cyrilzakka/clinical-trials huggingface dataset:
Global State of Digestive Endoscopy Training Survey

This is a 10 minutes web based survey aims at exploring the current, global state of digestive endoscopy training among physicians to identify what are the unmet needs and how to improve it.

Currently, gastrointestinal (GI) endoscopy training is not a standardized and is variable from country to country. A number of certifying authorities in different countries grant privileges of performing GI endoscopy according to predefined rules, requisites and regulations, especially in the Western countries (1-4). However, in many other countries, physicians who perform GI endoscopy as part of their medical practice may not require to be certified or acknowledged by a relevant regulatory body (5-8).

In the absence of quality assessment of GI training, patient safety and evidence-based medical care cannot be guaranteed. According to major societies of GI endoscopy, the credentialing decisions for GI endoscopy should be based on the evaluation of physicians' qualifications and procedural skills, as assessed by experienced doctors with whom they have trained, not solely on a simple counting of procedures performed (9). Therefore, there is a need for a WEO training guideline that defines training duration, procedural skills and competency that should be acquired by young GI endoscopists during their endoscopy training.

It is particularly important for WEO to standardize the fundamentals of GI endoscopy training globally by developing recommendations on endoscopic education and training to help medical institutions ensure the technical and cognitive competence of individuals requesting endoscopic privileges.

Objective:

To assess the current global state of GI endoscopy training programs and to identify the unmet needs and how to improve it through a web based questionnaire.

Methods:

Endoscopists from all over the world will be invited to answer in the questionnaire through e-mail invitations. Results will be analyzed to assess the current global status of GI endoscopy training in their countries, the unmet needs and to how improve it.

Survey link:

http://www.surveymonkey.net/create/survey/preview?r=true\&sm=R74C8rWWwbO8_2BQM2fg9Yr5HcAtrkz8XwZogb4Bbaqr8oC9mFJrq8WAvNY33O45r1

Eligibility Criteria:
Inclusion Criteria:

* Physicians practicing gastrointestinal endoscopy from all over the world

Exclusion Criteria:

* Any other persons whom are not physicians or physicians not practicing gastrointestinal endoscopy
Determination In-vivo KUF for Diacap Pro Hemodialyser

The main purpose of this study is the determination of the in-vivo ultrafiltration coefficient (in-vivo KUF) for Diacap Pro dialyzers following routine dialysis prescription in the United States.

The in-vivo KUF for Diacap Pro High Flux dialysers with the surface sizes of 1.3/ 1.6/ 1.9 sqm will be determined as required by the US guideline "Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers 1998" for comparison with the in-vitro KUF data.

Clinical data of at least 12 patients will be collected for determination of the in-vivo KUF complemented by safety-, performance-data for the removal of small and middle molecular substances and hemocompatibility data.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained from patient or parents/ guardian.
2. Subject age \> 18
3. Effective blood flow 350 ml/min and dialysate flow in the range of 500 - 800 ml/min
4. On hemodialysis for a minimum of 3 months
5. Use of Cimino- or Gore-tex shunts
6. Routine dialysis-treatment for 240 min and 3 times per week
7. Documented dialysis adequacy parameter spKt/V \>=1.2 that has been stable for past 3 months
8. Plan to dialyze at participating hemodialysis center for at least 3-months duration.
9. Free from any currently known unusual clotting or access problems
10. Hepatitis B surface antigen (HbsAg) negative, documented within the past 90 days or Hepatitis B surface antibody (anti-HBs) positive.
11. Anti HCV negative, documented within the past 90 days
12. Anti HIV negative, documented within the past 90 days Hematocrit (HCT) between 25 and 40% or haemoglobin (Hb) not less than 8 g/dL

Exclusion Criteria:

1. Patients who are unable to tolerate an effective blood flow of 350 ml/min
2. Patients using catheter for dialysis
3. Pregnant or nursing woman. Women of childbearing potential must agree to avoid pregnancy during the study period
4. Previous plan for extended absences from the participating hemodialysis centre
5. Expected to be transplanted (living related donor) within the maximum of 3 months for the study period
6. Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of the study
Knee Osteoarthritis, Aging and Metabolic Syndrome

Osteoarthritis (OA) is the most prevalent form of arthritis. Its pathogenesis remains poorly understood. Though historically regarded as a disease of mechanical degeneration, it is now appreciated that inflammation plays an important role in OA pathogenesis

1. Place of the study: Sohag university hospital.
2. Type of study: Cross-Sectional Observational study
3. Study period: Six months to one year The study will include Patients who met the American College of Rheumatology (ACR) clinical criteria for knee OA .

