cyrilzakka/clinical-trials huggingface dataset:
Antibiotics for Delirium in Older Adults With No Clear Urinary Tract Infection

Delirium is an acute confusional state that is experienced by many older adults who are admitted to hospital. To treat delirium the underlying cause needs to be identified promptly, but this is challenging. One of the potential causes of delirium is infection. Urine tests show that most patients experiencing delirium have bacteria in their urine, however, bacteria in the urine is common among older adults, and does not automatically indicate an infection is present. As a result it is difficult to know whether a lower urinary tract infection is present as individuals with delirium are frequently unable to report clinical signs of infection - symptoms of pain or discomfort with urination, having to urinate more frequently or pelvic discomfort. Very often, individuals with delirium are treated with antibiotics despite the fact that it is unknown whether antibiotics help to improve delirium in cases where bacteria in the urine is present. This proposed study is a randomized controlled trial that will examine if adults (age 60 or older) with delirium and suspected infection benefit from taking antibiotics.


Eligibility Criteria:
Inclusion criteria

* Age ≥ 60 and admitted to a hospital ward (including rehabilitation hospital);
* Active delirium (defined by CAM: \[1\] inattention AND \[2\] acute and fluctuating level of consciousness, and either \[3\] disorganized thinking OR \[4\] altered mental status; OR physician's diagnosis)
* Less than 24 hours of antibiotics (prior to trial assessment)
* Either pyuria (defined as white blood cells detected on urinalysis or dipstick) or bacteriuria (defined as bacteria growing on urine culture)

Exclusion criteria

* Fever (temperature \> 37.9C or \> 100.2F) in the past 48 hours;
* Signs of lower urinary tract infection symptoms (such as new dysuria) or upper urinary symptoms (such as costovertebral tenderness)
* In the opinion of the treating physician, there is a reason apart from delirium and urine test results to treat with antibiotics (e.g., pneumonia)
* Indwelling urinary catheter for \> 72 hours
* Receipt of an antibiotic where a single dose suffices for the treatment of a UTI (such as Fosfomycin)
Physical Therapy Versus Internet-Based Exercise Training for Patients With Knee Osteoarthritis

The purpose of this study is to examine the effectiveness of standard physical therapy and an internet-based exercise program for people with knee osteoarthritis (OA). Both of these programs will be compared to a "waiting list" control group. The investigators hypothesize that both treatments will result in greater improvement than the control condition and that the treatments will be similarly effective. The investigators also expect that some patients may do better with one treatment type or another and will explore this.


Eligibility Criteria:
Inclusion Criteria:

* Knee Osteoarthritis

Exclusion Criteria:

* no internet access
* rheumatoid arthritis, lupus, or any other rheumatic condition
* severe fibromyalgia
* gout in your knees
* on a waiting list for joint replacement surgery, or are you planning to have joint replacement surgery during the next year
* total knee replacement surgery, other knee surgery, a torn meniscus in your knee, or a torn ACL in your knee during the past 6 months
* hospitalized for a stroke, heart attack, heart failure, or had surgery for blocked arteries in the past 3 months
* currently undergoing physical therapy for knee OA
* meeting current recommendations for physical activity levels
* participating in another interventional study related to knee osteoarthritis or a study that involves physical activity
The URT and Middle Ear Microbiota in Health and During Chronic OME

This study analyses which bacteria are present in the middle ear space and adjacent upper respiratory tract niches in healthy people and in patients suffering from chronic otitis media with effusion (OME; glue ear). The aim is to identify and isolate bacteria that are more common and more abundant in healthy people and to evaluate their potential to protect against bacteria commonly involved in OME and other upper respiratory tract infections.

To this end, samples will be collected from both groups (healthy vs OME) and analysed through sequencing of the bacterial 16S gene. In addition, samples obtained from healthy participants will be cultivated to isolate bacteria of interest.


Eligibility Criteria:
Inclusion Criteria:

* Controls: undergo a surgery that gives access to the middle ear space (at least 30 participants; e.g. cochlear implant recipients) or the adenoids.
* OME patients: have fluid accumulation in the middle ear space for 3+ months and receive ventilation tubes. May also undergo adenoidectomy.

