cyrilzakka/clinical-trials huggingface dataset:
Assessing the Effect of Contact Isolation on Nosocomial Colonization With ESBL-EC in German Hematology/Oncology Wards

This study aims to evaluate the impact of contact isolation on the rate of hospital-acquired transmissions of ESBL-producing Escherichia coli (ESBL-EC) and the rate of colonization and infection. On the basis of this study, it will be possible to re-evaluate the need for contact isolation for patients colonized or infected with ESBL-EC.

The study aims to evaluate the impact of contact isolation on the rate of hospital-acquired transmissions of ESBL-producing Escherichia coli and the rate of colonization and infection.

Hematological and oncological wards in hospitals with a non-outbreak setting for ESBL-EC and adhering to at least the following standard of care are eligible for study participation:

* Fecal screening for the presence of ESBL-EC of all patients within 72 hours of each admission by use of a rectal swab or stool sample
* Follow-up fecal screening once a week and within 72 hours of discharge
* Implementation of clinical standards aimed at ESBL-EC decolonization is not allowed on wards participating in this study, including in the context of clinical studies.

Sites will be grouped according to their approach regarding contact isolation (see group description).

As a control for external factors a hand hygiene program, including training and adherence assessments, will be implemented.

Eligibility Criteria:
Inclusion Criteria:

* Wards adhering to at least the following standard of care are eligible for study participation:
* Fecal screening for the presence of ESBL-EC of all patients within 72 hours of each admission by use of a rectal swab or stool sample
* Follow-up fecal screening once a week and within 72 hours of discharge

Exclusion Criteria:

* none
Exosomes Detection for the Prediction of the Efficacy and Adverse Reactions of Anlotinib in Patients With Advanced NSCLC

Exosomes detection for the prediction of the efficacy and adverse reactions of Anlotinib in patients with advanced NSCLC

Explore blood exosomal miRNA as a biomarker for predicting the efficacy or risk of serious adverse reactions in patients with advanced lung adenocarcinoma (or lung squamous cell carcinoma) after anlotinib treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have signed informed consent.
2. Male or female, age between 18-75 years old.
3. Patients with advanced lung adenocarcinoma who failed standard treatment.
4. Complete prognostic assessment information.
5. Efficacy evaluation: PR/SD/PD.
6. Anlotinib single drug administration.
7. ECOG PS score: 0-1.
8. Patient's expected survival time is greater than 12 weeks.
9. The functions of main organs meets the following criteria: 1) absolute neutrophil count (ANC) ≥1.5×10\^9/L; 2) white blood cell count (WBC) ≥3.0×10\^9/L; 3) platelet (PLT) ≥100×10\^9/L; 4) hemoglobin (Hb) ≥90g/L; 5); creatinine clearance ≥50ml/min or serum creatinine (Cr) ≤1.5×upper limit of normal (ULN); 6)serum total bilirubin (TBIL) ≤1.5×ULN; 7) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; 8) left ventricular ejection fraction (LVEF) ≥ the lower limit of the normal (50%); 9) Serum Cr ≤ 1.5ULN or creatinine clearance (CCr) ≥ 60ml / min; 10) ALT and AST ≤ 5ULN; 11) activated partial coagulation activity Enzyme time (APTT), international normalized ratio (INR), prothrombin time (PT)≤1.5×ULN.
10. Women of childbearing age should make sure their pregnancy test is negative within 2 weeks before the study, and keep using contraceptive methods during the study and within 24 weeks after the last administration of Anlotinib. For men, they must agree to use contraceptive methods during the study period and also 24 weeks after the last administration of Anlotinib.

