cyrilzakka/clinical-trials huggingface dataset:
Comparison of Anesthesia Effects of Sevoflurane and Propofol Combined With Dexmedetomidine in Intraoperative Neuromonitoring During Thyroidectomy

According to the previous studies, it is reported that the use of sevoflurane in the maintenance of anesthesia may lead to delayed occurrence of positive electromyographic (EMG) signal and lower obtained signal amplitude. In this study, the investigators aimed to investigate the anesthetic effect of sevoflurane combined with dexmedetomidine for neuromonitoring during thyroid surgery. The investigators hypothesize that sevoflurane combined with dexmedetomidine can reduce the movement or spontaneous activity of vocal cords in patients and without affecting the EMG signals.

Recurrent laryngeal nerve (RLN) injury is one of the most serious common complications in thyroid operation. Compared with the traditional operation under direct eye vision alone, application of intraoperative neural monitoring (IONM) is able to help surgeon in identifying the RLN during thyroid dissection, and enabling continuous monitoring of the neurological function during operation, thus reducing the incidence of intraoperative RLN injury. Sevoflurane is a common inhaled anesthetic in clinical practice, with the effect of prolonging the action time of muscle relaxants. According to the previous studies, it is reported that the use of sevoflurane in the maintenance of anesthesia may lead to delayed occurrence of positive electromyographic (EMG) signal and lower obtained signal amplitude, which may affect the surgeon's judgment on neurological function during the operation. In this study, the investigators aimed to investigate the anesthetic effect of sevoflurane combined with dexmedetomidine for neuromonitoring during thyroid surgery. The investigators hypothesize that sevoflurane combined with dexmedetomidine can reduce movement or spontaneous activity of vocal cords in patients without affecting the IONM signal.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for thyroidectomy under general anesthesia
* American Society of Anesthesiologists (ASA) grade of I or II
* aged 18 to 65 years
* body mass index (BMI) \< 32 kg/m2.

Exclusion Criteria:

* patients with RLN or vagus nerve injury were identified preoperatively
* severe cardiovascular, pulmonary, liver and kidney diseases
* history of allergy to narcotic include rocuronium -pregnancy or lactation-
* history or current usage of medication which may interfere neuromuscular transmission;
* family or personal history of malignant hyperthermia
* myasthenia gravis
* potential risk of airway difficulty
* unable to cooperate.
Acute Effect of Empagliflozin vs Dapagliflozin Over Pulse Wave Velocity in Type Two Diabetes

To date one of the main independent biomarkers of cardiovascular disease is the arterial stiffness parameters measured by carotid-femoral pulse wave velocity. It is known that SGLT2 inhibitors develop cardiac protection over long term administration, but there's not enough studies about acute effects in early administration.

Measure basal carotid-femoral Pulse Wave Velocity through a Pulse Pen tonometer by DiaTecne among basic physical examination, blood test, anthropometric and hemodynamic measurements; then administrate randomly dapagliflozin 10 mg, empagliflozin 25 mg or placebo for 7 days and then perform all of the measurements and blood test again.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T2DM
* HbA1c \> 7 y \< 10
* BMI 25 - 34.9 kg/m2
* Signature of consent under information

Exclusion Criteria:

* Hypertension
* Treated with insulin and / or loop diuretics and thiazides
* T1DM
* Hypotension
* Any autoimmune disease
* Liver disease
* Women whitout birth control method
* Women taking oral birth control or under hormone replacement therapy
* Woman pregnant or breastfeeding
* Untreated thyroid disease
* Patients with a cardiovascular disease that contraindicates the use of this pharmacological class
* Glomerular filtration rate \<60ml/min (Cockcroft-Gault)
Exploratory Study of Additional Use of Scopolamine Butylbromide, Glucagon or NPO-11 Following Single Dose of NPO-11 in Healthy Adult Men

The purpose of this study is to evaluate the safety and efficacy of the additional administration of scopolamine butylbromide, glucagon or NPO-11 following a single intragastric dose of NPO-11 during endoscopy in healthy adult men. The safety will be evaluated based on adverse events and adverse drug reactions (ADRs) observed with NPO-11 + scopolamine butylbromide or glucagon, and following additional administration of NPO-11. The efficacy will be evaluated based on changes in the frequency of gastric peristalsis classification after the initial dose and the additional dose, and on the presence or absence of gastric peristalsis at each evaluation point.


