cyrilzakka/clinical-trials huggingface dataset:
Effects of rTMS on the Anxiety State of Older Patients With GAD

The purpose of this study is to evaluate the effects of low-frequency repetitive transcranial magnetic stimulation on anxiety state in older patients with generalized anxiety disorder.

Repetitive transcranial magnetic stimulation can alter nerve cell excitability, improve cerebral blood flow and metabolism, and is widely used in neuropsychiatric research. Studies have shown its efficiency and safety in treating anxiety disorders, however the senior patient group has not been adequately validated. The purpose of this study is to evaluate the effects of low-frequency repetitive transcranial magnetic stimulation on anxiety state in older patients with generalized anxiety disorder.

Eligibility Criteria:
Inclusion Criteria:

* 1）Age≥60 years, regardless of gender.
* 2）Meets the diagnostic criteria for generalized anxiety disorder in the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V) developed by the American Psychiatric Association.
* 3）HAMA score≥14 and HAMD-17 items score \<17.
* 4）No adjustment in the type and dose of anti-anxiety medication in the 3 months prior to randomization.
* 5）Willing to participate and sign the informed consent.

Exclusion Criteria:

* 1）Traumatic brain injury or other conditions affecting the brain, such encephalitis, brain tumors, or intracranial hypertension.
* 2）Previous history of epilepsy, family history of epilepsy or presence of seizure provoking factors or alcohol abuse.
* 3）History of other psychiatric disorders such as current post-traumatic stress disorder, substance use disorder (within 6 months), bipolar disorder and obsessive-compulsive disorder.
* 4）Unstable mental state with impulses toward self-harm or suicide.
* 5）Presence of intracranial metal implant, cochlear implant, built-in pulse generator (such as cardiac pacemaker), etc.
* 6）Medical or surgical disorders that are severe or unstable.
* 7）Pregnancy or breastfeeding.
* 8) Those who are participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to enrollment.
* 9) Other conditions that the researchers think are not suitable for the project.
CARMEDAS: Cost-Effectiveness Analysis of Imaging Strategies in Symptomatic Carotid Stenosis

PURPOSE: The purpose of this clinical trial is to study the cost-effectiveness ratios of diagnostic strategies for the imaging assessment of symptomatic carotid stenosis.

MATERIALS AND METHODS: The diagnostic accuracies of Doppler ultrasound (DUS), contrast-enhanced magnetic resonance angiography (CEMRA) and computed tomography angiography (CTA) were compared with digital subtraction angiography (DSA) in a multicenter study (CARMEDAS; 206 patients assessable) and in a meta-analysis (for CEMRA and CTA). The direct costs of each imaging method were calculated in 2 university medical centers. Eight hypothetical models were studied with DUS considered as the first-line imaging method and either CEMRA or CTA or DSA as the second or third line method. The effectiveness criterion was the number of potential avoided strokes for each strategy and for 1000 patients.


Eligibility Criteria:
Inclusion Criteria:

Carotid artery stenosis \> 50%
Assessment of Maxillary Acrylic Resin Complete Dentures Reinforced by Gold Plated Cr-Co Palatal Plate

Gold is widely used in prosthetics. Its use ranges from being employed in the fabrication of removable dentures, where the inner surface permanently touching oral cavity tissues, through to fixed dentures, and even some structures of certain implantological systems. All such items can be made of galvanized gold. Thus, new technologies have made gold and its alloys a kind of a universal material.

Gold is widely used in prosthetics. Its use ranges from being employed in the fabrication of removable dentures, where the inner surface permanently touching oral cavity tissues, through to fixed dentures, and even some structures of certain implantological systems. All such items can be made of galvanized gold. Thus, new technologies have made gold and its alloys a kind of a universal material.

Using metal alloys (gold alloys included) to make the framework for removable dentures is much better than using acrylic resin. This because the alloys have almost no destructive influence over the dentures bearing area. Due to the precise way it is made, the stability of shape, the lack of internal stresses and the close contact with the dentures bearing area, it is possible to achieve very good retention of the denture over a long span of time. Another advantage is that the metal framework conducts temperature changes and this facilitates keeping the tissues in good health. Also, a denture metal framework makes it much easier for the patient to maintain good oral hygiene by lowering the risk of plaque accumulation. However, a metal framework has a disadvantage as well - prosthesis relining cannot be made.

