cyrilzakka/clinical-trials huggingface dataset:
Yellow Fever Vaccination Under Low Dose Methotrexate Therapy

Travelers (n = 30, 15 taking low-dose methotrexate (MTX), 15 healthy controls (HC), seeking travel advice in one of the following Swiss Travel Centers (Aarau, Basel, Bern, Geneva, Lausanne, Zurich) and who have an indication for yellow fever (YF) vaccination according to the Swiss Federal Office of Public Health's vaccination recommendations are invited to participate in this study. After signing the consent form (i) YF viremia and (ii) anti-YF antibody production in patients taking low-dose MTX and HC will be compared after YF vaccination. It will be analyzed whether the percentage of people with protective antibodies differs between the two groups and (iii) vaccine side effects will be compared between the groups.

The study will be conducted in the form of a multi-center open-label prospective observational controlled pilot study. 15 patients under low dose methotrexate treatment and 15 healthy controls with an indication for yellow fever vaccination will be included. The study duration will be 28 days for each subject and will consist of 6 clinical visits on days 0, 3, 7, 10, 14 and 28.

YF antibodies will be measured on days 0, 7, 10, 14 and 28; viremia will be measured on days 3, 7, 10, 14 and 28.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Indication for yellow fever vaccination according to Swiss FOPH recommendations
* Individuals under low dose MTX (≤20mg/week) therapy or healthy individuals
* Male and Female travelers ≥18 years to \<60 years of age

Exclusion Criteria:

* Contraindications on ethical grounds
* Women who are pregnant or breast feeding
* Contraindication against yellow fever vaccination (e.g. hypersensitivity against vaccine ingredient)
* Current treatment with other immunosuppressive agent apart from low dose methotrexate
* Alemtuzumab or rituximab in the last year
* TNF-blocking therapy in past three months
* Immunocompromising condition in healthy control
* Other immunocompromising condition than MTX treatment itself and the underlying disease in patients under MTX
* Previous yellow fever vaccination
* No indication for yellow fever vaccination according to Swiss travel vaccination recommendations
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Ten Years Follow up of Peri-implant Surgery

To report 10-years follow up of patients following the surgical treatment of peri-implantitis and to identify possible risk indicators for the progression of disease during supportive peri-implant therapy.

The data for this retrospective clinical evaluation were collected from the files and radiographs of consecutive patients who had received surgical treatment of peri-implantitis between 2007 and 2009 and thereafter enrolled in supportive peri-implant treatment (SPT) .

Between 2007 and 2009, 41 patients with at least 1 implant with peri-implantitis that underwent peri-implant surgery were enrolled in a supportive peri-implant therapy.

At the 2-years follow up, two groups could be identified, one "responding group" (17 patients) who did not present any implants with peri-implantitis and a "no-responding Group" (22 patients), presenting still peri-implantitis.

Following the 2-years control visit, 17 patients of the responding group exited the supporting peri-implant therapy at the specialist clinic. They continued the routine controls at their referral clinics while the 22 patients of the no-responding group, continued the scheduled supportive peri-implant therapy (SPT) given at the specialist clinic.

Eligibility Criteria:
Inclusion Criteria:

- All patients treated with peri-implantitis surgery between 2007 and 2009 using an anti-infective protocol.

Exclusion Criteria:

* Patients treated with peri-implantitis surgery between 2007 and 2009 using a regenerative protocol at one single implants with peri-implantitis.
Rivastigmine in Mild Alzheimer's Disease, FMRI Study

The purpose of the study is to investigate the effect of rivastigmine given as an acute dose compared to placebo and after 1 month chronic dosing on fMRI response during a face recognition task. Furthermore, the aim is to investigate whether fMRI response is correlated with long term treatment effect at 6 months and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Probable Alzheimer's disease according to the NINCDS-ADRDA criteria
* mild disease, CDR 1
* the clinician is planning to start anticholinesterase treatment

Exclusion Criteria:

* cognitive impairment for other reason than Alzheimer's disease
* severe depression
* other unstable physical disease
* medal in body prevention MRI examination, claustrophobia
* cardiac pacemaker
* other significant neurologic or psychiatric disease
* contraindication for anticholinesterase treatment
Validation of a Real-time Urodynamic Measure of Urinary Urgency

Urinary urgency is a key symptom of overactive bladder syndrome (OAB) and may be more bothersome to a patient than the symptom of urinary frequency. Unfortunately, controversy continues to surround the term 'urgency' and there is no good tool to evaluate the severity of urgency. This fact has constrained the performance of clinical research in this field. The cause of urinary urgency is not fully understood and may vary from patient to patient.

