cyrilzakka/clinical-trials huggingface dataset:
Is Diverting Ileostomy Necessary in Stapled Ileoanal Pouch?

Total proctocolectomy with ileal pouch anal anastomosis is the first choice surgical operation for management of ulcerative colitis and familial adenomatous polyposis. The addition of diverting ileostomy may reduce septic complications. In this randomized study the investigators compare two groups of patients with stapled ileoanal pouch one of them had diverting ileostomy and in the other this step is omitted.


Eligibility Criteria:
Inclusion Criteria:

* patients having total proctocolectomy with ileal pouch anal anastomosis.

Exclusion Criteria:

* hypoalbuminemia
* prolonged steroid use
* anemia
* anastomosis under tension
* leak with air test
* bleeding
* poor vascular supply of anastomosis
VIM DBS Respiratory Modulation: N-of-1 Trial

Research from our group has demonstrated modulation of PEFR in patients with STN and PAG stimulation. However, the effect of VIM (motor thalamus) stimulation remains to be investigated. Our group has also been involved in research that indicates that VIM stimulation may reduce perception of breathlessness. However, methodological factors limit the conclusions that can be drawn from this prior work. N-of-1 trials, organised as a randomised multiphase crossover design, are uniquely well suited for DBS research where stimulation can be switched ON and OFF, and with simple tests that can be done quickly, multiple times. PEFR and breath-holding are simple tests that we will test in this way. Other respiratory tests will be carried out along side, as optional, in a single phase design. We aim to offer this study to a continuous cohort of patients scheduled to undergo VIM (ET/DT) DBS at our institution. We will establish a pre-operative baseline of respiratory function, and then perform the n-of-1 trial post-operatively, soon after the patient returns to hospital to receive their DBS programming.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for VIM DBS
* Diagnosis of ET or DT

Exclusion Criteria:

* None
Multicenter Study of Pharmacokinetic-Guided Docetaxel in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide

The purpose of this study is to adjust the amount of docetaxel participants receive based on the level of docetaxel measured in their blood. This method of dose adjustment is called pharmacokinetic (PK)-adjusted docetaxel. The researchers believe that adjusting the dose of docetaxel using this method will lessen the side effects associated with docetaxel in cancer treatment.


Eligibility Criteria:
Inclusion Criteria:

* Must have histologically confirmed localized or locally advanced breast cancer for which the treatment plan includes chemotherapy with 4 cycles of standard TC (docetaxel 75 mg/m\^2 and cyclophosphamide 600mg/m\^2)
* Age \>/= 65 years (Senior adult focused study given increased risk for toxicity)
* Participants must be female
* Eastern Cooperative Oncology Group (ECOG) performance status \<2
* Must have normal organ and marrow function
* No pre-existing neuropathy grade \> 1 per the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
* Be postmenopausal (defined as amenorrheic for at least 12 months)
* Must be informed of the investigational nature of this study and be willing to provide written informed consent in accordance with Institutional guidelines and Good Clinical Practice (GCP) indicating that they understand the purpose of and procedures required for the study and are willing to participate prior to the beginning of any specific study procedures.

Exclusion Criteria:

* Have uncontrolled illness (including, but not limited to, ongoing or active infection, congestive heart failure, angina pectoris, or cardiac arrhythmia) that would limit compliance with study requirements
* Have psychiatric illness that would limit compliance with study requirements
* Have history of allergic reactions attributed to compounds of similar chemical or biologic composition to taxanes (docetaxel or paclitaxel) or cyclophosphamide
* Have known seropositivity for human immunodeficiency virus, hepatitis C virus, hepatitis B surface antigen, or syphilis. Does not require serologic confirmation as a study procedure.
* Not willing to follow protocol requirements or to give informed consent
Nursing Care of Bipolar Patients With Sleeping Disorders Using Luminotherapy and /or Psychoeducation Program (BIPLUMINO)

Bipolar disorder affects more than 1% of the population. This pathology is considered as one of the most serious psychiatric disorder because of it is high suicide rates. It impacts patients life quality on many aspects, and specially their sleeping and circadian Rhythms. This can lead to more severe symptoms up to for thymic relapses. It was shown that Luminotherapy and Psychoeducation Program have a positive impact on these type of symptoms.