Exclusion Criteria:

1. Patients whose plasma is not qualified for the test (hemolysis, precipitation, etc.)
2. Patients who have used Anlotinib before.
3. Pathological diagnosis results do not meet the requirements for entry.
4. Patients never used TKIs.
5. Patients with hemoptysis, more than 50mL per day.
6. Patients with other kinds of malignancies within 5 years.
7. Patients who have taken systemic therapy (immunotherapy, cytotoxic therapy, or other targeted therapies) within 6 weeks before grouping.
8. Patients who have symptoms of diseases that affect the patient's medication.
9. Patients who have suffered non-relieving toxicity from previous treatment.
10. Patients who have habitus of hemorrhage; the history of ulcer or fracture and non healing wounds.
11. Patients who have suffered arterial/venous thrombosis within 24 weeks.
12. Patients who have been diagnosed with mental disorder.
13. Patients who have suffered other diseases that may affect the patient's life safety and the results of this experiment.
Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis

The purpose of this study is to compare the effectiveness and safety of ABP 501 against adalimumab (HUMIRA®) in adults with moderate to severe rheumatoid arthritis (RA) who have an inadequate response to methotrexate (MTX).


Eligibility Criteria:
Inclusion Criteria:

1. Men or women ≥ 18 and ≤ 80 years old
2. Subjects must be diagnosed with rheumatoid arthritis for at least 3 months before baseline
3. Active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints at screening and baseline
4. Subjects must be taking MTX for ≥ 12 consecutive weeks and on a stable dose of 7.5 to 25 mg/week for \> 8 weeks prior to receiving the study drug and be willing to remain on stable dose throughout the study
5. Subject has no known history of active tuberculosis

Exclusion Criteria:

1. Class IV RA, Felty's syndrome or history of prosthetic or native joint infection
2. Major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren's syndrome
3. Prior use of 2 or more biologic therapies for RA
4. Previous receipt of HUMIRA® (adalimumab) or a biosimilar of adalimumab
5. Ongoing use of prohibited treatments

Other Inclusion/Exclusion criteria may apply
Influence of Carob and Probiotics on Acute Diarrhea in Children

Comparison of Carob powder with probiotics vs oral hydration solution in diarrhea treatment in children.


Eligibility Criteria:
Inclusion Criteria:

* Acute diarrhea

Exclusion Criteria:

* Dehydration
* Chronic diseases
* Chronic diarrhea (more than 2 weeks)
* Septic shock
* Hypovolemia
* On medication
* Pregnancy
Neurofeedback From the Supplementary Motor Area for Tourette Syndrome

This is a clinical trial where adolescents aged 10-16 years old with Tourette Syndrome (or chronic tic disorder) are randomized to receive either real-time functional magnetic resonance imaging (fMRI) neurofeedback targeting the supplementary motor area (for the experimental intervention) or real-time fMRI neurofeedback (NF) from a control region (for the control intervention).

The training portion of this study involves three fMRI NF sessions, with six NF scans per session. NF scans alternate between up-regulate and down-regulate blocks in which participants are cued to increase or decrease activity in the target region while receiving feedback on activity in the region at the bottom of the screen in the form of a line graph. The experimental group receives feedback from the supplementary motor area (SMA) and the control group receives feedback from a control region of the brain.

Eligibility Criteria:
Inclusion Criteria:

* Boys and girls, 10 to 16 years of age
* A current diagnosis of Tourette Syndrome (TS) or chronic tic disorder (CTD), with active tics that can be executed without head movement, and a YGTSS score of at least 13 (for TS participants) or at least 12 (for CTD participants)
* Currently stable medication treatment and no planned changes in medication for the duration of the study.
* Family residence within 2 hours of Yale Medical Center with ability and willingness to attend assessment and fMRI visits.
* Children and their parents are expected to be able to speak and understand spoken English in order to participate in a clinical assessment of TS and related psychopathology.
* Subjects will be free of: 1) metal medical implants or braces, 2) pregnancy, and will have 3) a body weight of less than 250 lbs. and 4) no claustrophobia.

Exclusion Criteria:

* Intelligence quotient below 80
* Current diagnosis of autism spectrum disorder, bipolar or psychotic disorder or current suicidality
* Significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, seizure disorder
* Recently initiated psychotherapy. Participation in the study will not be allowed within 8 weeks of the initiation of psychotherapy. Ongoing, concurrent psychotherapy (that was initiated at least 8 weeks previously) for the child will be allowed, but parents will be asked not to initiate any new psychotherapy for the child during the study
* Subjects may also be excluded after the first MR scan if we are unable to localize the two regions in their brain that are used as targets for the active and control neurofeedback conditions.
Oral Immunotherapy for Peanut and Mammalian Meat Allergies

Pilot study to assess the effect of oral immunotherapy on specific Immunoglobulin E (IgE) levels and antigen consumption in two distinct food allergies.

