cyrilzakka/clinical-trials huggingface dataset:
The Risk Stratification in Patients With Multiple Myeloma Based on Fluorescence Flow Cytometry Quantitative Determination of the Circulating Plasma Cells in the Peripheral Blood

The main aim of this study is to evaluate the effectiveness of the clinical application of the XN-1000/20 hematology analyzer for risk stratification in patients with multiple myeloma based on the number of detected plasma cells in peripheral blood at the different stages of treatment. This clinical study is observational and does not involve drugs. 100 subjects with newly diagnosed multiple myeloma will be enrolled in this study and followed for 3 years.

The presence of circulating plasma cells in patients with multiple myeloma is considered as a marker for highly proliferative disease and associated with a worse prognosis.

Plasma cell counting is conventionally done by means of peripheral blood film morphology using light microscopy. However, this manual method is laborious as well as imprecise due to the low number of cells counted, and inter-observer variability. Flow cytometry with monoclonal antibodies is unsuitable as a screening test. The procedure is not automated, and it is expensive and time consuming. Therefore, new rapid, effective and inexepensive methods are needed for risk-stratification in patients with multiple myeloma.

Automated antibody-synthesizing or secreting cells counting from routine haematology systems (XN-1000/20) without sample preparation and in less than 1 minute will further reduce the workload in haematology laboratories and it can be used for counting circulating plasma cells in peripheral blood in patients with multiple myeloma.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis: Newly diagnosed symptomatic multiple myeloma
* Signed informed consent
* No second tumors

Exclusion Criteria:

* Monoclonal gammopathies of undefined significance
* Smoldering Multiple Myeloma
* Plasma cell leukemia
Effectiveness of Desensitisation and Pain Neuroscience Education in Patients With Carpal Tunnel Syndrome With Nosiplastic Pain

The aim of our study was to determine the effectiveness of desensitisation and pain neuroscience education in a group of patients with mixed phenotype pain (neuropathic and nosiplastic).

People between the ages of 18-65, diagnosed with Carpal Tunnel Sedrome, who are suitable for the Nosiplastic pain phenotype and who volunteer to participate in the study will be included. The 7 steps in the Clinical Criteria/Rating System determined by the International Association for the Study of Pain (IASP) for Nosiplastic Pain will be applied to patients with CTS. After determining the predominant pain phenotype in patients with CTS, patients with mixed type (neuropathic and nosiplastic pain phenotype) will be randomly divided into two groups. One group (Group 1) will receive desensitisation and the other group (Group 2) will receive desensitisation and pain neuroscience education. Numerical rating scale (NRS) will be used for pain assessment. Boston Carpal Tunnel Questionnaire - Symptom Severity Scale will be used for symptom severity assessment and Boston Carpal Tunnel Questionnaire - Functional Status Scale will be used for functional status assessment. Pressure pain threshold will be measured with an algometer to evaluate hypersensitivity. The Pain Catastrophising Scale and the Tampa Kinesiophobia Scale will be administered to the patients. Normality of the data distribution will be assessed using the Shapiro-Wilk test. Fischer's exact test and chi-square test will be used to verify the relationship between categorical variables. A mixed model ANOVA will be performed on 2 (group 1 and group 2) x 3 (time: baseline, post-intervention, 3 months post-intervention) different outcome measures (pain intensity, symptom severity, functional status, pain catastrophising and kinesiophobia) to detect between-group differences.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with CTS
* Being suitable for the nosiplastic pain phenotype
* Being between the ages of 18-65
* Volunteering to participate in the study

Exclusion Criteria:

* Having systemic inflammatory disease
* Having a disease that may cause polyneuropathy such as diabetes mellitus
* Having a pacemaker
* Having a disease affecting the central nervous system
* Having cervical radiculopathy
* History of previous operation or local steroid injection due to CTS
* Hypersensitivity to heat and cold
Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as topotecan and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with vinorelbine in treating patients with recurrent lung cancer.

OBJECTIVES:

Primary

* Determine the maximum tolerated dose of topotecan when combined with vinorelbine ditartrate in patients with recurrent lung cancer.

Secondary

* Assess the response and stable disease rates and the time to disease progression among treated patients.

OUTLINE: This is a dose-escalation study of topotecan.

