cyrilzakka/clinical-trials huggingface dataset:
Attitudes Towards Back and Back Pain in German-speaking Switzerland

This research aims to assess the cross-cultural validity and reliability of the German version of the Back-PAQ (Back-PAQ_G) within the German-speaking Swiss population.

The target population for this study includes individuals with and without back pain and primary care healthcare professionals. This includes physicians, physiotherapists, and nurses. The participants will be asked to fill out the Back-PAQ_G and similiar questionnaires online.


Eligibility Criteria:
Inclusion Criteria:

* Living within the German-speaking part of Switzerland

Exclusion Criteria:

* Insufficient German language skills
Impact Of Eplerenone On Cardiovascular Outcomes In Patients Post Myocardial Infarction

Administration of eplerenone within 24 hours of onset of symptoms of myocardial infarction, in patients without heart failure, reduces cardiovascular mortality / morbidity.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have experienced a myocardial infarction (STEMI) within the previous 24 hours confirmed by symptoms and ECG.

Exclusion Criteria:

* Subjects with a known low ejection fraction of less than 40% or any previous history of heart failure.
* Subjects treated with eplerenone or other aldosterone antagonists within the past 1 month.
* The subject has uncontrolled hypotension (SBP\<90mmHg).
* Subjects with eGFR ≤30ml/min (based on admission serum creatinine and the MDRD formula) or serum creatinine ≥220µmol/L.
A Study of Colesevelam for Lenalidomide-Associated Diarrhea

The purpose of this study is to test the safety of colesevelam and find out what effects, if any, colesevelam has on lenalidomide associated diarrhea in participants with multiple myeloma on lenalidomide maintenance.


Eligibility Criteria:
Inclusion Criteria:

* Memorial Sloan Kettering Cancer Center (MSK) confirmed diagnosis of multiple myeloma
* Treatment with single agent lenalidomide maintenance
* Patient must be \>/= 18 years of age at the time of informed consent
* Experiencing grade 1 or more diarrhea according to the CTCAE 5.0 criteria for at least 4 out of 7 days preceding screening and study inclusion
* Scheduled to receive lenalidomide maintenance cyles at MSK
* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures

Exclusion Criteria:

* Patients with history of bowel obstruction
* Patients with serum triglyceride levels \>300 mg/dL
* Patients wit history of hypertriglyceridemia-induced panreatitis
* Patients with known hypersensitivity to colesevelam or any component to the formulation
* Patients currently already receiving a bile acid sequestrant or have previously used bile acid sequestrant drugs for diarrhea and had no benefit
* Patients with diarrhea secondary to infection. Stool studies for GI pathogens should be collected prior to starting colesevelam but do not need to be resulted prior to starting Day 1 dose of colesevelam, unless infection is suspected by the treating investigator, in which case (Clostridium difficile PCR when clinically indicated, GI pathogen panel, stool ova and parasites, Giardia and Cryptosporum stool antigen tests will need to be resulted at investigator discretion.)
Cystadrops in Pediatric Cystinosis Patients From Six Months to Less Than Two Years Old (SCOB2)

Cystadrops® is currently indicated in adults and children from 2 years of age diagnosed with cystinosis with corneal crystal accumulation observed.

However administration of Cystadrops® in patients below 2 years old could be of value for these patients and prevent the crystal deposit. It is the reason why as part of the Cystadrops® pediatric investigational plan (PIP), RECORDATI Rare Diseases committed to conduct a clinical study to assess Cystadrops® safety and efficacy in the pediatric population from 6 months to less than 2 years old.