In subjects with mammalian meat allergy, the effect of daily oral cow's milk on immune parameters and desensitization will be assessed. Similarly, in subjects with a peanut allergy the effects of low dose peanut flour will be assessed and comparisons between two distinct food allergies.

Eligibility Criteria:
Inclusion Criteria:

* Presence or absence of specific IgE to alpha-gal or peanut

Exclusion Criteria:

* History of severe anaphylaxis
* allergy to cow's milk protein
Electrolytes in Chronic Kidney Disease Patients With Acute Coronary Syndrome

Study of serum calcium and phosphorus level in chronic kidney disease patients and its relation to occurrence of acute coronary syndrome in them.

Prospective study to :

1. find the relation between electrolytes disturbance and renal diseases
2. the effect of electrolyte abnormalities on atherosclerosis
3. prevalence of acute coronary syndrome in patients with chronic kidney disease

Eligibility Criteria:
Inclusion Criteria:

* 1-The CKD patients with or without dialysis who admitted to coronary care unit with chest pain consistent with ACS with any of following features :

  a- Electrocardiogram (ECG) changes:
* ST elevation.
* ST depression.
* T wave inversion.
* recent left bundle branch block.

  b- Troponin T elevation.

  2-The CKD patient with or without dialysis with no previous history of ACS.

Exclusion Criteria:

1. Patients who were diagnosed with primary hyperparathyroidism.
2. Acute Kidney injury (AKI) which is defined as any of the following:(KDIGO2012)

   * Increase in S.Cr by ≥ 0.3 mg/dl (≥ 26.5 μmol/l) within 48hours; or
   * Increase in S.Cr to ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days;or
   * Urine volume \<0.5 ml/kg/h for 6 hours
Reducing Antiretroviral Treatments

The purpose of this trial is to demonstrate at W48 the non-inferiority of a dual nucleoside analogues strategy with tenofovir (TDF) or tenofovir alafenamide (TAF) plus emtricitabine (FTC) or lamivudine (3TC) preceded by a 16 week induction period with TDF or TAF plus FTC or 3TC plus an integrase inhibitor (INI) relative to an immediate 2-DR strategy with dolutegravir plus 3TC in HIV-infected antiretroviral therapy (ARV) naïve participants with CD4 cells count greater than 300/mm3 and a low viral load defined as plasma HIV RNA strictly lower than 50 000 cp/mL

ANRS 173 ALTAR is a multicenter, comparative, international, open label, phase III randomized trial aiming at evaluating the non-inferiority of a TRI-BI (tritherapy-bitherapy) strategy (includes a 16 week - induction phase with 2 NRTI and a once daily integrase inhibitor followed by a bitherapy with TDF or TAF / XTC\*) in its capacity to achieve viral suppression at week 48 versus immediate BI (bitherapy) strategy (DTG/3TC) in participants naïve to antiretroviral therapy with plasma HIV RNA strictly less than 50 000 copies/mL and CD4 cells count above 300/mm3.

Eligibility Criteria:
Inclusion Criteria:

* Documented HIV-1 infection (positive HIV-1 serology or plasma viral load)
* Age ≥ 18 years
* Therapeutic antiretroviral treatment-naive participant (history of prophylaxy is accepted)
* CD4 cells count \> 300 cells/mm3 at screening visit
* HIV-1-RNA plasma viral load \<50 000 copies/mL at screening visit
* Full susceptibility to trial drugs (NRTI, INI) at screening visit
* eGFR (epidermal growth factor receptor) \> 60 mL /min (MDRD)
* AST (aspartate aminotransferase), ALT(alanine transaminase) \< 3x norm
* Absence of any AIDS-defining event and/or opportunistic infection
* Possible contact by phone and/or email in order to be informed in case of detectable HIV plasma viral load
* Negative urinary pregnancy test at screening visit for women of childbearing age
* Written and informed consent signed
* For French participants only: subject enrolled in or a beneficiary of a Social Security programme (including State Medical Aid (AME), only if Ethic Committee approves it)