The following details will be obtained:

* Demographic data : Age ,Sex ,Marital status ,Occupation ,Residence ,Education level

  ,Anthropometrical measures which included waist circumference (WC) and blood pressure (BP) will be obtained,History of chronic diseases (eg; Diabetes mellites, Hypertension)
* Clinical information: Symptom and its Duration. Plain radiographs of at least one knee \[anteroposterior (A/P), lateral} will be taken.
* Laboratory findings included fasting blood sugar, serum levels of triglycerides, High-density lipoprotein cholesterol and total cholesterol.

Eligibility Criteria:
Inclusion Criteria:

* Patients who met the American College of Rheumatology (ACR) clinical criteria for knee OA and had symptomatic OA of at least 1 knee (index knee), with a Kellgren / Lawrence (K/L) score ≥ 1 in that knee

Exclusion Criteria:

* Any patient with a history of trauma to the knee

  * Any other form of arthritis (e.g., rheumatoid arthritis, seronegative spondyloarthropathies, gout, pyrophosphate disease, or other crystal arthropathy)
A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD (or ASGES) in Primary Care Settings

The PRESET Registry--A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD (Age/Sex/Gene Expression score - ASGES) in Real World Clinical Care Settings (PRESET)--was designed as an observational, post-market, real-world registry to evaluate patterns of care, including referrals to a cardiologist, cardiac stress testing, CT angiography, within the first month after Corus CAD (ASGES) testing.

The prospective PRESET Registry (NCT01677156) enrolled stable, nonacute adult patients presenting with typical or atypical symptoms suggestive of obstructive coronary artery disease from 21 US primary care practices from August 2012 to August 2014. Demographics, clinical characteristics, and Corus CAD (Age/Sex/Gene Expression score - ASGES) results (predefined as low \[ASGES \<15\] or elevated \[ASGES \>15\]) were collected, as were referrals to Cardiology or further functional/anatomic cardiac testing after Corus CAD (Age/Sex/Gene Expression score - ASGES) testing. Patients were followed for 1 year post ASGES testing.

Eligibility Criteria:
Inclusion Criteria:

1. Symptoms suggestive of CAD, according to the opinion of the site registry clinician
2. Receiving Corus CAD (ASGES) to aid in the diagnosis of obstructive CAD
3. Age \>= 18 years
4. Willing and able to provide written informed consent

Exclusion Criteria:

1. History of myocardial infarction (MI)
2. Current MI or acute coronary syndrome
3. Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
4. Known/documented CAD
5. Diabetes Mellitus
Structural Cartography of the Insula in Temporal Epilepsy Patients

The purpose of this study is to investigate insula structural connectivity in temporal epilepsy patients. Insula being at the interface of frontal, parietal, occipital and temporal lobes, its structural organization reflects the brain function. We hypothetize that insular structural organization will be different according to the different subtypes of temporal epilepsy.

The purpose of this study is to investigate insula structural connectivity in temporal epilepsy patients. Insula being at the interface of frontal, parietal, occipital and temporal lobes, its structural organization reflects the brain function. We hypothetize that insular structural organization will be different according to the different subtypes of temporal epilepsy.

Eligibility Criteria:
Inclusion Criteria:

* epileptic patients: temporal epilepsy or temporal plus epilepsy (temporomesial epilepsy, basal temporal epilepsy, mesio lateral or lateral epilepsy, temporo insular epilepsy, operculo insular epilepsy)
* patients who underwent video EEG monitoring with recorded seizures (at least one)
* patients who underwent a brain MRI with DTI sequence before epilepsy surgery
* patients who did not refuse the use of their clinical and MRI data for this study

Exclusion Criteria:

* patients younger than 15 years old
* patients with previous brain surgery (before MRI)
* uncompleted MRI sequences (DTI, T1 anatomical)
Glutamine in Preventing Peripheral Neuropathy in Patients With Multiple Myeloma Receiving Bortezomib

This randomized phase II trial studies glutamine in preventing peripheral neuropathy in patients with multiple myeloma who are receiving bortezomib. Glutamine may help prevent peripheral neuropathy in patients receiving chemotherapy

PRIMARY OBJECTIVES:

I. Estimate the objective effect size of glutamine compared to placebo as a prophylactic intervention to prevent bortezomib-induced peripheral neuropathy in multiple myeloma patients 4 months after their first dose of study drug.

