cyrilzakka/clinical-trials huggingface dataset:
rTMS for Post-stroke Fatigue

This experimental trial is investigating the use of magnetic stimulation of the brain as a possible treatment for people with post-stroke fatigue. Fatigue is a common condition after a stroke and can negatively impact an individual's ability to perform desired social and physical activities. Magnetic stimulation of the brain has been shown to improve signs and symptoms of related psychological (e.g., depression) conditions. Participants in this trial will receive a type of magnetic stimulation called repetitive magnetic stimulation, or rTMS. The investigators will measure feelings of fatigue, and other clinical characteristics related to mood and cognition, before and after participants receive rTMS.


Eligibility Criteria:
Inclusion Criteria:

* 35 - 80 years of age
* more than 6 months post-stroke
* able to walk 10m unassisted
* Clinically present fatigue

Exclusion Criteria:

* Contraindications to MRI/TMS/rTMS (e.g. implanted metal within the head, history of seizures)
* Inability to follow simple three-step instructions
* Multiple strokes on opposite hemispheres
* Cerebellar and/or brainstem strokes
* Diagnosed comorbid neurological conditions (e.g. multiple sclerosis, Parkinson's disease, moderate/severe TBI)
* Comorbid psychological conditions (e.g. depression, anxiety, PTSD)
* strokes within stimulation sites
* Pregnancy
* Severe hypertension (resting SBP \> 200, DBP \> 120)
Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer

This is a Multicenter, Open Label, Phase 2 Study of Sipuleucel-T in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC).

Subjects received sipuleucel-T at 2-week intervals, for a total of 3 infusions. The study evaluated the safety and magnitude of the immune responses to treatment with sipuleucel-T. All subjects were followed for 30 days following the last infusion of sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse event (SAE)s and cerebrovascular event (CVE)s were collected via Long Term Follow-up Telephone Assessment occurring Q6 months.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented adenocarcinoma of the prostate
* Metastatic disease
* Castrate resistant prostate cancer
* Castrate level of testosterone (\< 50 ng/dL) achieved via medical or surgical castration
* Life expectancy of ≥ 3 months
* Men ≥ 18 years of age
* Adequate hematologic, renal and liver function

Exclusion Criteria:

* Presence of known lung, liver, or brain metastases
* Evidence of neuroendocrine or small cell features
* Eastern Cooperative Oncology Group (ECOG) performance status \> 2
* Prior treatment with 3 infusions of sipuleucel-T (infusions of APC8015F are not exclusionary)
* Imminent pathologic long-bone fracture (cortical erosion on radiography \> 50%) or spinal cord compression
* Known malignancies other than prostate cancer that are likely to require treatment within six months of registration
* A requirement for systemic immunosuppressive therapy for any reason
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or granulocyte-macrophage colony-stimulating factor
* Any infection requiring parenteral antibiotic therapy or causing fever (temp \> 100.5F or \> 38.1C) within 1 week prior to registration
* Any medical intervention or other condition which, in the opinion of the Principal Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives

Treatment with any of the following medications or interventions within 28 days of registration:

* Systemic corticosteroids. Use of inhaled, intranasal, intra-articular, and topical steroids is acceptable, as is a short course (ie, ≤ 1 day) of corticosteroids to prevent a reaction to the IV contrast used for CT scans
* Non-steroidal anti-androgens (eg, bicalutamide, flutamide, or nilutamide)
* External beam radiation therapy or major surgery requiring general anesthetic
* Any other systemic therapy for prostate cancer including secondary hormonal therapies, such as megestrol acetate (Megace®), diethylstilbestrol (DES), and ketoconazole. Medical castration therapy is not exclusionary
* Chemotherapy
* Treatment with any other investigational product
Infant Microbiome in Diaper Rash

The objective of this study is to evaluate the microbiome composition of infant's (9-12 month) skin experiencing diaper rash in order to determine if the onset and severity of erythema associated with diaper rash is influenced by the type of bacteria colonizing the skin.


Eligibility Criteria:
Inclusion Criteria:

* Infants aged 9-12 months with mild to moderate diaper rash

Exclusion Criteria:

* Use of topical or oral antibiotics or antifungals within the past 4 weeks.
* Use of zinc-containing diaper rash creams within 48 hours first sample
* Immunocompromised
Health Related Lifestyle and Quality of Life in Children With Cerebral Palsy

The primary aim of this study is assessing physical activity, the quality of sleep and health related quality of life in children with cerebral palsy, and parenting stress of caregivers of the children with cerebral palsy in Korea.

Monitor the physical activity, health related quality of life, parenting stress according to GMFCS level in children with cerebral palsy in Korea.

