cyrilzakka/clinical-trials huggingface dataset:
A Closed-loop Brain-computer Interface for Stroke

It may be hard to acquire stable sensorimotor rhythm from the affected motor cortex for patient without a response of paretic hand. A few studies suggest two ways to approaching closed-loop therapy: peripherally extracting the residual signals, for example electromyogram (EMG) at proximal muscles (deltoids) and centrally extracting the activity patterns from unaffected hemisphere during attempting to move paretic hand. Therefore, understanding neural signatures of residual upper extremity movement among stroke patients might help in discovering potential therapeutic target and developing tailored brain-computer interface (BCI) therapy. Additionally, 59.4% of stroke patients in acute stage impair at least one somatosensory modality. It remains unclear whether the patient with somatosensory impairment hinder BCI effect.

Investigators will consecutively enroll subacute (1-4 weeks after stroke onset) patients with first-time, unilateral, subcortical stroke and age-matched healthy controls. All participants will carry on 2 sequential experiments. In the first experiment, participants will perform 2 motor tasks using either paretic/nondominant upper extremity or non-paretic/dominant upper extremity, called motor attempt (M) condition or calibration condition. The second experiment contains 3 conditions: cyclic functional electrical stimulation (cFES), cFES during motor attempt (M-cFES), and functional electrical stimulation during brain-computer interface (BCI-FES) in random order. The sensorimotor oscillations from the electroencephalography (EEG), upper extremity sensorimotor function score (Fugl-Meyer test, Action Research Arm test, and Revised Nottingham Sensation Assessment), corticospinal excitability from the transcranial magnetic stimulation (TMS), and resting-state functional and structural neuroimage from magnetic resonance imaging (MRI) will be assessed before and after the final experiment, as well as 3 months after stroke.

Eligibility Criteria:
Inclusion Criteria:

* first-ever, unilateral infarction or hemorrhage at middle cerebral artery or posterior cerebral artery territory
* early subacute phase of stroke (between 1 and 4 weeks after stroke onset)

Exclusion Criteria:

* electroencephagraphy feature is not usable
* Fugl-Meyer Assessment of Upper Extremity score is over 50
* ataxia
* global aphasia
* concomitant neurological diseases
* psychiatric diseases
* participating in other interventional research during this period
* other conditions might interfere with experiment
A Study of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus

The primary purpose of this study is to evaluate the pharmacodynamic profile (blood glucose and urinary glucose excursion) of ASP1941 in patients with type 2 diabetes mellitus. Safety, tolerability and pharmacokinetics are also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients for at least 12 weeks
* HbA1c value between 7.0 and 10.0% at screening
* Fasting plasma glucose ≥ 126mg/dL and \< 240mg/dL at screening
* Body Mass Index (BMI) 20.0 - 45.0 kg/m2.

Exclusion Criteria:

* Type 1 diabetes mellitus patients
* Serum creatinine \> upper limit of normal
* Proteinuria（albumin/creatinine ratio \> 300mg/g）
* Dysuria and/or urinary tract infection
* Significant renal, hepatic or cardiovascular diseases
* Severe gastrointestinal diseases
B3 Buddy for Securing Urinary Drainage Bag to Patient While Walking

This clinical trial tests how well the Bag Below Bladder (B3) Buddy device works in securing urinary drainage bags while walking. Keeping a urinary drainage bag below the bladder is the standard of care to maintain urine flow and prevent urine from backing up into the bladder. Despite the use of modern urinary drainage bags for over 60 years, workarounds, including hooking the bag into pants pockets, are being used to secure the bags while walking. The B3 Buddy may help keep the urinary drainage bag at the proper level for drainage while walking.

PRIMARY OBJECTIVES:

I. To evaluate the acceptability of the B3 Buddy, from the patient's perspective.

II. To evaluate the usability of the B3 Buddy, from the clinician's perspective.

OUTLINE: Patients are assigned to 1 of 2 groups.

