cyrilzakka/clinical-trials huggingface dataset:
The Role of Antibiotic Prophylaxis in Cleft Palate and Velopharyngeal Insufficiency Repair

Cleft Lip and Palate surgical repair is one of the most common procedures performed by Plastic and Reconstructive Surgeons in the World. With this in mind, it is curious that no consensus exists regarding the usage of postoperative antibiotics or the effects this might have on wound complications such as cellulitis, dehiscence, or fistula formation. The surgical bed in cleft lip/palate repair is known to harbor a myriad of pathological organisms, indeed the human bite is one of the more clinically and microbiologically significant injuries to treat. This research study is to elucidate the role, if any, that prophylactic antibiotics have in the prevention of complications post cleft palate (CP) and VPI repair and potentially establish a new paradigm of care.

This will be a randomized prospective research study. Participants who will undergo an elective CP or VPI surgery will be randomized to receive either 1) antibiotics or 2) nothing postoperatively. All participants will be evaluated for infection, fistula formation, and dehiscence upon discharge and at 30-day follow-up based on standards of care.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 1 month to 60 years
2. Subjects undergoing independently scheduled elective Cleft Palate of VPI repair
3. Do not meet any exclusion criteria

Exclusion Criteria:

1. Any repeat repair
2. Symptoms of upper respiratory infection
3. Immunosuppressed
4. Allergy to Amoxicillin or any other Penicillins
5. Antibiotic usage \<2weeks prior to scheduled surgery other than immediate pre-operative antibiotics
6. Inability to follow up
Acupuncture, Chinese Traditional Medicine, in Embryo Transfer

The aim of the study is to prove that acupuncture applied before and after embryo transfer is able to increase pregnancy rates by means of reducing stress and improving endometrial vascularization in women receiving in vitro Fertilization (IVF) treatments.

Around 75% of all in vitro fertilization (IVF) treatments fail in providing a healthy baby at home. Most of the women undergoing those techniques suffer in some extent anxiety, depression and stress. Stress make IVF results worse and it has been prove by correlating cortisol, adrenaline and noradrenaline levels with failed cycles. Acupuncture has proved its ability to reduce stress levels. Moreover, Acupuncture has prove to have an effect inhibitory on the sympathetic system and this capacity improves vascularization in uterus and ovaries. Available literature concerning these two issues is not conclusive because of studies design. Acupuncture´s biological mechanism on controlled ovarian stimulation and embryo transfer has not been completely described; if it really has one. Published studies show very different designs and inconclusive/contradictory results can be withdrawn making very difficult to take the clinical decision of recommending acupuncture or not to in vitro fertilization (IVF) patients. If acupuncture really enhance pregnancy rates in IVF cycles still unanswered given that no randomized three arms study comparing no intervention to sham acupuncture to acupuncture has been published.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 37 years old
* 18-28 Body mass index (BMI)
* Medical indication of intracytoplasmic sperm injection (ICSI) treatment to treat sterility
* No previous in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatments
* No previous experience of acupuncture treatments
* At least one high quality embryo in the day of uterine transfer

Exclusion Criteria:

* Polycystic ovarian syndrome
* Endometriosis
* Reproductive surgeries: any on uterus, fallopian tubes or ovaries
* Ovarian cysts \>20mm at the beginning of the stimulation cycle
* Hormone treatment in the previous three months of the stimulation cycle, including oral contraceptives
* Previous miscarriages and ectopic pregnancies
* Coasting
* Oestradiol levels \>3500pg/ml or ovarian size \>65mm in human chorio gonadotropin (hCG) day.
* Failure to keep confidentiality
* Concomitant illness or severe adverse reaction
Fibrotic Interstitial Lung Disease Early Recognition and Strategic Therapy Study in China