1. Physical activity and quality of sleep are monitored by wearing Actigraph for a week.
2. Health related quality of life is checked by parents withChild Health Questionnaire Parent Form 50 (CHQ-PF50).
3. Parenting stress is monitored with Korean Parenting Stress Index-Short Form (K-PSI-SF) by parents.

Eligibility Criteria:
Inclusion Criteria:

* Children with cerebral palsy, 4-19 years old

Exclusion Criteria:

* Patients with progressive brain lesions, tumors, leukodystrophies, etc.
* Children with mitochondrial myopathy
* Some diseases that are known to progress, Rett syndrome, etc.
Human and Bacterial Protease Activity As Prognostic Tool of Foot Infections in Diabetic Patients

This study will establish whether human and bacterial protease activity can aid therapeutic decision-making, including targeted treatments.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient has been informed about the study objectives and purpose and their rights as a patient
* The patient is being treated in the Diabetes and Infectious Disease Department
* The patient has a chronic foot and/or heel wound classified as Grade 1-3 according to the Infectious Diseases Society of America.

Exclusion Criteria:

* The subject is participating in another category I interventional study, or has participated in another category I interventional trial in the previous 3 months, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patient is pregnant or breastfeeding
* The patient has chronic foot and/or heel wound classified as Grade 4 according to the Infectious Diseases Society of America
* Patient with critical ischemia defined by PSGo \<50 mmHg or PSCh \<70 mmHg
Patient Participation in Prevention of Loss of Functions

Randomized Clinical Trial (RCT) To investigate and compare the effect of two preventive interventions on readmission rates, loss of functions, quality of life and cost-benefit.

At baseline:

Nutritional status, BMI and weight, depression (GDS5), dementia (MMSE), pain (Verbal Ranking Scale), muscle strength (hand-grip strength, chair-to-stand-test), quality of life (EQ5D), coping (Sense of Coherence 13 item scale), patient experience (NORPEQ), medication management (MedMaide).

At follow-up three months after discharge:

BMI and weight, depression (GDS5), dementia (MMSE), pain (Verbal Ranking Scale), muscle strength (hand-grip strength, chair-to-stand-test) and EQ5D. In addition, need for initiated municipal assistance after discharge. Project employee who performs data collection is blinded to the group to which the patient is randomized.

The control group Patients in the control group undergo the same measurements and registrations at discharge and 3 - month follow-up, as the intervention groups, but receive otherwise usual treatment and care, and are discharged without further intervention. After six months control patients receive a report comprising the screening results, relevant information material and a cover letter. Patients' GP and municipality care section receive a summary of outcomes, as well as a cover letter.

Register data Information on mortality, readmissions and services in primary health care are obtained after 6 months from the National Patient Register, Population Register and municipalities.

Eligibility Criteria:
Inclusion Criteria:

* 65 years or older
* Living in their own home with no contact to the Municipality, both before and after admission
* Discharged from Department o105 or the Acute Receiving Unit \<48 hours from admission.

Exclusion Criteria:

* Patients with life-threatening disease in the terminal stage
* Patients who does not speak and understand Danish
* Patients who are not able to communicate and collaborate, with regards to the measurements
Investigation of the Relationship Between Foot Posture Index Score and Foot Function and Balance Performance

The foot is a terminal joint that opposes external resistance in the lower kinetic chain. It plays a primary role in weight transfer and ground response between the body and the ground. It plays a role in maintaining an upright posture, lowering the gravitational line against a narrow support surface during walking, providing stability and absorbing the shocks that occur during daily life activities.

Foot problems are common worldwide. These problems affect people negatively by giving symptoms during activities of daily living.

There is not much data on whether these changes are related to age or not. Deformities, kinetic chain disorders, and other problems that affect balance are likely to increase with age. For this reason, in our study, the relationship between foot posture and functional-balance was examined on the basis of age groups.

Body balance may be impaired by deficiencies in the strength and mechanical stability of any joint or structure along the lower extremity kinetic chain, or by decreased afferent feedback. It is necessary to know the foot posture and biomechanics about the causes of injury and susceptibility to injury during activities of daily living and sports.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 20 - 65,
* Volunteer.

Exclusion Criteria:

* Having a musculoskeletal or neuromuscular disease that limits mobility,
* Presence of lower extremity sequelae,
Effects of Code Sepsis Implementation on Emergency Department (ED) Sepsis Care

Sepsis is a life-threatening complication of infection that can be difficult to recognize and treat promptly. Timely administration of antibiotics for emergency department (ED) patients with sepsis is challenging. The goal of this study is to determine the potential effectiveness and unintended consequences of reorganizing ED care for patients with suspected sepsis.


Eligibility Criteria:
Inclusion criteria (overall):

1. Adult (age ≥18 years)
2. ED patient at Intermountain Medical Center, Utah Valley Hospital, Dixie Regional Medical Center
3. Arrival to study emergency department (ED) during study period of 11/13/2018 to 2/12/2021.