PATIENTS: Patients receive a short instructional session, wear the B3 Buddy device to secure urinary drainage bag and walk approximately 90 feet before urinary drainage bag is returned to the standard position on study.

CLINICIANS: Clinicians receive a short instructional session, secure the urinary drainage bag to the patient using the B3 Buddy device. Clinicians also assist patient with walking and then remove the device and return urinary drainage bag to the standard position on study.

Eligibility Criteria:
Inclusion Criteria:

* PATIENT PARTICIPANT: Must be English-speaking
* PATIENT PARTICIPANT: Able to comprehend and agree to consent
* PATIENT PARTICIPANT: Able to read and complete the Acceptability of Implementation Measure (AIM) survey
* PATIENT PARTICIPANT: Be willing to participate using the B3 Buddy device
* PATIENT PARTICIPANT: Have an indwelling urinary catheter or urostomy device connected to a drainage bag
* PATIENT PARTICIPANT: Have no restrictions in ambulation
* CLINICIAN PARTICIPANT: Must be English-speaking
* CLINICIAN PARTICIPANT: Able to comprehend and agree to consent
* CLINICIAN PARTICIPANT: Able to read and complete the System Usability Scale (SUS) survey
* CLINICIAN PARTICIPANT: Be willing to participate using the B3 Buddy device
* CLINICIAN PARTICIPANT: Have a professional role in assisting patients in ambulation in normal workday activities

Exclusion Criteria:

* Those patient participants that have more than one urinary-like drainage bags will be excluded. This exclusion is due to the limited prototype samples available to the research team. Limiting one device for one patient with multiple drainage bags may not allow for accurate assessment of the B3 Buddy device
Precision Assignment of Intervention Messages to Promote Physical Activity - Precision AIM

Our goal is to develop personalized decision rules for selecting the frequency, timing, and content of messages to promote physical activity. The objective of this project is to evaluate the acceptability and feasibility of two strategies for calibrating decision rules used to send those messages. Participants will wear an activity monitor for the collection of PA data and be randomly assigned to one of two adaptive intervention strategies. The decision rule for each participant will be refined on a monthly basis throughout the 6-month study based upon the accumulating data on how each participant is responding to different messages under different conditions. Our hypothesis is that more intensive intervention strategies will offer a better user experience because the resulting treatments will be experienced as more personalized.


Eligibility Criteria:
Inclusion Criteria:

* Participants capable of reading, speaking and understanding English and of giving informed consent.
* Participants between the ages of 18-29 years.
* Participants must be free of visual impairment that would interfere with the receipt of text messages on their phone.
* Participants must be willing to wear a Fitbit Versa 3 almost continually (23.5 hours/day) for a 6- month period of time.
* Participants must own an iPhone or Android smartphone that they would be willing to download the custom Precision AIM and Fitbit app onto and sync with a Fitbit Versa 3.
* Participants interested in setting goals to increase their physical activity levels over the 6-month study.

Exclusion Criteria:

* Participants engaging in 150 or more minutes of moderate- or greater intensity PA /week as assessed by a research grade accelerometer.
* Participants engaged in organized programs with mandated physical activity (e.g., varsity sports, ROTC).
* Participants with contraindications to normal physical activity on the Physical Activity Readiness Questionnaire.
* Participants who require an assistive device for mobility or have any other condition that may limit or prevent participation in moderate-intensity physical activity.
* Participants who are pregnant or planning to become pregnant within the next 6 months.
* Participants with a prior diagnosis of cancer, cardiovascular disease, diabetes or metabolic syndrome.
The Link Between Obesity And Vitamin D in Bariatric Patients With Omega-loop Bypass Surgery

The aim of the study is to increase vitamin D concentrations or to keep it on high level, respectively, by supplementing with vitamin D3 in a different dose regime, and to improve the overall health status in bariatric patients. In this project, the vitamin D status, the parameters of inflammation, bone turnover, insulin resistance, liver and depression score of bariatric patients are expected to improve, due to supplementation of a loading dose compared to the standard therapy.