Patents receive vinorelbine ditartrate IV over 8-10 minutes and topotecan IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which ≥ 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed lung cancer

  * All histologic types eligible
  * Recurrent or progressive disease after ≥ 1 prior chemotherapy regimen with or without radiotherapy

PATIENT CHARACTERISTICS:

* ECOG performance status (PS) ≤ 2
* Karnofsky PS ≥ 60%
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Total bilirubin ≤ 1.5 mg/dL
* Creatinine ≤ 1.5 mg/dL
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other active invasive malignancy
* No uncontrolled illness including, but not limited to:

  * Ongoing or active infection
  * Symptomatic congestive heart failure
  * Unstable angina pectoris
  * Cardiac arrhythmia
* No psychiatric illness/social situation that would limit compliance with study requirements
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to topotecan or vinorelbine ditartrate

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* At least 2 weeks since prior radiotherapy
* No prior therapy with topotecan or vinorelbine ditartrate
* No chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C)
* Recovered from agents administered \> 4 weeks earlier
* No other concurrent investigational agents
* No concurrent palliative radiotherapy
* No other concurrent anticancer therapies or agents
* No concurrent hormones or other chemotherapy except for the following:

  * Steroids for adrenal failure
  * Hormones for nondisease-related conditions (e.g., insulin for diabetes)
  * Intermittent dexamethasone as an antiemetic
Plerixafor Harvesting and No Chemotherapy for Transplantation of Autologous STem Cells in Cancer (PHANTASTIC)

To assess the efficacy and toxicity of plerixafor (AMD 3100) together with granulocyte-colony stimulating factor (G-CSF) for stem cell mobilisation, in patients with myeloma or lymphoma requiring high dose chemotherapy with stem cell rescue.


Eligibility Criteria:
Inclusion Criteria:

* All of the following must be satisfied:

Aged 18 or over

Able to give informed written consent.

Diagnosis of EITHER multiple myeloma or related plasma cell dyscrasia, OR any form of lymphoma or associated lymphoproliferative disease Autologous stem cell transplantation is planned as the next course of treatment.

The patient has not previously undergone a mobilisation attempt for the current transplant. Patients who have received previous autologous transplants at least 2 years previously are eligible, as long as stem cell mobilisation has not been attempted for the current transplant.

No serious concomitant illness (e.g. heart disease) that might preclude completion of the study.

Creatinine clearance of at least 30 mls/min. Note that a dose reduction of plerixafor is required where the creatinine clearance is between 30-50 mls/min; see section 3.3/5.1/5.3.

Negative pregnancy test in women of childbearing age.

Exclusion Criteria:

* Unable to give informed written consent

Pregnancy or lactating

Creatinine clearance of less than 30 mls/min. Patients with clearances lower than this may still be able to receive plerixafor at reduced dosage following discussion with the trial co-ordinators, but are not eligible for entry into this trial.

Any previous attempt at mobilisation for the current transplant. Patients with any form of leukaemia, INCLUDING PLASMA CELL LEUKAEMIA, are not eligible.
Efficacy and Safety Study of rTMS for Upper Extremity Motor Function Recovery in Ischemic Stroke Patients

The purpose of this study is to Evaluate Efficacy and Safety of rTMS 『TMS』 for Upper Extremity Motor Function Recovery in Patients with Ischemic Stroke

Repetitive transcranial magnetic stimulation (rTMS) can modulate the excitability of cortex but exact efficacy and safety of rTMS is not well established.

Eighty four patients will be recruited and will be divided into two groups. Each group will receive the real rTMS or sham rTMS, respectively, over the primary motor cortex of the dominant hand. Individual subject will receive ten sessions of rTMS. Each rTMS session is low frequency (1Hz), total 1800 stimulations.

The purpose of this study is to evaluate efficacy and safety of rTMS 『TMS』 for upper extremity motor function recovery in patients with ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

* 20-80 yrs old
* Radiologically confirmed ischemic stroke within 90 days
* Brunnström stage 3-5 in the affected hand (ischemic stroke-induced hemiplegic side)
* Patients received stroke treatment and on secondary prevention medication
* Written informed consent

Exclusion Criteria:

* Previous medical histories of stroke, cerebral vascular operation, seizure
* Pregnancy, Breastfeeding
* Patients with hemorrhagic stroke, traumatic brain injury
* Skin lesion in the stimulation site of scalp
* Metal implants in the body (cardiac pacemaker or aneurysm clip)
* Unable to have regular physical and occupational therapies on the affected hand
ECLS Versus IMPELLA™ as Bridge to LVAD (ECI-BLAD)

In this retrospective observational multicenter study the authors tested the hypothesis that the use of IMPELLA™ pump as bridge to bridge, by giving the opportunity of active rehabilitation, should improve patient's outcomes after the implantation of Left Ventricular Assist Device (LVAD).

End stage heart failure patients admitted in Intensive Care Unit (ICU) for refractory cardiogenic shock requiring short-term mechanical circulatory support as a bridge to a long-term LVAD might benefit from early mobilization and rehabilitation with IMPELLA™ inserted via the axillary artery. The aim of this study is to compare the early rehabilitation and outcomes after LVAD implantation between patients previously treated by IMPELLA™ or ExtraCorporeal Life Support (ECLS)

Eligibility Criteria:
Inclusion Criteria:

* patients supported with IMPELLA™ or ECLS for refractory cardiogenic shock as a bridge to long duration LVAD

Exclusion Criteria:

* Patient refusing to give access to their medical chart
* Guardianship and curactorship
* Deprived of liberty
* short term mechanical circulatory system weaned before LVAD implantation
Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer

RATIONALE: When irradiated donor lymphocytes are infused into the patient they may help the patient's immune system kill tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving irradiated donor lymphocytes works in treating patients with metastatic kidney cancer.