Eligibility Criteria:
Inclusion Criteria:

1. Patient aged from 6 months to less than 2 years old
2. Cystinosis diagnosed patients confirmed by the physician and with presence of corneal cystine crystal deposits assessed during ophthalmic examination
3. Evidence of a signed and dated informed consent document indicating that parents/ legally acceptable representatives had been informed of all pertinent aspects of the study (if required by regulation)
4. Parents/ legally acceptable representatives who are willing to comply with regular visits and ophthalmic exams

Exclusion Criteria:

1. Contraindications to any of the Cystadrops® components
2. Participation in another ophthalmic investigational study or intent to participate during the course of the study
3. Any medical condition that would, in the opinion of the Investigator, interfere with the evaluation of the study objectives
Evaluating the Validity of a Genetic Risk Assessment Tool in Identifying Autism Spectrum Disorder

There are three purposes to this study. The first purpose is to evaluate the value of a genetic test in determining risk for autism spectrum disorder. Processing for genetic samples will be completed at the Cleveland Clinic using research equipment provided by IntegraGen. The second purpose is to identify genetic changes that may be associated with autism spectrum disorder or attention deficit/hyperactivity disorder. The third purpose is to examine whether genetic differences and changes may predict which individuals benefit from medicine used to treat attention problems or other psychiatric difficulties.

Between 600-800 people are expected to participate in this study - approximately 300 individuals with an autism spectrum disorder, 75 individuals with attention deficit/hyperactivity disorder or another developmental or psychiatric disorder, 100 healthy siblings, and 125 unrelated individuals without a developmental or psychiatric disorder.

Study procedures will vary based upon the specific group participants are suspected to fall into (autism, attention deficit/hyperactivity disorder, psychiatric concerns/developmental delay, healthy sibling, or unrelated healthy control).

* All individuals will be asked to participate in a cheek swab (gently swabbing the inside of your cheek) to obtain cells used for genetic testing. Genetic material will be stored with identifiers such as numbers, letters or codes.
* Parents or caregivers will be asked to complete questionnaires that examine medical and family history as well as current symptoms and quality of life for the participant.
* Participants may undergo speech and language testing. This involves answering questions, looking at pictures or identifying items.
* Information recorded in participant medical records will be reviewed and collected for this study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Autistic Disorder, Pervasive Developmental Disorder, or Asperger's Disorder or have a clinical diagnosis of another developmental or psychiatric disorder (developmental/psychiatric controls), or have no specific developmental or psychiatric diagnosis (healthy controls).
* Age 1 to 12.

Exclusion Criteria:

* For individuals with ASD and developmental concern controls, presence of a known or strongly suspected genetic disorder based on all available clinical data.
* Age less than 1 or greater than 12.
* Individuals for whom DNA is not available for analysis.
* Individuals for whom it is anticipated that they will not be available for follow-up at the Cleveland Clinic during the study period.
* Any medical diagnoses that might preclude participation in a low risk, non-interventional research study and any participant who at the discretion of the clinical investigator is not medically able to participate in the study (e.g., unable to comply with cheek swab or other procedure or has serious medical condition which precludes participation).
To Evaluate SBI in the Dietary Management of Mild to Moderate Crohn's Disease

The objective of this study is to evaluate the nutritional therapy with SBI (a medical food) as compared to placebo in the clinical dietary management of mild to moderate Crohn's disease.

This is a randomized, double-blind, placebo-controlled, multi-center, pilot study evaluating SBI 10 g BID compared to matching placebo for 12 weeks followed by a 12 week open-label extension SBI 10 g BID (EnteraGam) in the dietary management of mild to moderate Crohn's disease.

The effect of SBI will be evaluated on Crohn's disease related symptoms and inflammation symptom control as measured by Crohn's disease activity index (CDAI) scores and plasma and stool markers of inflammation. The patient's quality of life will also be assessed as an indicator of disease state.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of mild to moderate Crohn's disease for at least 3 months.
* Screening CDAI between \>150 and ≤ 250 based on subject recall.
* Average of greater than two liquid or soft stools per day and an abdominal pain intensity score \>1.
* Subject has at least one positive biomarker of inflammation: fecal calprotectin \>100 µg/g; elevated C-reactive protein (CRP) \>2 mg/dL.

