cyrilzakka/clinical-trials huggingface dataset:
Physical Activity in Transfusion Dependent Patients With Myelodysplastic Syndrome

This study assesses feasibility and patient acceptability of using a Fitbit to monitor step count and heart rate in transfusion dependent patients with myelodysplastic syndrome. Information from this study may help researchers understand if there is any correlation between activity level and anemia.

This study assesses feasibility and patient acceptability of using a Fitbit to monitor step count and heart rate in transfusion dependent patients with myelodysplastic syndrome. Information from this study may help researchers understand if there is any correlation between activity level and anemia.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed pathologic diagnosis of MDS
* Requiring \>= 2 blood transfusions in the past month if previously diagnosed or hemoglobin =\< 8 g/dL if newly diagnosed
* Age \>= 18
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Ambulatory (use of a walking aid, such as a cane or rollator, is acceptable)
* Able to give informed consent
* Willing to comply with all study procedures and available for the duration of the study
* Able to read and/or understand English
* Have access to an iPhone 4S or later, iPad 3 generation or later, Android 5.0 or later, or Windows 10 device
* Have access to Bluetooth low energy (LE) and internet connection for syncing

Exclusion Criteria:

• Uncontrolled illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Emotional Processing and Oxytocin Mechanisms in Premenstrual Dysphoric Disorder: A Pilot Study

This research study will look at brain and symptom differences among women with severe premenstrual mood symptoms. One goal of this study is to look at the effects of taking a nasal spray containing oxytocin (a hormone made in the brain) on brain areas involved in emotion regulation while viewing pictures during a neuroimaging (fMRI) session. The investigators will also look at whether oxytocin improves premenstrual mood symptoms.

Purpose: The primary objective of this pilot study is to use functional neuroimaging techniques to begin to identify the central brain networks that may contribute to impairment in emotion regulation, interpersonal relationships, and marital and family function in women with premenstrual dysphoric disorder (PMDD), particularly for those women who also have a history of early life abuse (ELA).

Based on the evidence that the mammalian neuropeptide oxytocin (OT), best known for its role in lactation and parturition, plays a seminal role in social affiliation, emotion regulation, attachment, maternal behavior, trust, and protection against stress; and because OT neural pathways and receptors are prominently expressed in brain regions involved in emotion regulation and maternal/affiliative behavior; the study will: 1) use intranasal OT administration as a probe to assess whether it modifies activation of brain regions involved in emotion regulation in response to an emotional processing task; and 2) whether daily intranasal OT administration during the premenstrual phase improves symptoms in women with PMDD with or without a history of ELA.

Eligibility Criteria:
Inclusion Criteria:

* In order to be eligible to enter this study, subjects will have met PMDD Study Entry Criteria in the diagnostic feeder study (IRB# 05-3000)
* 18 to 52 years of age
* Regular menstrual cycles
* Ability to give informed consent

Exclusion Criteria:

* current psychiatric diagnosis of substance abuse or claustrophobia (fear of closed places)
* pregnancy (based on urine pregnancy test) or breastfeeding
* use of psychiatric medication (e.g. for depression, anxiety), hormonal medication, other agents that alter mood or thinking, or street drugs
* any foreign iron or steel metal objects in the body, such as a pacemaker, shrapnel, metal plate, certain types of tattoos, or metal debris
Mountain Hiking & Environmental Influences

In a randomized crossover design, approximately 50 healthy participants will be randomly exposed to outdoor mountain hiking (approximately 6 hours each) in two different areas: an anthropogenically influenced area and in a widely pristine area.


