cyrilzakka/clinical-trials huggingface dataset:
Nerve Block Anesthesia Combined With Sedative Anesthesia Versus General Anesthesia in Surgery for CSDH

A prospective, multicenter, randomized controlled trial is designed to evaluate the safety of nerve block anesthesia combined with sedative anesthesia versus general anesthesia during burr hole craniostomy with drainage for chronic subdural hematoma.

This is a prospective, multi-centre, randomised, controlled, single-blinded, non-inferiority trial. Patients with chronic subdural hematoma undergoing burr-hole drainage will be randomly allocated to receive either the cranial nerve block with dexmedetomidine sedation or general anaesthesia. Patients in the cranial nerve block with dexmedetomidine sedation group will receive cranial nerve block with 0.5% ropivacaine and 1% lidocaine mixture according to incision, combined with dexmedetomidine infusion at a rate of 2-4ug/kg for 10 minutes, followed by a continuous infusion of 0.5 to 1ug/kg/h until the end of the operation. Patients in the general anaesthesia group will be induced with propofol or etomidate, sufentanil, rocuronium or cis-atracurium and be maintained with total intravenous anaesthesia. The primary outcome is the incidence of intraoperative limb movement. Secondary outcomes include postoperative delirium within five days after surgery, anaesthesia conversion, postoperative neurological function, intraoperative awareness, and recurrence rate of hematoma within 6 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic subdural hematoma with preoperative neurological dysfunction for burr hole drainage;
* Age beween 18 to 80
* Chronic subdural hematoma verified on cranial computed tomography or magnetic resonance imaging with hematoma thickness \>1.0cm or midline shift \>1.0 cm.
* Written informed consent obtained

Exclusion Criteria:

* Preoperative unconsciousness (Glasgow Coma Scale\<13, or Markwalder Grade 2-4) or cognitive dysfunction (Mini-Cog≤3, or MMSE≤20)
* Preoperative sensory or motor aphasia
* Recurrence of hematoma with previous surgery for chronic subdural hematoma.
* Previous intracranial surgery or with intracranial lesion
* with severe comorbidity or other organ dysfunction
* Allergic to anesthetics
* Severe coagulopathy or high risk of life-threatening bleeding
* Participating in another research
Effect of High School Alcohol Policies on Students' Binge Drinking- a Natural Experiment

The aim of the project is to evaluate the effects of the introduction of new mutual alcohol policies in 30 high schools in 2017 on students binge drinking.

In August 2017, 13 high schools in Zealand and all of Funen's 11 high schools and 6 high schools in Ringkøbing introduced new mutual alcohol policy for alcohol on study trips, parties, cafes and other social events.

The background for the introduction of the alcohol policies was the aim of reducing alcohol intake among students and that alcohol should have a less dominant role. By setting the same framework, the alcohol policies aims at promoting community, responsibility and respect.

The aim of the project is to evaluate the effects of the introduction of new mutual alcohol policies on students binge drinking.

The analysis is a natural experiment that compare binge drinking among students at schools after the introduction of the policy with binge drinking among students a schools that did not introduce the policy.

Eligibility Criteria:
Inclusion Criteria:

* High school student

Exclusion Criteria:

-
Bleaching Procedures Performed During Treatment With Brackets and Clear Aligners

The aim of this study is to compare the effectiveness of different whitening methods used during orthodontic treatment with fixed appliances and clear aligners. It also aims to examine the effect of different whitening methods on white spot lesions and the color change they cause in the teeth.

During orthodontic treatment, if oral hygiene is not properly maintained or in long-term treatments, tooth discoloration may occur. In clear aligner treatment, failure to regularly clean the aligners or the consumption of staining foods and beverages while wearing the aligners can lead to staining and yellowing of the tooth surfaces.

The aim of this study is to compare the effectiveness of different whitening methods used during orthodontic treatment with fixed appliances and clear aligners. It also aims to examine the effect of different whitening methods on white spot lesions using quantitative light-induced fluorescence (QLF) and to evaluate the color changes in the teeth during the treatment process.

Eligibility Criteria:
Inclusion Criteria:

* No previous orthopedic or orthodontic treatment
* Mild or moderate malocclusion
* Non-smokers and non-alcohol consumers
* Consumes no more than 3 cups of tea or coffee per day
* Good oral hygiene and healthy periodontal tissues
* No cavities, restorations, pigmentation, or white spot lesions on the anterior teeth
* Chronological age between 16-30 years, regardless of bone age

Exclusion Criteria:

* Individuals requiring extraction-based treatment
* Individuals who have previously undergone whitening treatment
* Individuals with endogenous tooth discoloration
* Individuals with genetic tooth pigmentation
* Individuals in the mixed dentition phase
Impact of Patients Risk Factors on the Longevity of Aesthetic Restorations

The objective of this double-blind randomized clinical trial is to evaluate the influence of caries risk, occlusal stress and missing teeth on anterior restorations over a 10 years follow up period. 300 teeth will be randomized according to two adhesive systems: Single Bond 2 and Single Bond Universal (3M ESPE); and two composite resins: nanoparticulated (Filtek ™ Z-350- 3M ESPE) and nanohybrid (IPS Empress Direct - Ivoclar Vivadent). The randomization will be stratified according to the risk of caries and cavity type. The primary outcomes will be longevity, annual failure rate (AFR) and the success of the restorations, and the secondary outcome will be causes for restorations' failure.