Eligibility Criteria:
Main inclusion Criteria:

* Bipolar disorder (type 1 and 2 according to DSM V)
* Mood Disorder Questionnaire MDQ ˂ 7
* Sleeping and Circadian Rhythms Disorders
* Under treatment

Main exclusion Criteria:

* No addiction except for tobacco
* Narcolepsy
* Sleep Apnea
* Psychiatric comorbidities
* Suicidal ideation
PPAR-gamma: a Novel Therapeutic Target for Asthma?

To test the hypothesis that stimulation of PPAR-γ receptors has a therapeutic role in the treatment of asthma.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 of either sex with a clinical diagnosis of asthma,
* FEV1 ≥ 60% predicted and an increase in FEV1 of greater than 12% following inhaled salbutamol 400μg or Peak Expiratory Flow (PEF) variability \>12% during run-in.
* Allowed medication: 0-800μg inhaled beclomethasone diproprionate or equivalent and as required short acting beta agonist.

Exclusion Criteria:

* Current smoking,
* \> 10 pack years smoking history,
* Treatment with leukotriene antagonists,
* Liver or cardiovascular disease,
* Oral steroid treatment or exacerbation within 6 weeks,
* Females who are pregnant, lactating or not using adequate contraception,
* Any contra-indication to pioglitazone (hypersensitivity to pioglitazone, cardiac failure, history of cardiac failure, hepatic impairment, diabetic ketoacidosis),
* Oral or insulin treatment for diabetes,
* Treatment with gemfibrozil or rifampicin.
Incidence of Dyschromatopsia in Glaucoma

Incidence of dyschromatopsia

Incidence of dyschromatopsia should be elevated in glaucoma compared to a healthy control population. However, the actual incidence rate is not investigated.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of glaucoma
* age between 18 and 99 years old
* best corrected visual acuity(BCVA) \> 0.2 (decimal Snellen)

Exclusion Criteria:

* age \< 18 yo
* BCVA \< 0.2
* known dyschromatopsia
* known corneal disease
* St.p. corneal surgeries
* macula disease
* history of medication use that can influence color vision (e.g. hydroxychloroquine)
Rubber Hand Illusion in Anorexia Nervosa

The present research project aims to verify a possible difference in the recalibration of the real hand position (i.e. proprioceptive drift) in relation to the dimensions of the plastic hand in the Rubber Hand Illusion, among a group of female participants with anorexia nervosa compared with a normal weight control group.


Eligibility Criteria:
Inclusion criteria:

* Right-handed
* diagnosis of Anorexia Nervosa according to the APA criteria

Exclusion criteria:

• concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders.
Safety Study of XL765 (SAR245409) in Combination With Erlotinib in Adults With Solid Tumors

The purpose of this study is to evaluate the safety and tolerability of XL765 in combination with erlotinib (Tarceva®) in subjects with solid tumors. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. In preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells, whereas inactivation of mTOR has been shown to inhibit the growth of tumor cells. Erlotinib is an orally administered inhibitor of EGFR (also known as HER1) tyrosine kinase. It was approved by the FDA as a single agent for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen and in combination with gemcitabine for first line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of:

  * Advanced solid tumor that is no longer responding to therapies OR
  * Advanced or metastatic NSCLC that has previously been treated with erlotinib or gefitinib
* ECOG Performance Status 0-1
* Adequate organ and bone arrow function as defined by hematological and serum chemistry limits
* At least 18 years old
* Both men and women must practice adequate contraception
* Informed consent

Exclusion Criteria:

* Restriction of some therapies/medications within specific timeframes prior to enrollment and during the study including prior therapy with PI3K, cytotoxic chemotherapy, biologic agents, nitrosoureas or mitomycin C, small-molecule kinase inhibitors, non-cytotoxic hormonal agents
* Erlotinib intolerant
* Taking oral corticosteroids chronically or \> 1 mg/day warfarin
* Not recovered from the toxic effects of prior therapy
* History of diabetes mellitus and an HgbA1c \> 7%
* Uncontrolled intercurrent illness
* Pregnant or breastfeeding
* Congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study.
* HIV positive
* Diagnosis of another malignancy may exclude subject from study
A Longitudinal Study of Amyotrophic Lateral Sclerosis (ALS) Biomarkers

The purpose of this study is to collect biofluid samples for the banking and usage in ALS research. Through comparison of these samples, the researchers hope to learn more about the underlying cause of ALS, as well as find unique biological markers, which could be used to develop new therapies.

The purpose of the research study is to collect blood samples and cerebrospinal fluid (CSF) from people with amyotrophic lateral sclerosis (ALS). These samples will be collected approximately every 4 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Diagnosis of suspected, possible, probable or definite ALS according to El Escorial Criteria
* Vital capacity (VC) at least 50 percent predicted
* Able to undergo multiple lumbar punctures

Exclusion Criteria:

* Abnormal CSF pressure or intracranial/intraspinal tumors
* Use of anticoagulant medication that cannot be safely withheld
* Bleeding disorders

  * This is a partial listing.
Biobehavioral Mechanisms of Blood Pressure Regulation

To investigate the role of biobehavioral factors in the pathogenesis of concentric left ventricular hypertrophy.

BACKGROUND:

Hypertension is more prevalent in Black than white men, and is more prevalent in men than women. Furthermore, even controlling for blood pressure, concentric left ventricular hypertrophy, an early structural adaptation of hypertension, is more prevalent in Black than white men, and more prevalent in men than women. Concentric left ventricular hypertrophy is the strongest predictor, other than age, of the cardiovascular morbidity associated with high blood pressure.

DESIGN NARRATIVE:

In a biracial sample, concentric left ventricular hypertrophy and concentric remodelling were assessed by echocardiographic measures of left ventricular mass and relative wall thickness. Laboratory procedures were used to: (i) assess hemodynamic and neurohumoral responses during exposure to a diverse battery of physical and psychological stressors, and; (ii) evaluate alpha and beta adrenergic receptor responsiveness, baroreceptor reflex gain and minimal forearm vascular resistance. Since blood pressure during a typical workday was an established predictor of left ventricular hypertrophy, it was also assessed. A new biobehavioral model was tested that implicated the hemodynamic pattern of behaviorally-evoked pressor responses in the pathogenesis of concentric left ventricular hypertrophy. One prediction of this model was that a predisposition to exhibit increased vascular resistance during stress (characteristic of black men) would favor the development of concentric hypertrophy. Thus, systemic vascular resistance responses, evaluated in the laboratory, were hypothesized to independently predict left ventricular mass and relative wall thickness, even after controlling for established risk factors, including workday blood pressure. Sympathetic nervous system function was examined to test hypothesized mechanisms responsible for race and gender differences in the hemodynamic patterns of blood pressure regulation. The results of these studies emphasized the importance of race and gender in prescribing pharmacological and/or behavioral treatment for hypertensive heart disease.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
ReActivate: Physiotherapist Led Intervention for Adolescents With Pain and Psychological Distress.

Recurrent or persistent pain and psychological distress are alarmingly common problems among adolescents, in Sweden as well as globally. They often co-occur and have been shown to be predictors of sustained problems in adulthood. Adequate treatment early on in the development of problems has been shown important in order to decrease the risk of sustained problems in adulthood but available treatments have only modest effects. There is thus a need for treatment development, not in the least for (secondary) preventative purposes. The aim of this project is therefore to develop an evidence based and cost-effective secondary preventative intervention. Specifically, this project aims to develop and test a physiotherapist led treatment for adolescents with recurrent or persistent pain and psychological distress based upon graded exposure to physical activity and reactivation.