Exclusion Criteria:

* Acute upper respiratory tract infections (including acute otitis media)
* Chronic upper respiratory tract infections (except OME in patient group)
* URT malformations (e.g. as seen in people with Down Syndrome or cleft palate)
* Cystic fibrosis
* Autoimmune diseases or immunodeficiency
* Pregnancy
* Use of antibiotics or steroids 1 week before surgery
A Study of 2 Doses of MAP0010 in Adult Asthmatics

The purpose of this study is to examine the blood levels of two doses of MAP0010 (a corticosteroid) and two doses of an approved corticosteroid in adult asthma and safety with twice daily dosing over 7 days.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adult asthmatics with mild to moderate persistent asthma.
* 18 to 45 (up to the 46th birthday) years of age.
* Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH/NHLBI, EPR-3 criteria.
* Able to withhold short-acting bronchodilators (e.g., albuterol or ipratropium bromide) for at least 4 hours prior to clinic visits.
* Baseline FEV1 greater than or equal to 50% of predicted normal.

Exclusion Criteria:

* Any other significant illness/abnormality
* A history of upper or lower respiratory tract infection within 2 weeks
* A history of acute or severe asthma attack requiring ICU admission or ventilatory support.
Extension to Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

Buprenorphine (BPN) is an approved treatment for opioid dependence; however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood are low. Probuphine (buprenorphine implant) is an implant placed just beneath the skin that contains BPN. It is designed to provide 6 months of stable BPN blood levels. This study will test the safety and efficacy of Probuphine in the treatment of patient with opioid dependence. Patients who have completed 24 weeks of treatment in the Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients with Opioid Dependence, will be re-treated with Probuphine over an additional 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily provide written informed consent prior to conduct of any study-related procedures
* Completed 24 weeks of treatment in PRO-805
* Deemed appropriate for entry into this extension study by the Investigator
* Females of childbearing potential and fertile males must use a reliable means of contraception

Exclusion Criteria:

* Presence of aspartate aminotransferase (AST) levels ≥ 3 X upper limit of normal and/or alanine aminotransferase (ALT) levels ≥ 3 X upper limit of normal and/or total bilirubin ≥ 1.5 X upper limit of normal and/or creatinine ≥ 1.5 X upper limit of normal
* Current diagnosis of chronic pain requiring opioids for treatment
* Pregnant or lactating females
* Current use of agents metabolized through cytochrome P450 3A4 (CYP 3A4) such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), and protease inhibitors (e.g., ritonavir, indinavir, and saquinavir)
* Current anti-coagulant therapy (such as warfarin) or an INR \> 1.2
* Current use of benzodiazepines other than physician prescribed use
* Significant medical or psychiatric symptoms, cognitive impairment, or other factors which in the opinion of the Investigator, would preclude compliance with the protocol, patient safety, adequate cooperation in the study, or obtaining informed consent
* Concurrent medical conditions (such as severe respiratory insufficiency) that may prevent the patient from safely participating in study; and/or any pending legal action that could prohibit participation and/or compliance in study
Heart Rate Variability and Postoperative Pain

Postoperative pain stimulates the autonomic nervous system, induces the production of pro-inflammatory substances, reduces patient mobility and impairs vital functions. The ECG spectral analysis (ECGs) is a non-invasive marker of the autonomic nervous system state. To our knowledge, the correlation between the sympathovagal activity quantified by a non invasive method and the postoperative pain, has not been studied before.

* Principal Objective : 1)To quantify postoperative pain by the ECGs technique. 2) To compare the ECGs parameters with the visual analog pain scale (VAS) results.
* Secondary Objective : To determine the influence of preoperative chronic pain and pathophysiological profiles on the correlation between postoperative ECGs and VAS.
* Study design : An observational, prospective, single arm, single center study.
* Inclusion criteria : ¨Patients over 18 years old scheduled for surgery under general anesthesia. Patients capable of using the visual analog pain scale.
* Exclusion criteria : Pregnancy or breast feeding, impossibility to obtain an informed consent, incapacity to follow all the study schedule. Patient not protected by social security, patient likely to present hypovolemia or severe hemodynamic instability. Patient with a dysautonomia characterized by orthostatic hypotension, patients with cardiac disarrhythmias, likely to interfere with the ECG and/or the spectral analysis of ECG.
* Study plan: Patients will sign their informed consent during the V0 visit (preoperative). During V0, HF and LF (ECGs parameters) will be measured as well as the VAS-estimated pain. These results, medical history, concomitant diseases and medications will be reported in a case report form (CRF). The second and last visit, V1, takes place 1 hour after the patient wakes up, in the postoperative period. ECGs and VAS evaluation will be achieved in the same manner as the V0 visit. The only difference is that the measurements will be repeated to obtain a total of 5 data couples over 2 hours. These Intrapatient estimations will be used to improve statistical ECGs vs VAS correlation analysis.
* Number of subjects : 100

