cyrilzakka/clinical-trials huggingface dataset:
Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19

Low radiation doses produce anti-inflammatory effects, which may be useful in the treatment of respiratory complications of COVID-19. This type of treatment is non-invasive and therefore, a priori, it can be used in all types of patients.

Main objective: To evaluate the efficacy of low-dose lung irradiation as an adjunctive treatment in interstitial pneumonia in patients with COVID-19 by improving the PAFI O2 by 20% measured 48h after treatment with respect to the pre baseline measurement. -irradiation.

Study design: This is a prospective multicenter study in 2 phases:

1. Exploratory phase. It will include 10 patients, to assess the feasibility and efficacy of low-dose lung irradiation. If a minimum efficiency of 30% is not achieved, the study will not be continued.
2. Comparative phase in two groups, a control group, which will only receive pharmacological treatment, and an experimental one. It will include 96 patients, the allocation will be 1: 2, that is, 32 in the control arm and 64 in the experimental arm, which will receive low-dose lung irradiation.

Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years old
* Moderate to severe COVID-19 pneumonia with fewer than 8 days of symptom onset and currently receiving standard medication for COVID-19 at appropriate doses
* PAFIO2 of less than 300 mmHg or SaFI02 \<315 mmHg
* Patients who are not candidates for admission to the Intensive Care Unit due to age, concomitant diseases or general condition.
* One of the following conditions:

  * or IL6 greater than 40
  * or PCR\> 100mg / l

    * D-dimer greater than 1500ng / ml
    * Suspected cytokine release syndrome
* Have read the information sheet and signed the informed consent

Exclusion Criteria:

* Age \<18 years
* Failure to meet the inclusion criteria
* Leukopenia \<1000
* Pregnancy
* Not understanding or refusing the purpose of the study
Effects of Esketamine at Subanesthetic Dose on Emergence Delirium in Preschool Children Undergoing Ambulatory Laparoscopic Surgery

Emergence delirium (ED) is a manifestation of acute postoperative brain dysfunction that occurs with a relatively high frequency after pediatric anesthesia. The incidence varies depending on the diagnostic criteria used and the combination of administered anesthetic drugs. The goal of this clinical trial is to investigate whether a subanesthetic dose of esketamine can reduce incidence of ED.


Eligibility Criteria:
Inclusion Criteria:

1. laparoscopic inguinal hernia repair under general anesthesia
2. aged 24\~71 months
3. American Society of Anesthesiologists Physical Status I or II
4. body mass index for age between the 5th and 85th percentiles

Exclusion Criteria:

1. allergy to esketamine
2. abnormal liver or kidney function
3. glaucoma or neurological disorders
4. cardiovascular or endocrine dysfunction
5. asthma or respiratory infection in the last 2 weeks
6. developmental delay
Exploring the Mechanisms of Indoxyl Sulfate Production by Oral Tryptophan Challenge Test

Cardiovascular disease (CVD) is prevalent in patients with chronic kidney disease (CKD) and is associated with extremely poor prognosis. Traditional risk factors for the general population, such as diabetes mellitus, high blood pressure, and dyslipidemia, are more common in patients with CKD but cannot fully explain the increased risk of this population. New evidence suggests that the uremic milieu itself plays a critical role in the development and progression of CVD. The gut microbiota is markedly altered in CKD, with overgrowth of bacteria that produce uremic toxins. Indoxyl sulfate (IS) is among the most representative gut-derived uremic toxins and has been most frequently implicated as a contributor to the pathogenesis of CVD in CKD. IS is converted from indole, a gut bacteria metabolite of dietary tryptophan, by two hepatic enzymes, CYP2E1 and SULT1A1. The majority of studies have assessed IS toxicity in cultured cells and animal models. However, human data have been conflicting and the benefit of using orally administered adsorbents to reduce IS levels in unselected CKD patients was not supported by results from the recent randomized controlled trials. IS levels may fluctuate widely from time to time with dietary intakes. The investigators hypothesize that a postprandial IS concentration may more reflect its toxicity than a single time point (fasting or predialysis IS) concentration measured in clinical studies. Therefore, the investigators plan to establish an oral tryptophan challenge test (OTCT) by using an oral loading of 2 gm tryptophan to simulate the postprandial increase of plasma IS. The investigators will recruit 60 healthy volunteers to undergo OTCT. A pharmacokinetic study of IS after the OTCT will be performed in 20 of them to verify and simplify the design of OTCT protocol. The results of OTCT will be integrated with whole metagenome analysis of fecal microbiota and genetic polymorphism analysis of CYP2E1 and SULT1A1 to explore the mechanisms of IS production. In addition to the known genes in microbe produces indoles, other supporting bacteria or genes will be examined by using metagenomic shotgun sequencing data.