Eligibility Criteria:
Inclusion Criteria:

* voluntary participation

Exclusion Criteria:

* pregnancy
* breastfeeding
* chronic or acute diseases (already existing or diagnosed during the study)
* unable to be physically active assessed by the Physical Activity Readiness Questionnaire
A Pharmacokinetic Study of Subcutaneous and Intravenous Rituximab in Participants With Follicular Lymphoma

This 2 stage study will compare the pharmacokinetics and safety profile of subcutaneous and intravenous rituximab in participants with follicular lymphoma. In the first stage, participants who have achieved at least a partial response after induction treatment with intravenous rituximab will be randomized to one of 3 treatment cohorts, to receive rituximab 375 milligram per square meter (mg/m\^2) intravenously, 375 mg/m\^2 subcutaneously or 625 mg/m\^2 subcutaneously, and pharmacokinetics evaluated on an ongoing basis. Upon selection of the subcutaneous dose (800 mg/m\^2) which results in rituximab trough plasma concentration (C trough) values comparable to those achieved with the intravenous formulation, participants in the second stage of the study will be randomized to receive either the subcutaneous or intravenous formulation to demonstrate comparability of the C trough levels with both routes of administration. Maintenance therapy will continue every 2 or 3 months with the subcutaneous formulation.


Eligibility Criteria:
Inclusion Criteria:

* CD20-positive follicular non-Hodgkin's lymphoma (NHL)
* Documented partial or complete response a the end of induction treatment with rituximab
* Must have completed induction treatment, and received at least 1 dose of intravenous rituximab maintenance treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of less than and equal to (\<=) 2
* Life expectancy of greater than and equal to (\>=) 6 months

Exclusion Criteria:

* Histological evidence of transformation of NHL, or types of NHL other than follicular lymphoma
* Presence or history of central nervous system disease
* History of malignancy other than follicular NHL
* Recent major surgery (within 4 weeks prior to screening), excluding lymph node biopsy
A Study of SHR-1702 Alone or With Camrelizumab in Participants With Advanced Relapsed/Refractory Solid Tumors

The purpose of this study is to evaluate the safety of SHR-1702 monotherapy or in combination with Camrelizumab among advanced solid tumor subjects.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced relapsed/refractory solid tumors
* Must have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale
* Have an estimated life expectancy of 12 weeks, in judgement of the investigator；
* Must have at least 1 measurable lesion assessable using standard techniques by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
* Adequate hematologic and organ function
* Signed inform consent form

Exclusion Criteria:

* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
* Significant cardiovascular disease
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring
* History of autoimmune disease.
* Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid are permitted in the absence of active autoimmune disease.
* Positive test result for human immunodeficiency virus (HIV); Active hepatitis B or hepatitis C
* Active or untreated central nervous system (CNS) metastases
* Active infection within 2 weeks
* History of severe (or known) hypersensitivity to chimeric or humanized antibodies or fusion proteins
* Prior allogeneic bone marrow transplantation or solid organ transplant
* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
vHIT Testing for Presentation of Dizziness at a Comprehensive Stroke Center

The purpose of this study is to evaluate the sensitivity and specificity of the video head impulse test (vHIT) device, when implemented in the acute ED setting to identify acute ischemic stroke or central pathology vs peripheral vestibular dysfunction in patient's presenting with vertigo. This study will evaluate the implementation of the device, consistency with current diagnostic standards, unnecessary administration of antithrombolytics and will further study the reduction in hospital admissions and overall healthcare costs.

In the proposed study, subjects admitted to the Emergency Department (ED) with symptoms of dizziness, concerning for an acute ischemic stroke, will undergo routine triage (bedside neurologic examination, head impulse testing, CT scan) and will then be tested with a vHIT device to attempt to further identify the cause of dizziness, after standard of care testing has been performed. The clinician performing the vHIT will be blinded to the result of the CT scan before entering their report.

Eligibility Criteria:
Inclusion Criteria:

* Adults between the ages of 18-90
* Admitted to the MUSC ED with symptomatic dizziness, concerning for a stroke vs peripheral vestibular dysfunction.