Eligibility Criteria:
Inclusion Criteria:

Healthy adult male volunteers who meet all the following criteria will be enrolled in the study. Subjects have to provide written informed consent for voluntary participation in the study.

1. Volunteers who are in good health as confirmed by the investigator or subinvestigator
2. Volunteers (age from 35 to less than 65 years old at the time of consent)

Exclusion Criteria:

Volunteers who meet any of the following criteria will be excluded from the study.

1. Volunteers with any clinically significant symptoms, physical findings or laboratory values at screening visit which are considered unsuitable for participation in the study in the investigator's or subinvestigator's opinion
2. Volunteers with a history of surgery in the upper gastrointestinal tract
3. Volunteers with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)
4. Volunteers with a history of shock or hypersensitivity to scopolamine butylbromide, glucagon, lidocaine hydrochloride or heparin sodium
5. Volunteers who are contraindicated for administration of scopolamine butylbromide or glucagon in the investigator's or subinvestigator's opinion based on health interview
6. Volunteers who have been exposed to NPO-11
7. Volunteers who have received other investigational drugs within four months before consent or who are participating in other clinical studies
8. Volunteers otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion
An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Copegus (Ribavirin) in Participants With Chronic Hepatitis C (CHC), Genotype 2, 3, 1 or 4, Undergoing Opioid Maintenance Therapy

This prospective, multi-center, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) in participants with previously untreated chronic hepatitis C, genotype 2, 3, 1 or 4, who are undergoing opioid maintenance therapy. Data will be collected from eligible participants receiving Pegasys and Copegus treatment as prescribed by treating physician and treatment-free follow-up period of 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Participants undergoing an opioid maintenance therapy
* Serologic evidence of CHC prior to therapy
* CHC genotype 2, 3, 1 or 4
* Quantifiable serum hepatitis C (HCV) ribonucleic acid (RNA)
* All fertile males and females receiving ribavirin must use two forms of effective contraception during treatment with study drugs and for 7 months after completion of treatment

Exclusion Criteria:

* Harmful use of psychoactive substances (including excessive alcohol consumption) that precludes successful participation in the study at the discretion of the investigator
* Pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of the study
* Co-infection with hepatitis A, hepatitis B or Human Immunodeficiency Virus (HIV)
* Current diagnosis of a major depression or any psychotic disorder
Conservative Treatment Compared to Osteosynthesis in Patients With a Fractured Collar Bone

This study will compare non-operative treatment of displaced midshaft collarbone fractures with operative treatment using a precontoured titanium plate and screws.

The study hypothesis is that operation will provide better pain relief, faster return to activities, better function of the involved upper limb, and lower the risk of a non healing fracture (non union).


Eligibility Criteria:
Inclusion Criteria:

* fracture located to the mid third of the collar bone where there is no contact between the fractured surface of the main fragments on x-ray in one or two of two levels.

Exclusion Criteria:

* bilateral fracture
* imminent skin perforation
* open fracture
* associated neurovascular effect
* unstable fracture of neck of scapula "floating shoulder"
* fracture of coincidental upper extremity distal for the shoulder
* pathologic fracture
* the patient states that there was a unilateral or bilateral shoulder problem before the fracture
* fracture realized more than 14 days after it arose
* circumstances which make it impossible to carry out one of the two regimes, i.e. mental illness and abuse
* circumstances which make follow-up impossible, i.e. address far from the including departments and stays abroad of long duration
* medical contraindication against surgery or general anaesthesia
* former participation in the trial
* former fracture contra/ipsilateral at the age of 15 or older
Pediatric Pelvic Injuries - Epidemiology and Demography

A retrospective epidemiological study of pediatric pelvic injury from level 1 trauma centre.