This project aimed to: 1) construct a cohort of no less than 10000 cases of f-ILD (including pneumoconiosis ≥3000 cases) with continuous regular follow-up to reveal the clinical phenotypes closely related to the development, progression and prognosis of pulmonary fibrosis; 2) systematically evaluate the safety and effectiveness of frozen lung biopsy, surgical lung biopsy/thoracoscopic lung biopsy and other techniques, and to optimize the histological diagnosis method of f-ILD; 3) construct a set of artificial intelligence (AI) evaluation system for quantitative evaluation of pulmonary fibrosis and its severity, and develop application software; 4) excavate and verify important molecular targets for the formation of pulmonary fibrosis and identify biomarkers; 5) combined with clinical phenotype, imaging, pathology and biomarkers to establish f-ILD early recognition and progress model, intervention strategies, guidelines and consensus, and applicated nationwide.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as ILD

Exclusion Criteria:

* Lack of chest CT
* Patients refused to participant
Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia

Assess the effect of a customized audio track delivered via standard commercially-available bone conduction headsets on the quality of sleep

A single-center study in 25 subjects suffering from moderate to severe insomnia and assess the effectiveness of the intervention. Intervention consists of treatment using a customized audio track delivered via standard commercially-available bone conduction headsets daily for four (4) weeks. Effectiveness is defined by a statistically significant improvement in Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) at baseline versus the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Meets DSM 5 criteria for insomnia disorder
* Insomnia Severity Index (ISI) of 15 - 28

Exclusion Criteria:

* Use of sleep medications, sedating or alerting medications or antidepressants in the last 3 months
* Diagnosis of any autoimmune disorder or any medical or sleep disorder that could affect sleep
* Pregnancy
Culture and Well-Being for Latinos

The proposed K23 study is an intervention study using an experimental therapeutics approach. This pilot RCT asks: "Does SOCIAL-ENGAGE increase cultural-social engagement and decrease suicide risk among Spanish-speaking adults?" We will first optimize a behavioral intervention - SOCIAL ENGAGE (S-ENGAGE) - for target engagement using human-centered design approaches with Spanish-speaking adults at risk for suicide (n=5) and then conduct a pilot RCT (n=60) to test target engagement (cultural-social engagement) and clinical impact (suicide risk) of S-ENGAGE with this population. The ultimate goal is for S-ENGAGE to be offered as a suicide prevention program for Hispanics at risk for suicide.


Eligibility Criteria:
Inclusion Criteria:

* Identify as Hispanic/Latino adult (age 18+);
* Primary Spanish-Speaker;
* Patient in the UR health system;
* Low cultural-social engagement (i.e., score ≤ 2 on the adapted Berkman-Syme Social Network Index);
* Elevated suicide risk (i.e., presence of passive or active suicide ideation in the past month on the Columbia-Suicide Severity Rating Scale \[C-SSRS\]).

Exclusion Criteria:

* Medical or psychiatric comorbidities that impair ability to consent (e.g., active psychotic or manic episode, cognitive impairment).
Modeling Variation of the Objective Mental Workload for Tasks Requiring Different Cognitive Functions.

This study focuses on the identification of objective mental workload (through ElectroEncephaloGraphy) during tasks involving different cognitive functions.

In a medical context based on the solicitation of various cognitive functions, it is essential to be able to modulate the level of difficulty of the task, to maintain a constant level of mental workload while preserving the playful aspect of the activity. This must be sufficient to maintain the person's involvement without inducing too high a mental workload.

However, currently, there is no standardized model of variation of mental workload for cognitive tasks that could be used to modulate the difficulty. The present study is therefore part of this context and concerns the identification of the mental workload during tasks requiring cognitive functions such as memory or attention.

Further this study will allow to adapt in real time the difficulty of virtual tasks to the mental workload of people. In other words, to have a universal brain decoder of the mental workload.

Eligibility Criteria:
Inclusion Criteria:

* Age\> 20 years old and \<50 years old
* French-speaking men or women
* Fluent in French (native speaker or fluent)
* Hold at least a baccalaureate +2
* Right-handed
* Having normal or corrected to normal vision
* Having normal or corrected to normal hearing

Exclusion Criteria:

* Minors
* Adults under guardianship or curatorship
* Non-French speakers
* Sleep debt at the time of the experience
* Daltonism
* Vision and hearing uncorrected to normal
* Pregnant or breastfeeding women
* History of associated cranial trauma or any other neurological pathology altering the cerebral sensory-motor system or the cognitive capacities and higher functions.
BIBW 2992 (Afatinib) in Combination With Pemetrexed in Advanced Solid Tumours

This Phase I study will investigate the safety of BIBW 2992 in combination with standard dose pemetrexed (500mg/m2) given on a 21 day cycle in patients with advanced solid cancers. BIBW 2992 will be given on two different dose schedules; dosing on days 1-21 and dosing on days 1 to 6 of a 21 day cycle.