Although clinicians regularly obtain measures of bladder sensation during cystometry, little attention has been paid to the patient experience of urinary urgency. In this study, the researchers will use a non-significant risk device (i.e., an Urgeometer) to measure urinary urgency in women with overactive bladder.

At baseline, a small catheter is placed inside the participant's bladder. The bladder is filled with sterile water through the catheter. As the bladder is filled, the participant is asked to rate their urinary urgency using the Urgeometer. The Urgeometer lever marks a continuous scale from 0 'no urge at all' to 100 'maximum urge which you can tolerate'. The testing is stopped once the bladder is filled. To minimize the chance of infection, participants receive one dose of oral antibiotics prior to the bladder testing.

Following completion of the bladder test, participants will take 10mg solifenacin succinate (VesicareR) daily for 30 days. Afterward, participants repeat the bladder test. The change in participants' maximal tolerated cystometric capacity (MCC) will be measured in milliliters and used to evaluate the effectiveness of the drug.

Eligibility Criteria:
Inclusion Criteria:

* Have symptoms of urge or mixed incontinence (urge predominant) and desire treatment with anticholinergic medication.
* Demonstrated detrusor overactivity with or without incontinence during urodynamic testing.
* Are able to consent and fill out study documents, complete repeated urodynamic testing, and follow-up in 4 weeks.

Exclusion Criteria:

* Have been treated with any anticholinergic medication in the previous month.
* Have an elevated post -void residual volume as determined during their routine clinical care.
* Have had a urinary tract infection in the last month, as determined by history.
* Have untreated narrow angle glaucoma, by patient history.
* Have a known allergy or intolerance to solifenacin, as determined by patient history.
Investigation of Oral Microflora of Infants

The placement of cariogenic microorganisms in oral microflora is an important factor in dental caries. The aim of this study is to research from whom, when and how the cariogenic microorganisms are first transmitted to the infant. The investigators investigated of colonization of Streptococcus mutans, Lactobacillus spp., and Candida spp. in oral cavities of infants and their transmission to the infants.

Study sample size and design: When α = 0.05, 1-β (power) = 0.80 were taken to determine the sample volume, it was calculated that at least 46 babies should be sampled for 6 months to have an average amount of S. mutans change of 1.87 units. Considering the losses that may occur during the follow-up, the study was started by taking samples from 60 systemically healthy newborns.

The study commenced with 60 newborns and was completed with 47 infants due to losses during the follow-up. Oral swab samples were taken from 47 healthy infants within the first 24 hours after birth, at 1 month old and during the first tooth eruption. Saliva samples were taken from the mothers of all the infants and from the fathers of 20 of the infants in the last meeting.

Last interview with the parents, their oral examinations were performed, and their findings were processed as decayed (D), filled (F) and missing (M) teeth in accordance with the World Health Organization criteria, with the DMF (decayed, missing and filled) index being calculated. Furthermore, saliva samples were taken from the parents at the last interview. A questionnaire form including the sex of the infant, type of delivery, birth weight, and nutritional habits of the infant during the follow-up was filled in by gaining information from the parents on the first day and during the follow-ups.

Swab samples taken from infants with sterile swabs were transferred to the laboratory by placing sterile saline solution into dispensed 2 ml screw cap tubes. Sterile urine collection containers of 50 ml were used to collect saliva samples from the parents.