Exclusion criteria (overall):

(1) Trauma patient
Virtual Reality (VR) Therapy for Post-Traumatic Stress Disorder (PTSD)

It is proposed that using Virtual Reality as part of therapy will result in improvements in Post Traumatic Stress Disorder for Service Members with PTSD related to service in Iraq and/or Afghanistan.

In the treatment development phase, participants will be enrolled in Virtual Reality therapy. The therapy will be based on principals of exposure therapy, but will also incorporate aspects of physiological monitoring, and cognitive restructuring. The therapy will be modified as indicated by clinical feedback, with a fixed protocol to be developed (with length of treatment and exact methods to be used to be determined). After a fixed protocol is agreed upon, the project will enter the randomized phase. In this portion, subjects will be randomly assigned to receive either the Virtual Reality Treatment, or sent back to a waiting list during which time they will receive usual treatment. Participants will be assessed to determine which treatment (VR or treatment as usual) results in the greatest improvements in PTSD, as measured by independent assessors using the Clinician Administered PTSD scale.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Post Traumatic Stress Disorder related to military service in Iraq or Afghanistan by a Military Medical Provider.

Willing and able to give informed consent to participate Willing to give up intoxicating substances on the days of therapy

Exclusion Criteria:

* Actively suicidal, homicidal, psychotic, or having a diagnosis of alcohol dependence that does not show signs of at least early remission
A Study of LY3076226 in Participants With Advanced or Metastatic Cancer

The main purpose of this study is to evaluate the safety of the study drug known as LY3076226 in participants with advanced or metastatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Have advanced or metastatic cancer and be an appropriate candidate for experimental therapy.

  * Part B: Have a diagnosis of bladder cancer.
  * Part B: Have alterations of FGFR3.
* Have adequate organ function.
* Have discontinued previous treatments for cancer and have resolution, except where otherwise stated in the inclusion criteria, of all clinically significant toxic effects of prior chemotherapy, surgery, or radiotherapy to Grade ≤1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 (v 4.0).
* If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug. If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 7 days of the first dose of study drug and must not be breastfeeding.

Exclusion Criteria:

* Have received treatment within 28 days of the initial dose of study drug with an investigational product or non-approved use of a drug or device (other than the study drug/device used in this study) or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
* Have preexisting corneal disease that may interfere with assessment for potential eye toxicity during the study.
* Have preexisting Grade ≥2 skin disorder (for example, erythema, dermatitis).
* Have serious preexisting medical conditions (left to the discretion of the investigator).
* Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required). Participants with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants, and their disease is asymptomatic and radiographically stable for at least 28 days.
* Have current acute or chronic leukemia.
* Have an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
* Have a second primary malignancy that, in the judgment of the investigator and sponsor, may affect the interpretation of results. Curatively treated nonmelanoma skin cancer or in situ carcinoma of any origin is allowed.
* Have Fridericia-corrected QT interval (QTcF) \>480 milliseconds on screening electrocardiogram (ECG).
* Have a serious cardiac condition, such as congestive heart failure; New York Heart Association Class III/IV heart disease; unstable angina pectoris; myocardial infarction within the last 3 months; valvulopathy that is severe, moderate, or deemed clinically significant; or arrhythmias that are symptomatic or require treatment (not including participants with rate-controlled atrial fibrillation).
Randomized Clinical Trial by Conglomerates on the Efficacy of Maintenance of Physical Exercise in Myocardial Ischemia

Main objective: To assess the efficacy of a phase III cardiac rehabilitation program (CRP), based on counseling in the maintenance of physical exercise (time of physical exercise per week) for patients with myocardial ischemia (MI), once the supervised physical exercise program of phase II of CRP is completed.

Secondary objectives: To assess the efficacy of a phase III program of CRP based on counseling in the maintenance of physical exercise for the patient with MI in: 1) the energy expenditure per week, 2) body mass index and abdominal perimeter, 3) control of cardiovascular risk factors (smoking, high blood pressure, dyslipidemia and diabetes mellitus), 4) quality of life related to health, 5) assess the adherence to cardiac pharmacological treatment.

Method: Randomized clinical trial in conglomerates, open and controlled. The intervention group will carry out phase III of CRP based on counseling in the maintenance of physical exercise. The control group will receive the usual care. The main outcome will be the physical exercise time per week after finish the supervised physical exercise program of phase II of CRP and at 6 and 12 month later according to the 7-day Physical Activity Recall.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with myocardial ischemia, angina pectoris, other specific forms of chronic ischemic heart disease or unspecified ischemic heart disease.
* Patients who have completed the supervised physical exercise program of phase II of the CRP.
* Absence of cognitive deficit (Pfeiffer test: 0-2 mistakes).
* Sufficient functional capacity to follow the CRP (Barthel index \>60)
* Residence in catchment area of Bages and Moianès.
* Providing signed informed consent.

