cyrilzakka/clinical-trials huggingface dataset:
Tissue Characterization With Hyperspectral Imaging (HSI)

Hyperspectral Imaging (HSI) is a contact free method to analyse the from the tissue reflected light in the range of 500-1000nm. Aim of the study is to identify special reflex patterns to identify special tissue

This HSI-camera provides hyperspectral images with a high spectral resolution (5 nm) in the visible and near infrared range (500-1000 nm). A RGB image and 4 false color images that represent physiologic parameters are intraoperatively provided by an analysis software. But after the procedure all spectral datasets could be investigated. To analyse and differentiate the different tissues, a catalog database is needed of all tissues including Tumors.

Eligibility Criteria:
Inclusion Criteria:

* All patients with surgical procedure

Exclusion Criteria:

* inability to consent
Retrospective Study of Clinical Practice and Management of Imported Schistosomiasis in France

Schistosomiasis is a major public health issue. Clinical guidelines for the management of imported schistosomiasis are heterogeneous. The objective of this study is to describe the clinical management of schistosomiasis imported cases in France, regarding diagnosis, treatment and follow-up.

Schistosomiasis is a major public health issue. Clinical guidelines for the management of imported schistosomiasis are heterogeneous. The objective of this study is to describe the clinical management of schistosomiasis imported cases in France, regarding diagnosis, treatment and follow-up. It is a multicentric, retrospective, descriptive study. Inclusion criteria are an age ≥ 18, a positive western blot and / or a positive microscopy exam. Data concerning clinical presentation, biological samples, imaging, treatment and follow-up will be assessed. A descriptive analysis will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18, positive schistosomiasis immunoblot and / or positive microscopy examination for schistosomiasis eggs

Exclusion Criteria:

* - patients under guardianship
"All Comers" Post Market Clinical Follow-up (PMCF) With Multi-LOC for flOw liMiting Outcomes

The aim of the study is to assess the safety and efficacy of the Multi-LOC® peripheral stent system to treat de novo and restenotic lesions (no in-stent restenosis (ISR), no restenosis post drug coated balloon (DCB) after flow limiting plain old balloon angioplasty (POBA) and/or DCB dilatations in the superficial femoral artery (SFA) and popliteal segments (P1, P2 \& P3)

This study is an non-randomized, prospective, multi-center, non-interventional study (registry, for Germany: §23b MPG)

Eligibility Criteria:
Inclusion Criteria:

* Willingness to treat flow-limiting dissections/recoil after plain old balloon angioplasty (POBA)/drug coated balloon (DCB) interventions
* Patients in Rutherford classes 2 through 5
* Patients eligible for peripheral revascularization by means of percutaneous transluminal angioplasty (PTA) and stenting
* Patients must be at least 18 years of age
* Patient with a life expectance of at least 12 months
* Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in the following study protocol
* Patients must agree to undergo at least the 6-month clinical follow-up
* Patient is able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial, e.g. balloon angioplasty by means of other suitable stent devices. Patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document.
* Lesions with unsatisfying angiographic results due to recoil and/or dissections after POBA/DCB interventions
* Infra-inguinal lesions in the superficial femoral artery (SFA) and popliteal segments (P1,P2 \& P3) reference vessel diameters between 4 and 7.0 mm, lesion length suitable for the release of at least 2 Stent (up to 6) segments implanted with a minimum inter-stent distance of 1 cm
* Diameter stenosis pre-procedure must be larger or equal to 70%
* Vessels must have adequate distal run-off with at least one vessel to the foot or with collaterals in the calf supplying sufficient flow to the foot.

(Lesions separated by less than 2 cm are considered as one lesion)

Exclusion Criteria:

* Patient not suitable for revascularization by interventional means
Single Ascending Dose Study of PCSK-9 Inhibitor (IBI306) in Healthy Subjects.

IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol（LDL-C）uptake. This is a randomized, double-blind, placebo-controlled,single ascending dose study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics and immunogenicity of IBI306 in healthy adults.

Ascending dose design includes 6 dose levels （25 mg, 75 mg, 150 mg, 300 mg, 450 mg and 600 mg). Tolerance and safety data up to 14 days after dosing from all subjects of the previous cohort will be reviewed before proceeding to the next dose. Total duration of the study per subject is 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Chinese healthy men or women aged 18 to 55 years old at screening (inclusive）;
* Serum LDL-C concentration between 1.8 mmol/L and 4.9 mmol/L (inclusive）at screening;
* Body mass index between 19 and 28 kg/m2 (inclusive);
* Willing to maintain the current regular diet and physical activity;
* Female subjects and male subject's partner who could become pregnant should take effective contraceptions during the treatment period and 6 months after dosing;
* Without any medical history of serious diseases;
* Willing to comply with protocol required visit schedule and visit requirements and provide written informed consent.