Exclusion Criteria:

* HIV-2 co-infection
* Hepatitis B Virus infection (positive HBs antigen)
* Any comorbidity potentially related to a life expectancy below 12 months
* Any condition (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere with trial protocol compliance, adherence and/or trial treatment tolerance
* Pregnant women or breastfeeding women
* Women of childbearing age that do not want to use an effective method of contraception
* Participant under justice protection
* Galactose/lactose intolerance, Lapp lactase deficiency or glucose/galactose malabsorption (known or documented)
* Participation to another clinical trial evaluating a new treatment/therapy
Effects of Saffron on Mild to Moderate Generalized Anxiety Disorder (GAD)

anxiety disorder is one of the major public health problems worldwide. 25% of people experience anxiety disorders throughout life. Generalized anxiety disorder (GAD) is known as the most prevalent anxiety disorder. Saffron has previously approved as an effective adjuvant therapy in depression and might alleviate GAD symptoms.Since up to the best of our knowledge no human studies have assessed the therapeutic effect of saffron as an adjuvant therapy in GAD patients, Therefore, this study is planned to evaluateThe effect of saffron (Crocus satious L.) in the treatment of mild to moderate generalized anxiety disorder:


Eligibility Criteria:
Inclusion Criteria:

* Patients who diagnosed with GAD according to DSM-V criteria, Hamilton score of 18-25

Exclusion Criteria:

* pregnancy and lactation
* receiving antipsychotic medications in a month prior to the recruitment
* suffered from other psychological disorders (e.g. bipolar disorder, schizophrenia, mood disorders), and drug abuse
Advance Targeted Transfusion in Anemic Cardiac Surgical Patients for Kidney Protection: A Proof of Concept Pilot Study

One of the major complications of heart surgery is kidney injury, which occurs in up to 30% of patients and is associated with poor outcomes including death. We have found that patients whose hemoglobin concentration before surgery is lower than normal (i.e., are anemic) are at particularly high risk for this complication, likely because their hemoglobin concentration drops to very low levels during surgery, which reduces delivery of oxygen to the kidneys, increases blood loss, and necessitates blood transfusions. We and others have shown that these events are individually harmful to the kidneys, and can lead to kidney injury. We believe that we can prevent these events from occurring, and as a result reduce the risk of kidney injury, if we transfuse anemic patients at least 1 day before surgery rather than during surgery.

In anemic patients undergoing cardiac surgery, prophylactic transfusion of red blood cells (RBCs) before surgery will reduce the risk of acute kidney injury (AKI) after surgery by mitigating three inter-related risk factors for AKI.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing non-emergent aortocoronary bypass (ACB) surgery, or valve surgery, combined ACB and valve, or aortic root repair requiring CPB with a preoperative Hb concentration between 100 and 120 g/L.

Exclusion Criteria:

* Any conditions that may limit the ability of patients to tolerate the intervention:
* Severe aortic or mitral valve stenosis
* History of congestive heart failure within 30 days of surgery or severe ventricular dysfunction (ejection fraction \< 30%)
* Severe (\> 60%) left main coronary artery stenosis or unstable angina within 30 days of surgery
Effects of Exercise and Education in Patients With Chronic Pain After Total Knee Replacement

The purpose of the study is to investigate whether a 12-week neuromuscular rehabilitation program (NEMEX-TJR) combined with pain neuroscience education (PNE) provides greater pain relief, improvement in physical function and quality of life than PNE alone in a population of patients with chronic pain after primary total knee arthroplasty.

Hypothesis: Rehabilitation involving neuromuscular training and PNE will provide greater pain relief, improved function and improved quality of life compared to PNE alone at the primary endpoint, which is follow-up 12months after the start of the treatment.

Osteoarthritis is considered the most frequent cause of disability and pain in the elderly population, and the knee joint is one of the joints most commonly affected.