Eligibility Criteria:
Inclusion Criteria:

* (1) age older than 20 years
* (2) no exposure to antibiotics or probiotics within the 3 months before entering the study.

Exclusion Criteria:

* (1) recent gastrointestinal discomfort (such as nausea, vomiting, abdominal pain, constipation, or diarrhea) or
* (2) a history of chronic diseases including diabetes mellites, hypertension, CVD, CKD, liver disease, malignancy, and autoimmune disease.
* (3) pregnancy or breast feeding
* (4) currently use of antipsychotics, Hypnotics, Demerol, Dextromethorphan, tramadol, pentazocine
Loop Diuretic Dosage in Patients With Acute Heart Failure and Renal Failure: Conventional Versus Carbohydrate Antigen 125-guided Therapy (IMPROVE-HF)

Worsening renal function (WRF) is a frequent finding in patients with decompensated acute heart failure (AHF) and it is associated to increased length of hospitalization and higher morbidity and mortality. Traditionally, WRF in AHF setting has been attributed to low cardiac output, but recent evidence also suggests venous congestion play a crucial role. Loop diuretics are the mainstay treatment of AHF, but their use traditionally has been associated to WRF, but also renal function improvement in patients with unequivocal signs of congestion. Nevertheless, traditional symptoms or signs of patients with AHF have shown a limited accuracy to neither identify nor quantify the degree of venous congestion. Recent authors have reported that plasma levels of antigen carbohydrate 125 (CA125) are closely related to the degree of venous congestion.

The investigators hypothesize that CA125 may have a role for identifying the hyperhydrated (High CA125) patients that need high loop diuretic doses, and those with normal CA125 values needing low loop diuretic doses. In this randomized study (1:1) the investigators seek to evaluate whether a CA125 loop diuretic guided management therapy is superior to a standard strategy. The primary endpoint is the magnitude of changes of renal function at 24 and 72 hours after initiation of intravenous diuretic in an acute worsening of heart failure


Eligibility Criteria:
Inclusion Criteria:

Patients with the diagnosis of acute heart failure (AHF) and the concurrence of the following conditions:

1. Presence of symptoms (dyspnea at rest or minimal exertion) and signs attributable to congestion (signs of congestion on chest radiography, or presence of peripheral edema or ascites, or jugular venous distension at 45 degrees or presence of crackles on auscultation).
2. Elevated natriuretic peptide (NT-proBNP\> 1000 pg/ml or BNP\> 100 mg/dl).
3. Creatinine ≥1,4 mg/dl on admission, provided that the estimated glomerular filtration rate less than 60 ml / min / m2.
4. Intent to be treated with loop diuretics intravenously.

Exclusion Criteria:

1. Life expectancy less than 6 months of life due to other comorbid conditions.
2. Cardiogenic shock.
3. Diagnosis of acute coronary syndrome in the previous 30 days.
4. Pregnancy at the time of inclusion.
5. Restrictive or Obstructive pulmonary disease or severe degree.
6. Chronic renal insufficiency in stage V (estimated glomerular filtration rate \<15 ml / min / m2) or patient previously included in known dialysis program.
7. Participation in another clinical trial randomized at the time of inclusion.
8. Temperature ≥38 ° C or diagnosis of pneumonia.
Evaluation of Housing Adaptations and Mobility Devices

The rationale underlying this project is the fact that HA is a very common compensatory interven¬tion within municipality health care, undertaken to support an independent living in the own home. In addition, MD are frequently prescribed and used among HA clients in order to compensate for declined body functions. In spite of this, knowledge of their effects for the individual and the society is still scarce. In particular, systematic, evidence-based strategies based on clear-cut conceptual definitions and descriptions of procedures are lacking. Such strategies are crucial in order to evaluate the effects of HA and MD. In addition, longterm cost-effectiveness evaluations are crucial for policy implementation.

The overarching aim is to investigate outcomes of HA on aspects of home and health for sub-groups of persons with disabilities.