Exclusion Criteria:

* Breast-feeding or pregnant women;
* History of allergic reaction;
* Previously received any anti-PCSK-9 treatment;
* Vital signs, physical examination, clinical laboratory test, 12-lead ECG, and chest X-ray are abnormal with clinical significance;
* Not willing to stop intense physical activities (such as weight lifting or long-distance running) before 72 hours of the scheduled visits;
* Any hospitalization within one month before screening, or major surgery within six months before screening, or any other unstable medical condition;
* Received an investigational chemical agent within 30 days before dosing；
* Received an investigational biological agent within 90 days before dosing；
* Use of medications including over-the-counter medication within 14 days or less than 5 half-lifes of the agent;
* Use of herb,vitamins or nutraceutical in order to alter serum lipids;
* Positive screen of hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus or syphilis infection at screening；
* History or clinical evidence of alcohol or drugs of abuse within 12 months before screening;
* With any consumption of alcohol and caffeinated beverages within 72 hours prior to and during the trial;
* Blood donations or blood loss 200 ml and more within 2 months before screening;
* History of organ transplantation or malignant tumor;
* Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment.
Three-dimensional Airway Suction Model

The main purpose of this study is to use 3D printing technology to high-fidelity simulation respiratory models Furthermore, the results of this study will extent to medical school and hospital.

Background：

Most clinical teaching materials are expensive and inaccessible. To promote the accessibility of anatomy models and student learning effects in our medical school and hospital, we use 3D printing technology to print high-fidelity simulation respiratory models and apply them in medical education.

Study Design：

This is a single-site prospective study of medical education. Participants who are students of the School of respiratory therapy will be randomly divided into to control group and experimental group. Both groups will receive the same teaching program. The traditional education model will be used in the control group, and the 3D printed model will be used in the experimental group.

Methods：

The 3D scanning technology will be applied to create drawing files of high-fidelity simulation respiratory models, which are drawn by professional 3D drawing staff. Then, we print out the models with 3D printing technology. The output material will be close to the softness of the human models. The medical education of this study will be divided into two parts. The first part is the teaching of realistic airway suction; the second part is the simulation of advanced mechanical ventilation.

Effect：

We expect benefits that the use of 3D printing high-fidelity simulation respiratory models in medical education. For example, it can reduce the cost of education models and enhance efficacy in medical education. The experience and outcome will be shared with the medical school and hospital.

Keywords：

3D printing; medical education model; high-fidelity simulation; respiratory care.

Eligibility Criteria:
Inclusion Criteria:

* Student of Fu Jen Catholic University.

Exclusion Criteria:

* Refused to participate in the study.
Psychological Outcomes From a Study of Acupuncture Treatment on Experimentally Primary Dysmenorrhea

The objective of this study is to evaluate the associations between deqi, the effects of acupuncture and personality in primary dysmenorrhea and to characterize the nature of the deqi phenomenon on terms of the prevalence of sensations as well as the uniqueness of the sensations underlying the deqi experiment.

The mechanism, by which acupuncture works is not yet clear, therefore there is no unequivocal consensus about styles and sensations of acupuncture. whether psychological factor has influences on the effects of acupuncture? This study will adopt international practices such as visual analogue scale (VAS) to objective evaluation. The confident degree, feeling degree for acupuncture and pain intensity were evaluated by the patient with VAS, and the pain VAS scores before and after acupuncture were recorded as the indexes for assessment of the therapeutic effect.

Eligibility Criteria:
Inclusion Criteria:

1. Female, age between 18 and 30 years old, who had regular menstrual cycles (28-33 days);
2. Meeting diagnostic criteria for primary dysmenorrhea, having moderate to severe symptoms when unmedicated, and eligible for care through the military health system.

Exclusion Criteria:

1. Secondary dysmenorrhea;
2. Women with systemic disease, or hormonal, psychiatric or gynecologic disorders, or substance abuse;
3. Pregnant or trying to conceive, using oral contraceptives, smoker, breast-feeding.
Phase 2 Study of Gemcitabine or Gemcitabine + Enzastaurin in Participants With Advanced or Metastatic Pancreatic Cancer

The purpose of this research study is to determine the effects and toxicity of gemcitabine alone or gemcitabine plus enzastaurin in participants with pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of adenocarcinoma of the pancreas.
* Pretreatment tumor specimen must be available.
* No prior chemotherapy immunotherapy, biological therapy, or hormonal therapy for pancreatic cancer, including 5-fluorouracil (5-FU) with radiation therapy.
* Prior radiation allowed.
* Ability to stop some types of anti-seizure medicines within 14 days of enrollment.

