cyrilzakka/clinical-trials huggingface dataset:
Etiology of Orphan Community-based Meningitis and Meningo-encephalitis.

The primary purpose of this study is to assess the contribution of a non-invasive sampling (pharyngeal swab) in the diagnosis of community based meningitis or meningo-encephalitis.

Community-based meningitis and meningo-encephalitis are defined by the presence of more than 10 leukocytes per mL of cerebrospinal fluid (CSF), eventually reported to the number of red blood cells. They can be associated with encephalitis, defined by cerebral or cerebellar dysfunction in the case of the transmission. The evolution includes death, what makes the seriousness of this clinical situation. However the diagnostic performance of meningitis and meningo-encephalitis in a patient without contact with a care structure is less than 25% resulting in empirical support in half of the patients. Indeed, the microbiological diagnosis of meningitis and transmission target currently only five pathogens including HIV positive resulted in a significant change to support the patient in three areas, decision of hospitalization, decision of isolation and antibiotic or antiviral treatment decision. A weekly epidemiological monitoring of the microbiological diagnosis of meningitis and meningo-encephalitis has enabled us to see a mismatch between a curve of requests for analyses and a flat curve of produced diagnoses. This discrepancy is interpreted as indicating a community outbreak of meningitis or meningo-encephalitis non-diagnosed by routine methods, called orphan meningitis or orphan meningo-encephalitis. On this observation, our research project is to improve the performance of the etiological diagnosis of community-based meningitis or meningo-encephalitis. To do this, we will evaluate the diagnostic performance of an advanced technique, using a non-invasive sample, the pharyngeal swab from the patient, to find micro-organisms that are not part of the commensal flora of the pharynx and who are responsible for undetected in routine meningitis. Indeed the main pathogens and meningitis (enterovirus, pneumococcus, meningococcus) transmission give a pharyngeal carriage before being responsible for meningitis or meningo-encephalitis. These bacteria are Coxiella burnetii, Bartonella spp., Tropheryma whipplei, Leptospira spp. and Borrelia spp.

Eligibility Criteria:
Inclusion Criteria:

* Patient is aged more than 18 years old.
* Patient with clinical meningitis or meningo-encephalitis with community transmission.
* Patient with a prescription of microbiological diagnosis of meningitis or meningo-encephalitis.
* Patient who do not declined to have his medical records reviewed for research
* Patient with health insurance

Exclusion Criteria:

* Minor Patient (age \<18 years)
* Pregnant woman, parturient or breastfeeding
* Adult Patient under guardianship
* Patient deprived of liberty under court order
* Patient vital in emergency.
Induction of Immunity Against Measles in Pediatric Liver Transplant Recipients

Measles is a vaccine-preventable disease, which can be life-threatening in immunosuppressed children. Currently, measles vaccine is not recommended in pediatric orthotopic liver transplant recipients, because it is a live-attenuated vaccine.

We want to assess the influence of immunosuppression on immunity against measles in previously vaccinated children and to evaluate the induction of B cell and T cell response against measles elicited by vaccination in children at least 12 months after transplantation.

Eligible children in Group 2 will receive a standard dose (0.5 ml) of MMR vaccine during the first medical visit (V1). The lot number and the expiration date will both be recorded on the patient's case report form (CRF). A serological evaluation 4-8 weeks after MMR will identify children requiring an additional dose given 1-2 months apart, as currently recommended for subjects 1 year-old or with limited immune competence (i.e. HIV-infected children). Serological evaluation 4-8 weeks after the second dose or at the one-year follow-up will identify eventual non-responder requiring a third dose. Three will be the maximal number of administrated dose according to this protocol. The persistence of measles-specific antibodies will be assessed yearly, when patients come for their routine visit to the transplant center.

Children who do not need MMR immunization because of protective levels will be monitored yearly for maintenance of antibody levels during routine yearly visits/ blood samplings and will not have further intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 12 months
* Measles-specific IgG antibodies negative (\<0.2 IU/L), as detected by the routine ELISA assay
* ≥ 12 months from the time of transplantation and ≥ 2 months from the time of an acute rejection episode
* Steroids \< 2 mg/kg/day, tacrolimus \< 0.3mg/kg/day and tacrolimus level \< 8 ng/ml for \> 1 month.
* Total lymphocyte count ≥ 750 cells/ul at time of immunization

Exclusion Criteria:

* Known wild-type measles exposure during the last four weeks
* Measles-containing immunoglobulins administered within the 5 months preceding the measles vaccine. If the child receives measles-containing Ig before an additional dose of MMR vaccine, he/she will be withdrawn from the study
* Antiviral agents administered during the last four weeks
* Febrile illness (\>38.5°) in the 72 hours before vaccine administration
* Chronic aspirin therapy
* Any other immunization with a live-attenuated vaccine during the last four weeks
* Pregnancy
Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of PF-04287881 after a single oral dose in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers willing and able to be confined to the Clinical Research Unit and comply with study schedule.
* Women of non-childbearing potential only.
* Japanese subjects muct have 4 Japanese grandparents who were born in Japan.

