cyrilzakka/clinical-trials huggingface dataset:
Recolonisation of Bacteria in Hands and Possible Bacterial Leakage From Glove Cuff in Cardiac Surgery

This study aims to investigate if recolonisation of the hand flora occur after surgical hand washing and is there a bacterial leakage at the glove cuff site in cardiac surgery? Also investigate if thera are differences in microbial flora and recolonisation between hospital and non-hospital persons.

With emerging antibiotic resistant bacteria it is necessary to try to prevent surgical site infections (SSIs).Not only because of suffering and death but also because of increased costs. For a deep sternal infection the cost can be doubled or even tripled. Sternal wound complications can occur from low numbers up to almost 10%, with different severity, depending on follow up routines In an intraoperative environment causative bacteria often originate from either patient or surgical team. One of many preventing measures is to keep patients and surgical members as sterile as possible when it´s the number of bacteria that overcome the host defense that lead to infection. The most common bacteria causing sternal infection is Coagulase negative staphylococci (CoNS) 46% Staphylococcus aureus, 26% and gram- negative bacteria, 18%. One preventing measure is to wear surgical gloves, and to wear double gloving for easy detection of puncture in outer glove. When using indicator gloves there becomes a dark spot were the hole is which tells you to change the glove. At the glove cuff end it often indicate fluid of some sort by getting dark where the sleeve of the gown meets the glove cuff. One may suspect that the fluid thrives from the hand, and if so does the fluid contains any bacteria from the hands. In open heart surgery surgical team wear their gloves for a long period of time. Research implicates that it occurs some recolonisation of bacteria inside the gloves. Does recolonisation of the hand flora occur after surgical hand washing and is there a bacterial leakage at the glove cuff site? It´s discussed that people that are in contact with hospitals carries more bacteria than others and being admitted to hospital before surgery is a risk factor. It is also known that hospital workers are carriers of more bacteria and possibly also carriers of resistant bacteria. At the other hand hospital workers often wash and disinfect their hands. Are there differences in bacterial recolonization of hand flora between hospital staff at an operating department than people in average society who have little or no contact with hospitals?

Eligibility Criteria:
Inclusion Criteria:

* Operating nurse at the department and non-hospital persons

Exclusion Criteria:

* Participated previously in present study
* Use of gloves with antimicrobial effect
* Patient with a known infection
Tumor Perfusion and Hypoxia Assessed by DCE-MRI and 18F-FMISO PET as Biomarkers of Treatment Response in Cervical Cancer

This study is to assess how patients respond to their treatment for cervical cancer. This research does not involve a specific treatment for the cancer that will be recommended by the doctor and may include radiation therapy and/or chemotherapy. This is a separate research imaging study designed to assess how patients respond to their treatment for cervical cancer.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-documented, newly-diagnosed primary cervical cancer of all histopathology types.
* Clinically visible gross lesion (International Federation of Gynecology and Obstetrics (FIGO) stage IB1 and above).
* Treatment (chemoradiation), DCE-MRI and 18F-FMISO PET studies will be at MSKCC.
* Patients must be an adult female 18 years of age or older.

Exclusion Criteria:

* Patients who because of general medical or psychiatric condition, or physiologic status cannot give an informed consent.
* Patients who received prior radiation treatment to pelvis.
* Patients with contraindications to DCE-MRI (non-compatible cardiac pacemakers or intracranial vascular clips, allergy to Gadolinium, end-stage renal disease) and/or 18F-FMISO PET.
* Patients who do not fulfill the screening criteria for safe DCE-MRI or 18F-FMISO PET as per the Department of Radiology guidelines.
* Pregnant patients; and or patients who are breast-feeding their babies.
Evaluation of Pertuzumab-Trastuzumab and Taxane in the Standard Treatment of Metastatic Breast Cancer

This retrospective study evaluated the efficacy and the safety of use of this treatment combined with a taxane for the treatment of HER2-positive metastatic breast cancer and compared the clinical and demographic characteristics of real life patients to the patients of CLEOPATRA.