SECONDARY OBJECTIVES:

I. Estimate whether glutamine delays or prevents the onset or worsening of any neuropathy as determined by National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v4.03 criteria.

II. Determine if glutamine may improve adherence to bortezomib therapy.

III. Assess response rate (RR) and clinical benefit response rate (CBR) according to uniform international response criteria and modified European Group for Blood and Marrow Transplantation (EBMT) criteria.

IV. Determine if glutamine may improve quality of life (QOL) at 4 months.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive glutamine orally (PO) twice daily (BID). Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of multiple myeloma who received bortezomib at a dose of 1.3mg/m2 SQ weekly
* No evidence of severe pre-existing peripheral neuropathy, NCI-CTCAE v4.03 =\< 2
* Performance status =\< 2 on the Eastern Cooperative Oncology Group (ECOG) performance scale

Exclusion Criteria:

* Concurrent use of thalidomide, vincristine, platinum compound, or other agent known to cause significant neuropathy (concurrent lenalidomide will be allowed)
* Hospitalization with clinical evidence of active infections as manifested by recurrent fevers, positive blood culture results, or requiring intravenous antibiotic therapy
* Inadequate liver and renal function with liver transaminases 3x the upper limit of normal
* Glomerular filtration rate (GFR) according to Cockcroft-Gault \< 30 mL/min
* Uncontrolled congestive heart failure
* Uncontrolled mood disorders
* Fasting blood glucose \>150mg/dL or blood sugar (non-fasting) \>200mg/dL if no history of diabetes. Uncontrolled diabetes with HgA1C greater 7% with last evaluation.
* Seizure disorder
* Monosodium glutamate (MSG) allergy or soy allergy
* Life expectancy of shorter than 3 months based on clinical laboratory parameters and the investigator's opinion
* Uncorrected Vitamin B12 or folate deficiency on last evaluation.
* Use of over the counter (OTC) supplements other than one multivitamin tablet a day
* Women who are pregnant or breastfeeding
15-day Sequential Therapy for Helicobacter Pylori Infection in Korea

10-day sequential therapy was not sufficient to overcome tough situation for H. pylori eradication in Korea due to high antimicrobial resistance. The present investigators assumed that doubling duration of second phase of sequential therapy might have more potent bactericidal efficacy than previous 10-day sequential regimen. But 15-day regimen with initial 5-day PPI with amoxicillin followed by remaining 10-day PPI, clarithromycin with metronidazole was not ever tested before. Moreover, whether extending the sequential therapy to 15-day might be more effective than 10-day sequential therapy is unknown especially in Korea. From this background, the present investigators prepared clinical trials regarding modified sequential therapy which was extending the treatment duration to 15 days compared than previous 10-day sequential therapy regimen. In addition, pre-treatment antimicrobial susceptibility testing was performed to find the possibility to overcome antimicrobial resistance.


Eligibility Criteria:
Inclusion Criteria:

* patients with H. pylori infection who had never received treatment for H. pylori infection
* H. pylori infection defined by a positive rapid urease test (CLOtest, Delta West, Bentley, Australia) by gastric mucosal biopsy from the lesser curvature of the mid antrum or mid body or histological evidence of H. pylori by modified Giemsa staining in the lesser and greater curvature of the mid antrum or mid body, respectively or a positive C-urea breath test.

Exclusion Criteria:

* Patients with concurrent critical illness, a history of previous upper gastrointestinal surgery, contraindication to any of the study medications, recent frequent intake of NSAIDs, anticoagulants or steroids, an allergy to the study medications, and those that were pregnant or breast-feeding women were excluded from the study. Other exclusion criteria include recent use of antimicrobials and any condition probably associated with poor compliance such as drug abusers or alcoholics.
Pharmaco(Epi)Genetic, Proteomic, and Microbiomic Study of Obsessive-Compulsive Disorder

The purpose of this study is to determine whether pharmaco(epi)genetic study predict selective serotonin reuptake inhibitor (SSRI) responsiveness in advance before the appearance of the drug effect until 4 months(16 weeks), 6 months, and 1 year after administration of SSRIs.