Exclusion Criteria:

* Previous antibiotic use within 14 days prior to dosing.
* Use of antibiotics during hospitalization within 90 days prior to dosing.
* History of sensitivity to macrolides or ketolides.
* Presence of clinically significant eye conditions (other than corrective lenses).
The Accuracy of Computer Software Prediction of Soft Tissue Profile for Patients Undergoing Fixed Orthodontic Treatment

A clinical study to evaluate the accuracy of computer software in predicting soft tissue profile changes in patients undergoing fixed orthodontic treatment

The computer software programs exhibit certain soft tissue simulation . The purpose of the study to assess the accuracy of computer software in predicting profile changes in patients undergoing fixed orthodontic treatment

Eligibility Criteria:
The inclusion criteria included:

* Patient undergo fixed orthodontic treatment with the edgewise technique.
* Skeletal class I.
* Dental class I or II or III.
* Final class I occlusion without spacing or crowding, with normal overjet and overbite (2-4 mm)
* Availability of full diagnostic and therapeutic records before to and following orthodontic treatment, including medical and dental history, dental casts, panoramic and cephalometric x-rays, and photographic photographs.

The exclusion criteria included:

* Missing tooth or significant Bolton discrepancies (more than 3 mm).
* Craniofacial syndromes or skeletal abnormalities.
* Failed orthodontic treatment in the past.
* Cosmetic or reconstructive facial surgery during orthodontic treatment, or up to a year beforehand.
* Using drugs that could reduce the volume of soft tissues.
Transcranial Direct Current Stimulation on Post Stroke Depression

The aim of the research is to address the critical gap that limited number of RCTs are conducted on this topic. To further explore the efficacy of tDCs, large sample sizes, large follow up period and rigorously controlled randomized clinical trials are necessary. An optimum stimulation protocol is also needed on this study. Previous studies lack information regarding effects of this stimulation on depression, cognition, quality of life in relation to different severity levels of stroke.

Research studies revealed that PSD causes both cognitive and physical impairments to lower motivation, which hinders rehabilitation program participation and slows down executive functions. Due to depression, cognitive dysfunctions difficulty in executive, working memory and emotional deficits which declines quality of life (QoL). Thus, the combined effects of cognitive decline and PSD considerably more worsen stroke survivors' QoL with regard to psychological, environmental and physical well-being Evidence supports various techniques for minimizing PSD, restoring cognitive function, and enhancing QoL including mindfulness-based therapies, exercise therapy (aerobic and resistance trainings), progressive muscle relaxation exercises, cognitive behavioral therapy (CBT). Non-invasive brain stimulation (NIBS) include transcranial direct current stimulations (tDCS) demonstrated significant therapeutic outcomes in the PSD rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Stroke for more than 6 months Both gender with equal ratio on stroke severity basis Depression diagnosed by Psychiatrist Mild and moderate Depression at PHQ-9 National Institutes of Health Stroke Scale (NIHSS) for severity level; Mild (1-4), Moderate (5-15), Moderate to Severe (16-20), Severe (21-42)

Exclusion Criteria:

* Any medical condition like cardiac arrhythmias, uncontrolled hypertension. Individual with any pacemaker and metal implant in body. Patient with any other neurological and psychiatric condition.
Comparative Effectiveness of Endoscopic Assessment of Gastroesophageal Reflux and Barretts Esophagus

The hypothesis of this study was that the comparative effectiveness of unsedated transnasal endoscopy (uTNE) will be greater than sedated endoscopy (sEGD) in population screening for BE.

Barrett's esophagus (BE), a well-known complication of Gastroesophageal Reflux (GER), is the strongest known precursor of esophageal adenocarcinoma. Thus, identifying effective screening approaches for the early detection of BE are highly desired. Current impediments to BE screening include 1) the inability to utilize sedated endoscopy (sEGD) effectively in populations and 2) current GER-based paradigms for detecting BE. Referral center studies demonstrate comparable accuracy between unsedated transnasal endoscopy (uTNE) and sEGD. However, patient acceptability and diagnostic yield with uTNE in general populations remain unknown.