Eligibility Criteria:
Inclusion Criteria:

* Planned omega loop bypass surgery
* 25-hydroxy vitamin D \< 75 nmol/l
* BMI \>40 or ≥35 kg/m2 with co-morbidities e.g. diabetes mellitus, hypertension
* Body weight \<140 kg (due to limitation of DEXA measurement)
* Capability to consent

Exclusion Criteria:

* Another planned form of bariatric surgery
* Hypercalcemia (calcium \>2.63 mmol/l) or hypocalcemia (\<1.75 mmol/l)
* Renal insufficiency (creatinine \>133 μmol/l or GFR \<50 ml/min)
* Primary hyperparathyroidism
* Malignancy
* Infection e.g. human immunodeficiency virus
* Medical conditions requiring daily calcium supplements or antacid use
* Known hypersensitivity to cholecalciferol
* No capability to consent
* Imprisoned persons
Sufentanil Infusion vs Intravenous Methadone for Postoperative Analgesia Following Head and Neck Dissection With Free Flap or Rotational Reconstruction

The main purpose of this study is to determine which type of medication, sufentanil or methadone, is better at controlling pain during and, more importantly, after surgery in patients undergoing a head and neck dissection with free flap or rotational tissue reconstruction. Prior to their operation, subjects will be randomized to receive either Sufentanil or Methadone. After surgery, research staff will obtain information about recovery and pain levels.


Eligibility Criteria:
Inclusion Criteria:

* • Patients undergoing head and neck dissection with free flap or rotational reconstruction at Indiana University Health Adult Academic Health Center

  * ASA class 1, 2, or 3 (See Appendix)
  * Age 18 to 80
  * male or female
  * Able and willing to provide written informed consent

Exclusion Criteria:

* Any contraindication to opiates, (i.e. allergy to opioids, substance use disorder) as determined by PI review and any contraindications reported by the patient
* Patient on home methadone at any dose
* Any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery
* Known true allergy to the study medications (sufentanil, methadone)
* Any history of substance abuse in the past 6 months which would include heroin or any other illegal street drugs
* End stage liver disease, end stage renal disease
* Patient staying intubated or on mechanical ventilation after surgery
* Patient (home dose) taking more than 30mg PO morphine equivalent (OME) per day
* Any additional and concurrent surgical procedures to the patient
A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer

The purpose of this study is to find the safest dose and identify any bad side effects of EGFR-BATs (bispecific antibody-armed activated T cells) for people with advanced pancreatic cancer who have already received first-line standard chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological proof of pancreatic adenocarcinoma. Must have metastatic pancreatic cancer who have received at least first line chemotherapy. Disease stability or progression during or within 6 months after treatment with 5-Fluorouracil (5-FU)- or gemcitabine-based chemotherapy. KPS\>/= 70% or SWOG performance Status 0 or 1
* Evaluable disease by iRECIST criteria
* Absolute Neutrophil Count (ANC) \>/= 1,000/mm\^3
* Lymphocyte count \>/= 400/mm\^3
* Platelet Count \>/= 75,000/mm\^3
* Hemoglobin \>/= 8 g/dL
* Serum Creatinine \< 2.0 mg/dl, Creatinine Clearance \>/=50 ml/mm (can be calculated or measured)
* Total Bilirubin \</= 2 mg/dl (biliary stent is allowed)
* SGPT and SGOT \<5.0 times normal
* LVEF \>/= 55% at rest (\<UGA or Echo)
* Age \>/= 18 years at the time of consent (Written informed consent and HIPAA authorization for release of personal health information)
* Females of childbearing potential, and males, must be willing to use an effective method of contraception
* Females of childbearing potential must have a negative pregnancy test within 7 days of being registered for protocol therapy

Exclusion Criteria:

* Any chemotherapy related toxicities from prior treatment, \> grade 2 per CTCAE v4.0
* Known hypersensitivity to cetuximab or other EGFR antibody
* Treatment with any investigational agent within 14 days prior to being registered for protocol therapy
* Symptomatic brain metastasis
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Steroid premedication for imaging scans is allowed. Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to being registered for protocol therapy
* Active liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
* Known HIV infection
* Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed)
* Has an active infection requiring systemic therapy
* A serious uncontrolled medical disorder that in the opinion of the Investigator may be jeopardized by the treatment with protocol therapy.
* Females must not be breastfeeding
* Patient may be excluded if, in the opinion of the PI and investigator team, the patient is not capable of being compliant
Extension Study of EC145 (Vintafolide) for Subjects Enrolled in a Previous Study With EC145 (MK-8109-010)

This extension protocol is for those subjects that have completed the allowed duration of participation in an Endocyte-sponsored clinical trial of EC145 (vintafolide) and have continuing evidence of clinical benefit (stable disease or better) at the time that they completed participation in that study.

This extension protocol is for those subjects that have completed the allowed duration of participation in an Endocyte-sponsored clinical trial of EC145 and have continuing evidence of clinical benefit (stable disease or better) at the time that they completed participation in that study.

Following confirmation of eligibility, subjects will receive intravenously-administered EC145 at a dose of 2.5 mg. Dosing will occur on Monday, Wednesday, and Friday of weeks 1 and 3 of each 4-week cycle. No therapy will be administered during weeks 2 and 4. Subjects randomized to non-EC145-containing treatment arms of EC145 trials are not eligible for this study.

Eligibility Criteria:
Inclusion Criteria:

* Must have received prior treatment with EC145 within the context of an Endocyte-sponsored, IRB-approved clinical trial.
* Disease (i.e., cancer) that was considered "stable" at the last evaluation while participating in the previous EC145-containing study. "Stable" is defined as not having progression of disease per standard criteria (RECIST, etc). Stable disease may be indicated by previously attained complete or partial tumor shrinkage that has not progressed per standard criteria.
* No more than 10 weeks have elapsed since the last evaluation of "stable disease".
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Must have recovered (to baseline/stabilization) from prior EC145-associated acute toxicities.
* Adequate bone marrow reserve, hepatic, and renal function.
* Negative serum pregnancy test for women of childbearing potential
* Willingness to practice contraceptive methods for men and women of childbearing potential.

Exclusion Criteria:

* Pregnancy.
* Development of a secondary malignancy requiring treatment.
* Symptomatic central nervous system (CNS) metastasis.
* History of receiving any investigational treatment or other systemic therapy directed at controlling cancer since the subject's last dose on the parent EC145 study.
Deep Brain Stimulation for Patients With Parkinson's Disease.

Deep brain stimulation of the sub thalamic nucleus (STN-DBS) is an efficient treatment to improve motor and non motor signs of Parkinson's disease (PD). In people aged more 70 years, an increased rate of side effects such as post-operative cognitive decline and/or postural instability with falls has been suspected with less improvement in the quality of life. Here, Investigators aim further explore the effects of STN-DBS in 50 patients with PD people aged more 69 years in a randomized parallel controlled study.

The effects of combined bilateral deep brain stimulation of the subthalamic nucleus and medical treatment on the quality of life will be evaluated in 25 PD patients aged more 69 years in comparison to 25 PD patients aged more 69 years that only received medical drug treatment.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease
* disease duration \> 5 years
* levodopa related motor complications
* dopasensitivity \> 50%
* signed informed written consent
* medical social insurance

Exclusion Criteria:

* dementia
* contra-indication to neurosurgery
Phase III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation

This study is being conducted to demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm.

There are approximately 2 million reported prevalent cases of atrial fibrillation (AF) and atrial flutter in the United States (Heart Disease \& Stroke Statistics - 2003 Update, AHA). These arrhythmias may be occasional or sustained. While not directly fatal, these arrhythmias cause discomfort and can lead to stroke or congestive heart failure.

