cyrilzakka/clinical-trials huggingface dataset:
Directed Topical Drug Delivery for Treatment for PASC Hyposmia

This is a phase II randomized, double-blinded, placebo-controlled study to evaluate the efficacy of topical intranasal treatment of beclomethasone vs. placebo for improved olfactory function.

Eligible participants are randomized to receive either Beclomethasone or placebo intranasally via a microsponge twice on day 1 and day 14. Study duration is three months and includes 4 in-person study visits: 2 visits for drug administration at Baseline and Week 2, and 2 follow-up visits at Week 6 and Week 18. Participants will be expected to complete the Smell Identification Test (SIT) and Questionnaire on Olfactory Disorders (QOD) at baseline, Week 6, and Week 18. The investigator hypothesizes that the application of beclomethasone directly in the nasal cavity will result in improved olfactory function.

Eligibility Criteria:
Inclusion Criteria:

* Post-COVID hyposmia lasting greater than 3 months following COVID19 by history
* Male or female, aged 18 years or older

Exclusion Criteria:

* Pregnancy or lactation
* Known allergic reactions to components of microsponge (including shellfish) or to beclomethasone
* Known diagnosis of glaucoma
* Febrile illness within 1 week
* Treatment with another investigational drug or other intervention within 3 months
* Active sinonasal disease by nasal exam, i.e. rhinosinusitis, nasal polyps
* Adults unable to consent
* Prisoners, employees or subordinates
* Individuals who are not yet adults (infants, children, teenagers)
Pyridoxal Kinase Activity in Tardive Dyskinesia

Objectives: The mechanisms of tardive dyskinesia (TD) remain unclear, although pathophysiologic theories have proposed mechanisms such as dopamine receptor supersensitivity, the degeneration of cholinergic striatal interneurons, γ-aminobutyric acid (GABA) depletion, and an excess of free radicals.

Prior development of second generation antipsychotic agents, tardive movement disorders were widespread among neuroleptics treated patients. There were great expectations of the new novel drugs. Unfortunately, reports about tardive movement disturbances induced by these medications became more and more frequent, although it has been in use for less than two decades.

A recent study demonstrated that schizophrenic and schizoaffective patients suffering from TD had the mean level of pyridoxal 5'-phosphate (PLP) below lower limit of normal range, while those patients without TD had normal values. At the same time, some open and double-blind placebo-controlled, randomized clinical studies showed that vitamin B6 was very effective in treatment of TD.

Pyridoxal kinase is a key enzyme for the biosynthesis of PLP, the biologically active form of vitamin B6. Some publications reported that the finding of high vitamin B6 levels is consistent with recent reports of low levels of PLP and low activity of pyridoxal kinase. It may explain the functional need for high-dose vitamin B6 supplementation in subjects with TD.

Methods: A multicenter study including 300 schizophrenia and schizoaffective subjects will be performed. The trial will be consisted of 2 parts: the first part a single comparison pyridoxal kinase plasma activity in patients with and without TD; in the second part only TD schizophrenia and schizoaffective patients will continue. It will be a 12-week, randomized, double-blind placebo-controlled trial. Vitamin B6 (1200 mg/day) or placebo capsules will be added to the stable ongoing antipsychotic treatment of 150 schizophrenia patients. Participants will be assessed at baseline and after every 2 weeks of treatment till week 12. Pyridoxal kinase activity will be compared between patients who positively respond to vitamin B6 versus non responders. In addition, PLP levels will be monitored at baseline and at the end of the study.