The use of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs), including BIBW 2992 have demonstrated efficacy in solid tumors including non-small cell lung cancer (NSCLC). In addition, pemetrexed has demonstrated efficacy and has been approved as single agent chemotherapy in second-line NSCLC patients with adenocarcinoma. The data obtained from this trial shall allow for a conclusion as to whether BIBW 2992 may be safely administered in advanced cancer patients in combination therapy with pemetrexed.


Eligibility Criteria:
Inclusion criteria:

1. Age 18 or older.
2. Eastern cooperative oncology group performance status of 0-2.
3. Life expectancy of at least 12 weeks.
4. Measurable disease according to Response evaluation criteria in solid tumors 1.1 criteria.
5. Written informed consent

Exclusion criteria:

1. Treatment with an investigational drug within the past 28 days prior to the start of therapy
2. Persisting toxicities which are clinically significant from previous therapy
3. Patients who are unwilling or unable to take folic acid and vitamin B12 supplementation
4. Active brain metastases
5. Other active malignancy diagnosed within the past 3 years
6. Concomitant intercurrent illnesses that would limit compliance with trial requirement
7. Patients unable or unwilling to interrupt concomitant administration of Non-steroidal anti-inflammatory drugs (NSAIDS) as per pemetrexed prescribing information
8. Patients who have received prior therapy with BIBW 2992
9. Left ventricular function by echocardiogram or Multiple gated acquisition scan (MUGA) less than institutional lower limit of normal
10. Absolute neutrophil count (ANC) less than 1,500/mm3
11. Platelet count less than 100,000/mm3
12. Hemoglobin less than 90g/L
13. Total bilirubin less than 26µmol/L
14. Alanine amino transferase (ALT) and/or aspartate amino transferase (AST) greater than 2.5 X ULN, except in case of known liver metastasis where maximum 5 X ULN is acceptable
15. Serum creatinine level greater than 133µmol/L and/or creatinine clearance (measured or calculated) less than 45 ml/min
16. History or recent gastrointestinal bleeding, obstruction or perforation or malabsorption syndrome and must be able to swallow the BIBW 2992 in whole by mouth.
17. History of interstitial lung disease
18. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
19. Pregnancy or breast feeding
20. Known or suspected active alcohol or drug abuse
21. Patients unable to comply with the protocol
22. Has a diagnosis of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
23. Any known hypersensitivity to the trial drugs or their excipients
A Feasibility Study of Mindfulness Training Transcranial Direct Current Stimulation (tDCS) in Adults With Overweight and Obesity

This study will investigate the feasibility of combining an app-based Mindfulness training (MT) with at-home administered transcranial direct current stimulation (tDCS) in adults with overweight or obesity and assess whether MT with tDCS may improve weight-related behaviours in this population. Specifically, the study will assess whether MT+ active tDCS, as opposed to MT+ sham tDCS or waiting list control, reduces high calorie food craving and consumption. Findings will inform the development of a future large-scale randomised controlled trial. The trial will be conducted in the UK.

A randomised controlled feasibility trial with three parallel arms: \[MT + real tDCS\] vs \[MT + sham tDCS\] vs \[Waiting list control group\].

Eligibility Criteria:
Inclusion Criteria:

* Right-handed adults aged 18 to 60 w
* Overweight or obese (BMI ≥25 kg/ m2) according to World Health Organisation (WHO) criteria.
* Use and understand English as a language for everyday conversation.
* Have access to a laptop or desktop computer with webcam and to able to attend baseline, post intervention and follow up assessments in the Institute of Psychiatry, Psychology and Neuroscience (KCL).

