cyrilzakka/clinical-trials huggingface dataset:
Autoimmune Cytopenia and BcR Inhibitors

Efficacy of BCR Inhibitors in the Treatment of Autoimmune Cytopenias Associated with Chronic Lymphocytic Leukemia (CLL): A Retrospective Analysis of the French Innovative Leukemia Organization (FILO)

The investigators of the study propose a card of data collection, validated by the scientific council of the group FILO.

The data to be collected are entered on an e-CRF made available to the investigators on a secure site.

The main data collected are as follows

* anonymized demographic data
* Clinical and Biological Data of CLL at Diagnosis
* Previous treatments of LLC and CAI
* clinical and laboratory data at the time of initiation of BCRi treatment
* response to treatment with BCRi
* tolerance to BCRi treatment
* Progression under treatment with BCRi
* Recent news

Eligibility Criteria:
Inclusion Criteria:

* Patient with CLL
* Active autoimmune cytopenia
* Initiation of a treatment with ibrutinib or idelalisib for autoimmune cytopenia.

Exclusion Criteria:

* Other lymphoid hemopathy B
* Absence of documentation of the autoimmunity of cytopenia
Calanus Oil Supplementation and Maximal Oxygen Uptake

Copepod oil is extracted from the marine copepod Calanus finmarchicus, the dominant plankton species in the marine food web in the Norwegian Sea. Copepods constitute the largest renewable and harvestable resource in the Norwegian Sea and adjacent waters, and it is now developed knowledge and technology for sustainable harvesting of this "new" resource. The purpose of this study is to investigate whether Calanus copepod oil supplementation has an equivalent effect on maximal oxygen uptake in humans to that seen in experimental studies in mice.


Eligibility Criteria:
Inclusion Criteria:

* in good health
* Body mass index (BMI) between 18,5 and 29,9

Exclusion Criteria:

* Medical condition limiting VO2max (COPD or asthma).
* diagnosed coronary artery disease
* Any other significant medical condition
* medication effecting exercise capacity (e.i. betablockers)
* Pregnancy
* Participation in other clinical trials
* Shellfish allergies
* Systolic blood pressure \> 170 mmHG, or diastolic BP \> 105 mmHG.
* contraindications for maximal exercise testing
Steady State Study of Codeine Sulfate

Study to characterize the steady-state pharmacokinetics of codeine and its metabolites morphine, morphine-3-glucuronide (M3G), and morphine-6-glucuronide (M6G) after oral administration of Roxane Laboratories' codeine sulfate tablets administered at a dose of 15 mg Q4H x 5 days.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to codeine sulfate or any comparable or similar product.
To Demonstrate the Relative Bioavailability of Clarithromycin 250 mg Tablets Under Fasting Conditions

To demonstrate the relative bioavailability of Clarithromycin 250 mg tablets under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Dosing Study of Cranberry Capsules for the Prevention of Bacteriuria in Nursing Home Residents

This study will investigate whether there is a particular dose of cranberry capsules that is effective in preventing the occurrence of urinary tract infections in females at least 65 years of age or older who live in a nursing home and who have a history of urinary tract infections. The Yale research team will be enrolling 80 subjects in total over several nursing home locations within Connecticut.

Each subject was enrolled after providing a baseline urine specimen. Cranberry/placebo capsules were consumed for 30 days. Urine specimens were obtained weekly for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Female nursing home residents 65 years of age or older with history of urinary tract infection within the past year.

Exclusion Criteria:

* residents that are not expected to be in the nursing home for at least one month (i.e., short term rehabilitation, pending discharge, terminal \[life expectancy \< 1 month\]);
* residents who are on chronic suppressive antibiotic or anti-infective (i.e., mandelamine) therapy for recurrent UTI;
* residents with end stage renal disease on dialysis (they do not regularly produce urine);
* residents unable to produce a baseline clean catch urine specimen for collection;
* residents on warfarin therapy because of a potential interaction of warfarin and cranberry juice;
* residents with a history of nephrolithiasis because cranberry may increase the risk of nephrolithiasis.
COmmunities Aligned to Reduce Concussion and Head Impact Exposure

Head impacts in collision sports such as football are a public health concern, as repetitive head impacts, even if a concussion is not suspected, have negative effects on brain health. This study has partnered with a community stakeholder group to create a safety program for youth football named "COmmunities Aligned to reduce Concussion and Head impact exposure (COACH)", which seeks to improve knowledge and skills of youth coaches in effective and safe practice planning and to change attitudes and beliefs to prevent head impacts and promote safety. To continue advancing COACH as an approach to prevent head injuries in youth football, this R01 Research Project Grant will determine the ability of youth football organizations to adopt COACH and test if COACH is effective in reducing head impacts, concussion, and negative effects of brain health while monitoring how the program is implemented.