Eligibility Criteria:
Inclusion Criteria:

* none of the infants or their families had systemic disease

Exclusion Criteria:

* the infants or their families have systemic disease
VivaSight Left-sided Double Lumen Tube Study

The VivaSight™-DLT is a new OLV (one lung ventilation) device that contains an embedded camera. Therefore, a potential advantage is the continuous assessment of DLT position through continuous monitoring of the camera. The embedded camera of VivaSight™-DLT is positioned at the tracheal opening of the double lumen tube. It allows for continuous monitoring of the carina and bronchial tube placement.

The purpose of this study is to determine if a double lumen tube (DLT) with an embedded video camera, the VivaSight DLT, can be used in similar fashion to the standard double lumen tube with fiberoptic bronchoscopy. More specifically, the investigators would like to know the difference in time to optimal position in the left bronchus between the VivaSight DLT and the standard DLT with fiberoptic bronchoscopy. In addition, the investigators would like to know if the embedded camera on the VivaSight DLT provides a view that will allow for the optimum position of the DLT in the left bronchus.

The investigators will perform a prospective, randomized study in thoracic surgical patients undergoing one-lung ventilation where the patient will receive either the VivaSight DLT or standard left-sided DLT. Subjects will be selected and evaluated who are at least 18 years old, but no older than 90 years old.

The investigators will compare the intubation time for the VivaSight™-DLT with the intubation time for standard DLT. The intubation time parameters for the VivaSight™-DLT are the passage of the tube through the vocal cords and the confirmation of proper tube positioning by the embedded camera. Fiberoptic bronchoscopy is performed to reassess the proper tube positioning, however, this will not be counted for the intubation time in this group. For the standard DLT, the intubation time parameter begins similarly, on the passage of the tube through the vocal cords, but ends with the confirmation of the proper placement by fiberoptic bronchoscopy. In both groups, C-MAC blade is used to visualize the passage of the tube through the vocal cords. These intubation times will be tracked real-time in the operating room and will be based upon both observation as well as the verbal confirmation of the attending anesthesiologist.

The intubation time must be within 5 minutes. The intubation time required more than 5 minutes is considered as unsuccessful intubation.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Adult patient undergoing scheduled thoracic surgery which requires double-lumen tube placement

Exclusion Criteria:

* More than 90 years of age
* Patients with emergency surgery
* Prisoners
* Patient who cannot provide their own consent
* Patient refusal
* Non-English speaking patients
Ginger for Colorectal Cancer Prevention

The purpose of this study is to determine if ginger root extract when taken daily for 28 days is able to decrease levels of inflammatory chemicals called eicosanoids in the gut tissue of people who are at normal risk and those at increased of developing colorectal cancer compared to people taking placebo.


Eligibility Criteria:
Inclusion Criteria Normal Risk:

* 18 years or older and in good health as defined by an unremarkable medical history, physical and screening blood work (chemistry screen, complete blood count) within 60 days of study entry.
* No chronic medication use was allowed and participants could not have taken aspirin or related NSAIDs during the study or 14 days before the first dose of the study medication.
* Participants also had to be classified as being at normal-risk for developing colorectal cancer. Normal-risk was defined as having: no first-degree relatives with colon cancer diagnosed before the age of 60; no personal history of colorectal cancer and no adenomas \>1 cm in size or containing carcinoma in situ

Exclusion Criteria for both Normal and Increased Risk for Colorectal Cancer:

1. a history of peptic ulcer disease, gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin secreting tumors;
2. pregnant or lactating women;
3. history of cardiovascular disease;
4. lactose intolerance;
5. or an allergy to ginger
6. a history of familial colorectal cancer syndromes;.

Inclusion Criteria Increased Risk:

* 18 years or older and in good health as defined by an unremarkable medical history, physical and screening blood work (chemistry screen, complete blood count) within 60 days of study entry.
* No chronic medication use was allowed and participants could not have taken aspirin or related NSAIDs during the study or 14 days before the first dose of the study medication.
* Participants also had to be classified as being at increased-risk for developing colorectal cancer. Increased-risk is defined as having at least one of the following: a first-degree relatives with colon cancer diagnosed before the age of 60; a personal history of early stage colorectal cancer and/or no adenomas \>1 cm in size or containing carcinoma in situ
Prospective Asian Multicenter Prostate Cancer Focal Therapy Study (ProAMFocal)

This is a multicenter observational study of patients undergoing focal therapy for prostate cancer in Asia

Patients undergoing Focal Cryotherapy, Focal HIFU, Focal IRE, Focal Laser ablation, or other partial gland ablation modalities for prostate cancer will be recruited.