In 2013 the European Medicines Agency authorized the use of a new antibody named Pertuzumab in combination with Trastuzumab in first-line setting for patients with HER2-positive metastatic breast cancer. The efficacy and the safety were demonstrated in the CLEOPATRA study. This study had inclusion and exclusion criteria that might not be representative of a real life population of women with metastatic breast cancer. Few study tried to evaluate this treatment in real life settings but with discordant results. This retrospective study evaluated the efficacy and the safety of use of this treatment combined with a taxane for the treatment of HER2-positive metastatic breast cancer and compared the clinical and demographic characteristics of real life patients to the patients of CLEOPATRA.

Eligibility Criteria:
Inclusion Criteria:

* metastatic breast cancer
* HER2 positive
* Received pertuzumab in combination with trastuzumab and taxane chemotherapy

Exclusion Criteria:

* no HER2-positive breast cancer
* no association with taxane chemotherapy
* no metastatic breast cancer
* refusal to consent
CT-based Model for Predicting Prolonged Weaning in Patients With Abdominal Trauma

Critically ill patients often require tracheal intubation for mechanical ventilation, and timely weaning is crucial for airway management and reducing complications. However, there is currently a lack of an effective tool to predict weaning time in critically ill patients. This retrospective study established an effective nomogram model for predicting the time of weaning from mechanical ventilation in abdominal trauma patients by considering multiple perspectives. The model has been validated and demonstrated good performance in terms of discrimination, calibration, and clinical utility. Moreover, the model can effectively predict the prognosis of critically ill patients. The findings of this study have important implications for guiding respiratory management in clinically critically ill patients, particularly trauma patients.


Eligibility Criteria:
Inclusion Criteria:

* (1) with information on survival status and time;
* (2) aged 18-80 years;
* (3) admitted to ICU;
* (4) with abdominal CT performed within 1-week post-trauma;
* (5) use of mechanical ventilation.

Exclusion Criteria:

* (1) low-quality CT images;
* (2) history of mental illness.
Safety/Efficacy Study of Drospirenone/Estradiol to Treat Postmenopausal Chinese Women With Vasomotor Symptoms.

The study evaluates in Chinese post-menopausal women the combination of drospirenone 2 mg and estradiol 1 mg for the treatment of climacteric symptoms, such as hot flushes (vasomotor symptoms) and uro-genital complaints.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Chinese postmenopausal women with moderate to severe vasomotor symptoms

Exclusion Criteria:

* History of steroid hormone dependent malignant disease
* Known or suspected malignant or premalignant disease
* Current or history of severe heart, liver, renal, psychiatric disease
* Hyperlipemia
HPV in Adolescents

This study will assess the prevalence of HPV infection in perinatally HIV-infected adolescents, intraepithelial neoplasia, and E6E7 biomarker at cervical and anal sites.

Human Papillomavirus (HPV) is the most common sexually transmitted disease and it causes cervical and anal cancer. Prevalence and incidence of HPV infection among young adults who are sexually experienced is high. No data exist for HIV-positive adolescents in regards to HPV infection, cervical and anal intraepithelial neoplasia. This study will compare the prevalence of HPV infection, intraepithelial neoplasia and E6/E7 biomarker at cervical and anal sites among perinatally HIV-infected adolescents, behaviorally HIV-infected adolescents, and HIV-negative adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Perinatally-infected (documented positive HIV enzyme immunoassay (EIA) or nucleic acid testing (NAT) at any time and history of maternal HIV infection)
* behaviorally-infected (documented positive HIV enzyme immunoassay (EIA) or nucleic acid testing (NAT) at any time after sexual debut without history of maternal HIV infection)
* female with vaginal or receptive anal intercourse with a male OR male with receptive rectal intercourse with another male
* Signed informed consent. Volunteers aged 12-17 years can decide whether they wish for their parents to consent for their participation. Due to the confidential nature of the issues being studied, parental consent may be exempted

Exclusion Criteria:

* Have any conditions that may interfer with subjects' ability to understand and consent to the study
Safety And Efficacy Of Spirinolactone Plus Hydroflumethiazide In The Treatment Of Filipino Patients With Hypertension

Aldazide 25 mg OD will be given to Filipino hypertensive patients, and there will be 2 follow-up visits on week 4 and week 8 to monitor for safety and efficacy as primary and secondary outcomes, respectively.