Football has a high risk of concussion and incidence of subconcussive head impacts which have long-lasting negative effects on brain health. With roughly 3.5 million athletes participating in youth football each year, there is a critical need to reduce head impact exposure and concussion risk. Over an entire season, most of an athlete's head impact exposure is attributed to practice. Coach-directed activities (e.g., practice drills) influence the frequency and severity of head impact exposure. Practices are amenable to intervention; however, youth football leagues are often community-run organizations with limited resources, making implementation and enforcement of injury prevention strategies a challenge. Thus, engaging community members is essential for successful development, implementation, and sustenance of interventions. This study partnered with a community stakeholder group to co-design and implement an evidence-based intervention program: COmmunities Aligned to reduce Concussion and Head impact exposure (COACH). COACH seeks to improve knowledge and skills of youth football coaches in effective practice planning that incorporates safe drills and to change attitudes and beliefs toward contact in practice. COACH has been pilot tested in two teams and shown to be acceptable and feasible. A critical next step of this research is the pragmatic evaluation of the effectiveness of COACH on a larger scale, while identifying factors that influence implementation. This study addresses this critical next step by determining the capacity of youth football organizations to adopt COACH and by testing COACH's effectiveness while monitoring the implementation process.

Eligibility Criteria:
Inclusion Criteria:

* Participants without braces

Exclusion Criteria:

* Athletes will be excluded from participation if they currently have braces or plan to have braces during the football season, or have dental appliances that may impede the fit of the mouthpiece device (e.g., Herbst Appliance).
Referral Patterns for Hospital Acquired Acute Kidney Injury and Relevance to Renal Outcomes

Few studies analyzed the referral time to nephrologists and its impact on the patient outcome in a large cohort. The investigators described the incidence and determined the outcome with respect to renal function recovery, renal replacement therapy (RRT) requirement and in-hospital mortality of Hospital Acquired Acute Kidney Injury (HA-AKI) without nephrology referral (nrHA-AKI) and late referred HA-AKI patients to nephrologists (lrHA-AKI) compared with early referral patients (erHA-AKI). The patients included were admitted to the tertiary care academic center of Lausanne (Switzerland) between 2004 and 2008, in the medical and surgical services and in the intensive care unit (ICU).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients.
* Hospitalization in the medicine and surgery wards and in the intensive care unit.
* Hospitalized patients with acquired acute kidney injury according to the
* Acute Kidney Injury Network (AKIN)criteria.
* HA-AKI patients with no referral to the nephrologist (nrHA-AKI).
* HA-AKI patients referred late (more than five days \[\> 5 days\]) to the nephrologist (lrHA-AKI).
* HA-AKI patients early referred (within five days after sCr increase) to the nephrologist (erHA-AKI).

Exclusion Criteria:

* Patients with AKI at the time of the hospital admission and during the first
* 48 hours after admission.
* Patients hospitalized in other wards.
* Children under 18.
Care Pathway for Sub-acute Hip Rehabilitation

The effectiveness of integrated care pathways for hip fractures in sub-acute rehabilitation settings is not known. The study objective was to assess if a hip fracture integrated care pathway at a sub-acute rehabilitation facility would result in better functional outcomes, shorter length of stay and fewer institutionalisations. A randomised controlled trial on an integrated care pathway was conducted for hip fracture patients in a sub-acute rehabilitation setting. The study supports the use of integrated care pathways in sub-acute rehabilitation settings to reduce length of stay whilst achieving the same functional gains.

All patients admitted to St Luke's Hospital, a 185-bed hospital in Singapore providing multidisciplinary stepdown care, from 8 September 2004 to 14 June 2006 for the purpose of rehabilitation after a new hip fracture were included. Patients were excluded if any of the following criteria were present: (i) Pre-morbid non-ambulatory status, (ii) nursing home residents, (iii) palliative care patients, and (iv) patients previously enlisted for the trial. Administrative staff allocated patients to either ICP or usual care according to the last digit of their National Registration Identity Card (NRIC) numbers, odd numbers to the intervention group and even numbers to the control group. Patients were then admitted to 1 of 2 intervention wards or 1 of 3 control wards. Patients were enrolled by the principal investigators only after moving into their respective wards because of work flow limitations. Those who refused consent or were excluded remained in their assigned wards and received usual care. Both intervention and control groups were under the care of multidisciplinary teams but the intervention group had structured assessments and checklists in addition to usual care while the control group had usual care alone.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to St Luke's Hospital for the purpose of rehabilitation after a new hip fracture.

