cyrilzakka/clinical-trials huggingface dataset:
Long-term Longitudinal Imaging of Presynaptic Terminals in PD

AIM: To investigate whether SV2A loss spreads from brainstem to cerebral cortex with progression of Parkinson's disease (PD) and to determine whether longitudinal cortical SV2A loss correlates with cognitive decline in PD.

STUDY DESIGN: We will re-invite participants (both patients with PD and healthy controls) of a previous longitudinal study (NCT04243304, S61477) to undergo evaluation approximately 7 years after the initial baseline study visit (i.e. on average 10 years since the first motor symptoms). All participants will undergo clinical assessment of motor and non-motor symptoms (including cognitive testing), as well as 11C-UCB-J PET-CT (targeting synaptic density marker SV2A), 18F-FE-PE2I PET-CT (targeting DAT) and brain MRI.


Eligibility Criteria:
Inclusion Criteria:

* Participation in study S61477 (NCT04243304)

Exclusion Criteria:

* Neuropsychiatric diseases (unrelated to PD for PD patients)
* Major internal medical diseases
* History of alcohol or drug abuse
* Relevant abnormalities on MR brain
* Contraindications for MR
* Pregnancy or breastfeeding
* Previous participation in other research studies involving ionizing radiation with \> 1 mSv over past 12 months.
Staphylococcus Aureus Bacteraemia (SAB)-Support-Study

The main objective of this study is to investigate whether checklist-based close telephone consultation and process surveillance for S. aureus bacteraemia (SAB) can improve adherence to our in-house SAB-guidelines (prospective quality- improvement group).

In addition, the effects of telephone consultation on the clinical outcome of patients will be examined.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* Inpatient treatment at the University Medicine Greifswald university hospital
* First diagnosis of SAB in hospital

Exclusion Criteria:

* SAB already known before admission
* Palliative management within 48 hrs after SAB diagnosis
* Death within 48 hrs after SAB diagnosis
* Hospital discharge within 48hrs after SAB diagnosis
PMCF Study on the Safety and Performance of CESPACE 3D

Prospective, pure data collection of all CeSPACE 3D patients in selected centers (not interventional, multicenter)


Eligibility Criteria:
Inclusion Criteria:

* Patient is minimum 18 years old
* Written informed consent for the documentation of clinical and radiological results
* Patient's indication according to IFU
* Patient is not pregnant

Exclusion Criteria:

• Patient is not willing or able to participate at the follow-up examination
Evaluation of Endorings-2-assisted Colonoscopy: a New Accessory for Improvement of Adenoma Detection Rate?

Screening colonoscopy for colorectal cancer is essential to diagnose and remove adenomas, precancerous stages of colorectal cancer. Unfortunately approximately 25 % of all adenomas are missed during the examination. Recently a new colonoscopy accessory, the Endorings-2 (EndoAid Ltd., Casearea, Israel), has been designed to improved the detection of adenomas during colonoscopy (adenoma detection rate).

Endorings-2 is a silicone-rubber device that is fitted on the colonoscope and is equipped with circular flexible silicon rings mechanically stretching the colonic folds during withdrawal.

This study aims to evaluate the efficacy of Endorings-2 to improve the adenoma detection rate in a prospective, blinded clinical trial. 292 patients with an indication for a screening colonoscopy shall be included (1:1 randomization in standard colonoscopy versus Endorings-2-assisted colonoscopy).


Eligibility Criteria:
Inclusion Criteria:

* Patients with an indication for a screening colonoscopy.

Exclusion Criteria:

* Patients under 18 years, pregnancy
* Patients with prior colectomy or partial colectomy
* Patients with a history of colorectal cancer
* Patients with hereditary polyposis syndromes (FAP, HNPCC)
* Patients with a stricture of the colon
* Patients receiving anticoagulation prohibiting a colonoscopy
* inability to have a patient education
* bad conditions prohibiting a colonoscopy
A Study of Venetoclax Plus Lenalidomide and Dexamethasone for the Treatment of Newly Diagnosed t(11;14)-Positive Multiple Myeloma in Subjects Who Are Ineligible for High-Dose Therapy

This study will evaluate the safety and preliminary efficacy of venetoclax when combined with lenalidomide and dexamethasone for participants with newly diagnosed, active t(11;14) positive multiple myeloma (MM).