Exclusion Criteria:

* Positive stool test for pathogenic bacteria including Clostridium difficile or O\&P.
* Confirmed intestinal stricture with obstructive-like clinical symptoms.
* Bowel resection within the previous 6 months.
* Change in medical therapy: must have been on a stable dose of

  * corticosteroids (prednisone or prednisolone) less than or equal to 20 mg per day for 2 weeks prior to screening,
  * budesonide less than or equal to 9 mg per day for 2 weeks prior to screening,
  * 5-aminosalicylates for 2 weeks prior to screening, and
  * immunomodulators for 6 weeks prior to screening.
* Taking greater than 20 mg per day of a corticosteroid (prednisone or prednisolone) or greater than 9 mg of budesonide.
* Received biologic therapy in past 2 years.
* Diagnosis of one or more co-morbid condition (s) requiring medical or surgical therapy that may affect bowel function, gastrointestinal symptoms.
* Serious infection in the 3 months prior to enrollment.
* Allergy or intolerance to beef or to any ingredient used in the product.
* Participated in an investigational drug or device study within 30 days.
* Does not have access to the internet.
* Taken EnteraGam®
Risk Factors and Machine Learning Model for Proton Pump Inhibitor Related Acute Kidney Injury

Recent evidence concerns acute kidney injury (AKI) following proton pump inhibitor (PPI) application. Few actual studies have compared the incidence, risk factors, and predictive models of AKI associated with PPI. The present study was a single-center retrospective study. The researchers retrospectively analyzed data from patients who received PPI medications between January 2018 and December 2020. PPI drugs included omeprazole, esomeprazole, rabeprazole, and pantoprazole. The primary outcome of the study was AKI, as defined by kidney disease: improving global outcomes (KDIGO). Secondary outcomes included length of hospital stay, hospital costs, and continuous renal replacement therapy. Independent risk factors associated with AKI were identified by univariate analysis and multifactorial logistic regression analysis (P \< 0.05). Logistic regression models were constructed based on the variables obtained from the analysis. Internal validation of the model was performed by the ten-fold cross-validation method. Model discriminatory power was assessed by the area under the curve (AUC) of the receiver operating characteristic curve (ROC). The study aims to develop a PPI-related AKI prediction model based on an electronic medical record system that can be used to predict AKI in hospitalized patients and contribute to the early prevention, diagnosis and treatment of AKI, ultimately reducing morbidity and improving prognosis.


Eligibility Criteria:
Inclusion Criteria:

* All inpatients who used proton pump inhibitor during hospitalization
* Hospital stay ≥ 48h
* Age ≥18 years
* There are two or more blood creatinine tests during hospitalization

Exclusion Criteria:

* Hospital stay \< 48h
* Age \<18 years
* Glomerular filtration rate (GFR)\< 30ml/min/1.73m2 within 48 hours after admission
* AKI was diagnosed on admission
* Less than two Scr test results during hospitalization
* The Scr values were always lower than 40 μmol/L during hospitalization
* Cases with incomplete medical history information
Early Infectious Disease Consultations in Staphylococcus Aureus Bacteremia

The primary objective is to determine if early infectious disease (ID) consultation (defined as within 48 hours of a positive blood culture) will reduce mortality rates from Staphylococcus aureus bacteremia (SAB). This study will also determine if such consultations could reduce the duration of hospitalisation, recurrence and financial costs in patients with this infection.

Bacteremia is a serious manifestation of Staphylococcus aureus infection with an attributable mortality as high as 25% in MRSA bacteremia. More than a third of patients end up with complications such as endocarditis, osteomyelitis or pneumonia.