Prospective, non-interventional non-probability sampling

Eligibility Criteria:
Inclusion Criteria:

* Patients \>/= 18 years old with Stage 1 or 2 hypertension not controlled by monotherapy or by a combination of anti-hypertensives without any diuretic yet.

Exclusion Criteria:

* Pregnant or lactating women, with hypersensitivity to Aldazide, patients with resistant hypertension not controlled by a combination therapy with a diuretic in their regimen
LV Endocardial CRT for Patients With Intermediate QRS Width

This pilot study is designed as a multi-centre cohort study determining the degree of LV reverse remodeling in patients with intermediate QRS widths (120-149ms) who undergo CRT implant with transseptal LV leads, and comparing to the average expected reverse remodeling rate in patients with standard transvenous coronary sinus leads and QRS widths ≥150ms.

This is a multi-centre prospective cohort trial to establish the feasibility of endocardial CRT implants.This trial will assess feasibility of a larger scale randomized controlled study.

Patients consented to the study will receive a CRT device with or without ICD, placed in the same time frame, and will have RA and RV leads implanted as the standard of care. The device will be implanted in a facility that has the capacity to perform trans-atrial septal puncture with ultrasound guidance (TEE or ICE) at the time of implantation. The LV lead will be placed using a trans-atrial septal approach, using specially designed puncture tools and LVendo delivery tool kits specifically designed for this study. Special care will be taken to avoid the LV apex and transmural scar identified by pre-implant imaging. Electrical testing, and programming of the device will be standardized.

Eligibility Criteria:
Inclusion Criteria:

* Patients with NYHA Class II-IV ambulatory HF symptoms
* Optimal HF Medical Therapy of at least 3 months (2009 ACCF/AHA, ESC 2012)
* LVEF less than or equal to 35%
* Sinus rhythm (can have paroxysmal atrial fibrillation)
* QRS morphology is non-RBBB
* QRS duration 120-149 ms
* Patients with pacemaker or ICD that meet the above criteria may be upgraded to CRT-D or CRT-P
* Patients are able to receive oral anticoagulation

Exclusion Criteria:

* Patients with atrial septal defect closure
* Planned atrial fibrillation ablation within 12 months
* Patients with mitral prosthetic valve that precludes the placement of an LV lead trans-septally
* Patients with RBBB
* Patients with intra-cardiac thrombi
* Patients with permanent atrial fibrillation
* Patients with contraindications to oral anti-coagulation
* In-hospital patients with acute cardiac or non-cardiac illness that requires intensive care
* Acute coronary syndrome (including MI) \< 4 weeks
* Coronary revascularization (CABG or PCI) \< 3 months
* Uncorrected or uncorrectable primary valvular disease
* Restrictive, hypertrophic or reversible form of cardiomyopathy
* Severe primary pulmonary disease such as cor pulmonale
* Patients with a life expectancy of less than one year from non-cardiac cause.
* Patients included in other clinical trials that will affect the objectives of this study
* Those unable or unwilling to provide informed consent
* Those with a history of noncompliance to medical therapy
Buspirone as a Candidate Medication for Methamphetamine Abuse

Methamphetamine use disorders are an unrelenting public health concern. Intensive research efforts have yielded behavioral interventions that reduce methamphetamine use, however, these interventions are not universally effective and treatment effects diminish over time. Development of a pharmacotherapy that enhances the efficacy of these interventions is a priority for the National Institute on Drug Abuse. This study proposes to determine the impact of buspirone maintenance on self-administration of methamphetamine. These preliminary data will be used to support further research developing buspirone as a pharmacotherapy for methamphetamine use disorders. The investigators hypothesize that buspirone will attenuate the reinforcing effects of methamphetamine.


Eligibility Criteria:
Inclusion Criteria:

* Lifetime methamphetamine use

Exclusion Criteria:

* Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
* Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
* History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
* Females not currently using effective birth control
* Contraindications to methamphetamine or buspirone
Eradication of H. Pylori Therapy Individualized by the Mutation of 23S rRNA of H. Pylori

Patients infected with H. pylori are treated with the individualized regimen which is based on the mutation of 23S rRNA of H. pylori.