This Phase III trial is Cardiome's first pivotal study with RSD1235. The study seeks to confirm the findings of the Phase II proof-of-concept through demonstration of RSD1235's abilities to convert AF to sinus rhythm. The patient population will include recent onset AF (AF duration of 3 hours to 7 days) and patients with longer AF duration.

This is a double-blind, placebo-controlled, randomized study in patients with AF; stratification will be based on duration of AF. Treatment will be considered successful if there is a treatment-induced conversion of atrial arrhythmia to sinus rhythm for a minimum of 1-minute by Hour 1.5 (Time 0 = start of first infusion). All patients will be evaluated for safety.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older;
* Have an atrial arrhythmia with symptoms that has been sustained for greater than 3 hours and up to 45 days.
* Have adequate anticoagulant therapy.

Exclusion Criteria:

* Have a QRS \> 0.14 seconds unless patient has pacemaker or uncorrected QT \> 0.440 seconds as measured on a 12-lead ECG.
* Have serious diseases/illnesses that could interfere with the conduct or validity of the study or compromise patient safety.
* Have received intravenous Class I or Class III antiarrhythmic drugs or intravenous amiodarone within 24 hours prior to dosing.
Adalimumab in Combination With Ciprofloxacin/Placebo Treatment of Perianal Fistulas in Crohn's

To assess whether a combination of ciprofloxacin and adalimumab is more effective than adalimumab alone for the treatment of perianal fistulas in Crohn's disease

Dutch multicenter, randomized, double-blind study with two arms. 146 patients will be included.

Eligibility Criteria:
Inclusion Criteria:

* proven Crohn's disease
* Single or multiple draining perianal fistulas

Exclusion Criteria:

* Abscesses
* Infliximab, cyclosporine, tacrolimus and antibiotics for Crohn's disease within past 3 months
* active viral infection
* significate cardiovascular dysfunction
* Pregnancy, Lactation
* Surgical bowel resection to be expected within 6 months
* Positive stool culture for enteric pathogens
* Total parental nutrition
Breast Milk Composition: Interindividual Variations and Dietary Factors in Galicia

Human milk is not a uniform body fluid, but quite the opposite, its composition changes continuously adapting to the requirements of the newborn. It can be considered as the gold standard for infants' nutrition and exclusive breastfeeding is recommended by the WHO during the first months of life. Additionally, its composition should be used as reference or guidance for defining optimal nutrient intakes for infants that cannot be fully breastfed. In that connection, the nutritional status and dietary habits/patterns of the mother, along with certain genetic traits, exert also influence over breast milk. Considering all these facts, and their great impact on (present and future) infant health, detailed information of breast milk composition is required for specific populations, covering as many factors, elements and nutrients as possible.

In the present observational study, research is focused on breast milk in northwestern Spain, more precisely Galicia. In this context, the obtained data will serve to define the nutritional characteristics of breast milk from Galician women (interindividual variation), while at the same time evaluating the existence of specific features related to their particular diet (dietary factors), the Southern European Atlantic Diet (SEAD). All the variables measured in this research project will be related with breast milk composition. Expected primary outcomes can be divided as follows: fatty acid profiles, mineral composition, essential amino acid profiles, microbiota and steroid hormones. The key influencing factors taken into account are: lactation characteristics and maternal diet.

Recruitment of participants is based on all the following criteria, with no exceptions: female, living in Galicia, lactating, \> 18 years old, volunteer participation, written informed consent and agreement to complete questionnaires about lactation, diet and other socio-demographic factors. Samples are collected by participants, and stored at the University of Santiago de Compostela under a coded system so that it is impossible to identify the donor from whom the sample comes, with the exception of the investigators. The project is adhered to the principles of the Helsinki Declaration. Participants are allowed to withdraw their consent at any moment of the study.


Eligibility Criteria:
Inclusion Criteria:

* female
* lactating
* living in Galicia
* voluntary participation

Exclusion Criteria:

* none