Using the Rochester, Minnesota Epidemiology Project resources, random samples of Olmsted County residents were drawn, and those subjects were mailed validated gastrointestinal symptom questionnaires. These surveys allowed identification of a cohort of community subjects well characterized by the frequency of reflux symptoms. Eligible subjects who were greater than or equal to 50 years old, and who had no previous history of endoscopic evaluation and who were not known to have BE were randomized, stratified by age, sex, and reflux symptoms, and assigned to one of the 3 arms of the study. Subjects in each arm who met the eligibility criteria were initially sent generic invitation letters asking if they agreed to be contacted by phone in two weeks' time to inform them about a research study. If potential subjects explicitly declined to be contacted they were excluded from the study. Eligible subjects were contacted by telephone and only offered the endoscopy technique they had been randomized to. Subjects who accepted and signed an informed consent document were treated according to their randomized assignment and all 3 groups were followed up in the same manner.

Biopsies were taken from any endoscopically suspected BE and from the gastroesophageal junction and squamous mucosa in all subjects. The length of BE segment was defined using Prague criteria. All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete validated tolerability scales and adverse events questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Olmsted county, Minnesota resident
* Age 50 or older
* Able to give informed consent

Exclusion Criteria:

* History of known Barretts Esophagus (BE) or endoscopy within the last 10 years
* History of progressive dysphagia
* Known Zenkers or epiphrenic diverticulum
* History of recurrent epistaxis
* Illnesses that impair ability to complete questionnaires (e.g. metastatic cancer, stroke, dementia)
* Contraindication to esophageal biopsy (such as anticoagulation using warfarin or clopidogrel).
Interventions to Reduce Excess Weight Gain in Pregnancy

The study will use a comprehensive behavioral intervention adapted for pregnant women to change dietary intake, eating behavior and physical activity. The central hypothesis of this study is that the intervention will reduce excess gestational weight gain and achieve clinical and metabolic benefits in obese and overweight pregnant women and their infants over the first year of life.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-45 years
* In first trimester of pregnancy
* Must be willing to not join any other weight control program while in the study
* BMI of 25-40 kg/m2
* Willingness and ability to attend support group meetings either in person or via web
* Must be able to read, speak, and understand English

Exclusion Criteria:

* Carrying multiple fetuses
* Gestational diabetes mellitus at study entry
* Type 2 diabetes mellitus or blood glucose \>125 mg/dl at screening
* Self reported current substance abuse
* Current smoking
* Alchol consumption of more than 1 drink per day
* Preexisting medical conditions (includes bariatric surgery) or use of medications that would impact study involvement or outcomes testing
* Eating disorder in the past 2 years
* Depression or diagnosis of bipolar disorder
* Concurrent participation in any other research study that would impact participation in this investigation
Karydakis Flap Versus Burow's Triangle Advancement Flap in the Surgery of Sacrococcygeal Pilonidal Sinus Disease

In this study, we aim to compare the Karydakis flap and Burow's Triangle Advancement Flap techniques applied in the surgical treatment of pilonidal sinus in terms of complications, time to return to normal activity, and recurrence.

Pilonidal sinus disease (PSD) is a chronic and inflammatory disease that is often generated in the sacrococcygeal region. It is commonly observed in puberty and young adult period and usually affects men. The incidence of pilonidal sinus disease is 26:100,000 and rising globally.

PSD risk factors contain young age, obesity, male gender, Mediterranean ethnicity, deep natal cleft, hairiness, and poor hygiene. It has been shown that PSD incidence increases in parallel with body weight. The precise etiology of pilonidal sinus disease is unclear. Many conservative and surgical methods have been described in treating pilonidal sinus disease. After the sinus area is excised, excision with laying open (secondary healing), excision with primary closure, marsupialization, and various flap techniques can be applied in surgical treatment. The primary principle in treatment is to ensure that the patient returns to normal life as soon as possible and eliminate recurrences. Although the best surgical technique in treating pilonidal sinus is controversial, the ideal operation should be cost-effective, simple to perform, short hospital stay, and have a low recurrence and complication rates. There is no definite consensus on an ideal technique yet.

In this study, we aim to compare the Karydakis flap and Burow's Triangle Advancement Flap techniques applied in the surgical treatment of pilonidal sinus in our clinic in terms of complications (wound dehiscence, seroma, hematoma, surgical site infection), time to return to normal activity, and recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18-65
* Primary pilonidal sinus disease
* No abscess and absence of active infection during the operation

Exclusion Criteria:

* Patients under the age of 18 and over the age of 65
* Recurrent pilonidal sinus cases
* Patients with chronic comorbidities such as immunosuppression, collagen tissue disease, insulin-dependent diabetes mellitus, and neurological disease
* Patients with an ASA score of 3-4
* Patients with a body mass index greater than 35 kg/m2
* Patients with drug and alcohol addiction
Safety and Tolerability Study of 131I-TM-601 to Treat Adult Patients With Recurrent Glioma.