Patients infected with H. pylori undergo the gastroscopy. During the gastroscopy, gastric mucus samples are collected, from which DNA is extracted. The DNA samples are subjected the full-auto SNP analyzer and the from A to G mutation of 23s rRNA of H. pylori at the positions of 2142 and 2143 is measured. When the mutation is detected, patients are diagnosed to be infected with clarithromycin-resistant strains of H. pylori and therefore, treated with the triple therapy with vonoprazan 20 mg bid + amoxicillin 750 mg bid + metronidazole 250 mg bid for 1 week. When the mutation is not detected, patients are considered to be infected with clarithromycin-sensitive strains of H. pylori and therefore, treated with the triple therapy with vonoprazan 20 mg bid + amoxicillin 750 mg bid + clarithromycin 200 mg bid for 1 week. The success or failure of eradication was determined based on the 13C-urea breath test performed 1 month after the therapy. The total eradication rates with this strategy was compared with that by the standard regimen in Japan performed in the same period of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients infected with H. pylori are invited to the study.
* Patients not allergic to the any of the drugs used for eradication of H. pylori.
* Patients who has agreed to participate to the study.

Exclusion Criteria:

* Patients allergic to the any of the drugs used for eradication of H. pylori.
* Patients who do not agree to the study.
A Study to Determine if Ibuprofen in Combination With Pseudoephedrine HCl is More Effective Than Each Drug Alone in the Treatment of Nighttime Bedwetting

The purpose of the study is to determine if ibuprofen in combination with pseudoephedrine HCl in the treatment of nightime bedwetting in children is more effective than each drug alone and if the individual drugs are more effective than placebo.

The objective of this double-blind, placebo-controlled, randomized, parallel-group study is to determine whether the effectiveness of ibuprofen in combination with pseudoephedrine HCl is greater than the individual drugs alone and greater than placebo for the treatment of nighttime bedwetting in children. After a screening visit, parents of eligible patients are to record in a diary, the number of urinations and wet and dry nights. Patients then return and those who continue to be eligible are randomized to study medication, which they will take for two weeks. Patients are randomized into four treatment groups, and the dose of treatment medication is determined based on body weight. The four treatment groups are: 12.5 mg of ibuprofen suspension/kg of body weight (200-450 mg of ibuprofen) plus 15 mg or 30 mg of pseudoephedrine HCl, 12.5 mg of ibuprofen suspension / kg of body weight (200 - 450 mg of ibuprofen) plus placebo suspension, or two doses of placebo suspension. The primary efficacy measurement is the mean reduction in wet nights, for the 14-day baseline period to the 14-day treatment period. Safety assessments consist of monitoring adverse events, physical examination and assessment of vital signs. The study hypothesis is that ibuprofen in combination with pseudoephedrine HCl has a greater effect in the treatment of nighttime bedwetting than either ibuprofen or pseudoephedrine HCl alone, and the combination is well tolerated. Treatment medication are an oral suspension, expressed as mg/kg body weight. Patients will receive 1 of 4 treatments for 2 weeks: ibuprofen (12.5 mg/kg of body weight) plus 15 or 30 mg of pseudoephedrine, ibuprofen (12.5 mg/kg of body weight) + placebo, 15 or 30 mg of pseudoephedrine, or placebo

Eligibility Criteria:
Inclusion Criteria:

* Subject has nighttime bedwetting
* between the 5th and 95th percentiles for weight based on age and gender
* has a minimum of eight wet nights per 14 days of the baseline period
* healthy with no symptoms of any other complicating disease as determined by medical history review, physical examination, and clinical laboratory tests.