Exclusion Criteria:

* Symptoms of right heart failure producing pulmonary hypertension.
* Dyspnea caused by severe pulmonary pathology.
* Additional comorbidities affecting the prognosis of cardiac disease.
* Major comorbidities or limitations that could interfere with the exercise training programme.
Ciprofloxacin for the Prevention of Meningococcal Meningitis

This study evaluates the effect of antibiotic prophylaxis with ciprofloxacin, given to the contacts of meningitis cases, on the overall attack rate of meningitis during an epidemic. One third of enrolled villages will receive standard care; in one-third of villages, household contacts of meningitis cases will be offered a single dose of oral ciprofloxacin; and in one-third of villages, the entire village will be offered a single dose of oral ciprofloxacin after the notification of the first case in the village.

Antibiotic prophylaxis is not currently recommended for contacts of cases during a meningitis epidemic in the African Meningitis Belt. Reactive vaccination campaigns are the preferred strategy for prevention during an epidemic.

A novel strain of meningococcus, Neisseria meningitidis serogroup C (NmC), began circulating in Nigeria in 2013 and caused a major epidemic with over 10 000 cases in Nigeria and Niger in 2015.

There is currently a global shortage of vaccine against NmC, and a recent WHO expert panel called for the formal evaluation of antibiotic prophylaxis as another epidemic response strategy.

When taken as a single dose, oral ciprofloxacin effectively eliminates nasopharyngeal carriage of meningococcus.

This trial aims to investigate two different antibiotic prophylaxis strategies during an epidemic of meningococcal meningitis: ciprofloxacin prophylaxis to household members of cases and village-wide prophylaxis after the notification of a case in a village. These two strategies will be compared to villages receiving standard care.

Eligibility Criteria:
Inclusion Criteria:

* Resident in a village included in the study area

Exclusion Criteria:

* Patients currently exhibiting symptoms of meningitis (to be immediately referred for further care)
* Persons with a known allergy to fluoroquinolone antibiotics.
Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes

Study will monitor changes in HbA1c for subjects in Intervention arm vs control arm.

Randomized, Single-Center, Parallel-group, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Magnet Anastomosis System (MAS) When Used to Create a Dual-path Enteral Diversion Compared with Medical Therapy Alone To Effect Glycemic Control in Obese Patients with Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) 30 to 50.
* Subject Type 2 Diabetes Criteria:

  1. T2DM diagnosis ≥6 months but \< 10 years
  2. On 1 or more oral diabetes medications (with one at the minimum recommended therapeutic dose)
  3. Hemoglobin A1C (HbA1c) between and including 6.5 and 10.0% (58 mmol/mol to 86 mmol/mol) at time of enrollment and has had a stable HbA1c over a 3-month period (i.e., \<0.3% reduction)
  4. Stable medication regimen (i.e., no change in diabetes medications) for at least 3 months prior to Screening Visit.
* If subject has obesity-related comorbidities such as hypertension, dyslipidemia, and sleep apnea, these comorbidities must be well-controlled.
* Able to understand and sign informed consent document
* Has primary care physician and/or endocrinologist who follows patient for all comorbid conditions

Exclusion Criteria:

* Known or suspected allergy to nickel or titanium or Nitinol
* Type 1 Diabetes
* Use of injectable insulin
* Uncontrolled T2DM Fasting glucose ≥ 200 mg/dl (11.1 mmol/L)
* Probable insulin production failure, defined as fasting serum C Peptide \<1 ng/mL (0.3 nmol/l)
* Any documented conditions for which endoscopy/colonoscopy would be contraindicated.
* Contraindication to general anesthesia
* Congenital or acquired anomalies of the GI tract, including atresias, stenosis or malrotation.
* Any previous major surgery on the stomach (excluding sleeve gastrectomy), duodenum, hepatobiliary tree (excluding gallbladder), pancreas or right colon.
* Previous technically difficult or failed colonoscopy or endoscopy
* If on metformin, history of polycystic ovarian syndrome (PCOS)
* Unable or unwilling to perform home blood glucose monitoring
* History of or suspected gastrointestinal disease (e.g. cirrhosis, inflammatory bowel disease)
* Diagnosis of active malignancy (i.e. not in remission) with the exception of squamous or basal cell carcinoma of the skin
* Previous surgical or endoscopic treatment for obesity including but not restricted to intragastric balloons, endoscopic suturing or stapling procedures, malabsorptive sleeves.
* Specific genetic or hormonal cause of obesity (e.g. Prader-Willi syndrome)