Eligibility Criteria:
Inclusion Criteria:

1. Completely edentulous maxillary and mandibular ridges
2. Healthy mucosa and absence of remaining roots
3. Good physical and mental health
4. Willing to give informed consent
5. Normal maxilla-mandibular relationship Angle Class I
6. Adequate bone quality and quantity in terms of width and height in the anterior maxillary mandibular ridges verified by preoperative cone beam CT
7. Adequate inter-arch space to accommodate maxillary and mandibular implant prostheses

Exclusion Criteria:

1. Uncontrolled diabetes
2. Smoking habits
3. Radiotherapy
4. Clinical or radiographic signs of pathologic conditions
5. Osteoporosis
6. Patients on corticosteroids
7. Bruxism
DNA Analysis in Influencing Response to Rituximab in Samples From Patients With Follicular Lymphoma Treated on ECOG-E4402

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is studying DNA isolated from blood samples to see how well it influences response to rituximab in patients with follicular lymphoma treated on clinical trial ECOG-E4402.

OBJECTIVES:

* To test the influence of killer immunoglobulin-like receptor (KIR) and human lymphocyte antigen (HLA) genotype on response to anti-CD20 antibody lymphoma immunotherapy.

OUTLINE: DNA samples are analyzed for killer immunoglobulin-like receptor (KIR) and human lymphocyte antigen (HLA) genotyping with sequence-specific primers (SSP) by real-time PCR. KIR and HLA typing are analyzed according to KIR-HLA matched vs mismatched, KIR B haplotype content, and the number of inhibitory KIR-HLA pairs. Results are then correlated to each patient's overall response and duration of response to rituximab.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patients diagnosed with follicular lymphoma enrolled on ECOG-E4402

  * Treated with single-agent rituximab; the trial compared two different rituximab-dosing strategies - maintenance vs retreatment as needed
* Available germline DNA samples isolated from peripheral blood as well as clinical evaluation of disease status prior to and at initial response to the therapy

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Plasma Concentration of Lidocaine and Bupivacaine Axillary BPB Mixture Solutions [PCLBAxMix]

The doses of local anesthetics can be decreased with the use of ultrasound guidance. In case of using mixture solutions the benefits and drawbacks are controversial. The plasma concentrations were not studied up to this time in this kind of settings, so investigators believe that this is the first work that shows how lidocaine change the plasma concentration of bupivacaine after axillary approach to brachial plexus employed with different dilute and mixed solutions for upper limb surgery in trauma patients.

Total of 30 American Society of Anesthesiologist (ASA) I-III adult patients scheduled to elective or emergency trauma surgery of hand and forearm under ultrasound-guided (UG) brachial plexus block (BPB) are planned to be assigned into this randomized-prospective observational study after approval by the University Research Ethics Board, Pécs University Medical School, Hungary. All of the patients will receive detailed information about the planned BPB techniques and surgeries, then written informed consents will be obtained.

Study participants are planned to be assigned randomly by the research coordinator into 3 groups (Lidocaine, Bupivacaine and mixture solution) according to the concentration of lidocaine and bupivacaine in the mixture solution.

Standardized UG Axillary-supraclavicular (AX-SC) approach to the BP is planned to be performed under sterile conditions by the same anesthesiologist. The standardized dose is 0.4 ml/kg with the targeted maximized the single-shot volume of 30 ml.

Blood samples will be taken at 0-time point (straight after the administration of BP injection) and 30, 60, 240 and 480 minutes after. Plasma concentrations are determined, the results are collected and analyzed.

Under standard monitorization, vital parameters, data are collected on the onset time and duration of actions of local anesthetics (LAs).

