cyrilzakka/clinical-trials huggingface dataset:
Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation (STRIDE)

This is a prospective observational study collecting long-term clinical data and samples for research in pediatric inflammatory bowel disease (IBD) patients with gut inflammation and a control cohort of pediatric patients with disorders of the brain-gut interactions (DBGI) with no detectable gut inflammation.

Research procedures will coincide with clinical visits at institutional standards. As part of their clinical disease evaluation, participants will have blood, stool, and tissue collected as indicated by their disease course. Additional research samples or data will be collected during these visits. Participants will be asked to collect urine samples specifically for research.

Eligibility Criteria:
Inclusion Criteria:

* Suspected diagnosis of CD (Crohn's Disease), UC (Ulcerative Colitis) or Indeterminate colitis (IC)

Exclusion Criteria:

* Evidence of Other Complicating Medical Issues:
* Other serious medical conditions, such as neurological, liver, kidney, or systemic disease
* Pregnancy
* Tobacco, alcohol, or illicit drug abuse
Virtual Reality and Brain Stimulation, an Experiential Approach

The aim of this study is to assess feasibility, acceptability and efficacy of two VRET (Virtual Reality Exposition Therapy)session associated with either active anodal tDCS or sham tDCS on the ventromedial prefrontal cortex to decrease anxiety related to visual height intolerance

Subjects suffering from visual height intolerance are asked to go in 20 min as height as possible riding in two elevators of adjacents buildings separated by a board they have to cross at each stage.

Inclusion visit:

* Confirmation of eligibility criteria
* Written informed consent
* Completion of Acrophobia Questionnaire (AQ), Attitude towards Height Questionnaire (ATHQ), Height Interpretation Questionnaire (HIQ), Visual Height Intolerance scale(vHI), State-Trait Anxiety (STAI), Inventory and Clinical Global Impressions (CGI)
* Virtual task (10 minutes): riding in an elevator. At each level,subjects are asked to rate their Subjective Units Discomfort (SUD scale from 0 to 100).
* Assessment of basal cortisol before beginning of exposure to virtual reality (sampling saliva through a Salivette®)
* Pulse and blood pressure measurements before and after session

Session 1 (within 1 to 7 days following Inclusion Visit) and session 2 (within 48 hours following session 1):

* Randomization is made by the tDCS software (double bind).
* Equipment of subject with Vive Headset (virtual reality HTC vive), trackers and (tDCS). The subject does not see the experimental room.
* Virtual task (20 minutes): the subject has to ride in an elevator up to the next floor, cross a footbridge between 2 buildings to access the elevator on the other side and be able to climb to the next floor. At each level, the subject asked to rate their SUD. The objective is to climb as high as possible.
* The active or sham brain stimulation is applied randomly during the entire virtual task.
* Assessment of basal cortisol before and after exposure to virtual reality
* Pulse and blood pressure measurements before and after session
* After session: debriefing and explication of the subjective experience (30 minutes).

End of study visit:

* Identical to inclusion visit plus :
* acrophobia/visual height
* Completion of Simulator Sickness Questionnaire (SSQ) and Igroup Presence Questionnaire (IPQ)

Eligibility Criteria:
Inclusion Criteria:

* Without any particular ethnic and psychosocial criteria
* Subjects with fear of heights (anxiety AQ score \>45 and/or VHI score \>7)
* Subjects with SUD score\>50/100 assessed during first visit
* Subjects without psychiatric or addictive disorders
* Subjects without criteria of phobia according to DSM5 (Diagnostic Statistical Manual)

Exclusion Criteria:

* contraindication to tDCS (neurosurgical history, intracranial device, skin problems)
* current virtual reality intolerance
* history of psychiatric or addictive disorders
* Use of psychotropic drugs
* Use of non psychotropic treatments significantly influencing mood or level of anxiety
* Neurological pathology, locomotor disability, or sensory (vestibular, visual, auditory ...)
* pregnant or breast-feeding women
A Clinical Trial for Inactivated Vaccine(Vero Cell) Against EV71 in Chinese Healthy Young Adults and Children

Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused by viruses that belong to the enterovirus genus of the picornavirus family. Although most HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71 (EV71) can present with a high rate of neurological complications, including meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused by EV71 has become a major emerging infectious disease in Asia and the highly pathogenic potential of EV71 clearly requires the attention of world medical community.