Overall the outcome of patients with respect to mortality or recurrence is better in patients who have an eradicable focus and have received an appropriate antibiotic dose and duration. Also complicated bacteremia is more common in patients with

* persistent bacteremia or fever
* prosthetic device
* new murmur
* skin findings of a systemic infection

Based on this evidence, an ID consultation could improve the outcomes of patients with SAB by

* Advising adequate antibiotic dosage and duration
* Sourcing out and counselling eradication of any focus of infection

Eligibility Criteria:
Inclusion Criteria:

* All inpatients at the National University Hospital with Staphylococcus aureus (both methicillin sensitive and methicillin resistant) bacteremia isolated within the defined time period

Exclusion Criteria:

* Patients who died or were discharged before the notification from the laboratory
* Neonates
* Polymicrobial bacteremia
Psycho-behavioral Intervention for Depression in Chronic Heart Failure

The study aims to explore the effectiveness of psycho-behavioral intervention on depressive symptoms among older adults with chronic heart failure. Meanwhile, the effect on cardiac function and quality of life will also be explored.

Depression has been one of the emerging health concerns for older adults, especially for those with chronic heart failure (CHF). It was about 4-5 times more prevalent among patients with CHF than healthy population and independently associated with poor outcome of CHF. As suggested in the clinical management guideline of CHF, it is imperative to create integrative intervention for older adults with CHF, including timely detection and intervention, and ultimately improving the clinical outcome of CHF. However, the approach appropriate for depression intervention among Chinese older adults has yet been developed. This study aims to explore the effectiveness of psycho-behavioral intervention on depression associated with chronic heart failure in old age.

Eligibility Criteria:
Inclusion Criteria:

1. between 60 -85 years old.
2. male or female.
3. Diagnosis with depression as measured with PHQ-9 score of 5 and greater;
4. The subject is diagnosed with chronic heart failure according to their history, symptoms, signs, and adjuvant examinations (eg,echocardiography), in line with the diagnostic criteria for chronic heart failure presented in the China Heart Failure Diagnosis and Treatment Guidelines, with NYHA (New York Heart Association) grade II-III.
5. Reading and writing competency for completing the rating scales.
6. Sufficient physical condition, hearing and vision to ensure the completion of psychological behavior intervention.

Exclusion Criteria:

1. Currently taking antidepressant drugs, and drug dose is unstable.
2. With is a serious risk of suicide, suicide attempts and suicidal behavior (HAMD17 score of 30 or above, or suicide subscale score of 3 and above，or suicide subscale score of MINI of 6 or above).
3. Intact cognitive function with CSI-D score of less than 7.
4. Having other major mental disorders, including Alzheimer's disease, schizophrenia, schizoaffective psychiatric disorders, delusional disorders, undefined psychotic disorders, substance and alcohol abuse
5. Planned heart surgery within 9 months.
6. Unable to comply with psychological intervention due to serious physical conditions -
Antiangiogenic Effects of BCG on Urinary Concentration of Angiogenic Factors

To determine if there is an association between basic fibroblast growth factor,vascular endothelial growth factor, and interleukin levels and a patients response to BCG treatment ( as standard treatment)in the urine of patients with superficial TCC. To determine if the levels of these angiogenic factors can predict response to BCG, disease recurrence, progression risk factors.

200 patients that are candidates for intravesical BCG therapy and 20 control patients with no history of malignancy will be enrolled. The study group wol;; be asked to provide a urine sample just prior to receiving their first BCG treatment(week # 1) and just prior to receiving their last (week # 6) BCG treatment. The control patients will provide one urine sample only. Samples will be analysed by enzyme-linked immunosorbant assay(ELISA). clinical data will be reviewed on tumor stage and grade prior to BCG, timme to recurrence, tumor stage and grade of recurrence, time to disease progression and death, cause of death and total follow-up time.

Eligibility Criteria:
Inclusion Criteria:

200 study group 1. Must be a candidate for BCG therapy. 20 control group 1. No history of malignancy.

Exclusion Criteria:

* N/A
Efficacy of Dry Needling in the Spasticity Post-stroke

Stroke is a serious clinical condition and one of the leading causes of long-term disability in the world. One of the most serious complications of this condition is spasticity. Recently, dry needling has commented to be used as a treatment in muscle spasticity of chronic patients after a stroke, producing improvements in clinical conditions.

This study evaluates the effectiveness of dry needling technique in the spasticity of the hemiparetic limbs in chronic post-stroke patients. The Modified Ashworth Scale is used to measure the spasticity´s improvement after the procedure.


