients diagnosed as Fibromyalgia syndrome according to American College of Rheumatology over 1 year
* Patients' disease activity is stabil at least 3 months Inclusion Criteria (Control group) Patients have no physicologic or severe musculoskeletal and rheumatologic diseases

Exclusion Criteria:

* Patients with having other modd disorders
* Patients with severe musculoskeletal diseases
* Patients with other rheumatologic diseases
Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users

The etonogestrel (ENG) subdermal contraceptive implant (ENG implant) is a highly effective method of preventing pregnancy, but it has bleeding side effects that make it unappealing for many women. The only study to demonstrate a sustained reduction in bleeding lasting for two months was the selective estrogen receptor modulator (SERM) tamoxifen in users of the levonogestrel (LNG) contraceptive implant. Based on the investigators encouraging preliminary data of tamoxifen and ENG implant users, the investigators plan to perform additional studies on the impact of tamoxifen on the breakthrough bleeding experience by ENG implant users.

The investigators will perform a 2 phase trial for treatment of women experiencing frequent or prolonged bleeding while using the ENG contraceptive implant. The first phase will consist of a randomized, controlled, double blind placebo-controlled clinical trial over a 90-day reference period and the second phase will allow both study arms to receive open-label treatment over an additional 90-day reference period. The primary outcome of the study will be the total number of consecutive bleeding-free days in first 30 days from Day 1 of first treatment (TX1).

Eligibility Criteria:
Inclusion Criteria:

* English or Spanish speaking
* women aged 15-45 years of age
* Currently using the ENG-implant for at least 1 month and use proven on exam (palpation of implant at screening visit)
* Willing to continue using the implant for at least 6 months
* \>7 days of continuous bleeding/spotting, or 2 or more episodes of bleeding/spotting in the last 30 days.
* Cellphone that is able to receive and respond to a daily text or email message .

Exclusion Criteria:

* Postpartum within six months
* post-abortion within six weeks
* currently pregnant
* currently breast-feeding
* undiagnosed abnormal uterine bleeding pre-dating placement of contraceptive implant
* bleeding dyscrasia
* anticoagulation use
* active cervicitis
* allergy to tamoxifen
* history of venous thromboembolism
* current or past breast or uterine malignancy
* use of medication contraindicated with tamoxifen (coumadin, letrozole, bromocriptine, rifampicin, aminoglutethimide, phenobarbital).
Remicade® Crohn's Disease Registry Across Canada (Study P02793)

This registry is a multi-center, prospective, observational program that will gather and analyze data on subjects with Crohn's disease being treated with Remicade® as per approved product monograph in Canada. In contrast to a controlled clinical trial, there is no imposed experimental intervention and treatment with Remicade® is determined solely by the subject's physicians. Thus, the data captured and reported in this registry will reflect a "real world" approach to the treatment of Crohn's disease with Remicade®.

Subjects will be selected for this registry using a non-probability sampling method.

Eligibility Criteria:
Inclusion Criteria:

* Patient was given the Patient Information Brochure; AND,
* Patient has never been treated with Remicade® (patient is naïve to Remicade® at the time of registration); AND,
* Patient is a good candidate to receive Remicade® as per the product monograph; AND,
* Patient has agreed to complete the Patient Diary for one week prior to each visit in the registry; AND,
* Patient has signed the approved consent form.

Exclusion Criteria:

* Per product monograph
SCS Stimulation Clamp to Assess Impact of Stimulation on Glucose Metabolism