The development of vaccine against EV71 is active and ongoing in Asian countries now. Several studies have examined the effectiveness of inactivated viral vaccines against EV71 in animal model. A wide range of experimental EV71 vaccine approaches have been studied including heat-inactivated or formaldehyde-inactivated virion, EV71 virus-like particles (VLP) , VP1 recombinant protein ,VP1 DNA vaccine , VP1 peptide-based vaccine targeting the neutralizing domain, bacterial or viral vector expressing VP1, and a Vero cell-adapted live attenuated virus. Furthermore, neutralizing antibodies against EV71 have been suggested as one of the most important factors in prevention of the severe EV71 infection. Recently, an inactivated vaccine(vero cell) against EV71 has been licensed by SFDA in China, this clinical trial phase Ia is armed to evaluate safety and tolerance in Chinese healthy adults and children.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects aged from 5 to 22 years old as established by medical history and clinical examination
* The subjects or their guardians are able to understand and sign the informed consent
* Had never received the vaccine against EV71
* Subjects who can and will comply with the requirements of the protocol

Exclusion Criteria:

* Subject that has a medical history of HFMD
* subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
* Family history of seizures or progressive neurological disease
* Family history of congenital or hereditary immunodeficiency
* Women of pregnancy, lactation or about to be pregnant in 60 days
* Autoimmune disease or immunodeficiency
* Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
* Any prior administration of administration of immunoglobulins
ReceptIVFity &amp;amp; Immunology in ART

The goal of this clinical non-invasive observational pilot study is to improve the prediction of pregnancy success after In Vitro Fertilisation (IVF)/IVF -Intracytoplasmic Sperm Injection (ICSI) treatment by examining the vaginal microbiome and the immunological profile of menstrual blood in women (18-42) years old) undergoing their first IVF/IVF/ICSI treatment.

The main questions it aims to answer are:

What is the ReceptIVFity profile (low, medium, or high) of the vaginal microbiome in these women? How do the endometrial-derived lymphocytes respond to different immune stimuli and microbiota? Can the endometrial stromal cells decidualize effectively in the presence or absence of specific microbiota?

Participants will:

Self-perform a vaginal swab to determine the ReceptIVFity profile of their vaginal microbiome.

Self-collect menstrual blood during 24 hours in 2 blocks of 12 hours for immunological analysis.


Eligibility Criteria:
Inclusion Criteria:

1. Indication for an IVF or IVF/ICSI procedure.
2. 18 years - 42 years.
3. European origin
4. Willing to provide a vaginal swab with the ReceptIVFity-test.
5. Willing to provide informed consent.

Exclusion Criteria:

1. No transferable embryos after IVF or IVF/ICSI.
2. Emergency IVF for cancer or other reasons.
3. Women with endometriosis pre-treated with an Gn-RH analogue.
4. The use of (hormonal) contraceptives or antibiotics 3 months prior to start IVF or IVF/ICSI.
5. Women unable or unwilling to agree with the procedures.
6. Women unable or unwilling to give written informed consent.
Prematurity Related Risks of Cognitive Impairment at School Age

The main purpose of this study is to better evaluate prematurely born children cognitive development at school age, with regards to birth conditions but also to social situation, intra family relationships, and modalities of care.

The study will be divided into 3 parts:

1. Children born prematurely in our level III referral Center will undergo psychometric evaluation at 8 to 11 years of age by routine cognitive test. The relationships between cognitive scores and neonatal characteristics will be determined and compared to the results of schoolmates born at term.
2. The quality of parent and child relationship will be evaluated by a standardized questionnaire allowing the evaluation of persistent stress trauma related to premature birth.
3. An anthropologic study of the utilization of care resources will also be performed within the follow-up network taking care of these children.

Long term follow-up of vulnerable children such as infants born prematurely are generally studied without taking into account the social, familial and care resources available in the child environment.

Thus, the main purpose of this study is to evaluate prematurely born children cognitive development at school age, with regards to birth conditions but also to related social situation, intra family relationships, modalities of care and utilization of care resources.

The study will be divided into 3 parts:

1. Children born prematurely in our level III referral Center will undergo psychometric evaluation at 8 to 11 years of age by routine test (WISC IV). The relationship between cognitive scores and neonatal characteristics will be determined and compared with the results of schoolmate control children, born at term.
2. The quality of parent and child relationship will be evaluated by standardized questionnaire (Perinatal PTSD Questionnaire). This questionnaire allows evaluating persistent perinatal stress trauma related to prematurity.
3. An anthropologic study of care and utilization of care resources will be performed within the follow-up network taking care of these children. This part will use semi-directive interviews of caregivers involved in the follow-up network.