This study will consist of 2 parts: Part 1 Dose Escalation and Part 2 Dose Expansion.


Eligibility Criteria:
Inclusion Criteria:

* Must have documented, confirmed active multiple myeloma (MM) with greater than or equal to 10% clonal bone marrow plasma cells or biopsy-proven bone or extramedullary plasmacytoma and any one or more of the following myeloma-defining events:

  * Evidence of end organ damage attributed to the underlying plasma cell proliferative disorder and satisfying at least one of the protocol specified laboratory criteria for calcium elevation, renal failure, anemia, or lytic bone lesions; OR
  * One or more of the biomarkers of malignancy as described in the protocol.
* Must have MM positive for the t(11;14) translocation, as determined by methods described in the protocol.
* Must have measurable disease defined by at least one of the following criteria:

  * Serum M-protein ≥ 1.0 g/dL (immunoglobulin \[Ig\]G myeloma) or greater than or equal to 0.5 g/dL (IgA, IgM, IgD, or IgE myeloma);
  * Urine M-protein greater than or equal to 200 mg/24 hours;
  * Serum free light chain (FLC) greater than or equal to 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal.
* Newly diagnosed and not considered a candidate for high-dose therapy and hematopoietic stem cell transplantation (HSCT)
* Must have Eastern Cooperative Oncology Group performance status less than or equal to 2.

Exclusion Criteria:

* Has a co-existing condition as specified in the protocol.
* Has history of other active malignancies, including myelodysplastic syndromes (MDS) within the past 3 years with specific exceptions detailed in the protocol.
* Has been treated with or received any of the following:

  * Prior or current systemic therapy or hematopoietic stem cell transplantation (HSCT) for MM (a short course of treatment with corticosteroids equivalent to dexamethasone 40 mg/day for a maximum of 4 days is allowed before treatment); use of systemic strong or moderate inhibitor or inducer of cytochrome P450(CYP)3A within 7 days before the first dose of study drug.
  * Radiation therapy within 2 weeks of dosing
  * Plasmapheresis within 4 weeks of dosing
  * Immunization with live vaccine within 8 weeks of dosing
* Has a contraindication or inability to comply with antithrombotic prophylaxis.
Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT)

The purpose of this study is to determine how safe and effective fondaparinux is in treating patients with suspected or confirmed heparin-induced thrombocytopenia (HIT).

Currently, standard treatment of HIT involves the transition from a direct thrombin inhibitor (a type of anticoagulant or "blood thinner") to warfarin, a different type of anticoagulant. Direct thrombin inhibitors (DTIs) require IV administration and frequent blood draws for dose adjustments, which can lead to prolonged hospitalization. DTIs also affect blood test measurements, making it difficult to determine proper dosages of warfarin.

Fondaparinux is a drug that is approved by the FDA for the treatment of blood clots in deep veins and in the lungs. Fondaparinux is not FDA approved for the treatment of HIT. However, an increasing number of doctors are using fondaparinux instead of DTIs to treat HIT. Although fondaparinux appears to be more convenient and predictable than DTI medications, more research is needed to support its use as a treatment for HIT.