The purpose of this study is to determine the effects of (epi)genetic variants on the response to SSRIs in obsessive-compulsive disorder (OCD) subject.

The investigators will recruit drug-naive or drug-free(\> 3 months) OCD subjects (n=200). The participants will get SSRIs for their OCD symptoms. The type and dose of SSRIs will not be restricted and will depend on the individual participant's state. However, the investigators will be recommended to follow usual clinical guideline (the Korean treatment algorithm for OCD, 2004). At baseline, 4 month, 6 months, and 1 year after treatment, the participants will be evaluated by Yale-Brown Obsessive-Compulsive Scale(YBOCS), Montgomery Asberg Depression Rating Scale(MADRS), Dimensional Obsessive-Compulsive Scale(DOCS), Toronto alexithymia scale (TAS), interpersonal reactivity index (IRI), Barratt impulsiveness scale (BIS), and the Measure of Constructs Underlying Perfectionism(M-CUP), Beck Depression Inventory(BDI), Beck Anxiety Inventory(BAI), Intolerance of Uncertainty (IOU), Metacognition, Disgust scale, Early Trauma Inventory (ETI). And a part of participants will be taken resting state functional MRI.

The research participants will donate approximately 10-15 ml of blood, from which we will extract DNA and separate serum. Using various (epi)genetic analyses, proteomics, and microbiome analysis (circulating bacterial extracellular vesicles) methods, we will analyze the association of various (epi)genetic variants, protein profiles, microbiome and the anti-obsessive-compulsive responses.

Eligibility Criteria:
Inclusion Criteria:

1. age 19\~ 70
2. OCD by Diagnostic and Statistical Manual for Mental disorders, 4th edition (DSM-IV)
3. drug naive or drug free for more than 3 months

Exclusion Criteria:

1. any neurological disorder
2. comorbid psychotic disorders
3. alcohol or other substance dependence within past 6 months
4. any evidences for brain diseases
Vestibular Socket Therapy (VST) in Infected and Non Infected Sockets

Vestibular socket therapy with immediate implant placement is compared in infected and non-infected sockets regarding implant survival, bone thickness and soft tissue height .

For non infected sockets, a 15c blade (Stoma, Storz am Mark GmbH, Emmingen-Liptingen Germany) was used to cut a 1-cm long vestibular access incision , 3-4 mm apical to the mucogingival junction of the involved tooth. The socket orifice and the vestibular access incision were connected by a subperiosteal tunnel that was created using a periotome and a micro-periosteal elevator (Stoma, Storz am Mark GmbH, Emmingen-Liptingen Germany). Implants, (Biohorizons, Birmingham, Al, USA) , were installed using a 3D printed surgical guide (Surgical Guide Resin, Form 2, Formlabs). A flexible cortical membrane shield (OsteoBiol® Lamina, Tecnoss®, Torino, Italy) of heterologous origin, 0.6 mm in thickness was prepared by hydrating and trimming it. It was then tucked through the vestibular access incision, till it extended 1 mm below the socket orifice, and stabilized using a membrane tack (AutoTac System Kit, Biohorizons Implant Systems, Birmingham, Alabama Inc, USA) to the apical bone. The gap between the implant and the shield/the labial plate was then filled with particulate bone graft \[75% autogenous bone chips harvested form local surgical sites and 25% inorganic bovine bone mineral matrix (MinerOss X , Biohorizons, Birmingham, Al, USA)\]. For the infected sockets, the 6-day protocol was implemented. Atraumatic extraction of the infected tooth by the periotome was followed by curettage, mechanical debridement and chemical irrigation using metronidazole irrigation solution (500mg/100ml, Amrizole, Amria Pharma, Alexandria, Egypt). The root of the involved tooth was cleaned with an ultrasonic cleaner, cut to its apical third, reimplanted into the socket and maintained there for 6 days by bonding its crown to the adjacent teeth using composite resin. Implant and crown placement were done as described above for the non-infected socket group.