End-stage osteoarthritis is often treated with knee replacement, and total knee arthroplasty is considered an effective treatment for pain relief and improved function. However, several studies have reported less favorable outcomes after total knee arthroplasty, and systematic reviews found chronic pain after total knee arthroplasty at 12 months post-operative in 13-17% of the patients and chronic pain rates at 2-7 years post-operative varying between 8-27%. No randomized controlled trials evaluating exercise and pain education treatments to patients with chronic pain after total knee arthroplasty exists, and this highlights the need for evidence-based knowledge of which treatment should be considered for this population.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 19-40
* Subjects with primary total knee arthroplasty due to osteoarthritis ≥ 12 months post-operatively
* For the index knee, duration of knee pain \> 6 months
* For the index knee, the average daily pain score ≥ 4 (moderate-to-severe pain) over the last week prior to visit on a numeric rating scale

Exclusion Criteria:

* Specific reasons for chronic pain, such as loosening of implant, which requires revision surgery
* Secondary causes of arthritis to the knee, e.g. rheumatoid arthritis
* Surgery (including arthroscopy) of the index knee within 3 months prior to visit
* Injury to the index knee within 12 months prior to visit
* Recent history of acute pain affecting the lower limb and/or trunk
* Participation in other pain trials two weeks prior to this study
* Pregnancy
* Drug and alcohol abuse
* Previous neurologic illnesses or primary pain area other than knee, e.g. lower back, upper extremity pain or rheumatoid arthritis
* Lack of ability to adhere to protocol
Effect of Sensory Adapted Dental Environment on Children's Behavior During Dental Treatment

The objective of the present study is to determine the effect of sensory adapted dental environment (SADE) in healthy children during a routine dental restorative treatment. The hypothesis is that the SADE would have a favorable effect in calming the subjects during dental treatment.

the study is a random cross-over design. The participants will be randomly assigned into two groups. Group 1 will initially be treated under SADE (Time 1) and receive regular dental environment (RDE) on the second encounter (Time 2). For the second group, the procedure is reversed (RDE at Time 1 and SADE at Time 2).

* Dental treatment- will include restorations, crowns, pulp treatment, with local anesthesia. The use of oral/inhaled sedation will be decided according to the patient's behavior and cooperation assessment.
* Dental settings- The SADE: the sensory stimuli addressed are visual and auditory, as follows: (i) Visual sensation. All ceiling fluorescent lighting are removed. The adapted lighting consisted of slow-moving, repetitive visual color effects created by a projector, in the child's visual field. (ii) Auditory stimuli include rhythmic music, which was heard via loudspeakers. The RDE utilized fluorescent lighting on the ceiling, without special visual effects and without music stimulation.
* Instruments- 1) the children will be observed during the treatments. The observer will code all behaviors according to the Houpt Scale used for rating patient behavior during treatment. In addition, the examiner will count the number and duration (in minutes) of the anxious behavior (crying and movements). Because of the nature of the study (one environment with sensory adaptation and the other without), the observer cannot be blind to the treatment environment. 2) Physiologic arousal states, evaluated by the assessment of EDA (Mindlife Co, Jerusalem, Israel). Changes in the electrical conductance of the skin are a sensitive way of monitoring autonomic responses to external stimuli.

Eligibility Criteria:
Inclusion Criteria:

* ASA1
* Needs at least 2 similar dental treatment appointments

Exclusion Criteria:

* Needs only one dental treatment
Relative Bioavailability and Effect of Food Study With an Oral Mini-tablet Formulation of Filgotinib in Healthy Subjects

Open label study to assess relative bioavailability of filgotinib oral mini-tablet versus oral tablet formulation and effect of food on the mini-tablet formulation.


Eligibility Criteria:
Key Inclusion Criteria:

* A body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
* Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be no greater than 1.5x upper limit of normal range (ULN) and total bilirubin not greater than ULN. Other clinical laboratory safety test results must be within the normal ranges or test results that are outside the normal ranges need to be considered not clinically significant in the opinion of the investigator.

Key Exclusion Criteria:

* Known hypersensitivity to filgotinib ingredients or history of a significant allergic reaction to filgotinib ingredients as determined by the investigator.
* Treatment with any medication (including over-the-counter (OTC) and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) in the last 2 weeks or 5 half-lives of the drug, whichever is longer, prior to the first dosing.