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old scheduled for surgery under general anesthesia.
* Patient able to use the visual analog pain scale

Exclusion Criteria:

* Pregnancy or breast feeding
* Impossibility to obtain an informed consent
* Incapacity to follow all the study schedule
* Patient not protected by social security
* Patient likely to present hypovolemia or severe hemodynamic instability
* Patient with a dysautonomia characterized by orthostatic hypotension
* Patient with cardiac disarrhythmias, likely to interfere with the ECG and/or the spectral analysis of ECG
Trial of JYB1904 in Patients With Allergic Asthma

This phase IIa trial is meant to evaluate the pharmacokinetics, pharmacodynamics and safety of JYB1904 in patients with allergic asthma.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent voluntarily;
* Aged 18-75 years, weight ≥ 40 kg, male or female;
* Diagnosed Allergic asthma.

Exclusion Criteria:

* Prior exposure to anti-IgE therapy within 1 year;
* Allergic to anti-IgE biologics;
* Current smokers, or quit smoking within 1 year;
* Combined with other non-allergic diseases that cause IgE elevation；
* History of malignancy, autoimmune diseases, Immune complex mediated diseases, Hypereosinophilic syndrome;
* Other conditions unsuitable for the trial judged by the investigator.
Femoral Nerve Block for Analgesia After Anterior Cruciate Ligament Reconstruction

Femoral nerve block using 0.25% bupivacaine or 0.5% bupivacaine provides a longer time for analgesia after Anterior Cruciate Ligament (ACL) reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for ACL reconstruction
* ASA physical status I-II
* Body weight \> or = 50 kg.

Exclusion Criteria:

* Patients with redo ACL reconstruction
* Contraindication to neuraxial block
* allergy to local anesthetics, sulfa, NSAIDs, morphine, paracetamol
* Patients with communication problem
Human Amniotic Epithelial Cells for Asherman's Syndrome

This project aims to investigate the safety and effectiveness of human amniotic epithelial cells in the treatment of the severe refractory Asherman's syndrome.

Asherman's syndrome is a gynecological disorder caused by the destruction of the endometrium due to repeated or aggressive curettages and/or endometritis. As a result, there is a loss of functional endometrium in multiple areas and the uterine cavity is obliterated by intrauterine adhesions, which results in amenorrhea, hypomenorrhea, infertility and recurrent pregnancy loss. Transcervical resection of adhesion (TCRA) is the main treatment for Asherman's syndrome, so far the effect is usually poor in moderate to severe refractory cases.

Human amniotic epithelial cells (hAECs) are derived from human amniotic epithelium. hAECs retain the characteristics approximating to embryonic stem cells. Animal experiments have shown that the endometrial thickness and fertility of mice were significantly improved after intrauterine therapy with amniotic epithelial cells. To further explore the role of hAECs in Asherman's syndrome patients, this project plans to evaluate the safety of hAECs provided by Chongqing iCELL Biotechnology Co.,Ltd., which is a subsidiary of Shanghai iCELL Biotechnology Co.,Ltd., and find an effective treatment protocol.

Eligibility Criteria:
Inclusion Criteria:

* 1. Hysteroscopy examination confirms intrauterine adhesions, II -III according to the American Fertility Society (AFS) classification of uterine adhesions;
* 2. Regular Menstrual cycles and menstruation is normal before abortion or curettage;
* 3. Having a clear desire to fertility;
* 4. Normal blood coagulation, liver, heart, and kidney function, absence of HIV, Hepatitis B or C, syphilis and psychiatric pathology;
* 5. Serum β-hCG is negative;
* 6. Be willing to complete the study and sign the consent form.

Exclusion Criteria:

* 1. Having a history of malignant tumor;
* 2. Having other uterine diseases, such as, uterine fibroids, adenomyosis and uterine malformations;
* 3. Hysteroscopic adhesiolysis more than 3 times in the past;
* 4. Absence of peripheral vein access.
Treatment of Rheumatoid Hand With Magnetotherapy

Brief Summary:

Participants with rheumatoid arthritis with recommendation to physiotherapy.

Created 2 study groups:

1. Kinesiotherapy with static magnetic field
2. Kinesiotherapy with low-frequency pulsed magnetic field

Pulsed magnetic field give better effects then static magnetic field.