A battery of research tools will be used for assessment of movement disorders, psychopathology, and side effects. The study will be performed along a period of 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Inpatients
* DSM-IV diagnosis of schizophrenia or schizoaffective disorder with and without tardive dyskinesia (TD)
* Total ESRS score should be more than 20 in subjects with TD
* Ability to provide a written informed consent

Exclusion Criteria:

* Patients with concurrent medical illness or any movement disorder resemble TD
* Patients who received any vitamin medication
* Evidence of substance or alcohol abuse or a family history of movement disorder.
* Pregnancy and/or lactation.
Feasibility and Reproducibility of T1 Rho MRI in the Evaluation of Hip Cartilage

Hip osteoarthritis is a frequent and invalidating disease. Early detection of cartilage modifications could provide better patient treatment. The T1rho MRI sequence allows the quantification of the cartilage signal that is correlated to modifications of the cartilage matrix, notably of the proteoglycans. The primary objective is to evaluate normal values of hip cartilage in vivo using T1rho MRI in healthy subjects and the reproducibility of the measurements. T1rho and T2 mapping sequences were acquired twice during the same session with 30 minutes interval to see if values were modified after a 30 minutes delay in a supine position. The secondary objective was to assess the correlation between T1rho and T2 values.


Eligibility Criteria:
Inclusion Criteria:

* BMI \<30
* Accepting to participate in the study and signed the written informed consent
* Covered by a health insurance system

Exclusion Criteria:

* Pregnant woman or risk of pregnancy
* MRI contraindication
* Protected adults
* Language barrier
* Previous or current hip pain
Dose of Hepatitis B Vaccines in Non/Low-response Populations

An interventional study will be performed in subjects aged 1-65 years old to evaluate effects of different doses of hepatitis B vaccines in low or non-response population.

A randomized clinical study will be conducted to evaluate effects of different doses of hepatitis B vaccines in low or non-response population in China. 650 low or non-response subjects after hepatitis B vaccination will be enrolled under the premise of informed consent. 200 subjects aged 1-17 years will be divided into 3 groups and 450 subjects aged 18-65years will be divided into 4 groups. Group 1/2/3 will receive 3 doses of vaccine on day 0,30 and 180, with 5ug/10ug/20ug HBs-Ag respectively. Group 4 will receive 1 dose of vaccine with 60ug HBs-Ag, low or nonresponse subjects of which will receive the second dose by an interval of at least 28 days. All vaccinations will be done by specific study personnel, who do not take part in the assessment of safety or immunogenicity. Adverse events will be recorded after vaccination and blood samples were collected at day 30 after each vaccination for antibody detection.

The clinical program approved by the ethics committee will be performed by the researchers independently. Inspectors designated by the sponsor will take meticulous on-site audits to ensure the safety specifications during the whole process of research.

Eligibility Criteria:
Inclusion Criteria:

* aged 1-65 years old
* male or non-pregnant female volunteers
* provide written informed consents before joining the trial
* clinically healthy as determined by: medical history inquiring and physical examination
* negative for HBsAg,HBsAb,HBcAb,HBeAg,HBeAb within the past 1 year

Exclusion Criteria:

* No history of hepatitis B vaccine
* receipt of immunoglobulin within the past 1 month
* allergic to any ingredient of vaccine
* history of serious side effects, such as allergies, hives, breathing difficulties, angioedema or abdominal pain
* severe acute and chronic diseases
* autoimmune disease or immune deficiency
* axillary temperature \> 37.0 ℃ over the time of vaccination
Glutamate and Diastolic Function in Patients Undergoing Aortic Valve Repair

Purpose: The effect of intravenous glutamate infusion on myocardial diastolic function and overall hemodynamics were studied in patients undergoing elective aortic valve replacement with severe aortic stenosis and associated left ventricular hypertrophy .

Methods: 25 patients will be included in this double-blind randomized placebo-controlled study. Glutamate was administered intravenously immediately after aortic cross-clamp release. The patients receive either a low dose of 30mg kg-1 h-1 (LG-group) or high dose of 60 mg kg-1 h-1 (HG-group) or placebo (P-group) at a rate of 3.3ml kg-1h-1 for 2h. Transesophageal echocardiography (TEE) is used to measure diastolic and systolic ventricular function before sternotomy (T0), and 2h (T2), 3h (T3) and 6h (T4) after release of cross clamp. Additionally routine hemodynamic parameters are measured intraoperatively.