Eligibility Criteria:
Inclusion Criteria:

* unpremedicated patient scheduled for elective or emergency trauma surgery of hand and forearm under ultrasound-guided BPB

Exclusion Criteria:

* continuous peripheral nerve catheter technique or bilateral block was planned, or the patient refused to participate. Exclusion criteria included psycho-mental conditions interfering with consent or assessment; pre-existing chronic pain condition or daily analgesic or sedative consumption; sedative or analgesic premedication; pre-existing neurological disorders aﬀecting the brachial plexus.
BAY12-8039: 5 Days for Sinusitis vs Placebo

The purpose of the study is to evaluate the effectiveness and safety of Avelox in a 5 day treatment of adult patients with acute bacterial sinusitis and to measure the amount of time it takes for symptom relief. Avelox is currently not approved for the 5 day treatment of acute bacterial sinusitis, therefore in this study Avelox is considered an investigational drug. In this study Avelox will be compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all the following criteria at the time of enrollment:

* Age \>/= 18 years
* Clinical diagnosis of acute bacterial sinusitis with signs and symptoms present for = 7 days but \< 28 days as defined by A), radiographic, and B) clinical criteria, as follows:

  * Radiographic Criteria: The presence of one or more of the following on a radiographic paranasal sinus film (Waters' view): - Evidence of air-fluid levels - Opacification
  * Clinical Criteria: The presence of two major symptoms, or the presence of at least one major and one minor symptom as defined in the list below:

    * Major symptoms: - Purulent anterior or posterior nasal discharge - Unilateral facial pain or malar tenderness
    * Minor symptoms: - Frontal headache - Fever (oral = 38.0°C/100.4°F, tympanic = 38.5°C/101.2°F, axillary = 37.5°C/99.5°F) - Culture material obtained by sinus puncture; the aspirated specimen sent for Gram stain, quantitative culture and susceptibility testing prior to initiation of antimicrobial therapy

Exclusion Criteria:

Subjects with one or more of the following criteria will not be eligible for this study:

* History of chronic sinusitis defined as greater than four weeks of continuous symptoms (subjects with recurrent acute sinusitis will be included)
* History of sinus surgery (antral sinus puncture is not considered as a surgery)
* Any symptoms that suggest the subject's current illness is allergic rhinitis (e.g. repetitive sneezing, itchy nose or eyes, provocation by an allergen) and not acute bacterial sinusitis
* Known bacteremia, meningitis or infection infiltrating the tissues neighboring the sinuses
Efficacy of Gastric Biopsy for Culture and Antibiotic Sensitivity Assessment

Gastric biopsies will be taken to compare different methods of H.pylori disclosure.Standard methods will be compared to culture.


Eligibility Criteria:
Inclusion Criteria:

* all referred for gastroscopy with clinical or endoscopic signs of peptic disease

Exclusion Criteria:

* coagulation disorders
* pregnant women
A Study to Compare PK and Safety of CKD-381 and D026 in Healthy Male Subjects

A Study to compare pharmacokinetics and safety of CKD-381 and D026 in healthy male subjects

A randomized, open-label, multiple-dose, and three-way cross over clinical trial to compare pharmacokinetics and safety of CKD-381 and D026 in healthy male subjects

Eligibility Criteria:
Inclusion Criteria:

1. Between 19 aged and 50 aged in healthy male adult
2. Body weight more than 55kg
3. Body Mass Index more than 18.5 and under 25

Exclusion Criteria:

1. Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease.
2. Have a gastrointestinal disease history that can effect drug absorption or surgery.
3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family.
A Study on Antiretroviral Therapy (ART) Naïve Patients On Different Regimens to Treat Hiv (NORTHIV)