The specific aims are to:

* Investigate the effects of HA on home and health related outcomes, i.e. usability, fear of falling, activity/participation and health-related quality of life for different subgroups of persons, e.g. MD users and non MD-users
* Investigate the use of a new practice strategy for HA on home and health related outcomes for subgroups of persons with disabilities in terms of differences between municipalities
* Investigate societal level outcomes of HA and MD, i.e. costs and quality adjusted life years
* Gain a deeper understanding of the processes behind changes in outcomes We hypothesise that using a structure strategy for housing adaptation and mobility devices case management in ordinary practice in Swedish municipalities increase activity, participation, the usability of the home, and reduces societal costs.

The ultimate goal of the project is to improve the housing situation of older people and people with disabilities, by determining the long term effects of housing adaptations (HA) for clients and society, and transferring this knowledge into guidelines for practitioners in the housing and building planning sector.

Specific research questions are:

RQ1. What are the long-term effects of HA for clients (individual goals achievement, activity, participation, health-related quality of life, usability, falls, functional capacity and use of mobility devices (MD), mortality, health care and social services consumption, and relocation)? RQ2. What are the long-term effects of HA for society (costs and cost- effectiveness)? RQ3. What are the barriers and facilitators to knowledge transfer in the area of HA? RQ4. How can evidence based knowledge be transferred into practical guidelines for housing and building planning in Sweden?

Eligibility Criteria:
Inclusion Criteria:

* Persons receiving housing adaptation
* Above 20 years

Exclusion Criteria:

* Persons with language deficits and/or cognitive decline
Sildenafil in Sever Intrauterine Growth Retardation

Severe fetal growth restriction (FGR) complicates approximately 0.4% of pregnancies and severely increases the risk of perinatal morbidity and mortality.Sildenafil citrate may offer a potential therapeutic strategy to improve uteroplacental blood flow in IUGR pregnancies.

The aim of our study is to evaluate the effect of sildenafil citrate therapy on severe early and late onset intrauterine growth retardation.A total of 46 patients with severe early onset intrauterine growth retardation will be enrolled in a prospective case control study .

Patients will randomly be allocated to two groups with 23 patients in each group.Sildenafil citrate therapy may increase the likelihood of increased growth velocity \[measured by abdominal circumference (AC) (ultrasound)\] for fetuses of pregnancies complicated by severe early-onset IUGR .Sildenafil is a potent and selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP which results in increased levels of cGMP, leading to smooth muscle relaxation. Placental disease, consequent on deficient uteroplacental blood flow, includes FGR, pre-eclampsia, and placental abruption and has been implicated in more than 50% of iatrogenic premature births .For this reason, the problem of severe FGR forms a substantial portion of the population that tertiary care centres care.

Eligibility Criteria:
Inclusion Criteria:

• pregnancy complicated by severe IUGR \[abdominal circumference (AC)\< 5th percentile\] the gestational age \<25 weeks or an estimate of the fetal weight was \<600 gm (excluding known fetal anomaly/syndrome and/or planned termination) ( von Dadelszen.et al;2011).

Exclusion Criteria:

* known aneuploid anomaly, syndrome congenital infection.
* If there is a plan to terminate the pregnancy.
Efficacy of Narrative Exposure Therapy (NET) in Treating Women After Human Trafficking or Forced Prostitution

The purpose of this study is to perform an evaluation of a trauma-focused short-term intervention (Narrative Exposure Therapy; Schauer, M., Neuner, F. \& Elbert, T.) on a variety of clinical outcome measures (PTSD, Depression, Somatic Complaints, Dissociation) in women after sexual exploitation and women trafficking.


Eligibility Criteria:
Inclusion Criteria:

* Sexual Exploitation or Women Trafficked or Forced Prostitution
* Symptoms of Post Traumatic Stress Disorder

Exclusion Criteria:

* Current Psychotic Symptoms
Supervised Treadmill Intervention to Reduce Inflammation and Depression Through Exercise in HIV: The STRIDE Pilot Study

Depression in people living with HIV is associated with worse care engagement, drug adherence, and higher rates of pre-mature mortality. The prevalence of depression is three times greater in those with HIV than comparable controls. While antiretroviral therapy (ART) enables immune reconstitution, those with depression do worse clinically than those without depression even when controlling for HIV stage. However, treating depression in HIV-infected persons is challenging. Even among those virologically suppressed on ART, a significant percentage are resistant to standard pharmacotherapy or psychotherapy for depression. The reasons for this are complex and poorly understood. An emerging body of evidence indicates that inflammation may perpetuate depression. Given people with HIV have ongoing increased inflammation, this could help explain part of why depression rates are so high in people with HIV.