Exclusion Criteria:

* Prisoners
* COVID +
* Cognitively Impaired Individuals
Evaluation of Gastroesophageal Reflux in Patients on Continuous Positive Airway Pressure Ventilation for Obstructive Sleep Apnea

Patients with a clinically indicated sleep study will be enrolled in this study. They will have a diagnostic and a therapeutic sleep study with continuous positive airway pressure ventilation. For both studies a pH probe will be placed nasal to measure the amount of acidic reflux during each study. Baseline levels of reflux from the diagnostic sleep study will be compared to reflux episodes while on continuous positive airway pressure ventilation.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years of age, symptoms consistent with sleep apnea, agree to consent form and placement of pH probes

Exclusion Criteria:

* any unstable medical condition, previous upper gi surgery or anatomic abnormality of upper gi tract, acid suppressing medication
A Study To Investigate The Ability To Use 18FDG PET Scanning To Monitor The Effectiveness Of New Drugs In COPD Patients

It is hypothesised that there is a difference between the uptake of a radioactive substance (\[18F\]fluorodeoxyglucose (FDG)) in the lungs of patients with Chronic Obstructive Pulmonary Disease (COPD) and healthy volunteers.

Single site, eligible subjects enrolled in order of presentation.

Eligibility Criteria:
Inclusion Criteria:

* COPD Patients:
* Subjects with a Body Mass Index (BMI) between 18-32 kg/m2.
* Patients with a diagnosis, for at least 6 months, of moderate to severe (Stage II - III) COPD as defined by the NIH/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD, 2005 revision), whose disease has been stable for 3 months, and have not had a respiratory tract infection for 6 weeks prior to screening.
* Ability to be maintained off inhaled corticosteroids and other anti-inflammatory medications (e.g., theophylline) as required by the protocol
* Healthy Volunteers:
* Healthy volunteers should be age (+/- 5 years) and gender matched to the COPD subjects
* No history of asthma, COPD or other lung disease (including, sarcoidosis, pneumoconiosis, tuberculosis, lung surgery or resection, lung cancer, bronchitis).
* Free from clinically significant disease.

Exclusion Criteria:

* Exacerbation or hospitalisation for COPD within 3 months of screening, or more than twice during the preceding year.
* Use of oral corticosteroids in the 6 weeks prior to screen. (Patients who have been taking inhaled corticosteroids as maintenance COPD therapy are eligible provided the dose has remained stable for the previous 6 weeks and it is considered that they could tolerate withdrawal of inhaled corticosteroid for the duration of the study).
* A clearly documented history of adult asthma or other chronic respiratory disorders apart from COPD (e.g. clinically significant bronchiectasis, pulmonary fibrosis, pneumoconiosis).
* Previous history of bronchial carcinoma, or previous history of lung surgery (including lung resection, pleurodesis, open lung biopsy, video-assisted lung biopsy) or invasive lung procedure (e.g., bronchoscopy (with or without biopsy), bronchoalveolar lavage).
* Patients with a history of prior radiation exposure within the past year such that participation this study would put them over 5 rem for annual radiation exposure for research subjects.
* History or evidence, based upon a complete medical history, full physical examination, chest X-ray or clinical laboratory test results, of any other significant concomitant clinical disease that, in the opinion of the investigator, could interfere with the subject's safety or the conduct of this study.
Combination Chemotherapy for Patients With Brain Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy using paclitaxel and topotecan, plus G-CSF, in treating patients with glioblastoma multiforme or anaplastic astrocytoma that is refractory or recurrent.

OBJECTIVES: I. Determine the response rate in patients with refractory or recurrent glioblastoma multiforme or anaplastic astrocytoma treated with paclitaxel (TAX) and topotecan (TOPO) with granulocyte colony-stimulating factor (G-CSF) support. II. Determine survival in these patients. III. Describe the toxicity of TAX/TOPO/G-CSF. IV. Evaluate tumor p53 expression in relation to response to TAX/TOPO/G-CSF.