This study should allow to better correlate prematurely born children outcome with their global environment and propose improvements in care resources utilization for a better development.

Eligibility Criteria:
Inclusion Criteria:

* Former premature infants aged 8-11 years
* School grade appropriate for their age
* Schoolmate control children born at term aged 8-11 years

Exclusion Criteria:

* Any neurological sequelae
Registry Study of Pharmacotherapy and Clinical Outcomes in Elderly Patients With Coronary Heart Disease (PHARM-ageing)

A registry study on drug therapy and clinical outcomes in elderly patients with coronary heart disease


Eligibility Criteria:
Inclusion Criteria:

* Informed consent has been signed
* Patients diagnosed in our hospital with coronary heart disease
* Age ≥65 years

Exclusion Criteria:

* Severe lack of important information such as history of previous medication, history of previous disease, history of surgery.
* Mental disorders, or inability to communicate effectively with researchers, or failure to comply with research protocols.
Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone

The primary objective of this study is to evaluate change in weight as a result of switching from quetiapine to ziprasidone, in subjects with schizophrenia or schizoaffective disorder who have failed to achieve a satisfactory clinical response to quetiapine due to lack of efficacy or poor tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Males or females, between 18 and 55 years of age, at the time of consent.
* Subjects must have a primary diagnosis of schizophrenia, any subtype (code 295.xx), or schizoaffective disorder as defined in DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition)
* Subjects must have normal vital signs, physical examination, ECG, and laboratory findings except for minor deviations determined and documented to be clinically insignificant by the investigator or a sub-investigator who is a medical doctor.

Exclusion Criteria:

* Subjects who are unable to provide informed consent
* Subjects who meet criteria for a DSM-IV-TR Axis I (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition) diagnosis other than schizophrenia or schizoaffective disorder, including psychoactive substance abuse or dependence within one year of study entry
* Females who are pregnant, breast feeding, or lactating at screening.
Recovery Profiles of Remifentanil-based Regimen for Cardiac Surgery

Backgrounds: Monitoring of Bispectral index (BIS) has been regarded as useful to determine the degree of intraoperative hypnosis. Major factors of postoperative recovery after cardiac surgery include patient's recovery in cognitive function from the postoperative residual effects of anesthetics, such as opioids and sedatives, administered during intraoperative period. Therefore employing anesthetic regimens which can provide earlier recovery in cognitive function would be beneficial in facilitating fast-track cardiac surgery with earlier postoperative extubation and discharge from the intensive care unit (ICU).

Previous investigations suggested efficacy of BIS in evaluating the degree of postoperative hypnosis in the ICU.

The present study compares the time for reaching BIS greater than 80 after using 2 different anesthesia regimens for cardiac surgery, remifentanil-based regimen and sevoflurane-sufentanil balanced regimen.

Analyzing the changes immediately after cardiac surgery would be useful to determine the degree of patient's postoperative emergence.

Materials and Methods:

During study period, patients undergoing elective cardiac surgery in Konkuk University Medical Center are randomly assigned to get remifentanil-based regimen consisting of remifentanil 0.75 mcg/kg/min and supplemental propofol for maintaining BIS 40-60 (Group R) or sevoflurane (end-tidal 1.2-2.8 vol%) and sufentanil (0.015 mcg/kg/min) balanced regimen in Group S.

All patients get intravenous patient controlled anesthesia consisting of alfentanyl and ondansetron after surgery. Supplemental remifentanil 0.25-0.3 mcg/kg/min is administered during postoperative 2 hours in Group R.

As a primary objective, inter-group difference in the time for achieving BIS greater than 80 is determined.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective coronary artery bypass surgery

Exclusion Criteria:

* combined valve surgery
* preoperative intraaortic balloon pumping
* preoperative low cardiac output syndrome
* chronic obstructive pulmonary disease
Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of INV-101 in Healthy Male and Female Subjects

Single center, randomized, double-blinded, placebo-controlled, single ascending-dose study for the evaluation of the safety, tolerability, and PK following single oral doses of INV-101.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male or female
* Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively; and body weight ≥60 kg
* Non- or ex-smoker
* Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an investigator

Exclusion Criteria:

* Female who is pregnant or lactating
* Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability
* History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
* Presence of clinically significant ECG abnormalities at the screening visit, as defined by medical judgment (maximum QTc of 450 for males and 470 for females)
Long Term Follow-up Hybrid Revascularization

OBJECTIVES:

The objectives of the year study are two-fold:

1. To determine the 5-7 year patency rate (rate of open bypass grafts) of the LITA graft and stent of patients who have already had robotically-assisted Hybrid CABG surgery using CTA and MPS-MIBI.
2. To determine patient quality of life at 5-7 years after robotically-assisted Hybrid CABG surgery

New techniques such as robotically-assisted Hybrid CABG surgery need proper evaluation to ensure potential benefits gained are not harmful to that which we know to be of significant benefit to the patients, that being the left internal thoracic artery (LITA) graft (one of the main coronary arteries supplying your heart with blood). We are therefore proposing a 5-7 year CT-Angiography (CTA) and Myocardial Perfusion Scintigraphy (MPS-MIBI) to assess the patency rate of the LITA graft and the stented graft in patients that have already undergone robotically assisted Hybrid CABG.

Eligibility Criteria:
Inclusion Criteria:

- Patients that have previously had Hybrid robotic coronary artery revascularization performed approximately 5-7 years ago at the London Health Sciences Centre, University Hospital by Dr. Kiaii.

Exclusion Criteria:

- Patients not described above
Minimally Invasive Knee Replacement Outcomes (MIKRO) Study

The purpose of this study is to evaluate and compare the clinical, radiographic (x-ray) and cost effectiveness outcomes (cost relative to risks and benefits) of two different minimally invasive knee joint replacement surgical techniques. The primary study hypothesis is that in comparing total knee replacement performed with the two different surgical techniques that respect four minimally invasive surgery principles (low-profile instrumentation, "minimally invasive" incision, overall minimal knee surgical intervention), a faster return to function will result when the technique does not incise the tendon.

This study does not include financial compensation for treatments involved.

Eligibility Criteria:
Inclusion Criteria:

* Presence of severely symptomatic knee osteoarthritis that has failed non- operative treatment
* Males and non-pregnant females, 35-85 years of age at the time of surgery
* ASA class 1 or 2
* Procedure will not require computer navigation
* Patient/Surgeon has not requested another implant
* Patient has signed an IRB approved study consent form
* Patient is able and willing to actively participate in post-operative rehabilitation program
* Patient understands study requirements
* Patient is willing to comply with follow-up visits and diary documentations
* Patient is capable of independent ambulation

Exclusion Criteria:

* Skeletal immaturity
* More than 10 degrees of valgus or varus deformity as measured from a weight bearing AP alignment view
* Patients with bilateral knee osteoarthritis who are considering a simultaneous bilateral procedure
* Bone or ligament insufficiency that requires the use of augments or stems, or constrained component
* Daily pre-operative use of narcotic pain medication
* Prior knee arthroplasty
* Patient is a prisoner
* Patient has had prior tibial tubercle osteotomy
* Patient's surgical knee would require removal of hardware prior to TKA
* Patient has \< 95 degrees flexion pre-operatively
A Study of Flortaucipir PET in Healthy Volunteers and Cognitively Impaired Subjects

This study will test if two flortaucipir PET scans up to 4 weeks apart in healthy volunteers, MCI and AD subjects provide the same results.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers

  * Male or female subjects ≥ 50 years of age
  * Mini-mental state examination (MMSE) ≥ 29
* MCI Subjects

  * Male or female subjects ≥ 50 years of age
  * MMSE ≥ 24
  * Have MCI consistent with National Institute on Aging-Alzheimer's Association (NIA-AA) working group's diagnostic guidelines for AD
  * Have a study partner that can report on subject's activities of daily living
* Probable AD Subjects

  * Male or female subjects ≥ 50 years of age
  * MMSE \> 10
  * Meet clinical criteria for probable AD based on the NIA-AA working group's diagnostic guidelines for AD
  * Have a study partner that can report on subject's activities of daily living

Exclusion Criteria:

* Current clinically significant psychiatric disease
* Evidence of structural brain abnormalities
* Evidence of dementing illness other than AD
* Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes
* Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
* History of alcohol or substance abuse or dependence
* Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
* Have received or participated in a trial with investigational medications in the past 30 days
* have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session.
Study to Determine the Pharmacokinetics of Product 0405

The purpose of this study is to evaluate the Pharmacokinetics of Product 0405 in the Treatment of Atopic Dermatitis in Adolescent Subjects.

Treament medication will be administered topically twice daily for 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Atopic Dermatitis
* Good health with the exception of Atopic Dermatitis
* Percent body surface area minimums

Exclusion Criteria:

* Subject who are nursing, pregnant or planning a pregnancy