The present study aims to compare efficacy, side-effects, and treatment adherence of three different treatment regimens given to antiretroviral naïve HIV-1 infected patients. Treatment will be initiated in accordance with the Swedish National Guidelines. In the twice daily (BID) arm (1), which could be considered as a standard regimen at present, lopinavir/ritonavir, is co-administrated with 2 nucleoside reverse transcriptase inhibitors (NRTIs) administrated BID. The first once daily (QD) arm (2) combines the protease inhibitor (PI) atazanavir/ritonavir with 2 NRTIs administrated QD, and in the second QD arm (3), the non nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz is combined with 2 NRTIs administrated QD. All drugs used in the study are licensed in the participating countries and patients will be followed as in clinical practice. Patients could optionally, after informed consent, be followed with additional measurements of HIV-1 RNA after 1, 2, and 3 weeks of treatment to asses the kinetics of viral decline after initiation of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 16 years of age
* HIV-1 infected as documented by a licensed HIV-1 antibody ELISA
* Ability to understand and provide informed consent
* Indication for antiretroviral treatment
* Antiretroviral naïve
* All clinical laboratory values not clinically significant

Exclusion Criteria:

* Subjects being pregnant
* Women of childbearing potential not practicing birth control
* Subjects with renal failure requiring dialysis
* Drug interactions with any of the study drugs that are not manageable
* Resistance to any of the study drugs
Effects of the Spinal Manipulative Therapy and Myofascial Release in Individuals With Non-specific Chronic Low Back Pain

The aim will be to compare a experimental group submitted to a protocol of spinal manipulation and myofascial release; and a control group composed by spinal manipulation only, in individuals with chronic non-specific low back pain. This is a randomized controlled trial, characterized by the application of manual therapy, in two modalities: spinal manipulation plus myofascial release and spinal manipulation alone. Participants will be enrolled and randomly allocated into two groups: 1) spinal manipulation plus myofascial release, totaling 6 sessions, 2x/week, for 3 weeks; 2) spinal manipulation: 6 sessions, 2x/week, for 3 weeks. Participants will be evaluated in two different moments: 1) Baseline (pre-intervention); 2) at the end of intervention period (3 weeks); and 3) after 3 months follow-up. The primary outcomes will be pain intensity (measured in centimeters with the visual analogue scale - VAS) and disability (measured by the Quebec questionnaire - QDS). The secondary outcomes will be muscle fatigue (measured by the Biering-Sorensen test), postural balance (measured by the Y Balance test), pain threshold (algometry, in kgf) and perception of recovery (Likert scale of 6-points) and health status (measured by the Eq5d3L questionnaire). Data analysis will be performed with the SPSS (Statistical Package for the Social Sciences) software version 24.0. Data normality assumptions will be confirmed by the Shapiro Wilk test. If the assumptions were met, a mixed ANOVA with repeated measures will be adopted, based on the outcomes and the independent variables (groups), for the comparison between pre-intervention and post-intervention. Spinal manipulation plus myofascial release is expected to have better effects than spinal manipulation alone, associated with the outcomes of interest.


Eligibility Criteria:
Inclusion Criteria:

* presence of non-specific chronic low back pain for more than 12 consecutive weeks;
* have not performed Physical Therapy, Osteopathic and/or chiropractic sessions for at least 3 months prior to the research.

Exclusion Criteria:

* history of trauma or fractures in the trunk and lumbar spine;
* presence of neural root symptoms;
* infection and inflammation on spine and upper and lower limbs for at least 3 months prior to research;
* have undergone surgery on spine, chest and abdomen;
* rheumatologic and myopathic diseases;
* renal, digestion and neurological diseases;
* use of anti-inflammatories drugs and analgesic drugs for at least 2 weeks prior the research.
Tislelizumab in Combination With TACE in Advanced Hepatocellular Carcinoma

A multicentric, open-label, single-arm prospective study to assess the efficacy and safety of tislelizumab combined with TACE as first-line treatment in patients with unresectable BCLC stage C HCC.

This is a multicentric, open-label, single-arm prospective study to assess the efficacy and safety of tislelizumab combined with conventional transarterial chemoembolization(cTACE) as first-line treatment in BCLC stage C HCC patients without extrahepatic spread. The primary endpoint is time to progression (TTP).