Hypothesis: In the pediatric population, majority of pelvic injuries is of type A according to AO/OTA (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association) classification, the treatment is mostly conservative and complications of injury and treatment are less common than in adults.

Study design: Retrospective analysis (13 years), excluding pathological fractures. AO/OTA type, epidemiological data, mode of treatment, and complications were recorded. Data were analyzed using the Fisher exact test and the Wilcoxon test.

Eligibility Criteria:
Inclusion Criteria of primary study group:

* Age ≤ 18 years
* Single pelvic bone fractures or pelvic ring injuries

Inclusion Criteria of secondary study group:

* Age ≤ 18 years
* Combined pelvic and acetabular injuries
* Isolated fractures of the acetabulum

Exclusion Criteria:

* Pathological fractures
Intraoperative Dexamethasone in Pediatric Cardiac Surgery

Perioperative administration of steroids has been demonstrated to reduce systemic inflammatory response in infants undergoing cardiac surgery with cardiopulmonary bypass. However, data on effects of steroids on clinical outcomes are lacking. Hence the hypothesis of the present study: intraoperative administration of dexamethasone reduces complication rates and improves clinical outcomes in infants undergoing repair of congenital heart defects under cardiopulmonary bypass.


Eligibility Criteria:
Inclusion Criteria:

* elective repair of congenital heart defects under cardiopulmonary bypass

Exclusion Criteria:

* absence of written informed consent signed by parent or guardian;
* hypoplastic left heart syndrome;
* participation in conflicting randomised studies;
* emergency surgery;
* inotropic support prior to surgery;
* mechanical ventilation prior to surgery;
* bacterial, viral or fungal infection in the preceding 30 days;
* gestational age less that 37 weeks;
* perinatal central nervous system damage.
Pharmacokinetic Study on the Administration of Nadroparin Dosing Serum HGF in Gynecological Patients

The purpose of this study is to determine whether HGF serum concentration might be raised in vivo by administering nadroparin given with prophylactic purpose to gynecological patients.

The study consisted of two phases. In the first phase, the main HGF pharmacokinetic parameters were evaluated, comparing a group of six women treated with a single dose of calcic nadroparin to a control group of six untreated women. Venous blood was drawn in both groups at 0, 30, 60, 90, 120, 150, 180, 240, 300, 360, 480 and 720 min. In the second phase, the HGF basal and maximum concentrations were measured in 17 women, undergoing one month of calcic nadroparin daily treatment. Venous blood was drawn twice on day 1 (at 0 and 90 min after nadroparin administration), then once on days 8 and 28 (at 90 min after LMWH injection). Calcic nadroparin was given subcutaneously at 2850 IU/0.3 ml anti-Xa.

Patients' characteristics:

In the first phase, 12 patients were enrolled, 6 treated with nadroparin for prophylactic anticoagulation and another 6 untreated as the control group. The six nadroparin-group patients were affected by benign pelvic gynaecologic diseases: three requiring laparoscopy and three laparotomy.

In the control group, four were healthy women volunteers and two patients submitted to gynaecological pelvic surgery, but these women were not treated with prophylactic LMWH.

In the second phase, 17 patients were enrolled among women planning gynaecological pelvic surgery and treated for 4 weeks with nadroparin for prophylactic anticoagulation. All these patients underwent laparotomy; ten were affected by malignancy (ECOC) and seven by benign (uterine fibroma, ovarian cystadenoma) pelvic gynaecologic diseases.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* ECOG PS ≤ 1
* Neutrophils ≥ 1500 l -1, platelets ≥ 150,000 l -1, creatinine 0.6 to 1.2 mg dl -1, total bilirubin ≤ 1 mg dL -1, AST ≤ 35 U l-1, ALT ≤ 45 U l-1