Eligibility Criteria:
Inclusion Criteria:

* Prostate Adenocarcinoma
* Maximum Gleason score 4+4
* Maximum cancer volume 1.5 ml (up to 2 lesions) or 3 ml (single lesion)
* Maximum Prostate Specific Antigen (PSA) level 15 ng/dl
* Maximum clinical stage T2c
* American Society of Anesthesiologist Criteria 2 or less

Exclusion Criteria:

* Extra-prostatic Extension on multi parametric magnetic resonance imaging (mpMRI); capsular contact is permitted
Trial for Application of Laparoscopic Total Gastrectomy With Lymph Node Dissection for Gastric Cancer (KLASS-06)

Although Laparoscopic gastrectomy for both early and locally advanced gastric cancer has gained popularity, the use of laparoscopic total gastrectomy for proximal advanced gastric cancer is still limited to some experienced surgeons, because of its technical difficulties in D2 lymph node dissection and anastomoses.

Some retrospective and cohort studies regarding laparoscopic total gastrectomy with lymph node dissection suggested the likelihood of application of laparoscopic surgery for proximal gastric cancer. However, there has been no randomized clinical trial comparing results of laparoscopic total gastrectomy with D2 lymph node dissection with open conventional surgery.

Therefore, we aimed to verify the efficacy of laparoscopic total gastrectomy with D2(D2-10) lymph node dissection, technical and oncologic safety compared with open surgery via multicenter randomized clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are over 20 and below 80 years old
* Patients who have performance status of ECOG 0 or 1
* Patients with American Society of Anesthesiology score of class I to III
* Patients who are diagnosed with gastric adenocarcinoma not involving Z-line by endoscopy with biopsy
* Patients with tumors which can be curatively resected by total gastrectomy with lymph node dissection based on preoperative study
* Patients who have primary gastric carcinoma invaded into over muscle propria, and not into adjacent organ in preoperative studies (cT2 \~ cT4a)
* Patients who have no metastasis to lymph nodes or limited metastasis to perigastric lymph node metastasis in preoperative studies (cN0 \~ cN2)
* Patients who agree with participating in the clinical study with informed consents
* Patients who can be followed for at least 3 years after study enrollment

Exclusion Criteria:

* Patients who have possibility of distant metastasis in preoperative studies
* Patients who have history of gastric resection with any cause
* Patients who have complications (bleeding or obstruction) of gastric cancer
* Patients who are treated by chemo(radio)therapy or endoscopic submucosal dissection for gastric cancer
* Patients who are diagnosed and treated with other malignancies within 5 years
* Vulnerable patients
* Patients who participating or participated in other clinical trial within 6 months
Haemodynamic Changes During Robotic Prostatectomy

The aim of the study is to analyse the haemodynamic and ventilatory changes in patients undergoing robotic prostatectomy, compared to standard laparoscopic prostatectomy.

Prostatectomy is a standard operation, increasingly performed using robotic assistance. During robotic assisted procedures, the intraabdominal pressures are usually higher than in standard laparoscopic operations which can pose a risk of cardiovascular and respiratory adverse effects. The aim of this study is to investigate the haemodynamic and ventilatory effects of robotic assisted prostatectomy, compared to standard laparoscopic prostatectomy.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing prostatectomy in University Hospital in Motol between 1st December 2019 and 30th April 2020

Exclusion Criteria:

* body mass index over 35
* regular use of beta-blocking drugs
Evaluation of Acute Pain in Maltreated Children

The hypothesis of this study is nonrecognition by the medical team of pain in maltreated children. These children would have a particular painful behaviour, "quiet". The management of their pain would be then unsuited, which could explain their complex relation with the pain in the adulthood. A pilot study realized in the CHU of Nantes on 11 files of maltreated children showed that they had very low scores of evaluation of the pain, in spite of severe traumatisms. There is, at the moment, no data in the literature on the acute pain of the maltreated children.