Exclusion Criteria:

* Patients were excluded if any of the following criteria were present: (i) Pre-morbid non-ambulatory status, (ii) nursing home residents, (iii) palliative care patients, and (iv) patients previously enlisted for the trial.
Internal Limiting Membrane Flap in the Management of Retinal Detachment Due to Paracentral Retinal Breaks

To describe the technique and outcomes of using either inverted or free internal limiting membrane flap in the management of retinal detachment due to paracentral retinal breaks.

This retrospective observational case series includes nine patients received surgery for retinal detachment due to paracentral retinal breaks developed either from primary rhegmatogenous orgin, or secondary iatrogenic retinal breaks after prior membrane peeling or during surgery for tractional retinal detachment. Either inverted or free internal limiting membrane flaps were inserted in the identified breaks, followed by air fluid exchange and gas tamponade. Visual acuity and structural changes were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with retinal detachment and posterior paracentral retinal breaks located within the equator from January 2017 to January 2018

Exclusion Criteria:

* Patient with macular hole
* Patient with other ocular diseases including ocular hypertension, optic nerve atrophy, glaucoma or chronic uveitis
A Study of Immunotherapy Treatment in People With Sarcoma

The purpose of this study is to collect information from participants' medical records to improve our knowledge about immunotherapy use and how effective it is as a treatment for people with sarcoma. Immunotherapy drugs boost the immune system's ability to fight cancer by blocking proteins that act as a "brake" on the immune system. Blocking these proteins is like releasing the brakes, so that the immune system can target cancer cells and destroy them. This action is sometimes described as "immune checkpoint blockade.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a histologic diagnosis of sarcoma confirmed by an MSK pathologist.
* Any prospectively identified patient being treated or to be treated with an immune checkpoint inhibitor, such as anti-PD-1, anti-PD-L1, anti-CTLA-4, or anti-LAG3 inhibitor, either as monotherapy or in combination with additional systemic therapy o Novel immune checkpoints inhibitors that are developed after submission of this protocol will also be included) Please Note: there is no age requirement. Patients of all ages are eligible to enroll

Exclusion Criteria:

* Patient unwilling to consent to collection of historical and longitudinal clinicopathologic data in the patient medical record from baseline (the period prior to ICB initiation), during, and after ICB treatment
Diagnostic Algorithm in Patients With Minor Head Injury

The objective of this prospective study is to evaluate the reliability of plain x-rays vs.cranial computed tomography as a screening method for skull fractures and its prognostic value for intracranial bleeding (ICB).

In a consecutive patients series of about 12500, blunt head injuries were observed (during a 16 month period), in a prospective analysis.

Based on a retrospective study, we created a checklist of individual patients data which was completed for each patient.

In accordance with the institutions guidelines all patients with blunt head injury received plain skull x-ray in 2 plains and additional cranial CT-scan (CCT) in case of fracture or neurological symptoms. We developed also an diagnostic algorithm consisting of anamnestical data and clinical signs and symptoms to define these risk factors and to catch all patients with minor head injury who are at risk to develop intracranial bleeding.

Eligibility Criteria:
Inclusion Criteria:

* head injury, nausea, vomiting

Exclusion Criteria:

* no head injury
Dextrose Therapy on Physical Therapy in Subdeltoid Bursitis

Physical therapy and hypertonic dextrose prolotherapy are often used to treat subdeltoid bursitis. This study aims to investigate the effects of hypertonic dextrose injection on physical therapy through a double-blind, randomized study.