Eligibility Criteria:
Inclusion Criteria:

* Patients with restorative needs in anterior teeth;
* Patients able to understand and sign the informed consent form;
* Patients willing to return to follow up.

Exclusion Criteria:

* Patients who had a need for Class III and Class IV restorations that did not involve at least 1/3 of the tooth;
* Patients under orthodontic treatment;
* Patients with a compromised general health condition, presenting a greater risk than ASA II, according to the ASA-PS (American Society of Anesthesiologists - Physical Status);
* Patients who had no occlusal contact with an opposing tooth and/or crown;
* Patient with absence of bilateral balanced occlusion;
* Patient with deep caries lesions in close contact with the dental pulp and in need of expectant treatment or direct pulp capping;
* Patients with post-retained need in anterior teeth.
Effect of Core Muscles Activation for the Increase of Quality in Cardiopulmonary Resuscitation

The purpose of this study is to determine whether core muscle activation is effective in the increase of quality of cardiopulmonary resuscitation.


Eligibility Criteria:
Inclusion Criteria:

* Registered nurses who have experiences of CPR education

Exclusion Criteria:

* 1. Acute/chronic pain on body 2. History of cardiovascular disease 3. History of vertebral disease including herniated disc 4. Pregnancy
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression.

An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment with DSXS in Patients with Atopic Dermatitis

To evaluate the potential of DSXS topical product to suppress HPA axis function in patients with moderate to severe atopic dermatitis.

Eligibility Criteria:
Inclusion Criteria:

* Parent/legal guardian has signed informed consent form, which meets all criteria of current FDA regulations.

Exclusion Criteria:

* Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy
The Effect of Environmental Pollution on Colorectal Cancer

Colorectal cancer (CRC) is one of the most common malignancies worldwide, and its main risk factors include age, genetic factors, inflammatory bowel diseases (e.g., ulcerative colitis and Crohn's disease), unhealthy diets (e.g., high-fat, low-fibre diets), obesity, physical inactivity, smoking, and excessive alcohol consumption. The relationship between environmental pollution and colorectal cancer has received increasing attention in recent years. Studies have shown that long-term exposure to fine particulate matter in the air, such as passive smoking, soot and oil smoke exposure, incense burning exposure, occupational exposure and outdoor work, PM2.5, PM10 and NO2 may increase the risk of colorectal cancer. These particulate matter can enter the lungs through breathing and trigger a chronic inflammatory response in the systemic system, thus increasing the risk of cancer development. This study intends to determine the extent of air pollution's impact on colorectal cancer prognosis by analysing survival data of colorectal cancer patients in regions with different pollution levels. As well as to investigate the association between air pollution levels and postoperative recurrence in colorectal cancer patients, looking for possible mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years;
* patients diagnosed with colorectal cancer by pathological biopsy before surgery;
* patients did not undergo chemotherapy, radiotherapy, targeted and immunotherapy, etc. before enrolment;
* willing to participate in this study and sign an informed consent form;
* complete clinical data.

Exclusion Criteria:

* patients with primary malignant tumours other than colorectal cancer;
* patients with systemic diseases, such as severe cardiopulmonary insufficiency, that affect the choice of treatment options;
* patients who are not suitable for enrolment as assessed by the investigator;
* incomplete clinical data.
Randomized Controlled Trial of the Impact of Mobile Phone Delivered Reminders and Travel Subsidies to Improve Childhood Immunization Coverage Rates and Timeliness in Western Kenya

The project goal is to conduct a randomized controlled trial (RCT) to test whether mobile phone short message system (SMS) reminders, either with or without mobile-phone based travel subsidies will improve timeliness, coverage, and drop-out rates of routine EPI vaccines in rural western Kenya.


Eligibility Criteria:
Inclusion Criteria:

1. Mother of infant aged 0-4 weeks during the study period
2. Current resident of one of the study villages
3. Willing to sign informed consent for the study

Exclusion Criteria:

1. Plans to move out of the study area in the next 6 months
2. Resides in a village with active immunization intervention/program
3. Has already received immunizations other than birth dose of BCG or polio
Antimicrobial-free Production of Beef Cattle's Affect on Gut Microbiome

The primary purpose of this study is to assess whether consuming foods from animals raised with antimicrobial medications influences gut health in adults between the ages of 21-69 years old. Antimicrobial medications are commonly used to help animals avoid infections while growing.