Treatments for HIV-associated depression would likely be more effective if they were anti- inflammatory in nature. One possible treatment is exercise. Exercise is acutely pro-inflammatory due to catabolism but in the long term is anti-inflammatory. However, few studies have investigated exercise as a treatment for HIV-associated depression. The study objective is to perform a feasibility study to evaluate a larger trial evaluating the efficacy of exercise as an intervention for depression in people with HIV.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in Mildmay HIV clinic
* Adults 18-45 years old
* HIV positive
* Receiving HIV therapy
* HIV viral suppression (\&lt;400 copies/mL) per chart review
* Mild to Moderate (PHQ9 score \&gt;5 but \&gt;20)
* Not currently engaged in a formal exercise program or manual labor such as construction or delivery requiring a manual bike or walking
* Able to walk/run on a treadmill
* Informed consent

Exclusion Criteria:

* Women pregnant or breastfeeding
* Suicidal (PHQ-9 question 9 score \>2) or Severely Depressed (PHQ-9 score \>20)
* Uncontrolled hypertension (≥180 systolic or ≥100 diastolic blood pressure)
* Lower limb orthopedic limitations (e.g. amputations, arthritis)
* Resting heart rate \>90/min
* Known atherosclerotic or non-atherosclerotic peripheral artery disease.
* Exercise intolerance due to other known medical condition(s) which may make it unsafe for the patients to participate in.
Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid（5-ALA）

This trial is an open-label, multicenter, phase III clinical study，conducted in patients with newly diagnosed or recurrent malignant high-grade (WHO grades 3\~4) glioma, to evaluate the efficacy and safety of a single oral dose of 5-aminolevulinic acid (5-ALA) oral solution powder for fluorescence-guided tumor resection and photodynamic diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient's written informed consent
* Age 18-75 years
* Radiological suspicion of a malignant glioma
* Indication for surgical tumour resection
* Karnofsky Performance Status (KPS) ≥ 70

Exclusion Criteria:

* Tumor located in the basal ganglia, thalamus, cerebellum, or brainstem
* Porphyria, hypersensitivity to porphyrins，history of cutaneous photosensitivity or photosensitive skin diseases；
* known hypersensitivity to the test drug ingredients
* Any other condition that, in the opinion of the investigator, makes participation in the trial inappropriate;
Evaluation of the Effect of Caudal Epidural Pulsed Radiofrequency Stimulation on Chronic Pain

Postlumbar surgery syndrome (PLSS; failed back syndrome) is characterized by persistent pain in the lower back or lower extremities after spinal surgery. It occurs in 10-40% of patients who undergo a back surgery. The recently introduced pulsed radiofrequency (PRF) technique is widely used to provide relief from chronic pain and studies have shown that PRF stimulation can be used to control neuropathic pain by placing the needle electrodes into the caudal epidural space The aim of this study is evaluation of the effect of ultrasound guided caudal epidural pulsed radiofrequency stimulation in patients with chronic lumbosacral radicular pain due to postlumbar surgery syndrome.


Eligibility Criteria:
Inclusion Criteria:

* chronic pain in legs or back pain
* unsatisfactory response to at least one transforaminal, lumbar or caudal steroid injections

Exclusion Criteria:

* coagulation disorders
* psychiatric disorders
* rheumatoid disorders
* infections
Empagliflozin and Anakinra for the Treatment of Postprandial Hypoglycemia in Patients With Prediabetes

This study is to analyze whether the SGLT2-inhibitor empagliflozin or the IL-1 receptor antagonist anakinra may improve postprandial hypoglycemia in subjects with prediabetes.

Subjects with prediabetes may develop postprandial hypoglycemia. This is probably due to a dysfunction of the insulin producing β-cell characterized by a delayed and exaggerated insulin secretion leading to an initial peak in glycaemia followed by a rapid fall and eventually resulting in hypoglycemia. The latter occurring typically within 1 to 3 hours after food intake.