For patients in the study group: high-moderate risk of deep vein thrombosis (for the administration of LMWH for 30 days after surgery) under general anesthesia\> 30 minutes, laparoscopy + at least one risk factor (age\> 40 years, obesity, varicose veins, previous episode of deep vein thrombosis and / or pulmonary thromboembolism, thrombophilia, malignancy, prolonged immobility, congestive heart failure)

Exclusion Criteria:

* severe liver and renal disease
* diabetes
* hyperlipidemia
* marked osteoporosis
* HIV infection
* ongoing treatment with: immunosuppressive therapies, contraceptives, lipid-lowering drugs, NSAIDs, antiplatelet drugs, recent acute inflammatory or infectious (\<3 weeks)
* a history of allergies,
* drug possible confounding, caffeine, tobacco, ethanol (must not have been hired in the last 24 hours prior to sampling)
* high risk of bleeding: peptic ulcer, history of hemorrhagic stroke, or bleeding disorders, severe hypertension, cerebral aneurysms, arteriovenous malformations, brain metastases
Effects of a Rehabilitation Program on Physical Performance and Disease Self-management in Rheumatoid Arthritis.

The purpose of this study is to evaluate the effects of a group-based exercise and educational program for people with Rheumatoid Arthritis (RA) on physical performance and disease-self-management.

Currently, the effectiveness of a program consisting of education to improve disease self-management combined with intensive exercises is not clear. In the present study the investigators developed a group-based program for people with RA consisting of physical exercise to increase physical performance (i.e. aerobic capacity and muscle strength) combined with an educational program to improve disease self-management (self-reported health status and self-efficacy). The investigators called it the 'FIT program'. The aim of the present randomized controlled trial (RCT) was to examine the effects of the FIT program on aerobic capacity, muscle strength, self-reported health status and self-efficacy, in a population of people with RA. The investigators hypothesized that the FIT-program would have beneficial effects on physical performance (ie. aerobic capacity and muscle strength) and disease self-management (i.e. perceived health status and self-efficacy components) compared to a waiting list control group (WLCgroup).

Eligibility Criteria:
Inclusion Criteria:

* medical diagnosis of RA according to the American College of Rheumatology (ACR) criteria
* between 18 and 66 years of age

Exclusion Criteria:

* severe disease activity (Disease Activity Score:DAS-28 \> 5.1)
* cardiac or pulmonary diseases resulting in restrictions in their ability to follow a physical exercise program
* a Steinbrocker classification of functional capacity in RA ≥ 3
* no stable medication for the RA
* intra-articular injections during the time of the study
Characteristics of Episodic Ataxia Syndrome

Episodic ataxia (EA) is a rare genetic disease characterized by episodes of imbalance, incoordination, and slurring of speech. The underlying cause of EA is only partly understood, and currently there are no established treatments. There is also little information about the link between EA's clinical features and its genetic basis. The purpose of this study is to better characterize EA and disease progression. In turn, this may direct the development of future treatments.

Attacks of ataxia, or the loss of ability to coordinate muscular movement, are often triggered by stress or exertion. EA is likely caused by an inherited genetic mutation; many individuals with EA have abnormalities in the KCNA1 or CACNA1A genes. To date, two known subtypes of EA have been identified, and other types likely exist. Specific characteristics of each EA subtype, however, have not been adequately described. The purpose of this study is to better define the clinical features and genetic basis of the various subtypes of EA and to evaluate disease progression. The study will also establish relevant study endpoints for use in future therapeutic trials.

This multi-center observational study will involve both a cross-sectional data analysis and a prospective longitudinal analysis. Participants will initially attend an outpatient study visit that will last 7 hours. This initial evaluation will include a medical history, a physical examination, neurological testing, and an ataxia assessment. Blood will be collected for genetic testing. Additionally, the following procedures may be conducted: ocular motor test, electromyography/nerve conduction study, electroencephalogram, MRI, and digital videotaping. Follow-up evaluations will occur on a yearly basis for at least 2 years; each will last 4 hours.