Eligibility Criteria:
Inclusion Criteria:

* severe aortic stenosis
* left ventricular hypertrophy of more than 10mm IVS thickness
* normal ejection fraction
* SR

Exclusion Criteria:

* moderately or severely reduced systolic left ventricular function (ejection fraction \<30%)
* atrial fibrillation or flutter
* intolerance to glutamate.
Pediatric Oncology Recovery Trial After Surgery

Pediatric Oncologic Recovery Trial After Surgery (PORTS) trial is an investigator-initiated, multicenter, multidisciplinary prospective case-control study of the implementation of an Enhanced Recovery After Surgery (ERAS) protocol at five tertiary-care pediatric hospitals in pediatric patients undergoing abdominal or retroperitoneal surgical resections for cancer. A pilot phase will determine characteristics of a successful protocol implementation and an exploratory phase plans to examine adherence, objective patient outcomes, and patient-reported outcomes. After completing primary enrollment, this collaborative will continue to enroll patients in the shared data registry and continue to refine the underlying ERAS protocol developed for this project.

Two arms:

Historical patients ERAS patients

Number of patients: 288

Primary outcome

· Number of 90-day complications by Clavien-Dindo classification

Secondary outcome(s):

* Adherence to ERAS protocol items with # of items achieved (out of 20)
* Length of stay
* Re-admissions within 90 days
* Re-operations within 90 days
* Number of visits to the emergency room within 90 day period
* Minimum, mean, maximum daily pain score during first 7 days after surgery
* Mean daily IV morphine equivalents (mg/kg) usage during first 7 days after surgery

  * recurrence free survival (months)
  * overall survival (months)

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing operations at a pediatric hospital setting aged 1 month or older
* Parents of patients undergoing operations at pediatric hospital settings aged 1 month or older
* Undergoing urologic reconstruction, ureteral operations, pyeloplasty, intraabdominal on-cologic resections, urachal remnant excision, bariatric operations, pectus surgery, ap-pendicitis, orthopedic or neurosurgical operations and inflammatory bowel disease proce-dures
* Providers of patients undergoing surgery in pediatric settings

Exclusion Criteria:

* Less than 1 month in age
Awareness of Chinese National Adult Lipid Treatment Guideline (2007) and Rate of Patients Achieving the Treatment Goal

This study is designed to survey the awareness rate of Chinese National Adult Lipid Treatment Guideline (2007) by cardiologists; To survey the control rate of the patients with dyslipidemia in "real world"; and to evaluate the percentage of hyperlipidemia patients who achieved target LDL-C level according to the Chinese National Adult Lipid Treatment Guideline (2007) following 8-week treatment by Crestor® 5mg or 10mg


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as dyslipidemia by doctors
* Having lipids test and record within one months
* Diagnosed as hypercholesterolemia or mixed dyslipidaemias and has been prescribed Crestor® 5mg or 10mg

Exclusion Criteria:

* Unable or unwilling to provide the Inform Consent
Xanthohumol and Viral Infections (XL)

The aim of the present study is to determine if a regular oral supplementation of xanthohumol attenuate the severity of symptoms and duration of´viral infections.

In this placebo-controlled study, blood is taken on the first day of the study, followed by a 90-day intervention with xanthohumol or a placebo, which is taken twice daily. Blood samples will be taken on day 0, day 45 and day 90. Should the study participants develop a respiratory infection during the study, they will be asked to perform a self-test.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* BMI \>18 kg/m² or \< 28kg/m²

Exclusion Criteria:

* food intolerances
* food allergies
* chronic inflammatory diseases
* metabolic diseases
* viral or bacterial infections within the last 3 weeks of inclusion
* intake of immunosuppressive medication
* severe acute respiratory syndrome coronavirus type 2-infection in the last 4 months
* influenza infection in the "current" flu season
Data Collection for Prediction of Postoperative Chronic Pain for a Software

Postoperative Persistent Pain (PPP) is reported with a high incidence in adults 11.5-47%. This high incidence effects quality of life of patients causes social-economical problems and arises medico-legal issues. This study will be undertaken for producing a database by the evaluation of surgeries in 4 hospitals located in Istanbul. This database will be used in establishing a software by using data mining technology in the prediction of PPP

All cases operated in 4 different hospitals in one month period will be included Exclusion criteria: cases who could not be followed up to 2 months postoperatively by telephone call.