Eligibility Criteria:
Inclusion Criteria:

* Age between 0 and 6 years
* Consultation in the emergency cares for traumatism with type of fracture and/or burn
* Time of the traumatism lower than 24 hours
* Information of the two parents or the parental authority and collection of the non-opposition.

Exclusion Criteria:

* Old superior at 6 years
* Any type of traumatism other than a fracture and/or a burn
* Traumatism without possible dating or with a time of consultation higher than 24 hours
* Opposition of the parents formulated after their information by the medical team
* Child who can not have an evaluation of the pain with the chosen scales
An Interaction Study of Ketoconazole/Verapamil Versus AZD1305

The purpose is to study whether ketoconazole or verapamil have an effect on how AZD1305 is handled by the body, i.e the absorption, distribution, metabolism and excretion, when administered in combination with AZD1305.


Eligibility Criteria:
Inclusion Criteria:

* A body mass index (BMI=weight/height2) of 19 to 30 kg/m2

Exclusion Criteria:

* Potassium outside normal reference values
* ECG findings outside normal range
Baseline Sleep Apnea Study #2

This is a single group, unblinded, prospective clinical study. This study seeks to understand patient diagnostic and treatment journey and positive airway pressure (PAP) therapy compliance for Verily Sleep Apnea (VSA) program/app users. Participants will enroll remotely and may undergo a home sleep test (HST). Upon confirmation of obstructive sleep apnea (OSA) and prescription of PAP therapy, the participant will begin using the VSA app to supplement PAP treatment. After 90 days of active participation, the participant will be given instructions for follow-up care, as indicated.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 or older
* Able to speak and read English
* Legal United States Resident with a Government Issued ID
* Participating in the Project Baseline Community Study
* Demonstrates understanding of the study requirements and is able and willing to sign the informed consent form
* Own a smartphone with a data plan and be the primary user of the smartphone; smartphone must use Android Lollipop (5.1+/ API 22+) or iOS 11.X+
* Own a computer with a web camera
* Consistent access to electricity and wifi for the duration of the study
* Have a high risk of OSA as determined by screening questionnaire
* Good candidate for PAP therapy, in the opinion of the managing clinician
* Without significant limitation in ability to participate in the study, in the opinion of the investigator.

Exclusion Criteria:

* Previously diagnosed with sleep apnea or other sleep disorders, that in the opinion of the investigator, makes the participant ineligible (e.g., Obstructive Sleep Apnea, Central Sleep Apnea, Complex Sleep Apnea, chronic insomnia)
* Participant is a shift worker (indicated by having a night shift schedule on a regular basis, or a work shift that changes or rotates on a daily, weekly, or monthly basis)
* Sponsor employees and individuals working on Project Baseline
* Self reported to be pregnant or planning to become pregnant during the study period
* Current use of home oxygenation devices, such as supplemental oxygen
Telemedicin Counselling for Medical Abortion

The guidance on Safe abortion technology by the World Health Organization (WHO 2012) suggests the evaluation of internet provision and telemedicine, as further alternative service delivery channels of safe abortion, as a subject for future research (WHO 2012) Our studies have shown that telemedicine and provision of medical abortion through wow is safe, acceptable and with outcomes similar to medical abortion provided traditionally following face-to-face counselling. Furthermore, recently home self-assessment of the abortion outcome through a low sensitivity U-hCg test was shown to be highly acceptable to women. To evaluate whether counselling through telemedicine is non-inferior to face-to face counselling a RCT will be conducted including women who chose medical abortion up to 63 days of gestation with home administration of misoprostol and self assessment of the outcome. The results of this study could be of major importance to increase access to safe and acceptable abortion services.


Eligibility Criteria:
Inclusion Criteria:

* requesting termination of pregnancy by means of mifepristone followed by home administration of misoprostol at \< /=63 days of gestation, no contraindication to medical abortion and self administration of misoprostol at home, and who have given their informed consent

Exclusion Criteria:

* women who do not want home administration of misoprostol, women who are unable to communicate in Swedish, or English, and women with symptoms and signs of ectopic pregnancy.