In 1967 spinal cord stimulation (SCS) for the treatment of chronic neuropathic pain was established. Today various pain syndromes like the failed back surgery syndrome (FBSS), the complex regional pain syndrome (CRPS), ischemic pain or phantom limb pain are treated with SCS. The development of this technique based on the so called "Gate Control Theory" which states that stimulation of the mechanosensitive Aβ fibers suppresses the transmission of pain stimuli via the pain-sensitive C fibers to the brain in the spinal cord. Conventional SCS consists of periodically emitted tonic stimuli with a frequency between 30 and 120 Hz. During implantation, the electrodes are placed in the epidural space in such a way that the paraesthesia caused by nerve stimulation covers the painful area (dermatome), thus relieving the pain. In 2010 de Ridder et al. published an article presenting the so called "Burst Stimulation" where series of high-frequency impulses are released at defined time intervals (frequency: 40 Hz with peaks of 500 Hz per volley). Compared to the tonic SCS the burst technique is more effective and in most cases no paraesthesia is reported. However, potential effects of SCS stimulation on other organ systems have only been insufficiently examined.Especially possible effects of SCS on the glucose metabolism has not been investigated so far. However, it is important to investigate a possible effect for two reasons: SCS could cause severe hypoglycemia which must be avoided. Furthermore, if SCS affects blood sugar levels, it is also of interest what mechanisms are involved and how this knowledge can be used to control elevated blood glucose levels.

The present study is a pilot. The investigators want to examine possible effects of SCS therapy on blood glucose metabolism. Therefore hyperinsulinemic euglycemic clamps with an insulin infusion of 1mU / kg body weight per minute are performed. During the clamp the investigators apply different SCS techniques in a randomly order. Insulinsensitivity is determined at different time points.


Eligibility Criteria:
Inclusion Criteria:

* Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
* HbA1c \< 6,0%
* state after implantation of an neuromodulation device
* Clinical routine blood parameters within the normal ranges

Exclusion Criteria:

* diabetes mellitus
* Acute diseases such as infections (e.g.) within the last four weeks
* Hb \< 13 g/dl
* anamnestic heparin-induced thrombocytopenia
* any neurologic or psychiatric disease
Does Physical Therapy Prevent Total Knee Arthroplasty in Patients With End Stage Osteoarthritis

Purpose: For the target population of adult patients with end stage osteoarthritis, this randomized clinical trial will be used to evaluate the benefit of three months of physical therapy compared to no treatment in patients indicated for total knee arthroplasty.

Participants:Patients that are diagnosed with end stage osteoarthritis who are indicated for total knee arthroplasty.

Procedures: Patients will be randomized to either receive physical therapy or no treatment. They will be scheduled to return in 3 months for discussion of operative versus continued nonoperative treatment of their osteoarthritis.This will be determined by change in PROMIS (Patient Reported Outcome Measurement Information System) score and prevention of surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with grade 3 and 4 (severe) osteoarthritis and indicated for primary total knee arthroplasty.

Exclusion Criteria:

* Age less than 18 y/o
* Any form of arthritis other than osteoarthritis (traumatic, rheumatic, etc)
* Previous knee surgery
* Inability to personally consent to or participate with therapy due to cognitive impairment, physical disability, intoxication or sedation
* known contraindications would include patients that will be unable to participate with therapy or who will put themselves at significant risk due to therapy (this could be either severe cardiac or respiratory impairment that prevents the patient from ambulating or mental impairment preventing the patients from following instructions
Effect of the LEVAmethod by Bertz et al © in Subjects With Overweight or Obesity in Primary Health Care.

This study evaluates weight loss effect of the method LEVA by Bertz et al in subjects with overweight or obesity that are remitted to Primärvårdens Dietistenhet.

The method "Lifestyle at Effective Weight Loss During Breastfeeding" (LEVA method by Bertz et al) has been scientifically studied to provide sustainable weight loss for women with overweight or obesity after childbirth. Primary health care centers in Västra Götalandsregionen treat adult patients with overweight and obesity. If the LEVA method by Bertz et el also produces weight loss to other patient groups than women post partum, the method could be used as a treatment alternative.

Eligibility Criteria:
Inclusion Criteria:

* BMI 27 ≤ 35
* age 18-75 år

Exclusion Criteria:

* difficulty understanding Swedish, spoken or read
* does not manage/want to handle digital Tools
* the remittance was addressed to Primärvårdens Dietistenhet at wrong premises and the patient should be treated elsewhere.
Smart Insoles for Improving Sensation, Balance and Mobility in People with Diabetic Peripheral Neuropathy.