The researchers plan to investigate differences in the resistome (i.e., populations of antimicrobial resistance genes) and microbiome (populations of bacteria) in feces obtained from people when they consume diets containing beef derived from cattle raised conventionally (i.e. using antimicrobial drugs(AMDs)) vs. those produced in raised without antibiotics (RWA) systems. In addition, the researchers will investigate whether specific antimicrobial resistant (AMR) genes are transmitted from food to people.

The hypothesis is that beef is not a significant source of resistant bacteria, and there is no difference in the likelihood of gut colonization with resistant bacteria in people eating beef derived from cattle raised conventionally (i.e. using AMDs) vs. those eating beef produced in RWA systems.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 21-69 years old;
* BMI 22.0-34.9 kg/m2;
* Fasting serum total cholesterol \<240 mg/dL, low-density lipoprotein cholesterol \<160 mg/dL, triglycerides \<400 mg/dL, and glucose \<110 mg/dL;
* Systolic/diastolic blood pressure \<140/90 mmHg;
* Body weight stable (± 4 kg in previous 3 mo);
* Medication use stable for 6 months prior and not using medications or supplements known to impact gut function;
* No use of topical, oral or parenteral antibiotic medications in previous 6 months.
* Non-smoking;
* Physical activity regimen stable for 3 months prior;
* Not drinking more than 2 alcoholic drinks per day;
* No history of gastrointestinal disorders, surgeries or cancers;
* Non-pregnant and not lactating
* No acute illness and non-diabetic;
* Willing and able to consume the prescribed diets that may include meat, dairy and gluten-containing foods and beverages.

Exclusion Criteria:

* Male or female, \< 20 or \>70 years old;
* BMI \< 21.9- \>35 kg/m2;
* Fasting serum total cholesterol \>240 mg/dL, low-density lipoprotein cholesterol \>160 mg/dL, triglycerides \>400 mg/dL, and glucose \>110 mg/dL;
* Systolic blood pressure \>140 mmHg, diastolic blood pressure \>90 mmHg;
* Body weight stable for \< 3 months prior (±3 kg);
* Stable physical activity regimen \< 3 months prior;
* Medication use unstable for 6 months prior and using medications or supplements known to impact gut function;
* Smoking;
* Drinking more than 2 alcoholic drinks per day;
* Diabetic;
* A history of gastrointestinal disorders, GI surgeries or GI cancers;
* Pregnant or lactating
The Research of the Effect of Sevoflurane on Brain-protection of Cardiac Surgery in Infants.

To observe the effect of sevoflurane on the concentration of S100β and regional cerebral oxygen saturation in infants with congenital heart disease undergoing cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of congenital heart disease
* Undergoing heart surgery with cardiopulmonary bypass

Exclusion Criteria:

* Pulmonary arterial hypertension
* Sevoflurane allergy
Chemotherapy vs Hormonal Treatment in Platinum-resistant Ovarian Cancer Resistant or Refractory to Platinum and Taxane

A randomized study of chemotherapy versus hormonal treatment in patients with ovarian cancer resistant or refractory to platinum and taxane.

Patients with platinum-resistant invasive epithelial ovarian, fallopian tube or peritoneal cancer will be randomized 1:2 to either hormonal treatment with Tamoxifen 40 mg daily or chemotherapy of investigator's choice (weekly paclitaxel given as an 1 hour infusion of paclitaxel 80 mg/m2 or pegylated liposomal doxorubicin 40 mg/m2 given every 4 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Patients with invasive epithelial ovarian, fallopian tube or peritoneal cancer, being resistant to treatment with platinum and a taxane, either given in combination or sequentially.
* Patients with clinical progression during or within 6 months after end of treatment for primary disease or relapse.
* Patients with stable disease after 6 courses of chemotherapy for primary disease or relapse if further treatment is indicated.
* Patients with doubling of s-CA 125 to at least 70 IU/Ml within 3 months after end of treatment for primary disease or relapse.
* Age must be at least 18 years.
* Performance status must be 0-2 (WHO/ECOG, appendix 1).
* Informed consent given according to ICH/EU GCP guidelines and local or national laws

Exclusion Criteria:

* Patients with symptomatic brain metastasis
* Bilirubin greater than 2 x UNL (upper normal limits), white blood cell count below 3.0 x 109/L, neutrophil count below 1.5 x 109/L, platelets count below 100 x 109/L.
* Active infection or other serious underlying medical condition which might prevent the patient from receiving treatment or to be followed.
* Pregnant, lactating, or child bearing potential patients without adequate contraception
* Previous treatment with Tamoxifen.
5 Years Long Term Results After Standalone CyPass-Implantation

This study evaluates the results of all clinically relevant findings of glaucoma diagnostics 5 Years after stent-implantation concerning the safety and effectiveness of the cypass stent procedure. The comparison of Preoperative and long term postoperative results is the aim of this study to evaluate this young procedure of Glaucoma surgery

This is a post market study without interventions.The participants have been treated with CyPass-Stent implantation between 3 and 7 years ago to control the intraocular pressure . They will be invited for only one follow up visit to determine the present glaucoma status again, to determine the long term safety and effectiveness of the cypass stent procedure and to see whether addition therapy or surgical intervention is necessary.