Eligibility Criteria:
Inclusion Criteria:

* A clinically confirmed diagnosis of episodic ataxia as defined by one of the following three features:

  1. Clear-cut episodes of recurrent, transient ataxia
  2. Mutation confirmed in KCNA1 or CACNA1A
  3. Ataxic features with a first degree relative with episodic ataxia

Exclusion Criteria:

* Any other disorder known to cause episodic ataxia
Twice-daily SIB Radiotherapy Versus Standard Radiotherapy for Patients With SCLC

This trial is a multicenter, perspective, non-blinded, randomized controlled phase 3 trial. In order to establish whether the SIB technique can improve the results of twice-daily chemo-RT for patients with LS-SCLC, the investigators will primarily compare survival of patients treated with standard chemotherapy (cisplatin and etoposide) and either SIB twice-daily RT or standard dose twice-daily RT.

Three hundred and twenty-six patients with a histological or cytological proven diagnosis of SCLC will be recruited from 35 centers in 14 areas including provinces, municipalities and autonomous region, from May 2017 to May 2020.

Eligibility Criteria:
Inclusion Criteria:

* Read the patient information and Sign the informed consent before enrollment
* Either sex, age ≥18 and ≤70
* Histologically or cytologically confirmed SLCL
* Limited stage disease(AJCC, 2009 version 7), stage I-III(T any, N any, M0) that can be safely treated with definitive radiation doses, excludes T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan, clinical nonmalignant diagnosis by investigator when the pleural is too few to obtain cytological evidence.
* measurable lesion according RECIST 1.1
* PS ECOG 0-1
* having zero to two cycles of systemic chemotherapy with etoposide and cisplatin (cisplatin 60-80 mg/m2 at day1 or divided into two to three days, etoposide 100-120 mg/m2 at day 1 to 3, Q21d, and the treatment delay between two cycles shouldn't be more than 14days).
* patients especially female patients must satisfy the investigator that they are not pregnant, or are not of childbearing potential, or are using adequate contraception. Man must also use adequate contraception
* adequate haematological function: white blood cell ≥3.0×109/L , neutrophils ≥1.5×109/L, platelet ≥100×109/L, hemoglobin ≥90g/L.
* adequate liver and renal function: total bilirubin ≤1.5 ×upper limit normal , alanine transaminase and aspartate aminotransferase ≤1.5 ×upper limit normal, normal serum creatinine and/or calculated creatinine clearance ≥60ml/min.

Exclusion Criteria:

* prior surgical resection of the primary tumor or prior RT for lung cancer
* mixed small-cell and non-small-cell histological features
* contemporaneous immunotherapy or target therapy
* pregnancy or lactation
* physical or mental disease that could impact treatment plan
* unable to understand the trial, or could not follow the process
* to refuse the sign the informed consent.
* no history of previous malignancy in the past 5 years (except non-melanomatous skin or in situ servix carcinoma)
* be allergic to any known protocol in this trail
* be enrolled in other clinical trial in past 30days
DNA Cytometry for Cervical Cancer Screening in China

Very few screenings of any kind will be possible during a woman's lifetime in most low-resource regions, where 80% of the half-million global cases of cervical cancer occur every year. Although a single round of human papillomavirus (HPV) testing was associated with a significant decline in the rate of advanced cervical cancers and associated deaths, whether other methods like as DNA image cytometry can be used as an more accurate means than others in screening cervical cancer or not is yet to be verified. In addition, the accuracy of both DNA image cytometry and conventional cytology is not well known. The investigators hypothesized that DNA image cytometry was superior in screening cervical cancer than conventional cytology.


Eligibility Criteria:
Inclusion Criteria:

* Currently or had been married
* Not pregnant
* Had an intact uterus with no prolapse
* Had no history of cervical cancer
* Living in China

Exclusion Criteria:

* Not willing to participate or finish the study at any time
* History of cervical surgeries