The long-term effects of vibrating insoles on improving gait, balance and peripheral sensation in people with diabetic peripheral neuropathy remain unknown. The Pathfeel Clinical Trial will investigate the efficacy of vibratory insoles worn for ten days for enhancing sensory perception, gait quality, balance and physical activity in people with mild to severe diabetic neuropathy. The primary outcome will be changes in gait speed and postural and dynamic balance.

The Path Feel Clinical Trial will investigate the efficacy of foot sole vibration applied for 10 days during daily life for improving peripheral sensation, balance and mobility in people with diabetic peripheral neuropathy.

Twenty-two people with mild to severe diabetic neuropathy will perform a prospective comparison where they wear an insole system over the course of two interventional periods of 10 days each in a randomised, cross-over design, during which there will be a period where the device provides vibrational stimuli, vs a control condition where the device is worn, but provides no stimuli. Any changes in activity levels, peripheral sensation, quality of life and balance control will be compared between each condition to determine the longer-term effects of foot sole vibration.

Each participant will undertake four study visits with periods of device use between them. Participants will complete a set of questionnaires that will assess quality of life (NeuroQoL) and fear of falling (FES-I). Measurements of the level of peripheral neuropathy will be taken at both feet using non-invasive methods, including a neurothesiometer (i.e., Vibration Perception Threshold) and a composite score (i.e., modified Neuropathy Disability Score). Gait, postural and dynamic balance during daily activities, including walking, stair walking will be assessed through a combination of 3D Motion Capture system and force platforms. Changes in physical activity will be quantified by accelerometry.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes type 1 or 2
* ≥1 palpable foot pulses
* Presence of mild to moderate diabetic peripheral neuropathy defined by a vibration perception threshold ≥15 Volts and/or mNDS score ≥3.
* Aged ≥ 18 years
* Ability to walk unaided for 30 steps
* Able to understand the study requirements
* Ability to check their feet regularly (or have another person check).
* Able to read the study documents
* Fit shoe size EU 36-47.5 / UK 3.5-13.

Exclusion Criteria:

• Active foot ulcer

* Lower limb amputation (anything more than amputation of two lesser toes)
* Presence of Charcot deformity
* Dementia or other cognitive impairment
* Significant cardiopulmonary or other systemic disease limiting the patient's ability to walk 30 steps.
* Person's with bodyweight greater than 130kg (due to insole device limitations)
* Presence of implantable neurostimulators
* Presence of a pacemaker.
Efficacy of Tailored Bowel Preparation Strategy Guided by a Predictive Model

About 30% of patients were reported to suffer inadequate bowel preparation. So, it is desirable to prescribe personalized regimen according to patient's personal characteristics.

Colonoscopy is currently the main approach for detecting mucosal abnormalities in the whole colon. Inadequate bowel preparation is the predominant threaten to the efficacy of colonoscopy.Unfortunately, about 30% of patients were reported to suffer inadequate bowel preparation. In order to improve adequate bowel preparation rate, it is desirable to prescribe personalized regimen according to patient characteristics. We intend to create and verify a predictive model for inadequate bowel preparation. Then, in order to improve adequate bowel preparation rate, we aim to establish a bowel preparation strategy guided by the predicted model and verify it.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 or older
* patients undergoing colonoscopy

Exclusion Criteria:

* patients with a history of colorectal surgery
* patients with severe colonic stricture or obstructing tumor
* patients with dysphagia
* patients with compromised swallowing reflex or mental status
* patients with significant gastroparesis or gastric outlet obstruction
* patients with known or suspected bowel obstruction or perforation
* patients with severe chronic renal failure (creatinine clearance\<30 ml/min)
* patients with severe chronic renal failure (creatinine clearance\<30 ml/min)
* patients with uncontrolled hypertension (systolic blood pressure\>170 mm Hg, diastolic blood pressure\>100 mm Hg)
* patients with inflammatory bowel disease or megacolon
* patients with dehydration
* patients with dehydration
* patients with pregnancy or lactation
* patients hemodynamically unstable
* patients unable to give informed consent