OUTLINE: All patients receive paclitaxel, topotecan, and G-CSF every 3 weeks for at least 2 courses and until 2 courses beyond maximum response. Patients are followed every 3 months for 2 years, then every 6 months for relapse and survival.

PROJECTED ACCRUAL: A total of 35 patients will be entered if there are 1-3 responses in the first 20 patients.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Biopsy proven glioblastoma multiforme or anaplastic astrocytoma Central pathologic review at Dartmouth-Hitchcock Medical Center, including assay for tumor p53 expression No anaplastic oligodendroglioma No mixed oligodendroastrocytoma Recurrent or progressive disease following radiotherapy documented by CT or MRI within 2 weeks of entry

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100% Hematopoietic: WBC at least 3,000 ANC at least 1,500 Platelets at least 100,000 Hepatic: Bilirubin no greater than 1.0 mg/dL AST/ALT no greater than 2.5 times normal Renal: Creatinine no greater than 1.5 mg/dL Other: No documented sensitivity to E. coli-derived products No major medical or psychiatric illness that would interfere with therapy or compliance with scheduled follow-up No pregnant or nursing women Adequate contraception required of fertile patients

PRIOR CONCURRENT THERAPY: No prior taxanes or topoisomerase I inhibitors At least 4 weeks since chemotherapy (6 weeks since nitrosoureas) At least 4 weeks since radiotherapy
The Effect of Robotics-assisted Tilt Table and Functional Electrical Stimulation in Stroke Patients

Among subacute stroke patients (within 4 weeks after the onset), patients who are unable to walk are divided into experimental groups and control groups, and conventional rehabilitation treatment including physical therapy and occupational therapy is performed for 4 weeks or more in all groups.

Robot assisted inclined bed treatment and FES were performed, and the control group performed conventional inclined bed treatment.

The purpose of this study is to investigate the effect of robot-assisted inclined bed treatment by tracking observation and comparative analysis of the lower limb function, gait ability, bone density and muscle mass of each group.

Patients appropriate for the selection criteria are divided into experimental group and control group in random permuted blocks to conduct the study. In the experimental group, FES was performed at the same time as the robot-assisted inclined bed treatment once a day for 30 minutes, 5 days a week for 4 weeks, and the control group performed conventional inclined bed treatment for 30 minutes once a day for 4 weeks, 5 days a week. Separately from this in all groups, functional electrical stimulation treatment is performed once a day in the area except the lower extremities. In addition, all patients receive palliative physical therapy for 4 weeks for 1 hour a day. All subjects undergo a physical examination and whole body composition assessment before and after 4 weeks of treatment, and f/u after 4 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients within 4 weeks of onset of first stroke
2. Patients with an FAC score of 1 or less and at least one lower limb FMA of 15 or less
3. Adult male or female over 50 years of age
4. Those who have consented in writing to this clinical trial
5. A person who understands the purpose of the clinical trial and can adapt well to the treatment process

Exclusion Criteria:

1. Those with lower motor neuron lesions
2. A person who has an artificial implant due to a fracture of the lower extremity and spine, or a metal implant that generates an electrical signal such as an artificial pacemaker.
3. Those with a history of bone metabolism related diseases such as thyroid or parathyroid disease (excluding osteopenia and osteoporosis) or bone tumor
4. A person who has a history of fracture at the site of bone mineral density (ex. L1-L5, femoral head)
5. Those who have skin ulcers or skin diseases such as open wounds that make it difficult to apply robotic therapy
6. Those with the construction of the lower extremities
7. Those with deep vein thrombosis or arterial vascular disease of the lower extremities
8. Pregnant women
9. Not appropriate according to the judgment of other researchers
Minimally Invasive Surgery Versus Traditional Open Surgery In The Treatment Of Single Level Lumbar Stenosis

The purpose of this study is to determine the effectiveness of minimally invasive surgical technique over the traditional open surgical procedure in patients with degenerative lumbar stenosis


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75 years;
* Patient has single level degenerative lumbar spinal stenosis and an indication for a single level instrumented lumbar fusion for the treatment;
* Symptoms persisting for at least three months prior to surgery;
* Given written Informed Consent;
* Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.