Eligibility Criteria:
Inclusion Criteria:

* all patients were adults ≥ 18 years,
* 1-5 non-adjacent hopeless maxillary teeth in the esthetic zone.
* The involved teeth had type II sockets.
* To achieve optimum primary stability for the implants (30Ncm insertion torque), adequate palatal and at least 3 mm apical bone should be available to engage the immediately placed implants.

Exclusion Criteria:

* Smoking and/or pregnant patients
* systemic diseases
* a history of chemo- or radiotherapy within the past 2 years were excluded.
Prematurity and Parental Involvement in Child Development Care

The aims of the study is to evaluate the association between presence and parental participation in perinatal care and psychic development of the child at 24 months

In France, as in developed countries, the premature birth rate has been rising over the past few years. Premature labor is a particularly stressful birth. It is recognized that the level of parental stress is greater at a premature birth compared to a term birth. The neuro-developmental consequences of premature birth are important. A possible association between prematurity and the onset of mental disorders such as hyperactivity, inattention, emotional problems, conduct disorders, autistic disorders and social difficulties has been shown. It has been shown that parental presence, holding and skin to skin during hospitalization would be beneficial for the child's motor development and psychological well-being by reducing the stress of the child.

Eligibility Criteria:
inclusion criteria : child born very prematurely between 27 and 31 weeks gestational age + 6 days child taken in charge at the intensive care unit of Reims University Hospital for at least 3 weeks child aged 24 months (+/- 2 months) the holders of parental authority are more 18 years old the holders of parental authority know how to speak, read and write French the holders of parental authority agree to participate in the study

exclusion criteria :

- child has a serious pathology (abnormal brain MRI)
Single Dose Clinical Trial of MG-ZG122 in Chinese Healthy Adult Subjects

To determine the safety and tolerability of MG-ZG122 in Chinese healthy adult subjects

Main purpose: To determine the safety and tolerability of MG-ZG122 humanized monoclonal antibody injection (MG-ZG122 for short) in Chinese healthy adult subjects.

Secondary objective: To study the pharmacokinetic (PK) characteristics of MG-ZG122 in healthy Chinese adult volunteers, and to provide a basis for the design of clinical trial protocols for subsequent clinical trials; To evaluate the immunogenicity of MG-ZG122 in Chinese healthy adult volunteers; Preliminary exploration of the efficacy of MG-ZG122 in Chinese healthy adult subjects Impact of Biomarkers in Physiology (PD).

Eligibility Criteria:
Inclusion Criteria:

- 1. The subjects signed the ICF before the study and fully understood the research content, process and possible adverse reactions; voluntarily participated in the study and were able to complete the study according to the program requirements.

2. Chinese healthy adult subjects aged 18-65 years (including the boundary value) , both male and female; 3. Male volunteers weighing ≥50 kg; women weighing ≥40 kg; body mass index (BMI) within the range of 19.0-26.0 kg/m2 (including boundary values; BMI=weight kg/height 2 m2);

Exclusion Criteria:

1. Patients with acute or subacute infection (such as fever, cough, urgency, dysuria, abdominal pain, diarrhea and skin infection wounds, etc.) within 2 weeks before screening, or acute or chronic infection within 4 weeks before screening history, and receiving systemic anti-infective treatment;
2. Those who have a history of tuberculosis infection in the past;
3. The results of physical examination, vital sign measurement, laboratory examination, electrocardiogram, chest X-ray, etc. are abnormal and have clinical significance;
4. Those who are known to be allergic to monoclonal antibody drugs or excipients of MG-ZG122 injection, or food allergies judged by the investigator to be unsuitable to participate in the researcher;
5. Those who have been vaccinated within 1 month before screening or plan to be vaccinated during the study;
6. Those who have used any prescription drugs within 2 weeks before administration, those who have used non-prescription drugs or traditional Chinese medicines within 1 week before administration, or those who are expected to use prescription drugs, non-prescription drugs and traditional Chinese medicines during the study period;
7. Those who have received any research non-biological agents within 5 half-lives (if known) or within 3 months (whichever is longer) before administration, or have participated in other clinical trials or plan to participate in other clinical trials during the study period. clinical trial subjects;
8. Those who have special requirements for diet or cannot accept a unified diet;
9. Women who are lactating and pregnant, or female volunteers of childbearing age have a positive serum pregnancy test;