Eligibility Criteria:
Inclusion Criteria:

* high risk for HIT based on "Four Ts score" of 6 or more

Exclusion Criteria:

* pulmonary emboli at the time of enrollment
* arterial thrombosis at the time of enrollment
* limb threatening phlegmasia cerulea dolens at the time of enrollment
* Calculated Creatinin Clearance less than 50 ml/hr
* platelet count less than 50
* Weight less than 50 kg
* pregnancy
* allergy to fondaparinux
* bacterial endocarditis
* history of neuraxial anesthesia and post-operative indwelling epidural catheter
* active major bleeding (hemodynamically significant or requiring transfusions)
* inability to give informed consent
Study of Ticilimumab in Patients With Metastatic Colorectal Cancer Whose Disease Had Progressed After Treatment

This study is for patients with metastatic adenocarcinoma arising from the colon or rectum who have received treatment(s) for metastatic disease with subsequent disease progression. Patients who are intolerant to treatment(s) are also included. This is a study for good performance status colorectal cancer patients who have exhausted standard therapy options.


Eligibility Criteria:
Inclusion Criteria:

* Radiographic evidence of metastatic, progressive disease following standard therapies.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

Exclusion Criteria:

* Known brain metastases or uncontrolled pleural effusions.
* History of chronic inflammatory or autoimmune disease.
Power Exercise for Stroke Recovery: The POWER Feasibility Trial

Post-stroke deficits are highly common and functional impairment persists throughout life after stroke. Skeletal muscle mass and strength are fundamental contributors to mobility throughout the adult life course. Stroke-related muscle atrophy contributes to loss of strength, and declines in lower extremity function, cardiorespiratory fitness, and walking independence and post-stroke sarcopenia. Improving the quantity and function of skeletal muscle needs to be an important therapeutic target after stroke. Resistance exercise training (RET) has been shown to increase skeletal muscle mass, strength and power, reduce oxidative stress, improve cardiac function, and better regulate lipids after stroke. However, the feasibility and the effects of a power focused RET program for individuals with stroke need to be examined.

This study is a single-group, open label trial examining the feasibility and preliminary effect estimates of a 10-week power-focused exercise training program in people living with stroke. Fifteen participants with chronic stroke will participate in the exercise program 3 times per week for 10 weeks at a progressive intensity. The program will take place at a community exercise gym built for older adults and people with physical disabilities. Feasibility outcomes will be assessed throughout the trial. Effectiveness outcomes will be assessed at baseline and immediately post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* ≥6 months post-stroke
* Able to walk \>10 meters with or without the use of an assistive device
* Living in the community
* Mild to moderate stroke severity (modified Rankin Scale ≤3)

Exclusion Criteria:

* Any contraindications to exercise for people with cardiovascular disease, such as unstable angina, uncontrolled hypertension, orthostatic blood pressure with exercise, or uncontrolled arrhythmias
* Significant cognitive impairment that would preclude safe exercise participation (Montreal Cognitive Assessment score \<26)
* Actively engaged in stroke rehabilitation services
Miglustat in Niemann-Pick Type C Disease

This is a phase II randomized controlled study of miglustat in adult and juvenile patients with Niemann-Pick Type C disease. Up to 42 patients will be randomised in a 2:1 ratio to either treatment with miglustat or to a non-treatment group. Both groups will follow an identical visit schedule.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with Niemann-Pick Type C disease confirmed by abnormal cholesterol esterification and abnormal filipin staining.
2. Patients who can ingest a capsule.
3. Patients who are above the age of four (4) years of age.

Exclusion Criteria:

1. Patients younger than 18 years who are unable to give informed assent and/or whose legal guardian is unable to provide informed consent.
2. Patients aged 18 and over who cannot provide informed consent and/or whose legal guardian is unable to provide witnessed informed consent.
3. Sexually active and fertile patients who do not agree to use adequate contraception throughout the study and for three months after cessation of OGT 918 treatment.
4. Patients who cannot tolerate the study procedures or who are unable to travel to the study center as required by this protocol.
5. Patients currently undergoing therapy with other investigational agents or patients taking drugs or food supplements which may interfere with gastrointestinal absorption or motility.
6. Patients suffering from clinically significant diarrhea (\>3 liquid stools per day for \>7 days) without definable cause within 3 months of Screening Visit, or who have a history of significant gastrointestinal disorders.
7. Patients with an intercurrent medical condition that would render them unsuitable for the study e.g. HIV, hepatitis infection.
8. Patients who in the opinion of the Investigator (for whatever reason) are thought to be unsuitable for the study.
9. Patients with an adjusted Creatinine Clearance of less than 70 ml/min/1.73m2 (CrCl \<70).
10. Patients younger than four (4) years of age.
Characterization of Exosomes Platelets-released