Exclusion Criteria:

* Prior lumbar spinal fusion at any level;
* Other non-degenerative spinal conditions (e.g. infectious, traumatic, metabolic, inflammatory, neoplastic, structural or other pathology) that may have an impact on subject safety, wellbeing or the intent and conduct of the study;
* Any condition that cannot be treated with mini-invasive unilateral decompression and fusion;
* History or presence of any other major neurological disease or condition that may interfere with the study assessments (e.g. significant peripheral neuropathy, multiply sclerosis);
* Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).
Effect of Location of Tetanic Stimuli on Photoplethysmogram

The effect of the location of tetanic stimulus on photoplethysmography signals will be studies in patients under general anesthesia.

A 5 second 100 Hz 70 mA tetanic stimulus will be applied to three different locations in a random order in patients who are under general anesthesia. Tetanic stimuli are used routinely during general anesthesia to assess effectiveness of neuromuscular blockade. These tetanic stimuli are noxious stimuli that elicit a stress response which can be quantified using photoplethysmography. This study investigates if the magnitude of the tetanus induced stress response is dependent on the location of the tetanic stimulus as measured by photoplythysmography.

Eligibility Criteria:
Inclusion Criteria:

* Surgical patients general anesthesia able to consent in english

Exclusion Criteria:

* regional anesthesia unable to consent in english under 18 yrs of age
A Clinical Trial of Epizon-701 (EPN-701) in Subjects With End-Stage Renal Disease (ESRD)

Patients with End Stage Renal Disease (ESRD) are prone to early and accelerated vascular calcification. Both the prevalence and extent of the vascular calcification are predictive for cardiovascular morbidity and all-cause mortality in this population. There is a growing body of evidence suggesting that dialysis patients have a primary, functional deficiency of Vitamin K2 as evidenced by reduced levels of circulating biomarkers including carboxylated forms of Matrix Gla Protein (MGP), Osteocalcin, and Fetuin-A, which are important inhibitors of vascular calcification. Decreased levels of Vitamin K2 are known to lead to microvascular calcification and are associated with dermatological and cardiovascular conditions such as calciphylaxis and peripheral arterial disease (PAD).

The purpose of this Phase 2 study is to examine the safety and pharmacokinetics of EPN-701 (menaquinone-7; MK-7) and to assess the effects on certain circulating biomarkers when MK-7 is orally administered once daily for 14 days.

Patients with End Stage Renal Disease (ESRD) are prone to early and accelerated vascular calcification. Both the prevalence and extent of the vascular calcification are predictive for cardiovascular morbidity and all-cause mortality in this population. There is a growing body of evidence suggesting that dialysis patients have a primary, functional deficiency of Vitamin K2 as evidenced by reduced levels of circulating biomarkers including carboxylated forms of Matrix Gla Protein (MGP), Osteocalcin, and Fetuin-A, which are important inhibitors of vascular calcification. Decreased levels of Vitamin K2 are known to lead to microvascular calcification and are associated with dermatological and cardiovascular conditions such as calciphylaxis and peripheral arterial disease (PAD). The purpose of this Phase 2 study is to examine the safety and pharmacokinetics of EPN-701 (menaquinone-7; MK-7) and to assess the effects on certain circulating biomarkers when MK-7 is orally administered once daily for 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Consenting subjects.
* Adult male and female who were diagnosed with stable ESRD.
* Subjects treated with maintenance hemodialysis at least 3 times a week for at least 3 months prior to the first dose of study drug.
* Clinically stable.

Exclusion Criteria:

* Solid organ transplant.
* Malignancy.
* Severe infection requiring intravenous (IV) antibiotics.
* Any co-existing disease or condition that could have compromised the safety of study participants and/or the integrity of the study.