Participants with rheumatoid arthritis with recommendation to physiotherapy. All participants have dysfunction and pain of hand. Before entering the study, all patients were examined by a rheumatologist, who determined the degree of radiological and functional changes and measured blood pressure. Patients with II° and III° of radiological and functional changes were qualified for the study. All the patients gave their informed consent to participate in the study. The examination included an overall assessment of functional status. Patients were examined immediately before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Informed voluntary consent to participate in the study
2. II ° and III ° of advancement of radiological changes
3. II ° and III ° of advancement of functional changes
4. Remission, low or moderate RA activity: DAS28
5. Medical referral for physiotherapy treatment

Exclusion Criteria:

1. Additional physiotherapy treatments for the hands
2. Contraindications for magnetotherapy treatments
3. Lack of informed, voluntary consent to participate in the study
Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3

Primary objective:

To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (AD).

Secondary objectives:

To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, and health-related quality of life compared with placebo in combination with TCS.

To assess the safety of tralokinumab in combination with TCS when used to treat moderate-to-severe AD for 32 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above.
* Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
* History of AD for ≥1 year.
* Subjects who have a recent history of inadequate response to treatment with topical medications.
* AD involvement of ≥10% body surface area at screening and baseline.
* Stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.

Exclusion Criteria:

* Subjects for whom TCS are medically inadvisable e.g., due to important side effects or safety risks in the opinion of the investigator.
* Active dermatologic conditions that may confound the diagnosis of AD.
* Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
* Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to randomisation.
* Treatment with TCS, topical calcineurin inhibitors (TCI), or topical phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks prior to randomisation.
* Receipt of any marketed biological therapy (i.e. immunoglobulin, anti- immunoglobulin E) including dupilumab or investigational biologic agents within 3 months or 5 half-lives, whichever is longer prior to randomisation.
* Active skin infection within 1 week prior to randomisation.
* Clinically significant infection within 4 weeks prior to randomisation.
* A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
* Tuberculosis requiring treatment within the 12 months prior to screening.
* Known primary immunodeficiency disorder.
Transdiagnostic Behavioral Therapy for Anxiety and Depression in Autistic Adolescents

This study tests the effectiveness of a transdiagnostic cognitive behavioral therapy for autistic youth with anxiety and/or depression.

About 1 in 54 adolescents are estimated to be on the autism spectrum, with over half suffering from anxiety or depressive disorders. These disorders contribute to suicidality, family stress, social impairments, and difficulties transitioning to adulthood among autistic youth. Given the frequency of anxiety and depressive disorders among autistic adolescents and the increased risk of impairment, developing effective treatments for anxiety and depression tailored to this population is a top priority.

Transdiagnostic cognitive behavioral therapy (CBT) for other populations, including typically developing adolescents, may confer broader benefits than disorder-specific CBT and facilitate broader dissemination and implementation. However, there has been little research conducted on transdiagnostic treatments among autistic adolescents. Thus, this study proposes to address this gap by testing transdiagnostic CBT for autistic adolescents with anxiety and depression.

The study involves two phases: 1) a pilot intervention; and 2) a randomized controlled trial.

The pilot intervention will involve 12 adolescent-caregiver dyads to further refine the treatment model and its assessment measures. The randomized trial will involve 100 adolescent-caregiver dyads to further evaluate the clinical efficacy of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Child is between the ages of 12-17 at consent/assent.
* The child meets criteria for autism spectrum disorder using evidence-based assessment approaches (e.g., Autism Diagnostic Observation Schedule-Second Edition; Childhood Autism Rating Scale-Second Edition).
* The child meets criteria for clinically significant anxiety and/or depression symptoms based on elevated scores on the Pediatric Anxiety Rating Scale modified for Autism Spectrum Disorder (\>11) and/or the Children's Depression Rating Scale-Revised (\>39).
* Anxiety/depressive disorder is the primary presenting problem as determined by administration of the Mini International Neuropsychiatric Interview
* One parent/guardian is able and willing to participate.
* The parent/guardian is 18 years or older.
* Both parent and child can read and/or understand English.
* Both parent and child reside in Texas.

Exclusion Criteria:

* The child has a diagnosis of psychotic disorder and/or conduct disorder.
* The child has severe suicidal/homicidal ideation and/or self-injury requiring immediate intervention and/or a higher level of care.
* The child has limited verbal communication abilities.
* The child is receiving concurrent psychotherapy for anxiety/depression.
* The child has initiated psychotropic medications within 12 weeks of assessments (or 4 weeks for stimulants/benzodiazepines) or during therapy, and/or has changed dosage of psychotropic medication within 6 weeks of assessment (or 2 weeks for stimulants/benzodiazepines) or during therapy.