Exclusion Criteria:

* Insufficient written and spoken English
* All known contraindications to tDCS (Brunoni et al., 2012)
* Pregnancy; history of neurological disease and/or seizure
* Having any metallic implants in the head or body
* History of head or eye injury
* Significant health problems in the previous six months
* A lifetime diagnosis of substance dependence, psychosis, bipolar disorder, borderline personality disorder; any other primary psychiatric disorder requiring treatment in its own right
* Taking psychotropic medication
* Taking medication for weight loss Regular, current or past, mindfulness meditation or yoga practice (defined as \> 20 minutes, twice or more per week during the past 2 months)
* Consuming more than 14 units of alcohol per week who are unwilling to reduce their alcohol intake for the duration of the treatment
* Current illicit drug use
* Learning difficulties that would preclude safe tDCS self-administration and/or completion of questionnaire measures and neurocognitive tasks (e.g.; working memory and inhibitory control)
* Current atypical anorexia nervosa or purging once a week or more.
Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients

The aim of the study is to investigate the safety of a 6% hydroxyethyl starch (HES) solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in trauma patients.


Eligibility Criteria:
Inclusion:

* Male or female adult patients ≥18 years of age. Women of child bearing potential must test negative on standard pregnancy test (urine or serum) (as soon as possible during emergency care)
* Patients with blunt or penetrating trauma suffering from estimated blood loss of ≥ 500 ml
* Initial surgery deemed necessary within 24 hrs after trauma
* Deferred signed written informed consent form or as locally required
* No signs of intracranial or cerebral hemorrhage
* Administration of less than 15 ml/kg body weight colloid between trauma injury and hospital admission.

Exclusion:

* Hypersensitivity to the active substances or to any of the other excipients of the Investigational Products
* Body weight ≥ 140 kg
* Patients expected to die within 24h after traumatic injury
* Sepsis
* Burns
* Renal impairment (AKIN stage ≥ 1 or chronic) or acute and/or chronic Renal Replacement Therapy
* Critically ill patients (typically admitted to the intensive care unit)
* Hyperhydration
* Pulmonary edema
* Dehydration
* Hyperkalemia
* Severe hypernatremia
* Severe hyperchloremia
* Severely impaired hepatic function
* Congestive heart failure
* Severe coagulopathy
* Organ transplant patients
* Metabolic alkalosis
* Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)
Environmental and Genetic Determinants of Nasopharyngeal Carcinoma (NPC)

Nasopharyngeal carcinoma (NPC) is one of the most common malignant tumors in southern China and Southeast Asia. While infection with Epstein-Barr Virus (EBV) is believed to be necessary for the development of NPC, non-viral environmental factors have also been implicated to increase the risk of NPC including consumption of salted fish and other nitrosamine containing preserved foods, formaldehyde and wood dust exposure, and cigarette smoking. In addition to environmental factors, it is widely accepted that genetic susceptibility also plays an important role in the pathogenesis of NPC. Polymorphisms in genes involved in nitrosamine metabolism and DNA repair have been suggested to be associated with NPC risk, and various chromosomal regions linked to NPC development have been reported. These associations highlight the role of both environmental and genomic components in the etiology of NPC.

There is a longstanding history of international collaborative studies to elucidate the role of environmental and genetic factors associated with NPC between investigators in Taiwan and the USA. A case-control study (375 cases; 327 controls) was conducted in the early 1990s, and a large multiplex family study that was completed in 2006 (358 families; 3,216 individuals). Results from these studies have provided some of the most comprehensive epidemiological evidence regarding factors linked to NPC development to date.

As a next logical step, the opportunity now exists to undertake a genome-wide association study of NPC in Taiwan with carefully collected environmental exposure data to systematically examine environmental and genetic factors associated with NPC, and to evaluate gene-gene and gene-environment interactions. The investigators propose a case-control study of 2000 NPC cases (both retrospective \[n=800\] and prospective \[n=1,200\]) and 2,000 age-gender-matched hospital controls in northern Taiwan. The study objectives are to: 1) evaluate putative environmental exposures and NPC; 2) assess the effect of genetic factors, including both single nucleotide polymorphism and copy number variation through analysis of both main effect and gene-gene interaction; 3) investigate gene-environment interactions by testing for interactions between significant genome-wide genetic variations and EBV and other identified environmental risk factors; and 4) examine the natural history of EBV infection.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with NPC