OBJECTIVES:

* Determine the response rate in patients with metastatic renal cell carcinoma treated with HLA-partially matched related donor lymphocytes.
* Determine the rate and kinetics of clinical/radiological response in patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
* Determine the rates of graft-vs-host disease in patients treated with this regimen.

OUTLINE: Patients receive irradiated donor lymphocytes IV over 1 hour on day 0. Treatment repeats every 8-16 weeks for up to 6 donor lymphocyte infusions in the absence of disease progression or unacceptable toxicity.

Blood is collected periodically for research studies, including immunophenotypic analysis of cells and assay for cytotoxic T-lymphocytes and natural killer-cell activity against target cells.

After completion of study treatment, patients are followed for 60 days.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of clear cell renal cell carcinoma

  * Metastatic disease
* Measurable disease
* Previously treated with high-dose aldesleukin OR not eligible for or refused such therapy
* No brain metastases by MRI or CT scan
* HLA-partially matched (e.g., ≥ 2/6 HLA A, B, Dr match) related donor available

  * Patients who have no partially matched immediate family member available are eligible if they have a fully HLA-matched donor

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1
* Bilirubin ≤ 2 times upper limit of normal
* Creatinine clearance ≥ 40 mL/min
* AST ≤ 3 times ULN
* Cardiac ejection fraction ≥ 45%
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Risk of COVID-19 Infection After Vaccination

The purpose of this observational nationwide study is to evaluate the effects of three different COVID-19 vaccines for the outcome of different severities of incident COVID infection.


Eligibility Criteria:
Inclusion Criteria:

* Living in Sweden and vaccinated with BNT162b2, mRNA-1273 or ChAdOx1
* All individuals with a previous COVID-19 infection
* Controls matched 1:1 to the groups above

Exclusion Criteria:

* None
Extracellular Vesicles for HD

The primary objective of this study is to discover blood-based biomarker of brain Huntingtin (HTT) protein using extracellular vesicles to be used in evaluating target engagement in HTT lowering clinical trials.

Secondary objectives of this study include developing more accurate biomarkers of Huntington disease (HD) progression or conversion and to develop standard practices for extracellular vesicle biomarker discovery research.

The investigators hypothesize that brain-derived extracellular vesicles (EVs) isolated from human biofluids contain biological cargo specific to their tissue of origin that could allow their use as brain biomarkers for HD. EVs are lipid bilayer-delimited particles that are naturally released from cells in the brain.

The investigators will investigate if EVs contents reflect the pathological alterations occurring with disease progression when compared with EVs isolated from biofluids of healthy non-HD persons.


Eligibility Criteria:
Inclusion Criteria:

1. 18 - 75 years of age
2. can provide informed consent
3. able to read and speak English
4. agree to comply with study procedures (including overnight fasting, blood collection and lumbar puncture); and
5. has been diagnosed with HD (HD Carriers) or not been diagnosed with HD (Non-HD Carriers).

Exclusion Criteria:

1. younger than 18 or older than 75 years old
2. known to carry an intermediate CAG repeat between 27 and 39 or a larger expansion of 60 or more CAG repeats
3. receiving nutrition through a tube
4. pregnant
5. participated in a clinical drug trial within 30 days
6. use prescribed or non-prescribed medications that are not compatible with collection of the study samples (those that may cause excessive bleeding or prevent clotting)
7. positive for HIV, hepatitis B or C
8. have a confirmed or suspected immunodeficient condition/state
9. significant medical, psychiatric, or neurological morbidity is observed by the clinic physician on the day of sample collection that might impair completion of the study procedures
10. have needle phobia, frequent headache, significant lower spinal deformity or major surgery
11. received antiplatelet or anticoagulant therapy within 14 days prior to sample collection (including but not limited to: aspirin, clopidogrel, dipyridamole, warfarin, dabigatran, rivaroxaban and apixaban)
12. have a blood clotting or bruising disorder
13. do not comply with or are unwilling to undertake any of the study procedures
Use of High Flow Nasal Cannula Oxygen and Covid-19 Acute Hypoxemic Respiratory Failure

Nasal High Flow oxygen therapy (NHF) is commonly used as first line ventilatory support in patients with acute hypoxemic respiratory failure (AHRF). It's use has been initially limited in Covid-19 patients presenting with AHRF. The aim of the study is to describe the use of NHF in Covid-19-related AHRF and report the changes in the respiratory-oxygenation index (termed ROX index) over time in these patients.