Extracellular vesicles (EVs) play a key role in cell-to-cell communication. They are small vesicles that contain rich molecular cargo. Recently, they have been proposed as biomarkers for clinical diagnostics. EVs include three classes: small EVs (exosomes), large EVs (microparticles), and apoptotic bodies. Platelet-derived EVs (PEVs) are the most abundant class in human blood and can actively participate in numerous physiological and pathological processes. The information about the role of platelet exosomes in cardiovascular disease and the effect of antiplatelet agents on their release and content is very limited.

This study is a multicentre, observational. We plan to enrol 54 subjects from Centro Cardiologico Monzino IRCCS, and 121 buffy coat related to 121 subjects from Centro Trasfusionale Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico. biographical and anthropomorphic data will be recorded, a fasting blood venous sample (from ante-cubital vein) will be collected for the haematochemical analyses and for research samples.

Eligibility Criteria:
Inclusion Criteria:

* subjects without known pathologies

Exclusion Criteria:

* individuals with gastrointestinal diseases,
* individuals with history of hepatic diseases,
* individuals with history of urogenital diseases,
* individuals with history of hematological diseases,
* individuals with history of immunological diseases,
* individuals with history of renal diseases,
* individuals with history of metabolic diseases
* individuals with history of respiratory diseases
* individuals with history of cancer
* individuals with history of cardiovascular disease
* individuals having permanent organ damage
* individuals with major trauma in the last 6 months prior to enrollment
* individuals with surgery in the last 6 months prior to enrollment
* individuals taking medication in the 15 days prior to enrolment.
The Effects of Extracorporeal Shock Wave Therapy in Patients With Coccydynia: A Randomized Controlled Trial

The purpose of this study is to evaluate the effects of extracorporeal shock wave therapy (ESWT) on the outcomes of coccydynia.

Coccydynia is pain in the coccygeal region, and usually treated conservatively. Extracorporeal shock wave therapy (ESWT) was incorporated as non-invasive treatment of many musculoskeletal conditions. However, the effects of ESWT on coccydynia are less discussed. The purpose of this study is to evaluate the effects of ESWT on the outcomes of coccydynia. Patients were allocated to ESWT (n=20) or physical modality (SIT) group (n=21) randomly, and received total treatment duration of 4 weeks. The visual analog scale (VAS), Oswestry disability index (ODI), and self-reported satisfaction score were used to assess treatment effects. The VAS and ODI scores were significantly decreased after treatment in both groups, and the decrease in the VAS score was significantly greater in the ESWT group. The mean proportional changes in the ODI scores were greater in the ESWT group than in the SIT group, but the between-group difference was not statistically significant. The patients in the ESWT group had significantly higher subjective satisfaction scores than SIT group. The investigators concluded that ESWT is more effective and satisfactory in improving discomfort and disability caused by coccydynia than the use of physical modalities. Thus, ESWT is recommended as an optimal treatment option for patients with coccydynia.

Eligibility Criteria:
Inclusion Criteria:

* First-time diagnosed with coccydynia
* History of direct traumatic events to the buttocks, such as falls or slipping

Exclusion Criteria:

* Tumors of the cauda equina
* Pelvic surgery
* Herniation of the lumbosacral disc
* Internal procidentia
* Genitourinary or gastrointestinal complaints
* Psychogenic factors
Biological Markers and Advanced Imaging for Prostate Cancer Progression in Active Surveillance