See description of arms and intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age 12-19
* Psychological distress, such as anxiety, depressive symptoms or stress, ≥2 on a numeric rating scale 0-6 (0=not at all, 6=to a great extent)
* Persistent (consistently or weekly recurrent) musculoskeletal pain problems for ≥3 months, with pain intensity ≥2 on a numeric rating scale 0-6 (0=not at all, 6=to a great extent)
* Presence of avoidance behaviour and/or or worry about symptoms/problems, ≥1 on a numeric rating scale 0-6 (0=not at all, 6=to a great extent); \> 50 on at least one activity of the PHODA.
* Swedish speaking and able to fill out questionnaires

Exclusion Criteria:

* Serious/malignant disease
* Participation in other rehabilitation program
* Severe mental health problems
* Substance abuse
* Severe learning disabilities
Icing Effects on Neck Functions of the Boxers

Most boxing injuries occurs over head and neck which leads to potentially acute or chronic head and neck injuries. Patients with whiplash injury has been reported, reflected by increased body sway and reduced ability to overcome challenging balance tasks. The purpose of this research is to evaluate the fitness and balance outcomes between the boxers and the control group, and boxers undergoing posterior-neck icing effects.

Injuries are common in boxing, occurring most often to the head, neck, face, and hands. Traumatic minor cervical strains are common place in high-impact sports and premature degenerative changes have been documented in sports people exposed to recurrent impact trauma or repetitive forces. Whiplash injury may result in extensive trauma to muscles and ligamentous structures within the cervical spine . Many of these structures, particularly the muscles, contain mechanoreceptors that play a key role in position sense. Studies have shown that head and neck position sense may become impaired following whiplash injury. Subsequently, poor movement patterns, together with the perpetuation of pain and other symptoms may develop.

Posture control is achieved by integration of sensory inputs emanating from somatosensory, vestibular, and visual systems. Patients with whiplash injury has been reported, reflected by increased body sway and reduced ability to overcome challenging balance tasks. In this study we have attempted to evaluate the influence of boxing on balance performances, isometric strength and flexibility; furthermore, evaluate the therapeutic effect of ice massage on boxers.

Eligibility Criteria:
Inclusion Criteria:

* boxers
* Must be able to cooperate to our intervention

Exclusion Criteria:

* Any head and neck injury in recent six months
* personal history of head and neck surgery, tumor, infection, and musculoskeletal disease of neck
* Lesions of central or peripheral nervous system, such as visual or vestibular system, any of which may also affect performance of balance
Shared Decision-Making for the Promotion of Patient-Centered Imaging in the ED: Suspected Kidney Stones

Although a CT scan is required for some Emergency Department patients with signs and symptoms of a kidney stone, recent evidence has shown that routine scanning is unnecessary and may expose young patients to significant cumulative radiation, increasing their risk of future cancers. Shared Decision-Making may facilitate diagnostic imaging decisions that are more inline with patients' values and preferences. By comparing a shared approach to diagnostic decision-making to a traditional, physician-directed approach, this study lays the foundation for a future randomized trial that will reduce radiation exposure, improve engagement, and improve the quality and patient-centeredness of Emergency Department care.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-55,
2. with acute flank pain - for whom clinician believes acute flank pain may be from renal colic
3. who are deemed by the treating clinician to be at low risk for dangerous alternative diagnoses.
4. Clinician is considering imaging patient for kidney stones (any imaging)

Exclusion Criteria:

1. Recent trauma related to pain (including minor such as lifting/turning)
2. Pregnancy (previous or discovered during ED visit)
3. Recent surgical procedure on abdomen or pelvis (30d)
4. Recent urologic procedure (30d)
5. Recent childbirth (30d)
6. Signs of Systemic Infection: Fever \>100.9 (101 and up), SBP \<90, HR\>120
7. Moderate or severe abdominal tenderness or rebound/guarding, consistently present (present for more than one exam, or present after patient treated with pain medication)
8. Second doctor's visit (ED, PCP, urgent care) for THIS episode of pain (previous similar visits ok if pain gone for \>30d in between episodes) (if seen at PCP or urgent care in same day or 24 hour period, this is not an exclusion, but if seen at PCP/urgent care or ED 1-30 days prior to index visit, with same pain, excluded)
9. Known history of one kidney or other urological/renal abnormality (including neurogenic bladder, ESRD and paraplegia; or if solitary kidney discovered on US)
10. Known malignancy (any) within past year (or received treatment in the past 12 months)
11. Immunocompromised (chronic steroids, HIV, crohns, immunomodulators or severely ill chronically)
12. On anticoagulation
13. Crisis patient (behavioral health)/belligerent
14. Lacks capacity for medical decision-making
15. Unlikely to respond to follow-up calls (IVDA, homeless, no phone)
16. Clinician is concerned for alternative diagnosis requiring CT scan (appendicitis) (\>5% likelihood by clinician gestalt)
17. Patient is not improving clinically and clinician is considering admission
Effects of Low Frequency Magnet Therapy on Spasticity in Patients With Cerebral Palsy

Background: Spasticity is a major challenge in patients with cerebral palsy (CP). It may cause unwanted complications and may affect the patient's quality of life. Currently there is no satisfactory long lasting control of spasticity. Many lines of evidence indicate that magnet therapy may be a useful intervention in the management of spasticity. Several studies showed that magnet may inhibit neuronal firing in the human nervous system; however, its effects weren't studied on spasticity. Objectives: The goal of the present study was to determine the short-and long-term effects of pulsed low frequency magnetic field therapy on spasticity in patient with CP. Methods: 48 patients with CP, who have measureable level of spasticity, were selected. The sample was divided randomly into active magnet group (received magnet therapy, 32 subjects) and placebo group (16 subjects). At the end of the 4th week the magnet group was divided into two sub-groups: 1st sub-group received magnet therapy for another 4 weeks while the other received the placebo. Measurements was taken at baseline, 4th, 8th and 12th weeks. Modified Ashworth Scale was used to measure spasticity, foot pressure platform system was used to measure the contact area and the maximum force of the feet, gross motor function measure (GMFM) was used to measure the functional level of the patients. The cerebral palsy quality of life (CP-QoL) questionnaire was used to measure the patients' various dimensions of quality of life.


Eligibility Criteria:
Inclusion Criteria:

* A confirmed diagnosis of diplegic or quadriplegic CP of both genders,
* Able to stand without assistance.
* Age from 4-16 years
* Measureable spasticity (1 or more according to the Modified Ashworth Scale).

Exclusion Criteria:

* Have recent organ transplants.
* Have heart pace maker.
* Have cardiac arrhythmia, tachy cardiac conditions or large aneurysm.
* Have heavy psychosis.
* Underwent any neuromuscular blockers of Spasticity.
* Underwent any surgery of tendon lengthening before or during the study.
* Have epileptic episodes.
Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3043

The primary purpose of this study is to assess the safety and tolerability of AZD3043 following administration of single ascending bolus doses (Part A) and single ascending bolus doses followed by infusion (Part B).


Eligibility Criteria:
Inclusion Criteria:

* Subjects with suitable veins for cannulation or repeated venepuncture
* Pre-dose assessment judged without remarks by the investigator
* Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria:

* Abnormal vital signs, after 15 minutes supine rest, defined as any of the following:
* Systolic blood pressure \>140 mm Hg
* Diastolic blood pressure \>90 mm Hg
* Heart rate ≤45 or \>85 beats per minute
* Lack of normal phenotype for BuChE (Butyrylcholinesterase)