Exclusion Criteria:

* Subject has daytime urinary incontinence or abnormal bowel habits (i.e. fecal incontinence or constipation)
* has had episodes of dryness lasting one month or longer, at any time in the past
* has a medical condition which may be relevant to participation in the study
* has a known sensitivity or allergy to the study medications.
Prediction on the Recurrence of Manic and Depressive Episodes in Bipolar Disorder

Mood disorders (including bipolar disorder and major depressive disorder) are chronic mental disorders with high recurrent rate. The more the number of recurrence is, the worse long-term prognosis is. This study aims to establish a prediction model of recurrence of manic and depressive episodes in mood disorders, with a hope to detect recurrence relapse as early as possible for timely clinical intervention. We will adopt wearable smart watch to collect heart rate, sleep pattern, activity level, as well as emotional status for one year long in 100 patients with bipolar disorder, and annotated their mood status (i.e., manic episode, depressive episode, and euthymic state). We expect to establish prediction models to predict the recurrence of mood episodes.


Eligibility Criteria:
Inclusion Criteria:

* DSM-5 Bipolar disorder or depressive disorder
* 20\~60 years old
* Willing to carry smartwatch and smartphone most of the time

Exclusion Criteria:

* Comorbid with substance use disorder
* Unable to use smartwatch and smartphone
Neuroproprioceptive "Facilitation, Inhibition" and Brain Plasticity

This study investigates whether neuroproprioceptive "facilitation, inhibition" physical therapy induces plastic and adaptive processes of the CNS (white matter integrity changes), if they relate to clinical improvement, and whether therapeutic effect differs between different kinds of therapies.

In the Multi-Arm Parallel-Group Exploratory Trial, patients with multiple sclerosis were divided into three groups by an independent study coordinator, and underwent three kinds of neuroproprioceptive "facilitation, inhibition" physical therapy. At baseline and after the end of the two months' therapeutic program, a blinded assessor evaluated clinical outcomes and data from DTI .

Eligibility Criteria:
Inclusion Criteria:

* prevailed spastic paraparesis, stable clinical status and treatment in the preceding 3 months determined by neurologist,
* Expanded Disability Status Scale score (EDSS) max. 7.5

Exclusion Criteria:

* other neurological disease or conditions disabling movement
Study Comparing Efficacy and Safety of Mycophenolate Mofetil (Cellcept) With Delayed Introduction of Sirolimus and Discontinuation of Cyclosporine, With Those of Mycophenolate Mofetil and Long Term Continuation of Cyclosporine in Renal Transplant Recipients

This multicentre, prospective, randomized, open-label study will compare the safety and efficacy of mycophenolate mofetil with delayed introduction of sirolimus and discontinuation of cyclosporine, with those of mycophenolate mofetil and long term continuation of cyclosporine in renal transplant recipients receiving daclizumab (Zenapax) as induction treatment and followed by 8 month treatment with corticosteroids. The anticipated time on study treatment is 12 months. Participants who will complete the initial 12-month study and who will provide written informed consent will be eligible to participate in a 60-month follow-up phase.


Eligibility Criteria:
Inclusion Criteria:

* Receipt of a first cadaveric kidney graft
* Antilymphocyte antibodies and panel reactive antibodies (PRA) less than 30 percent (%) (historical peak and/or current value)
* Cold ischaemia time less than or equal to 36 hours

Exclusion Criteria:

* Kidney from a living donor; donor greater than (\>) 65 years of age; second renal graft, or more; or multiple organ transplant
* Known hypersensitivity to any of the drugs in the study or their components
* History of cancer or malignancy during previous 5 years, other than successfully treated spinocellular or basal cell cancer
* Participant presenting, on inclusion, either symptoms suggestive of active gastroduodenal ulcer, or gastroduodenal ulcer confirmed by fibroscopy and biopsy, and requiring treatment
* Participant with severe refractory hyperlipidaemia
* Pregnant woman or nursing mother

Exclusion Criteria for Follow-up Phase:

* Episode of acute rejection greater than or equal to grade I (Banff classification)
* Estimated creatinine clearance (CrCl) at week 12 less than (\<) 40 milliliter per minute (mL/min) (Cockcroft-Gault formula)
* Serum creatinine variations \>30% during the 15 days before randomization
* Proteinuria \>1 gram/24 hour, or mean mycophenolate mofetil dose \< 1.5 gram/day during the week before randomization