Exclusion Criteria:

* Endocrine pancreatic tumor or ampullary cancer.
* Central Nervous System (CNS) metastases.
* Inability to swallow tablets.
* 10% or greater weight loss over the 6 weeks before study entry.
Stereotactic Body Radiotherapy vs Intensity-modulated Radiotherapy in Prostate Cancer

The primary goal of this phase II study is to compare the change of EPIC HRQOL scores (1-year minus baseline) between SBRT and IMRT.


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of prostate adenocarcinoma
* Low or intermediate risk prostate cancer patients (i.e. T1-T2c and PSA 20 and Gleason score \< 8) with the risk of pelvic node metastasis 15% as calculated by Roach's formula
* ECOG performance score 0-1
* Age ≥ 18
* History/physical examination within 2 weeks prior to registration
* Able to sign informed-consent

Exclusion Criteria:

* Patients with previous diagnosis of cancer other than prostate cancer and non-melanoma skin cancer.
* Evidence of distant metastases
* Regional lymph node involvement
* Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer
* Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
* Previous hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide) or LHRHantagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g.DES), or surgical castration (orchiectomy)
* Unstable angina and/or congestive heart failure requiring hospitalization, transmural myocardial infarction within the last 6 months, acute bacterial or fungal infection requiring intravenous antibiotics, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiringhospitalization or precluding study therapy at the time of registration
* Patients who have received prior chemotherapy.
Social Virtual-reality on Enhancing Social Interaction Skills in Children With Attention-deficit/Hyperactivity Disorder

The study targets children with diagnosed ADHD and aims to (1) develop a social virtual reality-based intervention, (2) investigate its effects on improving the social skills and executive functioning of inhibitions, emotional control and attention of the children compared to traditional social skills training and (3) evaluate the subjects acceptability and compliance with social VR training for enhancing social interaction skills. It is hypothesised that the social interaction skills of the participants in the social VR training group are likely to perform better than those in the traditional social skills training group. Participants in the waitlist control group will receive no change in social interaction skills compared with the two intervention groups.

The study will be a three-arm randomised controlled trial comparing the effects of social VR-based intervention with traditional social skills training on social skills and executive functioning of children with ADHD. Participants in the social VR intervention group and traditional social skill training group will receive 12 training sessions for 3 weeks (4 sessions per week), and participants in the waitlist control group will be asked to retain their usual lifestyles for 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

* aged between 6 and 12 years
* ethnic Chinese
* residing in Hong Kong
* having received a diagnosis of ADHD by Child Assessment Service in Hong Kong or via private practice
* stable on pharmacological and/or psychological treatment for ADHD 8 weeks before baseline (determined by health care professionals on the basis of medication data and behavioural observation)
* no initiation or change of pharmacological treatment for ADHD during the intervention period
* the ability to read Chinese, and speak and listen to Cantonese by the child and by at least one of their parents or legal guardian
* willing to provide informed consent by both participants and one of their parents or legal guardian

Exclusion Criteria:

* comorbid autism
* mental retardation
* an estimated IQ lower than 85 (using the Wechsler Intelligence Scale for Children - Fourth Edition (Hong Kong) (WISC-IV(HK)))
* autism spectrum disorder (previously diagnosed by health care professionals)
* comorbid acute psychiatric disorder (previously diagnosed by health care professionals)
* with a severe physical disability (e.g., blindness, deafness) or learning disability (e.g., dyslexia).
Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease

The purpose of this study is to determine whether giving extra arginine to patients with sickle cell disease seeking treatment for vaso-occlusive painful events (VOE) will decrease pain scores, decrease need for pain medications or decrease length of hospital stay or emergency department visit.

Arginine is a simple amino acid that is found in many foods and is part of the proteins in a human's body. Patients with sickle cell disease have low levels of the amino acid arginine and these low levels may be related to pain episodes. Increasing levels of arginine in the blood may lower pain and/or lower the amount of pain medication (like morphine) that is needed to treated them. It may also decrease the amount of time spent in the hospital.

Available data suggest that, L-arginine is a safe \& efficacious intervention with narcotic-sparing effects in pediatric SCD patients with VOE. The addition of a higher loading dose to the standard dose or use of a continuous infusion may provide additional clinical benefits by overcoming multiple mechanisms that limit global arginine bioavailability in SCD.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of sickle cell disease--Hemoglobin SS (Hb-SS) or Sβᴼ-thalassemia
* 7-21 years of age
* Weight \>= 25kg (55lbs)
* Pain requiring medical care in an acute care setting (emergency department (ED), hospital ward, day hospital, clinic) requiring parenteral opioids, not attributable to non-sickle cell causes.