Exclusion Criteria:

* Case group and control group younger than 18 age. Control group, the reasons for hospitalization for the EB virus-related disease
Opioid Analgesic Reduction Study

The goal is to provide health care professionals, including dentists, with the best possible evidence for clinical decision making when deciding upon analgesics for acute post-surgical pain management, a double-blind, stratified randomized clinical trial will be conducted to test the hypothesis that a combination of over-the-counter non-opioid containing analgesics is at least as, if not more, effective (non-inferior) than the most commonly prescribed opioid analgesic. The impacted 3rd molar extraction model will be used due to the predictable severity of the post-operative pain and generalizability of results.

This double-blind, prospective, stratified, randomized pragmatic clinical trial will use the impacted 3rd molar extraction pain model.


Eligibility Criteria:
Inclusion Criteria:

An individual must meet all of the following criteria to be eligible to participate in the study:

* Be able to understand the informed consent.
* Provide signed and dated informed consent form
* Be able to understand all directions for data gathering instruments in English
* Be willing and able to comply with all study procedures and be available for the duration of the study
* Planning to undergo extraction of one or more partial or fully impacted mandibular 3rd molars
* Be 18 years or older
* Be in good general health as evidenced by medical history
* Women must agree to use one of the following methods of contraception while participating in this study:

  * contraceptive pill
  * intra-uterine device
  * condoms
  * abstinence

Exclusion Criteria:

Participants who self-report the following history will be excluded from participating:

* History of gastrointestinal bleeding and/or peptic ulcer
* History of renal disease (excluding kidney stones)
* History of hepatic disease
* History of bleeding disorder
* History of respiratory depression
* Any prior respiratory effect of an opioid or other anesthetic drugs that required respiratory support postoperatively
* Active or untreated asthma
* History of known allegoric reaction to ibuprofen, acetaminophen, hydrocodone, and/or anesthesia
* Currently taking any of the following medications:

  * CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), which may increase plasma concentrations of hydrocodone bitartrate and acetaminophen and prolong opioid adverse reactions, and which may cause potentially fatal respiratory depression
  * CNS depressants.
* Consumes 3 or more alcoholic drinks every day and/or has a history of alcoholism
* History of drug or alcohol abuse
* Family history of drug or alcohol abuse in a first-degree relative
* Has had no more than one opioid prescription filled within the past 12 months
* Currently pregnant or lactating

Participants would also be excluded due to any additional criteria that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study which includes:

* Prior participation in this study
* Inability or refusal to provide informed consent
Achieving Resilience in Acute Care Nurses (ARISE).

Nurses are exposed to myriad stressors, both in the workplace and in their everyday lives, which can lead to adverse personal and professional outcomes. While workplace stress cannot be eliminated, nurses can learn techniques to build resilience, mitigate stress, and decrease fatigue. Organizational employee health, wellness, and assistance programs are all intentioned to provide this type of support; however, nurses often lack awareness of options and opportunities, and access can be a challenge. The purpose of the proposed study is to assess the outcomes of a multi-modal intervention and toolkit, ARISE, designed to enhance resilience and promote awareness of organizational resources for health, wellness, and employee assistance. We will evaluate the impact of participation in ARISE on resilience and other outcomes in nurses in critical care and trauma settings. As a Best Practice Spotlight Organization designated by the Registered Nurses Association of Ontario (RNAO), this project will incorporate relevant recommendations from Best Practice Guidelines (BPG) related to Workplace Health, Safety, and Well-being of the Nurse; and Preventing and Mitigating Nurse Fatigue in Health Care.


Eligibility Criteria:
Inclusion Criteria:

* Nurse in the medical-surgical and trauma-neurosurgical intensive care units (MSICU and TNICU) and the medical/surgical floor (9CCN),
* full-time or part-time employment status,
* approval of clinical leader manager (CLM),
* receipt of written informed consent.

Exclusion Crieria:

* casual employment status
* inability to attend intervention days