A questionnaire will be filled preoperatively for each case after obtaining informed case . All cases will be anesthetized and pain therapy will be applied according to anesthesiologist's own practice and pain relief will be evaluated and noted. All patients will be telephoned postoperatively for the pain level at 15,30,45 and 60th day. All the information will be uploaded to computer and a software will be prepared for prediction of postoperative chronic pain.

Eligibility Criteria:
Inclusion Criteria:

* all cases operated in one month period

Exclusion Criteria:

* cases who cannot be followed for 2 months
Blood Flow Restriction Training Following Total Knee Arthroplasty

This study will evaluate blood flow restriction training as a rehabilitation modalities following total knee arthroplasty in order to determine if patient reported outcomes and objective functional outcomes can be improved through post-operative rehabilitation compared to standard physical therapy modalities currently in use.

Patients will be enrolled preoperatively in order to measure preoperative functional measures. They will then be followed at predetermined intervals post-operatively. All subjects will begin the study related physical therapy 6 weeks post-operatively and continue for 12 sessions. At the conclusion of 12 sessions, subjects will be retested to determine improvement. Subjects will then be followed for two years post-operative.

Eligibility Criteria:
Inclusion Criteria:

* S/p primary Total Knee Arthroplasty and cleared by surgeon for continued physical therapy
* Males and females 50-79 years of age
* Ability to consent to study enrollment
* Able to participate fully in physical therapy
* Tricare Beneficiary
* Implant restricted: primary cruciate retaining or posterior stabilized total knee arthroplasty
* Knee range of motion of surgical extremity from a minimum of 5 degrees from full extension to 90 degrees of flexion\*\*

  * only screened at secondary screening

Exclusion Criteria:

* Unable to consent for study participation
* Unable to participate in preoperative testing
* Any ligamentous or bony reconstruction performed at time of surgery that limits weight bearing or rehabilitation protocol
* History of deep venous thrombosis
* Injury or recent procedure to contralateral extremity within past 6 months
* History of endothelial dysfunction
* History of Peripheral Vascular Disease
* Patient endorsement of easy bruising
* Revision Total Knee Arthroplasty
* History of Surgical wound complication on involved extremity
* History of Cerebral Vascular Event
* History of Dementia
* History of Neuromuscular disorder
* History of Chronic Obstructive Pulmonary Disease requiring oxygen supplementation or limiting participants ability to perform therapy and/or testing
* History of previous intra-articular fracture of surgical extremity requiring open reduction and internal fixation or external fixation
* History of Sickle cell trait and/or disease
* Previously participated in blood flow restriction training interventions
* Planned or unplanned additional surgical procedures affecting their ability to complete all session of physical therapy or testing during the following 6 months from their primary intervention
* Patient reported history of functionally limiting arthritis in non-surgical lower extremity or ipsilateral hip or ankle
* History or previous contralateral total knee arthroplasty
* Any history of previous total hip arthroplasty
Therapeutic Drug Monitoring (TDM) of Voriconazole and Correlation With CYP2C19 Genotype in Korean Populations

Voriconazole (VCZ), the antifungal drug active against Candida and Aspergillus is a substrate of CYP2C19, whose proportion of poor metabolizers is about \~20% in Asian population. The AUC's of VCZ differs over 4 folds by CYP2C19 genotypes of homozygotic wild type, heterozygote, and homozygotic poor metabolizers. The Asian population enrolled in the metabolism of VCZ were mainly Japanese and Chinese, without Korean subjects. The proportion of poor metabolizers in Korean population is known to be around 12% (Pharmacogenetics. 1996 Dec;6(6):547-51). The importance of CYP2C19 genotypes on the pharmacokinetics (PK) of voriconazole is well established, Hence, it is desirable to individualize the dosage regimen of VCZ according to the genotypes of patients. Fungal infection in immunocompromised patients is a life threatening condition which needs critical care. Although the PK change by genotypes are well known, its clinical implication or need for different dosage regimen by genotypes is not established, yet.