This drug is being developed to treat a type of brain cancer, glioma. This study was designed to determine a safe and well tolerated dose. Patients must have had prior treatment for their glioma and be eligible for removal of their recurring tumor.

This is an open label single-dose study to be conducted in 18 evaluable patients with recurrent high-grade glioma. Patient will undergone debulking surgery and ventricular access device placement into the tumor cavity for administration of 131I-TM-601. High-grade glioma includes glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligo-astrocytoma and gliosarcoma. The amount of 131I will remain constant. Three doses of TM-601 will be administered using a dose escalating scheme.

Eligibility Criteria:
* Patient must have given informed consent
* Patient must have histologically confirmed supratentorial malignant glioma
* Patients must have recovered from toxicity of prior therapy
* Patients must be eligble for resection of the recurrent tumor
A Study to Compare PK, PD and Safety of UI058 and UIC202004 in Healthy Subjects

A Study to compare pharmacokinetics, pharmacodynamics and safety of UI058 and UIC202004 in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Subjects able to read and understand a written informed consent, and willing to decide to participate in the study
* Healthy subjects between the ages of 19 and 55 years at screening
* Body weight more than 50.0kg(male)/45.0kg(female)
* Body Mass Index more than 18.0kg/m2 and under 30.0kg/m2

Exclusion Criteria:

* Have clinically significant disease that hepatobiliary system, kidney, respiratory system, nervous system, hemato-oncology disease, cardiovascular system
* Have a gastrointestinal disease history that can effect drug absorption or surgery
* Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of investigational product
Targeted Hypoglossal Neurostimulation Study #2

The objective of the study is to confirm the safety and efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).


Eligibility Criteria:
Inclusion Criteria:

* AHI \>20
* Noncompliant to CPAP
* Willing to provide informed consent
* Willing to comply with all follow-up visits and evaluations

Exclusion Criteria:

* BMI limits
* COPD
* Central Sleep Apnea
* Anatomic variations interfering with device placement or stability.
Perception, Awareness, and Acceptance of Human Papillomavirus Disease and Vaccine Among Parents of Boys Aged 9 to 18 Years

The objectives of this study are:

1. to determine the degree of understanding and perceived risks for human papillomavirus (HPV) disease, to examine and assess attitudes for personal use of HPV vaccine and identify potential barriers to HPV vaccine access and utilization in a population of young men who have sex with men (MSM) (under 26 years of age)and in parents of boys aged 9 to 18 years
2. to determine HPV vaccine acceptance and predictors of acceptance in a population of young MSM and in patients of boys ages 9 to 18 years
3. to develop strategies to overcome potential barriers to vaccination and improve vaccine access and utilization via development of targeted educational initiatives.


Eligibility Criteria:
Inclusion Criteria:

* MSM group - under age 26 years
* Parent group - parent of boy(s) ages 9 to 18 years

Exclusion Criteria:

* MSM group - previous receipt of HPV vaccine
* Parent group - previous receipt of HPV vaccine by male child
Inducible Laryngeal Obstruction in Severe Asthma in Severe Asthma

The first part will be a comparative cross-sectional study to identify the frequency of ILO and other comorbidites among participants with asthma compared to a group of reference subjects without asthma, matched for age- and gender and race.

The second part will be a longitudinally observational study study following participants for one year after the cross-sectional study. The Maat-scores ILO-symptoms and asthma-outcomes longitudinally will be evaluated, .

Inducible laryngeal obstruction (ILO) is characterized by inappropriate closure of the structures of the larynx causing reduced airflow. The symptoms are breathing difficulties that resemble those seen in asthmatic patients, such as dyspnea, coughing and stridor. ILO may be diagnosed by the continuous laryngoscopy during exercise test (CLE-test), where the larynx is visualized live on video as the patient runs to exhaustion on a treadmill whilst having a laryngoscope placed through the nose.

The prevalence of ILO in asthmatic patients will be assesed by preforming a CLE-test twice in all participants at baseline and again after one year. Participant will be given visual feedback and instructed in breathing techniques. Others common comorbidities will be assessed by questionnaires and clinical interview. All patients with asthma will have a respiratory polygraph recording.

Changes in ILO-symptoms and asthma-symptoms and outcomes will be assessed after 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe asthma (GINA 5)
* Patients with mild-moderate well-treated asthma (GINA step 1-4)
* Agroup of age- and gender matched control subjects without asthma also aged 18- 70.
* The patients must have had a stable disease the last one month before performing the CLE-test

Exclusion Criteria:

* No have underlying neurologic disease.
* No known cancer in the lung-head-neck
* No known vocal cord pathology.
* No history of life-threatening asthma required hospitalization.