Eligibility Criteria:
Inclusion Criteria:

* patients who have undergone a standalone cypass implantation at least 3 years ago
* signed inform consent

Exclusion Criteria:

* Patients with too much travel distance between study center and home
* Patients who cannot visit the studycenter due to health problems
Efficacy of Continuous Sciatic Nerve Block in Diabetic Foot Patients

Patients who underwent surgery for diabetic foot were divided into three groups: sciatic nerve block (Group B), continuous nerve catheter (Group C) . Group B patients underwent preoperative popliteal ultrasound guided peripheral nerve blockage. 20 ml of 0.25% bupivacaine was administered. In Group C patients, 20% bupivacaine 20 ml was applied to the sciatic nerve with a peripheral nerve catheter and continuous infusion was started with patient controlled analgesia device.

Ethics committee approval was received on 12 December 2019, numbered 19/344. The study was planned to include 90 adult patients undergoing diabetic foot surgery at Gülhane Training and Research Hospital between 12 December 2019 and February 2020. These patients were divided into three groups: sciatic nerve block (Group B), continuous nerve catheter (Group C). Group B patients underwent preoperative popliteal ultrasound guided peripheral nerve blockage. 20 ml of 0.25% bupivacaine was administered. In Group C patients, 20% bupivacaine 20 ml was applied to the sciatic nerve with a peripheral nerve catheter and continuous infusion was started with patient controlled analgesia device. Preoperative and postoperative blood flow of the popliteal and tibialis posterior arteries, pain scores of patients were evaluated with numeric rating scale and wound healing was monitored and recorded. The differences between the groups were compared statistically.

Eligibility Criteria:
Inclusion Criteria:

* undergoing diabetic foot surgery
* spending the first postoperative night hospitalized
* age 40 years or older

Exclusion Criteria:

* inability to communicate with the investigators and hospital staff
* incarceration
* clinical neuropathy in the surgical extremity
EBV-associated Diffuse Large B Cell Lymphoma

The aim of this study is to characterize and compare clinical, pathological (histology, immunophenotype) and molecular features of EBV-related GZL and DLBCL: do they belong to the same entity or to two different subtypes of EBV-related lymphoma ?

Recent progresses in the understanding of lymphoma biology allowed the identification of new categories in the WHO classification of lymphoid neoplasm. Among these new entities, grey zone lymphoma (GZL) between classical Hodgkin lymphoma and diffuse large B cell lymphoma entered the classification as a provisional entity in 2008 and Diffuse large B cell lymphoma (DLBCL) EBV-associated not otherwise specified in patient without history of immunodepression in 2016. These entities need however to be further characterized as no clear pathological definition and distinction between EBV related GZL and EBV related DLBCL are proposed in the literature.

After primary infection that occurs in almost 80% of young adult population in western country, EBV latency state settles in a small portion of B cells. The virus is known to promote B-cells proliferation and transformation through complex mechanisms.

EBV-associated lymphoproliferative disorders have already been largely studied in immunocompromised host (human immunodeficiency virus, congenital immunodeficiency, immunosuppressor and post-transplant lymphoproliferative disorder, e.g.), but its role is largely unknown in patients with no history of immunodeficiency. Whether these patients arbor an underlying type of immune deficiency has not yet been established, even though immunosenecence in elderly or immaturity of the immune system in children has been postulated in those population.

Based on former definition, EBV-associated lymphoproliferation were usually the apanage of classical Hodgkin lymphoma (cHL) or immunodeficiency-associated lymphoproliferative disorders. However, as published recently, several different histological patterns with intermediate features between primary mediastinal B cell lymphoma (PMBCL) and classical Hodgkin lymphoma (cHL), namely grey zone lymphoma (GZL), but also diffuse large B cell lymphoma (DLBCL) were described to be EBV-associated. On the clinical point of view, patients with GZL are young and have a poor prognosis. Data regarding EBV+ DLBCL are discordant and further studies are warranted, even though initial report concluded to a poor prognosis for these patients.

Eligibility Criteria:
Inclusion Criteria:

* all EBV-related GZL and DLBCL in immunocompetent patients
* Age minimum: 18 years old

Exclusion Criteria:

* Another diagnosis than EBV-related GZL and DLBCL
* \<18 years old