The investigators are trying to set up voriconazole (VCZ) therapeutic drug monitoring (TDM) \& establish relationship with efficacy and safety in Korea. The investigators also want to propose the optimal dosage regimen for VCZ over different genotypes of CYP2C19 in the immunocompromised patients in Korea.

Eligibility Criteria:
Inclusion Criteria:

* Immunocompromised adults who are treated with voriconazole due to proven or probable invasive fungal infections

Exclusion Criteria:

* Patients who have been treated with other investigational drugs
* Patients with liver dysfunction (aminotransferase level ≥ 5 times the upper limit of normal, bilirubin or alkaline phosphatase level \> 3 times the upper limit of normal)
* Patients with renal dysfunction (Cr level \> 2.5 times the upper limit of normal)
* Pregnant women
* Patients younger than 15 years of age
Quantiferon-TB Gold in the Assessment of Latent TB in Patients Candidate to Treatment or Treated With TNFα Antagonists

The purpose of this study is to evaluate the value of Quantiferon-TB Gold (QFT-G) assay in the screening for latent tuberculosis infection (LTBI) in rheumatologic patients due to start or on treatment with TNFα antagonists. The results of QFT-G will be compared to tuberculin skin testing (TST) and correlated to clinical and demographic data. The study hypothesis is that the inclusion of QTF-G in the screening strategy will allow a more accurate assessment of LTBI infection.

Treatment with TNFα antagonists is associated with an increased risk of active tuberculosis. Screening for LTBI and adherence to published guidelines have been shown to greatly decrease the risk of active tuberculosis. However, the best screening strategy is still object of debate. The validity of TST in patients on immunosuppressive treatment has been questioned. Recently, interferon-γ assays based on RD1-specific antigens have shown to cause less confounding by BCG vaccination and from most non-tuberculosis mycobacteria than TST, and have shown improved accuracy over TST in several settings. However, data on their use in rheumatologic patients are limited, and their superiority in patients on immunosuppressive treatment is unclear since indeterminate results may limit their clinical usefulness in this setting.

Purpose of the study is to investigate the added value of the inclusion of QTF-G assay in the screening strategy of LTBI in rheumatologic patients before and during treatment with TNFα antagonists.

The study will compare the results of TST with the results of QFT-G assay in rheumatologic patients being evaluated for treatment with anti-TNFα agents or already on treatment with anti-TNFα agents. The rate of positive and negative results of the two test will be compared, end results correlated to clinical and demographic variables.

Eligibility Criteria:
Inclusion Criteria:

* Patients with rheumatological diseases being evaluated for treatment with TNFα antagonists or on treated with TNFα antagonists

Exclusion Criteria:

* Unable to sign informed consent
* Known hypersensitivity to tuberculin
Automatic Stop Orders for Urinary Catheters

Urinary tract infections are the most common type of hospital-acquired infection. The majority of these infections result from the use of indwelling urinary catheters. Often caregivers leave them in unnecessarily. The purpose of this study is to assess the effectiveness of an automatic stop order (automatic removal or urinary catheters when they no longer needed) in reducing urinary infections.

We will randomize patients with urinary catheters to either automatic stop orders or to usual care. The primary outcome will be urinary tract infection. Secondary outcomes will include days of indwelling urinary catheterization, symptomatic urinary tract infection, isolation of antimicrobial-resistant bacteria from catheterized urine, antimicrobial use, bacteremia (blood-stream) infection secondary to urinary tract infection, and cost. We hypothesize that use of the automatic stop order will significantly reduce hospital-acquired urinary tract infection.

Eligibility Criteria:
Inclusion Criteria:

* Urinary catheter for less than 48hrs

Exclusion Criteria:

* Patient with symptomatic urinary tract infection
* Latex allergy