Eligibility Criteria:
Inclusion Criteria:

1. 18-70 years old on the day the patients voluntary to participate in the study and signing in ICF.
2. Histological or clinical diagnosis of HCC.
3. BCLC stage C patients ineligible for surgical resection or liver transplantation.
4. No prior systemic therapy for HCC (including immunotherapy).
5. Have at least one uni-dimensional lesion measurable by CT scan or magnetic resonance imaging per mRECIST.
6. Child-Pugh A-B7.
7. ECOG PS 0-1.
8. Adequate hematological function (absolute neutrophil count ≥ 1.5 X 109/L, platelets count≥50 X109/L, and hemoglobin ≥85 g/L); Adequate hepatic function (both AST and ALT ≤ 3 ULN, serum total bilirubin ≤ 34.2 umol/L or 2mg/dl, serum albumin ≥ 29g/L); Adequate renal function (eGFR \> 30 ml/min/1.73 m2)
9. For patients with HBV or HCV infection, HBV DNA less than 500 IU/ml (2500 copies/ml) or HCV RNA detectable.
10. life expectancy of more than 3 months.
11. Patients must be able to understand and willing to sign a written informed consent document.
12. Patients suitable for TACE therapy assessed by investigators.

Exclusion Criteria:

1. Tumor thrombus involving main trunk of portal vein or inferior vena cava.
2. Prior local-regional therapy before beginning of study treatment (surgery or ablation allowed at BCLC stage 0-B) or radiotherapy on liver cancer.
3. Disease history of grade 2 or more hepatic encephalopathy.
4. Extrahepatic metastasis on baseline imaging.
5. HIV infection or syphilis.
6. Prior therapies with any anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 agents.
7. Tumor diffuse.
An Add-on Study to Evaluate the Efficacy and Safety of Xiyanping Injection in Pediatric Bronchitis Patients.

This is a multicenter, randomized, open Label,add-on study.

This is an add-on study of efficacy and safety of intravenous injection of Xiyanping injection in subjects with pediatric bronchitis.

The purpose to determine the efficacy and safety of conventional treatment combined with or without Xiyanping injection in the treatment of pediatric bronchitis and to further evaluate the clinical value of Xiyanping injection in shortening the course of pediatric bronchitis

The study will enroll 240 Pediatric bronchitis volunteers, who will be randomized into 2 groups (1:1 ratio): volunteers from the first group will receive Routine treatment for pediatric bronchitis and Xiyanping injection; volunteers from the second group will receive Routine treatment for pediatric bronchitis. Xiyanping injection will be administration as intravenous injection of 0.2-0.4mL/kg/day once daily for 5 days concomitantly with Routine treatment for pediatric bronchitis

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of pediatric bronchitis with hospital treatment needed
* Males and female subjects
* Age between 1 and 3 years old
* With fever, cough, gasp and expectoration symptoms
* Have wheeze and/ or mid-fine rales on one's lungs
* White blood cell count \< 12 x 109 / L, categorized priority to leukocyte
* C-reactive protein≤8mg/L or normal Super C- reactive protein
* Had experienced ≤48 h course before enrollment
* Previous Wheezing episodes≤2
* Written informed consent

Exclusion Criteria:

* Participants with severe clinical symptoms, meet any of the following：

  * SaO2≤0.92;（2）Shock or disturbance of consciousness;（3） Significantly speed up breathing , rapid pulse accompany with severe respiratory distress; or（4）Repeated occurrence of apnea or slow and irregular respiration;
* Acute infectious disease such as measles, pertussis and influenza
* Participants with bronchial asthma, bronchopneumonia and other respiratory diseases
* Chronic lung diseases
* Participants with complicated pyopneumothorax, airway obstruction, toxic encephalopathy, cardiac failure or respiratory failure
* Participants with complicated severe underlying myocardial, liver, kidney, digestive and hematopoietic system diseases
* Severe malnutrition and history of immune deficiency which may seriously affect the self-limiting process of the course
* Participants with epilepsy and other disturbances of central nervous system
* Participants with congenital diseases and psychosis
* use of any other antiviral drugs within the 2 weeks before enrollment
* use of systemic hormone within the 2 weeks before enrollment
* Participants had a history of allergic constitution and drug allergy; Allergenic to XiYanPing injection and Andrographolide
* Participants participated in other clinical research in the last three months
* Any condition which would make the subject, in the opinion of the investigator or designee, not suitable for the study for any reason