Nasal High Flow oxygen therapy (NHF) is one of the newer methods of oxygenation commonly used in critical care during acute hypoxemic respiratory failure (AHRF). For various reasons (fear of a putative risk of viral dispersion; initial recommendations for rapid intubation due to the rapid deterioration of patients), NHF seems to have been seldomly used during the current Covid-19 epidemic in France. However, the World Health Organization, and other scientific societies list NHF among the possible options for ventilatory support.

One of the risks however, identified with NHF is to delay an intubation that would have become necessary. This delay seems to be associated with a poorer prognosis for patients.

The respiratory-oxygenation index (termed ROX index) (defined as the ratio of pulse oximetry (SpO2) over inspired fraction in oxygen (FiO2) over respiratory rate (RR); SpO2/FiO2/RR) is used - along with other criteria - to assist the clinician in deciding whether or not to intubate patients on NHF for AHRF. In investigators'ICU, NHF is used in patients admitted for AHRFrelated to Covid-19 and the ROX index is measured and monitoring in investigators' patients. Investigators' initial experience - consistent with feedback from other ICUs - suggests that the respiratory rate of patients with Covid-19-related AHRF is sometimes lower than would be expected given the depth of the hypoxemia. In this case, the ROX index thresholds previously identified for predicting the success or failure of NHF could be different in the case of Covid-19-associated AHRF. The purpose of this work is to describe the use of NHF in Covid-19 patients with AHRF and the evolution of the ROX score over time in patients initially treated with NHF.

Eligibility Criteria:
Inclusion Criteria:

* Covid-19 pneumonia
* acute hypoxemic respiratory failure
* need for nasal high flow therapy as first line therapy
* admission to intensive care

Exclusion Criteria:

* intubation prior to NHF therapy
Living-Related Donor Bone Marrow Immunoregulation in Kidney Transplants

Diabetes and end-stage kidney, liver and heart disease are prominent health issues among veteran patients. Successful solid organ transplantation in the absence of chronic immunosuppressive therapy (specific acquired immunological tolerance) is a desirable therapeutic option. This project extends recent observations supporting the use of concommitant donor bone marrow cell infusion as a means of modulating the immune response in kidney transplantation, thereby allowing a substantial decrease or withdrawal of potentially toxic immunosuppressive drugs.


Eligibility Criteria:
Living related donor kidney transplant recipients and the living related donors.
Surgery Compared to Masking Device for Venous Pulsatile Tinnitus

The investigators aim to study whether surgical resurfacing of the sigmoid sinus and jugular bulb will result in elimination of venous pulsatile tinnitus.

Currently there is no known treatments with efficacy for venous pulsatile tinnitus without any pathology. The investigators hope to learn that in surgery, resurfacing of the sigmoid sinus and jugular bulb (acoustic dampening) will eliminate symptoms such as pulsatile tinnitus in patients. The knowledge learned will significantly help treat and alleviate future patients that have pulsatile tinnitus.

The purpose of the study is to examine whether surgical resurfacing of the sigmoid sinus and jugular bulb will result in elimination of pulsatile tinnitus in human subjects.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral venous pulsatile tinnitus
* Visual Analogue score of severity \>5

Exclusion Criteria:

* Surgery exclusion criteria
* Only hearing ear
* Unfit for surgery / anesthesia
* Visual Analogue score of severity 5 or less
Efficacy of Laser Hair Removal Therapy in HS

Hidradenitis suppurativa (HS) is a chronic, recurrent and debilitating inflammatory skin disorder, characterized by painful inflamed nodules, abscesses and tunnels in the skin folds such as the axilla, inguinal region and gluteal area. The primary event in HS is occlusion of the hair follicle. HS is a notoriously difficult to treat disease, because treatment options are limited and evidence based treatments are scarce. Prevention of diseases is an important topic in medicine. However, current clinical trials in HS are focusing on anti-inflammatory drugs in patients with severe HS, whereas prevention and treatment of patients with more common mild HS is neglected. Laser hair removal therapy is a non-invasive procedure with minimal treatment discomfort for patients. Previous limited studies have suggested positive results in favor of laser hair removal therapy in HS. We therefore hypothesize that hair depilation using laser hair removal therapy may prevent the formation of new lesions and flares of the disease. The objective is to assess the efficacy of laser hair removal therapy in patients with mild to moderate HS.


Eligibility Criteria:
Inclusion Criteria:

* IHS4 mild to moderate, without tunnels in the axillae.
* HS activity in at least one axilla.
* Age 18 years and over.

Exclusion Criteria:

* If the patient is not able or willing to provide informed consent.
* If the patient is allergic to clindamycin lotion.
* If the patient uses systemic therapy for HS such as antibiotics or biologicals.
* If a patient is pregnant.