This study aims to identify patients with low-risk prostate cancer (ISUP Grade Group 1) eligible for active surveillance who are at higher risk of upgrading to ISUP Grade Group 2 or higher at confirmatory biopsy one year after diagnosis. Patients with low-risk ISUP GG1 tumors will be selected and undergo:

* PSMA PET with calculation of SUVmax and PRIMARY-Likert score
* Whole Exome Sequencing (WES) analysis on diagnostic prostate biopsies
* Immunohistochemistry on diagnostic prostate biopsies
* Confirmatory biopsy one year after diagnosis, as recommended by international guidelines This prospective, monocentric, single-arm interventional study will assess the predictive accuracy of a multivariable model integrating next-generation imaging and molecular biomarkers to improve risk stratification in active surveillance patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven low-risk PCa (PSA ≤10 ng/ml; clinical stage ≤T2a, and biopsy ISUP GG 1)
* Non-metastatic status at study inclusion (patient enrollment).
* No prior or concomitant androgen deprivation therapy
* Ability to understand a written informed consent and willingness to sign it.

Exclusion Criteria:

* Unable to tolerate a PSMA-PET scan
* Unwillingness to be managed with AS
* Receipt of neoadjuvant or curative-intent therapies
* Pacemaker
* Inability to obtain the FFPE prostate biopsy specimens from the initial biopsy
Tobacco Constituents and Biomarkers

This proposal addresses several research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products as mandated by the Family Smoking Prevention and Tobacco Control Act. Scientific evidence supports the important role of tobacco and cigarette smoke carcinogens in the development of cancers associated with cigarette smoking. Regulation of the levels of harmful constituents in cigarette smoke is one of the tobacco control strategies that now can be employed by the FDA and may serve to reduce tobacco carcinogen exposures in those smokers who are unable or unwilling to quit smoking. Such regulation will require a valid and robust approach to the assessment of comparative toxicity and carcinogenicity among various cigarette brands. This proposal will help develop a testing approach that can produce meaningful predictions of changes in human exposure due to changes in constituent levels in cigarette smoke, and hence serve as a reliable measure for product regulation. Thus, the proposed research will generate findings and data that are directly relevant to inform the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health. The human trial deals with Aims 2 and 3 of this study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adult smokers 18-65 years of age, who smoke at least 7 cigarettes per day (to assure that biomarker levels are above the limit of quantitation) and do not have plans to quit smoking in the next month;
* Smoked the same brand for \>80% of their cigarettes over the course of at least 1 year, and smoked not more than 20 cigarettes (1 pack) of a different brand within two weeks prior to the eligibility screening;
* Not using any other nicotine or tobacco product;
* Subjects who are not taking any medications that affect relevant metabolic enzymes;
* Women who are not pregnant or nursing;
* Subjects have provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves use of tobacco products).

Exclusion Criteria:

* Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data;
* Current or recent alcohol or drug abuse problems (to ensure alcohol and drug use does not affect biomarkers of exposure and to maximize retention);
* Regular tobacco use (e.g., greater than weekly) other than cigarettes;
* Currently using nicotine replacement or other tobacco cessation products (to minimize confounding effects of another product);
* Pregnant or breastfeeding (due to toxic effects from tobacco products)
* Report smoking more than 1 pack (20 cigarettes) of a non-usual brand cigarette in the past two weeks \* Participants who report smoking 2 or more non-usual brand cigarettes the day before the clinic visit will be ineligible
A One-Year Study To Evaluate The Efficacy And Safety Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis

The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older with diagnosis for at least 12 months of moderate to severe plaque psoriasis covering at least 10% of body surface area
* A Psoriasis Area and Severity Index (PASI) score of 12 or greater
* Are considered to be candidates for systemic or light therapy
* Have no evidence of active or latent tuberculosis

Exclusion Criteria:

* Non-plaque or drug-induced forms of psoriasis
* Cannot discontinue current oral, injectible or topical therapy for psoriasis or cannot discontinue phototherapy (PUVA or UVB)
* Any uncontrolled significant medical condition