A double-blind, randomized, placebo-controlled clinical trial will be conducted to collect 44 patients with subdeltoid bursitis. In the first week and the third week, a total of 20% hypertonic dextrose 10 mL (experimental group) and normal saline 10 mL (placebo group) will be injected under sonographic guidance, and physical therapy (hot shoulder pack, interference wave, and exercise for 20 minutes each) 3 times per week for one month will be arranged. Shoulder pain by visual analog scale, function (including Disabilities of the Arm, Shoulder, and Hand: DASH and Shoulder Pain and Disability Index: SPADI), quality of life (Brief version of the World Health Organization Quality of Life Scale: WHOQOL-BREF) and high-resolution ultrasound examination will be arranged at before treatment, one week after treatment (i.e., one week after injection), one month, and three months after injection.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of subdeltoid bursitis age 20 or older 20 at least one positive in the painful arc, neer test, or Hawkins test can attend 3 months of intervention and follow up

Exclusion Criteria:

* history of malignancy previous shoulder operation or injury previous shoulder injections in the past 3 months
Switching From Twice-Daily to Once-Daily Clozapine Dosing in Schizophrenia

Plasma half-life has routinely been used to establish the dosing schedule of antipsychotics; for example, it is recommended that agents with a short plasma half-life be administered multiple times per day. However, to date, several randomized controlled trials (RCTs) have shown no differences in clinical outcomes between once- and twice-daily dosing of various antipsychotics, suggesting that once-daily dosing of antipsychotics is a viable option regardless of plasma half-life. This would apply to clozapine as well; however, there have been no studies comparing once-daily vs. twice-daily dosing regimens of clozapine in terms of efficacy and tolerability. To address this gap in the literature, the investigators shall conduct a pilot, double-blind, RCT to examine efficacy and tolerability following a switch to once-daily dosing regimen of clozapine in patients with schizophrenia receiving clozapine twice a day.

Plasma half-life has routinely been used to establish the dosing schedule of antipsychotics; for example, it is recommended that agents with a short plasma half-life be administered multiple times per day. To date, however, several randomized controlled trials (RCTs) have shown that once-daily dosing of antipsychotics including perphenazine, risperidone, olanzapine, quetiapine, and asenapine is comparable to twice-daily dosing in terms of efficacy and tolerability, suggesting that once-daily dosing of antipsychotics is a viable option regardless of plasma half-life.

This issue applies to clozapine as well, in that it has a relatively short plasma half-life of 12-16 hours; of note, the product monographs recommends that clozapine be administered more than once daily if the dose exceeds 200 mg/day in Canada. Despite this, in clinical practice clozapine is frequently administered once daily because of convenience and side effects such as a daytime sedation or somnolence, In support of this, a cross-sectional survey done at the investigators' own centre has revealed that clozapine was prescribed once daily in 75.1% of 676 patients, even though \>200 mg/day was administered in 88.6%. However, there have been no studies comparing once-daily vs. twice-daily dosing regimens of clozapine in terms of efficacy and tolerability. To address this gap in the literature, the investigators shall conduct a pilot, double-blind, RCT to examine efficacy and tolerability following a switch to once-daily dosing regimen of clozapine in patients with schizophrenia receiving clozapine twice a day.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with schizophrenia or schizoaffective disorder based on DSM-IV criteria
* Outpatient status
* Ages 18 years or older
* Has received clozapine twice a day, one of which is in the evening/bedtime, at the same dose and dosing regimen for at least 3 months
* Fluent in English and competent to provide written informed consent

Exclusion Criteria:

* Having significant medical or neurological illnesses
* Pregnant or lactating
Immediate Effects of a 10-minute Body Scan Meditation on People Who Has Central Sensitization

For patients with chronic pain, how does a 10 minute guided body scan meditation affect pressure pain threshold and extent of pain on a body diagram?

Patients who present with central sensitization in physical therapy will go through a 10 minute body scan meditation. If patient meets criteria then they will fill out pre-intervention measures including hand dominance, gender identity, duration of pain, work status, pain body diagram, current pain level, previous medication and a neck disability index or an oswestry disability index.

Subject will then be asked what position they feel most comfortable to be led through this body scan meditation.

After the meditation, the participant will fill out another pain body diagram, current pain level, global rating of change and pain pressure threshold.

At this point the study is over and the subject will return to their physical therapy treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects are from a convenience sample of patients seeking physical therapy care from a physician referral or direct-access to a privately owned physical therapy clinic English speaking
* Central Sensitization Inventory \> 40
* Subject complains of disproportionate non mechanical unpredictable pattern of pain provocation in response to multiple non-specific aggravating/easing factors
* Pain disproportionate to the nature and extent of injury or pathology
* Strong association with maladaptive beliefs and pain behaviors
* Diffuse, nonanatomic areas of pain and tenderness on palpation

Exclusion Criteria:

* Does not meet the criteria above