In patients with gastric bypass surgery and postprandial hypoglycemia the SGLT2-inhibitor empagliflozin and the IL-1 receptor antagonist anakinra reduced postprandial insulin release and prevented hypoglycemia. This study is to analyze whether a similar therapeutic approach using empagliflozin and anakinra may also improve postprandial hypoglycemia in subjects with prediabetes.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with prediabetes defined by Glycosylated haemoglobin A1c (HbA1c) 5.7-6.4 % or fasting plasma glucose 6.1-6.9 mmol/l) or plasma glucose 2 h following 75 glucose ingestion of 7.8-11.0 mmol/l.
* Hypoglycemia occuring 1 to 3 h following ingestion of a standardized liquid mixed-meal (75 g carbohydrates) and fulfilling the Whipple's triad (glucose below 3.0 mmol/l).
* Age ≥ 18 years
* For subjects with reproductive potential, willingness to use contraceptive measures adequate to prevent the subject from becoming pregnant during the study

Exclusion Criteria:

* Upper gastrointestinal surgery
* Diagnosis of any type of diabetes mellitus
* Signs of current infection
* Use of investigational drug up to one week prior to start of treatment phase
* Glucocorticoid therapy
* Neutropenia (leukocyte count \< 1.5 × 109/L or absolute neutrophil count (ANC) \< 0.5 × 109/L)
* Anemia (hemoglobin \< 11 g/dL for males, \< 10 g/dL for females)
* Clinically significant kidney or liver disease (creatinine \> 1.5 mg/dL, aspartate aminotransferase (AST)/ALT \> 2 × ULN, alkaline phosphatase \> 2 × ULN, or total bilirubin \[tBili\] \> 1.5 × ULN)
* Uncontrolled disease
* Currently pregnant or breastfeeding
* No subjects meeting the criteria for vulnerability
* Participation in another study with investigational drug within the 30 days preceding and during the present study.
A Pilot Study of Additional Chinese Formula for Concurrent Chemoradiotherapy in Oral Cavity Cancer Patients

The goal of this clinical trial is to learn about the clinical efficacy of San-Zhong-Kui-Jian-Tang (SZKJT), a formula of Chinese medicine in head and neck cancer patients receiving concurrent chemoradiotherapy (CCRT) treatments. The main questions it aims to answer are:

* Can SZKJT improve the completion rate of CCRT?
* Can SZKJT reduce the adverse effects of CCRT?
* How SZKJT affect the quality of life in the patients receiving CCRT
* How about the safety of using SZKJT in the patients receiving CCRT

Participants will be asked to:

* take SZKJT for 9 weeks during the whole CCRT course
* take questionnaires of quality of life

San-Zhong-Kui-Jian-Tang (SZKJT) is originated from the Secret Treasure of the Orchid Chamber written by Gao Li (AC1180 - 1251). SZKJT contains 16 herbs to treat abnormal swelling or nodules. In the theory of Chinese medicine, SZKJT can clear heat and resolve toxin, which leads to disperse swelling and binds in nodules.

The purpose of this study is to explore the clinical efficacy and safety of SZKJT in improving the completion rate of concurrent chemoradiotherapy (CCRT) in patients with head and neck cancer, and to evaluate the prevention and treatment effects of SZKJT on the side effects of chemoradiotherapy, as well as the improvement of quality of life.

The primary endpoint of the study is the completion rate of CCRT under SZKJT treatment. The secondary endpoints are adverse effects of CTCAE, body constitution questionnaire (BCQ) and the EORTC core quality of life questionnaire (QLQ-C30). Liver and kidney functions are considered as well for adverse effects of SZKJT. We hypothesized that additional SZKJT with CCRT might improve completion rate of CCRT and reduce severity of adverse effects of CCRT.

Eligibility Criteria:
Inclusion Criteria:

* aged from 20- to 65-year-old;
* firstly diagnosed as head and neck cancer with stage II, III or IV;
* adjuvant therapy with chemotherapy of Cisplatin or combined with radiotherapy after surgery;
* or chemotherapy of Cisplatin for those without surgery;
* wiliness to sign inform consent.

Exclusion Criteria:

* pregnancy;
* non-Squamous-cell carcinoma;
* secondary cancer or Carcinoma in situ in 5 years;
* any evidence of metastasis;
* abnormality of liver, kidney or bone marrow functions before treatments;
* unstable vital signs;
* episode of acute infection;
* unclear consciousness for inform consent;
* receiving other herbal, complementary or acupuncture therapy.