Eligibility Criteria:
Inclusion Criteria:

* First hemiplegic ischemic stroke.
* Chronic stroke (stroke at least 6 months before the trial).
* Present a level of spasticity equal or greater than 1 according to the Modified Asworth Scale.
* Preserve cognitive capacity.
* Being able to understand and follow simple instructions.
* Not afraid of needles.

Exclusion Criteria:

* Recurrent stroke.
* Subjects with cognitive disorders.
* Presenting any medical contraindication for the dry needling procedure or problems with coagulation or epilepsy.
* Alteration of sensitivity.
* Receives nerve block or botulinum toxin treatments in a period equal or less than 6 months, since ir can modify the results.
* Hemorrhagic stroke.
* Subjects who do not consent to participate in the study.
International Registry of Accidental Hypothermia

Transient mild hypothermia (core body temperature 35-32°C) is common and usually without consequences for the brain or other organs. However, prolonged severe accidental hypothermia (core body temperature below 28°C) due to accidents is rare, and usually fatal in more than 50% of cases. Little is known on its physiopathology, on prognostic factors for rewarming decision or ideal rewarming techniques for better survival. Furthermore, complications after successful rewarming are extremely frequent and very often severe or fatal.

Accidental hypothermia is a frequent problem during the winter months and can be caused by snow sport accidents, near drowning and urban cold exposure. The International Hypothermia Registry's principle goal is to increase knowledge on accidental hypothermia by creating the largest database on accidental hypothermia which will comprise enough patient data to give a statistical power since the causes of accidental hypothermia and its treatment varies greatly.

The International Hypothermia Registry (IHR) will enable improvement of pre- and in-hospital treatment and rewarming methods, study survival predictors and prevention of post-rewarming complications. By this way, the IHR will permit the establishment of evidence-based diagnosis and treatment guidelines.

The aim of the International Hypothermia Registry is to improve rescue, treatment and outcome of accidental hypothermia victims.

The principal objectives of the International Hypothermia Registry are:

* Improving the outcome of accidental hypothermic patients (survival and normal neurologic function);
* This outcome is dependent on the presenting status of the patient (temperature, trauma, cardiac arrest, etc.);
* The hospital treatment and rewarming method will also influence the outcome, invasive vs. non-invasive rewarming and rewarming rate.
* Quality control, assessment of hypothermia cases

This IHR is mainly prospective but retrospective entries are welcome.

There is no data limit on retrospective cases: cases of any year can be entered.

Eligibility Criteria:
Inclusion Criteria:

* Accidental hypothermia with body core temperatures equal or less than 35°C/95°F;
* Any cause leading to accidental hypothermia (e.g. mountain, water, urban);
* Any age, gender, or comorbidities;
* Any pre-hospital and hospital treatment and rewarming;
* Any outcome.

Exclusion Criteria:

* Patient opposition to be part of a study;
* Essential missing values, e.g. temperature.
A Long-Term Safety Study of BCX9930 in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)

This study was designed to evaluate the long-term safety of daily oral treatment with BCX9930 in participants who had participated in a previous BCX9930 trial for PNH and showed a benefit of treatment as determined by the Investigator. The study allowed continued access to BCX9930 for enrolled participants. The study also evaluated the long-term effectiveness and impact on quality of life and general well-being of BCX9930 treatment, and the participant's satisfaction with the medication.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating female participants
* Successfully participated in a previous BCX9930 study of PNH and experienced improvement in their PNH

Exclusion Criteria:

* Apart from a diagnosis of PNH, any clinically significant medical or psychiatric condition or medical history, other than those associated with PNH disease, that, in the opinion of the Investigator or Sponsor, would interfere with the participant's ability to participate in the study or participation would increase the risk for that participant
* Pregnant, planning to become pregnant, or having been pregnant within 90 days of Day 1, or lactating

Note: Other protocol-defined Inclusion/Exclusion criteria may apply