Exclusion Criteria:

* Decision to discharge home from acute care setting.
* Diagnosis of sickle cell disease with any of the following types: hemoglobin SC disease (HbSC), hemoglobin beta thalassemia (Hb-Beta Thal), hemoglobin SD disease (HbSD), hemoglobin SE disease (HbSE), hemoglobin SO disease (HbSO), hemoglobin AS carrier (Hb AS)
* Hemoglobin less than 5 gm/dL
* Immediate Red cell transfusion anticipated
* Renal dysfunction: Creatinine \>1.0 or 2 x baseline
* Mental status or neurological changes
* Acute stroke or clinical concern for stroke
* Pregnancy
* Allergy to arginine
* Previous hospitalization \< 7 days
* Use of inhaled nitric oxide, sildenafil or arginine within the last 14 days
* Not an appropriate candidate in the investigator's judgement
The Origin of Infrapyloric Artery

Infrapyloric artery(IPA) is of great importance for gastric cancer patients. According to previous study, the origin of IPA varies greatly among different studies. This trial aims to tell the distribution of IPA origin in Chinese patients.

Infrapyloric artery(IPA) is of great importance for gastric cancer patients. In early gastric cancer patients, the pylorus-preserving gastrectomy requires the preserving of IPA. In advanced gastric cancer patients, the subgroup of No. 6 lymph node might be associated with IPA. In Japanese Gastric Cancer Association(JGCA) gastric cancer classification guidelines, the No. 6 lymph nodes is defined as lymph nodes along the first branch and proximal part of the right gastroepiploic artery(RGEA) down to the confluence of the right gastroepiploic vein and the anterior superior pancreatoduodenal vein. However,if IPA origins from the gastroduodenal artery(GDA) or anterior superior pancreatoduodenal artery(ASPDA), the lymph nodes along the IPA can not be grouped into the No. 6 lymph nodes. Thus, a new definition of No. 6 lymph nodes is needed on the basis of the origin of IPA.

Previous studies about IPA origin are few and the origin of IPA varies greatly among different studies.

Eligibility Criteria:
Inclusion Criteria:

* Patients with gastric cancer who needs to receive total or distal gastrectomy.
* Signed informed consent

Exclusion Criteria:

* IPA not dissected, photo-taken or video-recorded.
The Pancreatic Enzymes After Gastrectomy Trial

This trial evaluates the effects (e.g. on quality of life, weight) of NORTASE® compared to standard care of patients who have undergone gastrectomy.


Eligibility Criteria:
Inclusion Criteria:

1. Gastrectomy (total and partial)
2. Age 18 or older
3. Written informed consent

Exclusion Criteria:

1. Indication for pancreas enzyme therapy
2. Gastrectomy with palliative intention
3. UICC (Union for International Cancer Control) Stage IV gastric malignancy
4. Malnutrition of other aetiology
5. Life expectancy \< 12 months
6. Known lactose intolerance
7. Known hereditary galactose intolerance
8. Patients on alpha-glucosidase inhibitors (AGIs)
9. Acute pancreatitis
10. Acute episode of chronic pancreatitis
11. Known hypersensitivity to moulds (mould allergy) or any other ingredient of NORTASE®
12. Participation in competing interventional trials may be allowed under circumstances
13. Patients under legal supervision or guardianship
14. Patients who are dependent on the investigator or the medical staff of the trial team or the coordinating investigator or the sponsor
15. Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial
16. Pregnant or nursing women
17. Suspected lack of compliance
18. Patients who were already enrolled in the trial
Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels

In this study, we will evaluate the effectiveness of several doses of oral selenomethionine in raising biomarkers of selenium status including plasma selenium concentrations.

Results of studies with animal tumor models and human clinical trials suggest that the essential nutrient selenium can be anti-tumorigenic if consumed at levels greater than nutritional requirements. If it is possible to increase plasma selenium concentrations above 120 nanograms per milliliter with less than 200 micrograms of selenium daily, then it is possible that supplementation can be accomplished through the use of selenium-containing foods.

Eligibility Criteria:
Inclusion Criteria:

* able to swallow capsules
* body mass index less than 40

Exclusion Criteria:

* Pregnancy
* Chronic liver or kidney disease
* taking medication that might affect liver and/or kidney
* blood pressure 140/90 or higher
* already taking more than 50 micrograms of selenium
Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil

The purpose of this study is to evaluate the effect of oral administration of probiotic Lactobacillus rhamnosus GG in middle ear and adenoid tonsil.


Eligibility Criteria:
Inclusion Criteria:

* recurrent otitis media
* secretory otitis media
* chronic rhinitis
* recurrent sinusitis

Exclusion Criteria:

* significant illness